Part A (Completed, June – August 2024):

A group of 5 Radiation Oncologists (ROs) with expertise in treating rectal cancer formed a rectal cancer quality audit group under the umbrella of Gastrointestinal Oncology Society of India (GIOS). The group represented institutions from diverse geographical [Northern (SM), Western (RK, SL), Southern (RM) and Eastern (MAS) India], administrative [public sector (RK, SM, RM) and private sector (SL and MAS)] as well as clinical [high patient volume (RK, SM, MAS) and medium patient volume (SL and RM)] contexts. Three out of five members have additional experience working with the Quality Improvement program of the National Cancer Grid of India (NCG - QI).

The ASTRO document on quality metrics was reviewed comprehensively by the group. The list of quality metrics was grouped into three categories –

1. Pre-treatment Workup
2. Radiotherapy Planning and Delivery
3. Follow up

An online survey form was created, consisting of each of the ASTRO metrics along with modifications for adapting to LMIC context (wherever applicable). All the five members were asked to vote on each of the metrics. ‘Full agreement’ with the metric (or the suggested modification) was voted as yes, ‘full disagreement’ as no, and ‘need for further discussion’ as maybe.

Subsequently, all the group members participated in two online meetings for further discussion. The relevance of each metric along with feasibility in documenting and implementing in LMIC context were extensively discussed. All the metrics that were voted as ‘maybe’ in the initial online survey were deliberated upon, and consensus was arrived at. Whenever there was a disagreement between members, a pre-specified threshold of 75% majority was considered for decision making.

In addition, an operational classification of the metrics across the domains into ‘essential’ and ‘optional’ was proposed through consensus, to accommodate the diversity in the availability of infrastructure, expertise and resources for implementation within the LMIC context. For each of the metrics across three categories ASTRO Expert panel has established a set of benchmarks referred to as the ‘Acceptable proportion’ against which the compliance of our patients will be documented and analyzed . This would be mandatory to be achieved for each of the essential metrics and as per institutional feasibility for optional metrics in our study.

Part B:

The modified quality metrics (QUARRC metrics) agreed upon in part A will serve as benchmarks against which all the five participating centers will evaluate their existing practice (current-state analysis).

Objectives of this retrospective evaluation will be -

1. To evaluate the documentation and implementation of QUARRC metrics across the five centers.
2. To identify the problem statements, root causes and key drivers for metrics that could not be documented / implemented at each center, using the A3QI methodology
3. To design interventions directed at improving the documentation and implementation of these metrics in a prospective manner (Part C)

Documentation and implementation of QUARRC metrics will be captured in electronic case record forms (eCRFs).

All metrics that are not documented / implemented as per the pre-defined acceptability criteria (as determined in Part A) will be included for current state analysis using established quality improvement methodology. Process mapping will be done to understand the potential causes and a fish bone analysis will be used to classify the root causes for non-compliance related to each metric. Recurrent factors will be identified using Pareto analysis and key drivers will be derived.

Once the key drivers are derived, each center will analyze the key drivers through a feasibility matrix, to understand the feasibility and potential impact of interventions aimed at improving compliance to each of the metrics. Considering the multi-centric context of the study, it is agreed upon that the interventions aimed at improving essential metrics will preferably (though not mandatorily) be implemented by all centers, while those targeting optional metrics will be further refined by each center based on local context and feasibility analysis.

Part C:

Objectives of this prospective component of the study will be –

           1.          To evaluate the feasibility of implementing the key interventions derived from Part B, in a multi-centre context

           2.          To evaluate the impact of the key interventions on documentation / implementation of QUARRC metrics in a multi-centre context

           3.          To identify the barriers for implementing the key interventions in a multi-center context

Once the key interventions are determined for each metric from Part B, implementation will be done in a systematic manner by each center. The acceptability criteria defined for each metric determined from Part A will serve as a general benchmark for determining SMART (Specific, Measurable, Achievable, Relevant and Time-bound) goals. However, to accommodate the multi-centre context of this study, and the potential for variability in problem statements / key drivers / interventions for each of the metrics, each center will be allowed to formulate context-specific SMART goals and pre-specify them before initiation of Part C. Impact of the interventions and the progress of implementation will be documented and monitored using run-charts for each metric.

Part D:

Objective of this prospective component of the study will be –

           1.          To evaluate the sustainability of the key interventions implemented successfully in Part C.

           2.          To identify barriers for sustaining effective interventions in a multi-centre context.

For all the metrics in which targets could be achieved in Part C, run charts will be used for documentation of sustainability. Achievement of goals at a minimum of three consecutive time points will be considered sustainable. 

During the entire course of the study, all the principal investigators will meet at monthly intervals (online) to update the status of the study at their respective centers. A cross-sectional analysis will be done at the end of Parts B, C and D separately to identify common / recurrent themes in multi-centre context.

Documentation and implementation of QUARRC metrics will be captured in electronic case record forms (eCRFs)

All metrics that are not documented / implemented as per the pre-defined acceptability criteria (as determined in Part A) will be included for current state analysis using established quality improvement methodology. Process mapping will be done to understand the potential causes and a fish bone analysis will be used to classify the root causes for non-compliance related to each metric. Recurrent factors will be identified using Pareto analysis and key drivers will be derived

Once the key drivers are derived, each center will analyze the key drivers through a feasibility matrix, to understand the feasibility and potential impact of interventions aimed at improving compliance to each of the metrics.

Impact of the interventions and the progress of implementation will be documented and monitored using run-charts for each metric.

Achievement of goals at a minimum of three consecutive time points will be considered sustainable. 

All data will be captured in electronic CRFs in the form of excel sheets. The eCRFs of all anonymized patients from each center will be evaluated by individual centers and a master excel sheet without any patient identifiers will be created by each center. Individual eCRFs will not be shared between centers, while master excel sheets with anonymized data will be shared for analysis. Each center will reserve their unconditional right to present / publish the outcomes of their individual institutional data. Separate MoUs (Memorandum of understanding) will be entered into with each participating center, documenting the data sharing policy.