Supporting Statement A
MUSCULOSKELETAL DISORDER (MSD) INTERVENTION EFFECTIVENESS IN WHOLESALE/ RETAIL TRADE OPERATIONS
Request for Office of Management and Budget (OMB) Review and Approval
for a Federally Sponsored Data Collection
Steve Wurzelbacher, Ph.D.
Research Industrial Hygienist
Project Officer
National Institute for Occupational Safety and Health
Division of Surveillance, Hazard Evaluations, and Field Studies
4676 Columbia Parkway Mail Stop R14
Cincinnati, Ohio 45226
513-841-4322 (phone)
513-841-4486 (fax)
August 11, 2011
Table of Contents
Section Title Page Number
A. JUSTIFICATION
A1. Circumstances Making the Collection of Information Necessary 4
A2. Purpose and Use of Information Collection 9
A3. Use of Improved Information Technology and Burden Reduction 12
A4. Efforts to Identify Duplication and Use of Similar Information 13
A5. Impact on Small Businesses or Other Small Entities 13
A6. Consequences of Collecting the Information Less Frequently 14
A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 14
A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 14
A9. Explanation of Any Payment or Gift to Respondents 18
A10. Assurance of Confidentiality Provided to Respondents 18
A11. Justification for Sensitive Questions 20
A12. Estimates of Annualized Burden Hours and Costs 21
A13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 23
A14. Annualized Cost to the Government 23
A15. Explanation for Program Changes or Adjustments 24
A16. Plans for Tabulation and Publication and Project Time Schedule 24
A17. Reason(s) Display of OMB Expiration Date is Inappropriate 25
A18. Exceptions to Certification for Paperwork Reduction Act Submissions 26
B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS 29
B1. Respondent Universe and Sampling Methods 29
B2. Procedures for the Collection of Information 31
B3. Methods to Maximize Response Rates and Deal with Nonresponse 40
B4. Tests of Procedures or Methods to be Undertaken 43
B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 44
LITERATURE CITED 46
LIST OF ATTACHMENTS
Attachment A: Occupational Safety and Health Act [29CFR § 671]
Attachment B: 60-Day Federal Register Notice
Attachment C: NIOSH Strategic Goals and Activities
Attachment D-1: Relation of Project to Broader CDC Research Agenda
Attachment D-2: Prior MSD Intervention Studies
Attachment E-1: OBWC - NIOSH Letter of Agreement.
Attachment E-2: Letter of Support from OBWC
Attachment E-3: Comparison of US and Ohio NAICS Codes
Attachment F: Information Security Plan
Attachment G-1: Informed Consent- Questionnaire Data Collection
Attachment G-2: Informed Consent- Low Back Functional Assessment
Attachment G-3: Verbal Consent of Photographic Image Release
Attachment H-1: Self-Reported Low Back Pain Questionnaire
Attachment H-2: Self-Reported Upper Extremity Pain Questionnaire
Attachment H-3: Self-Reported Specific Job Tasks and Safety Incidents Questionnaire
Attachment H-4: Self-Reported General Work Environment and Health Questionnaire
Attachment H-5: Early Exit Interview
Attachment I: Low Back Functional Assessment
Attachment J-1: Establishment Recruitment Flyer
Attachment J-2: OBWC Safety Grants Application
Attachment J-3: Volunteer Employee Responsibilities
Attachment J-4: Individual Recruitment Flyer
Attachment K: IRB approval for Data Collection
Attachment L-1: Details of Interventions
Attachment L-2: MSD Intervention Study Design
Attachment L-3: Descriptions of Outcome Measures.
Attachment L-5: Study Limitations
SECTION A. JUSTIFICATION
This is a new information collection request (ICR) from the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). This data collection is authorized by Section 20(a) (1) of the Occupational Safety and Health Act (29 U.S.C. 669) (Attachment A). The 60-day Notice for this collection was published in the Federal Register on June 1, 2011, as required by 5 CFR 1320.8(d) (Attachment B).
The proposed information collection will address the need to assess the effectiveness of occupational safety and health (OSH) interventions for musculoskeletal disorders (MSDs) among wholesale/ retail trade (WRT) workers. This need is expressed in a number of NIOSH Strategic Goals (Attachment C). This study will provide current important information on the health and safety of WRT workers that is not available elsewhere. This project is part of the mission of CDC-NIOSH to conduct rigorous scientific intervention effectiveness research to support the evidenced based prevention of occupational injuries and illnesses. Additional information on how this project integrates into CDC’s broader research agenda is provided in Attachment D-1.
MSDs currently account for approximately 28% of the total non-fatal injuries and illnesses with days away from work or restricted duty (DAW) in private industry (Bureau of Labor Statistics, BLS, 2010). Liberty Mutual has estimated direct workers’ compensation costs to industry in the US in 2008 to be $53.4 billion (up from $48.6B in 2006), with $15.2 billion (28%) attributed to MSDs ($13.4B overexertion, $1.8B repetitive motion) (Liberty Mutual 2010 Safety Index). The wholesale and retail trade (WRT) sector employs over 21 million workers, or nearly 19% of the annual average employment in private industry (Anderson, 2010). MSDs also currently account for 28% of the total non-fatal injuries and illnesses in the WRT sector (BLS, 2010). Among all sectors, the WRT sector has some of the highest rates of MSDs involving days away from work (DAW). For example, wholesale trade and retail trade rank 3rd and 4th among all sectors with respective rates of 42.7 and 42.5 MSD DAW cases per 10,000 FTE. Of MSD DAW cases in the WRT sector in 2006, the vast majority (67,250 cases, ~91%) were cases where the event or exposure was overexertion (e.g. during material handling) versus repetitive motion (6,640 cases, ~9%). Since the majority of MSDs in WRT are related to overexertion, identifying effective controls to reduce these types of outcomes is an important step to reduce the overall injury/ illness burden in the WRT sector.
