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Patient-centered outcomes research, or PCOR, is a type of research that focuses on patient values and needs. PCOR includes patients in many parts of the research process, including helping to plan and conduct the study. Institutional Review Boards, or IRBs, oversee research studies to make sure patients participating in a study are protected from harm. But current IRB guidance may not address ethical issues that arise when patients are involved in other roles.

In this study, the research team created recommendations to guide IRB oversight of PCOR studies.

Some research studies, called clinical trials, test treatments to see if they are safe and effective for patients. Before patients enroll in a trial, researchers ask patients for informed consent. In informed consent, a doctor or researcher explains what the trial is about and the benefits and risks of taking part. Patients then choose whether to enroll in the trial. If a patient is too sick to decide, a surrogate, such as a family member or friend, can decide on the patient's behalf.

Trials that test treatments in health emergencies, such as heart attack or stroke, may need a different informed consent process. Emergency situations can be stressful, and patients may have little time to learn about the trial.

In this study, the research team worked with patients and surrogates who had experience with informed consent for trials in health emergencies. They created a new informed consent process to use for trials about stroke and heart attack.

Sometimes a study can get better results using data from different sites. In these cases, researchers may want to share patient data, including personal and private information such as dates of birth and addresses. However, researchers may not want to share data across sites because of worries about patient privacy. Some statistical methods can change patients' sensitive individual data into summary data that hides individuals' personal information. These privacy-protecting methods, or PPMs, make it safe to share data across sites. But researchers don't know if PPMs produce accurate results.

In this study, the research team compared combinations of PPMs with methods that use patients' individual data.

To access the methods, software, and R package, please visit the distributed GitHub.

Before people can join a research study, they need to provide informed consent. Informed consent is a process that helps people know

• What a study is about
• What will happen in the study
• The benefits and risks people may experience
• That they have a choice whether to join the study

Getting informed consent can take a long time, and people may not understand all the details. Researchers want to know what patients think about having short or longer discussions with doctors for studies with low risk. Low risk means the study's risks are no greater than those in daily life or from usual health care. In this study, the research team compared people's views about a shorter consent discussion for a study on blood pressure with the usual, longer discussion.

The Study of Women's Health Across the Nation (SWAN) is a multi-site longitudinal, epidemiologic study designed to examine the health of women during their middle years. The study examines the physical, biological, psychological, and social changes during this transitional period. The goal of SWAN's research is to help scientists, health care providers and women learn how mid-life experiences affect health and quality of life during aging. The data include questions about doctor visits, medical conditions, medications, treatments, medical procedures, relationships, smoking, and menopause related information such as age at pre-, peri- and post-menopause, self-attitudes, feelings, and common physical problems associated with menopause.

The study is co-sponsored by the National Institute on Aging (NIA), the National Institute of Nursing Research (NINR), the National Institutes of Health (NIH), and the NIH Office of Research on Women's Health. The study began in 1994. Between 1997 and 1999, 2,881 of the 3,302 women that joined SWAN were seen for their first follow-up visit. The research centers are located in the following communities: Detroit, MI; Boston, MA; Chicago, IL; Oakland and Los Angeles, CA; Newark, NJ; and Pittsburgh, PA. SWAN participants represent five racial/ethnic groups and a variety of backgrounds and cultures.

Substance dependence (SD) is a chronic disease that requires specialty drug and alcohol treatment, primary care (PC), and management of related problems. Although patients with SD may be linked with specialty care and PC, their health care often remains episodic and fragmented, rather than longitudinal, comprehensive, integrated, and coordinated. As a result, adults with SD often enter addiction treatment later and require acute medical care, rather than entering the system earlier when interventions of lower intensity but longer duration might prevent catastrophes. Chronic disease management (CDM) is a collaborative, longitudinal approach to treatment of certain chronic medical illnesses proven to be more effective than routine care. CDM addresses individual patient and health systems barriers to receipt of needed treatment. However, the effectiveness of CDM for SD has not been tested. The objective of this Addiction Health Evaluation and Disease management (AHEAD) study, was to test the effectiveness of CDM for SD in PC.

Subject identification and recruitment occurred primarily at a local detoxification center, as well as by self and physician referral from the Boston Medical Center primary and ambulatory care clinics, emergency department, urgent care center, inpatient settings, and the community. The study enrolled 320 adults with drug dependence and 320 adults with alcohol dependence who were not in SD treatment, and randomized them to a SD CDM program (the AHEAD Clinic) integrated into a real-world PC clinic or to referral to standard PC. All subjects were assessed regarding SD diagnosis, substance use and problems, readiness to change, health-related quality of life, and medical and drug treatment utilization. Subjects were evaluated 3, 6, and 12 months later, and health services utilization data were collected for 2 years from a statewide database. Additionally, in order to better understand and explain the implementation and fidelity of the AHEAD Clinic, the primary care providers (PCPs) of AHEAD Clinic patients were surveyed. Each PCP was presented with a letter from the Principal Investigator explaining the purpose of the survey, the reason why s/he was being asked to complete the survey, compensation for completing the survey, and details about confidentiality and anonymity. The survey itself consisted of questions asking providers about their satisfaction and their attitudes towards caring for patients with alcohol and drug problems, their knowledge of services that the AHEAD Clinic provides, and their experience working with the AHEAD Clinic.

Primary outcomes were illicit drug use, alcohol use, substance-related problems, emergency department visits, and hospitalizations. The proposal's hypothesis was that compared with standard care, a health services delivery intervention (CDM for SD integrated in PC) would decrease alcohol and illicit drug use and related problems, and improve health care utilization patterns. Improved outcomes using the AHEAD approach would support the adoption of a health services delivery strategy, CDM, to better care for patients with SD.

• Dataset 1: 844 variables; 563 cases
• Dataset 2: 607 variables; 500 cases
• Dataset 3: 607 variables; 487 cases
• Dataset 4: 713 variables; 532 cases
• Dataset 5: 80 variables; 549 cases
• Dataset 6: 59 variables; 1,435 cases
• Dataset 7: 25 variables; 87 cases
• Dataset 8: 25 variables; 87 cases
• Dataset 9: 41 variables; 73 cases
• Dataset 10: 9 variables; 11,018 cases
• Dataset 11: 5 variables; 511 cases