Patients' and Members of the Public's Wishes Regarding Transparency in the Context of Secondary Use of Health Data: Scoping Review.

BACKGROUND: Secondary use of health data has reached unequaled potential to improve health systems governance, knowledge, and clinical care. Transparency regarding this secondary use is frequently cited as necessary to address deficits in trust and conditional support and to increase patient awareness. OBJECTIVE: We aimed to review the current published literature to identify different stakeholders' perspectives and recommendations on what information patients and members of the public want to learn about the secondary use of health data for research purposes and how and in which situations. METHODS: Using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, we conducted a scoping review using Medline, CINAHL, PsycINFO, Scopus, Cochrane Library, and PubMed databases to locate a broad range of studies published in English or French until November 2022. We included articles reporting a stakeholder's perspective or recommendations of what information patients and members of the public want to learn about the secondary use of health data for research purposes and how or in which situations. Data were collected and analyzed with an iterative thematic approach using NVivo. RESULTS: Overall, 178 articles were included in this scoping review. The type of information can be divided into generic and specific content. Generic content includes information on governance and regulatory frameworks, technical aspects, and scientific aims. Specific content includes updates on the use of one's data, return of results from individual tests, information on global results, information on data sharing, and how to access one's data. Recommendations on how to communicate the information focused on frequency, use of various supports, formats, and wording. Methods for communication generally favored broad approaches such as nationwide publicity campaigns, mainstream and social media for generic content, and mixed approaches for specific content including websites, patient portals, and face-to-face encounters. Content should be tailored to the individual as much as possible with regard to length, avoidance of technical terms, cultural competence, and level of detail. Finally, the review outlined 4 major situations where communication was deemed necessary: before a new use of data, when new test results became available, when global research results were released, and in the advent of a breach in confidentiality. CONCLUSIONS: This review highlights how different types of information and approaches to communication efforts may serve as the basis for achieving greater transparency. Governing bodies could use the results: to elaborate or evaluate strategies to educate on the potential benefits; to provide some knowledge and control over data use as a form of reciprocity; and as a condition to engage citizens and build and maintain trust. Future work is needed to assess which strategies achieve the greatest outreach while striking a balance between meeting information needs and use of resources.

The validity of diagnostic algorithms to identify asthma patients in healthcare administrative databases: a systematic literature review.

Objectives To review the available evidence supporting the validity of algorithms to identify asthma patients in healthcare administrative databases.Methods A systematic literature search was conducted on multiple databases from inception to March 2020 to identify studies that reported the validity of case-finding asthma algorithms applied to healthcare administrative data. Following an initial screening of abstracts, two investigators independently assessed the full text of studies which met the pre-determined eligibility criteria. Data on study population and algorithm characteristics were extracted. A revised version of the Quality Assessment of Diagnostic Accuracy Studies tool was used to evaluate the risk of bias and generalizability of studies.Results: A total of 20 studies met the eligibility criteria. Algorithms which incorporated ≥1 diagnostic code for asthma over a 1-year period appeared to be valid in both adult and pediatric populations (sensitivity ≥ 85%; specificity ≥ 89%; PPV ≥ 70%). The validity was enhanced when: (1) the time frame to capture asthma cases was increased to two years; (2) ≥2 asthma diagnostic codes were considered; and (3) when diagnoses were recorded by a pulmonologist. Algorithms which integrated pharmacy claims data appeared to correctly identify asthma patients; however, the extent to which asthma medications can improve the validity remains unclear. The quality of several studies was high, although disease progression bias and biases related to self-reported data was observed in some studies.ConclusionsHealthcare administrative databases are adequate sources to identify asthma patients. More restrictive definitions based on both asthma diagnoses and asthma medications may enhance validity, although further research is required to confirm this hypothesis.

Meta-consent for the secondary use of health data within a learning health system: a qualitative study of the public's perspective.

BACKGROUND: The advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta-consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public's attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec. METHODS: Eight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software. RESULTS: Our findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions. CONCLUSIONS: This qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec.

Citizens, Research Ethics Committee Members and Researchers' Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems.

A survey was conducted to assess citizens, research ethics committee members, and researchers' attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.

Informed consent within a learning health system: A scoping review.

