| 1. |
- Cars, Thomas, 1975-
(författare)
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Real-Time Monitoring of Healthcare Interventions in Routine Care : Effectiveness and Safety of Newly Introduced Medicines
- 2016
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Before market authorization of new medicines, their efficacy and safety are evaluated using randomized controlled trials. While there is no doubt about the scientific value of randomized trials, they are usually conducted in selected populations with questionable generalizability to routine care. In the digital data revolution era, with healthcare data growing at an unprecedented rate, drug monitoring in routine care is still highly under-utilized. Although many countries have access to data on prescription drugs at the individual level in ambulatory care, such data are often missing for hospitals. This is a growing problem considering the clear trend towards more new and expensive drugs administered in the hospital setting. The aim of this thesis was therefore to develop methods for extracting data on drug use from a hospital-based electronic health record system and further to build and evaluate models for real-time monitoring of effectiveness and safety of new drugs in routine care using data from electronic health records and regional and national health care registers.Using the developed techniques, we were able to demonstrate drug use and health service utilization for inflammatory bowel disease and to evaluate the comparative effectiveness and safety of antiarrhythmic drugs.With a rapidly evolving drug development, it is important to optimize the evaluation of effectiveness, safety and health economic value of new medicines in routine care. We believe that the models described in this thesis could contribute to fulfil this need.
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| 2. |
- Hovstadius, Bo, 1955-
(författare)
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On drug use, multiple medication and polypharmacy in a national population
- 2010
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The application of multiple medications has successively increased during a number of years and has thereby increased the potential risks of adverse drug reactions, interactions and non-adherence to drug therapy. This may result in unnecessary health expenditure, directly due to redundant drug sales, and indirectly due to the increased hospitalization caused by drug-related problems. The overall aim of this thesis was to investigate the occurrence and development of drug use, multiple medication, and polypharmacy in an entire national population by using individual-based data on dispensed drugs. The studies (I-V) in the thesis are based on data of dispensed prescription drugs for up to 6.2 million individuals obtained from the Swedish Prescribed Drug Register. The data in the studies cover different periods of time between July 2005-Sept 2008, and the data have been analyzed on the basis of epidemiological measures and statistical methods. The major conclusions of the studies are: the prevalence of dispensed drugs and multiple medications was extensive in all age groups and was higher for females than for males. Multiple medications should be regarded as a risk in terms of potential drug-drug interactions and adverse drug reactions in all age groups (I). Regional differences in the prevalence of polypharmacy were observed and partly explained by the regional age distribution in Sweden. The use of a novel weighted polypharmacy index indicated regional differences in drug therapy for individuals with polypharmacy (II). The number of drugs used by an individual not only increased the potential risks associated with multiple drug use, but also the potential burden of an increased therapeutic intensity, especially for elderly (III). Individuals with ten or more drugs accounted for almost fifty percent of the total acquisition costs of dispensed drugs. Therefore, interventions with a focus on the reduction of the number of prescription drugs for the small group of patients with a large number of different drugs may also result in a substantial reduction in the total drug costs (IV). In spite of national and regional efforts to reduce polypharmacy, the prevalence of polypharmacy and excessive polypharmacy and the mean number of drugs per individual continued to increase in Sweden 2005-2008 (V). The observed year-by-year increase in polypharmacy underlines the importance of monitoring the development of drug use in all ages. Individual-based registers studies of dispensed drugs provide high quality data and could serve as the basis for further research and also in terms of training health care personnel. It can also be used as a base for interventions and the evaluation of drug use. To enable better comparisons on drug use and its consequences, there is a need for standards concerning measurements, classification and criteria which encompass all types of medications. For clinicians, there is a need for information concerning the patient’s actual use of all different types of medications.
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| 3. |
- Bondesson, Elisabeth, et al.
