Project Design

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Overall Design

The project leveraged PDSA, or Plan-Do-Study-Act. PDSA is an iterative, four-stage problem-solving model used for improving a process or carrying out change.  The challenge of the multi-site, multi-PI, coalition-based project required an agile and responsive approach to understand and improve what “we didn't know. The design also allowed for formative outcomes from each stage of the PDSA process that will assist future planners and researchers to learn from the development of the project. 

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By bringing together a consortium of members, the project will include different perspectives and ideas on combination approaches and maintenance, but also had a pragmatic rationale--institutions from varying geographic areas would help answer questions of regionality regarding the real-world application of the findings. The collaborators include John Abraham, MD, an orthopedic oncology surgeon, Gerhard Maale, MD, an orthopedic surgeon, and R. Lor Randall, MD, an orthopedic surgeon. Dr. Abraham is affiliated with the Jefferson Musculoskeletal Oncology Center at the Kimmel Cancer Center, the Rothman Orthopaedic Institute, and the Dana Farber Cancer Center, one of the leading sarcoma centers globally. Dr. Maale is the founder of the Dallas Ft. Worth Sarcoma Group. Dr. Randall is affiliated with the UC Davis Comprehensive Cancer Center.  Having a range of expertise from along the patient journey will provide unique perspectives and aid in connecting both surgical and oncology communities to the findings.

 

Plan

The project was initiated in the Fall of 2021 with a Virtual Consortium Summit meeting with each PI and their respective member institutions for each location (Dallas, TX, Sacramento, CA, and Philadelphia, PA) via Zoom.

 

The outcome of this structured planning meeting was to develop the project's Aim Statement, which the faculty determined would be: To elucidate the scientific rationale and clinical evidence for the use of targeted systemic options in the management of TGCT through consideration of:

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• Histologic assessment of postoperative resections of patients who have received the drug with evaluation of the impact over different time points;

• Early oncologic outcomes such as the percent reduction of tumor volume seen on MRI or the symptomatic benefit to the patient;

• A review of the role of patient reported outcomes measures in developing patient-centric management approaches; and

• A Case Series of a set of real-world patients on systemic therapy; including the profile of their clinical presentation over time.

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We then moved into the development of the Process Map. This helped reveal gaps in care, emphasize the current barriers to optimal patient outcomes and illustrate examples of effective interventions.

 

This Process Map was reviewed and distilled into a Problem Statement that identifies causes of barriers and alternatives. One of the largest barriers was the recognition of the small number of patients there are to study, which impacted our study design and analysis. It was during this phase that the cross-institutional data parameters were determined and IRB initiated.

 

Do

The first action of the “Do” phase was a baseline data analysis of combined and de-identified patient cohort records from each institution. The initial segmentation was on ethnicity, race, age, sex and other demographic variables that may impact the findings. As determined during the Summit, inclusion criteria determined the cohorts and how best to measure the impact of combined systemic and maintenance therapy combined with surgery. Other demographics (ie, ethnicity and gender) were also evaluated. Data will be analyzed to assess how the maintenance of systemic therapy in combination with surgery, prior to and after the surgical intervention, sometimes called the “sandwich method,” enhances outcomes for patients with localized and diffuse TGCT. 

 

These data were distilled to case reviews to identify best practices across institutions. Gaps in care and missed opportunities (such as accounting for severity assessment) and how this, in turn, leads to a missed opportunity for referral and early treatment and side effect management by an oncologist and other multidisciplinary team members were evaluated. Patient engagement opportunities were also identified, including engaging the patient in shared decision-making and providing counseling about effective management of adverse events.

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Study

The group reconvened for a Virtual Consortium Summit II to assess the findings. An examination of the data as determined by the parameters to assess changes or improvements as described in the Aim Statement. 

 

Act

The consortium then coalesced these into a findings paper that includes what's left to be studied in future assessments. The results and implications are shared with the community here through this microsite and in our posters and abstracts as foundational to changing how providers approach TGCT. The findings are shared with the community and assessment tools are used to measure the impact of the project on perceptions and practices.