Predicting unplanned hospitalisations in older adults using routinely recorded general practice data.

BACKGROUND: Unplanned hospitalisations represent a hazardous event for older persons. Timely identification of high-risk individuals using a prediction tool may facilitate preventive interventions. AIM: To develop and validate an easy-to-use prediction model for unplanned hospitalisations in community-dwelling older adults using readily available data to allow rapid bedside assessment by general practitioners. DESIGN AND SETTING: Retrospective study using general practice electronic health records of 243,129 community-dwelling adults aged ≥65 years linked with national administrative data. METHODS: The dataset was geographically split into a development (58.7%) and validation (41.3%) sample to predict unplanned hospitalisations within 6 months. We evaluated the performance of three different models with increasingly smaller selections of candidate predictors (i.e. optimal, readily-available and easy-to-use model, respectively). We used logistic regression with backward selection for model development. The models were validated internally and externally. We assessed predictive performance by area under the curve (AUC) and calibration plots. RESULTS: In both samples, 7.6% had at least one unplanned hospitalisation within 6 months. The discriminative ability of the three models was comparable and remained stable after geographic validation. The easy-to-use model included age, sex, prior hospitalisations, pulmonary emphysema, heart failure and polypharmacy. Its discriminative ability after validation was AUC 0.72 [95% confidence interval: 0.72-0.71]. Calibration plots showed good calibration. CONCLUSION: Our models showed satisfactory predictive ability. Reducing the number of predictors and geographic validation did not impact predictive performance, demonstrating the robustness of the model. We developed an easy-to-use tool that may assist general practitioners in decision-making and targeted preventive interventions.

Medical Specialist Care Utilization Prior to the Explantation of Cosmetic Silicone Breast Implants: A Nationwide Retrospective Data Linkage Study.

BACKGROUND: Explantation is the proposed treatment for breast implant illness (BII). Little is known about which medical specialists are visited and what diagnoses are made before explantation is provided as the treatment. OBJECTIVES: This study investigated medical specialist care utilization in women with cosmetic breast implants who underwent explantation compared to women who chose breast implant replacement surgery and to women without breast implants. METHODS: Retrospective cohort study using data linkage with the Dutch Breast Implant Registry and the Dutch health insurance claims database. Visits to medical specialists were examined over the 3 years before explantation. A total of 832 explantation patients were matched and compared to 1463 breast implant replacement patients and 1664 women without breast implants. RESULTS: Explantation patients were more likely to have visited > 5 different medical specialties compared to both replacement patients (12.3% vs. 5.7%; p < 0.001) and women without breast implants (12.3% vs. 3.7%; p < 0.001). Among explantation patients, women who underwent explantation because of BII were more likely to have visited > 5 different medical specialties compared to women who underwent explantation because of other reasons (25.0% vs. 11.0%; p < 0.001). CONCLUSIONS: Women who underwent explantation of breast implants had higher utilization of medical specialist care in the years before explantation compared to women who underwent breast implant replacement surgery and women without breast implants. Medical specialist care use was especially high among women for whom BII was the registered reason for explantation. These findings suggest further research is needed into the link between BII and the use of medical specialist care. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease.

