#acl +All:read Default #format wiki #language en = Survey Design = == Investigators == * Ahmet Erdemir, PhD, Cleveland Clinic, +1 (216) 445 9523, erdemira@ccf.org * Joy Ku, PhD, Stanford University, +1 (650) 736 8434, joyku@stanford.edu The investigators are designing and conducting this survey based on the initiatives and advice of the Committee on Credible Practice of Modeling & Simulation in Healthcare. == Platform == The survey will be online utilizing Qualtrics (see http://qualtrics.com/). Stanford University has access to this platform. == Timeline == * '''August 15, 2014.''' Launching of survey. * '''February 15, 2015.''' Closing of survey site. * '''March 15, 2015 - June 15, 2014.''' Public dissemination and analysis of data. * '''September 1, 2015.''' Manuscript submission potentially to [[http://www.ploscollections.org/article/browse/issue/info:doi/10.1371/issue.pcol.v03.i01|PLoS Computational Biology: Ten Simple Rules Collection]]. == Human Subject Research Concerns == The study potentially qualifies exempt status as it is ''research involving surveys, interviews or educational tests and the data does not record any patient identifiers or codes linking to the patient'' (also see http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c4). Subject identifiers (name, address, social security numbers, etc.) will not collected and responses will not place the subject at risk for criminal or civil liability, financial harm, employability or reputation. The investigators will seek exemption from the Institutional Review Board of the Cleveland Clinic and if necessary, from that of Stanford University. == Overall Data Acquisition == This study is an online multi-institutional voluntary survey which will be delivered through the Qualtrics online survey system. The responses will be anonymous. The survey will not request direct subject identifiers (name, birth date, address, etc.) from the participants nor ethnic, racial, and gender information. The survey will collect information on continental geographical location, primary work setting, primary field, highest level of education of the participant. The familiarity of the participant with computational modeling and simulation and the context, in which they utilize modeling and simulation will be asked through categorical questions. All survey questions are optional, and the survey participant can leave the survey at any time by simply closing the internet browser window/tab. The survey will not include deception nor multimedia. There is no intent to have financial benefit from survey results. == Significance of Research == The investigators are surveying the worldwide stakeholder community to help narrow down simple rules/best practices that will guide the credibility of computational modeling and simulation approaches in healthcare research and medical practice. This information will help provide broadly applicable guidance to facilitate, safely apply, and possibly expedite the use modeling and simulation in healthcare. Moreover the practitioners of modeling and simulation, who are responding to the survey, may gain insight on how they can improve their modeling and simulation practices. The survey is inspired by the preliminary work of the Committee on Credible Practice of Modeling and Simulation in Healthcare. In various discussions, the Committee noted how interests and disciplinary backgrounds and context of use may influence opinions/perspectives on the “most important” principles of credible practice of computational medicine. These activities emphasized the need to solicit input from the global community in order to establish the guidance on credible practice of modeling and simulation in healthcare, which is likely to be a better reflection of the values of the global stakeholder community. == Study Aims == The goal of the survey is to prioritize guidelines to reliably establish credibility of modeling and simulation practice in healthcare. Secondary to this goal, granular information will be obtained on the perception of best practices as a function of geographical location, primary work setting, primary field, highest level of education, familiarity to computational modeling and simulation, and the contextual use of modeling and simulation. == Participant Pool == The survey is voluntary. The participants will not receive any payment or incentive. The participants may incur Internet or data access costs, e.g., cell phone charges, if they choose to take the survey. Such costs will not be reimbursed. Anyone 18 years of age or older will be able to participate. The survey is designed to be in English, so the participants are expected to have an adequate level of English to provide informed consent and fill in the survey questions. The survey will be available worldwide. There are no special arrangements for international participation. The survey will primarily target the primary stakeholders of computational modeling and simulation, healthcare and biological sciences. However, given that healthcare is generally valued by the global population, the survey will not be restricted to the primary stakeholders in the field. There will not be any focus groups. The investigators will reach out to [[Committee_External_Contact_List| numerous organizations and interest groups]] that have large memberships to ensure that the survey will be distributed to at least 20,000 people. Yet, the investigators will attempt to maximize the participant pool to reach more than 100,000 people. Survey participants will primarily be recruited by contacting leaders of key organizations and interest groups that are potential stakeholders of modeling and simulation in healthcare. Membership roster of such organization and interest groups will be invited to participate in the survey along with invitation of the general public through social media. In summary, the official survey invitations will be distributed through links at websites, e-mail distribution list, submissions to discussion forums, and requests to key leaders in the community to help distribute the invitation letter to other communities which the investigators may not be able to reach directly. == Participant Recruitment == An invitation will be provided to potential participants in various forms. A sample is provided below: ---- SUBJECT: Survey on credible practice of modeling and simulation in healthcare Dear Colleague , With this invitation, we are asking you to complete a survey aimed to establish good practice guidelines in order to realize credibility of computational modeling and simulation (M&S) in healthcare. The survey can be found at: https://stanforduniversity.qualtrics.com/SE/?SID=SV_4MeRluojMgdVR7n The survey site will be available until February 15, 2015. We sincerely appreciate your participation in this survey, which should take no longer than 10 minutes. Your participation is voluntary and your responses will be anonymous. You have been identified as a potential stakeholder in the M&S community. Your support will be instrumental in