Pharmacoepidemiology and Drug Safety

Article	Citations
Issue Information	66
Hepatitis B vaccine and risk of acute myocardial infarction among individuals with diabetes mellitus	44
Issue Information	44
External validity in distributed data networks	39
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Optimizing therapeutic decision‐making for off‐label medicines use: A scoping review and consensus recommendations for improving practice and research+	31
Correction to “Effect of tramadol and DOACs with special attention to dabigatran on concomitant use, on the risk of mayor bleeding using BIFAP database in Spain”	30
Exposure to Valsartan Products Containing Nitrosamine Impurities in the United States, Canada, and Denmark	30
Mixed Impact of Direct Healthcare Professional Communications When Considering Proximal Outcomes and the Targeted Population: A Systematic Review	28
Quantitative Benefit–Risk Assessment of Vaccination Against COVID‐19: A Systematic Review	27
Linkage of public health and all payer claims data for population‐level opioid research	26
Data Resource Profile: The Danish National Hospital Medicine Register	24
Management of epilepsy in Lebanon: Medication reviews and drug‐related problems	24
Validation of diagnosis codes for chorioamnionitis in medical encounter data, 2013–2018	24
Validation of Chronic Inflammatory Demyelinating Polyradiculoneuropathy Coding in US Claims Data	22
Comparison of drug prescribing before and during the COVID‐19 pandemic: A cross‐national European study	22
Antibiotics and Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome: Analysis of Brazilian Pharmacovigilance Registries	22
Issue Information	21
Predicting obesity and smoking using medication data: A machine‐learning approach	21
Uncommon side effects of common drugs in patients with familial dysautonomia	21
International trends in prescription opioid sales among developed and developing economies, and the impact of the COVID‐19 pandemic: A cross‐sectional analysis of 66 countries	21
Comment on: Exploring the impact of design criteria for reference sets on performance evaluation of signal detection algorithms: The case of drug–drug interactions	19
A comparison of confounder selection and adjustment methods for estimating causal effects using large healthcare databases	18
Use of gastrointestinal prokinetics and the risk of parkinsonism: A population‐based case‐crossover study	18
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Performance characteristics of code‐based algorithms to identify urinary tract infections in large United States administrative claims databases	18
Valproate utilisation trends among women of childbearing potential in Ireland between 2014 and 2019: A drug utilisation study using interrupted time series	18
Core concepts in pharmacoepidemiology: Violations of the positivity assumption in the causal analysis of observational data: Consequences and statistical approaches	17
Comorbidity influence in observational studies: Why ignore the real world?	17
Trends in the Dispensing of Oral Anti‐Cancer Medications Across Australia Over 10 Years	16
Pharmacological and epidemiological considerations while constructing treatment episodes using observational data: A simulation study	16
Validation of a Major and Clinically Relevant Nonmajor Bleeding Phenotyping Algorithm on Electronic Health Records	15
Use of Potentially Nephrotoxic Drugs in Type 2 Diabetes Patients on SGLT2i: A Trajectories Analysis	15
Prenatal and Early‐Life Anti‐Infectives and Obesity at Age 7 Years	15
Comparing survival in trial‐ versus routine‐care advanced urothelial cancer patients on immune checkpoint blockade	15
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Validity of ICD‐10‐based algorithms to identify patients with influenza in inpatient and outpatient settings	14
Validity of claims‐based algorithms to identify neurodevelopmental disorders in children	14
Advancing Research Transparency and Reproducibility in Pharmacoepidemiology	14
Metadata for Data dIscoverability aNd Study rEplicability in obseRVAtional Studies (MINERVA): Development and Pilot of a Metadata List and Catalogue in Europe	14
Post‐Market Evidence for Cancer Medicines in Regulatory and Clinical Decision‐Making: A Scoping Review	13
An Emulated Target Trial Case Study of Real‐World Overall Survival With Second‐Line Maintenance Niraparib Versus Active Surveillance in Patients With Recurrent Ovarian Cancer	13
Probabilistic precision calculations for the planning of studies assessing negative binomial rates	13
Issue Information	13
Hazard Ratios and Alternative Effect Measures: An Applied Illustration	13
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Pre‐ and post‐stroke oral antithrombotics and mortality in patients with ischaemic stroke	12
The impact of hydrocodone rescheduling on utilization, abuse, misuse, and overdose deaths	12
An individual segmented trajectory approach for identifying opioid use patterns using longitudinal dispensing data	12
Impact of Antibiotic Shortages on Antibiotic Utilisation in the Community	12
