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Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults: A Guidance Statement From the American College of Physicians

Author/s: 
Qaseem, A., Crandall, C.J., Mustafa, R.A., Hicks, L.A., Wilt, T.J., Clinical Guidelines Committee of the American College of Physicians

DESCRIPTION:

The purpose of this guidance statement is to guide clinicians on colorectal cancer screening in average-risk adults.

METHODS:

This guidance statement is derived from a critical appraisal of guidelines on screening for colorectal cancer in average-risk adults and the evidence presented in these guidelines. National guidelines published in English between 1 June 2014 and 28 May 2018 in the National Guideline Clearinghouse or Guidelines International Network library were included. The authors also included 3 guidelines commonly used in clinical practice. Web sites were searched for guideline updates in December 2018. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the quality of guidelines.

TARGET AUDIENCE AND PATIENT POPULATION:

The target audience is all clinicians, and the target patient population is adults at average risk for colorectal cancer.

GUIDANCE STATEMENT 1:

Clinicians should screen for colorectal cancer in average-risk adults between the ages of 50 and 75 years.

GUIDANCE STATEMENT 2:

Clinicians should select the colorectal cancer screening test with the patient on the basis of a discussion of benefits, harms, costs, availability, frequency, and patient preferences. Suggested screening tests and intervals are fecal immunochemical testing or high-sensitivity guaiac-based fecal occult blood testing every 2 years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years plus fecal immunochemical testing every 2 years.

GUIDANCE STATEMENT 3:

Clinicians should discontinue screening for colorectal cancer in average-risk adults older than 75 years or in adults with a life expectancy of 10 years or less.

Rivaroxaban Versus Vitamin K Antagonist in Antiphospholipid Syndrome: A Randomized Noninferiority Trial

Author/s: 
Ordi-Ros, J, Sáez-Comet, L., Pérez-Conesa, M., Vidal, X., Riera-Mestre, A., Castro-Salomó, A., Cuquet-Pedragosa, J., Ortiz-Santamaria, V., Mauri-Plana, M., Solé, C., Cortés-Hernández, J.

BACKGROUND:

The potential role of new oral anticoagulants in antiphospholipid antibody syndrome (APS) remains uncertain.

OBJECTIVE:

To determine whether rivaroxaban is noninferior to dose-adjusted vitamin K antagonists (VKAs) for thrombotic APS.

DESIGN:

3-year, open-label, randomized noninferiority trial. (EU Clinical Trials Register: EUDRA [European Union Drug Regulatory Authorities] code 2010-019764-36).

SETTING:

6 university hospitals in Spain.

PARTICIPANTS:

190 adults (aged 18 to 75 years) with thrombotic APS.

INTERVENTION:

Rivaroxaban (20 mg/d or 15 mg/d, according to renal function) versus dose-adjusted VKAs (target international normalized ratio, 2.0 to 3.0, or 3.1 to 4.0 in patients with a history of recurrent thrombosis).

MEASUREMENTS:

The primary efficacy outcome was the proportion of patients with new thrombotic events; the primary safety outcome was major bleeding. The prespecified noninferiority margin for risk ratio (RR) was 1.40. Secondary outcomes included time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding.

RESULTS:

After 3 years of follow-up, recurrent thrombosis occurred in 11 patients (11.6%) in the rivaroxaban group and 6 (6.3%) in the VKA group (RR in the rivaroxaban group, 1.83 [95% CI, 0.71 to 4.76]). Stroke occurred more commonly in patients receiving rivaroxaban (9 events) than in those receiving VKAs (0 events) (corrected RR, 19.00 [CI, 1.12 to 321.9]). Major bleeding occurred in 6 patients (6.3%) in the rivaroxaban group and 7 (7.4%) in the VKA group (RR, 0.86 [CI, 0.30 to 2.46]). Post hoc analysis suggested an increased risk for recurrent thrombosis in rivaroxaban-treated patients with previous arterial thrombosis, livedo racemosa, or APS-related cardiac valvular disease.

LIMITATION:

Anticoagulation intensity was not measured in the rivaroxaban group.

CONCLUSION:

Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.

PRIMARY FUNDING SOURCE:

Bayer Hispania.

Testing of a Tool for Prostate Cancer Screening Discussions in Primary Care

Author/s: 
Misra-Hebert, AD, Hom, G, Klein, EA, Bauman, JA, Gupta, N, Ji, X, Stephenson, AJ, Jones, JS, Kattan, Kattan, MW

The link to the study is available here: https://www.ncbi.nlm.nih.gov/pubmed/30003062

BACKGROUND:

As prostate cancer (PCa) screening decisions often occur in outpatient primary care, a brief tool to help the PCa screening conversation in busy clinic settings is needed.

