DR. ANDREA KNIGHT'S WORK HIGHLIGHTS THE UNMET AND DISPARATE MENTAL HEALTH NEEDS OF PEDIATRIC PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Andrea Knight, MD, MSCE is an Assistant Professor in the Department of Pediatrics at the Perelman School of Medicine of the University of Pennsylvania and an Attending Physician in the Center for Childhood Arthritis and Rheumatic Diseases at the Children's Hospital of Philadelphia. She is a core faculty member of two CHOP Research Institute Centers of Emphasis, the Center for Pediatric Clinical Effectiveness and PolicyLab.
Dr. Knight's research focuses on improving mental health outcomes for children and adolescents with systemic lupus erythematosus (SLE) by investigating ways to enhance identification and treatment of youth with SLE affected by depression and anxiety. She is also interested more broadly in psychosocial and patient-oriented outcomes, healthcare disparities and utilization in youth with SLE and other chronic rheumatic disease. Dr. Knight has led studies investigating depression and anxiety in youth with SLE, as well as a project examining the national inpatient healthcare burden on pediatric SLE patients. Dr. Knight has received funding support from the Lupus Foundation of America, a University of Pennsylvania Faculty Development Award, an NIH T32 grant, and from a CPCE Pilot Grant. She has applied for a NIH K23 award to fund the continuation of this work.
In a recent study, in order to better understand the psychosocial impact of lupus on adolescent patients, Dr. Knight's team examined anxiety and depression in this population and found a high prevalence of depression and anxiety in one third of youth with SLE and the SLE-like syndrome of mixed connective tissue disease. Depression was found to occur more frequently in those of non-white race, with suicidal ideation being significantly higher than in healthy peers. Depression in youth with SLE was associated with increased disease activity and damage, as well as longer disease duration. However, the high rates of depression and anxiety in youth with SLE were similar to age and sex-matched peers with type 1 diabetes mellitus, suggesting that the general burden of chronic disease may play a more central role in depression and anxiety than SLE-specific inflammation in the study cohort. Despite prevalent depression and anxiety symptoms, mental health treatment rates for youth with SLE were poor and those with depression had less frequent primary care visits than those without. Mental health treatment rates were also lower for youth with SLE than their diabetic peers. Dr. Knight's team's work highlights the unmet and disparate mental health needs of pediatric patients with SLE, implicating an important role for pediatric rheumatology providers in improving access to mental health care and interventions.
Ongoing research in this area focuses on developing interventional strategies to improve mental health care. Current investigations explore the perceptions, preferences and barriers to mental health care from the perspectives of patients with SLE and their parents, as well as those of clinicians. Dr. Knight also has research underway to understand the impact of depression on longitudinal outcomes for adults with childhood-onset SLE, as well as racial and ethnic disparities in psychiatric diagnoses and treatment in a national Medicaid population of adolescents with SLE. Future plans include further characterization of the impact of depression and anxiety on patient-oriented and other health-related outcomes and testing of interventional strategies to improve mental and overall health for youth with SLE.
CPCE and PolicyLab jointly host a seminar series that consists of Works-In-Progress sessions as well as visiting and faculty speakers' presentations.
Works-in-Progress sessions bring together health services researchers from across the hospital to discuss research projects that are in various stages of development, from protocol development all the way to data analysis, interpretation, and publication. CHOP Faculty and fellows who would like to receive feedback on their research are welcome to present. We offer 2 formats for Works in Progress sessions, Protocol Development sessions and Research Seminars. Protocol Development sessions are held at 3535 Market St., in room 1538a, and are open to CPCE and PolicyLab faculty and fellows and the research team of the presenter.
Research seminars are also held at 3535 Market St. on the 16th floor in conference room "A" or an equivalent large conference room. All interested CHOP faculty, fellows, and research staff are invited to attend research seminars.
Faculty Seminars provide a forum for CHOP faculty to present their research to the CHOP community. The goals of the Seminars are (1) To educate CHOP faculty and staff on state of the art knowledge of best practices in the management of pediatric conditions or development of health policy, and (2) To introduce some methodological concepts used in research elucidating best practices (e.g. basic statistical and study design issues).