Studies indicate that overexertion MSDs are primarily caused by physical risk factors associated with manual material handling (MMH), including high task repetition, excessive biomechanical loading on body joints, and awkward body postures (Kumar 2001). It has also been indicated that combined exposure to multiple risk factors (versus single physical risk factors) produce the most adverse health effects (Marras 2000). For example, repetitive and heavy manual lifting in awkward postures have been found to be major risk factors for low back disorders in many studies (Waters et al., 1993; Waters et al., 1998; Marras et al., 1995; Westgaard et al., 1996; NIOSH 1997; Gagono et al., 2000). Although it is proposed that primary prevention interventions designed to reduce the multiple risk factors involved in MMH (high force, awkward postures, task repetition) will reduce future overexertion MSDs, relatively few true experimental studies have been conducted to test this hypothesis. Most MSD intervention effectiveness studies have been quasi-experimental (e.g. pre- and post- intervention studies without control groups or randomization). Those studies that have focused on the effectiveness of MSD engineering controls alone have tended to focus on short term workload assessments as outcomes rather than MSD symptoms/ cases and have been mixed in quality and findings (van der Molen et al 2005). For example, several recent literature reviews (Bigos et al. 2009; van Duijvenbode et al 2009; Sahar et al 2009; Tveito et al 2004) found few high-quality studies to support the efficacy of engineering ergonomic interventions designed to reduce low back pain. See Attachment D-2 for additional information on prior MSD intervention studies.
Clearly there is a need to conduct rigorous experimental research to define further the effectiveness of MSD control interventions. A renewed partnership between NIOSH and the Ohio Bureau of Workers Compensation (OBWC) provides a timely opportunity to conduct such research in a relevant, efficient, and impactful manner. Although several researchers have published studies using OBWC data in the past, OBWC and NIOSH have recently developed a formal agreement (Attachment E-1) to collaborate on a number of research goals, including descriptive WC data analyses, evaluation of prior OBWC-sponsored programs, and prospective intervention research. OBWC has many strengths as a potential research partner, including its size (approximately 250,000 insured establishments), diversity of industry that is largely representative of the larger US in both industry classification [both general 2-digit North American Industry Classification System (NAICS) and WRT sub sectors] and establishment size distribution (Attachment E-3), geographical proximity to the Cincinnati, OH and Morgantown, WV locations of NIOSH, and perhaps most importantly, their active engagement in intervention research. OBWC represents an ideal translational research partner. OBWC is an extremely pro-active workers compensation insurance carrier that spends millions of dollars annually supporting many programs to encourage insured companies to improve their primary through tertiary OSH prevention programs. For example, in 1999 OBWC initiated a program known as “Safety Grants” to provide matching funds to insured employers to put into place OSH controls and measure effectiveness. From 1999 to 2009, this was a 3-1 (OBWC to employer) matching with up to $40,000 per grant. Over the history of the program, OBWC has provided over 1,500 Safety Grants (111 in the WRT sector), with approximately 100 grants implemented per year and a total of $3 million annually in matching funds. As with all OBWC programs, insured companies are encouraged to participate and submit grant applications. Initial ideas for feasible controls often originate during field consultation visits by OBWC loss control staff (safety, ergonomics, and industrial hygiene specialists) while working directly with the personnel of insured companies. Occasionally, OBWC targets specific industries with interventions. For example, OBWC targeted nursing homes because of high MSD rates and the presence of feasible control options (patient handling devices and practices). To receive the grant, OBWC requires that companies participate in onsite evaluations to document before and after workplace changes and provide 2 years of follow-up data. A number of completed Safety Grant projects (~15%) are shared as “best practices” for various sectors (including WRT) through the OBWC website.
In summary, OBWC has years of experience in developing, implementing, evaluating, and disseminating OSH controls with clients and has in effect conducted 1,500 quasi experimental intervention studies. Although OBWC has actively engaged in prevention research, the organization is dedicated to demonstrating the effectiveness of their various programs using the most scientifically rigorous methods possible. For this reason, OBWC is eager to collaborate with NIOSH on a number of research projects including this MSD intervention research study. In this way, evidence based practices can be shared with the greatest audience possible and OBWC can efficiently allocate their own resources among program alternatives that range widely from primary prevention to disability management.
For the current study, NIOSH and the OBWC will collaborate on a multi-site intervention study at OBWC-insured WRT companies from 2011-2014. In overview, MSD engineering control interventions (stair-climbing, powered hand trucks and powered truck lift gates) will be tested for effectiveness in reducing self-reported back and upper extremity pain among 960 employees performing delivery operations in 72 WRT establishments using a prospective experimental design (multiple baselines across groups with randomization).
Privacy Impact Assessment
The study will collect both potentially sensitive data (self-reported MSD symptoms and results from low back functional assessments) and personal identifiers (name, address, phone number, employee clock number). The method of handling the information will comply with the Freedom of Information Act and the Privacy Act of 1974. Disclosure under the Privacy Act System is permitted: to private contractors assisting NIOSH; to collaborating researchers under certain limited circumstances to conduct further investigations; to the Department of Justice in the event of litigation; and to a congressional office assisting individuals in obtaining their records. All data collection and records management practices and systems (including the online survey) will adhere to all applicable federal, Health and Human Services (HHS), Centers for Disease Control (CDC), and NIOSH IT security policies and procedures [Security Requirements for Federal Information Technology Resources, January 2010; Health and Human Services Acquisition Regulation (HHSAR), Clause 352.239-72]. For example, data will be stored on encrypted CDs, flash drives, and/or file transfer protocol (ftp) sites according to applicable Federal Information Processing Standards Publications (FIPS PUBS, see http://www.itl.nist.gov/fipspubs). See the Information Security Plan in Attachment F for more information.