(författare)
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Utilization of healthcare and prescription medicines after non-pharmacological interventions for depression - A 3-year register follow-up of an RCT in primary care
- 2022
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Ingår i: Preventive Medicine Reports. - : Elsevier. - 2211-3355. ; 25
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Tidskriftsartikel (refereegranskat)abstract
- Depression is a common, recurrent disorder. There is a need for readily available treatments with few negative side effects, that demands little resources and that are effective both in the short- and long term. Our aim was to investigate the long-term effectiveness of two different interventions; physical exercise and internet-based cognitive behavioural therapy (internet-CBT), compared to usual care in patients with mild to moderate depression in a Swedish primary care setting. We performed a register-based 3-year follow-up study of participants in the randomized controlled trial REGASSA (n = 940) using healthcare utilization and dispensed medicines as outcomes. We found no difference between the three groups regarding proportion of participants consulting healthcare due to mental illness or pain during follow-up. Regarding number of consultations, there was no difference between the groups, except for consultations related to pain. For this outcome both treatment arms had significantly fewer consultations compared to usual care, during year 2-3, the risk ratio (RR) for physical exercise and internet-CBT was 0.64 (95% CI = 0.43-0.95) and 0.61 (95% CI = 0.41-0.90), respectively. A significantly lower proportion of patients in both treatment arms were dispensed hypnotics and sedatives year 2-3 compared to the usual care arm, RR for both physical exercise and internet-CBT was 0.72 (95% CI = 0.53-0.98). No other differences between the groups were found. In conclusion, considering long-term effects, both physical exercise and internet-CBT, being resource-efficient treatments, could be considered as appropriate additions for patients with mild to moderate depression in primary care settings.
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| 4. |
- Frisk, Pia, 1968-
(författare)
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Surveys and services : The feasibility of conducting research in Swedish community pharmacies
- 2018
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- For the past decades, there has been a shift in community pharmacy practice from dispensing and compounding towards provision of pharmacy services. Research is important to generate evidence for new services within pharmacy practice. Pharmacy practice research can be divided in two main themes: research related to pharmacy as a data source and to the pharmacy as the object of research, respectively.The purpose of this thesis is to increase the understanding of the conditions required for successful involvement of Swedish community pharmacy staff in pharmacy-based research, and to evaluate the data generated through a certain type of research: pharmacy-based patient surveys on drug utilization.Specific aims were to evaluate if there is a selection bias in drug utilization surveys conducted in Swedish community pharmacies, to explore the experiences of pharmacists either conducting the surveys or recruiting patients to research on adherence-promoting services, and to describe barriers and facilitators to conducting research in community pharmacies.Data were collected via pharmacy-based patient surveys, dispensing data, individual interviews, a cross-sectional staff survey and focus group interviews.In community pharmacy-based surveys or services research, with the dispensed drug as the trigger for inclusion, patients aged 75 years or older are underrepresented since they less often visit the pharmacy to redeem their prescriptions themselves. Due to their perceived workload, dispensing pharmacists sometimes avoid including patients perceived as complex due to age, polypharmacy or communication difficulties. These processes contribute to a healthy selection effect in both types of research and pharmacy services not reaching the patients in most need of support with their medication.The pharmacists were generally positive to conducting surveys and being involved in services research, but reported a perceived lack of sufficient communication and research skills, and a lack of time.Since competing commercial priorities hamper pharmacists’ research involvement, separate research funding is an important facilitator. For surveys to include all eligible patients, services to be relevant for both practice and patients and to target the patients in most need of support with their medication, research collaboration with healthcare, other professions and across pharmacies is also necessary.
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| 5. |
- Norberg, Helena, 1984-
(författare)
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Bridging the gap between clinical trials and clinical practice : sacubitril-valsartan in heart failure as a model
- 2020
