Assessing the impact of privacy-preserving record linkage on record overlap and patient demographic and clinical characteristics in PCORnet®, the National Patient-Centered Clinical Research Network.

OBJECTIVE: This article describes the implementation of a privacy-preserving record linkage (PPRL) solution across PCORnet®, the National Patient-Centered Clinical Research Network. MATERIAL AND METHODS: Using a PPRL solution from Datavant, we quantified the degree of patient overlap across the network and report a de-duplicated analysis of the demographic and clinical characteristics of the PCORnet population. RESULTS: There were ∼170M patient records across the responding Network Partners, with ∼138M (81%) of those corresponding to a unique patient. 82.1% of patients were found in a single partner and 14.7% were in 2. The percentage overlap between Partners ranged between 0% and 80% with a median of 0%. Linking patients' electronic health records with claims increased disease prevalence in every clinical characteristic, ranging between 63% and 173%. DISCUSSION: The overlap between Partners was variable and depended on timeframe. However, patient data linkage changed the prevalence profile of the PCORnet patient population. CONCLUSIONS: This project was one of the largest linkage efforts of its kind and demonstrates the potential value of record linkage. Linkage between Partners may be most useful in cases where there is geographic proximity between Partners, an expectation that potential linkage Partners will be able to fill gaps in data, or a longer study timeframe.

Establishing a framework for privacy-preserving record linkage among electronic health record and administrative claims databases within PCORnet®, the National Patient-Centered Clinical Research Network.

OBJECTIVE: The aim of this study was to determine whether a secure, privacy-preserving record linkage (PPRL) methodology can be implemented in a scalable manner for use in a large national clinical research network. RESULTS: We established the governance and technical capacity to support the use of PPRL across the National Patient-Centered Clinical Research Network (PCORnet®). As a pilot, four sites used the Datavant software to transform patient personally identifiable information (PII) into de-identified tokens. We queried the sites for patients with a clinical encounter in 2018 or 2019 and matched their tokens to determine whether overlap existed. We described patient overlap among the sites and generated a "deduplicated" table of patient demographic characteristics. Overlapping patients were found in 3 of the 6 site-pairs. Following deduplication, the total patient count was 3,108,515 (0.11% reduction), with the largest reduction in count for patients with an "Other/Missing" value for Sex; from 198 to 163 (17.6% reduction). The PPRL solution successfully links patients across data sources using distributed queries without directly accessing patient PII. The overlap queries and analysis performed in this pilot is being replicated across the full network to provide additional insight into patient linkages among a distributed research network.

An analysis of patient-provider secure messaging at two Veterans Health Administration medical centers: message content and resolution through secure messaging.

OBJECTIVE: We sought to understand how patients and primary care teams use secure messaging (SM) to communicate with one another by analyzing secure message threads from 2 Department of Veterans Affairs facilities. METHODS: We coded 1000 threads of SM communication sampled from 40 primary care teams. RESULTS: Most threads (94.5%) were initiated by patients (90.4%) or caregivers (4.1%); only 5.5% were initiated by primary care team members proactively reaching out to patients. Medication renewals and refills (47.2%), scheduling requests (17.6%), medication issues (12.9%), and health issues (12.7%) were the most common patient-initiated requests, followed by referrals (7.0%), administrative issues (6.5%), test results (5.4%), test issues (5.2%), informing messages (4.9%), comments about the patient portal or SM (4.1%), appreciation (3.9%), self-reported data (2.8%), life issues (1.5%), and complaints (1.5%). Very few messages were clinically urgent (0.7%) or contained other potentially challenging content. Message threads were mostly short (2.7 messages), comprising an average of 1.35 discrete content types. A substantial proportion of issues (24.2%) did not show any evidence of being resolved through SM. Time to response and extent of resolution via SM varied by message content. Proactive SM use by teams varied, but was most often for test results (32.7%), medication-related issues (21.8%), medication renewals (16.4%), or scheduling issues (18.2%). CONCLUSIONS: The majority of messages were transactional and initiated by patients or caregivers. Not all content categories were fully addressed over SM. Further education and training for both patients and clinical teams could improve the quality and efficiency of SM communication.

Foraging for Information in the EHR: The Search for Adherence Related Information by Mental Health Clinicians.

In this project we sought to qualitatively describe clinician's search for information related to the complex construct of adherence. Nineteen think aloud observations and semi-structured interviews were conducted with mental health providers as they prepared for a patient visit. The transcripts were coded according to constructs from information foraging theory (information goal, patch, scent, enrichment, and opportunity cost). The search strategies uncovered were complicated: provider's searches were sometimes multi-staged (e.g. a search of the EHR led to further enquiry when interviewing the patient), and involved multiple 'patches' (i.e. data from the EHR, the patient and other providers were all sought out). In addition, some information that providers considered relevant to understand adherence related questions was non-obvious (e.g. the absence of specific information was considered a useful cue). Providers' information search strategies for complex constructs are at times non-intuitive; implications for the design of EHR summarization tools are discussed.

Data monitoring committees for pragmatic clinical trials.

In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical trials require careful consideration when developing interim data monitoring plans, and trial sponsors, investigators, and data monitoring committees should agree on a plan before trial inception. Finally, special expertise, such as an informatics, may be helpful on data monitoring committees for some pragmatic clinical trials. Patient representatives may provide particularly valuable insights in the monitoring process.