Questionnaires will be administered primarily using a self-administered secure web portal. The survey will be on a secure web site that will be accessible by sampled members of the participating establishments. The hyperlink and internet address to the survey will only be made available to members of participating establishments and researchers conducting the study. The information will not be directed at children under the age of thirteen years. Aggregated survey results will be made available on the NIOSH public internet site. Please see below for additional information related to the Privacy Impact Assessment.
Questionnaires will be administered using several options (self-administered secure web portal, self-administered hard copy forms, and telephonic interviews). The respondent will be strongly encouraged to use the self-administered web-based format of the survey. It is estimated that the vast majority (95%) will be collected via the online system. For those respondents lacking internet connections or those who do not wish to complete a web-based survey, a hard copy format will next be offered. An interview option will be offered as a last resort for those respondents who do not find the web-based or hard copy formats acceptable. Survey data will be collected for this study primarily using an online secure website that will comply with applicable 508 requirements to accommodate individuals with disabilities (http://www.hhs.gov/od/508policy). NIOSH researchers will primarily conduct the data collection and contractors will be used in support roles for data management. Information will be maintained until the conclusion of the study in 2015.
Information in identifiable form (IIF) will be collected as part of the informed consent forms (Attachments G-1 and G-2) for this study. This includes: first and last name, street address, phone number, email address, and date of birth.
Additional information collected is described below. All information will be used to determine whether there are significant differences in reported musculoskeletal pain and functional back pain score ratios (pre/ post intervention scores) when intervention and control groups are compared, while controlling for covariates. Individual participant personal information will not be published in any identifiable form and will be protected to the extent allowed by law (Freedom of Information Act and the Privacy Act). The questionnaire data and clinical examination are standard tools used to establish the degree of clinical disorder (lumbago) and upper extremity pain among the participants. The study is designed to determine the usefulness of the prophylactic intervention in preventing lumbago and upper extremity pain.
1: Primary Questionnaires (administered to all 960 participants at baseline and every 3 months for 2 years; 15 minutes estimated time for all primary questionnaires combined per data collection):
Self-reported low back pain: The first main outcome will be self-reported low back pain, as measured by the North American Spine Society (NASS) Lumbar Spine Outcome Assessment Instrument (17 items; 5 minutes estimated time combined per data collection Attachment H-1).
Self-reported upper extremity pain: The second main outcome will be self-reported upper extremity pain, as measured by the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire (16 items; 5 minutes estimated time combined per data collection Attachment H-2).
Self-reported specific job tasks and safety incidents: This questionnaire will collect exposure information regarding specific tasks related to the use of the intervention, material handling exposures, and safety incidents (20 items; 5 minutes estimated time combined per data collection Attachment H-3).
2: Secondary Questionnaires
Self-reported general work environment and health: This questionnaire will collect covariate exposure information related to overall work conditions, health, and behaviors (28 items, administered to all 960 participants at baseline and every 12 months for 2 years; 10 minutes estimated time combined per data collection) (Attachment H-4).
3: Clinical Examination (administered to a 20% sample of participants at baseline and every 12 months for 2 years; 20 minutes total required time per data collection):
Low Back Functional Assessment: A test conducted onsite (e.g. by a physical therapist) at the volunteer establishment, where participants will be asked to perform several functions (e.g. back movements) to test range-of-motion (ROM) and current back pain (Attachment I).
A limited amount of digital video may be collected at participant sites to document the types of tasks being conducted pre and post intervention. This video data will not be linked back to any individual participant data. All video data will be kept confidential and managed in accordance with the Privacy Act of 1974, Title 5, United States Code, Section 522 (a). To ensure participants’ privacy, the only identification in the video databases will be a NIOSH assigned participant company code and task code. The code identifiers will be kept in a secure location in the principal investigators’ office. Videos will be saved on a NIOSH computer network that is only accessible by the principal investigator, study co-investigators, and some supporting staff for the study. The participating companies will not have access to the videos. Prior to the video data collection, participants will be asked for permission to video, and uses of participants’ video data will be explained to them (Attachment G-3). The digital video data saved on the NIOSH network will be transferred to DVD discs and saved in a file cabinet located in the principal investigator’s office. The principal investigator and study co-investigators may use the video data for designing future interventions or understanding material handling tasks in the WRT sector.
As described, the proposed research will involve the collection of information through a secure website. The research will not direct any website content at children under 13 years of age. All data collection and records management practices and systems (including the online survey system) will adhere to all applicable federal, Health and Human Services (HHS), Centers for Disease Control (CDC), and NIOSH IT security policies and procedures [Security Requirements for Federal Information Technology Resources, January 2010; Health and Human Services Acquisition Regulation (HHSAR), Clause 352.239-72]. See the Information Security Plan in Attachment F for more information.
All information collected will be used to determine whether the tested MSD interventions are effective in reducing self-reported back and upper extremity pain among WRT delivery personnel. Results of the study (in de-identified and aggregated form) will be disseminated in the scientific literature and in educational materials through NIOSH and OBWC channels (website, publications). The privacy of all data collected will be protected to the extent legally possible, as covered by the Privacy Act of 1974, Title 5, United States Code, Section 522 (a). Individual participant personal information will not be published in any identifiable form.