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- When novel treatments prove more effective than standard therapies, a swift and effective implementation is needed to reach cost-effectiveness and to benefit eligible patients. Meanwhile, women and elderly are often under-represented in clinical trials, which creates a knowledge gap on how to optimize treatment in clinical practice. The arrival of the angiotensin receptor-neprilysin inhibitor sacubitril-valsartan to patients with chronic heart failure and reduced ejection fraction (HFrEF) offered an opportunity to develop and test a new systematic introduction approach, as well as to investigate eligibility and management of sacubitril-valsartan in clinical practice. The aims of this thesis were to investigate obstacles to implement sacubitril-valsartan in a real-world heart failure population, as well as to develop a systematic and effective method to implement novel treatments in patients with chronic disease.With an observational cross-sectional study design, patients were retrospectively included if they had a heart failure diagnosis, living within the Umeå University Hospital catchment area, and had at least one visit at the Heart Centre or Department of internal medicine between January 2010 and March 2016. Eligibility to sacubitril-valsartan was based on the enrollment criteria applied in the landmark trial, PARADIGM-HF. We showed that the primary obstacle to implement sacubitril-valsartan was that only a quarter of the real-world HFrEF population was eligible. The most prominent difference was that real-world patients were significantly older compared with the PARADIGM-HF population. Disproportionally many patients, especially women, were ineligible for sacubitril-valsartan due to intolerance of renin-angiotensin system inhibitors in target doses. With multivariable linear regression analyses, we showed that the lower target doses in women were explained by biological sex differences.Management of heart failure treatment involve many titration steps that risk stressing the resources of both healthcare and patients. We prospectively investigated a direct switch to maximum dose sacubitril-valsartan in patients who tolerated target dose renin-angiotensin system inhibitors (equivalent to enalapril 10 mg twice daily). We showed that the simplified introduction was safe and generally well tolerated during the first year.The systematic introduction approach is a seven-step procedure:1) define a few main criteria2) primary scan patients with the one or two main criteria using computerized medical records/databases/clinical registries3) identify patients applying the other predefined criteria4) evaluate if any examinations/laboratory test updates are required5) summon identified patients with an information letter6) discuss treatment with the patient and prescribe if appropriate7) follow-up on initiated therapy and evaluate the process.We evaluated the approach with a mixed method, including both a case study of the sacubitril-valsartan implementation and an interview study with qualitative content analysis. The new systematic introduction approach effectively implemented sacubitril-valsartan in clinical practice, by identifying eligible patients with limited resources and time. The patients were overall satisfied with the new approach and their confidence in healthcare was maintained.In conclusion, we found that the strict inclusion criteria in the PARADIGM-HF trial would exclude a majority of patients with heart failure if they are implemented and that these criteria have an inherent bias versus the old and the frail, which in turn disproportionately affects women. We further found that patients who are on maximum recommended dose of renin-angiotensin system inhibitors can be safely switched to maximum dose sacubitril-valsartan and that our method of systematic introduction was effective in implementing sacubitril-valsartan to a heart failure population.The approach is a promising example of how to reduce the gap between clinical trials and clinical practice in patients with chronic disease.
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| 6. |
- Nordqvist, Ola
(författare)
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Epidemiological aspects of drug-related vitamin D deficiency and osteoporotic fractures
- 2022
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: Vitamin D deficiency, secondary osteoporosis and low-energy fractures (LEF) as side effects of specific drugs were first described more than half a century ago. These effects are recognized in guidelines where patients prescribed risk drugs are recommended follow-up with testing and supplementation. How these drugs are managed within Swedish healthcare has not been previously investigated. Aim: To study epidemiological aspects of drug-related vitamin D deficiency and osteoporotic fractures.Methods: The association between drugs for continual use and vitamin D levels in the elderly was investigated in a clinical study including more than 550 patients (paper I). Real-world data on drug prescriptions, laboratory testing and demographic variables from electronic health records were thereafter used to assess the clinical management and vitamin D levels. More than 12 000 patients prescribed risk drugs were included in this cross-sectional study (paper II). Focus group interviews were then undertaken to explore determinants of risk drug management among physicians from seven primary care centers. Thematic analysis with an inductive approach was used to create a framework addressing adherence to medical guidelines (paper III). Finally, a multifactorial risk assessment tool was developed from LEF risk factors in more than 15 000 patients prescribed antiepileptic risk drugs in a retrospective open cohort study (paper IV).Results: A weak inverse association between the number of prescribed drugs and levels of vitamin D was found (paper I). Fewer than one in fifteen patients prescribed risk drugs were tested for vitamin D while close to a third were supplemented. Differences in management and vitamin D levels with regard to type of risk drug were found (paper II). Awareness levels, expressed beliefs and perceived responsibility were reasons behind these differences (paper III). The Kalmar Epilepsy Fracture Risk Index (KEFRI) confirmed previously suggested risk factors (paper IV). Conclusions: Drugs generating vitamin D deficiency, secondary osteoporosis and LEF are often overlooked in healthcare. Awareness and attitudes need to be improved and strategies to better manage patients prescribed these drugs are required in order to avoid unnecessary side effects. The KEFRI could aid clinicians in treatment decisions, potentially reducing fracture risks in specific patient groups.
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| 7. |
- Nyberg, Fredrik, et al.
