Required Sections & Information:
Complete
the following sections in a separate document (please
number and date pages) and attach them to the Application to
Conduct Research. The nine sections included here correspond with the criteria
used to evaluate your proposal. Each
section should provide sufficient summary information for a reviewer to
determine whether the review criteria have been met. The attachment should be
between three to twelve pages long. References to an attached, full proposal
for details are acceptable, but cannot be the sole response for a section.
The
following Section Headings with the required information must be included for
the application to be ruled complete and be considered for review. The following information is provided to
clarify the content of each section.
State precisely what the research described in this
application is intended to accomplish. State the specific aims of your study
(an aim is a specific, measurable outcome) and the overall research question
and/or a testable hypothesis.
Approximate length: 2-4 pages
State the importance of the research described in
this application to the scientific community and to
HealthPartners. Briefly identify the specific knowledge gap that the project is
intends to fill. Describe the effect on
the concepts or methods that drive this field. Include a brief review of past
research in this area. Attach your literature citations at the end of the
Science and Merit form.
Describe any preliminary results you may have that
support your proposal. If this is a continuation of a previous study please
include a progress report.
Provide information as to how the results of the
study could impact the health of HealthPartners members and the community;
include plans to disseminate the results in the public domain and to translate
the results of the study into care within the HealthPartners’ system and for
HealthPartners’ personnel. All research
conducted within HealthPartners Research Foundation is intended for
publication. We encourage investigators to begin developing their publication
and translation plans early in the development of the project. Please outline how you will communicate your
results within HealthPartners as well as possible publications and target
journals for this study.
Methods
Briefly summarize the conceptual framework,
experimental design, methods, and the procedures to be used to accomplish the
specific aims of the project. Please include specific information about what
tasks you will accomplish when doing the study. Describe the protocols to be
used and a tentative sequence or timetable for the investigation. Include a
discussion of the kinds of data you expect to obtain, and specify the validity
and reliability of data collection instruments to be used. The data to be
collected and justification of its use should be clearly stated. Describe any
new methodologies and their advantages over existing methodologies. Discuss the
potential difficulties and limitations of the proposed procedures and
alternative approaches to achieve the aims.
Point out any procedures, situations or materials that may be hazardous
to personnel, and the precautions to be exercised. Attach as Appendices, any
questionnaires, surveys and/or data collection instruments to be used in the
study.
Analysis
Begin
this section with a brief restatement of the primary hypotheses that will be
tested. For each hypothesis, state the variables that will be included in the
analysis (dependent/outcome, independent/predictor, and covariates), ensuring
that it is clear whether each variable will be considered binary, categorical,
or continuous in the analysis. Describe the statistical methods that will be
used to test each hypothesis, including an explanation of their
appropriateness. Finally, please describe how the results of the analysis will
speak to the objectives of the study. Statements
such as "appropriate analyses will be performed" or "a
statistician or data analyst will be hired" and naming the statistical
software package to be used do not provide sufficient information for review.
Example 1:
The primary hypothesis to be tested states that there
will be a higher 24-hour survival rate in the experimental treatment group
relative to the standard treatment group. The primary and secondary outcomes of
interest are binary (i.e., yes/no, success/failure) and will be explained by
treatment group (experimental, standard) with age (grouped into quartiles),
gender (male, female), and whether the heart attack was witnessed (yes, no) as
covariates. The primary hypothesis test will be performed using logistic
regression analysis or the Cochran-Mantel-Haenszel test for the common odds
ratio with emergency units as strata. This will allow us to test whether the
relationship between treatment group and the binary outcome variables is
significant while controlling for other factors. It is expected that the odds
ratio predicting “yes” or “success” outcomes from treatment group will be
significantly greater than 1.0 and indicate that the experimental group has a
higher rate of success outcomes than the standard treatment group, controlling
for age, gender, and whether the heart attack was witnessed.
Example 2:
The
primary objective of this research is to obtain preliminary data speaking to
women’s satisfaction with outcomes following a hysterectomy. Descriptive
statistics will be computed for satisfaction ratings (1=not at all satisfied, 5
= extremely satisfied), including measures of centrality (mean, median) and
dispersion (minimum, maximum, interquartile values, standard deviation,
standard error) for each item separately and the mean of all items combined.
In
addition to this descriptive information, we are interested in whether women
who had a hysterectomy that fell within acceptable guidelines will be more
satisfied following surgery than women who had a hysterectomy that did not fall
within guidelines. As this is a pilot study, we do not have specific
predictions about the proportion of women who will fall into each of these
groups, or the likely satisfaction across these groups. However, based on the
aforementioned chart review, women will be categorized into two groups
(acceptable, unacceptable) and their satisfaction ratings will be compared.
Presuming the aggregate satisfaction variable is normally distributed and the
within-group variances are equal, a Student’s t-test will be performed. If
either of these assumptions is sufficiently violated a Wilcoxon two-sample
(Mann-Whitney U) test will be carried out instead. We expect the t-test to
indicate that women in the “acceptable guidelines” group will be more satisfied
with their surgery than women in the “unacceptable guidelines” group.