The European Drug–Drug Interaction (EuroDDI) Study Protocol: A Cross‐Country Comparison of Drug–Drug Interaction Prevalence in the Older Community‐Dwelling Population	12
Issue Information	12
Validity of ICD‐10‐CM diagnoses to identify hospitalizations for serious infections among patients treated with biologic therapies	12
Federated analyses of multiple data sources in drug safety studies	12
Hypertension medication from guidelines to practice: A cohort study in western Iran	12
Impact of Lookback Duration on the Performance of a Claims‐Based Frailty Proxy in Women With Stage I–III Breast Cancer	11
Letter to the Editor re Davis et al., 2023: BELpREG, the first of its kind real‐world data source on medication use in pregnancy in Belgium	11
Validation of new medication use algorithms as proxies for worsening disease activity in patients with juvenile idiopathic arthritis	11
Development and validation of an electronic health records‐based opioid use disorder algorithm by expert clinical adjudication among patients with prescribed opioids	11
Validation of alopecia coding in US claims data among women of childbearing age	11
Classification and visualization of longitudinal patterns of medication dose: An application to interferon‐beta‐1a and amitriptyline in patients with multiple sclerosis	11
Validation of an algorithm to identify fractures among patients within the Veterans Health Administration	11
Using pooled electronic health records data to conduct pharmacoepidemiology safety studies: Challenges and lessons learned	10
Validation of diagnostic coding for bronchiectasis in an electronic health record system in Hong Kong	10
Consistency between the National Patient Register and the Swedish Cancer Register	10
Association between pre‐admission anticoagulation and in‐hospital death, venous thromboembolism, and major bleeding among hospitalized COVID‐19 patients in Japan	10
Sensitivity analyses of unmeasured and partially‐measured confounders using multiple imputation in a vaccine safety study	10
Issue Information	10
Effectiveness and use of reverse transcriptase polymerase chain reaction point of care testing in a large‐scale COVID‐19 surveillance system	10
Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations	10
Use of Omalizumab for Pediatric Asthma After US Food and Drug Administration Expanded Indications	10
Assessing medical product safety during pregnancy using parameterizable tools in the sentinel distributed database	10
Drug interactions in hospital prescriptions in Denmark: Prevalence and associations with adverse outcomes	9
Core concepts in pharmacoepidemiology: Key biases arising in pharmacoepidemiologic studies	9
Utilization of drugs with reports on potential efficacy or harm on COVID‐19 before, during, and after the first pandemic wave	9

Trends in clomiphene citrate and gonadotropins use in women with infertility between 2010 and 2017: A population‐based study in France	9
ISPE20 Author Index	9
Characterization of SARS‐CoV‐2 Diagnostic Tests and Liver Function Tests Among Patients With COVID‐19 Diagnosed in Outpatient Settings Using Administrative Healthcare	9
The risk of miscarriage after COVID‐19 vaccination before and during pregnancy	9
Issue Information	9
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Descriptive analysis on disproportionate medication errors and associated patient characteristics in the Food and Drug Administration's Adverse Event Reporting System	9
Adherence to prescription proton pump inhibitor therapy amongst individuals diagnosed with Barrett's esophagus	9
More extreme duplication in the U.S. FDA FAERS database and a suggested check point for disproportionality analysis	9
Sex‐specific incidence of hepatitis B virus flares among Bcr‐Abl tyrosine kinase inhibitor users in Taiwan	9
Risk of clinically relevant hyperglycemia with metoprolol compared to carvedilol in older adults with heart failure and diabetes	9
Perinatal pharmacoepidemiology: How often are key methodological elements reported in publications?	9
RE: Gout and sodium‐glucose cotransporter‐2 inhibitors	9
Detecting and Dating Early Non‐live Pregnancy Outcomes: Generation of a Novel Pregnancy Algorithm From Norwegian Linked Health Registries	8
ABSTRACTS of the 2024 ISPE Annual Meeting, Berlin, Germany, 24–28 August 2024	8
Sodium‐glucose cotransporter‐2 inhibitors and the risk of gout: A Danish population based cohort study and symmetry analysis	8
Background rates of five thrombosis with thrombocytopenia syndromes of special interest for COVID‐19 vaccine safety surveillance: Incidence between 2017 and 2019 and patient profiles from 3	8
Prevalence of Polypharmacy in Elderly Population Worldwide: A Systematic Review and Meta‐Analysis	8
A drug utilization study of thiocolchicoside‐containing medicinal products for systemic use in France and Italy: A cross‐sectional electronic medical records database study	8
Validation Assessment of Privacy‐Preserving Synthetic Electronic Health Record Data: Comparison of Original Versus Synthetic Data on Real‐World COVID‐19 Vaccine Effectiveness	8
Dipeptidyl Peptidase‐4 Inhibitors and Risk of Heart Failure in Patients With Type 2 Diabetes Mellitus and End‐Stage Renal Disease Requiring Dialysis	8
