|
What is Project Harmony?
What IS THE PURPOSE OF Project harmony
The full title of Project Harmony is: “Project Harmony: A Virtual Clinical Trials study for PTSD and Alcohol and Other Drug Disorders”. Project Harmony is a National Institute on Alcohol Abuse and Alcoholism (NIAAA) R01-funded study (1R01AA025853-01A1) that has integrated data from 36 existing studies on the treatment of posttraumatic stress disorder (PTSD) and comorbid alcohol and other drug disorders (AODs), including over 4,000 study participants. The overarching goal of Project Harmony is to examine the relative efficacy of different PTSD/AOD treatments. We are currently examining potential moderators and mechanisms of PTSD/AOD treatments - stay tuned!
Project Harmony is led by a team of experts in PTSD/AOD treatment and clinical trials design from The Center of Alcohol & Substance Use Studies, Rutgers University-New Brunswick (Hien (MPI)), RTI International (Morgan-Lopez (MPI) & Saavedra), Medical University of South Carolina (Back & Killeen), UC San Diego (Norman), City College of New York (Lopez-Castro & Ruglass), and York University (Fitzpatrick). Project Harmony uses three novel and sophisticated data analytic approaches (i.e., meta-analysis of individual patient data, integrative data analysis, and propensity score weighting) to provide clear and definitive recommendations regarding PTSD/AOD treatment effectiveness. With these approaches, we can indicate whether specific individuals are more or less likely to benefit from specific treatments, and whether the moderators and mechanisms of change in the treatments are similar or distinct.
Project Harmony is led by a team of experts in PTSD/AOD treatment and clinical trials design from The Center of Alcohol & Substance Use Studies, Rutgers University-New Brunswick (Hien (MPI)), RTI International (Morgan-Lopez (MPI) & Saavedra), Medical University of South Carolina (Back & Killeen), UC San Diego (Norman), City College of New York (Lopez-Castro & Ruglass), and York University (Fitzpatrick). Project Harmony uses three novel and sophisticated data analytic approaches (i.e., meta-analysis of individual patient data, integrative data analysis, and propensity score weighting) to provide clear and definitive recommendations regarding PTSD/AOD treatment effectiveness. With these approaches, we can indicate whether specific individuals are more or less likely to benefit from specific treatments, and whether the moderators and mechanisms of change in the treatments are similar or distinct.
Who is participating in project harmony?
We have developed a consortium of principal investigators, called “PPIs” (Participating Principal Investigators) who have agreed to share their data with Project Harmony. We invited investigators whose project(s) were identified using a systematic review to take part in this project. A list of investigators who initially agreed to share their data can be found at faq_ppi_list_.pdf. In addition, all of the Project Harmony PIs (Hien, Morgan-Lopez, Back, Killeen, Norman, Ruglass) and Scientific Advisory Board Members (Kaysen, McGovern, Mills, & Petrakis) are sharing their data.
FAQs for Contributors
What are the benefits of my participating in project harmony?
*We are no longer looking for PPIs*
There are several important benefits of participating in Project Harmony. First, your work will be utilized to help substantially advance the existing PTSD/AOD treatment knowledge, which cannot be accomplished by a single study alone. By being a part of Project Harmony, you are supporting a broader movement that integrates a critical mass of research to help reduce the global, personal, and economic burden of PTSD/AOD.
In addition, by working with Project Harmony, you are part of a rapidly growing consortium of PTSD/AOD treatment researchers. The Project Harmony executive leadership team believes that it is important and ethical that the contributions and collaborations of all participating principal investigators (PPIs) are acknowledged. Therefore, as detailed below, you will have opportunities for authorship on Project Harmony primary outcome papers that utilize your data.
There are several important benefits of participating in Project Harmony. First, your work will be utilized to help substantially advance the existing PTSD/AOD treatment knowledge, which cannot be accomplished by a single study alone. By being a part of Project Harmony, you are supporting a broader movement that integrates a critical mass of research to help reduce the global, personal, and economic burden of PTSD/AOD.
In addition, by working with Project Harmony, you are part of a rapidly growing consortium of PTSD/AOD treatment researchers. The Project Harmony executive leadership team believes that it is important and ethical that the contributions and collaborations of all participating principal investigators (PPIs) are acknowledged. Therefore, as detailed below, you will have opportunities for authorship on Project Harmony primary outcome papers that utilize your data.
What did we do with the data?
what data Did we ask for?
*We are no longer requesting data.*
There are several key de-identified variables that we requested. The list of these variables is here variable_request_list.pdf. The variables in all but the last column of the table will likely be measured at only a single time point. The critical data that we asked for is in the last column, which may be measured at multiple time points. We accepted data for these variables at all time points assessed (e.g., baseline, weekly, mid-treatment, post-treatment, follow-up), when available. We requested data at the item/symptom level, rather than aggregated means or summed scores. Item-level data is pertinent for the use of sophisticated analytic techniques that is allowing us to harmonize data that is collected via distinct measures.
There are several key de-identified variables that we requested. The list of these variables is here variable_request_list.pdf. The variables in all but the last column of the table will likely be measured at only a single time point. The critical data that we asked for is in the last column, which may be measured at multiple time points. We accepted data for these variables at all time points assessed (e.g., baseline, weekly, mid-treatment, post-treatment, follow-up), when available. We requested data at the item/symptom level, rather than aggregated means or summed scores. Item-level data is pertinent for the use of sophisticated analytic techniques that is allowing us to harmonize data that is collected via distinct measures.
When and How will I gain access to the final dataset?
