-
effectivehealthcare-admin.ahrq.gov/sites/default/files/substance-abuse-horizon-scan-high-impact-1412.pdf
December 01, 2014 - Experts wanted to see additional clinical trial data assessing
baclofen’s long-term safety and efficacy … solution to a reference
product; a user experience study with adult and juvenile volunteers; and a safety … All adult volunteers, and 15 of 19 adolescent volunteers,
successfully used Evzio, removing the safety … to patients’ families that it be available for emergency use at home. … ,
and patients’ families, the experts concluded.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/psoriasis-chronic_disposition-comments.pdf
November 27, 2012 - For this reason, it is also
important to capture long-term safety to
obtain a global aspect of how … these
therapies impact patient care, both benefits
and harms. … For KQ 1, what does this patient population look like? … Efficacy and safety of infliximab vs. … One patient was reported to have hypertension in patients who
switched from methotrexate to infliximab
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/crohns-disease_disposition-comments.pdf
February 25, 2014 - centered outcomes, and observational studies along with RCT
for safety. … All patients in global safety summary
were Crohn’s Disease patients. … Please consider inclusion of this safety data. … According to our analytic
framework, patient-reported
outcomes are relevant. … questions
in terms of final patient important outcomes.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/wysiwyg/pdf/mhs-IV-epc-grand-rounds-slides.pptx
January 01, 2023 - safety and quality researchers; policymakers who work on patient safety and quality issues.
10
MHS … safety issues, and patient/consumer perspective. … safety subject matter experts within Penn Medicine and JHU’s Armstrong Institute for Patient Safety … , AHRQ’s Patient Safety Network (PSNet) website, the Joint Commission’s National Patient Safety Goals … , the National Quality Forum’s Patient Safety Report, and Becker’s Hospital Review 10 Top Patient Safety
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/registries-guide-2nd-edition_disposition-comments.pdf
March 03, 2010 - who get entered into
registry vs. (2) universe of patients with condition of interest to provide an … General
The use of registries for product safety assessment should augment all of
the other safety … safety assessments. … and patient complexity. … used to examine safety for medical devices.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/weight-gain-prevention_research-protocol.pdf
January 01, 2020 - help provide an evidence base
for future practice guidelines to influence individual decision making, patient … The safety issues to be addressed will also help individuals and clinicians to
take into consideration … Objectives
We aim to compare the effectiveness, safety and impact on quality of life of individual … Health Indicators Warehouse. Healthy Weight in Adults. … http://www.healthindicators.gov/Indicators/Healthyweightinadults_1207/Profile/Data
.
3.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/stem-cell-children_surveillance.pdf
October 29, 2012 - , 4, 5 and 6 up to date
• Expert opinion: conclusions still valid
• There are no new significant safety … using searches through August, 2011 and
addressed six key questions to evaluate effectiveness and safety … Administration (FDA), Health Canada, and Medicines and Healthcare Products Regulatory
Agency (MHRA) safety … Taken
into consideration the totality of evidence (i.e., updating signals, expert opinion, and safety … Experts: Still valid
Safety surveillance alerts: No
Conclusion: Up to date
7
Table 1.
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effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/antipsychotics-children_research-protocol.pdf
June 04, 2010 - • The following outcomes were added: patient or parent/caregiver preferences, work-related
functional … outcomes, patient insight into illness. … followup), patient baseline characteristics (diagnosis and age at diagnosis, age, sex, race,
weight … in each group, and the number of patients affected. … Adults
Pediatric use: safety & effectiveness not
established in patients <18 yr
1. agranulocytosis
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/osteoarthritis-pain-2006_appendixes.pdf
January 01, 2006 - Peds: safety and efficacy
not established in pediatric
patients
sulindac Elimination half-life: … Patient
masked? … Patient
masked? … Trials of etoricoxib and lumiracoxib (Safety only)
Author
Year
Patient
masked? … Patient global
response pooled data indicated that patients taking 25mg rofecoxib v celecoxib had good-excellent
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cancer-anemia-update_disposition-comments.pdf
April 25, 2013 - or specific patient populations since
there is evidence that certain groups of patients may not
necessarily … However, that group was part of
the patient population defined for the review. … more in this manuscript because it is relevant to clinical practice and
it is the reason for ongoing safety … measures in accordance
with the AHRQ Methods Guide, these data are clinically important to consider for
safety … Since the 2008 ODAC meeting,
there have been no new safety signals that would warrant the conclusion
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/diabetes-horizon-scan-high-impact-1306.pdf
January 01, 2016 - for calibrating the
CGM (as applicable) and checking sensor performance as needed plus associated
reagents … But the experts called for
longer safety and efficacy studies to determine whether this system would … Genentech has a patient assistance program to help defray costs for
qualified patients.135
Several … Efficacy and safety of exenatide once weekly
versus sitagliptin or pioglitazone as an adjunct to … Efficacy,
safety, and tolerability of exenatide once weekly
in patients with type 2 diabetes mellitus
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cancer-anemia_executive.pdf
May 01, 2006 - What are the comparative efficacy and safety of
epoetin (alfa or beta) and darbepoetin?
