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Presenting risks in different ways affects perceptions

Clinical question Do patients make decisions differently depending on how benefits of treatment are presented?

Bottom line Using hypothetical scenarios of taking drugs to prevent either heart attack or hip fracture, patients were more likely to consent to treatment if the information was couched in terms of prevention of disease (using number needed to treat). They were less likely to consent to treatment if the value of the drug was presented as a postponement of disease (using disease-free interval). In other words, presenting the same information in different ways drastically affected patients’ perceptions. Unfortunately, the study doesn’t tell us which therapy is the right one to use; it just shows us that patients will use preventive therapy more often if numbers needed to treat are used to present the benefit. (Level of evidence = 1b)

Synopsis To determine how patients will respond to different types of risk estimates, the authors developed two hypothetical scenarios. One scenario presented the effectiveness of drug therapy in patients at risk for heart attack to 1,754 people at high or low cardiovascular risk; the second scenario presented data on hip fracture prevention to 1,000 people taking part in a regional health survey. The patients were randomly assigned to receive information in 1 of 3 ways: (1) prevention, using number needed to treat (eg, 13 patients have to take a drug for 5 years to prevent a heart attack); or postponement using either (2) a short, average disease-free interval (eg, patients will live approximately 2 months longer) or (3) a longer survival for some patients (eg, 1 in 4 patients who take the drug for 5 years will live approximately 8 months longer). Response rates to this mailed survey were 80% or better in both groups. Patients were more likely to consent to therapy if given the information as a number needed to treat. The least likely to consent were patients given the average disease-free interval. For the heart attack scenario, 93% of patients presented with number needed to treat data consented, 82% of patients who were presented with the outcome of a large postponement for all patients consented, and 69% of patients who were presented with a short postponement for all patients consented. In the hip fracture scenario, the consent rates were 74%, 56%, and 34%, respectively.

Halvorsen PA, Selmer R, Kristiansen IS. Different ways to describe the benefits of risk-reducing treatments: a randomized trial. Ann Intern Med. 2007;146(12):848-856.

Observation is an option for prolonged sciatica

Clinical question Is it safe to delay surgery in patients with prolonged sciatica?

Bottom line Patients with sciatica for 6 weeks or more and who do not have progressive or serious neurologic deficits should be offered the option of immediate surgery versus conservative treatment with pain medications. Some patients may prefer to have surgery and a shorter duration of pain, whereas others may prefer to put up with a longer duration of pain to avoid surgery. (Level of evidence = 1b–)

Synopsis We advise our patients with sciatica that as long as they do not have evidence of progressive or serious neurologic deficits they should wait 6 weeks before considering surgery. Should they wait longer? These Dutch researchers randomized (with allocation properly concealed) 283 adults with severe sciatica of 6 to 12 weeks’ duration to either immediate surgery or conservative therapy focused on pain control and improving mobility. Patients in the surgery group underwent microdiskectomy within an average of 2 weeks, whereas those in the conservative therapy group received pain medications from their primary care physicians, encouragement about the condition’s favorable prognosis, and physical therapy if indicated. If patients had progressive neurologic deficits or weren’t improving after 6 months, the opportunity to cross over into the surgery group was offered. Groups were balanced at randomization, and only 2 or 3 patients in each group were lost to follow-up. Patients in the surgery group felt better faster as measured by scores for leg pain, back pain, and disability. However, after 1 year their outcomes on these measures were identical to those in the conservative treatment group. Surgical outcomes were good, with only 1.6% having a complication (dural tear or hematoma). On average, patients in the conservative therapy group took 8 weeks longer to recover (4 weeks vs 12 weeks).

Peul WC, van Houwelingen HC, van den Hout WB, et al; Leiden-The Hague Spine Intervention Prognostic Study Group. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med. 2007;356(22):2245-2256.

Folic acid does not reduce risk of colorectal adenomas

Clinical question Does folic acid supplementation reduce the risk of colorectal cancer in adults?

