Doctoral DissertationProspectus PaperTemplate
Australian Expert Writers
School of Business(SB)
Version: December 2017© Northcentral University, 2017
Submitted to Northcentral University
Graduate Faculty of the School of Businessin Partial Fulfillment of theRequirements for the Degree of
San Diego, CA
Statement of the Problem 2
Purpose of the Study 2
Research Questions 2
Brief Review of the Literature 2
Theme/Sub-Topic 1 2
Theme/Sub-Topic 2 2
Research Method 2
Operational Definition of Variables 2
Appendix A Using the Microsoft Word References and Bibliography Tools 2
Appendix B Working with Lists of Document Contents 2
Appendix C Working with Figures and Tables 2
Radiopharmaceuticals used in molecular and nuclear imaging serve a vital purpose in patient care (Donde et al, 2013). Such imaging provides a unique functional and therapeutic resource for the physician whose patients face cardiovascular, neurologic, and oncologic disease challenges (Hughes, 2012). However, the impending continued challenges with acquiring the radiopharmaceutical and the additional cost pressures in the supply chain are posing challenges for organizations both financially and operationally (Filzen et al, 2017).
Radioactive Component Issues
Mo99 is a radionuclide whose decay (daughter) product, Tc99m, is the isotope of choice used in SPECT diagnostic imaging (Radioactive Isotopes in Clinical Medicine and Research, 2002). In the United States, approximately 50,000 patients are imaged daily using SPECT; Tc99m is the most widely used radioisotope in diagnostic nuclear medicine, it is radiolabeled to chemical ligands for injection to visualize the heart, lungs, brain, bone, and other organs, thus revealing physiological and functional capabilities or alterations in normal function (Gulli et al, 2019). It is estimated that more than 80% of the nearly 25 million diagnostic nuclear medicine studies conducted annually are performed with this single isotope (High Level Group, 2016).
Currently, Mo99 is produced by seven foreign nuclear research reactors, whose supply chain has been shaky. In 2009, unexpected research reactor shutdowns reduced the world’s supply of Mo99 to less than one-half of the world demand and negatively affected the entire diagnostic imaging community (Host, 2016). The shortage raised serious questions domestically about an aging research reactor fleet and the dependence on international reactors to produce Mo99. In addition, the growing threat of international terrorist groups attempting to acquire the radioactive material by product (HEU) to build nuclear or “dirty” bombs was identified as a security risk. In response, the United States and the international community took several steps to ensure a long-term reliable Mo99 supply, including investing in commercial domestic companies to eliminate the use of HEU in Mo99 production and increase the stability of supply.
Non-Radioactive Component Issues
Additionally, manufacturing of the nonradioactive portion (ligand) of the final Tc99m radiopharmaceutical is also costly and difficult to acquire. During the past 20 years, manufacturers have divested away many generic pharmaceuticals (known as “cold kits”) that are chemical or protein links to the Tc99m moiety, and consolidation within the industry has seen the emergence of sole-source, proprietary producers (Duong, 2019).
One main factor driving pharmaceutical price increases is drug shortages. According to the FDA, one of the most common reasons drug shortages occur is due to quality/manufacturing issues with the final product (Center for Drug Evaluation and Research, 2017) However, there are several other reasons that pharmaceutical companies experience drug shortages, including production delays, delays experienced in the delivery of raw materials, contract manufacturing and technology transfer , and discontinuations within the product portfolio or changing pharmaceutical life cycle management strategies where the FDA cannot require a firm to continue to manufacture a drug it wants to discontinue, especially if newer, more profitable drugs can be produced instead (Center for Drug Evaluation and Research, 2017)
These shortage and cost increase issues have been an area of focus over the past few years especially as it relates nontraditional price hikes on these generic pharmaceuticals, also known in the radiopharmaceutical industry as “cold reagent kits” or “cold kits.” For purposes of clarity, a nontraditional single price increase can range from several hundred to several thousand percent. This trend costs end users hundreds of thousands of dollars, and is unfortunately becoming more commonplace (Nisen, 2015).