Percutaneous left atrial appendage occlusion and risk of stroke, hospitalized bleeding and death in Medicare beneficiaries	8
Issue Information	8
Adverse drug reaction signal detection methods in spontaneous reporting system: A systematic review	8
A meta‐analysis assessing the prevalence of drug–drug interactions among hospitalized patients	8
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The Effects of Removing the Requirement for Prior Reimbursement Approval on Anticoagulant Use in Ireland: A Cross‐Sectional Study	7
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Signal detection of COVID‐19 vaccines adverse events using spontaneous reports from South Korea	7
Use of antidepressants and risk of repeat self‐harm in older adults 75+ with nonfatal self‐harm: A 1‐year prospective national study	7
Corrigendum	7
Issue Information	7
Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual‐level drug dispensing data	7
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Evaluation of Medication Adherence Among Prevalent Users in Hypertension, Dyslipidemia, and Diabetes Using Health Insurance Claims: A Population‐Based Cohort Study in Japan	7
A framework for the use of biological medicines in the free state province, South Africa	7
Response to letter to the editor regarding “Development and validation of a predictive model algorithm to identify anaphylaxis in adults with type 2 diabetes in U.S. administrative claims d	7
The Effect of Isoniazid for Tuberculosis Prevention on Pregnancy Risk Among Women Living With HIV on Antiretroviral Treatment and Progestin‐Based Hormonal Contraception	6
Accuracy of identifying diagnosis of moderate to severe chronic kidney disease in administrative claims data	6
Core Concepts in Pharmacoepidemiology: Principled Use of Artificial Intelligence and Machine Learning in Pharmacoepidemiology and Healthcare Research	6
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Development and Validation of Claims‐Based Algorithms for Conjunctivitis and Keratitis	6
Biases associated with epidermal necrolysis reporting in pharmacovigilance: An exploratory analysis using World Health Organization VigiBase	6
A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe	6
The use of uncertain exposure—A method to define switching and add‐on in pharmacoepidemiology	6
The impact of more restrictive hydrocodone rescheduling on unintentional pediatric opioid exposures	6
Rescheduling gabapentinoids had negligible effects on prescribing behaviour by general practitioners in England	6
Opioid Use After Hip Fracture and Subsequent Fracture Outcomes: A Self‐Controlled Case Series Design	6
Patterns of filled prescriptions and the association with risk of drug‐induced death. A population‐based nested case‐control register study	6
Comparison of record linkage software for deduplicating patient identities in California's Prescription Drug Monitoring Program	6
Opioid tapering and mental health crisis in older adults	6
Core Concepts: Self‐Controlled Designs in Pharmacoepidemiology	6
Joint longitudinal trajectories of pain intensity and opioid prescription in veterans with back pain	6
Sampling in the case‐time‐control design among drug users when outcome prevents further treatment	6
Validation of coding algorithms for the identification of herpes zoster among children	6
A methodology to assess the population size and estimate the needed resources for new licensed medications by combining clinical and administrative databases: The example of glycated haemoglobin in ty	6
Using administrative healthcare database records to study trends in prescribed medication dispensed during pregnancy in Belgium from 2003 to 2017	6
Accuracy and validity of reported opioid prescription days' supply	6
Prescribing of valproate and oral antiepileptics for women of childbearing age and during pregnancy in Germany between 2010 and 2020	6
Method used to identify adenomyosis and potentially undiagnosed adenomyosis in a large, U.S. electronic health record database	6
To wait or not to wait: Weighing the pros and cons of early identification of safety concerns for medications used in pregnancy	6
Examining the potential direct cardiovascular benefit of tumor‐necrosis factor inhibitor in rheumatoid arthritis: Natural and controlled direct effect analyses	6
SUPPLEMENTARY ABSTRACTS of ICPE 2021, the 37th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), 23–25 August, 2021 (virtual)	6
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Severe Cutaneous Adverse Reactions in Hospitalized Children: A Pilot Validation Study	5
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Use patterns of systemic immunomodulators in the United States before and after dupilumab approval in adults with atopic dermatitis	5
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Effect of concomitant antiplatelet therapy on ischemic and hemorrhagic events in patients taking oral anticoagulants for nonvalvular atrial fibrillation in daily clinical practice	5
Mobile apps for quick adverse drug reaction report: A scoping review	5