METHODS:

A previously created 9-item tool to aid PCa screening discussions was tested in five diverse primary care clinics. Fifteen providers were recruited to use the tool for 4 weeks, and the tool was revised based upon feedback. The providers then used the tool with a convenience sample of patients during routine clinic visits. Pre- and post-visit surveys were administered to assess patients' knowledge of the option to be screened for PCa and of specific factors to consider in the decision. McNemar's and Stuart-Maxwell tests were used to compare pre-and post-survey responses.

RESULTS:

14 of 15 providers completed feedback surveys and had positive responses to the tool. All 15 providers then tested the tool on 95 men aged 40-69 at the five clinics with 2-10 patients each. The proportion of patients who strongly agreed that they had the option to choose to screen for PCa increased from 57 to 72% (p = 0.018) from the pre- to post-survey, that there are factors in the personal or family history that may affect PCa risk from 34 to 47% (p = 0.012), and that their opinions about possible side effects of treatment for PCa should be considered in the decision from 47 to 61% (p = 0.009).

CONCLUSION:

A brief conversation tool for the PCa screening discussion was well received in busy primary-care settings and improved patients' knowledge about the screening decision.

Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is a disorder characterized by hyperandrogenism, ovulatory dysfunction, and
polycystic ovaries. Its etiology remains unknown, and treatment is largely symptom based and empirical. PCOS has the
potential to cause substantial metabolic sequelae, including an increased risk of diabetes and cardiovascular disease,
and these factors should be considered when determining long-term treatment. The purpose of this document is to
examine the best available evidence for the diagnosis and clinical management of PCOS.

Preventing Firearm-Related Death and Injury

Author/s: 
Pallin, R., Spitzer, S.A., Ranney, M.L., Betz, M.E., Wintemute, G.J.

Deaths and injuries from firearms are significant public health problems, and clinicians are in a unique position to identify risk among their patients and discuss the importance of safe firearm practices. Although clinicians may be ill-prepared to engage in such discussions, an adequate body of evidence is available for support, and patients are generally receptive to this type of discussion with their physician. Here, we provide an overview of existing research and recommended strategies for counseling and intervention to reduce firearm-related death and injury.

Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation

Author/s: 
Lindson, Nicola, Chepkin, Samantha C., Ye, Weiyu, Fanshawe, Thomas R., Bullen, Chris, Hartmann-Boyce, Jamie

BACKGROUND:

Nicotine replacement therapy (NRT) aims to replace nicotine from cigarettes to ease the transition from cigarette smoking to abstinence. It works by reducing the intensity of craving and withdrawal symptoms. Although there is clear evidence that NRT used after smoking cessation is effective, it is unclear whether higher doses, longer durations of treatment, or using NRT before cessation add to its effectiveness.

OBJECTIVES:

To determine the effectiveness and safety of different forms, deliveries, doses, durations and schedules of NRT, for achieving long-term smoking cessation, compared to one another.

SEARCH METHODS:

We searched the Cochrane Tobacco Addiction Group trials register, and trial registries for papers mentioning NRT in the title, abstract or keywords. Date of most recent search: April 2018.

SELECTION CRITERIA:

Randomized trials in people motivated to quit, comparing one type of NRT use with another. We excluded trials that did not assess cessation as an outcome, with follow-up less than six months, and with additional intervention components not matched between arms. Trials comparing NRT to control, and trials comparing NRT to other pharmacotherapies, are covered elsewhere.

DATA COLLECTION AND ANALYSIS:

We followed standard Cochrane methods. Smokingabstinence was measured after at least six months, using the most rigorous definition available. We extracted data on cardiac adverse events (AEs), serious adverse events (SAEs), and study withdrawals due to treatment. We calculated the risk ratio (RR) and the 95% confidence interval (CI) for each outcome for each study, where possible. We grouped eligible studies according to the type of comparison. We carried out meta-analyses where appropriate, using a Mantel-Haenszel fixed-effect model.

MAIN RESULTS:

