Patient Participation In Research Research Articles

SP0219 Patient Involvement in Research: Flemish Training of 18 Patient Research Partners

IntroductionMore and more, the expertise of patients is used to improve the care for people with RMD's. But also in scientific research, patients can contribute in a most valuable way....

Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS): architecture.

We describe the architecture of the Patient Centered Outcomes Research Institute (PCORI) funded Scalable Collaborative Infrastructure for a Learning Healthcare System (SCILHS, http://www.SCILHS.org) clinical data research network, which leverages the $48 billion dollar federal investment in health information technology (IT) to enable a queryable semantic data model across 10 health systems covering more than 8 million patients, plugging universally into the point of care, generating evidence and discovery, and thereby enabling clinician and patient participation in research during the patient encounter. Central to the success of SCILHS is development of innovative ‘apps’ to improve PCOR research methods and capacitate point of care functions such as consent, enrollment, randomization, and outreach for patient-reported outcomes. SCILHS adapts and extends an existing national research network formed on an advanced IT infrastructure built with open source, free, modular components.

The organization of the health care provider's practice influenced patient participation in research: a multilevel analysis

ObjectiveTo analyze the participation of the patients in a survey about prevention, according to their own medical (hypertension and inclusion during house call) and social (occupational class and birthplace) characteristics and characteristics related to the organization of their physicians' practice. Study Design and SettingFifty-nine randomly recruited physicians from the Paris metropolitan area enrolled every consecutive patient seen during a 2-week period. Actual patient participation (responding to the telephonic questionnaire) was analyzed with a logistic mixed model separately for male and female patients. ResultsThe participation rate among 4,106 eligible patients was 66.7% and varied among physicians (from 48.7% to 80.8% for the 10th and 90th percentiles of the distribution). Participation was better for higher occupational classes, patients included during office visits, men with hypertension, and women born in France. After controlling for all patient characteristics, participation was best if the physician saw at least some patients by appointment [odds ratio (OR), 2.12; 95% confidence interval (CI): 1.12, 4.01 for men and OR, 3.38; 95% CI: 1.72, 6.63 for women). This characteristic explained 14% of the variability between physicians for participation by men and 28% of that by women. ConclusionCluster studies should take the characteristics of the health care providers into account in their design, particularly their practice organization.

Patient Participation in Research Among Solid Organ Transplant Recipients in the United States

In many healthcare contexts, evidence exists that patients who participate in research protocols (PRP) significantly differ from nonparticipants. These differences may affect the external validity of study findings, reflect access to care, and potentially explain sources of difference in patient outcomes. There is no comprehensive study evaluating PRP among transplant recipients. We evaluated the national Scientific Registry of Transplant Recipients from 2000 to 2008 for liver, kidney, heart, lung, and simultaneous pancreas/kidney transplant recipients in the United States for which PRP for immunosuppressive medications is reported at follow-up. Our primary aims were to evaluate participant characteristics, compare outcomes between participants and nonparticipants, and assess variability of PRP between centers and medications. The national proportions of PRP at 1 year by organ were kidney (8.2%), liver (2.9%), heart (5.0%), lung (2.6%), and simultaneous pancreas/kidney (2.8%). Factors associated with PRP included recipients' educational attainment, insurance, race/ethnicity, gender and age, donor age, transplant number, income, distance to center, and center volume. Graft and patient survivals were significantly higher among PRP for kidney, liver, and lung transplant recipients. PRP varied markedly between centers (range, 0%-58%) and by immunosuppressant medications. There are systematic differences between participants and nonparticipants in research in the transplant population that may affect the external validity of research findings. Superior outcomes among participants may suggest that participation in research itself affords certain benefits. Future research evaluating the mechanisms for differential participation rates and improved survival among participants is needed.

Institutional review board (IRB) approved research utilizing reproductive tissues: encouraging patient participation in research for advancing infertility care

Access to reproductive tissues is critical for development of new therapies in reproductive care. To optimize research utilization of reproductive tissues generated during IVF cycles, an IRB protocol was designed to encourage and maximize patient participation. Descriptive Study. An IRB protocol was designed to allow patients to donate several types of reproductive tissue generated by IVF. A consent for research is presented to couples in advance of treatment listing five statements to which the couple may agree or disagree. The statements include donation of 1) normally discarded cellular material and 2) normal embryos in excess of clinical need. Participants also consent to or refuse 1) usage for future research of infertility or inherited genetic disease and 2) usage for future research to learn about, prevent, or treat any other health problems. The fifth option allows Mayo investigators to release material to outside institutions for collaborative research. Of 316 couples offered participation, nineteen (6%) declined any participation. Of the consenting 297 couples, all but one (99.7%) agreed to research on discard-type material while 20% of patients were uncomfortable donating excess embryos. Interestingly, 15% of couples were uncomfortable with their tissues going to outside institutions. See distribution of results in the following table. Tabled 1Table.StatementAgree (%)Disagree (%)Decline ParticipationDonation of normally discarded cellular material generated during an IVF cycle296 (93.7%)1 (0.3%)19 (6.0%)Donation of excess embryos following a maximum 10 year storage period237 (75.0%)60 (19.0%)19 (6.0%)Storage for future research of infertility or inherited genetic disease295 (93.4%)2 (0.6%)19 (6.0%)Storage for future research to learn about, prevent or treat any other health problems292 (92.4%)5 (1.6%)19 (6.0%)Allow sharing of anonymous material with outside institutions253 (80.1%)44 (13.9%)19 (6.0%) Open table in a new tab The majority of couples agreed to participate in donation indicating strong patient support of research. This type of inclusive IRB protocol allows for the storage of multiple types of reproductive tissue. As research projects are identified, specific IRB protocols are submitted for use of the previously stored materials. This prospective generalized consent process is a flexible method of obtaining research materials that can be used for a wide range of research to further advance fertility care.

