Registry-Based Research
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1 Registry-Based Research CSI Seminar 25/05/2016 Magnus Ekström MD, PhD Department of Respiratory Medicine and Allergology Clinical Sciences Lund University, Lund, Sweden
2 Karlskrona
3
4 Research
5 Focus of the Talk Examples of registry-based studies Data sources in Sweden The process to obtain data
6 Health care Linkage Drugs Swedevox Diagnoses Home oxygen Ventilator CPAP Mortality
7 Ekström MP, Franklin KA, Ström KE. Chest 2010;137 Material: Patients starting LTOT for COPD in Swedevox. Causes of Death Register Lund University / Faculty of Medicine / Department of Respiratory Medicine & Allergology
8 Excess mortality for the main causes of death Women Men Diagnosis entity Obs / Exp SMR (95% CI) SMR (95% CI) Obs/Exp COPD 1860 / ( ) ( ) 1762 / 11.3 Ischemic heart disease 191 / ( ) 3.8 ( ) 280 / 73.6 Lung cancer 116 / ( ) 8.7 ( ) 123 / 14.2 Heart failure 70 / ( ) 4.1 ( ) 50 / 12.2 Stroke 45 / ( ) 1.0 ( ) 34 / 35.7 Aortic aneurysm 15 / ( ) 3.1 ( ) 22 / 7.1 Venous thromboembolism 13 / ( ) 6.7 ( ) 20 / 3.0 Tuberculosis 17 / ( ) 23.0 ( ) 7 / 0.3 Pneumonia 8 / ( ) 1.1 ( ) 13 / 12.3 Colon cancer 13 / ( ) 1.2 ( ) 8 / 6.8 Total SMR Women 12.0 (95% CI, ) Men 7.4 (95% CI, ) Lund University / Faculty of Medicine / Department of Respiratory Medicine & Allergology
9 Cardiovascular drugs and survival time Time-dependent analysis of drug exposure E 1 = 0 E 2 = 0.5 E 3 = 1 E 4 = 0 E 5 = 0 E 6 = 0.4 E 7 = 1 Start of follow-up End of follow-up Adjusted for age, sex, hypoxemia, PaCO 2 air, body mass index, WHO performance status och comorbidity (anemia, diabetes mellitus, renal failure and cardiovascular disease). Lund University / Faculty of Medicine / Department of Respiratory Medicine & Allergology
10 Ekström M et al. AJRCCM 2013; 187
11 Safety of Benzodiazepines and Opioids COPD, N = 2,449 Hospitalization 3 months Dose of medication Death from all causes Adjusted for : age, sex, FEV 1, blood gases, BMI, WHO performance status, morbidities, prev hospitalizations, and oral glucocorticoids.
12
13 Swedish Registry of Palliative Care Thorax 2016; 71
14 Combined Two Quality Registries SRPC=Swedish Registry of Palliative Care
15 Ahmadi et al. Thorax 2016; 71
16 Ahmadi et al. Thorax 2016; 71
17 Ahmadi et al. Thorax 2016; 71
18 Data Sources in Sweden Health care quality registries (QR) Governmental public registries Study databases
19 Quality Registries (QR) Emilsson. J Intern Med 2015; 277 Single data source Combine (QR, public reg, study) Recruitment base (observ or intervent)
20 No. Quality Registries Per Discipline Emilsson. J Intern Med 2015; 277
21 Emilsson. J Intern Med 2015; 277
22 Swedish Cancer Registry (4% missing diagnoses) All malignant disease nationwide Reporting: laboratory + clinician PID, age, sex, place of residence Diagnosis type and date Tumour site, hist type, stage (2004 -) + more disease-specific data in sub-registries (INCA registries)
23 Swedish Registry of Palliative Care About 60% of deaths in Sweden > 85% of deaths in people with cancer Data on last 7 days of life Reported by staff (nurses) within 7 days after death Unit, resources, preference for place of death Presence of symptoms, level of relief, validated assessment As needed medications Emilsson. J Intern Med 2015; 277
24 End of Life Questionnaire.
25 How are QRs Governed? Funded by the government (liberal ---->?) Responsible authority (Country Council) QR does not own but nurture the data Social security number Public Access to Information and Secrecy Act but formal process not devoid of bureaucracy
26 How QRs are run Government (Sw Assoc of Local Authorities and Regions); oversight/strategy Responsible County Council Registry Steering commitee Data management unit Care units
27 How are Public Registers Governed? National Board of Health and Welfare (Socialstyrelsen) Mortality: 100% coverage; Hosp and diagn: > 90% for somatic; Drugs: 100% of outpatient prescriptions Standardized process to request and obtain data Data provided de-identified Study ID instead of social security number Can save key to social security number > 3 yrs
28 The Process to Obtain Data 1. Quality Registry as Lone Data Source Identify authority/region Regional Ethics Project plan Data County Council Registry
29 The Process 2. Aggregated public data (rates of hospitalization, diagnoses, mortality ) Project plan Data No ethics approval needed
30 The Process 3. Combination of Registries / Study Data Saves ID key x 1 No ID Identify authority/region Regional Ethics Project plan ID Data County Council x 1..n Registry, study
31 Potential Advantages Of Registry-Based Studies Large sample sizes and high precision Capture rare conditions or events Routinely collected, feasability, cost-effective Prospective data (exposures before outcomes) Hard endpoints (death) High rate of follow-up (depending on outcome) Representativeness, generalizability
32 Potential Limitations Of Registry-Based Studies Bias (generally unaffected by increasing sample size) Data quality Real-world studies?
33 Registry-Based RCT (R-RCT) Registry Consent Eligibility Randomization Intervention Comparison Outcome Assessment Registry Research unit James et al. Nat Rev Cardiol 2015; 12
34 The first TASTE of the R-RCT
35 Included 85% of eligible patients 61% of all with STEMI in Sweden Fröbert et al. NEJM 2013; 369
36 Mortality at 30 days Complete follow-up Fröbert et al. NEJM 2013; 369
37 Suitable in Advanced Disease? Facilitate recruitment Follow-up Cost-effective Challenges Suitable outcomes (PROMs) Assessment of adverse events Fröbert et al. NEJM 2013; 369
38 R-RCT of Long-Term Oxygen Eligibility Consent Randomization LTOT 24 h/d LTOT 15 h/d Registry data Death Hospitalizations Diagnoses Prescribed drugs Questionnaire PROMs
39 Last Words Rich network of registry data in Sweden Possibilities for collaborations Needs ideas, time, some bucks Development of R-RCTs
40 Thanks a lot! pmekstrom@gmail.com
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