OBJECTIVES: This study aimed to assess the impact of on-demand versus continuous prescribing of proton pump inhibitors (PPIs) on symptom burden and health-related quality of life in patients with gastroesophageal reflux disease (GERD) presenting to primary care. METHODS: Thirty-six primary care centres across Europe enrolled adult GERD patients from electronic health records. Participants were randomised to on-demand or continuous PPI prescriptions and were followed for 8 weeks. PPI intake, symptom burden, and quality of life were compared between the two groups using mixed-effect regression analyses. Spearman's correlation was used to assess the association between changes in PPI dose and patient-reported outcomes. RESULTS: A total of 488 patients (median age 51 years, 58% women) completed the initial visit, with 360 attending the follow-up visit. There was no significant difference in PPI use between the continuous and on-demand prescription groups (b=.57, 95%CI:0.40-1.53), although PPI use increased in both groups (b = 1.33, 95%CI:0.65 - 2.01). Advice on prescribing strategy did not significantly affect patient-reported outcomes. Both symptom burden (Reflux Disease Questionnaire, b=-0.61, 95%CI:-0.73 - -0.49) and quality of life (12-item Short Form Survey physical score b = 3.31, 95%CI:2.17 - 4.45) improved from baseline to follow-up in both groups. Increased PPI intake correlated with reduced reflux symptoms (n = 347, ρ=-0.12, p = 0.02) and improved quality of life (n = 217, ρ = 0.16, p = 0.02). CONCLUSION: In real-world settings, both continuous and on-demand PPI prescriptions resulted in similar increases in PPI consumption with no difference in treatment effects. Achieving an adequate PPI dose to alleviate reflux symptom burden improves quality of life in GERD patients. EudraCT number 2014-001314-25.

Continuous and on-demand prescription increase in proton pump inhibitor consumption equally in real-world settings and did not result in different outcomes.Reaching a sufficient dose of proton pump inhibitor to reduce reflux symptom burden improves quality of life in patients with gastroesophageal reflux disease.

Regression calibration of self-reported mobile phone use to optimize quantitative risk estimation in the COSMOS study.

The Cohort Study of Mobile Phone Use and Health (COSMOS) has repeatedly collected self-reported and operator-recorded data on mobile phone use. Assessing health effects using self-reported information is prone to measurement error, but operator data were available prospectively for only part of the study population and did not cover past mobile phone use. To optimize the available data and reduce bias, we evaluated different statistical approaches for constructing mobile phone exposure histories within COSMOS. We evaluated and compared the performance of four regression calibration (RC) methods (simple, direct, inverse, and generalized additive model for location, shape, and scale), complete-case (CC) analysis and multiple imputation (MI) in a simulation study with a binary health outcome. We used self-reported and operator-recorded mobile phone call data collected at baseline (2007-2012) from participants in Denmark, Finland, the Netherlands, Sweden, and the UK. Parameter estimates obtained using simple, direct, and inverse RC methods were associated with less bias and lower mean squared error than those obtained with CC analysis or MI. We showed that RC methods resulted in more accurate estimation of the relation between mobile phone use and health outcomes, by combining self-reported data with objective operator-recorded data available for a subset of participants.

Natural language processing systems for extracting information from electronic health records about activities of daily living. A systematic review.

Objective: Natural language processing (NLP) can enhance research on activities of daily living (ADL) by extracting structured information from unstructured electronic health records (EHRs) notes. This review aims to give insight into the state-of-the-art, usability, and performance of NLP systems to extract information on ADL from EHRs. Materials and Methods: A systematic review was conducted based on searches in Pubmed, Embase, Cinahl, Web of Science, and Scopus. Studies published between 2017 and 2022 were selected based on predefined eligibility criteria. Results: The review identified 22 studies. Most studies (65%) used NLP for classifying unstructured EHR data on 1 or 2 ADL. Deep learning, combined with a ruled-based method or machine learning, was the approach most commonly used. NLP systems varied widely in terms of the pre-processing and algorithms. Common performance evaluation methods were cross-validation and train/test datasets, with F1, precision, and sensitivity as the most frequently reported evaluation metrics. Most studies reported relativity high overall scores on the evaluation metrics. Discussion: NLP systems are valuable for the extraction of unstructured EHR data on ADL. However, comparing the performance of NLP systems is difficult due to the diversity of the studies and challenges related to the dataset, including restricted access to EHR data, inadequate documentation, lack of granularity, and small datasets. Conclusion: This systematic review indicates that NLP is promising for deriving information on ADL from unstructured EHR notes. However, what the best-performing NLP system is, depends on characteristics of the dataset, research question, and type of ADL.

Healthcare utilization patterns of individuals with depression after national policy to increase the mental health workforce in primary care: a data linkage study.

