Version date | Version number | Section of protocol | Amendment or update | Reason |
---|---|---|---|---|
<Date of the protocol version change> | <Number or other identifier for the protocol version> | <Brief text description of which sections of the protocol were amended> | <Brief text description of what changes were involved with the protocol amendment> | <Brief text description of the rationale for the protocol amendment> |
Study protocol
Based on the HARPER template
1 Title page
This protocol is based on the HARmonized Protocol Template to Enhance Reproducibility (HARPER) of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force (HARPER) protocol by Wang SV et al.1,2
Title
Research question and objectives
Protocol version
Contributors
Primary investigator contact information:
Contributor names:
Study registration
Site:
Identifier:
Sponsor
Organization:
Contact:
Conflict of interest
2 Abstract
3 Amendments and updates
4 Milestones
Milestone | Date |
---|---|
<Milestone description> | <Date> |
<Milestone description> | <Date> |
<Milestone description> | <Date> |
5 Rationale and background
What is known about the condition:
What is known about the exposure of interest:
Gaps in knowledge:
What is the expected contribution of this study?
The purpose of this protocol is to describe the emulation of trial INSERT TRIAL NAME. The primary trial estimate targeted for emulation is INSERT. Market availability of EXPOSURE began DATE.
6 Research question and objectives
Table 2: Research questions and objectives
Study element | Specification |
---|---|
Objective: | <Text> |
Hypothesis: | <Text> |
Population (mention key inclusion-exclusion criteria): | <Text> |
Exposure: | <Text> |
Comparator: | <Text> |
Outcome: | <Text> |
Time (when follow up begins and ends): | <Text> |
Setting: | <Text> |
Main measure of effect: | <Text> |
Study element | Specification |
---|---|
Objective: | <Text> |
Hypothesis: | <Text> |
Population (mention key inclusion-exclusion criteria): | <Text> |
Exposure: | <Text> |
Comparator: | <Text> |
Outcome: | <Text> |
Time (when follow up begins and ends): | <Text> |
Setting: | <Text> |
Main measure of effect: | <Text> |
7 Research methods
7.1 Study design
Research design (e.g. cohort, case-control, etc.):
Rationale for study design choice:
7.2 Study design diagram3,4
7.3 Setting
7.3.1 Context and rationale for definition of time 0 (and other primary time anchors) for entry to the study population
Study population name(s) | Time Anchor Description (e.g. time 0) | Number of entries | Type of entry | Washout window | Care setting | Code type | Diagnosis position | Incident with respect to… | Measurement characteristics/ validation | Source of algorithm |
---|---|---|---|---|---|---|---|---|---|---|
<Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> |
7.3.2 Context and rationale for study inclusion criteria
Criterion | Details | Order of application | Assessment window | Care settings | Code Type | Diagnosis position | Applied to study populations: | Measurement characteristics/ validation | Source of algorithm |
---|---|---|---|---|---|---|---|---|---|
<Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> |
7.3.3 Context and rationale for study exclusion criteria
Criterion | Details | Order of application | Assessment window | Care settings | Code Type | Diagnosis position | Applied to study populations: | Measurement characteristics/ validation | Source of algorithm |
---|---|---|---|---|---|---|---|---|---|
<Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> |
7.4 Variables
7.4.1 Context and rationale for exposure(s) of interest
Algorithm to define duration of exposure effect:
