Abstract
Keywords
Introduction
Variation in healthcare delivery processes have been widely studied at the patient-level (e.g. knowledge, preferences) and provider-level (e.g., attitudes and beliefs), (MacLaughlin et al., 2019; Perkins et al., 2013; Plourde et al., 2016); however, system-level factors are less well-documented (Kim et al., 2019). Heterogeneity in healthcare systems’ organizational structures, policies, and approach to decision-making influences practice implementation and care delivery. Research consortia, like the Population-based Research to Optimize the Cancer Screening Process (PROSPR), (Barlow et al., 2020; Kamineni et al., 2019; National Cancer Institute Division of Cancer Control and Population Sciences, 2021; UT Southwestern Medical Center, 2021) that aim to understand multi-level variation in the delivery of cancer screening care across health care settings, have helped to establish associations between care delivery stepsand outcomes (Barnes et al., 2018; Martin et al., 2017; Pruitt et al., 2018). Adding qualitative inquiry to the examination of cancer screening at diverse healthcare systems has the potential to produce a more complete understanding of the impact of care delivery and context on cancer outcomes. This helps inform future design of modifications to system-level processes and practical interventions that improve quality of care and outcomes (Lee et al., 2018; Persaud & Nestman, 2006).
The importance of harmonizing quantitative data in population health studies has been extensively discussed (Rolland et al., 2015; Sholle et al., 2017). Benefits include the ability to ask questions for which individual studies are underpowered and to focus on rare outcomes. Similarly, harmonizing qualitative data across heterogeneous settings would enable analyses to be conducted across the combined data set as a whole; this would be valuable for understanding the role of local context and variations in organization and management across multiple health systems and processes (Jenkins et al., 2018). However, less is known about the methodology for harmonizing qualitative data because most studies to date have been conducted in similar healthcare settings (e.g., small community organizations, clinics within a large managed care organization, the Veterans Administration) (Burau et al., 2018; Coronado et al., 2018; Damschroder et al., 2009, 2022; Hamilton et al., 2017). Given uniformity in organizational structure, such studies emphasized adherence to policies and procedures, adoption and integration of interventions to existing practices, and provider decision-making. Few have qualitatively studied clinical care delivery processes across diverse organizational settings, (Burau et al., 2018; Damschroder et al., 2009, 2022; Freeman et al., 2019) or across the cancer care continuum (Anhang Price et al., 2010; Scott, 2012).
Harmonization refers to processes of data integration – from different participants (e.g., individuals in various roles encompassing different responsibilities, decision-making authority, and activities in each setting), clustered in different organizational units (e.g., clinic, hospital, multi-hospital system), across sites. Thus, while preserving the context-relevant details at each site, harmonization requires identification of common data elements across heterogeneous care delivery processes to conduct meaningful analyses across diverse healthcare systems. Harmonization can be used to identify, for example, how organizational leaders decide and enact clinical guidelines, which in turn affect clinical practices. These analyses are then synthesized to identify targets for quality improvement that are potentially transferrable across sites to enhance care delivery in diverse systems.
Cervical cancer screening has become an increasingly complex process (Beaber et al., 2015); organizations must integrate evolving screening and management guidelines (Fontham et al., 2020; Perkins et al., 2020; US Preventive Services Task Force, 2018) that require data on an individual’s age, prior screening history, current screening modality and test results (Kinney et al., 2018). This integration involves multiple steps and interfaces (communication and transfer of responsibilities) across primary and gynecology care to provide care for women across the life course (Anhang Price et al., 2010; Beaber et al., 2015) and management commensurate with individual cancer risk (Kinney et al., 2018; Loomans-Kropp & Umar, 2019; Marcus et al., 2016). Because the effectiveness of screening relies on identifying and managing abnormal findings, (Anhang Price et al., 2010; Taplin et al., 2012; Zapka et al., 2010) differences in health insurer payer mix (e.g., use of public payer programs to cover the uninsured) may further complicate a healthcare system’s policy decisions on the delivery of screening services and management of abnormal results (Breen et al., 2019).