BACKGROUND: The deployment of the mental health nurse, an additional healthcare provider for individuals in need of mental healthcare in Dutch general practices, was expected to substitute treatments from general practitioners and providers in basic and specialized mental healthcare (psychologists, psychotherapists, psychiatrists, etc.). The goal of this study was to investigate the extent to which the degree of mental health nurse deployment in general practices is associated with healthcare utilization patterns of individuals with depression. METHODS: We combined national health insurers' claims data with electronic health records from general practices. Healthcare utilization patterns of individuals with depression between 2014 and 2019 (N = 31,873) were analysed. The changes in the proportion of individuals treated after depression onset were assessed in association with the degree of mental health nurse deployment in general practices. RESULTS: The proportion of individuals with depression treated by the GP, in basic and specialized mental healthcare was lower in individuals in practices with high mental health nurse deployment. While the association between mental health nurse deployment and consultation in basic mental healthcare was smaller for individuals who depleted their deductibles, the association was still significant. Treatment volume of general practitioners was also lower in practices with higher levels of mental health nurse deployment. CONCLUSION: Individuals receiving care at a general practice with a higher degree of mental health nurse deployment have lower odds of being treated by mental healthcare providers in other healthcare settings. More research is needed to evaluate to what extent substitution of care from specialized mental healthcare towards general practices might be associated with waiting times for specialized mental healthcare.

Lessons learned from the development of a national registry on dementia care and support based on linked national health and administrative data.

Introduction: This paper provides insight into the development of the Dutch Dementia Care and Support Registry and the lessons that can be learned from it. The aim of this Registry was to contribute to quality improvement in dementia care and support. Methods: This paper describes how the Registry was set up in four stages, reflecting the four FAIR principles: the selection of data sources (Findability); obtaining access to the selected data sources (Accessibility); data linkage (Interoperability); and the reuse of data (Reusability). Results: The linkage of 16 different data sources, including national routine health and administrative data appeared to be technically and legally feasible. The linked data in the Registry offers rich information about (the use of) care for persons with dementia across various healthcare settings, including but not limited to primary care, secondary care, long-term care and medication use, that cannot be obtained from single data sources. Conclusions: A key lesson learned is that in order to reuse the data for quality improvement in practice, it is essential to involve healthcare professionals in setting up the Registry and to guide them in the interpretation of the data.

Dutch GP healthcare consumption in COVID-19 heterogeneous regions: an interregional time-series approach in 2020-2021.

BACKGROUND: Many countries observed a sharp decline in the use of general practice services after the outbreak of the COVID-19 pandemic. However, research has not yet considered how changes in healthcare consumption varied among regions with the same restrictive measures but different COVID-19 prevalence. AIM: To investigate how the COVID-19 pandemic affected healthcare consumption in Dutch general practice during 2020 and 2021, among regions with known heterogeneity in COVID-19 prevalence, from a pre-pandemic baseline in 2019. DESIGN & SETTING: Population-based cohort study using electronic health records. The study was undertaken in Dutch general practices involved in regional research networks. METHOD: An interrupted time-series analysis of changes in healthcare consumption from before to during the pandemic was performed. Descriptive statistics were used on the number of potential COVID-19-related contacts, reason for contact, and type of contact. RESULTS: The study covered 3 595 802 contacts (425 639 patients), 3 506 637 contacts (433 340 patients), and 4 105 413 contacts (434 872 patients) in 2019, 2020, and 2021, respectively. Time-series analysis revealed a significant decrease in healthcare consumption after the outbreak of the pandemic. Despite interregional heterogeneity in COVID-19 prevalence, healthcare consumption decreased comparably over time in the three regions, before rebounding to a level significantly higher than baseline in 2021. Physical consultations transitioned to phone or digital over time. CONCLUSION: Healthcare consumption decreased irrespective of the regional prevalence of COVID-19 from the start of the pandemic, with the Delta variant triggering a further decrease. Overall, changes in care consumption appeared to reflect contextual factors and societal restrictions rather than infection rates.

