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Research article:

Can analyses of electronic patient records be independently and externally validated? The effect of statins on the mortality of patients with Ischaemic heart disease: a cohort study with nested case-control analysis

Reference:

David Reeves, David Springate, Darren M Ashcroft, Ronan Ryan, Tim Doran, Richard Morris, Ivan Olier, Evangelos Kontopantelis(2014) Can analyses of electronic patient records be independently and externally validated? The effect of statins on the mortality of patients with Ischaemic heart disease: a cohort study with nested case-control analysis. BMJ Open, doi: doi:10.1136/bmjopen-2014-004952

Link to fulltext article
Abstract
Objective To conduct a fully independent and external validation of a research study based on one electronic health records database, using a different electronic database sampling the same population. Design Using the Clinical Practice Research Datalink (CPRD), we replicated a published investigation into the effects of statins in patients with ischaemic heart disease (IHD) by a different research team using QResearch. We replicated the original methods and analysed all cause mortality using: (i) a cohort analysis and (ii) a case-control analysis nested within the full cohort. Setting Electronic health record databases containing longitudinal patient consultation data from large numbers of general practices distributed throughout the UK. Participants CPRD data for 34925 patients with IHD from 224 general practices, compared against previously published results from QResearch for 13,029 patients from 89 general practices. The study period was January 1996 to December 2003. Results We successfully replicated the methods of the original study very closely. In cohort analysis risk of death was lower by 55% for patients on statins, compared to 53% for QResearch (adjusted HR 0.45, 95% CI 0.40 to 0.50; versus 0.47, 95% CI 0.41 to 0.53). In case-control analyses patients on statins had a 31% lower odds of death, compared to 39% for QResearch (adjusted OR 0.69, 95% CI 0.63 to 0.75; versus OR 0.61, 95% CI 0.52 to 0.72). Results were also close for individual statins. Conclusion Database differences in population characteristics and in data definitions, recording, quality and completeness had minimal impact on key statistical outputs. The results uphold the validity of research using CPRD and QResearch, by providing independent evidence that both datasets produce very similar estimates of treatment effect, leading to the same clinical and policy decisions. Together with other, non-independent, replication studies there is a nascent body of evidence for wider validity.
Author for correspondence
David Reeves
Email for correspondence
david.reeves@manchester.ac.uk

