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.

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).

Methodological gaps in the assessment of risk minimization interventions: a systematic review.

INTRODUCTION: Since the introduction of therapeutic risk management regulatory guidance, an increase in the number of risk minimization interventions (RMIs) published in the literature has been observed. Methods used to evaluate their effectiveness remain, however, poorly examined. OBJECTIVE: This paper aimed to conduct a literature review on the methods of evaluation of effectiveness of RMIs and to identify methodological gaps. METHODS: The search was conducted using MEDLINE and Embase between 1 January 2000 and 31 December 2010, and updated on 1 April 2013. The following characteristics were extracted from each study: target population for the RMI, target population for the assessment of effectiveness, study design, data sources, and effectiveness outcome(s). RESULTS: A total of 188 unique RMIs were identified in the literature, of which effectiveness was evaluated in only 65 (34.6%) at the time of publication. The largest proportion of studies reviewed (n = 49, 75.4%) attempted to evaluate changes in behavior through prescribing or laboratory test practices. One quarter of studies evaluated the effect of RMIs on the occurrence of adverse events. Only a minority of studies used robust designs, such as randomized controlled trials (n = 6, 9.2%) or a quasi-experimental design with a parallel comparison group (n = 8, 12.3%). CONCLUSION: Lack of robust methodological design used in published studies on RMI effectiveness evaluation is an important methodological gap in the evaluation of RMI effectiveness. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

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.

Patterns of antidepressant use in Quebec children and adolescents: trends and predictors.

Antidepressants are highly prescribed in youth although most products have not been approved for use in this population. Furthermore, regulatory warnings have led to changes in antidepressant use that might have differed across various countries. Our study aimed at determining factors associated with antidepressant prescribing practices and at assessing trends in use from 1997 to 2005 in Quebec youth.A retrospective cohort study was conducted through claims databases of the Quebec public health care program (RAMQ). The study included 5094 children (age 2-14) and 11,121 adolescents (age 15-19) who were incident users of antidepressant between 1997 and 2005. The characteristics of users and prescribers were the main independent variables.Tricyclics were the most frequently dispensed products among children (50.9%) and selective serotonin reuptake inhibitors among adolescents (58.8%). Selection of an antidepressant class was associated with patient characteristics and with prescriber specialty. The number of antidepressant users increased from 1997 until 2001 then decreased thereafter.The selection of an antidepressant class was associated with clinical and non-clinical characteristics. Although antidepressant use decreased after regulatory warnings, there appears to be a care gap between the evidence generated by efficacy studies and the products prescribed in a real-life setting.

Validated methods for identifying individuals with obesity in health care administrative databases: A systematic review.

BACKGROUND: Health care administrative databases are increasingly used for health studies and public health surveillance. Cases of individuals with obesity are selected using case-identification methods. However, the validity of these methods is fragmentary and particularly challenging for obesity case identification. OBJECTIVE: The objectives of this systematic review are to (1) determine the case-identification methods used to identify individuals with obesity in health care administrative databases and (2) to summarize the validity of these case-identification methods when compared with a reference standard. METHODS: A systematic literature search was conducted in six bibliographic databases for the period January 1980 to June 2019 for all studies evaluating obesity case-identification methods compared with a reference standard. RESULTS: Seventeen articles met the inclusion criteria. International Classification of Diseases (ICD) codes were the only case-identification method utilized in selected articles. The performance of obesity-identification methods varied widely across studies, with positive predictive value ranging from 19% to 100% while sensitivity ranged from 3% to 92%. The sensitivity of these methods was usually low while the specificity was higher. CONCLUSION: When obesity is reported in health care administrative databases, it is usually correctly reported; however, obesity tends to be highly underreported in databases. Therefore, case-identification methods to monitor the prevalence and incidence of obesity within health care administrative databases are not reliable. In contrast, the use of these methods remains relevant for the selection of individuals with obesity for cohort studies, particularly when identifying cohorts of individuals with severe obesity or cohorts where obesity is associated with comorbidities.

