Abstract:
OBJECTIVE:Evidence-based guidelines recommend adjuvant chemotherapy in early stage breast cancer whenever treatment benefit is considered sufficient to outweigh the associated risks. However, many groups of patients were either excluded from or underrepresented in the clinical trials that form the evidence base for this recommendation. This study aims to determine whether using administrative health care data-real world data-and econometric methods for causal analysis to provide "real world evidence" (RWE) are feasible methods for addressing this gap. METHODS:Cases of primary breast cancer in women from 2001 to 2015 were extracted from the Scottish cancer registry (SMR06) and linked to other routine health records (inpatient and outpatient visits). Four methods were used to estimate the effect of adjuvant chemotherapy on disease-specific and overall mortality: (1) regression with adjustment for covariates, (2) propensity score matching, (3) instrumental variables analysis, and (4) regression discontinuity design. Hazard ratios for breast cancer mortality and all-cause mortality were compared to those from a meta-analysis of randomized trials. RESULTS:A total of 39,805 cases were included in the analyses. Regression adjustment, propensity score matching, and instrumental variables were feasible, whereas regression discontinuity was not. Effectiveness estimates were similar between RWE and randomized trials for breast cancer mortality but not for all-cause mortality. CONCLUSIONS:RWE methods are a feasible means to generate estimates of effectiveness of adjuvant chemotherapy in early stage breast cancer. However, such estimates must be interpreted in the context of the available randomized evidence and the potential biases of the observational methods.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Gray E,Marti J,Brewster DH,Wyatt JC,Piaget-Rossel R,Hall PSdoi
10.1016/j.jclinepi.2019.01.006subject
Has Abstractpub_date
2019-05-01 00:00:00pages
125-132eissn
0895-4356issn
1878-5921pii
S0895-4356(18)30813-8journal_volume
109pub_type
杂志文章abstract::The application of rigorous epidemiologic methods to clinical questions has broadened the scope of research in epidemiology and enhanced the quality of clinical research. The International Clinical Epidemiology Network (INCLEN) has enabled physicians from developing countries to obtain training in epidemiologic method...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
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journal_title:Journal of clinical epidemiology
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更新日期:2019-09-01 00:00:00
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journal_title:Journal of clinical epidemiology
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journal_title:Journal of clinical epidemiology
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更新日期:1997-08-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2020.07.021
更新日期:2021-01-01 00:00:00
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journal_title:Journal of clinical epidemiology
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更新日期:2007-06-01 00:00:00
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更新日期:1991-01-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
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更新日期:2004-11-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
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更新日期:2017-02-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(89)90076-0
更新日期:1989-01-01 00:00:00
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journal_title:Journal of clinical epidemiology
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doi:10.1016/s0895-4356(01)00492-9
更新日期:2002-04-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2008.06.017
更新日期:2009-04-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(99)00171-7
更新日期:2000-02-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2014.11.015
更新日期:2015-04-01 00:00:00
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doi:10.1016/0895-4356(92)90083-y
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更新日期:2016-11-01 00:00:00
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journal_title:Journal of clinical epidemiology
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更新日期:2001-08-01 00:00:00
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更新日期:2000-11-01 00:00:00
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journal_title:Journal of clinical epidemiology
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更新日期:2003-07-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,随机对照试验
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更新日期:2007-06-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2012.12.004
更新日期:2013-06-01 00:00:00
abstract::A 110-item food frequency questionnaire was tested among 152 community controls of the Kuopio Breast Cancer Study. They completed the questionnaire twice and kept two 7-day diet records at 3-month intervals. The intraclass correlations for nutrients varied from 0.49 (thiamine with supplements) to 0.81 (lactose), and f...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(95)00551-x
更新日期:1996-04-01 00:00:00
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journal_title:Journal of clinical epidemiology
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更新日期:2021-01-06 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2001-09-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(92)90101-r
更新日期:1992-05-01 00:00:00
abstract::To assess fracture risk following bilateral oophorectomy, we conducted a population-based retrospective cohort study among the 463 Rochester, Minnesota women who underwent bilateral oophorectomy for benign ovarian conditions in 1950-1979. During 7220 person-years of observation, there appeared to be a modest increase ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(96)00211-9
更新日期:1996-10-01 00:00:00