As specified in the awarded grant, data for the proposed study will be stored on one of RTI’s network computers, accessible only by Drs. Morgan-Lopez, Saavedra and RTI data analysis team members. The Project Harmony executive leadership team, as well as the Scientific Advisory Board Members and Participating Principal Investigators (PPIs), will be working closely with the RTI team. The Scientific Advisory Board Members, PPIs, and outside researchers will gain direct access to the compiled dataset after Project Harmony has published the findings related to the study’s primary and secondary aims. After the project is completed, our copy of your individual data set will be destroyed. However, your study data will have been integrated to the final data set.
In accordance with National Institutes of Health’s data sharing policies, once findings pertaining to the aims of the present study are published, any contributing investigators who wish to use this dataset for secondary data analysis may submit a request to do so. At that point in time, the executive leadership team will review data request forms submitted for such a request. The data from this project will be available to investigators only under a data use agreement (DUA) that ensures: (1) a commitment to using the data only for research purposes as specified in the DUA, (2) a commitment to securing the data using appropriate computer technology, (3) non-transferability of the data to others (e.g., they will not share the data with anyone who is not listed on the DUA), (4) agreement to destroy or return the data after analyses are completed, and (5) commitment to comply with all applicable rules and regulations for the protection of human subjects. Investigators who do not agree to sign the DUA will not be granted access to the data. Recipients of the data will be asked to provide the executive leadership team with a copy of any manuscript or other documents (e.g., conference abstract) at least 14 days in advance of submission for publication or presentation, and to acknowledge the contributions of funding sources.
In accordance with National Institutes of Health’s data sharing policies, once findings pertaining to the aims of the present study are published, any contributing investigators who wish to use this dataset for secondary data analysis may submit a request to do so. At that point in time, the executive leadership team will review data request forms submitted for such a request. The data from this project will be available to investigators only under a data use agreement (DUA) that ensures: (1) a commitment to using the data only for research purposes as specified in the DUA, (2) a commitment to securing the data using appropriate computer technology, (3) non-transferability of the data to others (e.g., they will not share the data with anyone who is not listed on the DUA), (4) agreement to destroy or return the data after analyses are completed, and (5) commitment to comply with all applicable rules and regulations for the protection of human subjects. Investigators who do not agree to sign the DUA will not be granted access to the data. Recipients of the data will be asked to provide the executive leadership team with a copy of any manuscript or other documents (e.g., conference abstract) at least 14 days in advance of submission for publication or presentation, and to acknowledge the contributions of funding sources.
Were preliminary or not of the "highest quality" studies shared?
Yes. We sought all trials that focus on either reducing PTSD or AOD in a comorbid PTSD/AOD sample. As long as the study tested an intervention, we could likely incorporate its data into Project Harmony (interventions can either be behavioral, pharmacological or both, and comparators can be anything from treatment as usual to another kind of intervention). The executive team considered all studies and made a decision if there was uncertainty. One of the particular advantages of Project Harmony’s approach over traditional meta-analyses is that we included a fuller range of studies from randomized controlled trials to preliminary, pilot, and open label trials. If you have any questions about the eligibility of the studies or how its data was employed, we encourage you to contact us.
Were All the participants in the studies included?
All participants with PTSD and AOD measures were included in the study. We are looking at baseline, within treatment, and post-treatment outcomes. We were able to select those participants from your data files that meet the inclusion criteria. All individually identifiable or proprietary data is excluded per HIPAA policy.
Who “extracted” the data from the datasets?
PPIs were given unique usernames and passwords to upload their data through secure FTP sites at RTI International. There were two options for how PPIs provided us with these variables:
OPTION 1: They provided us with their full de-identified dataset(s) and codebook(s) and a research assistant at RTI International extracted the relevant variables for our study aims. If they did not have a codebook, we still accepted the variables in the dataset.
OPTION 2: We provided the PPI with a targeted list of study variables that we needed, and they sent us a reduced de-identified dataset (i.e., a dataset with variables that were not listed as part of our requested variables removed) and codebook(s) with only those variables.
As an honorarium, we provided up to $250 in funding to support the time and effort of the research staff at the various institutions.
OPTION 1: They provided us with their full de-identified dataset(s) and codebook(s) and a research assistant at RTI International extracted the relevant variables for our study aims. If they did not have a codebook, we still accepted the variables in the dataset.
OPTION 2: We provided the PPI with a targeted list of study variables that we needed, and they sent us a reduced de-identified dataset (i.e., a dataset with variables that were not listed as part of our requested variables removed) and codebook(s) with only those variables.
As an honorarium, we provided up to $250 in funding to support the time and effort of the research staff at the various institutions.
How are PPIs involved?
Will there be opportunities for co-authorship?
As a PPI you will be listed as participating member of the Consortium on Addictions, Stress, and Trauma (CAST) on select Project Harmony papers.
What kind of data use agreements dID PPIs need to get?
A data use agreement (DUA) is an agreement that is required under the Privacy Rule and must be entered into before there is any use or disclosure of a limited data set (defined below) to an outside institution or party. A limited data set is still protected health information (PHI), and for that reason, covered entities like RTI International must enter into a data use agreement with any recipient of a limited data set from RTI International. This is usually done when sharing data from a study with different aims. For this study, because the aims of your study overlap with the aims of Project Harmony, data use agreements aren’t usually necessary and are covered under the IRB of your original study and the Project Harmony IRB.
What were the IRB regulations for sharing data?
IRB regulations for sharing your data are dictated by your institution and can vary from institution to institution.
