Mildrey Silverio  Week 13 Mildrey Silverio COLLAPSE Top of Form According to the article, Insulin adjustments to maintain glycemic control in individuals with type 1 diabetes often lead to wide glucose fluctuations, hypoglycemia, and increased body weight. Dapagliflozin, an insulin-independent sodium–glucose cotransporter 2 (SGLT2) inhibitor, increases glucosuria and reduces hyperglycemia in individuals with type 2 diabetes. The primary objective of this study was to assess short-term safety of dapagliflozin in combination with insulin; secondary objectives included pharmacokinetic, pharmacodynamic, and efficacy parameters. The study design is explained as a 2-week, dose-ranging, randomized, double-blind, placebo-controlled proof-of-concept study randomly assigned 70 adults with type 1 diabetes (HbA1c 7–10%), who were receiving treatment with stable doses of insulin, to one of four dapagliflozin doses (1, 2.5, 5, or 10 mg) or placebo. The insulin dose was not proactively reduced at randomization but could be adjusted for safety reasons. In my opinion, this is a pilot study. Large-scale research projects tend to be complex, take a lot of time to design and execute, and typically require quite a bit of funding. Conducting a pilot study before hand allows a researcher to design and execute a large-scale project in as methodologically rigorous a way as possible, and can save time and costs by reducing the risk of errors or problems. For these reasons, pilot studies are common among quantitative sociology studies, but are often used by qualitative researchers too. A pilot study is a research study conducted before the intended study. Pilot studies are usually executed as planned for the intended study, but on a smaller scale. Although a pilot study cannot eliminate all systematic errors or unexpected problems, it reduces the likelihood of making a Type I or Type II error. Both types of errors make the main study a waste of effort, time, and money. The second study I found is named “Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study”. In this study, Data from newly diagnosed NYHA FC III/IV PAH patients (n=19) initiated on upfront triple combination therapy (intravenous epoprostenol, bosentan and sildenafil) were collected retrospectively from a prospective registry. Reference Henry, R. R., Rosenstock, J., Edelman, S., Mudaliar, S., Chalamandaris, A. G., Kasichayanula, S., ... & Griffen, S. C. (2015). Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study. Diabetes care,38(3), 412-419. Sitbon, O., Jaïs, X., Savale, L., Cottin, V., Bergot, E., Macari, E. A., ... & Montani, D. (2014). Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study. European Respiratory Journal, 43(6), 1691-1697. Bottom of Form Yanicsi Yong  Yanicsi Yong Week 13 COLLAPSE Top of Form Sympathetic overactivation, is reduced ...

1. Mildrey Silverio
Week 13 Mildrey Silverio
COLLAPSE
Top of Form
According to the article, Insulin adjustments to maintain
glycemic control in individuals with type 1 diabetes often lead
to wide glucose fluctuations, hypoglycemia, and increased body
weight. Dapagliflozin, an insulin-independent sodium–glucose
cotransporter 2 (SGLT2) inhibitor, increases glucosuria and
reduces hyperglycemia in individuals with type 2 diabetes. The
primary objective of this study was to assess short-term safety
of dapagliflozin in combination with insulin; secondary
objectives included pharmacokinetic, pharmacodynamic, and
efficacy parameters. The study design is explained as a 2-week,
dose-ranging, randomized, double-blind, placebo-controlled
proof-of-concept study randomly assigned 70 adults with type 1
diabetes (HbA1c 7–10%), who were receiving treatment with
stable doses of insulin, to one of four dapagliflozin doses (1,
2.5, 5, or 10 mg) or placebo. The insulin dose was not
proactively reduced at randomization but could be adjusted for
safety reasons.
In my opinion, this is a pilot study. Large-scale research
projects tend to be complex, take a lot of time to design and
execute, and typically require quite a bit of funding. Conducting
a pilot study before hand allows a researcher to design and
execute a large-scale project in as methodologically rigorous a
way as possible, and can save time and costs by reducing the
risk of errors or problems. For these reasons, pilot studies are
common among quantitative sociology studies, but are often
used by qualitative researchers too. A pilot study is a research
study conducted before the intended study. Pilot studies are
usually executed as planned for the intended study, but on a
smaller scale. Although a pilot study cannot eliminate all

