Registry-Based Research CSI Seminar 25/05/2016 Magnus Ekstrm MD, - - PowerPoint PPT Presentation

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Registry-Based Research CSI Seminar 25/05/2016 Magnus Ekstrm MD, - - PowerPoint PPT Presentation

Dec 03, 2022 21 likes •424 views

Registry-Based Research CSI Seminar 25/05/2016 Magnus Ekstrm MD, PhD Department of Respiratory Medicine and Allergology Clinical Sciences Lund University, Lund, Sweden pmekstrom@gmail.com Karlskrona Research Focus of the Talk

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Registry-Based Research

CSI Seminar 25/05/2016 Magnus Ekström

MD, PhD Department of Respiratory Medicine and Allergology Clinical Sciences Lund University, Lund, Sweden pmekstrom@gmail.com

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Karlskrona

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Research

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Focus of the Talk

  • Examples of registry-based studies
  • Data sources in Sweden
  • The process to obtain data
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Swedevox Drugs Diagnoses Health care Mortality

Linkage

  • Home oxygen
  • Ventilator
  • CPAP
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Lund University / Faculty of Medicine / Department of Respiratory Medicine & Allergology

Material: Patients starting LTOT for COPD 1987 – 2004 in

  • Swedevox. Causes of Death Register.

1987 2005

Ekström MP, Franklin KA, Ström KE. Chest 2010;137

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Lund University / Faculty of Medicine / Department of Respiratory Medicine & Allergology

Excess mortality for the main causes of death

Women Men Diagnosis entity Obs / Exp SMR (95% CI) SMR (95% CI) Obs/Exp COPD 1860 / 6.4 292.2 (279.2 – 305.8) 155.4 (148.3-162.8) 1762 / 11.3 Ischemic heart disease 191 / 37.0 5.2 (4.5 – 6.0) 3.8 (3.4 – 4.3) 280 / 73.6 Lung cancer 116 / 7.3 15.8 (13.2 – 19.0) 8.7 (7.3 – 10.3) 123 / 14.2 Heart failure 70 / 7.6 9.2 (7.3 – 11.6) 4.1 (3.1 – 5.4) 50 / 12.2 Stroke 45 / 26.8 1.7 (1.3 – 2.3) 1.0 (0.7 – 1.3) 34 / 35.7 Aortic aneurysm 15 / 2.6 5.9 (3.5 – 9.8) 3.1 (2.1 – 4.7) 22 / 7.1 Venous thromboembolism 13 / 2.7 4.7 (2.8 – 8.2) 6.7 (4.3 – 10.3) 20 / 3.0 Tuberculosis 17 / 0.3 68.9 (42.9 – 110.8) 23.0 (11.0 – 48.2) 7 / 0.3 Pneumonia 8 / 5.9 1.4 (0.7 – 2.7) 1.1 (0.6 – 1.8) 13 / 12.3 Colon cancer 13 / 5.4 2.4 (1.4 – 4.1) 1.2 (0.6 – 2.4) 8 / 6.8

Total SMR Women 12.0 (95% CI, 11.6 - 12.5) Men 7.4 (95% CI, 7.1 - 7.6)

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Lund University / Faculty of Medicine / Department of Respiratory Medicine & Allergology

Time-dependent analysis of drug exposure

Adjusted for age, sex, hypoxemia, PaCO2 air, body mass index, WHO performance status och comorbidity (anemia, diabetes mellitus, renal failure and cardiovascular disease).

E6 = 0.4 E5 = 0 E4 = 0 E2 = 0.5 E3 = 1 E7 = 1

Start of follow-up

E1 = 0

End of follow-up

Cardiovascular drugs and survival time

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Ekström M et al. AJRCCM 2013; 187

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Safety of Benzodiazepines and Opioids

COPD, N = 2,449 3 months Dose of medication Hospitalization Death from all causes Adjusted for : age, sex, FEV1, blood gases, BMI, WHO performance status, morbidities, prev hospitalizations, and

  • ral glucocorticoids.
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Swedish Registry of Palliative Care

Thorax 2016; 71

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Combined Two Quality Registries

SRPC=Swedish Registry of Palliative Care

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Ahmadi et al. Thorax 2016; 71

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Ahmadi et al. Thorax 2016; 71

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Ahmadi et al. Thorax 2016; 71

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Data Sources in Sweden

  • Health care quality registries (QR)
  • Governmental ”public” registries
  • Study databases
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  • Emilsson. J Intern Med 2015; 277

Quality Registries (QR)

  • Single data source
  • Combine (QR, public reg, study)
  • Recruitment base (observ or intervent)
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  • No. Quality Registries Per Discipline
  • Emilsson. J Intern Med 2015; 277
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  • Emilsson. J Intern Med 2015; 277
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Swedish Cancer Registry

  • 1958 -

(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)

https://www.socialstyrelsen.se/register/halsodataregister/cancerregistret/inenglish

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Swedish Registry of Palliative Care

  • 2011 –
  • 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

http://palliativ.se/

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End of Life Questionnaire

….

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  • 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

How are QRs Governed?

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How QRs are run

Government (Sw Assoc of Local Authorities and Regions); oversight/strategy

County Council

Registry

Responsible Steering commitee Data management unit Care units

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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
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The Process

to Obtain Data

  • 1. Quality Registry as Lone Data Source

Regional Ethics

Project plan

Identify authority/region

Registry

County Council

Data

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The Process

Project plan

  • 2. Aggregated public data

(rates of hospitalization, diagnoses, mortality …) Data

No ethics approval needed

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The Process

  • 3. Combination of Registries / Study Data

Regional Ethics

Project plan

Identify authority/region County Council

x 1 x 1..n

Registry, study

Data

ID No ID Saves ID key

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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
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Potential Limitations

Of Registry-Based Studies

  • Bias (generally unaffected by increasing sample size)
  • Data quality
  • ”Real-world studies”?
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Registry-Based RCT (R-RCT)

  • Consent
  • Eligibility

Intervention Comparison

Randomization

Outcome Assessment

  • Registry
  • Research unit

Registry

James et al. Nat Rev Cardiol 2015; 12

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The first TASTE of the R-RCT

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Fröbert et al. NEJM 2013; 369

Included 85% of eligible patients 61% of all with STEMI in Sweden

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Mortality at 30 days

Fröbert et al. NEJM 2013; 369

Complete follow-up

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Suitable in Advanced Disease?

  • Facilitate recruitment
  • Follow-up
  • Cost-effective
  • Challenges
  • Suitable outcomes (PROMs)
  • Assessment of adverse events

Fröbert et al. NEJM 2013; 369

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R-RCT of Long-Term Oxygen

  • Eligibility
  • Consent

LTOT 24 h/d LTOT 15 h/d Randomization

Registry data Death Hospitalizations Diagnoses Prescribed drugs Questionnaire PROMs

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Last Words

  • Rich network of registry data in Sweden
  • Possibilities for collaborations
  • Needs ideas, time, some bucks
  • Development of R-RCTs
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Thanks a lot!

pmekstrom@gmail.com