Bottom line Folic acid supplementation (1 mg/d) does not reduce the risk of colorectal adenoma. Interestingly, daily folic acid actually increased the risk of advanced colorectal lesions, suggesting supplementation might actually increase the risk of cancer. (Level of evidence = 1b)

Synopsis Recent evidence suggests that folic acid may have an antineoplastic effect in the large intestine. These investigators enrolled 1,021 adults, aged 21 to 80 years, with a recent history of colorectal adenoma without known colon cancer. Eligible subjects randomly received, in double-blind fashion with concealed allocation assignment, aspirin plus 1 mg folic acid per day, aspirin alone, 1 mg/d folic acid alone, or placebo. Findings associated with aspirin were reported separately (N Eng J Med. 2003;348[10]:891-899). Individuals assessing outcomes remained masked to treatment group assignment. Follow-up occurred for 91% of subjects for up to 8 years. Using intention-to-treat analysis, there was no significant difference at 3 years or at 6 to 8 years in the incidence of colorectal adenoma detected by colonoscopy between the group taking folic acid and those taking placebo (44.1% vs 42.4%; 41.9% vs 37.2%, respectively). The incidence of at least one advanced colorectal lesion was, however, significantly higher among patients assigned to the folic acid supplementation group (11.6% vs 6.9%).

Cole BF, Baron JA, Sandler RS, et al; Polyp Prevention Study Group. Folic acid for the prevention of colorectal adenomas: a randomized clinical trial. JAMA. 2007;297(21):2351-2359.

Cardiac resynchronization therapy is effective for HF

Clinical question In addition to optimal pharmacotherapy, is cardiac resynchronization therapy incrementally safe and effective for adults with advanced heart failure (HF) due to left ventricular systolic dysfunction?

Bottom line Cardiac resynchronization therapy (CRT) with or without implantable cardioverter-defibrillator devices (ICDs) reduces overall morbidity and mortality in adults with advanced left ventricular systolic dysfunction (New York Heart Association [NYHA] class 3 or 4) and prolonged QRS duration. It remains uncertain whether there is any incremental benefit to combined CRT-ICD over CRT alone. (Level of evidence = 1a)

Synopsis The investigators thoroughly searched multiple databases including MEDLINE, the Cochrane Registry, EMBASE, Science Citation Index, abstracts of annual meetings, reference lists of pertinent articles, and data from device manufacturers for studies evaluating the safety and effectiveness of CRT with or without ICDs in adults with advanced left ventricular systolic dysfunction. Study selection and quality assessment occurred independently by multiple investigators. From an initial 7,110 citations, the authors identified 14 randomized controlled trials (RCTs) (including 4,420 patients) evaluating CRT effectiveness. In addition, findings from other studies were pooled to assess success rates and safety outcomes. In all trials, eligible patients had significant left ventricular dysfunction (mean ejection volume = 21% to 30%), prolonged QRS duration (155 to 209 ms), and symptomatic HF (91%, NYHA class 3 or 4; 9%, class 2). All patients received optimal pharmacotherapy. After pooling data from the RCTs, patients receiving CRT and pharmacotherapy compared with those receiving pharmacotherapy alone significantly improved symptomatically by at least 1 NYHA class (59% vs 37%, respectively). Other significantly improved outcomes for patients receiving CRT included reduced hospitalization rates (19% vs 27%) and reduced all-cause mortality (13.2% vs 15.5%). No significant heterogeneity in results among the various trials was detected. Implant success rate for eligible patients was 93%, and 0.3% of patients died during the procedure. Overall, evidence was insufficient to demonstrate any significant benefit to CRT alone versus CRT plus ICDs.

McAlister FA, Ezekowitz J, Hooton N, et al. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007;297(22):2502-2514.

Antiplatelet agents prevent preeclampsia

Clinical question Do antiplatelet agents prevent preeclampsia in high-risk women?

Bottom line In women at increased risk of developing preeclampsia, antiplatelet therapy (primarily aspirin) modestly decreases the rate of developing preeclampsia, the rate of delivering before 34 weeks, and the overall rate of poor outcomes, without increasing the risk of bleeding complications. (Level of evidence = 1a)

