Nurses study

NOTICE OF INTENT TO ISSUE A PURCHASE ORDER. The Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH), Cincinnati, Ohio, hereby announces its intent to issue a purchase order to Brigham and Women's Hospital, for: Occupational Exposures in the Nurses Health Study III - Pilot Project Phase II. Background and Need Over 2.5 million nurses are employed in the U.S., 95% of whom are female. Female nurses are exposed to a wide variety of known and potential reproductive hazards including chemical and biological agents, physical demands, and shift work. Preliminary results from our ongoing collaboration between NIOSH and the Nurses' Health Study II (NHS-II) team showed that spontaneous abortion was associated with night work, long working hours, and reported exposure to sterilizing agents, antineoplastic agents, and x-rays; and that preterm birth was associated with reported exposure to sterilizing agents and prolonged standing. We now have the opportunity to build on our collaboration with the NHS-II team by participating in the NHS-III, a new groundbreaking study, with improved study design, including prospectively-collected data, in-depth questions on occupational exposures, and access to non-occupational covariate data and biological samples. Eligible participants will be female Registered Nurses or Licensed Practical / Vocational Nurses between the ages of 22-42. Potential participants will be mailed a letter of invitation, which has been previously approved by NIOSH, from the study principal investigator. NIOSH investigators will collaborate with the NHS-III team to develop modules to assess shift work, long working hours, physical factors, and occupational chemical exposure. Data will be collected via a web-based baseline questionnaire and pregnancy questionnaires. In addition to occupational exposures, data will also be collected for smoking, caffeine, and alcohol consumption, age, race/ethnicity, body mass index, prior spontaneous abortion, parity, medical conditions, and medication use. Data will be collected, stored, and analyzed at Brigham and Women's Hospital with oversight from NIOSH investigators. Letters of invitation for the first phase of the pilot study have been mailed to 12,000 women. We had anticipated that approximately 1200 (10%) would have enrolled. However, only 120 enrolled in the first phase of the pilot study (1%), which is unacceptable. Therefore, we would like to conduct a second phase of the pilot study to try to increase the participation rate to 10%. Project Objective The overall objective of this study is to contribute towards a pilot study of a new longitudinal, occupational cohort of female nurses of reproductive age, the Nurses' Health Study III (NHS-III). In this study, we propose to collaborate with the NHS-III team on a second phase of a pilot study, including the redesign of occupational questions into a paper questionnaire that is suitable for direct electronic scanning, recruitment of nurses, data collection, and data analysis and evaluation. The proposed study would be adapted from the web-based version used in the first pilot study phase. The NHS-III is modeled after the highly successful Nurses' Health Studies. In the first pilot phase, web-based questionnaires were tested among an initial group of 120 nurses. The second phase of the pilot study will differ in several ways. The first strategy (the "viral" strategy) will be to ask current participants of NHS and NHS-II to contact younger colleagues and invite them to participate in the new cohort. A group of 500 current participants will be sent emails asking them to forward the email message with the invitation to participate to colleagues who may be interested in participating. In addition, the invitation materials should also give the option of horizontal transmission (i.e. nurses invited by current NHS participants will be asked invite other nurses who might be interested in participating). The second strategy will be to send a 4-page paper baseline questionnaire along with the invitation letter. Participants will be given the option of returning the paper questionnaire or completing the same questionnaire on-line. The idea is to use the paper questionnaire to gain credibility and then switch over to internet as many participants as possible. The NHS-III study team is also investigating the possibility of offering continued education (CE) credits as an incentive to complete the questionnaire. An on-line education program for nursing has been contacted to help recruit nurses for the study, as well as provide free CE credits to NHS-III participants. In addition, phone calls will be made to non-responders in an attempt to convert them to responders. The following specific aims are proposed: Specific Aim 1: To redesign occupational question modules for the baseline and pregnancy questionnaires for a paper questionnaire formatted for direct electronic data scanning. Specific Aim 2: To obtain names and addresses of 6,000 nurses for mailing of invitations for the second phase of the pilot study. Specific Aim 3: To develop invitations for the "viral" method to be sent by e-mail to existing NHS and NHS-II participants. Specific Aim 4: To assess the feasibility of the study by conducting and evaluating a second pilot phase. Scope of Work The NHS-III pilot study phase II will assess whether participation would be maximized by offering a mailed questionnaire. It will also investigate the "viral" method of enrollment. Technical Requirements Sub-Task A. To redesign occupational question modules for the baseline and pregnancy questionnaires in scanable, paper format. The purpose of this sub-task is to redesign occupational exposure modules from the existing web-based baseline and pregnancy questionnaires for a format that will be on paper and will have the ability to be scanned electronically (Specific Aim 1). Occupational exposures and activities on the baseline and pregnancy questionnaires shall include work schedule, night work, and average hours worked per week over the previous year. There are also two lifetime shift work questions. Data shall also be collected on physical factors, such as lifting at work and hours spent standing or walking at work, on average, over the previous year. Separate exposure modules shall be developed to collect information on lifetime occupational chemical exposures to anti-viral and antineoplastic medication administration, high-level disinfectants, and anesthetic gases. The occupational exposure modules shall also collect information on exposure controls, such as ventilation and use of personal