Predicting sepsis-related mortality and ICU admissions from telephone triage information of patients presenting to out-of-hours GP cooperatives with acute infections: A cohort study of linked routine care databases.

BACKGROUND: General practitioners (GPs) often assess patients with acute infections. It is challenging for GPs to recognize patients needing immediate hospital referral for sepsis while avoiding unnecessary referrals. This study aimed to predict adverse sepsis-related outcomes from telephone triage information of patients presenting to out-of-hours GP cooperatives. METHODS: A retrospective cohort study using linked routine care databases from out-of-hours GP cooperatives, general practices, hospitals and mortality registration. We included adult patients with complaints possibly related to an acute infection, who were assessed (clinic consultation or home visit) by a GP from a GP cooperative between 2017-2019. We used telephone triage information to derive a risk prediction model for sepsis-related adverse outcome (infection-related ICU admission within seven days or infection-related death within 30 days) using logistic regression, random forest, and neural network machine learning techniques. Data from 2017 and 2018 were used for derivation and from 2019 for validation. RESULTS: We included 155,486 patients (median age of 51 years; 59% females) in the analyses. The strongest predictors for sepsis-related adverse outcome were age, type of contact (home visit or clinic consultation), patients considered ABCD unstable during triage, and the entry complaints"general malaise", "shortness of breath" and "fever". The multivariable logistic regression model resulted in a C-statistic of 0.89 (95% CI 0.88-0.90) with good calibration. Machine learning models performed similarly to the logistic regression model. A "sepsis alert" based on a predicted probability >1% resulted in a sensitivity of 82% and a positive predictive value of 4.5%. However, most events occurred in patients receiving home visits, and model performance was substantially worse in this subgroup (C-statistic 0.70). CONCLUSION: Several patient characteristics identified during telephone triage of patients presenting to out-of-hours GP cooperatives were associated with sepsis-related adverse outcomes. Still, on a patient level, predictions were not sufficiently accurate for clinical purposes.

Health and Care Data: Approaches to data linkage for evidence-informed policy.

An indispensable prerequisite for answering research questions in health services research is the availability and accessibility of comprehensive, high-quality data. It can be assumed that health services research in the coming years will be increasingly based on data linkage, i.e., the linking, or connecting, of several data sources based on suitable common key variables. A range of approaches to data collection, storage, linkage and availability exists across countries, particularly for secondary research purposes (i.e., the use of data initially collected for other purposes), such as health systems research. The main goal of this review is to develop an overview of, and gain insights into, current approaches to linking data sources in the context of health services research, with the view to inform policy, based on existing practices in high-income countries in Europe and beyond. In doing so, another objective is to provide lessons for countries looking for possible or alternative approaches to data linkage. Thirteen country case studies of data linkage approaches were selected and analysed. Rather than being comprehensive, this review aimed to identify varied and potentially useful case studies to showcase different approaches to data linkage worldwide. A conceptual framework was developed to guide the selection and description of case studies. Information was first identified and collected from publicly available sources and a profile was then created for each country and each case study; these profiles were forwarded to appropriate country experts for validation and completion. The report presents an overview of the included countries and their case studies (Chapter 2), with key data per country and case study in the appendices. This is followed by a closer look at the possibilities of using routine data (Chapter 3); the different approaches to linkage (Chapter 4); the different access routes for researchers (Chapter 5); the use of data for research from electronic patient or health records (Chapter 6); foundational considerations related to data safety, privacy and governance (Chapter 7); recent developments in cross-border data sharing and the European Health Data Space (Chapter 8); and considerations of changes and responses catalysed by the COVID-19 pandemic as related to the generation and secondary use of data (Chapter 9). The review ends with overall conclusions on the necessary characteristics of data to inform research relevant for policy and highlights some insights to inspire possible future solutions - less or more disruptive - for countries looking to expand their use of data (Chapter 10). It emphasises that investing in data linkage for secondary use will not only contribute to the strengthening of national health systems, but also promote international cooperation and contribute to the international visibility of scientific excellence.

