What Should Oversight of Clinical Decision Support Systems Look Like?

A learning health system provides opportunities to leverage data generated in the course of standard clinical care to improve clinical practice. One such opportunity includes a clinical decision support structure that would allow clinicians to query electronic health records (EHRs) such that responses from the EHRs could inform treatment recommendations. We argue that though using a clinical decision support system does not necessarily constitute a research activity subject to the Common Rule, it requires more ethical and regulatory oversight than activities of clinical practice are generally subjected to.

A Portfolio Analysis of Culturally Tailored Trials to Address Health and Healthcare Disparities.

In 2010, Patient-Centered Outcomes Research Institute (PCORI) was authorized by Congress to improve the quality and relevance of evidence available to help patients, caregivers, employers, insurers, and policy makers make better-informed health decisions. We conducted a qualitative analysis of behavioral health trials in the PCORI Addressing Disparities portfolio to examine cultural tailoring strategies across the following priority populations: racial and ethnic minorities, rural populations, people with low-income or low socioeconomic status, individuals with disabilities, people with low health literacy, and lesbian, gay, bisexual, and transgender (LGBT) communities. The model was used to examine cultural tailoring strategies within trials.

A patient and community-centered approach selecting endpoints for a randomized trial of a novel advance care planning tool.

Background: Despite a movement toward patient-centered outcomes, best practices on how to gather and refine patients' perspectives on research endpoints are limited. Advanced care planning (ACP) is inherently patient centered and would benefit from patient prioritization of endpoints for ACP-related tools and studies.

Objective: This investigation sought to prioritize patient-centered endpoints for the content and evaluation of an ACP video being developed for patients undergoing major surgery.

An overview of the impact of rare disease characteristics on research methodology.

Background: About 30 million individuals in the United States are living with a rare disease, which by definition have a prevalence of 200,000 or fewer cases in the United States ([National Organization for Rare Disorders], [About NORD], [2016]). Disease heterogeneity and geographic dispersion add to the difficulty of completing robust studies in small populations. Improving the ability to conduct research on rare diseases would have a significant impact on population health.

Healthcare experience among older cancer survivors: Analysis of the SEER-CAHPS dataset.

Objective: Little is known about factors affecting medical care experiences of cancer survivors. This study examined experience of care among cancer survivors and assessed associations of survivors' characteristics with their experience.

Materials And Methods: We used a newly-developed, unique data resource, SEER-CAHPS (NCI's Surveillance Epidemiology and End Results [SEER] data linked to Medicare Consumer Assessment of Healthcare Providers and Systems [CAHPS] survey responses), to examine experiences of care among breast, colorectal, lung, and prostate cancer survivors age >66years who completed CAHPS >1year after cancer diagnosis and survived ≥1year after survey completion.

Engaging Stakeholders and Promoting Uptake of OMERACT Core Outcome Instrument Sets.

Objective: While there has been substantial progress in the development of core outcomes sets, the degree to which these are used by researchers is variable. We convened a special workshop on knowledge translation at the Outcome Measures in Rheumatology (OMERACT) 2016 with 2 main goals. The first focused on the development of a formal knowledge translation framework and the second on promoting uptake of recommended core outcome domain and instrument sets.

Cancer Care Coordination: a Systematic Review and Meta-Analysis of Over 30 Years of Empirical Studies.

Background: According to a landmark study by the Institute of Medicine, patients with cancer often receive poorly coordinated care in multiple settings from many providers. Lack of coordination is associated with poor symptom control, medical errors, and higher costs.

Purpose: The aims of this systematic review and meta-analysis were to (1) synthesize the findings of studies addressing cancer care coordination, (2) describe study outcomes across the cancer continuum, and (3) obtain a quantitative estimate of the effect of interventions in cancer care coordination on service system processes and patient health outcomes.

Challenges of Developing an Observable Parent-Reported Measure: A Qualitative Study of Functional Impact of ADHD in Children.

Background: Informant-reported outcome measures, usually completed by parents, are often administered in pediatric clinical trials with the intention of collecting data to support claims in a medical product label. Recently, there has been an emphasis on limiting these measures to observable content, as recommended in the US Food and Drug Administration guidance on patient-reported outcomes. This qualitative study explores the concept of observability using the example of childhood attention deficit/hyperactivity disorder (ADHD).

The National Cancer Institute Community Cancer Centers Program (NCCCP): Sustaining Quality and Reducing Disparities in Guideline-Concordant Breast and Colon Cancer Care.

Background: The National Cancer Institute Community Cancer Centers Program (NCCCP) pilot was designed to improve quality of cancer care and reduce disparities at community hospitals. The NCCCP's primary intervention was the implementation of the Commission on Cancer Rapid Quality Reporting System (RQRS). The RQRS is a hospital-based data collection and evaluation system allowing near real-time assessment of selected breast and colon cancer quality of care measures.

The PCORI Engagement Rubric: Promising Practices for Partnering in Research.

