Temporal Trends in Clinical Evidence of 5-Year Survival Within Electronic Health Records Among Patients With Early-Stage Colon Cancer Managed With Laparoscopy-Assisted Colectomy vs Open Colectomy

Hou, Jue; Zhao, Rachel; Cai, Tianrun; Beaulieu‐Jones, Brett K.; Seyok, Thany; Dahal, Kumar; Yuan, Qian; Xiong, Xin; Bonzel, Clara-Lea; Fox, Claire; Christiani, David C.; Jemielita, Thomas; Liao, Katherine P.; Liaw, Kai–Li; Cai, Tianxi

doi:10.1001/jamanetworkopen.2022.18371

Cited by 5 publications

(20 citation statements)

References 45 publications

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“…We retrieved 3133 unique records, of which 200 were included in the review (Figure 1). All reasons for excluding records after full-text review are given in eAppendix 6 in Supplement 1.…”

Section: Resultsmentioning

confidence: 99%

“… The included studies spanned 26 fields of medicine, predominately infectious disease (43 [22%]; 27 [14%] on COVID-19), cardiology (30 [15%]), and oncology (30 [15%]) . One hundred and thirty-one studies (66%)…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…One-hundred and fifteen studies (58%) completely reported how the target trial protocol was emulated. Eighty-seven studies (44%) provided both the protocol of the target trial and described how it was emulated (Table 2). The following items of the emulation were frequently reported: eligibility criteria (193 [97%]), treatment strategies (191 [96%]), assignment procedures (173 [87%]), primary outcome (196 [98%]), the follow-up period (186 [93%]), a causal contrast (146 [73%], and an analysis plan (194 [97%]) (Table 2).…”

Section: Resultsmentioning

confidence: 99%

“…Seventy studies (35%) reported in the title that the study aimed to emulate a target trial; 180 (90%) did so in the Methods section. Twenty studies (10%) reported the study was prospectively registered, 16 of these 20 (80%)…”

Section: Resultsmentioning

confidence: 99%

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Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Hansford,

Cashin,

Jones

et al. 2023

JAMA Netw Open

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ImportanceObservational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice.ObjectiveTo assess the reporting of observational studies that explicitly aimed to emulate a target trial.Evidence ReviewWe searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation.FindingsA total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation.Conclusion and RelevanceIn this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.

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“…We retrieved 3133 unique records, of which 200 were included in the review (Figure 1). All reasons for excluding records after full-text review are given in eAppendix 6 in Supplement 1.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Hansford,

Cashin,

Jones

et al. 2023

JAMA Netw Open

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LATTE: Label-efficient incident phenotyping from longitudinal electronic health records

Wen,

Hou,

Bonzel

et al. 2024

Patterns

Self Cite

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Comparative Effectiveness of Laparoscopic versus Open Colectomy in Colon Cancer Patients: A Study Protocol for Emulating a Target Trial Using Cancer Registry Data

Abera,

Robers,

Kästner

et al. 2024

Preprint

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Introduction: The objective of this study is to compare the 5-year overall survival of patients with stage I – III colon cancer surgically treated by laparoscopic colectomy versus open colectomy. Methods: Using Mecklenburg-Western Pomerania Cancer Registry data from 2008 to 2018, we will emulate a phase III, multicenter, open-label, two-parallel-arm hypothetical target trial in adult patients with stage I – III colon cancer who received laparoscopic or open colectomy as an elective treatment. An inverse probability-weighted parametric (Royston‒Parmar) survival model (IPWPSM) will be used to estimate the hazard ratio of laparoscopic versus open surgery after baseline factors are balanced between the two treatment arms. An inverse probability weighted Kaplan‒Meier curve will be used to compare five-year overall survival in both treatment arms. The hazard ratio will be complemented by absolute differences in the restricted mean survival time (at 1-year, 3-years, and 5-years) between laparoscopic and open surgical treatment. Various comparator and sensitivity analyses will be performed to check the robustness of the results that will be estimated by the IPWPSM main model. Treatment period- and stage-specific results will also be provided. Discussion: This study aims to causally model the effect of laparoscopic versus open colectomy on 5-year overall survival using a target trial emulation approach. As the cancer registry data do not cover BMI, comorbidity, and previous abdominal surgery for non-malignant indications, the potential for residual confounding arising from these factors is a limitation of this study. This will be approached in a quantitative bias analysis using the E-method. The results will substantiate existing evidence on the comparative effectiveness of laparoscopic versus open colectomy in patients with stage I – III colon cancer and may guide clinical decisions as to whether a laparoscopic approach is as safe as an open approach in terms of improving 5-year overall survival in these patient groups.

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Temporal Trends in Clinical Evidence of 5-Year Survival Within Electronic Health Records Among Patients With Early-Stage Colon Cancer Managed With Laparoscopy-Assisted Colectomy vs Open Colectomy

Cited by 5 publications

References 45 publications

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

LATTE: Label-efficient incident phenotyping from longitudinal electronic health records

Comparative Effectiveness of Laparoscopic versus Open Colectomy in Colon Cancer Patients: A Study Protocol for Emulating a Target Trial Using Cancer Registry Data

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