In this article, we illustrate a methodologic approach guiding qualitative data harmonization for the PROSPR Cervical Research Center, a large multi-site, mixed methods study evaluating cervical cancer screening care delivery across three diverse healthcare systems. We attend to both the context and the broader applicability of findings, and offer data sampling, collection, and analytic tools and techniques for strengthening qualitative claims. By sharing our framework, we advance use of qualitative methodology in implementation science, (National Cancer Institute, 2018) where assessing the role of context is key to responding to organizational challenges and shaping implementation strategies across multiple healthcare systems (Harrison & Grantham, 2018; Nilsen & Bernhardsson, 2019). We illustrate how harmonized data enables the production of aggregate findings and site-specific insights to inform system-level quality improvement across diverse healthcare systems.
Methods
Healthcare Settings
Healthcare System Characteristics of METRICS PROSPR II Cervical Research Center, 2010–2019.
aAs of 2019. Outpatient care centers may have multiple clinics or medical offices onsite as well as a laboratory department and a radiology facility.
bIncluding MD/DO fellows and residents, nurse practitioners and physician’s assistants providing primary care, specialty care (i.e., cervical procedure), or HPV vaccination services to at least one cohort member from 2010-19.
cSites differed in policies regarding screening strategies, particularly whether policies endorsed a particular screening modality. For example, MGB supported clinician discretion regarding Pap with reflex HPV versus co-testing; KPWA offered Pap only with reflex HPV until 2012, then added a co-testing option in 2013; PHHS has preferred Pap only with reflex HPV for average-risk women during the entire period and supports clinician selection of co-testing for under-screened women.
Sampling
We executed a multimodal qualitative data collection strategy consisting of participant observation, semi-structured interviews, and document analysis. The first step in the data harmonization process was to develop a data dictionary to define stakeholders and identify a common sampling strategy of target interview and observation participants. To promote consistency across healthcare systems, we grounded our sampling strategy in Barlow et al.’s (2020) cancer screening process model (Figure 1) (Barlow et al., 2020). Accordingly, we recruited participants from roles across the multiple phases of the clinical care continuum (e.g., detection, diagnosis, treatment), locations delivering each care step (e.g., primary care, dysplasia or gynecology clinics, pathology), specific duties and roles (see Table 2). Data harmonization requires a balance between uniformity and flexibility to accommodate heterogeneity in organizational structures and staffing across sites and must recognize variation of staff roles and responsibilities. For example, selection of interview and observation targets was tailored, in part, on whether particular care delivery policies and steps were managed by a centralized team (e.g., population health) versus local clinics, or physicians versus advanced practice providers (APPs). Thus, during a 3-day in-person conference and subsequent biweekly videoconferencing meetings, members of each site collaboratively developed a strategy to ensure that participants were sampled according to comparable duties/roles in the screening process model, regardless of their unique physical location at each site. Cancer screening process model, adapted from Barlow, et al. (2020). Footnotes: * Organ-specific screening modalities—Breast: mammography; Cervical: Pap or Pap/HPV (co-test); Colorectal: gFOBT/FIT, sigmoidoscopy, colonoscopy. † For cervical and colorectal detected abnormalities, excisional treatment may precede surveillance. ‡ Depends on cancer type and screening modality. Sampling Strategy of Exemplar Roles by Screening Process Phase, Location, and Duties.
Multi-Modal Data Collected by Role and Healthcare System.
Within our multimodal data collection strategy, observations generally preceded interviews in order to first obtain an initial understanding of organizational processes, key players, and roles. Individuals in leadership positions were purposefully selected for interviews to provide an overview of clinic functions and “big picture” concerns. Other individuals were selected for interviews based on their role as identified through observation or on the recommendation of the administrative leader. Documents were requested when they were identified during observation and interviews as being relevant to communication and documentation processes, e.g., letters from providers/clinics to patients; screen shots of EMR functions; and clinic policies and procedures. Data collectors at each healthcare system were responsible for identifying the most appropriate data collection modality and target participants based on the unique qualities of their organization.
Data Collection
We co-developed tools to structure data collection. Semi-Structured interview guides included questions informed by the overall research objectives: to better understand how clinicians understood and managed abnormal cervical pathology results; how they managed populations with elevated risk (e.g., women who are immunocompromised) or altered risk (e.g., women who are pregnant); and how they used their EHR systems, created workarounds, or identified gaps in care delivery. Observation guides directed the observer to assess potential areas of difference across healthcare systems, such as workflow patterns, communication among stakeholders, and use of the EHR. Document collection guides targeted key domains across systems, such as tailored guidelines for screening and management of abnormal results, scheduling forms and procedures, lab order forms and procedures, EHR processes, patient communication tools, and provider training documents.
