US Clinical Practice Guidelines Research Articles

Ultrasound better than mammography for women younger than 40 years with symptoms of breast cancer

Researchers have found that ultrasound is superior to mammography in evaluating women aged 30 years to 39 years with symptoms of breast cancer. They recommend that US clinical practice guidelines, which currently recommend mammography as the first evaluation in these women, should be reconsidered. The study, which to the authors' knowledge is the largest analysis to date comparing these 2 modalities for women in this age bracket, was conducted by researchers at the Seattle Cancer Care Alliance (SCCA) and the University of Washington and published in the American Journal of Roentgenology.1 The study was led by Constance Lehman, MD, PhD, director of radiology at SCCA. She and her colleagues identified all women aged 30 years to 39 years who presented for diagnostic breast imaging evaluation at SCCA between January 2002 and August 2006. In the 1208 cases they identified, sensitivity for ultrasound was 95.7%, compared with 60.9% for mammography. Ultrasound examinations found 22 cancers versus 14 detected by mammography. Dr. Lehman notes that mammography still is the best tool for screening women aged 40 years and older but that ultrasound is “the tool of choice” in evaluating symptomatic women aged younger than 40 years. The use of ultrasound in the under-40 age group is common practice in Europe, where it is recommended as the primary diagnostic imaging tool. Women in this group tend to have symptoms such as palpable lumps, localized pain, and tissue thickening. The risk of malignancy in these women is approximately 1.9%, Dr. Lehman says. The current guidelines for this age group, issued by the American College of Radiology, recommend mammography as the primary diagnostic tool. It's difficult to develop guidelines in this area due to the sparse amount of data available, says Dr. Lehman. She and her coauthors added that the use of adjunct mammography added little diagnostic value, but should still be considered when malignancy is highly suspected.

Medical therapies for hepatocellular carcinoma: a critical view of the evidence

The management of hepatocellular carcinoma (HCC) has substantially changed in the past few decades. Improvements in patient stratification (for example, using the Barcelona Clinic Liver Cancer staging system) and the introduction of novel therapies (such as sorafenib) have improved patient survival. Nevertheless, HCC remains the third most common cause of cancer-related deaths worldwide. Decision-making largely relies on evidence-based criteria, as depicted in the US and European clinical practice guidelines, which endorse five therapeutic recommendations: resection; transplantation; radiofrequency ablation; chemoembolization; and sorafenib. However, areas still exist in which uncertainty precludes a strong recommendation, such as the role of adjuvant therapies after resection, radioembolization with yttrium-90 or second-line therapies for advanced HCC. Many clinical trials that are currently ongoing aim to answer these questions. The first reported studies, however, failed to identify novel therapeutic alternatives (that is, sunitinib, erlotinib or brivanib). Moreover, genomic profiling has enabled patient classification on the basis of molecular parameters, and has facilitated the development of new effective drugs. However, no oncogene addiction loops have been identified so far, as has been the case with other cancers such as melanoma, lung or breast cancer. Efforts that focus on the implementation of personalized medicine approaches in HCC will probably dominate research in the next decade.

Citalopram versus other anti-depressive agents for depression.

Recent US and UK clinical practice guidelines recommend that second-generation antidepressants should be considered amongst the best first-line options when drug therapy is indicated for a depressive episode. Systematic reviews have already highlighted some differences in efficacy between second-generation antidepressants. Citalopram, one of the first selective serotonin reuptake inhibitors (SSRI) introduced in the market, is one of these antidepressant drugs that clinicians use for routine depression care. To assess the evidence for the efficacy, acceptability and tolerability of citalopram in comparison with tricyclics, heterocyclics, other SSRIs and other conventional and non-conventional antidepressants in the acute-phase treatment of major depression. We searched The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Central Register of Controlled Trials up to February 2012. No language restriction was applied. We contacted pharmaceutical companies and experts in this field for supplemental data. Randomised controlled trials allocating patients with major depression to citalopram versus any other antidepressants. Two reviewers independently extracted data. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy (the number of patients who responded or remitted), patient acceptability (the number of patients who failed to complete the study) and tolerability (side-effects). Thirty-seven trials compared citalopram with other antidepressants (such as tricyclics, heterocyclics, SSRIs and other antidepressants, either conventional ones, such as mirtazapine, venlafaxine and reboxetine, or non-conventional, like hypericum). Citalopram was shown to be significantly less effective than escitalopram in achieving acute response (odds ratio (OR) 1.47, 95% confidence interval (CI) 1.08 to 2.02), but more effective than paroxetine (OR 0.65, 95% CI 0.44 to 0.96) and reboxetine (OR 0.63, 95% CI 0.43 to 0.91). Significantly fewer patients allocated to citalopram withdrew from trials due to adverse events compared with patients allocated to tricyclics (OR 0.54, 95% CI 0.38 to 0.78) and fewer patients allocated to citalopram reported at least one side effect than reboxetine or venlafaxine (OR 0.64, 95% CI 0.42 to 0.97 and OR 0.46, 95% CI 0.24 to 0.88, respectively). Some statistically significant differences between citalopram and other antidepressants for the acute phase treatment of major depression were found in terms of efficacy, tolerability and acceptability. Citalopram was more efficacious than paroxetine and reboxetine and more acceptable than tricyclics, reboxetine and venlafaxine, however, it seemed to be less efficacious than escitalopram. As with most systematic reviews in psychopharmacology, the potential for overestimation of treatment effect due to sponsorship bias and publication bias should be borne in mind when interpreting review findings. Economic analyses were not reported in the included studies, however, cost effectiveness information is needed in the field of antidepressant trials.