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.

The TRANSFoRm project: Experience and lessons learned regarding functional and interoperability requirements to support primary care.

INTRODUCTION: The current model of medical knowledge production, transfer, and application suffers from serious shortcomings. Learning health systems (LHS) have recently emerged as a potential solution-systems in which health information generated from patients is continuously analyzed to improve knowledge that will be transferred to patient care. METHOD: Various approaches of data integration already exist and could be considered for the implementation of a LHS. We discuss what are the possible informatics approaches to address the functional requirements of LHS, in the specific context of primary care, and present the experience and lessons learned from the TRANSFoRm project. RESULT: Implemented in 4 countries around 5 systems, TRANSFoRm is based on a local-as-view data mediation approach integrating the structural and terminological models in the same framework. It clearly demonstrated that it has the potential to address the requirements for a LHS in primary care, by dealing with data fragmented across multiple points of service. Also, it has the potential to support the generation of hypotheses from the context of clinical care, retrospective and prospective research, and decision support systems that improve the relevance of medical decisions. CONCLUSION: The LHS approach embodies a shift from an institution-centered to a patient-centered perspective in knowledge production and transfer and can address important challenges in the primary care setting.

Chronic physical comorbidity burden and the quality of depression treatment in primary care: a systematic review.

OBJECTIVE: We examined whether the treatment and follow-up care for depression in routine primary care differs between adults with higher chronic physical comorbidity burden compared to adults with lower chronic physical comorbidity burden and explored factors leading to divergent results across studies. METHODS: We conducted a systematic review of English and French articles using Medline, Embase, PsycINFO, CINAHL and Cochrane Controlled Trials Register from inception to July 2013. Reference list and reverse citation searches were also conducted. Search terms included depression, primary care, general practitioner, chronic disease and comorbidity. Study eligibility required inclusion of relevant quality indicators and data contrasting participants with higher and lower chronic physical comorbidity burden. Study selection and quality appraisal were carried out independently by two review authors. A narrative synthesis of results was performed. RESULTS: Our search yielded 5817 unique citations and 46 studies met inclusion criteria. Studies provided data on quality of pharmacotherapy (n=28), psychotherapy (n=4), combined measures of treatment quality (n=14), and follow-up care (n=9). Across studies, evidence that higher chronic physical comorbidity burden was associated with lower depression treatment or follow-up care quality was reported in 13 studies whereas evidence for the opposite relationship was reported in 15 studies. Four studies reported mixed results and 14 studies observed no relationships between comorbidity burden and depression treatment or follow-up care quality. CONCLUSION: Review findings suggest that chronic physical comorbidity does not consistently lead to lower quality of depression treatment or follow-up care in primary care.

The influence of comorbid chronic physical conditions on depression recognition in primary care: a systematic review.

OBJECTIVE: People with depression often suffer from comorbid chronic physical conditions and such conditions are widely believed to interfere with primary care providers' ability to recognize their depression. We aimed to examine the evidence related to the influence of chronic physical comorbidity burden on depression recognition in routine, community-based primary care settings. METHODS: We conducted a systematic review of the literature on depression recognition in primary care that featured comparisons between patient groups with higher and lower burdens of chronic physical comorbidity. Medline, Embase, PsycINFO, CINAHL and Cochrane Central Register of Controlled Trials were searched from inception to July 2013. Reference list and reverse citation searches were also performed. A narrative synthesis was conducted given clinical and methodological heterogeneity between studies. RESULTS: Our search identified 5817 unique citations, out of which we identified 13 studies reporting data on the relationship between chronic physical comorbidity burden and depression recognition in primary care. Four studies provided some evidence that higher chronic physical comorbidity burden negatively affected primary care providers' ability to recognize depression. In contrast, two studies reported higher rates of recognition in patients with higher comorbidity burden and seven studies reported no differences in recognition between comorbidity groups. CONCLUSION: Chronic physical comorbidity burden does not consistently affect depression recognition negatively in primary care. Instead, recognition seems to vary depending on the specific conditions or combination of conditions examined. Methodological choices of authors, such as approaches to measuring recognition and chronic medical comorbidity, also likely explain some divergent results across studies.