2. … Are any patient characteristics at baseline or early
hematologic changes useful to select patients or … empirically evaluated to determine whether the
degree of change is perceptible and meaningful to
the patient … treated with epoetin; this prompted an FDA safety
review in May 2004 and revised product labeling to … Neither higher than recommended
target Hb nor any other single patient- or treatment-
related factor
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/diabetes-update-2015_research-protocol.pdf
January 01, 2015 - patients who cannot initiate or who cannot tolerate
metformin remains unclear. … outcomes will be especially
useful to clinicians, patients, investigators, guideline developers, and … Patients and patient advocates also will find the information valuable when making decisions
about treatment … • We will exclude studies of patients with
type 1 diabetes, impaired glucose
tolerance, metabolic … using a co-morbidity scale or index; by including other medical
conditions or medications used by the patient
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cancer-radiation_executive.pdf
November 01, 2009 - Each of four reviewers
extracted study, patient, and treatment
characteristics; clinical outcomes;
and … CS=cancer-specific survival; GI=gastrointestinal; OvS=overall survival.
3
Most studies reported patient … This Technical Brief did not intend to assess outcomes
or evaluate the validity of claims on the safety … focused systematic reviews will not be
able to provide a definitive answer on the effectiveness
and safety … studies (preferably randomized) are likely
necessary to provide meaningful answers on the relative
safety
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cannabis-2023-surv-rep-4.pdf
January 01, 2023 - Cannabis for
chronic pain: cardiovascular safety in a nationwide
Danish study. … Pharmacokinetics and pharmacodynamics of cannabis-
based medicine in a patient population included in … Medicinal cannabis for Australian patients with chronic
refractory pain including arthritis.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/health-careassociated-infections_executive.pdf
November 01, 2012 - safety practices:8
• Theory behind patient safety practice
• Existing patient safety infrastructure … patient safety culture and teamwork at the unit level. … Safety Practice 9 3 4 0 16
Existing Patient Safety Infrastructure 8 6 2 4 20
External Factors 9 7 … Assessing the Evidence
for Context-Sensitive Effectiveness and Safety of Patient
Safety Practices: … Advancing
the science of patient safety. Ann Intern Med. 2011 May
17;154(10):693-6.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/field-triage-glascow_research-protocol.pdf
February 25, 2016 - severity score ≥16, head AIS score >2 or >3,
presence of intracranial hemorrhage, and utilization indicators … • KQ1: Predictive utility for mortality, morbidity, injury severity score ≥16,25 or
utilization indicators … score of Glasgow
Coma Scale
Intermediate
outcomes
Over- or under-
triage
Utilization indicators … National Highway Traffic Safety Administration. Washington, DC. … patients.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/s16.pdf
October 01, 2007 - evidence is centered on the protocol-driven ran-
domized trials, which the FDA requires to establish safety … information from
industry-funded trials may remain unpublished, limiting the
ability to examine potential safety … carefully studied in trials (especially rare or
slow emerging harms); explore sources of heterogeneity in
safety … may depend on severity of
strokes, patient preferences. … patients; audits could examine the rates at which
women and patients over age 80 are undergoing surgery
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/colon-cancer-gene-profiling_technical-brief.pdf
December 01, 2012 - Patient-oriented and patient-advocacy Web sites for colon cancer were searched. … These GEP assays are all prognostic indicators.
Table 1. … The FDA addresses the safety and effectiveness of diagnostic tests and the quality
of the design and … Historically, the FDA has subjected test kits to premarket review of safety and effectiveness, but
not … result from both preanalytic factors (e.g.,
sample preparation) as well as analytic factors (such as reagents
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/depression-horizon-scan-high-impact-1412.pdf
December 01, 2014 - Adoption could be limited by ketamine’s
cost, inconsistent clinical trial data, and safety risks, multiple … But one expert with a research
5
background, citing ketamine’s safety risk and lack of long-term … be limited; these experts cited ketamine’s safety risks and lack of robust clinical
trial data as … In
contrast, scopolamine’s known safety profile and possible oral and patch delivery options, bolstered … A
study to evaluate the safety and efficacy of
intranasal esketamine in treatment-resistant
depression