DR. TASIAN'S KIDNEY STONE RESEARCH RECEIVES WIDESPREAD MEDIA COVERAGE
The incidence of kidney stones (nephrolithiasis) among children has increased dramatically over the last 25 years for reasons that are not well described. This rapid rise in the prevalence of pediatric nephrolithiasis has resulted in uncertainty of how to best evaluate children with suspected kidney stones and how to effectively decrease recurrence for patients whose first stone developed during childhood. Dr. Tasian's research program addresses these knowledge gaps.
Dr. Tasian's research on the effect of temperature on kidney stone presentation has recently been featured on NBC-Harrisburg and 6ABC and received widespread international media coverage.
He and his colleagues found that the risk of presenting with kidney stones increased as the daily temperature rose above 82°F, and also increased at low temperatures (<40°F) in cities with colder climates (ref 1). This increased risk was likely due to dehydration caused by increased insensible water loss and decreased thirst responses at hot and cold temperatures, respectively. He is currently investigating the difference in the effect of temperature on kidney stone presentation between adults and children, who are more vulnerable to temperature extremes. In order to offset the adverse effects of temperature on stone risk, Dr. Tasian is also developing interventions to improve adherence to water intake -- an effective, inexpensive, and safe treatment that decreases kidney stone recurrence.
Dr. Tasian is also investigating ways to decrease unnecessary radiation exposure for children with kidney stones. In a collaboration with the NIH-supported Urologic Diseases in America Project, which includes investigators from UCLA and the RAND Corporation, Dr. Tasian demonstrated that use of CT as the initial imaging study for children with kidney is common in the United States despite guidelines that recommend ultrasound as the initial imaging study for children with suspected nephrolithiasis (ref 2). Dr. Tasian and colleagues from CHOP also found that the presence of clinical pathways that use ultrasound as the first imaging study for children with suspected nephrolithiasis was associated with decreased CT utilization (ref 3). They are actively investigating if these pathways reduce CT and increase ultrasound use in the Emergency Department.
1. Tasian GE, Pulido JE, Gasparrini A, et al. Daily mean temperature and clinical kidney stone presentation in five u.s. Metropolitan areas: a time-series analysis. Environ Health Perspect 2014;122:1081-7.
3. Ziemba JB, Canning DA, Lavelle J, Kalmus A, Tasian GE. Patient and Institutional Characteristics Associated with Initial CT Use for Children Presenting to the Emergency Department with Kidney Stones. J Urol 2014.
5. Pulido JE, Furth SL, Zderic SA, Canning DA, Tasian GE. Renal parenchymal area and risk of ESRD in boys with posterior urethral valves. Clinical journal of the American Society of Nephrology : CJASN 2014;9:499-505.
CPCE and PolicyLab jointly host a seminar series that consists of Works-In-Progress sessions as well as visiting and faculty speakers' presentations.
At Works-In-Progress Sessions, projects in any stage of development – from conception to study design/data analysis to manuscript preparation – are presented. CHOP investigators who would like to receive feedback from center faculty are invited to present their projects under development at a works-in-progress session. Works-In-Progress Sessions are held in conference room 1538a, 15th floor, 3535 Market and are open to center faculty and fellows, along with the research team members of the presenter.
Faculty Research Seminars provide a forum for CHOP faculty to present their research with the goals of educating faculty and staff about state of the art knowledge of best practices in the management of pediatric conditions, and introducing some methodologic concepts used in research elucidating best practices (e.g. basic statistical and study design issues). Visiting speakers' presentations consist of nationally recognized health research lecturers speaking on topics of general interest to researchers and clinicians. Faculty and visiting speaker seminars are generally held on main campus, usually in ARC or CTRB, and are offered 4‐6 times per year. These sessions are open to all CHOP faculty as well as research and clinical staff. Lunch is served at all seminars.
If you have a research project you would like to present or if you have a recommendation for a visiting speaker please contact Casey Frazier at firstname.lastname@example.org.
CPCE Faculty and Visiting Speaker Seminars qualify for Category 2 CME credit. Use the self-reporting log to record your attendance. You can also obtain documentation of attendance at CPCE Seminars by contacting Debra Hillman at email@example.com.
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 Deb Hillman 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.
Dingwei Dai, PhD
3535 Market Street, Room 1405
Wu Gong, MS, MPH
3535 Market Street, Room 1409
Jin Long, PhD
3535 Market Street, Room 1406
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 these sections of the research intranet site (authentication may be required):
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