A provincial adaptation of clinical practice guidelines for depression in primary care: a case illustration of the ADAPTE method.

RATIONALE, AIMS AND OBJECTIVES: Mental health services for patients with a major depressive disorder are commonly delivered by primary care. To support the uptake of clinical practice guidelines in primary care, we developed and disseminated a practice protocol for depression tailored for a multidisciplinary audience of primary mental health care providers with the ADAPTE methodology. The research questions addressed in this study aimed at examining the experience of the development process of a mental health practice protocol in terms of adaptation, facilitation and implementation. METHODS: We present a descriptive case study of the development and implementation of a practice protocol for major depressive disorder for primary mental health care in the organizational and cultural context of the province of Québec (Canada), following the steps of the ADAPTE methodology. An expert committee composed of general practitioners, mental health specialists, health care administrators and decision makers at regional and provincial levels participated in the protocol development process. RESULTS: The practice protocol was based on two clinical practice guidelines: the NICE guideline on the treatment and management of depression in adults (2009, 2010) and the Canadian Network for Mood and Anxiety Treatments clinical guidelines for the management of major depressive disorder in adults (2009). A stepped care model was embedded in the protocol to facilitate the implementation of clinical recommendations in primary mental health care. A multifaceted dissemination strategy was used to support the uptake of the protocol recommendations in clinical practice. CONCLUSIONS: The ADAPTE methodology provided structure, rigour and efficiency to the trans-contextual adaptation of guideline recommendations. We will share the challenges associated with the adaptation of clinical recommendations and organizational strategies for a mental health guideline, and the dissemination of the practice protocol in primary care.

Effectiveness of risk communication interventions on the medical follow-up of youth treated with antidepressants.

Following reports of a potential association between antidepressants (ADs) and suicidal behaviour in youth, regulatory warnings were issued in May 2004, and clinical recommendations on medical follow-up were published in November 2007. Our study aimed at assessing the association between these communication interventions and medical follow-up of children (age 10-14) and adolescents (age 15-19) who initiate an AD treatment. A retrospective cohort study (1998-2008) was conducted among youth members of the Quebec public drug plan. Study outcomes consisted of adequate follow-up practice, defined as at least 1 medical visit per month during the first 3 months of treatment. The effect of each intervention on follow-up practices was determined through multivariate logistic regression analysis. The cohort included 4576 children and 12,419 adolescents. Two thirds of both children and adolescents had at least one medical visit during the first trimester of treatment, but only 20% had a frequency of at least one visit per month (i.e. adequate). The occurrence and frequency of visits did not change after either the warning nor the publication of the guidelines. Further interventions designed to optimize monitoring practices should be envisaged.

Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

BACKGROUND: Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. OBJECTIVE: The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. METHODS: Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. RESULTS: A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black-box warnings (n = 22; 19%) and therapeutic drug monitoring (n = 11; 9%). The website review produced a total of 1112 interventions: 326 posted between the years 2000 and 2004, and 786 between the years 2005 and 2009. The main interventions observed were: educational material (n = 956; 86%), black-box warnings (n = 45; 4%) and withdrawals (n = 39; 4%). LIMITATIONS: Additional regulatory resource websites were available in the post-guidances periods that were not available in the earlier years of the pre-guidances periods, and may bias the post-guidances results. Also, not all global regulatory websites were searched. Finally, only English-language websites were searched, limiting the variation of RMIs observed. Classification and categorizing for this particular review may not be consistent with future reviews by other researchers. CONCLUSION: The US is the sole region with a substantial increase in published RMIs during the post-guidances period, while the EU, Japan and the US all indicated an increase in the number of interventions on their websites.