Purpose: Engaging patients, caregivers, and other health care stakeholders as partners in planning, conducting, and disseminating research is a promising way to improve clinical decision making and outcomes. Many researchers, patients, and other stakeholders, however, lack clarity about when and how to engage as partners within the clinical research process. To address the need for guidance on creating meaningful stakeholder partnerships in patient-centered clinical comparative effectiveness research, the Patient-Centered Outcomes Research Institute (PCORI) developed the PCORI Engagement Rubric (Rubric).

Dissemination and Implementation of Shared Decision Making Into Clinical Practice: A Research Agenda.

Shared decision making (SDM) is essential to advancing patient-centered care in emergency medicine. Despite many documented benefits of SDM, prior research has demonstrated persistently low levels of patient engagement by clinicians across many disciplines, including emergency medicine. An effective dissemination and implementation (D&I) framework could be used to alter the process of delivering care and to facilitate SDM in routine clinical emergency medicine practice.

Learning the landscape: implementation challenges of primary care innovators around cancer survivorship care.

Purpose: This study describes the experiences of early implementers of primary care-focused cancer survivorship delivery models.

Methods: Snowball sampling was used to identify innovators. Twelve participants (five cancer survivorship primary care innovators and seven content experts) attended a working conference focused on cancer survivorship population strategies and primary care transformation.

Interventions to improve the quality of life and survivorship of older adults with cancer: The funding landscape at NIH, ACS and PCORI.

Identifying knowledge gaps and research opportunities in cancer and aging research was the focus of a three-part conference series led by the Cancer and Aging Research Group from 2010 to 2015. The third meeting, featured representatives from the NIA, NCI, ACS and PCORI each of whom discussed research priorities and funding opportunities in cancer and aging at their respective agencies. This manuscript reports on the proceedings of that conference with a specific focus on funding priorities for interventions to improve the quality of life and survivorship of older adults with cancer.

Satisfaction with Therapy Among Patients with Chronic Noncancer Pain with Opioid-Induced Constipation.

Background: Greater satisfaction with medication is associated with better adherence; however, specific to opioid-induced constipation (OIC), data on the relationship between medication satisfaction and efficacy are lacking.

Objective: To understand satisfaction with therapy among patients with chronic noncancer pain and OIC.

Methods: A prospective longitudinal study was conducted in the United States, Canada, Germany, and the United Kingdom using web-based patient surveys.

A vision for using online portals for surveillance of patient-centered communication in cancer care.

The Veterans Health Administration (VHA) is charged with providing high-quality health care, not only in terms of technical competence but also with regard to patient-centered care experiences. Patient-centered coordination of care and communication are especially important in cancer care, as deficiencies in these areas have been implicated in many cases of delayed cancer diagnosis and treatment. Additionally, because cancer care facilities are concentrated within the VHA system, geographical and system-level barriers may present prominent obstacles to quality care.

Ethics Review of Survey Research: A Mandatory Requirement for Publication?

National regulations governing human subjects research differ with regard to whether they require survey research to be overseen by institutional ethics boards or committees. In cases where ethical review has been waived, or was provided by an individual or group other than an institutional ethics board, journals may question the appropriateness of the waiver or alternative review when making determinations about whether to accept the manuscript for publication. The purpose of this article is to provide guidance for journals to consider when making determinations about the necessity of ethical review for survey research projects.

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.

Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for "human research subjects" under conventional research ethics regulations.

Stakeholders' Views of Alternatives to Prospective Informed Consent for Minimal-Risk Pragmatic Comparative Effectiveness Trials.

As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with patients from Geisinger and Johns Hopkins health systems. The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low-risk pragmatic comparative effectiveness trials of widely-used therapies.

A failing heart and the downside of life-prolonging technology.

For a man with end-stage heart failure, a left ventricular assist device prolongs life but brings dire complications.

Providers' Note-Writing Practices for Post-traumatic Stress Disorder at Five United States Veterans Affairs Facilities.

The capacity of electronic health records (EHRs) to capture desired information depends on the practices of health care providers. These practices have not been well studied in relation to post-traumatic stress disorder (PTSD). This qualitative study investigated how providers write EHR notes on PTSD through 38 interviews with providers working at five Veterans Affairs (VA) hospitals across the United States of America.

Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned.

Background: Patients and healthcare stakeholders are increasingly becoming engaged in the planning and conduct of biomedical research. However, limited research characterizes this process or its impact.

Objective: We aimed to characterize patient and stakeholder engagement in the 50 Pilot Projects funded by the Patient-Centered Outcomes Research Institute (PCORI), and identify early contributions and lessons learned.

Development of a patient-reported outcome instrument to assess complex activities of daily living and interpersonal functioning in persons with mild cognitive impairment: The qualitative research phase.

Introduction: As drug development research efforts move toward studying patients earlier in the course of Alzheimer's disease (AD), it is important to incorporate the patient's perspective into measurement of outcomes.

Methods: This article summarizes the qualitative work of the Patient-Reported Outcome Consortium's Cognition Working Group in the development of a new self-reported outcome measure in persons with mild cognitive impairment (MCI) due to suspected AD, herein referred to as MCI.

Results: The draft measure captures the patient's voice for two functional domains, complex activities of daily living and interpersonal functioning.