As with the sampling strategy, master guides were then adjusted based on system-specific characteristics and individual informants’ responsibilities. For example, within the Texas system, the centralized dysplasia clinic within the OB/GYN department performed most of the follow-up procedures and surveillance tests for patients with abnormal screening results while at the Massachusetts system, some individual primary care practices and community health centers managed abnormal results locally. These local adjustments to the interview guides provided flexibility to also identify influential individuals who functioned as champions in their local settings and who may not be in leadership roles. Data were collected by local teams of qualitatively trained researchers from diverse disciplinary backgrounds (e.g., anthropology, psychology, medicine). Data collection strategically encompassed the entire cervical cancer screening continuum in each health system while also capturing variation at individual (e.g., roles and responsibilities) and system (e.g., centralized vs. de-centralized) levels. We obtained verbal informed consent from participants in observation and interviews in accordance with human subjects protocols approved by the Institutional Review Boards at each institution [UT Southwestern Medical Center #STU 2019-0979, Kaiser Permanente Washington Research Institute #1480422, and Mass General Brigham IRB #2019P002451].
Data Analysis
The research teams across the three healthcare systems shared data as it was collected through an online portal. Members from all three teams met in biweekly videoconferencing calls to assess appropriateness of data collection guides, identify gaps in sampling to adjust recruitment, and review findings to note commonalities and differences across systems. As such, data collection and analysis proceeded iteratively in a grounded theory approach, with intra-system development and inter-system comparisons continually informing data collection strategies, suggesting new theories of interpretation.
Systematic thematic coding commenced approximately half-way through the data collection process, with one healthcare system serving as the analysis hub based on capacity and expertise. Team members at the hub first reviewed approximately 60% of existing interview transcripts, interview field notes, and observation field notes to develop a codebook consisting of nodes and definitions corresponding to the cervical cancer screening process model and operational domains addressed in the interview guides. Coding also drew from the Consolidated Framework for Implementation Research (CFIR) (Damschroder et al., 2009) constructs to reflect internal and external organizational motivators, and from the Normalization Process Theory (May et al., 2018; McNaughton et al., 2020) (NPT) constructs to reflect actors’collective awareness and actions related to the screening delivery process. Integrating CFIR and NPT provides a more nuanced understanding of interactions among actors, processes, and contexts that can support the development of quality improvement strategies within unique settings (Schroeder et al., 2022). The analysis hub circulated the codebook draft to solicit feedback from data collection team members at the other health systems.
Coding Exemplar By Data Source, Theme, and Analytic Constructs.
aConsolidated Framework for Implementation Research (CFIR).
bNormalization Process Theory (NPT).
A non-coder member of the analysis hub conducted quality review checks on 10% of the sample to ensure consistency and enhance rigor. Members of the data collection team met monthly with the analysis hub to review and clarify any data that were unclear or could benefit from additional contextual understanding. Once all documents had been coded, members of the analysis hub created summary reports for each code to synthesize findings and extract representative quotes for major themes. Team members from all healthcare systems reviewed and discussed summary reports. Data management and analyses were facilitated by NVivo 12.0 (QSR Australia).
Finally, we harmonized data by comparing findings that were coded under the same thematic code (e.g., abnormal follow-up) that also shared at least one CFIR or NPT construct (e.g., intervention characteristics). Harmonized data could originate from any data source type (i.e., observation, interview, document) and involve any staff role (i.e., primary care provider, pathologist, specialist).
Results
As mentioned in Table 3, across the three healthcare systems we collected a total of 118 documents, and observed and conducted 84 total interviews with providers, ancillary staff, administrative leaders, EHR/IT professionals, pathologists, and cytologists. Findings are based on our analysis of these 202 total data sources, including interview transcripts, fieldnotes, and documents.