Sample Size
The
estimate of the sample size needed or the estimate of the power given a limited
sample size should be driven by the primary objective of the research
study. The sample size should be large
enough to have sufficient power to detect the minimum difference in the primary
outcome variable(s) that is viewed to be clinically significant. Reasons for picking this minimum difference
should be provided. The sample size
should also be large enough to take into account dropouts if appropriate. If the estimated sample size is unattainable
due to various factors (limited recruitment time, limited number of patients,
etc.), you may only have sufficient power to detect very large
differences. In these cases, a power
calculation should still be performed and you should state the difference you
will have sufficient power (>80%) to detect.
The power you will have to detect the minimum difference viewed to be
clinically important (worth detecting) should also be stated.
The
method used to determine the appropriate sample size depends on what type of
analysis will be used for the primary outcome variable or hypothesis. If there are more than one primary outcome
variables or hypotheses, sample size calculations should be done for each one
and the largest sample size selected.
The following are some examples and sample wording for various
situations.
Example
1: Primary objective is to estimate the prevalence of cesarean sections
Our
primary objective is to estimate the prevalence of cesarean sections. We anticipate 10% of births to be cesarean
sections (cite source, i.e. preliminary study, historical value). In order to achieve 95% confidence intervals
of +/- 3% we need to include 500 women in our sample. With a sample size of 500 there is a 95%
probability that the estimate obtained will be within 3% of the population
value.
Source:
Fleiss, Statistical Methods for Rates and Proportions
Example
2: Primary objective is to compare smoking cessation rates between two groups
Our
primary objective is to compare smoking cessation rates between group A and
group B. Group A is expected to have a
20% cessation rate (cite source, i.e. preliminary study, historical value). A 15% difference in cessation rates between
the two groups is viewed to be clinically significant (provide reasons). Randomizing 140 subjects to each group will
give us >80% power to detect a 15% difference in cessation rates (p1=0.20,
p2=0.35, two-tailed test, type I error rate=0.05). With an expected 10% dropout rate we will
need to recruit 156 subjects per group for a total sample size of 312.
Source:
Power Analysis and Sample Size software, version 6.0
Example
3: Primary objective is to compare average weights between two groups
Our
primary objective is to compare the average weight between group A and group
B. Group A is expected to have an
average weight of 150 pounds. Previous
studies have shown the standard deviation of weight to be 12 pounds. We would like to have 90% power to detect an
average weight difference of 10 pounds.
Using a two-sample t-test with a two-sided significance level of 0.05,
we need 32 subjects in each group to have 90% power to detect this difference
(x1=150, x2=160, standard deviation=12).
Source: nQuery Advisor software, version 3.0
Limitations of this research
Describe
the limitation of the proposed approach and analysis. This may be especially true when
collaborating with external researchers.
Destruction of Identifiers
Explain
your plan for destroying identifiers at the earliest possible time.
Describe the roles and responsibilities
on this project of each member of the investigative staff (PI,
co-investigators, and statistician). If the overall PI is not at
HealthPartners, describe the role of the HealthPartners’ PI in the
project. Provide assurances that the
HealthPartners’ PI is qualified to lead this project.
Explain what efforts have been made to minimize
disruption and overuse of HealthPartners’ resources, personnel, or
members/patients and why the proposed environment is the appropriate for the
proposed study. Include any efforts to
establish collaborative working relationships with other entities, consortium
contractual arrangements, and/or organizational structures that are being
constructed, including appropriate funding responsibilities of all
aspects. Attach any flow charts as
Appendices.
Describe all of the resources (i.e., clinics,
charts, labs, equipment) needed to implement the project and the agreements you
have with departments, clinics and managers to access these resources.
Include a budget form and budget justification. A budget must be developed for all
projects regardless of funding source, including departmental funds. Budget
forms in Excel are available with the application materials. Instructions for
completing the form are embedded as comments. A budget justification is a
narrative that explains how you determined the figures in your budget. Describe
the activities to be undertaken by each person, identify all supplies and
costs, explain any deviations from standard fees and indirect cost rates.
Acknowledge that the treatment strategy (drug or
service treatments) proposed in the application does not commit HealthPartners
to covering or continuing to provide the treatment or program support after the
study is completed. If this study is a
drug study, state whether or not the drug is FDA approved and currently listed
on the HealthPartners’ formulary.
Explain
whether or not this proposal has been submitted for other review and/or
received approval/rejection in another review, including, but not limited to:
Federal, collaborative agency, previous HealthPartners’ (rejected), or other
funding sources (e.g. nonprofit foundation review). Provide dates of submission and status of
review (approved, pending, or rejected).
Attach
literature citations after the last section on the Science and Merit form.
Applications are due the 3rd Friday of the month;
reviews will be completed by the 3rd week of the following
month. Send or bring the original and 20 additional copies of this
application, appendices and materials to:
HealthPartners Research Foundation
8170 Building
Mail Stop 21111R
Questions? Call 651-254-2928 for more
information.