INTRODUCTION: A major consideration for the implementation of a learning health system (LHS) is consent from participants to the use of their data for research purposes. The main objective of this paper was to identify in the literature which types of consent have been proposed for participation in research observational activities in a LHS. We were particularly interested in understanding which approaches were seen as most feasible and acceptable and in which context, in order to inform the development of a Quebec-based LHS. METHODS: Using a scoping review methodology, we searched scientific and legal databases as well as the gray literature using specific terms. Full-text articles were reviewed independently by two authors on the basis of the following concepts: (a) LHS and (b) approach to consent. The selected papers were imported in NVivo software for analysis in the light of a conceptual framework that distinguishes various, largely independent dimensions of consent. RESULTS: A total of 93 publications were analysed for this review. Several studies reach opposing conclusions concerning the best approach to consent within a LHS. However, in the light of the conceptual framework we developed, we found that many of these results are distorted by the conflation between various characteristics of consent. Thus, when these characteristics are distinguished, the results mainly suggest the prime importance of the communication process, by contrast to the scope of consent or the kind of action required by participants (opt-in/opt-out). We identified two models of consent that were especially relevant for our purpose: metaconsent and dynamic consent. CONCLUSIONS: Our review shows the importance of distinguishing carefully the various features of the consent process. It also suggests that the metaconsent model is a valuable model within a LHS, as it addresses many of the issues raised with regards to feasibility and acceptability. We propose to complement this model by adding the modalities of the information process to the dimensions relevant in the metaconsent process.

Validity of Algorithms for Identification of Individuals Suffering from Chronic Noncancer Pain in Administrative Databases: A Systematic Review.

BACKGROUND: Secondary analysis of health administrative databases is indispensable to enriching our understanding of health trajectories, health care utilization, and real-world risks and benefits of drugs among large populations. OBJECTIVES: This systematic review aimed at assessing evidence about the validity of algorithms for the identification of individuals suffering from nonarthritic chronic noncancer pain (CNCP) in administrative databases. METHODS: Studies reporting measures of diagnostic accuracy of such algorithms and published in English or French were searched in the Medline, Embase, CINAHL, AgeLine, PsycINFO, and Abstracts in Social Gerontology electronic databases without any dates of coverage restrictions up to March 1, 2018. Reference lists of included studies were also screened for additional publications. RESULTS: Only six studies focused on commonly studied CNCP conditions and were included in the review. Some algorithms showed a ≥60% combination of sensitivity and specificity values (back pain disorders in general, fibromyalgia, low back pain, migraine, neck/back problems studied together). Only algorithms designed to identify fibromyalgia cases reached a ≥80% combination (without replication of findings in other studies/databases). CONCLUSIONS: In summary, the present investigation informs us about the limited amount of literature available to guide and support the use of administrative databases as valid sources of data for research on CNCP. Considering the added value of such data sources, the important research gaps identified in this innovative review provide important directions for future research. The review protocol was registered with PROSPERO (CRD42018086402).

Effects of climate and fine particulate matter on hospitalizations and deaths for heart failure in elderly: A population-based cohort study.

BACKGROUND: There are limited data on the effects of climate and air pollutant exposure on heart failure (HF) within taking into account individual and contextual variables. OBJECTIVES: We measured the lag effects of temperature, relative humidity, atmospheric pressure and fine particulate matter (PM2.5) on hospitalizations and deaths for HF in elderly diagnosed with this disease on a 10-year period in the province of Quebec, Canada. METHODS: Our population-based cohort study included 112,793 elderly diagnosed with HF between 2001 and 2011. Time dependent Cox regression models approximated with pooled logistic regressions were used to evaluate the 3- and 7-day lag effects of daily temperature, relative humidity, atmospheric pressure and PM2.5 exposure on HF morbidity and mortality controlling for several individual and contextual covariates. RESULTS: Overall, 18,309 elderly were hospitalized and 4297 died for the main cause of HF. We observed an increased risk of hospitalizations and deaths for HF with a decrease in the average temperature of the 3 and 7days before the event. An increase in atmospheric pressure in the previous 7days was also associated with a higher risk of having a HF negative outcome, but no effect was observed in the 3-day lag model. No association was found with relative humidity and with PM2.5 regardless of the lag period. CONCLUSIONS: Lag effects of temperature and other meteorological parameters on HF events were limited but present. Nonetheless, preventive measures should be issued for elderly diagnosed with HF considering the burden and the expensive costs associated with the management of this disease.

Association between Floods and Acute Cardiovascular Diseases: A Population-Based Cohort Study Using a Geographic Information System Approach.