As a result of the harmonization process, we identified similarities and differences across health systems at various points in the screening process model. These areas indicate where process inefficiencies or opportunities for potential adaptation or improvement at one system might be tested in other health systems to enhance patient outcomes. For example, at both Systems B and C, processing of abnormal results was centralized in the pathology department; however, communication of abnormal results differed. At System B, results were communicated individually from pathology to ordering providers, whereas at System C, pathology sent weekly aggregrated reports to centralized dysplasia clerks who then communicated abnormal diagnoses to patients and scheduled follow-up appointments; ordering providers were notified by EHR inbox. The process exemplified at System C presented a potential process improvement opportunity for the other healthcare systems.
Harmonization Insights Across Health Systems by Thematic Codes and Constructs.
aConsolidated Framework for Implementation Research (CFIR).
bNormalization Process Theory (NPT).
Discussion
In this article, we provided selected excerpts to illustrate how we harmonized qualitative data sampling, collection, and analysis across three diverse healthcare systems using cervical cancer screening care as an exemplar care delivery process. To enable systematic comparison, a consistent sampling strategy aligned participant roles with process model phases from Barlow et al.’s cancer screening model. The shared conceptual model facilitated discussion among team members and allowed us to identify commonalities and differences in the care continuum across systems while offering flexibility to accommodate local contextual variation in actual decision-making authority and responsibilities of individuals across the continuum. Interviewing and observing healthcare providers in diverse roles provided insight into variations in processes within healthcare systems that identify opportunities for potential intervention (Weiner et al., 2012).
Using the cervical cancer screening process as an exemplar, we demonstrate how qualitative data harmonization is an underutilized tool that can greatly enhance multi-site system comparisons to highlight opportunities for cross-system learning and quality improvement. Identified commonalities based on aggregate findings from multiple healthcare systems increases relevance and potential feasibility that may motivate stakeholders for planned initiatives. As opportunities for future interventions are identified, implementation strategies can be developed to leverage local variation (Bracher & May, 2019; Hawe et al., 2009). Knowledge of local context across multiple system settings, then, should lead to greater feasibility for dissemination to diverse systems (Gold et al., 2016).
Our methodology posed several challenges in its operationalization. The COVID-19 pandemic disrupted our data collection efforts, specifically hindering observational research as the healthcare systems reduced services and limited access. As a result, we adjusted our strategy and emphasized document collection to reduce response burden on clinical partners who necessarily prioritized COVID-related clinical responsibilities. Additionally, interview data reflect processes before and during COVID-19 as systems responded to the pandemic by modifying clinic workflows (e.g., prioritizing or delaying procedures, increasing telehealth appointments). Analytically, multi-sited primary data collection is resource intensive, requiring local experts at each study site and strong communication to manage and coordinate qualitative data collection and analysis. Social distancing prevented the study team from meeting in-person and the impact of relying solely on virtual communications to harmonize our data across sites is not clear.
Understanding the impact of multi-level factors on care delivery processes and outcomes is a growing area of research. By examining cervical cancer screening and follow-up processes and the different forms in which care can be delivered, findings from harmonized qualitative data can produce greater insight into harmonized quantitative data by identifying potential factors affecting cervical cancer screening utilization and outcomes across settings (Hawe et al., 2004). Our approach also has implications for screening and management of abnormal results in other preventive services. Systematically collecting and harmonizing qualitative data from stakeholders at each step in the screening continuum elucidates the impact of process factors and may accelerate efforts to identify potential interventions with greater likelihood of adoption.
By illustrating how we have harmonized qualitative data from three different healthcare systems, we hope this description enables others to apply our theory-driven methodologic framework to further advance implementation science in other disease contexts. In the United States, healthcare settings are quite diverse in their organizational structures, resources, and challenges; better understanding of their heterogeneity can shape selection of implementation strategies and better predict what adaptations to strategies would be needed across different health systems. As a whole, more rigorous qualitative investigation should better elucidate the impact of process factors and accelerate efforts to identify intervention opportunities to improve healthcare delivery.
Footnotes
Acknowledgments
Declaration of conflicting interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Kruse has a family financial interest in Dimagi Inc., a digital health company. All other authors declare no conflict of interest.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Cancer Institute at the National Institutes of Health, UM1CA221940.
Research ethics
We obtained verbal informed consent from participants in observation and interviews in accordance with human subjects protocols approved by the Institutional Review Boards at the University of Texas Southwestern Medical Center (STU 062017-102), Mass General Brigham (2019 P0002451) and Kaiser Permanente Washington (1480422-6).