The data collection for the MSD intervention study is part of a multi-phase project between NIOSH and OBWC that is fully funded from Fiscal Year 2011 through Fiscal Year 2014. The project was awarded federal funds through the NIOSH National Occupational Research Agenda (NORA) competitive process for intramural research. OBWC is also funding the majority of costs of the actual interventions (powered hand trucks and lift gates) through a 2:1 matching grant process.
The data collection is justified because very few clinical trials for the effectiveness of MSD controls have been conducted. Clearly there is a need to conduct rigorous experimental research to define further the effectiveness of MSD control interventions. This will enable evidence based practices to be shared with the greatest audience possible. Such data has practical utility to the federal government, state government, and private stakeholders.
For example, the federal Occupational and Safety and Health Administration (OSHA) is seeking input about the relevance of MSD-focused safety and health regulations. Recently, OSHA announced intention to restore a record keeping regulation to document MSDs on OSHA 300 logs (US Federal Register, 2010a). OSHA has also proposed a regulation for an injury/illness prevention program that could include the framework for MSD control (US Federal Register, 2010b). OSHA is in the process of soliciting input for both potential standards. OSHA is also required to submit justification for the implementation of proposed regulations. Without rigorous studies on the effectiveness of primary prevention approaches in general, and MSD interventions specifically, such analyses can be difficult.
State organizations such as the OBWC that sponsor prevention programs are seeking to evaluate the effectiveness of their various programs using the most scientifically rigorous methods possible. For this reason, OBWC is eager to collaborate with NIOSH on this project and OBWC has offered substantial financial resources (over $500,000 in matching grants) to support the proposed prospective intervention study. The goal is to identify evidence based practices and programs can be shared with the greatest audience possible. In this way, OBWC can efficiently allocate their resources among program alternatives that range widely from primary prevention to disability management. OBWC and NIOSH have also formalized an agreement (Attachment E-1) to outline a collaborative research partnership and specify a data sharing agreement to ensure data security. This MSD intervention study represents one of the first steps towards addressing many of the partnership goals, starting with the WRT sector and OBWC is committed to supporting these projects (see the letter of support from OBWC in Attachment E-2).
The results of the current study are also relevant for private companies (such as WRT companies, workers compensation or health insurance carriers) that may sponsor prevention programs. Sponsored-grant programs for engineering controls (like the OBWC Safety Grants program involved in this study) are currently rare among private insurance companies. If a rigorous experimental study can determine the level of effectiveness of such a program, other insurance and WRT companies may utilize this data to determine whether such a program should be implemented or expanded.
The findings from this project will also be transferred to private stakeholders and OSH practitioners using several main channels:
OBWC (website, publications, annual safety conference, and personnel)
The OBWC has a developed infrastructure to reach companies within the state of Ohio. NIOSH and OBWC just signed a formal agreement and this project will leverage this collaboration to encourage participation in the studies, solicit input from WRT companies, and provide results as they become available. As well, OBWC offers a free yearly safety conference (with an average attendance of ~6,000) where presentations and workshops about the studies will be conducted.
NIOSH (website, publications, and personnel)
Links to the same dissemination products outlined in the OBWC section above will also be cross promoted on the WRT portion of the NIOSH website.
WRT trade organizations (website, publications, and personnel)
Links to the same dissemination products will also be provided directly to several trade organizations (such as the Retail Industry Leaders Association). Additional outreach is already being conducted with other WRT trade organizations within the state of Ohio (e.g. Ohio Grocers Association) to raise awareness of NIOSH in general, and the specific studies with OBWC and to solicit input and participation in the research. Aspects of the studies will also be submitted for publication in trade journals.
Peer reviewed journals
For this study, at least one manuscript will be submitted for publication in a peer reviewed journal. Main audiences for these types of journals are fellow researchers, but also OSH practitioners.
Information in identifiable form (IIF) will be collected as part of the informed consent forms (Attachments G-1 and G-2) for this study. This includes: first and last name, street address, phone number, email address, and date of birth. Individual information will not be collected on the other surveys, which will be identified only using unique identifier (created by NIOSH) to track the responses of the participant over the course of the study. Individual participant personal information will not be published in any identifiable form and will be protected to the extent allowed by law (Freedom of Information Act and the Privacy Act). Information will be maintained until the conclusion of the study in 2015. The IIF data will only be used by NIOSH researchers for the purposes outlined below.
IIF Being Collected
|
Purposes
|
First and last name of individual participant |
The participant’s first and last name (in combination with their birth date) will be used to link to a unique identifier (created by NIOSH) to track the responses of the participant over the course of the study.
|
Street address of individual participant |
The street address will be used to send the participant hard copy questionnaires if the participant requests paper versions for their mode of data collection. The street address will also be used to send a hard copy of final study results if requested by the individual.
|
Phone number of individual participant |
The phone number will be used if the participant requests a phone interview for their mode of data collection. If the participant gives permission, the phone number will be used to prompt participants to submit quarterly data collections. If the participant gives permission, the phone number will also be used for the early exit interview to contact those participants who choose to leave the study.
|
Email address of individual participant |
If the participant gives permission, the email address will be used to prompt participants to submit quarterly data collections.
|
Date of birth |
The participant’s date of birth (in combination with their first and last name) will be used to link to a unique identifier (created by NIOSH) to track the responses of the participant over the course of the study. The date of birth will also be compared to a self-reported “age in years” that will be used as a covariate in analyses.
|
The proposed survey contains one question that may be considered sensitive as it is related to sexual behavior (item 13 in the standard NASS Lumbar Spine Outcome Assessment Instrument, Attachment H-1). The question is not explicit (described in A11 below) only inquires about sexual behavior for the purposes of establishing the level of back pain. The impact on the privacy of the individual is considered to be minimal if there were a breach of security.