protective equipment. Sub-Task B: To obtain names and addresses of 6,000 nurses for mailing of invitations for the second phase of the pilot study. This sub-task will require the contractor to obtain names and addresses of 6,000 eligible nurses for inclusion in the mailing of invitations that include paper questionnaires (specific aim 2). The contractor shall work with the mailing house to ensure that the mailings take place in a professional and timely manner. The mailings shall also include a return postage-paid envelope and a copy of frequently asked questions. In addition, a "warning" postcard shall be mailed to all potential participants indicating that a letter will be arriving in a week. Sub-task C: To develop invitations for the "viral" method to be sent by e-mail to existing NHS and NHS-II participants. This sub-task will involve recruitment of participants through the "viral method" (specific aim 3). This method will be to ask current participants of NHS and NHS-II to contact younger colleagues and invite them to participate in the new cohort. A group of 500 current participants will be sent emails asking them to forward the email message with the invitation to participate to colleagues who may be interested in participating. In addition, the invitation materials should also give the option of horizontal transmission (i.e. nurses invited by current NHS participants will be asked invite other nurses who might be interested in participating). Sub-task D: To evaluate the pilot study phase II. Before conducting the full cohort study and to make improvements to the study design, questionnaires, or recruitment strategies, the contractor shall evaluate the pilot phase (Specific Aim 4). We conservatively estimate that 10% of those invited to participate will respond, based on the response rate to the NHS-II. However, the pilot study efforts to date have only produced a 1% participation rate. If the actual response rate remains to be less than 10%, NIOSH will collaborate with the contractor to evaluate whether the full study is feasible. The contractor shall provide summary statistics to NIOSH of key variables from the baseline and pregnancy questionnaires, including occupational variables, demographic variables, and other health outcomes. The summaries shall include frequency statistics for categorical variables and means and range of continuous variables, as well as the percent missing data. The accuracy and completeness of data and feasibility of data analysis shall also be evaluated by the contractor, with input from NIOSH investigators. The contractor shall evaluate whether mailed questionnaires improve participation, and by how much. Personnel Requirements Contract staff should include an epidemiologist, a computer programmer / statistician, and a web-programmer. The epidemiologist should have experience in reproductive epidemiology, epidemiology methods, and statistical analysis, and should have familiarity with the methods of the Nurses' Health Studies. The computer programmer /statistician should have experience with the Nurses' Health Studies data and be familiar with using SAS. The web-programmer associated with the NHS-III is necessary to the contract to facilitate programming the occupational modules and redesigning the questionnaire into a shorter, paper format that is suitable for direct electronic scanning. Reporting Schedule The contractor shall submit monthly progress reports and budget updates. These reports shall include information on enrollment, demographic information on participants, and progress of data analyses, when applicable. In addition, the contractor shall communicate regularly (via bi-weekly conference calls) with the NIOSH technical monitor to resolve problems and discuss progress. The estimated period of performance is 13 months after award of contract. References: The following references may be helpful: Information on the Nurses' Health Studies: http://www.channing.harvard.edu/nhs/ The following publication resulted from our ongoing collaboration with the Nurses' Health Study II: Work schedule during pregnancy and spontaneous abortion.Whelan EA, Lawson CC, Grajewski B, Hibert EN, Spiegelman D, Rich-Edwards JW. Epidemiology. 2007 May;18(3):350-5. Deliverables The following deliverables shall be transmitted to NIOSH in the timeframe indicated: 1. The occupational and pregnancy paper version of the questionnaires (3 months after award). 2. A report summarizing the mailing of introductory letters and postcards to potential participants of the pilot study phase II. The report shall include number of mailings, participation status, and known demographic information on the target population (3 months after award). 3. A report evaluating the efficacy of the "viral" method, including number of responses and demographic information on participants. 4. A report summarizing the evaluation of the pilot phase II, number of participants, summary statistics of data from the baseline and pregnancy questionnaires, summary results of non-participant surveys, estimated average time spent on survey, participant feedback, and completeness of occupational, reproductive, and demographic data. (13 months after award). PROJECT OFFICER: Christina C. Lawson, Ph.D. National Institute for Occupational Safety and Health Brigham and Women's Hospital possess the data needed. This project is supported by justification for other than full and open competition to Brigham and Women's Hospital under authority of 41 U.S.C.253(c)(1). Responsible sources that believe they possess the expertise and capabilities can submit to the Contracting Officer within 15 days from the posting date of this notice, their written capabilities statement and pricing information in the format they choose, not to exceed 10 pages. Please forward the capability statement and pricing information to Jennifer Bayer, reference 000HCCKC-2008-60968, CDC, NIOSH, 4676 Columbia Parkway, Mail Stop C-4. All vendors must be registered in the Central Contractor Registry (CCR) prior to an award of a federal contract. The website is: www.ccr.gov. The Government will review any/all capabilities statements and pricing information submitted and determine if other qualified sources do exist that could provide this requirement. Information received in response to this announcement will be used solely for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 15 days, in accordance with FAR 13.106-1(b)(1), negotiations will be conducted with Brigham and Women's Hospital as the only source and a purchase order will be issued without any additional notices being posted.