developing broadly applicable best practices in M&S, for their ultimate utilization in healthcare. This survey is an initiative of the Committee on Credible Practice of Modeling & Simulation in Healthcare, to understand global and multidisciplinary perspectives in best practices to establish credibility of computational medicine. The Committee was formed as part of interactions within the Interagency Modeling and Analysis Group (IMAG) and Multiscale Modeling Consortium, which provide a platform to facilitate discussions between federal agencies in the United States and investigators within the United States and worldwide. Please feel free to forward this invitation to others that may have an interest in providing their insight. Thank you for your support. If you have any questions, please feel free to contact me by phone, +1 (216) 445 9523, or by e-mail, erdemira@ccf.org. Regards, Ahmet Ahmet Erdemir, PhD on behalf of Committee on Credible Practice of Modeling & Simulation in Healthcare http://wiki.simtk.org/cpms ---- Survey participants will primarily be recruited by various mechanisms, including but not limited to: 1. Making an official announcement on the website, wiki and forum of the Committee on Credible Practice for Modeling and Simulation in Healthcare (https://simtk.org/home/cpms) 1. e-mails to membership rosters of numerous organizations and interest groups after obtaining permission from leaders of such organizations, 1. requesting leaders of organizations distribute the invitation letter to their communities, 1. e-mails to distribution lists, 1. submissions to online discussion forums, 1. submissions to social media and professional networking portals such as Facebook, LinkedIn, Twitter, Google+ and others, 1. encouraging each survey participant to invite others to take part in the survey, and 1. announcing the survey during conference, workshop and meeting presentations. Candidate participants may receive multiple invitations to complete the survey. The schedule of these invitations is anticipated to be 1. at the initial survey dissemination phase, 1. at the mid-term point of the study period, and 1. close to the survey closing date. The candidate participants will not be contacted after the closure of survey. Invitations will be submitted to groups (blind copied) rather than to specific individuals. The investigators will retain minimum information until the end of the survey period to keep track of the groups (not individuals) contacted. Once the survey period closes, the invitation e-mails to candidate participants will be deleted along with any responses to these e-mails along with automated replies. == Study Variables == The survey starts with a description of the survey and its goals. The text also informs the potential participant about the age requirement and the voluntary nature of the survey. The participant is also informed that they can exit the survey any time they like. The participant needs to confirm that he/she is 18 years of age or older. Essentially, the first page provides the necessary information for informed consent of the participant. If the participant chooses to continue participating in the survey, also confirming that they are 18 years of age or older, a captcha is provided for the participant to fill in, in order to verify that the participant is human. The survey will consist of 35 credible practice rule statements that the participant can optionally score using a score from 0 to 5, where 5 means very important. Some of these statements are repeated to evaluate the consistency of the participant's responses. None of these questions are mandatory to fill in. A comment box is also provided, in case the participant wants to provide his/her thoughts on common practice guidelines for implementation of computational modeling and simulation in healthcare. The participant is not obligated to fill in this comment box. The survey also includes broad questions about the participant filling the survey. These questions are categorical and include continental geographical location, primary work setting (e.g., academia), primary field (e.g., engineering), highest level of education of the participant (e.g., PhD), the familiarity of the participant with computational modeling and simulation (e.g., more than five years of experience), and the context in which they utilize modeling and simulation (e.g., for scientific research). None of these questions are mandatory to answer. == Data Safety & Longevity == The data will be stored at the Qualtrics site, which is a secure web site utilizing secure sockets layer (SSL) for encrypted user access. The data will be accumulated in this password protected site requiring user authorization and authentication. Only the investigators will be authorized to have access to this site. Upon completion of the data collection, the investigators will ensure anonymity of the data and remove any potential subject identifiers to prepare the raw data set for public dissemination. In following, a copy of the data set will be provided at the website of the Committee on Credible Practice of Modeling & Simulation in Healthcare (https://simtk.org/home/cpms) for others to download and analyze. It is anticipated that the anonymized, de-identified data set will be retained indefinitely. Responses will only be collected when the participant submits a response. However, once submitted, it is not possible to retract the responses as the investigators will not be able to identify a certain participant's response due to the anonymous nature of the survey. == Data Analysis == The data from the survey will be used to rank credible rule practice statements, overall or in a categorical manner. The raw data set, which is already anonymous, will be provided publicly for anyone to test different ranking approaches. Before public release the investigators will remove any potential subject identifiers, e.g. those which may have been provided in the comment box. This open science approach will allow both the investigators and the community to analyze the ranking of credible rule practice statements as a function of continental geographical location, primary work setting, primary field, highest level of education of the participant, the familiarity of the participant with computational modeling and simulation, and the context, in which the modeling and simulation has been utilized. An initial overall ranking will be conducted by the investigators. For a given participant, the scores of repeated credible practice rule statements will be compared. Closer scores will indicate consistency of participant's responses and a higher weight to the participant's responses will be assigned. Otherwise, e.g., when scores of repeated statements mismatch, a lower weight to the participant's responses will be assigned. Responses from all participants will be accumulated to calculate a population rank score for a given statement. This analysis will likely result in submission of a scholarly manuscript to a peer-reviewed scientific journal.