In order to maximize efficiency and reduce burden, a web-based survey is proposed for the majority (estimated 95%) of all data collection. At a secure web site, the survey will be constructed for easy respondent use, allowing the automatic administration of skip patterns, while maintaining a simple, seamless navigation. Web-based surveys have gained increasing acceptance as a research tool as they offer many advantages, including:
On-line surveys create cost efficiencies because respondents complete them during a much shorter window of time than other survey modes, and at a substantially reduced cost (i.e., less labor is involved than telephone or in-person surveys; postage is required for mail-based surveys);
On-line surveys create time efficiencies (i.e., less time to complete the survey because it can be programmed to efficiently guide respondents through skip patterns so that they are not asked questions that do not apply to them or have to spend time navigating through complex instructions);
All responses are automatically recorded, allowing for minimal data cleaning, and rapid tabulation and analysis of findings;
Respondents potentially have the option of answering questions in a private setting where they feel comfortable and at ease (e.g., at home);
Respondents can complete the survey within their own time schedule, and can exit the survey at any time and resume the survey where they ended;
Previous research [Catalano et al 2006] suggests that workers in some industries prefer completing an online survey when given a choice between a web survey and a paper survey.
The respondent will be strongly encouraged to use the self-administered web-based format of the survey. For those respondents lacking internet connections or those who do not wish to complete a web-based survey, a hard copy format will next be offered. It is estimated approximately 5% of respondents will require hard copy formats. An interview option will be offered as a last resort for those respondents who do not find the web-based or hard copy formats acceptable. It is estimated approximately less than 1% of respondents will require personal interview formats.
NIOSH has searched the scientific literature, contacted colleagues at NIOSH and OSHA, contacted professional, labor and industry organizations representing WRT workers. To date, NIOSH is unaware of any prospective MSD intervention effectiveness study being conducted in the WRT sector with such an experimental design as the proposed study. As evidenced by the letters of support (Attachment E-2), the OBWC agrees that there is a need for such a rigorous study to determine the effectiveness of the sponsored grant program and identify evidence based practices.
Small OBWC-insured WRT businesses that perform delivery operations will be included in this study. To reduce burden for all respondents, a web-based survey will be used for the majority of data collection. All participants will be asked to complete the entire survey, but questions have been held to the minimum required for the intended use of the data.
Respondents will be asked to respond to the data collection at baseline and every 3 months for a 2 year period. The data being collected includes self-reported low back/ upper extremity pain, material handling exposures and usage of the MSD intervention (Attachments H1- H4). The frequency of this data collection is justified because musculoskeletal pain and exposures can vary over time (McGorry et al 2011) and less frequent measures would not be sensitive to episodes of pain that resolve within a 3 month period or to changing work exposures. The planned frequency of data collection is already at a minimum level to reduce burden on respondents while also retaining sensitivity for a valid intervention effectiveness study. There are no legal obstacles to reduce the burden.
There are no special circumstances associated with this data collection activity. This request fully complies with regulation 5 CFR 1320.5.
A: In accordance with 5 CFR 1320.8(d), a review of the proposed study was sought through a 60-day publication period in the Federal Register (May 18, 2011, Vol. 76, No. 96, pages 28788 -28789), (Attachment B). No comments were received in response to the Federal Register notice.
B: NIOSH has consulted with numerous individuals and organizations outside the agency regarding the availability and usefulness of the proposed data collection. The following chronology documents these contacts:
NIOSH researchers met several times with OBWC representatives from 2009-2010 to establish a long term and sustainable research partnership and discuss research goals and projects. A formal agreement (Attachment E-1) was then developed outline a collaborative research partnership and specify a data sharing agreement to ensure data security. An early stated goal was to evaluate the effectiveness of the OBWC sponsored prevention programs such as the Safety Grants program described earlier. NIOSH and OBWC co-developed the current MSD research study as a way to determine if the grants were functioning to reduce MSD symptoms in target employees. As indicated in the background literature review, very few MSD intervention studies have been designed in such a rigorous way and conducted for this purpose.
January 2010
During the development phase of this project, NIOSH conferred with other researchers from the Institutes for Work and Health (Dr. Ben Amick) about the design of the MSD intervention study.
Benjamin C. Amick III, PhD
Professor of Behavioral Sciences and Epidemiology
University of Texas School of Public Health
713-500-9496
The MSD intervention study was peer-reviewed as part of a multi-phase project between NIOSH and OBWC and rated based on project approach, potential impact, innovation, and significance through the NIOSH National Occupational Research Agenda (NORA) competitive process for intramural research. The project received favorable scores and was chosen for funding by NIOSH from Fiscal Year 2011 through Fiscal Year 2014. The OBWC is also funding the majority of costs of the actual MSD interventions (powered hand trucks and lift gates) through a 2:1 matching grant process.
December 9, 2010
NIOSH and OBWC presented an overview of the study to the NIOSH MSD NORA Cross-Sector meeting. This meeting includes MSD researchers from across NIOSH and academic institutions. The MSD intervention study was discussed informally during the meeting and feedback was received.
NIOSH continued to work with OBWC to refine the MSD intervention protocol. As part of this process, NIOSH solicited input from OBWC staff ergonomists to determine what ergonomic engineering controls (equipment, tools, work station designs) they have recommended for WRT clients, which controls have been most effective in reducing MSDs in WRT, and what controls need to be developed for WRT. This information was used to develop background information for the focus meeting described next. Those contacted are listed below.