2. systematic errors or unexpected problems, it reduces the
likelihood of making a Type I or Type II error. Both types of
errors make the main study a waste of effort, time, and money.
The second study I found is named “Upfront triple combination
therapy in pulmonary arterial hypertension: a pilot study”. In
this study, Data from newly diagnosed NYHA FC III/IV PAH
patients (n=19) initiated on upfront triple combination therapy
(intravenous epoprostenol, bosentan and sildenafil) were
collected retrospectively from a prospective registry.
Reference
Henry, R. R., Rosenstock, J., Edelman, S., Mudaliar, S.,
Chalamandaris, A. G., Kasichayanula, S., ... & Griffen, S. C.
(2015). Exploring the potential of the SGLT2 inhibitor
dapagliflozin in type 1 diabetes: a randomized, double-blind,
placebo-controlled pilot study. Diabetes care,38(3), 412-419.
Sitbon, O., Jaïs, X., Savale, L., Cottin, V., Bergot, E., Macari,
E. A., ... & Montani, D. (2014). Upfront triple combination
therapy in pulmonary arterial hypertension: a pilot
study. European Respiratory Journal, 43(6), 1691-1697.
Bottom of Form
Yanicsi Yong
Yanicsi Yong Week 13
COLLAPSE
Top of Form
Sympathetic overactivation, is reduced by renal denervation in
drug-resistant hypertension. A similar role for renal denervation

3. in heart failure remains unstudied, partly due to the concern
about potential concomitant deleterious blood pressure
reductions. This pilot study evaluated the safety of renal
denervation for heart failure using an intensive follow-up
protocol. According to the study, 7 patients (mean age 69 years)
with chronic systolic heart failure (mean BP on referral 112/65
mm Hg) on maximal tolerated heart failure therapy underwent
bilateral renal denervation May–July 2011. Patients were
admitted for pre-procedure baseline assessments and in-patient
observation for 5 days following denervation. Follow-up was
weekly for 4 weeks, and then monthly for 6 months. Pilot
studies represent a fundamental phase of the research process.
The purpose of conducting a pilot study is to examine the
feasibility of an approach that is intended to be used in a larger
scale study. The roles and limitations of pilot studies are
described here using a clinical trial as an example. A pilot study
can be used to evaluate the feasibility of recruitment,
randomization, retention, assessment procedures, new methods,
and implementation of the novel intervention.
A pilot study is not a hypothesis testing study. Safety, efficacy
and effectiveness are not evaluated in a pilot. Contrary to
tradition, a pilot study does not provide a meaningful effect size
estimate for planning subsequent studies due to the imprecision
inherent in data from small samples. Feasibility results do not
necessarily generalize beyond the inclusion and exclusion
criteria of the pilot design. A pilot study is a requisite initial
step in exploring a novel intervention or an innovative
application of an intervention. Pilot results can inform
feasibility and identify modifications needed in the design of a
larger, ensuing hypothesis testing study. Investigators should be
forthright in stating these objectives of a pilot study. Grant
reviewers and other stakeholders should expect no more. I found
another study where patients with metastatic CRC with BRAF
V600 mutations were recruited to an expansion cohort at the
previously determined maximum-tolerated dose of 960 mg
orally twice a day.

4. Reference
Davies, J. E., Manisty, C. H., Petraco, R., Barron, A. J.,
Unsworth, B., Mayet, J., ... & Francis, D. P. (2013). First-in-
man safety evaluation of renal denervation for chronic systolic
heart failure: primary outcome from REACH-Pilot
study. International journal of cardiology, 162(3), 189-192.
Kopetz, S., Desai, J., Chan, E., Hecht, J. R., O'Dwyer, P. J.,
Maru, D., ... & Issa, J. P. J. (2015). Phase II pilot study of
vemurafenib in patients with metastatic BRAF-mutated
colorectal cancer. Journal of Clinical Oncology, 33(34), 4032-
4038.
Bottom of Form
CASE STUDY
PROJECTMANAGEMENT
IN ACTION
Project Leadership Roles at TriHealth
TriHealth is a company that manages several large hospitals and
a variety of other health organizations, such as physical fitness
facilities and nursing services. Due to the company
’
s increasing size and complexity, TriHealth leadership decided
they needed to formally de-
fine roles of project executive sponsor, project leader,
performance improvement consultant, core team member, and
subject matter expert. These roles are shown below.
Project Executive Sponsor
Initiating Stage
•
Empower project leader with well-defined charter, which is the
overarching guide
•