Exposure group name(s) | Details | Washout window | Assessment window | Care settings | Code Type | Diagnosis position | Applied to study populations: | Incident with respect to... | Measurement characteristics/ validation | Source of algorithm |
---|---|---|---|---|---|---|---|---|---|---|
<Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> |
7.4.2 Context and rationale for outcome(s) of interest
Outcome name | Details | Primary outcome? | Type of outcome | Washout window | Care settings | Code Type | Diagnosis position | Applied to study populations: | Measurement characteristics/ validation | Source of algorithm |
---|---|---|---|---|---|---|---|---|---|---|
<Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> |
7.4.3 Context and rationale for follow up
Time point | Select all that apply | Specify |
---|---|---|
Follow up start | <Text> | <Text> |
Follow up end | <Text> | <Text> |
Date of outcome | <Text> | <Text> |
Date of death | <Text> | <Text> |
End of observation in data | <Text> | <Text> |
Day X following index date | <Text> | <Text> |
End of study period | <Text> | <Text> |
End of exposure | <Text> | <Text> |
Date of add to/switch from exposure | <Text> | <Text> |
Other date | <Text> | <Text> |
7.4.4 Context and rationale for covariates (confounding variables and effect modifiers, e.g. risk factors, comorbidities, comedications)
Characteristic | Details | Type of variable | Assessment window | Care settings | Code Type | Diagnosis position | Applied to study populations: | Measurement characteristics/ validation | Source of algorithm |
---|---|---|---|---|---|---|---|---|---|
<Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> | <Text> |
7.5 Data analysis
7.5.1 Context and rationale for analysis plan
7.5.1.1 A. Primary analysis
Table 10: Primary, secondary, and subgroup analysis specification
Analysis element | Specification |
---|---|
Hypothesis: | <Text> |
Exposure contrast: | <Text> |
Outcome: | <Text> |
Analytical software | <Text> |
Model(s): | <Text> |
Conofunding adjustment method | Name method and provide relevant details, e.g. bivariate, multivariable, propensity score matching (specify matching algorithm ratio and caliper), propensity score weighting (specify weight formula, trimming, truncation), propensity score stratification (specify strata definition), other |
Missing data methods | Name method and provide relevant details, e.g. missing indicators, complete case, last value carried forward, multiple imputation (specify model/variables), other. |
Subgroup Analyses | List all subgroups |
Analysis element | Specification |
---|---|
Hypothesis: | <Text> |
Exposure contrast: | <Text> |
Outcome: | <Text> |
Analytical software | <Text> |
Model(s): | <Text> |
Conofunding adjustment method | Name method and provide relevant details, e.g. bivariate, multivariable, propensity score matching (specify matching algorithm ratio and caliper), propensity score weighting (specify weight formula, trimming, truncation), propensity score stratification (specify strata definition), other |
Missing data methods | Name method and provide relevant details, e.g. missing indicators, complete case, last value carried forward, multiple imputation (specify model/variables), other. |
Subgroup Analyses | List all subgroups |
Analysis | What is being varied? | Why (expected learning)? | Strengths of the sensitivity analysis compared to primary | Limitations of the sensitivity analysis compared to primary |
---|---|---|---|---|
<Text> | <Text> | <Text> | <Text> | <Text> |
7.6 Data sources
7.6.1 Context and rationale for data sources
Reason for selection:
Strengths of data source(s):
Limitations of data source(s):
Data source provenance/curation:
Data element | Data 1 | Data 2 | Data 3 |
---|---|---|---|