Health and care data: approaches to data linkage for evidence-informed policy

An indispensable prerequisite for answering research questions in health services research is the availability and accessibility of comprehensive, high quality data. It can be assumed that health services research in the comingyears will be increasingly based on data linkage, i.e., the linking, or connecting, of several data sources based on suitable common key variables. A range of approaches to data collection, storage, linkage and availability exists across countries, particularly for secondary research purposes (i.e., the use of data initially collected for other purposes), such as health systems research. The main goal of this review is to develop an overview of, and gain insights into, current approaches to linking data sources in the context of health services research, with the view to inform policy, based on existing practices in high-income countries in Europe and beyond. In doing so, another objective is to provide lessons for countries looking for possible or alternative approaches to data linkage. Thirteen country case studies of data linkage approaches were selected and analyzed. Rather than being comprehensive, this review aimed to identify varied and potentially useful case studies to showcase different approaches to data linkage worldwide. A conceptual framework was developed to guide the selection and description of case studies. Information was first identified and collected from publicly available sources and a profile was then created for each country and each case study; these profiles were forwarded to appropriate country experts for validation and completion.

What can we learn from experiences in general practice during the COVID-19 pandemic? A qualitative study.

BACKGROUND: Experiences with organizational changes in daytime general practices and out-of-hours (OOH) services during the COVID-19 pandemic may help to address the challenges in general practice care that were already a concern before the crisis. This study aimed to describe these experiences and the potential usefulness of the organizational changes for future general practice care and any future pandemics. METHODS: Semi-structured interviews were performed among 11 directors of OOH services, and 19 (locum) general practitioners (GPs) or practice managers, who were purposively sampled. Video or telephone interviews were performed in two rounds: between November 2020 and January 2021 and between May 2021 and August 2021. The data were analyzed using thematic analysis methods. RESULTS: Three themes emerged from the data: (1) Changes in the triage procedures; in GP practices and OOH services, stricter triage criteria were implemented, and GPs were more actively involved in the triage process. These measures helped to reduce the number of 'low urgency' face-to-face consultations. (2) Changes in GP care; there was a shift towards video and telephone consultations, allowing GPs to spend more time with patients during the remaining face-to-face consultations. For chronic patients, the shift towards telemonitoring appeared to encourage self-care, and postponing face-to-face consultations for regular checkups appeared to be unproblematic for stable patients. (3) Coordination of GP care and information communication flow during the COVID-19 pandemic; OOH directors perceived a lack of consistency in the information from various governmental and non-governmental parties on containment measures and guidelines related to COVID-19, making it difficult to act on them. The COVID-19 pandemic intensified collaboration between GPs, OOH services, and other healthcare professionals. CONCLUSIONS: The results of this study indicate that some of the organizational changes, such as stricter triage, remote consultations, and changes in managed care of chronic patients, may help in tackling the pre-existing challenges in GP care from before the COVID-19 pandemic. However, more extensive research and continuous monitoring are necessary to establish the effects on patients and their health outcomes. To navigate future pandemics, the intensified collaboration between health professionals should be maintained, while there is considerable room for improvement in the provision of unambiguous information.

Healthcare utilization patterns for knee and hip osteoarthritis before and after changes in national health insurance coverage: a data linkage study from the Netherlands.