Steve Hanna, Ergonomist, OBWC, 330-904-4315, [email protected]
Dennis Apple, Ergonomist, OBWC, 740-435-4333, [email protected]
Mike Rienerth, Ergonomist, OBWC, 216-538-9724, [email protected]
January 24, 2011
NIOSH held a focus group meeting at NIOSH in Cincinnati, OH with 8 OBWC staff to discuss additional interventions and target industries to add to the MSD intervention study to meet OBWC’s needs further and broaden study reach. OBWC Attendees included:
Cheryl Giordano, Ergonomist, 513-520-7071, [email protected]
Mark Giordano, Ergonomist, 513-520-2618, [email protected]
Trish Harris, Service Office Manager, 513-583-4512, [email protected]
Mike Lampl, Ergonomics Technical Advisor, 614-995-203, [email protected]
Carol Morrison, Manager, Business Development, 614-644-8225, [email protected]
Theresa Paxton, Ergonomist, 513-520-8167, [email protected]
Mireya Springer, Ergonomist, 614-562-5417, [email protected]
Ivana Wireman, Ergonomist, 937-269-6040, [email protected]
As a summary, the group agreed that the best way to expand the study would be to keep the focus on the material handling of large items (100+ lbs.) or stacked smaller items (1-100 lbs. per item, 100+ lbs. per stack), mainly during delivery-related operations, but include a wider variety of WRT companies (appliance/ furniture delivery; beverage distribution; food distribution; heating/ ventilation suppliers; vending services; and office supplies- copier service). The group also agreed that the study should focus on two priority controls (powered hand trucks and lift gates). The group further agreed that the expanded WRT study will meet many of the needs for ergonomic research in the transportation sector because the focus will be mainly on delivery operations with similar risks. Next steps were outlined to:
Find current and potential users of priority controls among OBWC WRT clients
Seek input from WRT clients about ergonomic best practices through Safety Council meetings and onsite visits to build case study library
Facilitate NIOSH visits to OBWC WRT clients (especially current users of controls)
Begin informal recruiting of new clients for study
Prepare a new Safety Grants application for WRT study for formal recruiting
February to March 2011
NIOSH and OBWC contacted several OBWC WRT clients who were current users of the intended controls. Feedback via emails and phone calls was received about the effectiveness of the control and the general design of the new study. Those contacted are listed below.
Roger Patten, [email protected]
Ken Norris, [email protected]
Rick Stephenson, [email protected]
NIOSH and OBWC also contacted trade associations (Ohio Association of Wholesaler – Distributors, Ohio Council of Retail Merchants, Ohio Wholesale Marketers Association, Wholesale Beer & Wine of Ohio) to advertise the study and solicit feedback . Those contacted are listed below.
Trade Organization |
Contact |
Contact Phone |
Contact Email |
Ohio Association of Wholesaler - Distributors |
Ed Cain |
614.221.7833 |
|
Ohio Council of Retail Merchants |
Gordon Gough |
614.221.7833 |
|
Ohio Wholesale Marketers Association |
Beth A. Wymer |
614.224.3435 |
|
National Retail Hardware Association |
Thomas Smith |
317.275.9432 |
|
Wholesale Beer & Wine of Ohio |
Susan Remy |
614.224.3500 |
March 15, 2011
NIOSH sponsored a meeting in Cincinnati on March 15, 2011 to discuss the overall NIOSH and OBWC research collaboration. The MSD intervention study was discussed informally during the meeting and feedback was received.
March 31, 2011
NIOSH gave a session presentation on March 31, 2011 at the Ohio Safety Congress (an annual conference sponsored by OBWC that averages over 6,000 attendees) to detail current research including the current MSD intervention study. Informal feedback was solicited about the study among OBWC-insured WRT clients and OBWC staff. The study was also highlighted during the one of the conference’s keynote addresses. An informational flyer about the study (Attachment J-1) was also disseminated at the conference.
April 2011
NIOSH and OBWC sent the informational flyer (Attachment J-1) to all OBWC safety and health staff, and to all OBWC-sponsored Safety Councils. The safety councils include over 20 regional groups throughout Ohio that are composed of diverse group of members including labor organization representatives, trade association members, and OBWC-insured company safety and health staff. The purpose of the Councils is to provide a forum for sharing best safety/ health practices among members through regular meetings and events. The councils were informed about the study and asked for feedback.
Participants will be given a $5 cash card (useable anywhere that accepts major credit cards) upon completion of each combined questionnaire data collection (a total of $45 for the entire study). Participants who complete surveys will also be entered into drawings each quarter to win prizes such as electronic gear. Participants who participate in the low back functional assessment (Attachment I) will be given a $25 gift certificate if the test is conducted outside of normal work hours. It has been demonstrated that incentives increase participation and reduce non-response bias among study participants [Dillman 1996, as reported by Shettle and Mooney 1999]. Belman et al. [2005] offered a monetary incentive of $20 for participation in their study, achieving a 70% participation rate. Comments received during focus groups with OBWC staff and other stakeholders indicated that incentives would encourage delivery personnel to participate in this study.
The interview will collect potentially sensitive information about health status. Risks to participants are low since the only information in identifiable form (IIF) is being collected for the purposes of informed consent. Each participant that enrolls in the study will be subsequently identified only with a code on all other information collection forms.
IRB approval for this data collection has been obtained (Attachment K).
Several controls (safeguards) will be put into place to minimize the possibility of unauthorized access, use, or dissemination of the information being collected. Records will be retained and destroyed in accordance with the applicable CDC Records Control Schedule (see http://aops-mas-iis.od.cdc.gov/Policy/Doc/policy449.htm). Planned controls are summarized in the table below.