BACKGROUND: Floods represent a serious threat to human health beyond the immediate risk of drowning. There is few data on the potential link between floods and direct consequences on health such as on cardiovascular health. This study aimed to explore the impact of one of the worst floods in the history of Quebec, Canada on acute cardiovascular diseases (CVD). METHODS: A cohort study with a time series design with multiple control groups was built with the adult population identified in the Quebec Integrated Chronic Disease Surveillance System. A geographic information system approach was used to define the study areas. Logistic regressions were performed to compare the occurrence of CVD between groups. RESULTS: The results showed a 25%-27% increase in the odds in the flooded population in spring 2011 when compared with the population in the same area in springs 2010 and 2012. Besides, an increase up to 69% was observed in individuals with a medical history of CVD. CONCLUSION: Despite interesting results, the association was not statistically significant. A possible explanation to this result can be that the population affected by the flood was probably too small to provide the statistical power to answer the question, and leaves open a substantial possibility for a real and large effect.

Patterns and Predictors of Use of Anticoagulants for the Treatment of Venous Thromboembolism Following Approval of Rivaroxaban.

BACKGROUND: Few studies have identified patterns and predictors of use of direct oral anticoagulants for venous thromboembolism (VTE). OBJECTIVE: To describe the use of anticoagulants and assess predictors associated with the prescription of rivaroxaban over vitamin K antagonist (VKA) for the subsequent treatment of VTE. METHODS: This cross-sectional study was built with all consecutive patients newly diagnosed with acute VTE admitted between February 18, 2013, and September 18, 2013, in an academic tertiary care center in Quebec, Canada. Patient characteristics and VTE treatments were described. Univariate analyses and a multiple forward stepwise logistic regression were performed to assess predictors of rivaroxaban use over VKA for the subsequent treatment of VTE. RESULTS: The study included 256 patients, 36.7% with a diagnosis of deep vein thrombosis (DVT) and 63.3% with pulmonary embolism (PE). Mean age was 63.1 years, and 28.1% of patients had cancer-associated VTE. Overall, rivaroxaban was prescribed in 1.6% of patients for the initial treatment and in nearly 20% of patients for the subsequent treatment of VTE. Low-molecular-weight heparin and VKA were mostly prescribed. Independent predictors associated with the prescription of rivaroxaban over VKA were as follows: age < 65 years (OR: 2.86, 95% CI 1.29-6.37), a diagnosis of DVT versus PE (OR 2.54, 95% CI 1.20-5.40), and an emergency department visit rather than a hospitalization (OR 2.24, 95% CI 1.06-4.71). CONCLUSION: Several months following its availability, rivaroxaban was rarely prescribed for acute VTE disease. It also appears to be prescribed in different patient populations than VKA.

Management of chronic obstructive pulmonary disease in patients admitted to a tertiary care centre for exacerbation of their disease.

BACKGROUND: Acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with an accelerated decline in lung function and a significant decrease in health status. Maintenance therapy with respiratory medications can reduce the risk of such exacerbations. OBJECTIVE: To determine whether respiratory maintenance medications were being prescribed in accordance with the 2007 COPD guidelines of the Canadian Thoracic Society for patients admitted to hospital for acute exacerbation of COPD. METHODS: A chart review was conducted for admissions to the Centre hospitalier universitaire de Sherbrooke, in Sherbrooke, Quebec, for acute exacerbation of COPD (according to diagnostic codes in the International Statistical Classification of Diseases and Related Health Problems, 10th revision) between January 1, 2008, and January 31, 2011. Data were extracted from patients' medical charts concerning respiratory medications prescribed before the admission, during the hospital stay, and at discharge. RESULTS: A total of 846 hospital admissions involving 561 patients were reviewed. In almost 70% of admissions for which data were available on respiratory medications prescribed before the admission, during the hospital stay, and at discharge (238/341 [69.8%]), a combination of 3 medications was prescribed at discharge: tiotropium, a long-acting ß(2) agonist, and an inhaled corticosteroid. For more than 80% of the admissions, a prescription for at least one inhaled long-acting bronchodilator was documented both on admission and at discharge. Few patients had a prescription for inhaled corticosteroid without long-acting ß(2) agonist, but the number of admissions with a prescription for regular use of systemic corticosteroids increased at discharge. CONCLUSIONS: Respiratory medications were generally prescribed in accordance with Canadian COPD guidelines, but improvements could be made regarding use of the combination of tiotropium, long-acting ß(2)agonist, and inhaled corticosteroid, as well as long-term use of systemic corticosteroids.