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Assessment of patient selection bias in prospective studies for heart failure

Session Poster Session 1

Speaker Gert-Jan de Vries

Event : Heart Failure 2016

  • Topic : coronary artery disease, acute coronary syndromes, acute cardiac care
  • Sub-topic : Coronary Artery Disease (Chronic)
  • Session type : Poster Session

Authors : JJG De Vries (Eindhoven,NL), I Sokoreli (Eindhoven,NL), G Geleijnse (Eindhoven,NL), SC Pauws (Eindhoven,NL), JM Riistama (Eindhoven,NL), A Tesanovic (Eindhoven,NL), A Crundall-Goode (Hull,GB), KM Goode (Hull,GB), JG Cleland (London,GB), AL Clark (Hull,GB)

Authors:
JJG De Vries1 , I Sokoreli1 , G Geleijnse1 , SC Pauws1 , JM Riistama1 , A Tesanovic1 , A Crundall-Goode2 , KM Goode2 , JG Cleland3 , AL Clark2 , 1Philips Research, Healthcare - Eindhoven - Netherlands , 2University of Hull - Hull - United Kingdom , 3Imperial College London, National Heart & Lung Institute - London - United Kingdom ,

Citation:
European Journal of Heart Failure Abstracts Supplement ( 2016 ) 18 ( Supplement 1 ), 55

Purpose: Various types of recruitment bias can occur in clinical studies. These may occur deliberately through the use of pre-specified trial inclusion/exclusion criteria, or indirectly as a consequence of the place and method of enrolment; due to a patient's perception of the value, risk and inconvenience of being involved; or pre-selection bias by the clinicians approaching the patient. We set out to explore these biases. Methods: OPERA-HF is a prospective, observational study enrolling patients hospitalized for or with heart failure. Other inclusion criteria are: age >18 years, treatment with loop diuretics and at least one of the following: left ventricular ejection fraction ≤40%, left atrial dimension >4.0 cm or NT-ProBNP >400 pg/mL (if sinus rhythm) or >1200 pg/mL (if atrial fibrillation). Three different study participation levels were possible: full, partial and routine care (via audit). All patients were eligible for the study, but might not be approached if the clinician thought it inappropriate; patients could choose which group to join if they declined to take part in the full study. Relative risk, for binary variables, and Wilcoxon rank-sum tests, for continuous variables, were estimated to compare data at different study participation levels. Conclusion: Patients recruited into the full study had fewer comorbidities and used less medication than those recruited into the partial and routine care arms. They also had a lower risk of readmission and mortality. Trials should be interpreted in the light of possible selection bias for less ill patients. Whether the selection bias was due to clinicians/nurses or patient choice needs further study.

Full Participation (n = 428) Partial Participation (n = 110) Routine Care (n = 243)
Age 74 [66 - 81] 77 [68 - 84]* 77 [69 - 83]*
NT-proBNP 4924 [2010 - 10085] 3942 [1962 - 9803] 5288 [2476 - 10912]
Myocardial infarction 45 (10.6%) 21 (19.6%)* 43 (18.4%)*
Cerebrovascular accident 33 (9.1%) 11 (11.0%) 28 (20.9%)*
Ace inhibitor 217 (50.6%) 53 (48.2%) 170 (70.0%)*
Beta blocker 259 (60.4%) 75 (68.2%) 192 (79.0%)*
30 day readmission 8 (3.0%) 3 (2.9%) 15 (7.8%)
1 year death 41 (20.4%) 22 (23.4%) 65 (33.3%)*
Results of key characteristics by study participation level, represented as median [IQR] or # (%). Missing data were excluded. * Indicates significant (p < 0.05) difference compared with Full Participation.

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