INTRODUCTION: Medical guidelines aim to stimulate stepped care for knee and hip osteoarthritis, redirecting treatments from hospitals to primary care. In the Netherlands, this development was supported by changing health insurance coverage for physio/exercise therapy. The aim of this study was to evaluate healthcare utilization patterns before and after health changes in health insurance coverage. METHOD: We analyzed electronic health records and claims data from patients with osteoarthritis in the knee (N = 32,091) and hip (N = 16,313). Changes between 2013 and 2019 in the proportion of patients treated by the general practitioner, physio/exercise therapist or orthopedic surgeon within 6 months after onset were assessed. RESULTS: Joint replacement surgeries decreased for knee (OR 0.47 [0.41-0.54]) and hip (OR 0.81 [0.71-0.93]) osteoarthritis between 2013-2019. The use of physio/exercise therapy increased (knee: OR 1.38 [1.24-1.53], hip: OR 1.26 [1.08-1.47]). However, the proportion treated by a physio/exercise therapist decreased for patients that had not depleted their annual deductibles (knee: OR 0.86 [0.79 - 0.94], hip: OR 0.90 [0.79 - 1.02]). This might be affected by the inclusion of physio/exercise therapy in basic health insurance in 2018. CONCLUSION: We have found a shift from hospitals to primary care in knee and hip osteoarthritis care. However, the use of physio/exercise therapy declined after changes in insurance coverage for patients that had not depleted their deductibles.

Care by general practitioners for patients with asthma or COPD during the COVID-19 pandemic.

The impact of the COVID-19 pandemic on general practitioners' (GP) care for patients with asthma and/or COPD is largely unknown. To describe the impact of the pandemic on asthma or COPD-related GP care, we analysed routinely recorded electronic health records data from Dutch general practices and out-of-hours (OOH) services. During the COVID-19 pandemic (2020), the contact rates for asthma and/or COPD were significantly lower in GP practices and OOH services compared with the pre-pandemic period (2019) (respectively, 15% lower and 28% lower). The proportion of telephone contacts increased significantly with 13%-point in GP practices and 12%-point at OOH services, while the proportion of face-to-face contacts decreased. Furthermore, the proportion of high urgent contacts with OOH services decreased by 8.5%-point. To conclude, the overall contact rates in GP practices and OOH services decreased, while more contacts were remote. Lower contact rates have, after a short follow-up, not resulted in more patients with exacerbations in OOH care. However, this might still be expected after a longer follow-up.

General Practices' Experiences With Patients' Web-Based Access to Medical Records: Survey Study.

BACKGROUND: Patients' web-based access to their medical records is expected to promote their role and responsibility in managing their own health and treatments and supporting shared decision-making. As of July 2020, general practices in the Netherlands are legally obliged to provide their patients access to their electronic medical records. Web-based access provision is facilitated and stimulated through a national support program named OPEN. OBJECTIVE: We aimed to investigate general practice staff experiences with providing web-based access; investigate its impact on patient consultations, administrative actions, and patient inquiries; and investigate how it affects routine general practice workflow processes. METHODS: In October 2021, a total of 3813 general practices in the Netherlands were invited to complete a web-based survey that included questions regarding their experiences with the provision of web-based access to medical records and how it affects routine general practice workflow. Responses of general practices that started providing web-based access before 2020, in 2020, or in 2021 were analyzed to identify trends. RESULTS: Of 3813 invited general practices, 523 (13.72%) completed the survey. Approximately all responding general practices (487/523, 93.1%) indicated that they provide web-based access. Experiences with patients' web-based access were diverse, with 36.9% (178/482) primarily positive, 8.1% (39/482) primarily negative, 42.3% (204/482) neutral, and 12.7% (61/482) could not (yet) indicate how they experienced web-based access. Of the total, two-thirds (311/473, 65.8%) reported an increase in e-consultations and a similar percentage (302/474, 63.7%) indicated an increase in administrative actions associated with web-based access provision. A small proportion of the practices (≤10%) experienced a decrease in patient contacts. Earlier adoption of web-based access was associated with a more positive attitude toward web-based access and more positive experienced effects related to patient contacts and general practice workflow. CONCLUSIONS: The surveyed general practices mainly experienced providing web-based access as either neutral or mostly positive, despite an increased number of patient contacts and administrative burden that were associated with its adoption. Periodic monitoring of experiences is needed to understand the temporal or structural nature of both the intended and unintended effects of patients' web-based access to medical records for general practices and their staff.

Sex and gender differences in primary care help-seeking for common somatic symptoms: a longitudinal study.

