In the
NEWS Report Outlines Best Practices in Patient-Centered Outcomes Research Emphasis is on evidence and allowing patients to be heard in decision making.
Anne C. Beal, MD, MPH, PCORI’s executive director and chief officer for engagement. Photo courtesy of PCORI.
T
he Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee released a major report in November 2013, outlining best practices for researchers conducting patient-centered outcomes research (PCOR), which it defines as “comparative clinical effective-
ness research focused on providing useful information about the outcomes that are important to patients and those who care for them.” Helping patients and clinicians make informed health care decisions in our increasingly complex health care system is the fundamental goal of PCOR. Initially released in draft form in July 2012, the updated report now reflects extensive public comments. (Read the full report at http://bit.ly/ 1hhdaQY.) Congress authorized the creation of the PCORI through the Affordable Care Act of 2010. Its mandate was to “develop and improve the science and methods of comparative clinical effectiveness research,” which included the development of methodology standards and the creation of a “translation table,” a tool that aids in transparency and “guides the choice of study designs by helping balance such factors as the validity of the resulting evidence, appropriate use of scarce research
resources, and timeliness of results for specific questions.” As the report states, “Unless there is a good match between research priorities and the information needs of patients and clinicians, methodological standards will have limited effect.” The report summarizes the committee’s work in both areas and includes numerous anecdotes and examples to illustrate the ways methodology affects patient care. It identifies 47 methodology standards, of which five pertain to most PCOR studies: formulation of research questions, patient centeredness, data integrity and analysis, prevention and handling of missing data, and heterogeneity of treatment effect. Other standards are relevant to particular types of studies. Some are designed to promote transparency in the research process. The authors write that the standards should be considered “minimal,” subject to further evolution. —Laura Wallis
NewsCAP
Evidence shows that braces for idiopathic scoliosis may avert surgery in teens. The effectiveness of
bracing to avoid surgery in the setting of scoliosis has been controversial, mostly because research findings regarding benefits have been inconsistent. To better evaluate the benefits of bracing, researchers conducted a multicenter study of adolescents with scoliosis. Those whose parents agreed to randomization were assigned to either an observation group that didn’t receive treatment or to bracing with a rigid thoracolumbosacral brace for at least 18 hours daily. Because recruitment was slow, a second group was allowed to choose which arm of the study to be in, bracing or observation. The results showed that treatment with a brace significantly increased the likelihood that a patient would reach skeletal maturity with a curvature of less than 50°. Curvatures greater than 50° usually indicate a need for surgery. The longer patients stayed in the brace, the more benefit they received. Findings appeared in the October 17, 2013, New England Journal of Medicine. 16
AJN ▼ February 2014
▼
Vol. 114, No. 2
ajnonline.com
NEWS Report Outlines Best Practices in Patient-Centered Outcomes Research Emphasis is on evidence and allowing patients to be heard in decision making.
Anne C. Beal, MD, MPH, PCORI’s executive director and chief officer for engagement. Photo courtesy of PCORI.
T
he Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee released a major report in November 2013, outlining best practices for researchers conducting patient-centered outcomes research (PCOR), which it defines as “comparative clinical effective-
ness research focused on providing useful information about the outcomes that are important to patients and those who care for them.” Helping patients and clinicians make informed health care decisions in our increasingly complex health care system is the fundamental goal of PCOR. Initially released in draft form in July 2012, the updated report now reflects extensive public comments. (Read the full report at http://bit.ly/ 1hhdaQY.) Congress authorized the creation of the PCORI through the Affordable Care Act of 2010. Its mandate was to “develop and improve the science and methods of comparative clinical effectiveness research,” which included the development of methodology standards and the creation of a “translation table,” a tool that aids in transparency and “guides the choice of study designs by helping balance such factors as the validity of the resulting evidence, appropriate use of scarce research
resources, and timeliness of results for specific questions.” As the report states, “Unless there is a good match between research priorities and the information needs of patients and clinicians, methodological standards will have limited effect.” The report summarizes the committee’s work in both areas and includes numerous anecdotes and examples to illustrate the ways methodology affects patient care. It identifies 47 methodology standards, of which five pertain to most PCOR studies: formulation of research questions, patient centeredness, data integrity and analysis, prevention and handling of missing data, and heterogeneity of treatment effect. Other standards are relevant to particular types of studies. Some are designed to promote transparency in the research process. The authors write that the standards should be considered “minimal,” subject to further evolution. —Laura Wallis
NewsCAP
Evidence shows that braces for idiopathic scoliosis may avert surgery in teens. The effectiveness of
bracing to avoid surgery in the setting of scoliosis has been controversial, mostly because research findings regarding benefits have been inconsistent. To better evaluate the benefits of bracing, researchers conducted a multicenter study of adolescents with scoliosis. Those whose parents agreed to randomization were assigned to either an observation group that didn’t receive treatment or to bracing with a rigid thoracolumbosacral brace for at least 18 hours daily. Because recruitment was slow, a second group was allowed to choose which arm of the study to be in, bracing or observation. The results showed that treatment with a brace significantly increased the likelihood that a patient would reach skeletal maturity with a curvature of less than 50°. Curvatures greater than 50° usually indicate a need for surgery. The longer patients stayed in the brace, the more benefit they received. Findings appeared in the October 17, 2013, New England Journal of Medicine. 16
AJN ▼ February 2014
▼
Vol. 114, No. 2
ajnonline.com