Code list: Statins

104 codes in list

Code Coding system Description Entity type List name drug_substance BNF_chapter BNF_code
10172 CPRD_product_code ezetimibe with simvastatin tablets 10mg + 40mg drug Statins simvastatin/ezetimibe Statins/Ezetimibe 02120400/02120200
10183 CPRD_product_code simvastatin with ezetimibe tablets 40mg + 10mg drug Statins simvastatin/ezetimibe Statins/Ezetimibe 02120400/02120200
10206 CPRD_product_code simvastatin with ezetimibe tablets 80mg + 10mg drug Statins simvastatin/ezetimibe Statins/Ezetimibe 02120400/02120200
11627 CPRD_product_code fluvastatin 24 hour modified release tablets 80mg drug Statins fluvastatin sodium Statins 02120400
11815 CPRD_product_code simvastatin with ezetimibe tablets 20mg + 10mg drug Statins simvastatin/ezetimibe Statins/Ezetimibe 02120400/02120200
1219 CPRD_product_code pravastatin tablets 40mg drug Statins pravastatin sodium Statins 02120400
1221 CPRD_product_code LIPOSTAT tablets 10mg [SQUIBB] drug Statins pravastatin sodium Statins 02120400
1223 CPRD_product_code LIPOSTAT tablets 40mg [SQUIBB] drug Statins pravastatin sodium Statins 02120400
13041 CPRD_product_code SIMVADOR tablets 10mg [DISCOVERY] drug Statins simvastatin Statins 02120400
14219 CPRD_product_code ezetimibe with simvastatin tablets 10mg + 80mg drug Statins simvastatin/ezetimibe Statins/Ezetimibe 02120400/02120200
15252 CPRD_product_code CRESTOR tablets 20mg [ASTRAZENEC] drug Statins rosuvastatin calcium Statins 02120400
16186 CPRD_product_code INEGY tablets 10mg + 80mg [M S D] drug Statins simvastatin/ezetimibe Statins/Ezetimibe 02120400/02120200
17059 CPRD_product_code INEGY tablets 10mg + 40mg [M S D] drug Statins simvastatin/ezetimibe Statins/Ezetimibe 02120400/02120200
17683 CPRD_product_code LIPITOR tablets 80mg [PFIZER] drug Statins atorvastatin calcium Statins 02120400
17688 CPRD_product_code CRESTOR tablets 5mg [ASTRAZENEC] drug Statins rosuvastatin calcium Statins 02120400
18442 CPRD_product_code LIPOBAY tablets 400micrograms [BAYER] drug Statins cerivastatin sodium Statins 02120400
21020 CPRD_product_code INEGY tablets 10mg + 20mg [M S D] drug Statins simvastatin/ezetimibe Statins/Ezetimibe 02120400/02120200
2137 CPRD_product_code fluvastatin capsules 40mg drug Statins fluvastatin sodium Statins 02120400
22579 CPRD_product_code ZOCOR tablets 80mg [M S D] drug Statins simvastatin Statins 02120400
25 CPRD_product_code simvastatin tablets 20mg drug Statins simvastatin Statins 02120400
2718 CPRD_product_code ZOCOR tablets 10mg [M S D] drug Statins simvastatin Statins 02120400
28 CPRD_product_code atorvastatin tablets 10mg drug Statins atorvastatin calcium Statins 02120400
2955 CPRD_product_code LIPITOR tablets 40mg [PFIZER] drug Statins atorvastatin calcium Statins 02120400
31658 CPRD_product_code cerivastatin tablets 800micrograms drug Statins cerivastatin sodium Statins 02120400
31930 CPRD_product_code ZOCOR HEART-PRO tablets 10mg [MCNEIL] drug Statins simvastatin Statins 02120400
32909 CPRD_product_code SIMVASTATIN tablets 80mg [HILLCROSS] drug Statins simvastatin Statins 02120400
32921 CPRD_product_code PRAVASTATIN tablets 10mg [DR REDDY`S] drug Statins pravastatin sodium Statins 02120400
33082 CPRD_product_code SIMVASTATIN tablets 20mg [HILLCROSS] drug Statins simvastatin Statins 02120400
3411 CPRD_product_code LIPITOR tablets 10mg [PFIZER] drug Statins atorvastatin calcium Statins 02120400
34312 CPRD_product_code SIMVASTATIN tablets 20mg [GEN (UK)] drug Statins simvastatin Statins 02120400
34316 CPRD_product_code SIMVASTATIN tablets 20mg [TEVA] drug Statins simvastatin Statins 02120400
34353 CPRD_product_code SIMVASTATIN tablets 40mg [GEN (UK)] drug Statins simvastatin Statins 02120400
