Research article:
Can analyses of electronic patient records be independently and externally validated? Study 2: the Effect of Beta-Adrenoceptor Blocker Therapy on Cancer Survival; a Retrospective Cohort Study
Reference:
David a Springate, Darren M Ashcroft, Evangelos Kontopantelis, Tim Doran, Ronan Ryan, David Reeves(2015)
Can analyses of electronic patient records be independently and externally validated? Study 2: the Effect of Beta-Adrenoceptor Blocker Therapy on Cancer Survival; a Retrospective Cohort Study.
BMJ Open, doi: 10.1136/bmjopen-2014-007299
- Link to fulltext article
- Abstract
- Objectives
To conduct a fully independent and external validation of a research study based on one electronic health record database, using a different database sampling the same population.
Design
Retrospective cohort analysis of beta-blocker therapy and all-cause mortality in cancer patients.
Setting
Two UK national primary care databases (PCDs): the Clinical Practice Research Datalink (CPRD) and Doctors’ Independent Network (DIN).
Participants
CPRD data for 11302 cancer patients compared to published results from DIN for 3462 patients.
Study period
January 1997 to December 2006.
Primary and secondary outcome measures
All-cause mortality: overall; by treatment subgroup (betablockers only, beta-blockers plus other blood pressure lowering medicines (BPLM), other BPLMs only); and by cancer-site.
Results
Using CPRD, beta-blocker use was not associated with mortality (HR=1.03, 95%CI 0.93-1.14, vs patients prescribed other BPLMs only), but in DIN beta-blocker users had significantly higher mortality (HR=1.18, 95%CI 1.04 to 1.33). However, these hazard ratios were not statistically different (p=0.063), but did differ for patients on beta-blockers alone (CPRD=0.94, 95%CI 0.82-1.07; DIN=1.37, 95%CI 1.16-1.61;
p<0.001). Results for nine individual cancer sites differed by study, but only significantly for prostate and pancreas cancers. Results were robust under sensitivity analyses, but we could not be certain that mortality was identically defined in both databases.
Conclusions
We found a complex pattern of similarities and differences between databases. Our finding that overall treatment effect estimates were not statistically different, adds to a growing body of evidence that different UK PCDs produce effect estimates comparable within statistical tolerance. However, some subgroup effects differed significantly and individually the two studies lead to different conclusions
regarding the safety of beta-blockers for cancer patients. Single studies based on internally well-validated databases therefore do not guarantee generalisable results, especially for subgroups. In all cases, confirmatory studies using at least one other independent data source are strongly recommended.
- Author for correspondence
- David Reeves
- Email for correspondence
- david.reeves@manchester.ac.uk
Code list: res24: colon cancer
20 codes in list
Code |
Coding system |
Description |
Entity type |
List name |
|
|
|
B13..00 |
Read |
Malig neop of colon |
diagnostic |
res24: colon cancer |
|
|
|
B130.00 |
Read |
Malig neop hepatic flex colon |
diagnostic |
res24: colon cancer |
|
|
|
B131.00 |
Read |
Malig neop of transverse colon |
diagnostic |
res24: colon cancer |
|
|
|
B132.00 |
Read |
Malig neop of descending colon |
diagnostic |
res24: colon cancer |
|
|
|
B133.00 |
Read |
Malig neop of sigmoid colon |
diagnostic |
res24: colon cancer |
|
|
|
B134.00 |
Read |
Malig neop of caecum |
diagnostic |
res24: colon cancer |
|
|
|
B135.00 |
Read |
Malig neop of appendix |
diagnostic |
res24: colon cancer |
|
|
|
B136.00 |
Read |
Malig neop of ascending colon |
diagnostic |
res24: colon cancer |
|
|
|
B137.00 |
Read |
Malig neop splenic flex colon |
diagnostic |
res24: colon cancer |
|
|
|
B138.00 |
Read |
Mal neop overlap lesn of colon |
diagnostic |
res24: colon cancer |
|
|
|
B13y.00 |
Read |
Malig neop oth spec site colon |
diagnostic |
res24: colon cancer |
|
|
|
B13z.00 |
Read |
Malig neop of colon NOS |
diagnostic |
res24: colon cancer |
|
|
|
B14..00 |
Read |
Malig neop of rectum and anus |
diagnostic |
res24: colon cancer |
|
|
|
B140.00 |
Read |
Malig neop rectosigmoid junct |
diagnostic |
res24: colon cancer |
|
|
|
B141.00 |
Read |
Malig neop of rectum |
diagnostic |
res24: colon cancer |
|
|
|
B142.00 |
Read |
Malig neop of anal canal |
diagnostic |
res24: colon cancer |
|
|
|
B142000 |
Read |
Mal neopl of cloacogenic zone |
diagnostic |
res24: colon cancer |
|
|
|
B143.00 |
Read |
Malig neop of anus unspecified |
diagnostic |
res24: colon cancer |
|
|
|
B14y.00 |
Read |
Malig neop oth rectum and anus |
diagnostic |
res24: colon cancer |
|
|
|
B14z.00 |
Read |
Malig neop rectum and anus NOS |
diagnostic |
res24: colon cancer |
|
|
|
0 comments have been posted.
Please log in to leave a comment.