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Risk of ischemic stroke associated with direct oral anticoagulants discontinuation on patients with non‐valvular atrial fibrillation	5
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Issue Information	5
Overview of global real‐world data sources for pediatric pharmacoepidemiologic research	5
Real world prescription of beta‐blockers in patients with asthma	5
Use of Causal Framework to Evaluate Effect of Abuse Deterrent Properties of Extended‐Release Oxycodone on Tampering in a Real‐World Settings	5
Association of Pharmacist Interventions With Adverse Drug Events and Potential Adverse Drug Events	5
ABSTRACTS of the virtual 2nd Annual African Regional Interest Group Meeting (AfRIG), 11–13 July, 2022	5
Correction to “A data‐informed approach using individualised dispensing patterns to estimate medicine exposure periods and dose from pharmaceutical claims data”	5

The Awareness of and Adherence to the Pregnancy Prevention Program for Oral Retinoids: A Questionnaire Survey in Denmark	5
Validation of an electronic algorithm for Hodgkin and non‐Hodgkin lymphoma in ICD‐10‐CM	5
Prevalence of self‐medication practices among pregnant women in India: A systematic review and meta‐analysis	5
Core Concepts in Pharmacoepidemiology: Quantitative Bias Analysis	5
INSIGHT: A Tool for Fit‐for‐Purpose Evaluation and Quality Assessment of Standardized Observational Data Sources for Real World Evidence on Medicine and Vaccine Safety	5
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Validation studies of Japanese administrative health care data: A scoping review	5
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Myopericarditis following COVID‐19 mRNA vaccination	4
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Moxifloxacin monotherapy for treatment of uncomplicated pelvic inflammatory disease: A systematic review and meta‐analysis with trial sequential analysis of randomized controlled trials	4
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The Medicines Intelligence Data Platform: A Population‐Based Data Resource From New South Wales, Australia	4
Achieving comparability in glycemic control between antidiabetic treatment strategies in pregnancy when using real world data	4
Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real‐world data	4
Trends in strong opioid prescribing in Ireland: A repeated cross‐sectional analysis of a national pharmacy claims database between 2010 and 2019	4
Validity of claims data for identifying cancer incidence in the Japan public health center‐based prospective study for the next generation	4
Tell me what you want, what you really really want: Estimands in observational pharmacoepidemiologic comparative effectiveness and safety studies	4
Implementation of risk minimization measures to reduce the risk of tuberculosis among tumor necrosis factor medication users	4
Core concepts in pharmacoepidemiology: Fundamentals of the cohort and case–control study designs	4
Association between methylphenidate and risk of myocardial infarction: A multinational self‐controlled case series study	4
ISPE MidYear 2021	4
Where to begin? Thirty must‐read papers for newcomers to pharmacoepidemiology	4
A Two‐Step Framework for Validating Causal Effect Estimates	4
Pain‐related hospitalization and emergency room visit following initial analgesic prescription after outpatient surgery	4
Lessons learned from a multi‐data source research collaboration: The mirabegron post‐authorization safety study program	4
Impact on In‐ and Out‐of‐Hospital Drug Prescriptions of Including a More Expensive Me‐Too Antidepressant in a Hospital Drug Formulary: a Controlled Longitudinal Study	4
Antidepressant Use Trajectories and Risk of Discontinuation After Adolescents and Young Adult Cancer Diagnosis	4
Use of sedating medications around nursing home admission in Denmark	4
Utilization of opioid versus non‐opioid analgesics in Medicaid and CHIP enrolled children with current asthma	4
Pharmacoepidemiology and Drug Safety's core concepts in pharmacoepidemiology section at 1 year: Where do we go from here?	4
Impact of Regulatory Action on Dose Maximalization for Vitamin B6 Dietary Supplements on the Reporting Pattern for Neuropathy	4
Kidney function and prescribed dose in middle‐aged and older patients starting selective serotonin reuptake inhibitors	4
Gout and sodium‐glucose cotransporter‐2 inhibitors	4
Potentially inappropriate medication use by level of polypharmacy among US Veterans 49–64 and 65–70 years old	4
Real‐world treatment patterns and outcomes for patients with advanced melanoma treated with immunotherapy or targeted therapy	4
STUDENT ABSTRACTS of ISPE's 2024 Mid‐Year Meeting, Orlando, Florida, USA, 14–16 April 2024	4
Risk of Suicidal Ideation and Behavior Following Early‐Onset Idiopathic Restless Legs Syndrome Treatment	4
Comparative Effectiveness and Safety of Torsemide Versus Furosemide in Older Adults With Heart Failure	4
Stratified analysis in comparative effectiveness studies that emulate randomized trials	4
Clarifying the causal contrast: An empirical example applying the prevalent new user study design	4