Visiting Speaker seminars
Visiting speakers' presentations consist of nationally recognized health research lecturers speaking on topics of general interest to researchers and clinicians. These sessions are offered 2 to 3 times per year, and are generally held on the CHOP Main campus, usually in the Abramson or Colket building. These sessions are open to all CHOP faculty as well as research and clinical staff. Lunch is served at all seminars.
If you have questions about the CPCE and PolicyLab Seminar Series, would like to present at one of our seminars, or have a recommendation for a faculty or visiting speaker, please email CPCE@email.chop.edu.
CPCE and PolicyLab Faculty and Visiting Speaker Seminars qualify for Category 2 CME credit. CHOP faculty members can obtain documentation of their CME credits completed at CHOP by visiting the CHOP Continuing Medical Education site.
Pilot Grant Program
CPCE offers awards twice each year through its Pilot Grant Program. The purpose of this program is to promote and support CHOP investigators in clinical effectiveness pilot research studies that will attract external support for large-scale studies. Investigators from all CHOP departments and divisions, including fellows in their final year of fellowship transitioning to a faculty position at CHOP, are encouraged to apply. Selected proposals will be supported for up to a maximum of $10,000 for one year. Projects should be able to be completed within one year.
Application and Submission Process:
- Please submit proposals in NIH format to include project summary/abstract, specific aims, and a research strategy section which includes significance, innovation and approach. (5 page maximum)
- Proposals must also include a cover page, an investigator biosketch in NIH format and project budget, budget justification, and references. (not included in 5 page maximum)
- Budgets must be reviewed by your business manager prior to submission.
- Funding may not be used for investigator salary support. Staff salaries are allowable budget items.
- There are two submission deadlines per year. The 2015 deadlines are Wednesday, April 1 (awards announced in mid-May) and Thursday, October 1 (awards announced in mid-November).
- Selected applications must show documentation of IRB submission within 30 days of award notification.
- Proposals submitted for other awards (e.g., Foerderer) are not eligible for CPCE pilot grant consideration.
- Please submit the proposal as a single Word document via email to Deb Hillman, at Hillman@email.chop.edu no later than 4:00 p.m. on the deadline date.
For a submission template, please click here.
Review Process and Selection Criteria
As detailed above, the review process will consist of two rounds. Applications meeting the definitions (above) for pilot clinical effectiveness research studies, and judged by the Pilot Grant Steering Committee to be of sufficient quality for further review, will be assigned to a reviewer, critiqued and scored. Reviewers will meet in a study section to discuss the merits and limitations of the competing proposals and to determine the awardee(s). All applicants whose proposals qualify for round two will receive a copy of reviewers' comments and score. Those applications that do not qualify for round two will be returned to the applicant without further review, critique or score.
The following criteria will be used to score the proposals. They are adapted from NIH Study Section Criteria.
- Significance of Study: Does the project address an important problem or a critical barrier to progress in the field?
- Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?
- Likelihood of Impact of Clinical Effectiveness: If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
- Appropriateness of Budget: Is the proposed budget and period of support appropriate in relation to the proposed research?
- Likelihood of Future Research: If the aims of the project are achieved, will the results lend themselves to future research?
- Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
The above criteria will be scored on a scale from 1 (high impact) to 9 (low impact).
Common Pitfalls of Past CPCE Pilot Grant Applications:
- Failure to anticipate difficulties or address limitations
- Uncertainty regarding future direction or funding
- Incomplete significance section; failure to adequately describe rationale
- Overambitious for pilot study; unrealistic timeline
- (Budget) Underestimate of biostatistical support needed to complete aims
Although projects may be funded up to a maximum of $10,000 priority will be given to those projects that include a prudent spending plan. CPCE will attempt to fund all requested budgets in full, but may elect to partially fund certain protocols in order to increase the number of funded proposals.
- Principal investigators must submit a report at the end of the grant period for review by the Pilot Grant Program steering committee. The reports should include progress, expenditures and plans for disseminating results. Subsequent reports will be requested to include publications and extramural funding resulting from the research.
- Funds unspent at the end of the one-year grant period will be returned to CPCE. However, requests for rollover of funds for an additional year will be considered with adequate justification. We are very excited about the opportunity to support fellows and junior faculty who are interested in advancing CPCE's goals.