The Revenue Cycle Issue
Although a bundled payment system is presently widely believed to be the most effective reimbursement method for controlling costs, in the future it could present health care organizations with a significant challenge. The cost of a prepared radiopharmaceutical could become the dominant part of the total procedure cost, potentially turning the bundled reimbursement into a loss leader and forcing health care organizations to either bear the full burden of market price increases from their own budgets or choose to perform less efficacious diagnostic tests, which could potentially lead to unfavorable patient outcomes or may force patients to other imaging studies.
Statement of the Problem
For over 10 years, the nuclear medicine market has experienced several challenges related to the acquisition and stability of supply of the radioactive component MO-99 (molybdenum 99) and non-radioactive components needed to produce the isotope used most in nuclear medicine diagnostic exams (NAS, 2016). The U.S. is one of the largest global consumers of these isotopes not responsible for manufacturing these domestically, and that has presented challenges of its own (Schwartz, 2015). However, since the global industry shortages have occurred, it is believed that many healthcare providers look to diagnose patients through other imaging modalities to ensure adequate treatment (Gannon, 2017.)
If this type of behavior in the market continues, there is potential to be economic and/or clinical implications that arise from this shift in care. The cost of these radiopharmaceuticals are rising at levels that reimbursement may not be able to sustain, forcing healthcare leaders to determine best methods in their facilities to continue to achieve superior patient outcomes.
Purpose of the Study
The purpose of this qualitative study is to better understand the decision criteria healthcare management uses to determine what diagnostic imaging study clinicians should use in place of a preferred nuclear medicine study in times of intermittent product shortages of Molybnenum-99.
The study design that will be implemented for this study will be using a descriptive case study design focused on in depth interviews.
The construct of this study will focus on decision making criteria and the creation and implementation of standard operating procedures.
In this study, the imaging study chosen (the dependent variable) is dependent on the choice made by healthcare management. The independent variable(s) are how healthcare management make these decision (i.e. either clinical or financial).
The target population is the nuclear medicine healthcare providers in the United States.
The setting for this qualitative research will be conducted in the healthcare facility’s natural setting. There will be no manipulation of the environment and will not have experimental and control groups.
Sample frame will be radiology business managers in Academic Medical Centers and/or Large IDNs in the United States.
Concept sampling will be used in this study. The researcher will select prestigious major academic medical centers and/or integrated delivery networks (IDNs) to sample for this study.
To adequately make inferences about a population from a sample, it is best to use 3 or more the most prestigious academic medical centers or IDNs. This should give the study validity offer sufficient statistical power due to their industry leading status in the U.S. Healthcare Market.
Data collection method (including instrumentation)
Data collection will primarily include in-depth interviews and/or focus groups depending on the facility. This will be achieved through semi-structured using interview forums to include but not limited to the surveyor’s open-ended questions.
Data analysis method
Data analysis will be performed primarily through extracts from field notes and interview transcripts.
Software to be used for analysis
The software to be used will be excel.
This study looks to uncover the decision making process of clinicians or business managers decide what diagnostic imaging study will be performed in the event the nuclear medicine study is not able to be performed due to intermittent industry shortages. This study will outline the how they determined the study or choice, who helps make these decisions and how high up the management chain these decisions are made.
When there is a product shortage of Moly99, what does your organization do?
What other studies do you send patients to?
How do you decide which studies patients will get?
Who helps make the decision for which studies patients will get?
How many departments are involved in the decision?
How far up the chain does this go to make this decision? (i.e. CFO)
Who makes the call when the product is available to bring the patients back to Nuclear medicine – or do they continue to stay with the other imaging modality?
What can healthcare providers do to mitigate loss to another modality?
What other things need to be considered when making a change to anther modality?
Select a method and design appropriate for a PhD study. PhD quantitative studies must demonstrate both internal and external validity (e.g., large, random samples, statistical power and representativeness). Qualitative studies must demonstrate validity within the context of the specific qualitative design (e.g., credibility, dependability, transferability, trustworthiness). Replication studies are not permitted. Your summary must address the following:
Note a specific method and design you plan to use in your research.
Describe and substantiate the appropriateness of the method and design to respond to the stated problem, purpose, and research questions.