Synopsis The authors searched multiple databases to identify randomized controlled trials of antiplatelet agents (aspirin or dipyridamole) given to women at risk of developing preeclampsia. Additionally, they attempted to locate unpublished studies by asking experts in the field. At least two researchers assessed potentially eligible studies for inclusion and resolved any discrepancies by discussion. Women were considered to be at risk of developing preeclampsia if they had gestational hypertension, intrauterine growth retardation, a pre-existing medical condition (eg, renal disease, diabetes, immune disorder, chronic hypertension), or obstetric risk factors early in their current pregnancy (eg, being a primigravida or having a multiple pregnancy). The researchers identified 38,026 patients in 63 eligible trials, but were only able to obtain data for 34,288 (90% of the potential pool) from 36 trials. In this paper, they report only on the 32,217 women recruited for primary prevention. Approximately 90% of the included women had at least one risk factor for preeclampsia. The authors used intention-to-treat analysis to assess the outcomes in the mothers and the babies. Twenty-seven studies accounted for 98% of the women. In those studies, the active treatment group took aspirin (50 to 150 mg/d). In the remainder of the studies, the women in the active treatment group took aspirin plus dipyridamole (Persantine), dipyridamole alone, heparin, or ozagrel. Antiplatelet therapy modestly reduced the rate of developing preeclampsia (7.9% vs 8.7%). Additionally there were modest benefits in preventing delivery before 34 weeks’ gestation (6.5% vs 7.2%) and pregnancies with serious adverse outcomes (preeclampsia, premature delivery, fetal/neonatal death, small-for-gestational-age infants, or maternal death; 17.9% vs 19.7%). Although there were slight decreases in fetal/neonatal death (3.1% vs 3.4%) and small-for-gestational-age infants (5.3% vs 5.9%), these were not statistically significant. Finally, there was no significant difference in bleeding complications.

Askie LM, Duley L, Henderson-Smart DJ, Stewart LA; PARIS Collaborative Group. Antiplatelet agents for prevention of pre-eclampsia: a meta-analysis of individual patient data. Lancet. 2007;369(9575):1791-1798.

Combination therapy improves COPD symptoms

Clinical question Does the addition of either salmeterol (Serevent) or fluticasone-salmeterol (Advair) to tiotropium (Spiriva) improve clinical outcomes in chronic obstructive pulmonary disease (COPD)?

Bottom line The addition of fluticasone-salmeterol to a regimen that includes tiotropium reduces hospitalizations and improves quality-of-life symptom scores, but does not decrease the frequency of chronic COPD exacerbations. The addition of salmeterol to tiotropium has no effect on hospitalizations and no clinically significant effect on other quality-of-life measures. (Level of evidence = 1b)

Synopsis The authors randomly assigned 449 patients with moderate to severe COPD from 27 Canadian sites to receive 1 of 3 combinations: tiotropium/placebo, tiotropium/salmeterol, or tiotropium/fluticasone-salmeterol. All patients had COPD with at least one exacerbation in the previous year that required additional treatment. Additional inclusion criteria included age older than 35 years, at least a 10-pack/y smoking history, and documented chronic airflow obstruction as measured by pulmonary function tests. The dosages used were: tiotropium 18 mcg daily, salmeterol 2 puffs (25 mcg/puff) twice a day, fluticasone-salmeterol 2 puffs (250/25 mcg/puff) twice a day. The study period was 52 weeks. Using intention-to-treat analysis, combination treatment did not decrease the proportion of patients who experienced a COPD exacerbation and did not decrease the overall number of exacerbations. Dyspnea scores improved in all groups, but were not statistically different when compared with the overall group. However, the addition of fluticasone-salmeterol to tiotropium decreased the overall rate of hospitalizations and COPD-specific hospitalizations by almost 50% (incidence rate ratio = 0.53; P = .01). The fluticasone-salmeterol intervention group also showed a statistically and clinically significant improvement in quality of life scores over placebo as measured by the St. George’s Respiratory Questionnaire (P = .01). The two intervention arms were compared with tiotropium plus placebo. The placebo group had a high dropout rate compared with the fluticasone-salmeterol group (47% vs 26%), which could have diluted true differences between groups in an intention-to-treat analysis. However, analyzing only patients who continued treatment did not show any statistically significant difference on the outcomes measured.

Aaron SD, Vandemheen KL, Fergusson D, et al; Canadian Thoracic Society/Canadian Respiratory Clinical Research Consortium. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2007;146(8):545-555.

Levels of evidence in Bottom line are explained at www.infopoems.com/levels.html.