PP290 Ongoing Swedish Initiatives To Improve The Potential For Real World Data Assessment Of Medical Devices

IntroductionIn 2020, the Swedish regions cemented a national managed-introduction project for medical devices, to ensure equal, cost-effective, and appropriate use. Health technology assessment (HTA) is an important component of the project. Swedish national health registers have world-class coverage and completeness but may lack information enabling adequate evaluation of medical devices. This study reviews the current situation and ongoing initiatives. Additionally, the potential for medical device health economics and outcomes research (HEOR) using Swedish registers is assessed.MethodsA review of Swedish national health registers was undertaken, focusing on available data, and contextualized for the purpose of HEOR for medical devices. Additionally, the review included an evaluation of the Swedish reimbursement authority's (The Dental and Pharmaceutical Benefits Agency, TLV) ongoing initiatives to improve the potential to follow-up the impact of the technologies they assess and develop value-based pricing schemes.ResultsFive registers were deemed the most relevant national health registers for device research. They include high-quality longitudinal data and are linkable on a per-patient basis. For devices, main limitations include limited data on specialized outpatient care, lags in updating certain registers, lack of laboratory data, and challenges in identifying the specific device used. Reports indicate that certain limitations are being addressed, including pilot-studies investigating the opportunity for automated reporting of data from regional systems, and app-collected patient-reported health data.ConclusionsSwedish registers provide comprehensive sources for HEOR studies, but limitations related to the assessment of medical device impact remain. As is common with register data reporting grouped diagnoses and interventions, specific devices are not directly identifiable in the national health registers. For some devices, this might be addressable through linkage with other data-sources. Swedish authorities are undertaking several initiatives that will likely improve the potential for HTA and follow-up of medical devices using national health register data.

A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)

It is necessary to carry out large observational studies to generate robust evidence about the safety of drugs used during pregnancy. In the Nordic countries, nationwide population-based health registers that document all births and dispensed prescribed drugs are valuable resources for such studies. A common data model (CDM) is a data harmonization and structuring tool that enables a unified and streamlined analytic approach for studies including data from multiple countries or databases. We describe a CDM developed for the Nordic Pregnancy Drug Safety Studies (NorPreSS), including details on data sources and structure of the data tables. We also provide an overview of the advantages and disadvantages of the approach (e.g. sharing of data analysis programs versus extra initial work to create CDM datasets from raw data).

Data from national health registers as endpoints for the Tromsø Study: Correctness and completeness of stroke diagnoses

Aim: To assess whether stroke diagnoses in national health registers are sufficiently correct and complete to replace manual collection of endpoint data for the Tromsø Study, a population-based epidemiological study. Method: Using the Tromsø Study Cardiovascular Disease Register for 2013–2014 as the gold standard, we calculated correctness (defined as positive predictive value, PPV) and completeness (defined as sensitivity) of stroke cases in four different data subsets derived from the Norwegian Patient Register and the Norwegian Stroke Register. We calculated the sensitivity and PPV with 95% confidence intervals (CIs) assuming a normal approximation of the binomial distribution. Results: In the Norwegian Stroke Register we found a sensitivity of 79.8% (95% CI 74.2–85.4) and a PPV of 97.5% (95% CI 95.1–99.9). In the Norwegian Patient Register the sensitivity was 86.4% (95% CI 81.6–91.1) and the PPV was 84.2% (95% CI 79.2–89.2). The overall highest levels were found in a subset based on a linkage between the Norwegian Stroke Register and the Norwegian Patient Register, with a sensitivity of 88.9% (95% CI 84.5–93.3), and a PPV of 89.3% (95% CI 85.0–93.6). Conclusions: Data from the Norwegian Patient Register and from the linked data set between the Norwegian Patient Register and the Norwegian Stroke Register had acceptable levels of correctness and completeness to be considered as endpoint sources for the Tromsø Study Cardiovascular Disease Register. The benefits of using data from national registers as endpoints in epidemiological studies must be weighed against the impact of potentially decreased data quality.

Maternal use of sedative drugs and its effects on pregnancy outcomes: a Finnish birth cohort study

Our aim was to evaluate maternal use of sedative drugs before, during, and after pregnancy and to assess the influence of use of these drugs on pregnancy outcomes. The study cohort (N = 6231) consists of all primiparous women, who lived in the city of Vantaa, Finland, and who delivered a singleton between 2009 and 2015. Data were obtained from Finnish national health registers. Of the women, 3.2% (n = 202) purchased at least once sedative drugs within 90 days before conception, during pregnancy and/or within 90 days after delivery. Sedative drug users were older, less likely to cohabitate, more often smokers, had lower educational attainment and had more mental diseases (for all p < 0.001) compared with non-users. Sedative drug users purchased more often antidepressants and drugs for the alimentary tract, musculoskeletal and nervous system than non-users (for all p < 0.001). No adverse birth or pregnancy outcomes were found in the group using sedative drugs compared with the non-users. Studies in larger cohorts are needed to confirm our study findings.

