-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/off-label-use-research-priorities_research.pdf
May 01, 2009 - Our
model also incorporated FDA-identified safety concerns, mean prescription prices, marketing
expenditures … should focus on drugs used frequently with
inadequate supporting evidence, particularly if further concerns … Our quantitative analysis
identified particular concerns with the off-label use of antipsychotic and … were scored
as 0.5 for less concerning, and other drugs scored as zero for this index.15,16
Cost concerns … Similarly, support is lacking for their use in
dementia where safety concerns have been raised about
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effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/stakeholders-engagement-others_research-2012.pdf
January 01, 2012 - It can be used to ensure an accurate understanding and reflection of the issues,
concerns, and agreement … institution represented (if any)
Purpose of meeting
8
•
•
•
•
Key points discussed
Issues or concerns … Some common concerns or situations requiring facilitator interruption include:
•
•
•
•
•
•
• … Perhaps we can set a time to discuss your concerns further
after the call so that we can make sure we … Perhaps we can set a time to discuss your concerns further
after the call so that we can make sure we
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/polyunsaturated-fatty-protocol.pdf
January 01, 2024 - Assuming no other major flaws (which would suggest a high risk of bias determination),
● If there are concerns … for analytically, the observational study will be considered to be high risk of bias
● If there are concerns … about missing data, outcome measurement, analytic method,
selective reporting, or other concerns, … the observational study will be considered to be
high risk of bias
● If there are no major concerns … the
observational study will be considered to be at moderate risk of bias
● If there are no major concerns
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/saturated-fat-replacement-protocol.pdf
January 01, 2024 - Assuming no other major flaws (which would suggest a high risk of bias determination),
● If there are concerns … for analytically, the observational study will be considered to be high risk of bias
● If there are concerns … about missing data, outcome measurement, analytic method,
selective reporting, or other concerns, … the observational study will be considered to be
high risk of bias
● If there are no major concerns … observational study will be considered to be at moderate risk of bias
9
● If there are no major concerns
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cell-free-dna-draft-report.pdf
December 01, 2024 - GRAIL;
PATHFINDER
NCT04241796
Prediagnostic
prospective cohort
Unclear ROB;
Notable concerns … Diagnostic
case-control;
High ROB;
Notable concerns
175 (43.4% female) ages 21 to 84 years; … a As assessed by the Tool for Assessing Conflicts of Interest in Trials (TACIT); concerns is assessed … as “notable concerns” or “no notable concerns.” 47
AFP = alpha fetoprotein; CCGA = Circulating Cell-free … We assessed
this review as having an unclear ROB (Appendix C, Table C-6) and no notable concerns for
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/deliberative-methods-demonstration-executive-131125.pdf
November 01, 2013 - Participants expressed concerns that boundaries create logistical and practical challenges. … This case study juxtaposed concerns about having access to a “better” high-
volume hospital versus the … Further, unlike the other case
studies, community concerns undermined rather than supported the primacy … • Given that participants have particular concerns about the impact of harms—and are
willing to … These concerns have implications for generation of
evidence and translation of research findings.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/epstein1.pdf
January 01, 2009 - • Knowing and honoring the patient’s perspective (e.g., concerns, feelings,
expectations, values)
•
-
effectivehealthcare-admin.ahrq.gov/health-topics/patient-safety?page=0
April 02, 2025 - To reduce the risk of medical errors, you can
Ask questions if you have doubts or concerns.
-
effectivehealthcare-admin.ahrq.gov/health-topics/patient-safety
April 02, 2025 - To reduce the risk of medical errors, you can
Ask questions if you have doubts or concerns.