Note how the proposed method and design accomplish the study goals, why the design is the optimum choice for the proposed research, and how the method aligns with the purpose and research questions.
Provide appropriate foundational research method support for the proposed study design.
Explain the particular data gathering techniques and data analyses processes. Sample size of the study population should be identified and must be appropriate and justified based on the nature of the study design. Quantitative analyses must include justified sample size determination.
Length: 2-3 pages, not including title and reference pages
Because the research plan is in the prospectus paper stage, a highly detailed research design is not expected – this is a preliminary work. The prospectus paper, however, does provide a foundation for the next step in the dissertation process, the development of the proposal. A well-conceived, well written and well researched prospectus paper serves as a foundation for the remainder of dissertation work. Dissertation research is an iterative and often recursive process. Students should expect to revise numerous times before each milestone document is finalized. Although not required at this stage, students and faculty may find it useful to review the dissertation proposal template to begin to consider what will be required at the proposal stage, for example, design details and ethical considerations.
Note: If students wish to provide additional subheadings to organize the content of the discussion in this section, the dissertation proposal template Ch. 3 subheading wording/organization/format should be followed rather than developing unique subheadings.
[Text… Discuss the proposed research method (quantitative, qualitative, or constructive). An Applied Research study (DBA) must reflect an applied study goal and demonstrate validity within the context of the chosen research design and overall scientific rigor. Case studies, action research, and program development/ evaluation are appropriate.
Academic research in a Ph.D. program using quantitative studies must demonstrate both internal and external validity (e.g., large, random samples, statistical power and representativeness). Statistical analysis of existing data resources or survey results are appropriate examples
Qualitative studies must demonstrate validity within the context of the specific qualitative design (e.g., credibility, dependability, transferability, trustworthiness). Replication studies are not permitted. Case studies, narrative analysis, and ethnographies are appropriate examples.
Constructive research should provide a measurable benefit to the academic community in the form of an artifact, extension of an artifact, or application of an artifact in a new way.
A clear rationale behind the chosen questions for study, the particular data gathering techniques and data analyses should be provided. Clear decision paths are provided based on the associated research method/design. Sample size and method must be appropriate and justified based on the nature of the study design. Quantitative analyses must include justified sample size determination. Given an appropriate rationale for replication, replication studies in an original context are permitted. Constructive research studies involve the creation, design, application, etc. of an artifact as well as measurement of success in meeting your stated goal. Your research design and success measurements should be justified with appropriate evidence from similar studies.
In this section, describe and substantiate the appropriateness of the method and design to respond to the stated problem, purpose and research questions. The discussion should not simply be a listing and description of research designs; rather, elaboration demonstrates how the proposed method and design accomplish the study goals, why the design is the optimum choice for the proposed research, and how the method aligns with the purpose and research questions. Provide appropriate foundational research method support for the proposed study design; for example, refer to Moustakas and other appropriate authors to describe a phenomenological design and Yin to describe the appropriate application of a case study design.
Note: Avoid introductory research design and analyses descriptions as well as excessive reference to textbook authors such as Creswell and Neuman. General research methods textbooks are not intended to provide the detail needed to implement qualitative research designs. Do not provide detailed descriptions of particular methods or designs that were not chosen.]
Operational Definition of Variables
(Quantitative/Mixed Studies Only. Delete this section if the proposed study is qualitative or constructive.)
[Text (optional)… Identify each of the primary constructs associated with the research question(s), and hypotheses. Include a brief overview of how each will be operationally defined for the proposed study. Operational definitions should be based on published, validated, research and instruments (describe and document how previous authors and/or the proposed instrument operationally defined each variable construct. Note: Operational Definitions are distinct from the Definition of Terms.]
Construct/Variable 1. Description/Operational Definition.
Describe each variable, the nature of the variable (e.g., nominal, ordinal, interval), how each variable will vary (e.g., the range 1 – 5, 0 – 100) or levels (low, medium, high; male, female) and the data sources (e.g., archival data, survey items, and if appropriate, how the specific scores (categories, etc.) used in the analysis will be derived from the raw data such as summing or averaging responses to survey items or assessments.). Review the previous, established use of proposed instrument, the nature of the variable data collected and analytics for examples.