We identified 63 trials with 41,509 participants. Most recruited adults either from the community or from healthcare clinics. People enrolled in the studies typically smoked at least 15 cigarettes a day. We judged 24 of the 63 studies to be at high risk of bias, but restricting the analysis only to those studies at low or unclear risk of bias did not significantly alter results, apart from in the case of the preloading comparison. There is high-certainty evidence that combination NRT (fast-acting form + patch) results in higher long-term quit rates than single form (RR 1.25, 95% CI 1.15 to 1.36, 14 studies, 11,356 participants; I2 = 4%). Moderate-certainty evidence, limited by imprecision, indicates that 42/44 mg are as effective as 21/22 mg (24-hour) patches (RR 1.09, 95% CI 0.93 to 1.29, 5 studies, 1655 participants; I2 = 38%), and that 21 mg are more effective than 14 mg (24-hour) patches (RR 1.48, 95% CI 1.06 to 2.08, 1 study, 537 participants). Moderate-certainty evidence (again limited by imprecision) also suggests a benefit of 25 mg over 15 mg (16-hour) patches, but the lower limit of the CI encompassed no difference (RR 1.19, 95% CI 1.00 to 1.41, 3 studies, 3446 participants; I2 = 0%). Five studies comparing 4 mg gum to 2 mg gum found a benefit of the higher dose (RR 1.43, 95% CI 1.12 to 1.83, 5 studies, 856 participants; I2 = 63%); however, results of a subgroup analysis suggest that only smokers who are highly dependent may benefit. Nine studies tested the effect of using NRT prior to quit day (preloading) in comparison to using it from quit day onward; there was moderate-certainty evidence, limited by risk of bias, of a favourable effect of preloading on abstinence (RR 1.25, 95% CI 1.08 to 1.44, 9 studies, 4395 participants; I2 = 0%). High-certainty evidence from eight studies suggests that using either a form of fast-acting NRT or a nicotine patch results in similar long-term quit rates (RR 0.90, 95% CI 0.77 to 1.05, 8 studies, 3319 participants; I2 = 0%). We found no evidence of an effect of duration of nicotine patch use (low-certainty evidence); 16-hour versus 24-hour daily patch use; duration of combination NRT use (low- and very low-certainty evidence); tapering of patch dose versus abrupt patch cessation; fast-acting NRT type (very low-certainty evidence); duration of nicotine gum use; ad lib versus fixed dosing of fast-acting NRT; free versus purchased NRT; length of provision of free NRT; ceasing versus continuing patch use on lapse; and participant- versus clinician-selected NRT. However, in most cases these findings are based on very low- or low-certainty evidence, and are the findings from single studies.AEs, SAEs and withdrawals due to treatment were all measured variably and infrequently across studies, resulting in low- or very low-certainty evidence for all comparisons. Most comparisons found no evidence of an effect on cardiac AEs, SAEs or withdrawals. Rates of these were low overall. Significantly more withdrawals due to treatment were reported in participants using nasal spray in comparison to patch in one trial (RR 3.47, 95% CI 1.15 to 10.46, 922 participants; very low certainty) and in participants using 42/44 mg patches in comparison to 21/22 mg patches across two trials (RR 4.99, 95% CI 1.60 to 15.50, 2 studies, 544 participants; I2 = 0%; low certainty).

AUTHORS' CONCLUSIONS:

There is high-certainty evidence that using combination NRT versus single-form NRT, and 4 mg versus 2 mg nicotine gum, can increase the chances of successfully stopping smoking. For patch dose comparisons, evidence was of moderate certainty, due to imprecision. Twenty-one mg patches resulted in higher quit rates than 14 mg (24-hour) patches, and using 25 mg patches resulted in higher quit rates than using 15 mg (16-hour) patches, although in the latter case the CI included one. There was no clear evidence of superiority for 42/44 mg over 21/22 mg (24-hour) patches. Using a fast-acting form of NRT, such as gum or lozenge, resulted in similar quit rates to nicotine patches. There is moderate-certainty evidence that using NRT prior to quitting may improve quit rates versus using it from quit date only; however, further research is needed to ensure the robustness of this finding. Evidence for the comparative safety and tolerability of different types of NRT use is of low and very low certainty. New studies should ensure that AEs, SAEs and withdrawals due to treatment are both measured and reported.

Screening for Breast Cancer in Average-Risk Women: A Guidance Statement From the American College of Physicians

Author/s: 
Qaseem, Amir, Lin, Jennifer S., Mustafa, Reem A., Horwitch, Carrie A., Wilt, Timothy J., Clinical Guidelines Committee of the American College of Physicians

Description:

The purpose of this guidance statement is to provide advice to clinicians on breast cancer screening in average-risk women based on a review of existing guidelines and the evidence they include.

Methods:

This guidance statement is derived from an appraisal of selected guidelines from around the world that address breast cancer screening, as well as their included evidence. All national guidelines published in English between 1 January 2013 and 15 November 2017 in the National Guideline Clearinghouse or Guidelines International Network library were included. In addition, the authors selected other guidelines commonly used in clinical practice. Web sites associated with all selected guidelines were checked for updates on 10 December 2018. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the quality of guidelines.

Target Audience and Patient Population:

The target audience is all clinicians, and the target patient population is all asymptomatic women with average risk for breast cancer.

Guidance Statement 1:

In average-risk women aged 40 to 49 years, clinicians should discuss whether to screen for breast cancer with mammography before age 50 years. Discussion should include the potential benefits and harms and a woman's preferences. The potential harms outweigh the benefits in most women aged 40 to 49 years.

Guidance Statement 2:

In average-risk women aged 50 to 74 years, clinicians should offer screening for breast cancer with biennial mammography.

Guidance Statement 3:

In average-risk women aged 75 years or older or in women with a life expectancy of 10 years or less, clinicians should discontinue screening for breast cancer.

Guidance Statement 4:

In average-risk women of all ages, clinicians should not use clinical breast examination to screen for breast cancer.

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