Contact Megan Foley at firstname.lastname@example.org with any questions about the CPCE Pilot Grant Program or submission process.
The Healthcare Analytics Unit is a service unit of CPCE and PolicyLab. The HAU serves as a resource for investigators who want to use administrative or other existing data to answer research questions. HAU offers the services of programmer/analysts to pull, clean, manage, model and analyze data. The unit provides access to and expertise in the use of PHIS, KID, Medicaid, Premier, NHDS, NAMCS and other databases.
Examples of databases to which the HAU provides access and expertise:
- Pediatric Health Information System (PHIS)
- Kids' Inpatient Database (KID)
- NAMCS (National Ambulatory Medical Care Survey)
- NHDS (National Hospital Discharge Survey)
- Premier Perspective Database
To see samples of articles published using PHIS data, click here
To see samples of poster presentations using PHIS data, click here
For PHIS Data Use Forms, click here
Yuan-Shung (Vera) Huang, MS, Director
3535 Market Street, Room 1404
Ms. Huang has over 20 years of research data management and programming experiences in the areas of medical, mental health, child welfare, and juvenile justice studies. As a biostatistician she has experience working with large and complicated data sources, including national administrative and survey data (e.g., Medicaid and NSCAW), data from State and local agencies, and medical and clinical trial data (e.g. PHIS, Multum), and helps end-users assessing data usability for specific needs.
Wu Gong, MS, MPH
3535 Market Street, Room 1409
Lanyu Mi, MS
3535 Market Street, Room 1406
3535 Market Street, Room 1406
Lihai Song, MS
3535 Market Street, Room 1405
Requesting Data Services from the HAU
Contact us via email at email@example.com
We will contact you to schedule an appointment to discuss your project's feasibility and cost.
IRB APPROVAL FOR STUDIES THAT UTILIZE HAU SERVICES
The IRB has increasingly judged large datasets, such as those obtained from PHIS, to contain data that is not readily identifiable and therefore, outside the requirements for prospective IRB review and approval. Regulatory statements have made clear that "readily identifiable" does not mean possibly or potentially identifiable. This lowers the barriers for receipt and use of these datasets.
HIPAA does apply to the receipt/use of these datasets.
- If the dataset is a limited dataset, then all that is required to obtain and use it would be a data use agreement (no IRB approval required) with the data source (e.g. CHCA for PHIS data).
For research that utilizes datasets containing identifiable PHI, or for which data will be prospectively collected, IRB review/approval will continue to be needed.
It is the responsibility of the investigator to obtain IRB review and approval for those studies that require it, and to complete any data use agreements required by the data source. For more complete information regarding what must be reviewed by the IRB, the use of registries/repositories for research, and other related topics, please see the ORCRA website on the research intranet at: https://intranet.research.chop.edu/display/deptcomp/ORCRA+-+Research+Compliance+and+Regulatory+Affairs
SUBMITTING MANUSCRIPTS BASED ON RESEARCH UTILIZING DE-IDENTIFIED OR LIMITED DATASETS
When submitting a manuscript for publication, for a study that utilized PHIS or a comparable large and not readily identifiable dataset, and which therefore did not require IRB review/approval, the following boilerplate text can be used when needed during the journal's submission process. There are two versions, please choose the appropriate one, depending on the nature of your dataset.
1) In accordance with the Common Rule (45 CFR 46.102(f)) and the policies of the The Children's Hospital of Philadelphia IRB, this research, which utilized a de-identified dataset, was determined to not meet the definition of human subjects research.
2) In accordance with the Common Rule (45 CFR 46.102(f)) and the policies of the The Children's Hospital of Philadelphia IRB, this research, which utilized a limited dataset according to the terms of a valid data use agreement, was determined to not meet the definition of human subjects research.
Sample Table To help define your population and measures, inclusion/exclusion criteria, etc
ICD 9 codes -- Use ICD 9 codes in your table to define population of interest
CTC codes (©2008 Thomson Healthcare) please use the appropriate PDF from the list below:
- Medical Supplies
- Laboratory Services
- Imaging Services
- Clinical Services
- Other Transacted Services
If you have questions about HAU services, please contact:
Yuan-Shung (Vera) Huang, MS