We have covered the first two steps in this multi-part series. In Step 1 we talked about assembling a team of experts to participate in the study project. In step 2 we identified the problem statement. Now, in Step 3 we will look how the study is conducted and the methodology used to structure the analysis.  

Quality studies are, by intent, a process that is used to help the cancer program grow and improve the patient care delivery process. They are not a boring, or unnecessary, task needed to meet a requirement. Conducting a quality study relies on each member of the team being committed to the process and what it brings to the table. The results cannot be assumed or forced without going through the discovery process. Skipping the planning of the methodology and analysis phase will prevent the team from exploring, following clues, and taking the necessary baby steps that lead to inspired and appropriate action.  

Much of the value in the project team’s work comes from the ideas that are generated during the planning phase. Using brainstorming sessions, process mapping or multi-voting, a process used to help narrow down the list of priorities, are all useful in identifying the criteria and data elements. This information also guides the team as they identify a nationally recognized study structure or framework of reference.     

The criteria used to evaluate the problem, or the study methodology, must identify the types of data needed to effectively evaluate the study topic or answer any quality-related questions that come out of the brainstorming sessions.

There are five general categories of quality problems:

1. Conformance, or unsatisfactory performance in a well-structured system where the team or patients are not happy with the system outcomes,
2. Unsatisfactory performance in a poorly structured system or a system where expectations are not clearly defined,
3. Efficiency problems stemming from the standpoint of the facility, providers or staff who perform their work within the system,
4. Product design problems that occur because of an incomplete or poorly structured product or service,
5. Process design problems resulting from gaps, lack of training or non-compliance with a prescribed process.

Understanding the type or category of the problem will point to the types of data or information to be gathered during the project. After identifying the problem category, use the following questions for further planning.   

• What population is identified in the problem statement? Such as gender, ethnicity, age, city of residence, or payor.
• What data sets are needed to analyze the problem? For example, cancer type, histology, stage, treatment modality, visit dates, in/out time stamps or clinic schedules,    
• What type(s) of data are needed to effectively study the problem? This question begins with identifying the category of the problem as described above then drilling down to identify the data type. If the study problem is looking at the scheduling problems for mammography screening, for example, then it may be an efficiency problem and the process used by the scheduling staff based on process flows and procedures.  
• Who will conduct the study and how will the results be compiled? Tasks should be assigned to the project team members and describe the deliverables and their due dates.

When the project team is confident that the study problem and methodology is clearly defined, they should take another look at the documented plan before launching the analysis. The team can review the plan to determine if the methodology is complete enough or suitable for answering the question(s) raised by the problem.   If it is not, then they can go back and adjust the plan where needed to answer the questions.   If all the questions are answered then the team can move to Step #4 and begin conducting the study.  

Identifying a nationally recognized framework or method to conduct the study does not need to be intimidating. There are many resources available to the cancer program to use as reference guides in conducting quality studies or to describe the various study methods, such as PDSA, GEMBA, DMAIC or other nationally recognized study frameworks.   These references can be found online, some for purchase or many available at no charge. Your facility’s Quality Improvement Department may also be able to help.

In summary, after the team is assembled and the problem statement clearly defined, the next step is planning the framework for how the team plans to collaborate and conduct the study activity. This methodology should be documented and shared with the team members prior to moving to the next step.   While it is not always known what the team will encounter or learn as they move through the study process, having a well-planned and agreed upon method for conducting the analysis keeps everyone on track and ultimately leads to a value-added outcome.

• Part 1: Creating a Team of Subject Matter Experts
• Part 2: Identifying the Problem 
• Part 3: Planning and Methodology
• Part 4: Conducting the Study According to the Methodology
• Part 5: Preparing the Summary Analysis
• Part 6: Benchmarking to Measure Performance
• Part 7: Corrective Action Plans for Lasting Improvement