Control Descriptions |
Control Type |
|
Technical |
|
Physical
|
1. Security Plan: The system security plan for this information collection is detailed in Attachment F.2. Contingency Plan: Files be backed up will be backed-up weekly using an offsite Microsoft SQL server based in Atlanta, GA CDC offices.3: User Manuals: Created for this information collection.4. Personnel Training: All CDC and contract personnel (principal investigator, managers, operators, contractors and/or program staff) will receive yearly training using the system and made aware of their responsibilities for protecting the information being collected and maintained.5. Contractor Adherence: Contracts for staff that operate or use the system will include clauses ensuring adherence to privacy provisions and practices.6. Access Levels: Methods will be put into place to ensure the least privilege possible (e.g., access is “role based” on a “need to know” basis). Accountability will be ensured through yearly security reviews.7. IIF Policy: There are CDC policies or guidelines in place with regard to the retention and destruction of IIF.
|
Administrative |
A. The CDC’s Information Collection Review Office has reviewed this application and has determined that the Privacy Act is applicable.
B. Access to individual data will be limited to authorized NIOSH researchers and contractors. Physical controls: NIOSH facilities have 24-hour security guards, and key card ID badges must be used to enter the buildings. Data in hardcopy form will be stored in locked rooms or cabinets. Technical controls: all electronic data will be stored on secure servers that are protected with firewalls and passwords. Any contractor charged with data collection, preparation, or management tasks to be performed away from a NIOSH facility will be required to follow equivalent procedures.
The process for handling security incidents is defined in the system's Information Security Plan (Attachment F). Event monitoring and incident response is a shared responsibility between the system's team and the Office of the Chief Information Security Officer (OCISO). Reports of suspicious security or adverse privacy related events should be directed to the component's Information Systems Security Officer, CDC helpdesk, or to the CDC Incident Response Team. The CDC OCISO reports to the HHS Secure One Communications Center, which reports incidents to US-CERT as appropriate
C. Respondents will be provided be asked to sign written consent form (Attachments G-1 and G-2). The forms describe how respondents are informed about the intended uses of the information collection and plans for sharing the information.
D. Respondents will be informed that their participation is voluntary, and that they may discontinue the survey at any time. They will also be advised that they will not lose any benefits to which they are otherwise entitled if they chose not to participate. The Privacy Act does apply and the informed consent forms (Attachments G-1 and G-2) address the effect on the respondent of not responding to the data collection request, the intended uses of the data, with whom information will be shared, and the legal authority for the data collection.
A11. Justification for Sensitive Questions
The proposed survey contains one question (included in the standard NASS Lumbar Spine Outcome Assessment Instrument, Attachment H-1) related to sexual behavior that may be considered sensitive. This question is provided below:
13. In the past week, how has pain affected your sex life?
My sex life is unchanged.
My sex life is unchanged, but causes some pain.
My sex life is nearly unchanged, but it is very painful.
My sex life is severely restricted by pain.
My sex life is nearly absent because of pain.
Pain prevents any sex life at all.
The question is not explicit and only inquires about sexual behavior for the purposes of establishing the level of back pain. This question is part of the NASS instrument has been found to have acceptability, high re-test reliability, internal reliability, and validity for low back pain and disability in multiple language translations (Daltroy et al 1996; Schochat et al 2000; Pose et al 1999; Padua et al 2001; Bosković et al 2009; Schneider et al 2007; Schluessmann et al 2009; Sigl et al 2006; Weigl et al 2006; Schaeren et al 2005). To remove this question may negatively affect the scoring of the questionnaire and comparisons to numerous other studies that have used the questionnaire with this particular question. Answering these questions poses little risk to the driver since all NASS questionnaires will be coded with a participant ID and only linked to data of individually identifiable form (IIF) that is being collected for the informed consent process.
A. Annualized Burden to Respondents
No direct costs will accrue to respondents other than their time to complete the survey. We estimate that a maximum of 960 individuals will participant in the MSD intervention data collection. This includes 384 individuals per intervention and a 25% uncertainty factor for second-year replacement firms/individuals. It is estimated that 75% of participants will be male based on expected demographics for delivery operations of large items. The hour-burden estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. All hour-burden estimates were derived based on estimates reported in the literature for these instruments, from prior CDC-NIOSH studies that utilized these forms, and informal pilot testing. No new formal samples of respondents were performed. The number of early exit interviews is based on an estimated 11% exit rate.
Table A.12-1. Estimated Annualized Burden to Respondents
Type of Respondent |
Form Name |
Number of Respondents |
Number of Responses per Respondent |
Avg. Burden per Response (in hours) |
Total Burden (in hours) |
Delivery Workers in Wholesale/ Retail Trade (WRT) Operations |
Self-reported low back pain |
960 |
4.5 |
5/60 |
360 |
Self-reported upper extremity pain |
960 |
4.5 |
5/60 |
360 |
|
Self-reported specific job tasks and safety incidents |
960 |
4.5 |
5/60 |
360 |
|
Self-reported general work environment and health |
960 |
1.5 |
10/60 |
240 |
|
Informed Consent Form (Overall Study) |
960 |
.5 |
5/60 |
40 |
|
Low Back Functional Assessment |
192 |
1.5 |
20/60 |
96 |
|
Informed Consent Form (Low Back Functional Assessment) |
960 |
.5 |
5/60 |
40 |
|
Early Exit Interview |
106 |
.5 |
5/60 |
4.4 |
|
Total Hours |
1,500 |
||||
B. Annualized Cost to Respondents
The total estimated annualized cost to respondents is $39,565.99, as summarized in Table A.12-2. The mean hourly wage rate for Transportation and Material Moving in the wholesale/ retail trade industry is $13.19 (Bureau of Labor Statistics - Table 3. Hourly mean wage rates by industry and occupational group, May 2009).