Association of Benzodiazepine Prescription With Short‐Term Prognosis in Elderly Patients Attended in Emergency Department: Results From the EDEN PROJECT	4
Antibiotic use in children before, during and after hospitalisation	3
Risk of acute pancreatitis among new users of empagliflozin compared to sulfonylureas in patients with type 2 diabetes: A post‐authorization safety study	3
MetaLAB‐HOI: Template standardization of health outcomes enable massive and accurate detection of adverse drug reactions from electronic health records	3
Initiation of antidepressant medication in people with type 2 diabetes living in the United Kingdom—A retrospective cohort study	3
Use of electronic health record data to examine administrations of pro re nata analgesics during hip fracture post‐acute care	3
Statin persistence and adherence among older initiators: A nationwide cohort study using the national health insurance claims database in Japan	3
Decision and timing of safety‐related labeling changes for new drugs in Japan: Comparison with the United States and the European Union	3
Categorization of COVID‐19 severity to determine mortality risk	3
Cost‐effectiveness analysis of treatment with varenicline for nicotine dependence compared with smoking cessation without pharmacotherapy in the real world	3
Is it possible to identify risk factors for adverse drug reactions using a pharmacovigilance database based on spontaneous reporting?	3
Assessment of pharmacovigilance guidelines in the Southern African Development Community: A document review	3
Development of a multivariate prediction model to identify individual case safety reports which require clinical review	3
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High‐throughput screening for prescribing cascades among real world statin initiators	3
Prevalence, Associated Risk Factors, and Adverse Cardiovascular Outcomes of Statins Discontinuation: A Systematic Review	3
Sex disparities in medication changes after metformin initiation are associated with small, clinically non‐relevant, sex differences in HbA1c levels during follow‐up	3
Trend adjustment of the sequence difference when performing sequence symmetry analyses	3
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Risk of interstitial lung disease in patients treated for atrial fibrillation with dronedarone versus other antiarrhythmics	3
An investigation on the association between sodium glucose co‐transporter 2 inhibitors use and acute pancreatitis: A VigiBase study	3
Issue Information	3
Validation of an ICD‐10 case‐finding algorithm for endometrial cancer in US insurance claims	3
Peer Review of Real‐World Data Studies and Open Science—Connecting the Last Mile	3
Prescriber Adherence to Antihypertensive Prescription Guidelines and the Impact of Patient Socioeconomic Factors: A Cross‐Sectional Study Using Data From the Irish Longitudinal Study on Ageing	3
Altered liver function test after Covid‐19 vaccines: A retrospective control group study	3
Hydrochlorothiazide Use and Risk of Skin Cancer: A Population‐Based Retrospective Cohort Study	3
Maternal cyclobenzaprine exposure and risk of birth defects in the National Birth Defects Prevention Study (1997–2011) and Birth Defects Study to Evaluate Pregnancy exposureS (2014–2018)	3
IncidencePrevalence: An R package to calculate population‐level incidence rates and prevalence using theOMOPcommon data model	3
Obituary: Professor Joerg Hasfrod	3
The marked oscillatory pattern in prescription opioid utilization in Canada since 2000: Selected observations and questions for outcomes and policy	3
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Performance of an automated deep learning algorithm to identify hepatic steatosis within noncontrast computed tomography scans among people with and without HIV	3
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Quantitative Measurement of the Direct Public Health Impact of Medicines Withdrawals in Europe: Development of a Modelling Method and Proof‐of‐Concept Study to Estimate the Morbidity and Mortality Pre	3
Association Between β‐Adrenoreceptor Agonists and Antagonists and Parkinson's Disease: Systematic Review and Meta‐Analysis	3
A Real‐World Pharmacovigilance Study of FDA Adverse Event Reporting System Events for Obeticholic Acid	3
Issue Information	3
Exploring parity in female authorship of pharmacoepidemiology articles: A case study of the Canadian Network for Observational Drug Effect Studies and its citing articles	3
Pain Medication and Pain Intensity Following Hip Fractures—Analyses Based on the ProFem Cohort Study	3
A European, Observational, 3‐Year Cohort Comparative Study on the Safety of the Fixed Dose Combination Pravastatin 40 mg/Fenofibrate 160 mg vs. Statin Alone in Real Clinical Practice: The POSE	3
More extreme duplication in FDA Adverse Event Reporting System detected by literature reference normalization and fuzzy string matching	3
Validation of an algorithm for identifying incident cancer cases based on long‐term illness and diagnosis related group program data from the French National Health Insurance Informati	3
Role of private prescriptions in the long‐term use of benzodiazepines and Z‐drugs: A patient‐related follow‐up study	3