(författare)
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Swedish Covid-19 Investigation for Future Insights-A Population Epidemiology Approach Using Register Linkage (SCIFI-PEARL)
- 2021
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Ingår i: Clinical Epidemiology. - : Dove Medical Press. - 1179-1349. ; 30, s. 347-348
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Tidskriftsartikel (refereegranskat)abstract
- Background: In response to the Covid-19 pandemic, we designed and initiated a nationwide linked multi-register, regularly updated, observational study for timely response to urgent scientific questions. Aim: To describe the SCIFI-PEARL (Swedish Covid-19 Investigation for Future Insights - a Population Epidemiology Approach using Register Linkage) linked database encompassing essentially all known diagnosed Swedish Covid-19 patients plus a large general population comparison cohort and outline its utility in the current and future phases of the pandemic. Methods: Individuals with Covid-19 from the entire country are identified on a regularly updated basis, from different sources: all individuals from SmiNet, the national database of notifiable diseases, with positive SARS-CoV-2 polymerase chain reaction (PCR) test results; patients identified in the healthcare system by condition (ICD-10) or procedure codes in the National Patient Register or Cause-of-Death Register; patients identified through several disease-specific national quality registers (NQRs); and in two regions additionally patients identified in primary care. A comparison population was obtained by stratified random sampling from Swedish national population registers. Data from all these registers plus the National Prescribed Drug Register, the Cancer Register, national sociodemographic registers, some additional NQRs, the National Vaccination Register, and further data sources, are then linked to all study subjects (Covid-19 cases and population cohort). New cases in the study population and all data for all subjects are updated every few months, as required. Conclusion and Utility: The SCIFI-PEARL study cohort captures Swedish residents with Covid-19 on an ongoing basis, includes a representative general population comparison cohort, and links to a broad range of national and regional healthcare data for a comprehensive longitudinal view of the Covid-19 pandemic. By combining high-quality national registers with short time delay and continuous repeated linkage and updating, the project brings timely and internationally relevant data for epidemiological research on SARS-CoV-2. Our efforts provide an example and important learnings for similar efforts internationally in the future.
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| 8. |
- Sjölander, Maria, 1970-
(författare)
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Use of secondary preventive drugs after stroke
- 2013
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background Stroke is a serious condition that can have significant impact on an individual’s health and is a significant burden on public health and public finances. Secondary preventive drug treatment after stroke is important for decreasing the risk of recurrent strokes. Non-adherence to drug treatment hampers the treatment effect, especially in long-term preventive treatments. The aim of this thesis was to study the use of secondary preventive drugs after stroke among Swedish stroke patients in terms of inequalities in implementation in clinical practice and patient adherence to treatment over time.Methods Riks-Stroke, the Swedish stroke register, was used to sample stroke patients and as a source of information on background characteristics and medical and health care-related information including information on prescribed preventive drugs. The patients that were included had a stroke between 2004 and 2012. Individual patient data on prescriptions filled in Swedish pharmacies were retrieved from the Swedish Prescribed Drug Register and used to estimate patient adherence to drug treatment. Data on education, income, and country of birth were included from the LISA database at Statistics Sweden. A questionnaire survey was used to collect information about patients’ perceptions about stroke, beliefs about medicines, and self-reported adherence.Results Results showed that a larger proportion of men than women were prescribed statins and warfarin after stroke. There was also a social stratification in the prescribing of statins. Patients with higher income and a higher level of education were more likely to be prescribed a statin compared to patients with low income and low level of education. Statins were also more often prescribed to patients born in Nordic countries, Europe, or outside of Europe compared to patients born in Sweden. Primary non-adherence (not continuing treatment at all within 4 months of discharge from hospital) was low for preventive drug treatment after stroke. Data on filled prescriptions, however, indicated that the proportion of patients who continued to use the drugs declined during the first 2 years after stroke. For most drugs, refill adherence in drug treatment was associated with female sex, good self-rated health, and living in institutions and (for antihypertensive drugs and statins) having used the drug before the stroke. For statins and warfarin, a first-ever stroke was also associated with continuous drug use. Self-reported adherence 3 months after stroke also showed associations with patients’ personal beliefs about medicines; non-adherent patients scored higher on negative beliefs and lower on positive beliefs about medicines.Conclusion Inequalities between men and women and between different socioeconomic groups were found in the prescribing of secondary preventive drugs after stroke. Only a small proportion of Swedish stroke patients did not continue treatment after discharge from hospital, but the proportion of non-adherent patients increased over time. Poor adherence to preventive drug treatment after stroke is a public health problem, and improving adherence to drug treatment requires consideration of patients’ personal beliefs and perceptions about drugs.
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