OBJECTIVE: Women are reported to consult general practitioners (GPs) more frequently than men. However, previous studies on sex differences in help-seeking behavior for somatic symptoms do not distinguish between sex and gender, do not account for sex differences in presented symptoms, and are frequently conducted in clinical settings, automatically excluding non-help seekers. Therefore, we aim to assess the independent associations of sex and gender with primary care help-seeking for somatic symptoms in the general population. DESIGN AND SETTING: Records from the longitudinal population-based Lifelines Cohort Study were linked to routine electronic health records from GPs. SUBJECTS: Participants reporting new-onset common somatic symptoms. MAIN OUTCOME MEASURES: Associations between sex and gender, operationalized via a novel gender-index, with primary care help-seeking for somatic symptoms and differences in the strength of the association between gender and help-seeking for somatic symptoms between women and men. RESULTS: Of 20,187 individuals with linked data, 8325 participants (67.5% female; mean age = 44.5 years [SD = 12.9]) reported at least one new-onset somatic symptom. Hereof, 255 (3.1%) consulted the GP within 6 weeks of symptom onset. Female sex was positively associated with consulting the GP (OR = 1.78; 95%CI = 1.13-2.80), whereas feminine gender was not (OR = 0.67; 95%CI = 0.39-1.16). The latter association did not differ in strength between men and women. More paid working days are negatively associated with help-seeking (OR = 0.95; 95%CI = 0.91-0.98). CONCLUSIONS: The results suggest that female sex rather than feminine gender is associated with primary care help-seeking behavior for somatic symptoms. Nevertheless, clinicians should be aware that gender-related variables, such as mean paid working days, may be associated with help-seeking behavior.

Opt-In and Opt-Out Consent Procedures for the Reuse of Routinely Recorded Health Data in Scientific Research and Their Consequences for Consent Rate and Consent Bias: Systematic Review.

BACKGROUND: Scientific researchers who wish to reuse health data pertaining to individuals can obtain consent through an opt-in procedure or opt-out procedure. The choice of procedure may have consequences for the consent rate and representativeness of the study sample and the quality of the research, but these consequences are not well known. OBJECTIVE: This review aimed to provide insight into the consequences for the consent rate and consent bias of the study sample of opt-in procedures versus opt-out procedures for the reuse of routinely recorded health data for scientific research purposes. METHODS: A systematic review was performed based on searches in PubMed, Embase, CINAHL, PsycINFO, Web of Science Core Collection, and the Cochrane Library. Two reviewers independently included studies based on predefined eligibility criteria and assessed whether the statistical methods used in the reviewed literature were appropriate for describing the differences between consenters and nonconsenters. Statistical pooling was conducted, and a description of the results was provided. RESULTS: A total of 15 studies were included in this meta-analysis. Of the 15 studies, 13 (87%) implemented an opt-in procedure, 1 (7%) implemented an opt-out procedure, and 1 (7%) implemented both the procedures. The average weighted consent rate was 84% (60,800/72,418 among the studies that used an opt-in procedure and 96.8% (2384/2463) in the single study that used an opt-out procedure. In the single study that described both procedures, the consent rate was 21% in the opt-in group and 95.6% in the opt-out group. Opt-in procedures resulted in more consent bias compared with opt-out procedures. In studies with an opt-in procedure, consenting individuals were more likely to be males, had a higher level of education, higher income, and higher socioeconomic status. CONCLUSIONS: Consent rates are generally lower when using an opt-in procedure compared with using an opt-out procedure. Furthermore, in studies with an opt-in procedure, participants are less representative of the study population. However, both the study populations and the way in which opt-in or opt-out procedures were organized varied widely between the studies, which makes it difficult to draw general conclusions regarding the desired balance between patient control over data and learning from health data. The reuse of routinely recorded health data for scientific research purposes may be hampered by administrative burdens and the risk of bias.

The burden of disease of fatal and non-fatal burn injuries for the full spectrum of care in the Netherlands.

