an industry trade association, the Care Continuum Alliance, convened industry leaders to develop consensus guidelines for measuring clinical and financial outcomes in disease management, wellness and other population-based programs. Contributing to the work were public and private health and quality organizations, including the federal Agency for Healthcare Research and Quality, the National Committee for Quality Assurance, URAC, and the Joint Commission. The project produced the first volume of a now four-volume Outcomes Guidelines Report, which details industry-consensus approaches to measuring outcomes. Tools include web-based assessment tools, clinical guidelines, health risk assessments, outbound and inbound call-center-based triage, best practices, formularies, and numerous other devices, systems and protocols. Experts include actuaries, physicians, pharmacists, medical economists, nurses, nutritionists, physical therapists, statisticians, epidemiologists, and human resources professionals. Equipment can include mailing systems, web-based applications (with or without interactive modes), monitoring devices, or telephonic systems. Effectiveness Possible biases When disease management programs are voluntary, studies of their effectiveness may be affected by a self-selection bias; that is, a program may "attract enrollees who were [already] highly motivated to succeed". At least two studies have found that people who enroll in disease management programs differ significantly from those who do not on baseline clinical, demographic, cost, utilization and quality parameters. To minimize any bias in estimates of the effectiveness of disease management due to differences in baseline characteristics, randomized controlled trials are better than observational studies. Even if a particular study is a randomized trial, it may not provide strong evidence for the effectiveness of disease management. A 2009 review paper examined randomized trials and meta-analyses of disease management programs for heart failure and asserted that many failed the PICO process and Consolidated Standards of Reporting Trials: "interventions and comparisons are not sufficiently well described; that complex programs have been excessively oversimplified; and that potentially salient differences in programs, populations, and settings are not incorporated into analyses." Medicare Section 721 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 authorized the Centers for Medicare and Medicaid Services (CMS) to conduct what became the "Medicare Health Support" project to examine disease management. Phase I of the project involved disease management companies (such as Aetna Health Management, CIGNA Health Support, Health Dialog Services Corp., Healthways, and McKesson Health Solutions) chosen by a competitive process in eight states and the District of Columbia. The project focused on people with diabetes or heart failure who had relatively high