34366 CPRD_product_code SIMVASTATIN tablets 20mg [IVAX] drug Statins simvastatin Statins 02120400
34376 CPRD_product_code SIMVASTATIN tablets 40mg [TEVA] drug Statins simvastatin Statins 02120400
34381 CPRD_product_code SIMVASTATIN tablets 40mg [IVAX] drug Statins simvastatin Statins 02120400
34476 CPRD_product_code SIMVASTATIN tablets 20mg [RATIOPHARM] drug Statins simvastatin Statins 02120400
34481 CPRD_product_code SIMVASTATIN tablets 10mg [IVAX] drug Statins simvastatin Statins 02120400
34502 CPRD_product_code SIMVASTATIN tablets 40mg [HILLCROSS] drug Statins simvastatin Statins 02120400
34535 CPRD_product_code SIMVASTATIN tablets 10mg [GEN (UK)] drug Statins simvastatin Statins 02120400
34545 CPRD_product_code SIMVASTATIN tablets 40mg [RATIOPHARM] drug Statins simvastatin Statins 02120400
34560 CPRD_product_code SIMVASTATIN tablets 10mg [RATIOPHARM] drug Statins simvastatin Statins 02120400
34746 CPRD_product_code SIMVASTATIN tablets 20mg [NICHE] drug Statins simvastatin Statins 02120400
34814 CPRD_product_code SIMVASTATIN tablets 20mg [WOCKHARDT] drug Statins simvastatin Statins 02120400
34820 CPRD_product_code PRAVASTATIN tablets 40mg [HILLCROSS] drug Statins pravastatin sodium Statins 02120400
34879 CPRD_product_code SIMVASTATIN tablets 40mg [NICHE] drug Statins simvastatin Statins 02120400
34891 CPRD_product_code SIMVASTATIN tablets 20mg [KENT] drug Statins simvastatin Statins 02120400
34907 CPRD_product_code SIMVASTATIN tablets 40mg [WOCKHARDT] drug Statins simvastatin Statins 02120400
34955 CPRD_product_code SIMVASTATIN tablets 10mg [HILLCROSS] drug Statins simvastatin Statins 02120400
34969 CPRD_product_code SIMVASTATIN tablets 40mg [ACTAVIS] drug Statins simvastatin Statins 02120400
36377 CPRD_product_code PRAVASTATIN tablets 20mg [TEVA] drug Statins pravastatin sodium Statins 02120400
3690 CPRD_product_code LIPOSTAT tablets 20mg [SQUIBB] drug Statins pravastatin sodium Statins 02120400
37434 CPRD_product_code SIMVASTATIN tablets 40mg [SANDOZ] drug Statins simvastatin Statins 02120400
379 CPRD_product_code fluvastatin capsules 20mg drug Statins fluvastatin sodium Statins 02120400
39060 CPRD_product_code SIMVASTATIN tablets 20mg [DEXCEL] drug Statins simvastatin Statins 02120400
39652 CPRD_product_code simvastatin sugar free oral suspension 40mg/5ml drug Statins simvastatin Statins 02120400
39675 CPRD_product_code SIMVASTATIN oral suspension 20mg/5ml [MARTINDALE] drug Statins simvastatin Statins 02120400
39870 CPRD_product_code SIMVADOR tablets 80mg [DISCOVERY] drug Statins simvastatin Statins 02120400
40340 CPRD_product_code SIMVASTATIN tablets 10mg [TEVA] drug Statins simvastatin Statins 02120400
40382 CPRD_product_code PRAVASTATIN tablets 20mg [HILLCROSS] drug Statins pravastatin sodium Statins 02120400
40601 CPRD_product_code SIMVASTATIN tablets 20mg [RANBAXY] drug Statins simvastatin Statins 02120400
41657 CPRD_product_code SIMVASTATIN tablets 80mg [TEVA] drug Statins simvastatin Statins 02120400
42 CPRD_product_code simvastatin tablets 10mg drug Statins simvastatin Statins 02120400
420 CPRD_product_code cerivastatin tablets 100micrograms drug Statins cerivastatin sodium Statins 02120400
43218 CPRD_product_code PRAVASTATIN tablets 10mg [TEVA] drug Statins pravastatin sodium Statins 02120400
44528 CPRD_product_code SIMVASTATIN sugar free oral suspension 20mg/5ml [ROSEMONT] drug Statins simvastatin Statins 02120400
44650 CPRD_product_code SIMVASTATIN tablets 40mg [DEXCEL] drug Statins simvastatin Statins 02120400
44878 CPRD_product_code RANZOLONT tablets 10mg [RANBAXY] drug Statins simvastatin Statins 02120400
45219 CPRD_product_code SIMVASTATIN tablets 40mg [KENT] drug Statins simvastatin Statins 02120400