Barriers to translating EU and US CVD guidelines into practice in China

With the increasing globalization of clinical research and evidence, clinical-practice guidelines (CPGs) developed by the European Union (EU) and the USA are also becoming increasingly international. However, these CPGs can encounter barriers to their practical application. In this Perspectives article, we analyze the main obstacles to the application of EU and US CPGs for cardiovascular diseases from the unique perspective of China, and highlight some potential problems in the globalization of CPGs. Currently, China and other countries with limited independent evidence for CPG development must localize or adapt the CPGs developed by the EU, the USA, or international medical organizations, with systematic consideration of cost-effectiveness and alternative strategies on the basis of the available evidence from the native populations. At the same time, comprehensive capabilities to collect and review clinical evidence to produce population-specific CPGs should be developed.

Integrating Tobacco Treatment Into Mental Health Settings

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Results from the International Cataract Surgery Outcomes Study

Results from the International Cataract Surgery Outcomes Study

Evolution of Clinical Practice Guidelines: Evidence Supporting Expanded Use of Medicines

Previous studies have shown that the primary factor underlying increased spending on pharmaceuticals has been the rising utilization of medications, rather than increases in unit drug price. This study examined the evolution of clinical practice guidelines to assess possible reasons for the rising drug volume. Clinical practice guidelines from 1970 to the present were reviewed for the six most prevalent treatable medical conditions/risk factors listed as priority areas by the Institute of Medicine. We searched the National Guidelines Clearinghouse, PubMed and Medline databases, and Web sites of relevant national organizations for US clinical practice guidelines published through January 2005. Information pertaining to the therapeutic regimen (eg, the frequency and duration of recommended treatment, when treatment should be initiated, the patient population for whom the guideline was intended) was abstracted and entered into evidence tables. Changes in guidelines were distributed across three themes that recommended evidence-based increases in medication use, including: (1) changes in the size of the treatable population; (2) changes in the number and type of recommended pharmaceutical therapeutic options, including movement from monotherapy to combination therapy, treatment of comorbidities, and use of newer types of medicines; and (3) changes in the therapeutic regimen, including a shift from episodic care to preventive and chronic care. Many of these changes point to an important, but not often noticed, addition of secondary prevention of disease effects to the objectives of medical care. These trends are likely to continue with important economic, clinical, and policy ramifications.

Implementation of clinical practice guidelines for upper respiratory infection in Thailand

Objective: To determine the effectiveness of implementing clinical practice guidelines (CPG) on antibiotic prescribing for adults with upper respiratory infection (URI) in terms of the changes in diagnosis and prevalence and patterns of antibiotic prescribing. Methods: The CPG on antibiotic treatments for adults with URI published in the Annals of Internal Medicine 2001; 134: 479–52 were considered to be of high quality and applicable to Thai patients. A one-page clinical practice protocol in Thai was prepared from these guidelines. The dissemination strategy provided CPG and clinical practice protocol to 12 general practitioners in Siriraj Social Security Program in Bangkok during interactive educational meetings in April 2001. The information on 837 URI episodes from January to March (pre-CPG phase) and 774 URI episodes during May to July (post-CPG phase) were extracted from the patients’ medical records. Telephone follow up for patients without antibiotics in the post-CPG phase was also attempted. Results: Changes in the post-CPG period included (1) The diagnosis of URI was used less frequently whereas the diagnosis of common cold, pharyngitis and acute bronchitis were used more frequently ( p<0.05). (2) Antibiotic use fell from 74.0% to 44.1% ( p<0.001). (3) Fewer prescriptions for amoxicillin, roxithromycin, co-trimoxazole and doxycycline, and more for penicillin V ( p<0.05). Patients ( n=97) not given antibiotics reported recovery in 83.5% and improvement in 16.5%. Conclusion: A locally prepared clinical practice protocol based on US CPG for appropriate antibiotic use for URI combined with interactive educational meetings is effective in promoting appropriate diagnosis and antibiotic therapy in an ambulatory setting in a tertiary care hospital in Thailand.

Clinical efficacy of bupropion in the management of smoking cessation.

Nicotine addiction is a chronic relapsing condition that can be difficult to treat. Until recently, pharmacological options for the treatment of tobacco dependence were primarily limited to nicotine replacement therapy (NRT). Sustained-release bupropion (bupropion SR) is the first non-nicotine pharmacological treatment approved for smoking cessation. Bupropion SR is recommended for first-line pharmacotherapy alongside NRT in the updated US Clinical Practice Guidelines and the UK Health Education Authority Guidelines. The UK National Institute of Clinical Excellence recommends NRT and bupropion SR for smokers who have expressed a desire to quit smoking. This review presents evidence that bupropion SR is an effective first-line therapy for smoking cessation in a wide range of patient populations. It is associated with significantly higher smoking cessation rates compared with placebo in patients with or without a history of prior bupropion SR or NRT use, and its effect is independent of gender. Bupropion SR treatment is effective in the prevention of relapse to smoking in those patients who have successfully quit, and re-treatment is effective in smokers who recommence smoking after a previous course of bupropion SR. Bupropion SR treatment relieves the symptoms of craving and nicotine withdrawal, and attenuates the weight gain that often occurs after smoking cessation. Data collected from motivational support programmes and employer-based studies provide strong evidence of the effectiveness of bupropion SR as an aid to smoking cessation in 'real life' situations, and confirm the efficacy seen in clinical trials.