Time for a change

Time for a change

Ensuring public and patient participation in research: a case study in infrastructure development in one UK Research and Development consortium

There is a policy drive in the UK National Health Services (NHS) towards public involvement in service, education and research, with a number of national initiatives such as INVOLVE that have championed effective user input on research and development (R&D). The requisites of research governance include a balance of professional and public input, and the structures for this now exist at primary care level. There is a need for examples of how such policies can be implemented in Primary Care Trusts, and this article aims to show in detail the way in which a systematic approach to user involvement in R&D has been implemented. The PPIRes (Public and Patient Involvement in Research) project, whose progress over two years from 2003 to 2005 is reported, has been funded by NHS R&D monies allocated through a research consortium in Norfolk, and has been hosted in an NHS – academic partnership between Norwich Primary Care Trust and the Institute of Health at the University of East Anglia. The profile of volunteers, recommendations for good practice in public involvement, and the ‘facilitators and challenges’ to the programme are described.

Patient Participation in Health Research: Research With and for People With Spinal Cord Injuries

Traditionally, patients are rarely seen as partners in health research; their influence on priority setting, research design, the undertaking of research, and interpretation and dissemination of findings was marginal. Nowadays, health researchers, funding agencies, governments, and patient organizations are beginning to acknowledge that the passive role of patients in health research is no longer satisfactory. The emerging commitment and consensus concerning the aims and features of patient participation in research have created a need for an appropriate method to engage patients as partners in health research. In this article, the author argues that a responsive-constructivist approach to evaluation fits with the aims and features of patient participation. She illustrates its potential with a case example that concerns a dialogue among patients and (clinical) researchers in the field of spinal cord injuries. She reflects on learning experiences and the (un)expected difficulties and potentials in creating social conditions for patient participation in health research.

Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research

This article argues that there is a need to relax the precautions taken to ensure voluntary participation of patients in research involving the comparison of two or more established therapies to see whether one is superior to the alternative(s). For many medical problems, physicians can choose among multiple therapeutic options, and the choice is typically based more on hunch than on data. Patients would benefit greatly from studies that clarify the relative benefits and risks of different options for their illnesses. When a patient could be offered one of multiple established treatments, doctors should be able to offer treatment only if the patient agrees to participate in research aimed at determining which of the treatments is most effective.

Inappropriate hospital admissions: patient participation in research.

Although political interest in reducing the number of inappropriate hospital admissions is mounting, methods for researching the rate of inappropriate admissions have several major limitations. Whereas traditional studies have tended to be predominantly subjective, more recent studies using clinical review instruments also have a number of limitations. Chief among these is the failure to consider the potential input of the individual patient. To illustrate some of the possible benefits of patient participation, this article cites findings from a study in Birmingham, which sought to involve individual older people in a research study into emergency hospital admissions.

Diagnosis and management of progressive supranuclear palsy.

Because of the relevance of an early and accurate diagnosis for prognosis, management, and participation of patients in research, the classical clinical features--features that should raise suspicion of progressive supranuclear palsy (PSP) and those that should make the diagnosis of PSP unlikely--are discussed in this article. The accuracy of currently used clinical diagnostic criteria and the role of laboratory investigations in the diagnosis of PSP are reviewed. New terminology for the clinical diagnostic criteria for PSP is proposed. The main neuropathologic and neurochemical features supporting current main symptomatic and hypothesized experimental biologic therapies are suggested.

Patient participation in research in the managed care environment: key perceptions of members in an HMO.

This study's objective was to elicit the views of research among enrollees in an HMO. A questionnaire was mailed to 207 adult enrollees, 55% had been exposed to research and 45% had not. Ninety-four percent of respondents supported research within the HMO, and 87% thought using information from medical records for research was acceptable. Sixty-three percent thought participation in research increased patient understanding of health care. Significantly more prior research participants thought that participation in research improves care. More patients would participate if written information were provided (67%), if feedback of results was provided (72%), and if their clinician invited them (67%). Only a modest percentage (20%) of patients would participate in a randomized trial.

Research and ethics: leaving exclusion behind

Research into mental disorders has continued to stimulate ethical debate during the past year. The urgent need for research in this field remains transparent, but the need for balance between enabling research and protecting patients continues to generate argument. Informed consent has been the subject of earnest debate in the United Kingdom, while attempts to protect incapacitated patients in the United States have attracted accusations of stifling research. From this baseline, a new movement is emerging, where there are few blanket bans or endorsements of specific types of research on specific groups of people. Instead, the emphasis is switching to patient participation in research and to the process of involving people in research projects.