Long term follow-up in a trial

Newcastle CTU is currently supporting a non-CTIMP RCT of management of heart disease in older adults. The primary objective is to determine the impact of a routine invasive strategy on one-year cardiovascular death and non-fatal myocardial infarction (MI) compared with a conservative treatment strategy in older patients (≥75 years) with NSTEMI.  Secondary objectives are to determine the impact of a routine invasive strategy compared with a conservative strategy on:
•1. All-cause death
•2. Cardiovascular or non-cardiovascular death
•3. Recurrent myocardial infarction
•4. Urgent coronary revascularisation
•5. Recurrent hospitalisation for myocardial infarction
•6. Hospitalization for heart failure
•7. Stroke
•8. Procedural and in-hospital complications
•9. The length of time spent at home
•10. Frailty and quality of life
•11. Cost-effectiveness

Primary outcome is time to cardiovascular death or non-fatal MI within one year. Secondary outcomes are:

1. All-cause, cardiovascular and non-cardiovascular death rates
2. Recurrent myocardial infarction
3. Hospitalisation for heart failure
4. Urgent coronary revascularisation
5. Recurrent hospitalisation for myocardial infarction
6. Stroke
7. Procedural complications including death, MI, major bleeding (BARC definition), 25% increase in serum creatinine concentration from baseline, need for renal replacement therapy, stroke
8. Length of time spent at home
9. Fried and Rockwood frailty scores
10. Quality of Life using EQ-5D-5L and quality adjusted life years (QALY)
11. Costs to the NHS and personal social services
12. Incremental cost per QALY gained at 1 year

The study is currently funded for 5 years, and we will continue to collect outcome data on enrolled patients over that period of time using a mixture of routine and study-specific clinical records, HSCIC data (ONS and HES) and patient self-report (QoL and costs).  The CI would like to continue to follow-up patients out to 10 years, using ONS and health record data only (i.e. no patient visits or patient-completed questionnaires).  Obviously, there would be cost implications of this in terms of HSCIC data provision and staff time to manage these data.

 

Our questions for you relate to implications for definition of end of trial, safety reporting and reporting to REC.  We know that many cancer trials in particular involve long-term follow-up for mortality.  We would welcome your experiences and views on the proposed long-term follow-up

Thanks

Elaine McColl, Deborah Stocken and Lesley Hall

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