Supporting Statement Part B

SUPPORTING STATEMENT

Part B

Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the Evidence-based Practice Center Program

Version: November 16, 2015

Agency of Healthcare Research and Quality (AHRQ)

Table of contents

B. Collections of Information Employing Statistical Methods 3

B1. The Potential Respondent Universe and any Sampling or other Respondent Selection Methods to be Used 3

B2. The Procedures for the Collection of Information

B3. Methods to Maximize Response Rates and to Deal with Issues of Non-response

B4. Tests of Procedures or Methods to be Undertaken

B5. Consultants 5

B. Collections of Information Employing Statistical Methods

B1. The Potential Respondent Universe and any Sampling or other Respondent Selection Methods to be Used

The SRC is contacting industry stakeholders such as investigators, pharmaceutical and device manufacturers, app developers, and other non-governmental institutions and professional associations for the purposes of supplementing evidence and data collected from published and grey literature searches. In 2014, 336 industry stakeholders were contacted a total of 517 times. Of those 517 requests sent, 14.1% received a response; 56.2% of the responses contained submissions of information on the results of interventions. See Table B1 for an outline of the respondent universe.

Table B1.

Entity	Requests	Response Rate	Submission Rate
Manufacturers (Drugs, Devices, Biologics, & Supplements)	353	16.4%	9.1%
Non-governmental Institutions, Initiatives, & Associations	59	10.2%	6.8%
Academic & Professional Associations	22	13.6%	9.1%
Government Units	40	7.5%	0.0%
Investigators	3	33.3%	33.3%
Other (e.g., Insurance Companies, App Developers, Vendors)	40	7.5%	7.5%
Aggregate	517	14.1%	7.9%

Table B1 illustrates a glimpse at how industry stakeholders view a request of supplemental evidence and data for systematic reviews (SEADS). AHRQ and the SRC believe these response rates will improve upon using the data in such a way as to explicitly assess the completeness of the evidence-base for each review. For each report, a table generated for the purpose of displaying this assessment for studies that did or did not receive a submission will be made available. Increasing the visibility of the how confident EPCs are regarding the completeness of their evidence-base using this table will provide industry stakeholders a better understanding of the value in contributing any information they have, especially considering a statement to the effect that they have either provided all the available information on the intervention in question or that they do not have any information to provide at all. The online submission form (OSF) is set up to retrieve this information without creating a heavy burden on the responder.

B2. The Procedures for the Collection of Information

The information collection process is initiated with a written request letter sent to industry stakeholders by electronic and postal mail (see Attachment A). Stakeholders are given three ways to respond to the request: email, postal or package services, or an online submission form (OSF; see Attachment B).

The OSF was developed to provide stakeholders with flexibility in how they respond to the request. At a minimum, respondents are requested to input their organization’s name and contact information, the intervention being addressed, and a description of the submission. The description of their submission entails endorsing a statement about the completeness of their submission 1) submitted all possible information, 2) they have nothing to provide, or 3) “other” wherein they are provided a memo field to describe their submission in more detail. Respondents that choose option “1” or “3” will be given the option to upload documents or enter specific study details into the online form or a downloadable excel template which can be uploaded or e-mail to the SEADS coordinator.

No stratification will be performed on the data. Each request is a single unique event reflecting the topic chosen by AHRQ and its partners that is not repeated unless it is deemed ready for an update at an undetermined future date.

B3. Methods to Maximize Response Rates and to Deal with Issues of Non-response

Before letters are sent every effort is made to obtain specific contacts at the organizations of interest. If an individual was last contacted over 6 months prior to a new request, confirmation of their employment or responsibility over handling requests of this nature are established before sending.

The purpose of SEADS requests is not to collect generalizable data, but to supplement the published and grey literature searches EPCs are conducting. Furthermore, considering the evidence and data included in responses collected from industry stakeholders, an assessment pertaining to the completeness of the evidence-base will be produced. This, AHRQ and the SRC believe will increase the value of the AHRQ’s research reviews to end-users and potentially provide stakeholders a better understanding of how their submissions are used. Moreover, given that there may be studies the SRC knows exist, but are unable to access, the SRC has considered the idea of a follow-up request asking for specific studies justified on the basis of their inaccessibility.

Additionally, in an attempt to maximize response rates the SRC SEADS Coordinator sends out a reminder e-mail to those stakeholders with working e-mail accounts (or web forms capable of sending the entire request letter). No physical letter is sent. This reminder occurs roughly 2 weeks into the 4 week portal of time available for stakeholders to respond and submit information.

B4. Tests of Procedures or Methods to be Undertaken

Tests will likely include asking fewer than ten individuals to review the OSF for any confusion or user interface improvements.

B5. Consultants

Name	Phone No.
Ryan McKenna, MS	(503) 220-8262 x58653
Erick Turner, MD	(503) 220-8262 x56176
Mark Helfand, MD, MPH, MS, FACP	(503) 220-3406
Lisa Hartling, BScPT, MSc	(780) 492-6124
Thomas Trikalinos, MD	(401) 863-6917
Gillian Sanders-Schmidler, PhD	(919) 668-8700
Karen Schoelles, MD, SM, FACP	(610) 825-6000 x5337
Eric Bass, MD, MPH	(410) 955-9871
Evelyn Whitlock, MD, MPH	(503) 335-6787
Hassan Murad, MD, MPH	(507) 266-1829
Robert Kane, MD	(612) 624-1185
Roger Chou, MD, FACP	(503) 494-5367
Paul Shekelle, MD, PhD	(310) 393-0411 x6669
Meera Viswanathan, PhD	(919) 316-3930
Michael White Pharm.D.	(860) 341-6513
Melissa McPheeters, PhD, MPH	(615) 936-8317
Harlan Krumholz, MD	(203) 764-5885
Kay Dickersin, PhD	(410) 502-4421
Steven Goodman, MD, PhD	(650) 723-8524

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