Psychiatric care use among migrants to Sweden compared with Swedish-born residents: a longitudinal cohort study of 5 150 753 people

BackgroundTo investigate differences in psychiatric care use over time between Swedish born and those born abroad who migrate to Sweden.MethodsPopulation-based cohort study analysing linked population and health registers, following individuals born 1944–1990 from 1 January 2005 to 31 December 2016. Time-stratified survival analysis using Cox regression estimated time to psychiatric care use. Population included 5 150 753 individuals with 78.1% Swedish born. Migrant status was coded as Swedish born or migrant. Migrants were grouped by year of immigration and region of origin. The main outcome: psychiatric care use, defined as any psychiatric care; psychiatric inpatient or outpatient care; or use of psychotropics.ResultsMigrants arriving before 2005 had a higher use of any psychiatric care relative to Swedish born but migrants arriving 2005 onwards had lower use. Migrants from sub-Saharan Africa and Asia had a lower use of any psychiatric care during the first decade in Sweden whereas migrants from Middle East and North Africa had a higher use, driven by use of psychotropics.ConclusionsThe lower use of psychiatric care during the first decade contrasts with higher use among migrants with a longer duration of stay. Psychiatric care use among migrants should be analysed multi-dimensionally, taking duration of stay, region of origin and type of care into account.

No association between moist oral snuff (snus) use and oral cancer: pooled analysis of nine prospective observational studies

Aims: Worldwide, smokeless-tobacco use is a major risk factor for oral cancer. Evidence regarding the particular association between Swedish snus use and oral cancer is, however, less clear. We used pooled individual data from the Swedish Collaboration on Health Effects of Snus Use to assess the association between snus use and oral cancer. Methods: A total of 418,369 male participants from nine cohort studies were followed up for oral cancer incidence through linkage to health registers. We used shared frailty models with random effects at the study level, to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) adjusted for confounding factors. Results: During 9,201,647 person-years of observation, 628 men developed oral cancer. Compared to never-snus use, ever-snus use was not associated with oral cancer (adjusted HR 0.90, 95% CI: 0.74, 1.09). There were no clear trends in risk with duration or intensity of snus use, although lower intensity use (⩽ 4 cans/week) was associated with a reduced risk (HR 0.65, 95% CI: 0.45, 0.94). Snus use was not associated with oral cancer among never smokers (HR 0.87, 95% CI: 0.57, 1.32). Conclusions: Swedish snus use does not appear to be implicated in the development of oral cancer in men.

The use of stimulants in depression: Results from a self-controlled register study

Objective: To investigate the effectiveness of stimulants in patients with depression, by using naturalistic outcome measures, such as psychiatric admissions, psychiatric bed-days and incidents of intentional self-harm or suicide attempts. Methods: Via linkage of the Danish nationwide health registers, we identified all patients with a diagnosis of depression initiating stimulants, including methylphenidate, modafinil, amphetamine, dexamphetamine or lisdexamphetamine, from 1995 to 2012. We used a mirror-image model to test whether redemption of a stimulant prescription was associated with a reduction in psychiatric admissions, inpatient days and incidents of intentional self-harm or suicide attempts. Specifically, the number of these outcomes in the 2 years leading up to redemption of a stimulant prescription was compared to the two subsequent years. Similar outcomes were used in a reverse mirror-image model to investigate the effect of stimulant termination. Results: A total of 3354, 935 and 105 patients diagnosed with depression redeemed prescriptions for methylphenidate, modafinil or amphetamine/dexamphetamine/lisdexamphetamine, respectively. Initiation of methylphenidate was not associated with a significant change in psychiatric admissions (mean: −0.02 admissions, p = 0.11) or inpatient days (mean: 0.13 days, p = 0.74). Similar findings were made for modafinil and the amphetamines. In addition, no clinically relevant change in psychiatric admissions or inpatient days was found after termination of a stimulant. After initiation of methylphenidate, the incidents of self-harm or suicide attempts were reduced by 54%, from 68 to 31 events ( p = 0.004). No significant change in incidents of self-harm or suicide attempts were found for modafinil or the amphetamines. Conclusion: This nationwide study, using naturalistic outcomes, does not support the use of stimulants in patients with depression. However, the use of methylphenidate was associated with a 54% reduction in incidents of self-harm or suicide attempts, indicating that methylphenidate may potentially be useful in patients with depression with suicidal- or self-harming behaviour. However, further studies are needed, before any firm conclusions can be made.