5. Clearly define expected outcomes Demonstrate commitment to
and prioritization of
project
•
Define decision-making methods and responsibility
sponsor/project leader/team
•
Partner with project leader to identify obstacles, barriers, and
silos to overcome
Planning Stage
•
Ensure Project Leader understands business context for
organization
•
Ensure Project Leader develops overall project plan
•
Assist Project leader in developing vertical and horizontal
communication plan
•
Demonstrate personal interest in project by investing time and
energy needed
•
Secure necessary resources and organizational support
Executing Stage
•
Communicate and manage organizational politics
•
Visibly empower and support Project Leader vertically and
horizontally
•
Build relationships with key stakeholders
•
Actively listen to and promote team and project to Stakeholders
•
Remove obstacles and ensure progress of project
•

6. Ensure goals are met and Stakeholders are satisfied Closing
Stage
•
Ensure closure; planned completion or termination
•
Ensure results and lessons learned are captured and
shared
•
• Ensure assessment of related applications or opportunities
• Ensure any necessary next steps are assigned and resourced
• Recognize contributions and celebrate completion
Negotiate follow-up date(s) to assess project status
Project Leader
All of the roles listed are the ultimate responsibility of
the project leader. However, in the development of the
charter, the Sponsor and the Project Leader will have a
discussion about the Project Leader role. At that time,
the individuals will determine if the Project Leader
needs additional assistance or skills to facilitate the
project success and which of these responsibilities
need to be delegated to others with expertise in those
areas.
• Leads negotiation with Sponsor for charter definition.
• Collaborates with Sponsor to clarify expectations.
• Provides direction to the team with integrity, leader-
ship, and communication skills.
• Facilitates productive meetings and supports the
team’s decisions.

7. • Prepares the high-level work plan and timeline.
• Champions the project on the management level
and with the staff.
• Leads the implementation of the project.
• Manages project flow, including agenda setting,
meeting documentation, and coordination of team
assignments.
• Develops implementation, education, and commu-
nication plans for the project.
• Responsible for the team and project progress and
proactively intervenes to promote team and project
success.
• Identifies, communicates, and facilitates the re-
moval of barriers to enable successful project
completion.
•
Supports the team with tools and methodologies to accomplish
goals.
80
Part 1
Organizing Projects
• Facilitates collection and analysis of data.
• Leads the team in developing a plan to sustain the
change and monitor effectiveness.
• Leads team in developing recommended next steps.

8. • Closes project with Sponsor and assure lessons
learned are captured.
• Establish with Sponsor the dates for post-project
check-up and overall measurable effectiveness of
project.
Performance Improvement Consultant
If the Sponsor and the Project Leader determine additional
support/expertise is needed, a Performance Improvement
Consultant can provide the following
expertise:
• Provides direction to the Project Leader in establish-
ing targets and a measurement and monitoring
system.
• Mentors the Project Leader on leading the team
through the project management process.
• Collaborates with the Project Leader to prepare a
work plan and timeline for the project.
• Proactively intervenes to promote team and project
success based on teamwork and interactions.
• Assists the Project Leader in identifying, communicating,
and removing barriers to enable successful project completion.
• Assists in the researching of research, best practices, and
benchmarking.
• Coaches the Project Leader on the development and
implementation of a comprehensive communication, education,
and
change management plan.

9. • Provides the Project Leader support in assuring regular
communication
With the Sponsor and Stakeholders.
• Offers expertise to the team with tools and methodologies to
accomplish goals.
• Collaborates with the Project Leader on the collection and
analysis of data.
• Assures a system-wide perspective is considered and
downstream effects analyzed.
• Provides change management education and as-
sists the Project Leader in developing key strategies
for successful change management
• Provides coaching to the Project Leader on key strat-
egies for successful planning, implementation, and
sustainability of the project.
Core Team Member
• Takes responsibility for the success of the team.
• Attends meetings for duration of the project.
• Actively participates in team meetings.
• Understands the entire range of the project.
• Actively participates in the decision-making process.
• Supports the team’s decisions

10. .
• Completes outside assignments.
• Carries out many of the project activities; produces
deliverables on time.
• Provides testing or validation of decisions being
made by the team.
• Provides data collection and reporting.
• Participates in the communication, education, im-
plementation, and evaluation of the project.
• Gathers input from the areas they represent, if
appropriate.
•Shares team decisions and plans throughout the
project.
•May work directly with Stakeholders or Subject Mat-
ter Experts.
Subject Matter Expert
•Not a core team member of the team.
•Participates in demonstrations/presentations and/or
team meetings, as needed.
•Carries out project activities as assigned; produces
deliverables.
•Responsible for supplying requirements.
•Provides input to the team or complete activities
based on a specific expertise he or she possesses
that is essential to the project.