-
effectivehealthcare-admin.ahrq.gov/products/off-label-use-research-priorities/research
June 01, 2020 - Notably, while raising some concerns about off-label use, the studies also identify disease- and patient-specific … were scored as 0.5 for less concerning, and other drugs scored as zero for this index. 15 , 16
Cost concerns … three primary components described above representing volume of use with inadequate evidence, safety concerns … Similarly, support is lacking for their use in dementia where safety concerns have been raised about … .50
.50
1.00
Uncertain Evidence Uses
.167
.25
FDA Safety Concerns
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cer78_procalcitonin_disposition_20121210.pdf
October 05, 2012 - PR (#6) Results Overall, I had no additional concerns, comments or
questions on the results section. … However, their
main conclusive statements don’t include these concerns
and their research gaps also … do not include these
concerns. … I’ll discuss these separately:
Concerns about effectiveness and mortality are addressed below
PR … This limitation is raised by the current
We appreciate these issues as unresolved concerns and we’ll
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/progestogens-preterm-birth-disposition-121205.pdf
September 07, 2012 - We share concerns about
lack of safety data and have amplified that in
the final version of the report … Peer Reviewer #7 Results Opening section of KQ1 has the best list of clinical concerns that
I have seen … We
share concerns about lack of large scale
safety data and have amplified that in the final
version … We don’t have substantive
concerns about gaps or weaknesses that limit
the utility of the report. … decisions, because they do not take into account
the examination of the key trial by the FDA and the concerns
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/data-repository-reviews_white-paper.pdf
September 01, 2012 - In the course of this conversation, it was speculated that intellectual property (IP) concerns
might … Aside from standard attribution practices, we believe that IP concerns with regards to the
SRDR are … continue throughout the development process to proactively address any
potential complexities or concerns … User Certification
Data security and integrity are central concerns for any electronic repository of … In order to address these concerns, we propose granting tiered access to SRDR data and
functionality
-
effectivehealthcare-admin.ahrq.gov/products/saturated-fat-replacement/protocol
November 01, 2024 - Assuming no other major flaws (which would suggest a high risk of bias determination), If there are concerns … for analytically, the observational study will be considered to be high risk of bias If there are concerns … about missing data, outcome measurement, analytic method, selective reporting, or other concerns, the … observational study will be considered to be high risk of bias If there are no major concerns about … then the observational study will be considered to be at moderate risk of bias If there are no major concerns
-
effectivehealthcare-admin.ahrq.gov/products/polyunsaturated-fatty/protocol
November 01, 2024 - Assuming no other major flaws (which would suggest a high risk of bias determination), If there are concerns … for analytically, the observational study will be considered to be high risk of bias If there are concerns … about missing data, outcome measurement, analytic method, selective reporting, or other concerns, the … observational study will be considered to be high risk of bias If there are no major concerns about … then the observational study will be considered to be at moderate risk of bias If there are no major concerns
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/wysiwyg/white-paper-outcome-measure-harmonization-depression.pdf
November 01, 2020 - completed for patients who screen positive for suicide ideation on the PHQ-9
or when a clinician has concerns … not routinely used and would be
added for the purposes of this study only, both registries expressed concerns … The registries noted
concerns about the availability of these data within the participating sites’ EHRs … The registries also
noted concerns about the possibility that these data will be missing entirely from … measures.
11
Mortality Data
As with suicide ideation and behavior, the registries noted concerns
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/atrial-fibrillation_disposition-comments.pdf
June 28, 2013 - TEP #1 ES (General) Additional concerns include:
1. … TEP #6 ES (General) I had several concerns with regard to key question 5. … TEP #6 Introduction No specific concerns Thank you. … TEP #3 Methods No concerns. Thank you. … No concerns. Thank you.
TEP #3 Results KQ6. No concerns. Thank you.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/mental-health-mobile-apps-disposition-of-comments.pdf
May 20, 2022 - toward evaluating specific aspects of health apps
(e.g., usability) and do not adequately reflect concerns … Saba Akbar, Enrico Coiera,, Farah Magrabi, Safety concerns with
consumer-facing mobile health applications … None of this is
oversighted with these medical intervention apps which can cause severe safety
concerns … This framework aims to
address the concerns
addressed by the reviewer
by systematically
classifying … The Framework was created
and refined to address concerns with safety, efficacy, data privacy and consumer
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/palliative-care-tools-disposition.pdf
May 04, 2017 - authors are commended for their efforts to
provide an overview of key issues in this area, discuss
concerns … Thank you for your comment.
75 Key Informant #7 General Comments Concerns:
"Assessment tools" - … collects data at the individual
patient or caregiver level.
76 Key Informant #7 General Comments Concerns … We have
addressed your concerns about our findings in previous
comments.
91 Key Informant #7 Next … No concerns Thank you for your comment.
95 Key Informant #8 Guiding Questions No concern Thank you for
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/palliative-care-tools-disposition.pdf
May 04, 2017 - authors are commended for their efforts to
provide an overview of key issues in this area, discuss
concerns … Thank you for your comment.
75 Key Informant #7 General Comments Concerns:
"Assessment tools" - … collects data at the individual
patient or caregiver level.
76 Key Informant #7 General Comments Concerns … We have
addressed your concerns about our findings in previous
comments.
91 Key Informant #7 Next … No concerns Thank you for your comment.
95 Key Informant #8 Guiding Questions No concern Thank you for