45235 CPRD_product_code SIMVASTATIN tablets 20mg [SANDOZ] drug Statins simvastatin Statins 02120400
45245 CPRD_product_code SIMVASTATIN tablets 20mg [ACTAVIS] drug Statins simvastatin Statins 02120400
45346 CPRD_product_code SIMVASTATIN tablets 40mg [ARROW] drug Statins simvastatin Statins 02120400
46878 CPRD_product_code SIMVASTATIN tablets 40mg [ALMUS] drug Statins simvastatin Statins 02120400
46956 CPRD_product_code SIMVASTATIN tablets 80mg [ARROW] drug Statins simvastatin Statins 02120400
47065 CPRD_product_code atorvastatin chewable tablet 20mg drug Statins atorvastatin calcium Statins 02120400
47090 CPRD_product_code atorvastatin chewable tablet 10mg drug Statins atorvastatin calcium Statins 02120400
490 CPRD_product_code pravastatin tablets 10mg drug Statins pravastatin sodium Statins 02120400
4961 CPRD_product_code LIPOBAY tablets 300micrograms [BAYER] drug Statins cerivastatin sodium Statins 02120400
5009 CPRD_product_code cerivastatin tablets 200micrograms drug Statins cerivastatin sodium Statins 02120400
51 CPRD_product_code simvastatin tablets 40mg drug Statins simvastatin Statins 02120400
5148 CPRD_product_code simvastatin tablets 80mg drug Statins simvastatin Statins 02120400
5251 CPRD_product_code cerivastatin tablets 300micrograms drug Statins cerivastatin sodium Statins 02120400
5278 CPRD_product_code cerivastatin tablets 400micrograms drug Statins cerivastatin sodium Statins 02120400
5775 CPRD_product_code atorvastatin tablets 80mg drug Statins atorvastatin calcium Statins 02120400
5985 CPRD_product_code LESCOL XL tablets 80mg [NOVARTIS] drug Statins fluvastatin sodium Statins 02120400
6168 CPRD_product_code ZOCOR tablets 40mg [M S D] drug Statins simvastatin Statins 02120400
6213 CPRD_product_code rosuvastatin tablets 20mg drug Statins rosuvastatin calcium Statins 02120400
713 CPRD_product_code rosuvastatin tablets 10mg drug Statins rosuvastatin calcium Statins 02120400
7196 CPRD_product_code ZOCOR tablets 20mg [M S D] drug Statins simvastatin Statins 02120400
730 CPRD_product_code pravastatin tablets 20mg drug Statins pravastatin sodium Statins 02120400
7347 CPRD_product_code CRESTOR tablets 10mg [ASTRAZENEC] drug Statins rosuvastatin calcium Statins 02120400
7374 CPRD_product_code LIPITOR tablets 20mg [PFIZER] drug Statins atorvastatin calcium Statins 02120400
745 CPRD_product_code atorvastatin tablets 40mg drug Statins atorvastatin calcium Statins 02120400
75 CPRD_product_code atorvastatin tablets 20mg drug Statins atorvastatin calcium Statins 02120400
7552 CPRD_product_code ezetimibe with simvastatin tablets 10mg + 20mg drug Statins simvastatin/ezetimibe Statins/Ezetimibe 02120400/02120200
7554 CPRD_product_code rosuvastatin tablets 5mg drug Statins rosuvastatin calcium Statins 02120400
802 CPRD_product_code SIMVADOR tablets 40mg [DISCOVERY] drug Statins simvastatin Statins 02120400
818 CPRD_product_code simvastatin sugar free oral suspension 20mg/5ml drug Statins simvastatin Statins 02120400
8380 CPRD_product_code LESCOL capsules 20mg [NOV/SANDOZ] drug Statins fluvastatin sodium Statins 02120400
9153 CPRD_product_code LESCOL capsules 40mg [NOV/SANDOZ] drug Statins fluvastatin sodium Statins 02120400
9315 CPRD_product_code LIPOBAY tablets 100micrograms [BAYER] drug Statins cerivastatin sodium Statins 02120400
9316 CPRD_product_code LIPOBAY tablets 200micrograms [BAYER] drug Statins cerivastatin sodium Statins 02120400
9897 CPRD_product_code rosuvastatin tablets 40mg drug Statins rosuvastatin calcium Statins 02120400
9920 CPRD_product_code SIMVADOR tablets 20mg [DISCOVERY] drug Statins simvastatin Statins 02120400
9930 CPRD_product_code CRESTOR tablets 40mg [ASTRAZENEC] drug Statins rosuvastatin calcium Statins 02120400

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