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Some children benefit by being a part of a study for a new diagnostic test or an experimental treatment that is not yet available to everyone else. Children may also benefit by seeing subspecialist investigators who can help manage their condition.
Just as parents are encouraged to take an active role in their child’s regular health care, many parents enjoy the opportunity to learn more about their child’s condition and treatment and give feedback to the researchers during a study.
Studies can also provide investigator consultation to pediatricians regarding specific patient management decisions. Investigators are generally immediately available to clinicians and families participating in research studies.
Participating in research can keep pediatricians up-to-date on the latest evidence and guidelines for the care of children with the specific condition being studied. Clinicians can often learn about the overall study findings relevant to practice before they are published.
Clinically useful research results about individual patients who participate in studies may also enhance care. An additional benefit is that members of the research team can provide concierge care to participating patients that can save practice staff time. For example, research team members may schedule specialty tests and be available to families during or after the testing. Investigators can also provide consultation to pediatricians regarding patient management decisions about conditions that are part of the investigator’s area of expertise.
There are a variety of study types that can generally be categorized according to these subsets:
Descriptive studies are used to accurately describe specific characteristics of a group of children or families, or to compare groups based on some variable. In these studies, information is obtained from participants without manipulating the environment in any way. Self-report surveys, individual or group interviews, behavioral observation, and clinical information reviews are all descriptive approaches. Descriptive studies answer questions such as, “What do first-time mothers-to-be think about breastfeeding?” or “Is there a relationship between school performance and BMI?” or “How do children handle bully behavior?”
Clinical trials are used to test the efficacy of an intervention such as a new illness prevention strategy, diagnostic test or clinical treatment. The results of clinical trials can lead to changes in care. Pediatric practices can play an important role. For example, the latest American Academy of Pediatrics Urinary Tract Infection Clinical Practice Guidelines were a direct outcome of clinical trials conducted in partnership with primary care practices. In the video below, the doctors from Children’s Hospital of Pittsburgh of UPMC who led this study, discuss the guidelines and other UTI clinical research activities.
Practice improvement studies are used to test changes intended to improve the way patient care is delivered and/or increase the efficiency and effectiveness of how a practice is run. For example, a clinical practice may want to test whether a change in how exam rooms are assigned can reduce waiting room time for patients, or how adding prompts to the electronic medical record improves the documentation of developmental milestones.
Primary care practices may be approached by individual investigators who are typically affiliated with research universities and hospitals, pharmaceutical companies, or practice-based research networks (PBRNs).
PBRNs are comprised of multiple primary care practices that join together to answer common practice questions. PBRNs are overseen by a network director who protects the needs of pediatricians and their patients and whose staff members serve as liaisons between investigators and practices.
Examples of PBRNs include the American Academy of Pediatrics’ Pediatric Research in Office Settings (PROS) and the University of Pittsburgh Clinical and Translational Science Institute’s Pediatric PittNet.
Primary care providers have some things to consider before agreeing to participate in a clinical research study. While there are numerous benefits to being a research home, additional activity in one’s practice can impact patient care, practice cost, and patient satisfaction.
Before agreeing to be a partner in a research project, consider the following:
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