Data Sources: | <Text> | <Text> | <Text> |
Study Period: | <Text> | <Text> | <Text> |
Eligibile Cohort Entry Period: | <Text> | <Text> | <Text> |
Data version (or date of last update): | <Text> | <Text> | <Text> |
Data sampling/extraction criteria: | <Text> | <Text> | <Text> |
Type(s) of data: | <Text> | <Text> | <Text> |
Data linkage | <Text> | <Text> | <Text> |
Conversion to CDM: | <Text> | <Text> | <Text> |
Software for data management: | <Text> | <Text> | <Text> |
7.7 Data management
7.8 Quality control
7.9 Study size and feasibility
8 Limitation of the methods
9 Protection of human subjects
10 Reporting of adverse events
11 References
12 Appendices
13 Session info
13.1 Loaded packages
package | loadedversion | |
---|---|---|
dplyr | dplyr | 1.1.1 |
forcats | forcats | 1.0.0 |
ggplot2 | ggplot2 | 3.4.2 |
gt | gt | 0.9.0 |
here | here | 1.0.1 |
lubridate | lubridate | 1.9.2 |
purrr | purrr | 1.0.1 |
readr | readr | 2.1.4 |
stringr | stringr | 1.5.0 |
tibble | tibble | 3.2.1 |
tidyr | tidyr | 1.3.0 |
tidyverse | tidyverse | 2.0.0 |
13.2 Session info
R version 4.2.1 (2022-06-23)
Platform: x86_64-apple-darwin17.0 (64-bit)
locale: en_US.UTF-8||en_US.UTF-8||en_US.UTF-8||C||en_US.UTF-8||en_US.UTF-8
attached base packages: stats, graphics, grDevices, datasets, utils, methods and base
other attached packages: gt(v.0.9.0), here(v.1.0.1), lubridate(v.1.9.2), forcats(v.1.0.0), stringr(v.1.5.0), dplyr(v.1.1.1), purrr(v.1.0.1), readr(v.2.1.4), tidyr(v.1.3.0), tibble(v.3.2.1), ggplot2(v.3.4.2) and tidyverse(v.2.0.0)
loaded via a namespace (and not attached): tidyselect(v.1.2.0), xfun(v.0.38), pander(v.0.6.5), colorspace(v.2.1-0), vctrs(v.0.6.0), generics(v.0.1.3), htmltools(v.0.5.4), yaml(v.2.3.7), utf8(v.1.2.3), rlang(v.1.1.0), pillar(v.1.9.0), glue(v.1.6.2), withr(v.2.5.0), bit64(v.4.0.5), sessioninfo(v.1.2.2), lifecycle(v.1.0.3), munsell(v.0.5.0), gtable(v.0.3.3), htmlwidgets(v.1.6.2), evaluate(v.0.20), knitr(v.1.42), tzdb(v.0.3.0), fastmap(v.1.1.1), parallel(v.4.2.1), fansi(v.1.0.4), Rcpp(v.1.0.10), renv(v.0.16.0), scales(v.1.2.1), vroom(v.1.6.1), jsonlite(v.1.8.4), bit(v.4.0.5), hms(v.1.1.3), digest(v.0.6.31), stringi(v.1.7.12), grid(v.4.2.1), rprojroot(v.2.0.3), cli(v.3.6.0), tools(v.4.2.1), magrittr(v.2.0.3), sass(v.0.4.5), crayon(v.1.5.2), pkgconfig(v.2.0.3), xml2(v.1.3.3), timechange(v.0.2.0), rmarkdown(v.2.20), rstudioapi(v.0.14), R6(v.2.5.1) and compiler(v.4.2.1)
13.3 Repositories
repos:
CRAN https://cran.rstudio.com
14 Change log
Detailed change log based on previous commits.
Mon, 24 Apr 2023 14:32:47 -0400
Changes made by: jweberpals@bwh.harvard.edu
Commit hash: 69ec58d
Changes made: added references
Thu, 20 Apr 2023 16:16:33 -0400
Changes made by: jweberpals@bwh.harvard.edu
Commit hash: ac5ff1f
Changes made: echo is only false for protocol
Tue, 18 Apr 2023 15:16:00 -0400
Changes made by: jweberpals@bwh.harvard.edu
Commit hash: 48390ee
Changes made: styling of tables
Mon, 17 Apr 2023 17:12:00 -0400
Changes made by: jweberpals@bwh.harvard.edu
Commit hash: bfb71b5
Changes made: added index
Mon, 17 Apr 2023 16:58:04 -0400
Changes made by: jweberpals@bwh.harvard.edu
Commit hash: 4705250
Changes made: some modifications
Mon, 17 Apr 2023 16:14:43 -0400
Changes made by: jweberpals@bwh.harvard.edu
Commit hash: c0f1b13
Changes made: with format gt
Mon, 17 Apr 2023 15:24:42 -0400
Changes made by: jweberpals@bwh.harvard.edu
Commit hash: 106faf2
Changes made: attempt to balance html and pdf output using gt
Sun, 16 Apr 2023 19:20:26 -0400
Changes made by: jweberpals@bwh.harvard.edu
Commit hash: f0bde2b
Changes made: first HARPER draft; TODO: Tables in pdf
Sun, 16 Apr 2023 19:12:50 -0400
Changes made by: jweberpals@bwh.harvard.edu
Commit hash: 34b0c71
Changes made: initial commit