BACKGROUND: A comprehensive overview of the burden of disease of burns for the full spectrum of care is not available. Therefore, we estimated the burden of disease of burns for the full spectrum in the Netherlands in 2018, and explored whether the burden of disease changed over the past 5 years (2014-2018). METHODS: Data were collected at four levels: general practice, emergency department, hospital, and mortality data. For each level, years lived with disability (YLD), years of life lost (YLL), and disability-adjusted life-years (DALY) were estimated using a tailored methodology. RESULTS: Burns resulted in a total of 9278 DALYs in the Netherlands in 2018, comprising of 7385 YLDs (80%) and 1892 YLLs (20%). Burn patients who visited the general practice contributed most DALYs (64%), followed by deceased burn patients (20%), burn patients admitted to hospital (14%) and those treated at the emergency department (2%). The burden of disease was comparable in both sexes (4734 DALYs (51%) for females; 4544 DALYs (49%) for males), though the distribution of DALYs by level of care varied; females contributed more DALYs at the general practice level, and males at all other levels of care. Among children boys 0-4 years had the highest burden of disease (784 DALYs (9%)), and among adults, females 18-34 years old (1319 DALYs (14.2%)) had the highest burden of disease. Between 2014 and 2018 there was a marginal increase of 0.8% in the number of DALYs. CONCLUSIONS: Burns cause a substantial burden of disease, with burns requiring care at the general practice level contributing most DALYs. Information on burden of burns by the full level of care as well as by subgroup is important for the development of tailored burn prevention strategies, and the updated figures are recommended to be used for priority setting and resource allocation.

Setting up a Governance Framework for Secondary Use of Routine Health Data in Nursing Homes: Development Study Using Qualitative Interviews.

BACKGROUND: In the nursing home sector, reusing routinely recorded data from electronic health records (EHRs) for knowledge development and quality improvement is still in its infancy. Trust in appropriate and responsible reuse is crucial for patients and nursing homes deciding whether to share EHR data for these purposes. A data governance framework determines who may access the data, under what conditions, and for what purposes. This can help obtain that trust. Although increasing attention is being paid to data governance in the health care sector, little guidance is available on development and implementation of a data governance framework in practice. OBJECTIVE: This study aims to describe the development process of a governance framework for the "Registry Learning from Data in Nursing Homes," a national registry for EHR data on care delivered by nursing home physicians (in Dutch: specialist ouderengeneeskunde) in Dutch nursing homes-to allow data reusage for research and quality improvement of care. METHODS: Relevant stakeholders representing practices, policies, and research in the nursing home sector were identified. Semistructured interviews were conducted with 20 people from 14 stakeholder organizations. The main aim of the interviews was to explore stakeholders' perspectives regarding the Registry's aim, data access criteria, and governing bodies' tasks and composition. Interview topics and analyses were guided by 8 principles regarding governance for reusing health data, as described in the literature. Interview results, together with legal advice and consensus discussions by the Registry's consortium partners, were used to shape the rules, regulations, and governing bodies of the governance framework. RESULTS: Stakeholders valued the involvement of nursing home residents and their representatives, nursing home physicians, nursing homes' boards of directors, and scientists and saw this as a prerequisite for a trustworthy data governance framework. For the Registry, involvement of these groups can be achieved through a procedure in which residents can provide their consent or objection to the reuse of the data, transparency about the decisions made, and providing them a position in a governing body. In addition, a data request approval procedure based on predefined assessment criteria indicates that data reuse by third parties aligns with the aims of the Registry, benefits the nursing home sector, and protects the privacy of data subjects. CONCLUSIONS: The stakeholders' views, expertise, and knowledge of other frameworks and relevant legislation serve to inform the application of governance principles to the contexts of both the nursing home sector and the Netherlands. Many different stakeholders were involved in the development of the Registry Learning from Data in Nursing Homes' governance framework and will continue to be involved. Engagement of the full range of stakeholders in an early stage of governance framework development is important to generate trust in appropriate and responsible data reuse.