Note: Dissertations are not typically appropriate sources for instruments and operational definitions. Consult the Dissertation Center for guidance on locating pre-existing instruments. Also, review peer-reviewed, published empirical research related to the research topic for potential pre-existing study instruments that may be used as is or adapted with author(s) permission for the purpose of the study.
Consult research design sources (including Dissertation Center resources) and ensure that the measurement level of each variable and the expected distributional characteristics of the data are appropriate to, and meet the assumptions of, the proposed statistical analyses (for example, is it likely that the responses will be normally distributed?) Become familiar with non-parametric alternatives to parametric tests toaccount for the possibility that the data do not meet parametric assumptions. See the Dissertation Center for more information.
[Text…Provide a brief description of how study data will be collected, measured and analyzed. Describe the proposed instrument. Please note that survey self-development should be considered only after an exhaustive search for an existing validated instrument. In addition, survey self-development will require a multi-step development and validation process, including pilot testing. (See the Dissertation Center (Research Methods Help/Research Workshop) for a tutorial on the multi-step development and validation process for a survey instrument). Review the scholarly literature for examples of how relevant concepts have been measured in the past.
For a constructive study, provide justification for your proposed measurements and metrics such as examples from previous attempts to solve the same or similar problem.
Although a highly detailed description is not required at the Prospectus Paper stage, study variables must demonstrate appropriateness to the study purpose and meet the assumptions of the proposed statistical tests. For qualitative studies, describe the proposed instrument or collection (e.g., interviews, observations), and how concepts will be coded and analyzed as appropriate to the proposed design based on primary qualitative research methods and design authors. Include appropriate support for the application of the proposed design. Consult research design and analysis sources including those available in the Dissertation Center for guidance.]
Center for Drug Evaluation and Research. (2017). Frequently asked questions about drug shortages. Question 3: How many drug shortages were there between 2011 and 2015? And do we expect fewer, as many, or more shortages in the future? Food and Drug Administration website.http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm – q3. Accessed March 21, 2019
Center for Drug Evaluation and Research. (2017) Frequently asked questions about drug shortages. Food and Drug Administration website. https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm. Accessed March 21, 2019.
Dondi, M., Kashyap, R., Pascual, T., Paez, D., & Nunez-Miller, R. (2013). Quality Management in Nuclear Medicine for Better Patient Care: The IAEA Program. Seminars in Nuclear Medicine, 43(3), 167–171. https://doi-org.proxy1.ncu.edu/10.1053/j.semnuclmed.2012.11.006
Filzen, L. M., Ellingson, L. R., Paulsen, A. M., & Hung, J. C. (2017). Potential Ways to Address Shortage Situations of 99Mo/99mTc. Journal of Nuclear Medicine Technology, 45(1), 1–5. https://doi-org.proxy1.ncu.edu/10.2967/jnmt.116.185454
Gulli, L. F., Cataldo, L. J., Suvan, J., & Mori, A. (2019). Single Photon Emission Computed Tomography (SPECT). Retrieved from https://search-ebscohost-com.proxy1.ncu.edu/login.aspx?direct=true&db=edsgvr&AN=edsgcl.2491200464&site=eds-live
High-level Group on the Security of Supply of Medical Radioisotopes. (2016) Nuclear Energy Agency website. http://www.oecd-nea.org/med-radio/security/. Accessed March 21, 2019.
Host, V. (2016). IRE ongoing effort to develop reliable LEU Mo-99 supply. Mo-99 topical meeting.
Hughes, S. J. (2012). Nuclear medicine functional imaging of the brain. Clinical Medicine, 12(4), 364–368. Retrieved from https://search-ebscohost-com.proxy1.ncu.edu/login.aspx?direct=true&db=a9h&AN=79100300&site=eds-live
Nisen M. (2015). Massive, unexpected drug price increases are happening all the time. Quartz website. https://qz.com/514553/massive-unexpected-drug-price-increases-are-happening-all-the-time/. Published October 1, 2015. Accessed April 2019.