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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 will integrate data from over 50 existing studies on the treatment of posttraumatic stress disorder (PTSD) and comorbid alcohol and other drug disorders (AODs), including over 4,500 study participants. The overarching goal of Project Harmony is to examine the relative efficacy of different PTSD/AOD treatments. We will also examine potential moderators and mechanisms of PTSD/AOD treatments.
Project Harmony is led by a team of experts in PTSD/AOD treatment and clinical trials design from The Center of Alcohol Studies, Rutgers University-New Brunswick (Hien (MPI) & Ruglass), RTI International (Morgan-Lopez (MPI) & Saavedra), Medical University of South Carolina (Back, Brady, & Killeen), City College of New York (Lopez-Castro), and Division on Substance Use Disorders, Columbia University (Campbell). Project Harmony will use 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. It will also 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 Studies, Rutgers University-New Brunswick (Hien (MPI) & Ruglass), RTI International (Morgan-Lopez (MPI) & Saavedra), Medical University of South Carolina (Back, Brady, & Killeen), City College of New York (Lopez-Castro), and Division on Substance Use Disorders, Columbia University (Campbell). Project Harmony will use 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. It will also 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 are developing a growing consortium of principal investigators, called “PPIs” (Participating Principal Investigators), like yourself, 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, Brady, Killeen) and Scientific Advisory Board Members (Kaysen, McGovern, Mills, & Petrakis) are sharing their data.
FAQs for Potential Contributors
What are the benefits of my participating in project harmony?
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 will become 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.
In addition, by working with Project Harmony, you will become 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 are you going to do with my data?
what data are you asking for?
There are several key de-identified variables that we are requesting. 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 are asking for is in the last column, which may be measured at multiple time points. We would like the data for these variables at all time points assessed (e.g., baseline, weekly, mid-treatment, post-treatment, follow-up). We expect that you may not have all of the variables in this list, and that is not a problem. We will happily accept the ones that you do have. Similarly, if you have measured variables at some time points, but not others, we will happily accept the data from the time points that you collected it for. Please note that we are requesting 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 will allow 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.
What if my study is preliminary or is not of the "highest quality"? Should I still share it?
Yes. We are seeking all trials that focus on either reducing PTSD or AOD in a comorbid PTSD/AOD sample. As long as your study tests an intervention, we can 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 will consider all studies and make a decision if there is uncertainty. One of the particular advantages of Project Harmony’s approach over traditional meta-analyses is that we can include 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 your study or how its data will be employed, we encourage you to contact us.
Will All the participants in my studies be included?
All participants with PTSD and AOD measures will be included in the study. We will be looking at baseline, within treatment, and post-treatment outcomes. We are 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 will be “extracting” the data from my datasets?
PPIs will be given unique usernames and passwords to upload their data through secure FTP sites at RTI International. There are two options for how to provide us with these variables:
OPTION 1: You can provide us with your full de-identified dataset(s) and codebook(s) and a research assistant at RTI International will extract the relevant variables for our study aims. If you do not have a codebook, we will still accept the variables in your dataset, but a codebook is preferable. Especially if you do not provide a codebook, please ensure that the variables are clearly labelled.
OPTION 2: We can provide you with a targeted list of study variables that we need, and you can send us a reduced de-identified dataset (i.e., a dataset with variables that were not listed as part of our requested variables removed) and your codebook(s) with only those variables.
Once you provide the variables, we will reach out to you with follow-up questions (e.g., about how variables were coded).
As an honorarium, we will provide up to $250 in funding to support the time and effort of your research staff at your institution.
OPTION 1: You can provide us with your full de-identified dataset(s) and codebook(s) and a research assistant at RTI International will extract the relevant variables for our study aims. If you do not have a codebook, we will still accept the variables in your dataset, but a codebook is preferable. Especially if you do not provide a codebook, please ensure that the variables are clearly labelled.
OPTION 2: We can provide you with a targeted list of study variables that we need, and you can send us a reduced de-identified dataset (i.e., a dataset with variables that were not listed as part of our requested variables removed) and your codebook(s) with only those variables.
Once you provide the variables, we will reach out to you with follow-up questions (e.g., about how variables were coded).
As an honorarium, we will provide up to $250 in funding to support the time and effort of your research staff at your institution.
How will I be involved?
Will there be opportunities for co-authorship?
We encourage participating principal investigators (PPIs) involvement in papers for co-authorship that are directly and specifically related to the originally-submitted aims of the grant that will emerge from the combined Project Harmony dataset. Some examples of papers include:
- Measurement and Scoring Papers with the full Project Harmony dataset
- Item Response Theory Scoring for PTSD and AOD severity measures
- Measurement Bias in PTSD and AOD symptoms across
- Studies
- Time
- Gender
- Race/Ethnicity
- Military Status
- Main Individual-Patient Meta-Analysis
- PTSD
- Alcohol Use
- Days of Use
- Heavy Use
- Substance Use
- Secondary Effects on Depression and Anxiety
- Meta-analytic mediation
- Examining the impact of treatment types on SUD/Alcohol use, as mediated by PTSD with and without comorbid depression and anxiety
- Moderator Effects
- Gender
- Race/Ethnicity
- Military Status
What kind of data use agreements do I 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 are the IRB regulations for sharing my data?
IRB regulations for sharing your data will be dictated by your institution and can vary from institution to institution.