Table A.12-2. Estimated Annualized Cost to Respondents
Type of Respondent |
Form Name |
Total Burden (in hours) |
Average Hourly Wage Rate |
Total Respondent Costs |
Delivery Workers in Wholesale/ Retail Trade (WRT) Operations |
Self-reported low back pain |
360 |
$13.19 |
$4748 |
Self-reported upper extremity pain |
360 |
$13.19 |
$4748 |
|
Self-reported specific job tasks and safety incidents |
360 |
$13.19 |
$4748 |
|
Self-reported general work environment and health |
240 |
$13.19 |
$3,166 |
|
Informed Consent Form (Overall Study) |
40 |
$13.19 |
$528 |
|
Low Back Functional Assessment |
96 |
$13.19 |
$1,266 |
|
Informed Consent Form (Low Back Functional Assessment) |
40 |
$13.19 |
$528 |
|
Early Exit Interview |
4.4 |
$13.19 |
$58 |
|
Total |
$19,790 |
|||
A13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers
There are no capital or maintenance costs to respondents.
Total costs include work performed over the course of four years by CDC research personnel (1 industrial hygienist, 2 epidemiologists, and 1 statistician) and contracted administrative personnel, including tasks such as: (1) development of survey materials; (2) development of sampling frame and sample selection; (3) survey conduct; (4) sample tracking; (5) data receipt and processing; and (6) data entry and delivery. Estimated annualized costs to the Federal Government for the survey period are presented in Table A.14-1 below.
Table A.14-1. Estimated Annualized Cost to the Federal Government
|
FY2011 |
FY2012 |
FY2013 |
FY2014 |
TOTAL PROJECT |
Annualized Cost |
CDC Personnel Salaries and Benefits a |
$16,588.60 |
$17,418.03 |
$18,288.93 |
$19,203.38 |
$71,498.94 |
$17,874.73 |
Travel |
$1,180.00 |
$1,470.00 |
$1,470.00 |
$1,450.00 |
$5,570.00 |
$1,392.50 |
Contractual |
$13,000.00 |
$13,000.00 |
$13,000.00 |
$13,000.00 |
$52,000.00 |
$13,000.00 |
Supplies |
$2,500.00 |
$2,500.00 |
$2,500.00 |
$2,000.00 |
$9,500.00 |
$2,375.00 |
OTHER (Incentives for participants to complete surveys) |
$9,000.00 |
$9,000.00 |
$9,000.00 |
$9,000.00 |
$36,000.00 |
$9,000.00 |
|
|
|
|
TOTAL |
$138,568.94 |
$34,642.23 |
The annualized cost to the Federal Government is $34,642.
This is a new data collection.
Statistical Analysis of the Data
Data collection will be completed over two years, followed by statistical analysis and dissemination of data. A full description of the statistical protocol is provided in Part B1 and B2 of this ICR. Results will be made available through publication in scientific journals and notices in trade publications, and through digital media such as the Internet.
Project Time Schedule
Table A.16-1. Project Time Schedule
Activity |
Time Schedule (Months After OMB Approval) |
All survey data collection systems (e.g. online systems, materials) will be finalized. |
Within 3 months after OMB approval |
Individual participants will be recruited from establishments who have been recruited to receive the MSD interventions. Informed consent forms (Attachments G-1, G-2) will be completed by participants. |
Within 6 months after OMB approval |
The MSD interventions will be placed in Group A establishments. Baseline data will be collected (exposure and outcome surveys, Attachments H1-H4) for Group A/B establishments will be collected. A 20% sample of individuals will complete low back functional tests (Attachment I). |
Within 6 months after OMB approval |
First quarter data will be collected (self-reported low back/ upper extremity pain, tasks, and safety incidents at 3 months, Attachments H1-H3). |
Within 9 months after OMB approval |
Second quarter data will be collected (self-reported low back/ upper extremity pain, tasks, and safety incidents at 6 months, Attachments H1-H3). |
Within 12 months after OMB approval |
Third quarter data will be collected (self-reported low back/ upper extremity pain, tasks, and safety incidents at 9 months, Attachments H1-H3). |
Within 15 months after OMB approval |
The MSD interventions will be placed in Group B establishments. First annual (fourth quarter) data will be collected (exposure and outcome surveys, Attachments Attachments H1-H4) for Group A/B establishments will be collected. The same 20% sample of individuals (from baseline) will complete low back functional tests (Attachment I). |
Within 18 months after OMB approval |
Fifth quarter data will be collected (self-reported low back/ upper extremity pain, tasks, and safety incidents at 15 months, Attachments H1-H3). |
Within 21 months after OMB approval |
Sixth quarter data will be collected (self-reported low back/ upper extremity pain, tasks, and safety incidents at 18 months, Attachments H1-H3). |
Within 24 months after OMB approval |
Seventh quarter data will be collected (self-reported low back/ upper extremity pain, tasks, and safety incidents at 21 months, Attachments H1-H3). |
Within 27 months after OMB approval |
Second annual (eighth quarter) data will be collected (exposure and outcome surveys, Attachments H1-H4) for Group A/B establishments will be collected. The same 20% sample of individuals (from baseline) will complete low back functional tests (Attachment I). This is the end of survey and low back functional test data collection. |
Within 30 months after OMB approval |
The analysis of study data will be completed to determine the effectiveness of multi-site MSD intervention at OBWC WRT establishments. |
Within 42 months after OMB approval |
There is no request for an expiration date display exemption.
There are no exceptions being sought to the certification statement.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | NATIONAL SURVEY OF U |
| Author | Jan Birdsey |
| File Modified | 0000-00-00 |
| File Created | 2021-01-31 |