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Importance Little is known regarding whether Institute of Medicine (IOM) standards for managing conflicts of interest (COI) have been met in the development of recent important clinical guidelines. Objective To evaluate adherence to the IOM standards for limits on commercial COI, guideline development, and evaluation of evidence by the 2013 American College of Cardiology and American Heart Association cholesterol management guideline and the 2014 American Association for the Study of Liver Diseases and Infectious Diseases Society of America hepatitis C virus management guideline. Design, Setting, and Participants This study was a retrospective document review of the June 2014 print version of the cholesterol guideline and the final September 2015 print version of the hepatitis C virus guideline. Each guideline was assessed for adherence to the IOM standards for commercial COI published in the 2011 special report Clinical Practice Guidelines We Can Trust . Main Outcomes and Measures The IOM standards call for no commercial COI among guideline committee chairs and cochairs and for less than 50% of committee members to have commercial COI. Guideline and contemporaneous article disclosure statements were used to evaluate adherence to these standards. Each guideline was also reviewed for adherence to other IOM standards for guideline development and evidence review. Results Among the 16 cholesterol guideline committee members, 7 (44%) disclosed commercial COI, all 7 reported industry-sponsored research, and 6 (38%) also reported consultancy. Of 3 guideline chairs and cochairs, 1 (33%) disclosed commercial COI. Review of contemporaneous articles identified additional commercial COI. Among the 29 hepatitis C virus guideline committee members, 21 (72%) reported commercial COI. Eighteen (62%) disclosed industry-sponsored research, 10 (34%) served on advisory boards, 5 (17%) served on data safety monitoring boards, 3 (10%) were consultants, and 3 (10%) reported other honoraria. Of 6 guideline cochairs, 4 (67%) disclosed commercial COI. All 4 disclosed additional COI in other publications that were not listed in their guideline disclosures. Contemporaneous literature review revealed an additional cochair with commercial COI. Of the 9 IOM guideline development and evidence standards, the cholesterol guideline met 5 (56%), and the hepatitis C virus guideline met them all. Conclusions and Relevance Neither the cholesterol guideline nor the hepatitis C virus guideline fully met the IOM standards for commercial COI management, and discordance between committee leader guideline disclosures and those in contemporaneous articles was common. Adherence to additional IOM standards for guideline development and evidence review was mixed. Adoption of consistent COI frameworks across specialty societies may help ensure that clinical guidelines are developed in a transparent and trustworthy manner.

Source of Review The Institute for Clinical and Economic Review developed an evidence report, including a systematic reviewof the literature, a costeffectiveness model, and a budget impact assessment, to support a public meeting of the New EnglandComparativeEffectiveness Public Advisory Council (CEPAC) on October 27, 2015.1 The report evaluates the comparative clinical effectiveness and comparative value of proprotein convertase subtilisin/ kexin type9 (PCSK9) inhibitors as a class for the treatmentof adults with familial hypercholesterolemiaor cardiovascular disease (CVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C) levels.

The only def initive method for diagnosing Alzheimer disease (AD) has been a combination of clinical diagnosis and findings of pathognomonic amyloid-β (Aβ) plaques and neurofibrillary tangles of hyperphosphorylated forms of the protein tau on examination of the brain at autopsy. In April 2012, however, the Food and Drug Administration approved Aβ positron emission tomography (PET) with florbetapir F-18 (Amyvid; Lilly USA) to identify areas of accumulation of Aβ plaques.1 The label for florbetapir F-18 states that a negative scan result indicates a reduced likelihood that any cognitive impairment is due to AD, but that a positive scan result does not establish a diagnosis of Alzheimer or any other neurodegenerative disease because excess Aβ is also found in adults with normal cognition. Although this review assessed the evidence for all purported diagnostic tests for AD, it focused on the evidence related to Aβ PET scans.

Importance Despite increasing concerns regarding the cost of health care, the consideration of costs in the development of clinical guidance documents by physician specialty societies has received little analysis. Objective To evaluate the approach to consideration of cost in publicly available clinical guidance documents and methodological statements produced between 2008 and 2012 by the 30 largest US physician specialty societies. Design Qualitative document review. Main Outcomes and Measures Whether costs are considered in clinical guidance development, mechanism of cost consideration, and the way that cost issues were used in support of specific clinical practice recommendations. Results Methodological statements for clinical guidance documents indicated that 17 of 30 physician societies (57%) explicitly integrated costs, 4 (13%) implicitly considered costs, 3 (10%) intentionally excluded costs, and 6 (20%) made no mention. Of the 17 societies that explicitly integrated costs, 9 (53%) consistently used a formal system in which the strength of recommendation was influenced in part by costs, whereas 8 (47%) were inconsistent in their approach or failed to mention the exact mechanism for considering costs. Among the 138 specific recommendations in these guidance documents that included cost as part of the rationale, the most common form of recommendation (50 [36%]) encouraged the use of a specific medical service because of equal effectiveness and lower cost. Conclusions and Relevance Slightly more than half of the largest US physician societies explicitly consider costs in developing their clinical guidance documents; among these, approximately half use an explicit mechanism for integrating costs into the strength of recommendations. Many societies remain vague in their approach. Physician specialty societies should demonstrate greater transparency and rigor in their approach to cost consideration in documents meant to influence care decisions.

The US Affordable Care Act mandates that private insurers cover a list of preventive services without cost sharing. The list is determined by 4 expert committees that evaluate the overall health effect of preventive services. We analyzed the process by which the expert committees develop their recommendations. Each committee uses different criteria to evaluate preventive services and none of the committees consider cost systematically. We propose that the existing committees adopt consistent evidence review methodologies and expand the scope of preventive services reviewed and that a separate advisory committee be established to integrate economic considerations into the final selection of free preventive services. The comprehensive framework and associated criteria are intended to help policy makers in the future develop a more evidence-based, consistent, and ethically sound approach.

Source of Review The Institute for Clinical and Economic Review developed an evidence report, including a systematic review of the literature, a cost-effectivenessmodel, anda budgetary impact analysis, to support a publicmeeting of the California Technology Assessment Forum (CTAF) on July 14, 2015.1 The focus was on the comparative clinical effectiveness and comparative value of surgical procedures, devices, and new medications vs conventional weight-lossmanagement (eg, lifestyle and dietarymodification, older medications).

SummaryofFindings Thereviewwaslimitedtopatientswithgenotype1,2,and3infec-tions,whichaccountformostHCVcasesintheUnitedStates.Atthetimeofthereview,nohead-to-headtrialsofthedirect-actinganti-viraldrugshadbeenperformed,andmostofthedataonsofosbu-vircamefromuncontrolledstudiesWethereforeusednetworkmeta-analytic techniques to perform indirect comparisons of sustainedvirologic response outcomes across treatment options 6 and usedtheseresultsastheinputtoasimulationmodelthatcomparedtheestimatedclinicalandeconomicoutcomesoftreatmentafter1and20years.Forpatientswithgenotype1infectionswhohavenotreceivedprior treatment, the network meta-analysis results indicated thatboth sofosbuvir plus pegylated interferon and ribavirin andsimeprevir plus pegylated interferon and ribavirin improve therate of sustained response from historical benchmarks of 50% to75% to approximately 85%. For patients who have been treatedpreviously,neitherofthenewestdrugsprovidesaclinicallysignifi-cant improvement in sustained virologic response, although asingle uncontrolled and ongoing study