Excellent piece. I need to learn more about the issue of lead time bias in observational studies of “screening”.
Agree that there will always be limitations with observational studies, and that RCT are required. You mentioned difficulties with doing RCT in breast cancer screening….what are the barriers? If there have not been RCT showing …
Excellent piece. I need to learn more about the issue of lead time bias in observational studies of “screening”.
Agree that there will always be limitations with observational studies, and that RCT are required. You mentioned difficulties with doing RCT in breast cancer screening….what are the barriers? If there have not been RCT showing mammography to causally improve hard outcomes, then clinical equipoise must exist.
To wit, Nordicc (colonoscopy)and Dancavas (cardiac multimodality) fit that bill. Importantly, however, RCT of screening strategies need to analyze at the level of “invitation to screening” to be analogous to ITT. Both Nordicc (by some margin) and Dancavas (very barely) were negative for overall survival, but screening proponents have continued to argue for analysis of those “actually screened” which would be akin to an on-treatment analysis.
I think Strong HF is a great study. However, I agree it is NOT a study of GDMT per se, but rather one of care systems. If you worked in a system capable of providing 4 medical visits within 2 months of discharge from HF hospitalization (and another visit within 1 week of each Med titration)(avg number of visits in study =5), AND your pts look like theirs (avg age 63), then this is a fantastic treatment strategy to reduce subsequent HF hospitalizations. I don’t know about you, but I don’t work in such a system, and my typical pt is not 63. However, for younger pts, I have started to try more rapid uptitration of therapies on the basis of this study (although I find the guideline mantra that all HFrEF pts need to be on all 4 drugs to be idiotic, and I continue to apply the criteria from individual landmark studies for the respective agents).
Excellent piece. I need to learn more about the issue of lead time bias in observational studies of “screening”.
Agree that there will always be limitations with observational studies, and that RCT are required. You mentioned difficulties with doing RCT in breast cancer screening….what are the barriers? If there have not been RCT showing mammography to causally improve hard outcomes, then clinical equipoise must exist.
To wit, Nordicc (colonoscopy)and Dancavas (cardiac multimodality) fit that bill. Importantly, however, RCT of screening strategies need to analyze at the level of “invitation to screening” to be analogous to ITT. Both Nordicc (by some margin) and Dancavas (very barely) were negative for overall survival, but screening proponents have continued to argue for analysis of those “actually screened” which would be akin to an on-treatment analysis.
I think Strong HF is a great study. However, I agree it is NOT a study of GDMT per se, but rather one of care systems. If you worked in a system capable of providing 4 medical visits within 2 months of discharge from HF hospitalization (and another visit within 1 week of each Med titration)(avg number of visits in study =5), AND your pts look like theirs (avg age 63), then this is a fantastic treatment strategy to reduce subsequent HF hospitalizations. I don’t know about you, but I don’t work in such a system, and my typical pt is not 63. However, for younger pts, I have started to try more rapid uptitration of therapies on the basis of this study (although I find the guideline mantra that all HFrEF pts need to be on all 4 drugs to be idiotic, and I continue to apply the criteria from individual landmark studies for the respective agents).