-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/meditation_research-protocol.pdf
October 17, 2012 - information on general study characteristics (e.g., study design, study period, and
follow-up), study participants … • Did the strategy for recruiting participants into the study differ across study groups? … Detection Bias:
• Were those who collected data on the participants blind to the allocation? … , subject proficiency with meditation, instructor
qualifications, and study selection criteria for participants … There are concerns that participants in
meditation studies are highly selected, such as trained meditators
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/glaucoma-treatment_executive.pdf
April 01, 2012 - We included studies of participants with primary open-
angle glaucoma or open-angle glaucoma suspects … We excluded studies that enrolled participants with
conditions other than open-angle glaucoma if they … Outcomes
For KQ 1, the outcome is the proportion of participants
with moderate, severe, and profound … KQ 2 deals with patient-reported outcomes, so we
considered participants’ mean total or relevant item … Finally, we compared the proportion of participants
experiencing the following adverse events among
-
effectivehealthcare.ahrq.gov/products/transparency-neuropathy/research-protocol
September 06, 2016 - ClinicalTrials.gov captures several data elements including number of enrolled and completed trial participants … if the intervention was the same AND 1 or more groups in the trial had an identical number of study participants … Reasons for delays (if any)
Population
Total enrollment, sample size in each arm, drop-outs
Participants
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/rti-item-bank-bias-precision_research.pdf
September 01, 2011 - Blinding Blind administration
Were study
participants blinded
to their group
assignment? … Completeness of
follow-up
Are all participants
in all study arms
accounted for in
follow-up? … Were the outcome assessors blinded to the intervention or exposure status of participants? … Follow-Up
Equality of Length of Follow-Up for Participants
16. … Abstractor: When follow-up was the same for all study
participants, the answer is yes.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/autism_disposition-comments.pdf
November 01, 2010 - The minimum number (N) of ten participants was selected in
consultation with our content experts and … The authors used correlates of change or post-
treatment outcome for participants in a single
group … In terms of
scientific logic, it is as if the participants did not
receive a treatment because the … All
participants were in the same all-day center-
based program. … /educational/allied health studies with
fewer than 10 participants.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/methods-guidance-bias-individual-studies_methods.pdf
March 01, 2012 - x
Were participants analyzed within the groups they were originally assigned to? … x x x
Were the outcome assessors blinded to the intervention or exposure status of participants? … Participants also recognized that many of the tools being used were not based on empirical
evidence … The domains are sequence generation; allocation concealment;
blinding of participants and personnel; … Was the TOTAL NUMBER of participants affected by harms specified for each study arm?
14.
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effectivehealthcare.ahrq.gov/sites/default/files/s50.pdf
October 01, 2007 - , (3) recruit
participants from heterogeneous practice settings, and (4)
collect data on a broad range … Likewise, in RCTs in health services
research, study participants are randomized into either a
treatment … If this purity is compromised, intention-to-treat
analyses (which keep all participants in the study … Selection Criteria, Patient Recruitment,
and Generalizability
To reduce variation among study participants … Because their participants are screened,
selected, and subjected to scrutiny and intervention control
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/assessing-the-risk-of-bias-in-systematic-reviews-of-health-care-interventions-01_0.pdf
May 01, 2005 - more prognostic variables (factor
that predict the outcome of interest) influences
whether study participants … into the
studyg
When participants (or initial followup time for
some participants only) are selected … are not accounted for in the analyses
• Outcome data are reasonably completeh and proportion of
participants … X
• Confounding variables that are controlled for in the analysis
are reasonably complete across participants … X
• Outcomes are measured using valid and consistent
procedures and instruments across all study participants
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/glaucoma-screening_disposition-comments.pdf
April 01, 2012 - Peer Reviewer #2 Methods Why were case series of 100 participants or less
excluded? … These studies should include
participants that one would encounter in a screening setting. … We acknowledge that the inclusion of studies that have
included participants with known or suspected … Including participants who are not representative of those
one reasonably expects to encounter in a … Open-angle glaucoma
participants with VF loss had lower scores than
participants with no VF loss.”
-
effectivehealthcare.ahrq.gov/products/coronary-stents-effectiveness/abstract
April 14, 2010 - Participants, setting and expected sample size: Study population will consist of: 1) 3,300 CAS patients
-
effectivehealthcare.ahrq.gov/sites/default/files/product/pdf/assessing-the-risk-of-bias-in-systematic-reviews-of-health-care-interventions-01.pdf
May 01, 2005 - more prognostic variables (factor
that predict the outcome of interest) influences
whether study participants … into the
studyg
When participants (or initial followup time for
some participants only) are selected … are not accounted for in the analyses
• Outcome data are reasonably completeh and proportion of
participants … X
• Confounding variables that are controlled for in the analysis
are reasonably complete across participants … X
• Outcomes are measured using valid and consistent
procedures and instruments across all study participants
-
effectivehealthcare.ahrq.gov/products/cerebral-palsy-feeding/research-protocol
June 12, 2012 - We anticipate that participants in studies of surgical interventions likely have more severe feeding … and personnel)
Described all measures used, if any, to blind study participants and personnel from … Reviewer Comments:
Performance bias due to knowledge of the allocated interventions by participants … Not described in sufficient detail
Judgment: Blinding (participants and personnel)
High
Low
Unclear … Detection bias
Were the outcome assessors blinded to the intervention or exposure status of participants
-
effectivehealthcare.ahrq.gov/products/osteoarthritis-knee-update/research-protocol
June 16, 2016 - In addition, the proportion of participants who experienced improvement should be abstracted if reported … If three or more RCTs of a particular intervention are included that enroll at least 50 participants … one knee only may improve pain in that knee but may not markedly improve function
Studies that use participants … way that outcomes are assessed (self-assessment, blinded assessor) and expressed (e.g., percent of participants … Assessing Applicability
We will consider applicability of participants and interventions separately
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoarthritis-knee-update_research-protocol.pdf
June 15, 2016 - In addition, the proportion of participants who experienced improvement should be
abstracted if reported … § If three or more RCTs of a particular intervention are included that enroll
at least 50 participants … knee only may improve pain in that knee but may not markedly
improve function
o Studies that use participants … Assessing Applicability – We will consider applicability of participants and interventions
separately … populations (mean age less than 50), those with only
early stage or mild disease, those enrolling participants
-
effectivehealthcare.ahrq.gov/products/cancer-communication/research
March 28, 2013 - Many participants reflected that the items measured important aspects of their interactions with clinicians
-
effectivehealthcare.ahrq.gov/products/undescended-testicle/research
December 11, 2012 - testing may predict anorchia, but evidence is insufficient, with only two studies of fewer than 50 participants
-
effectivehealthcare.ahrq.gov/products/global-health-evidence-evaluation-framework/white-paper
June 24, 2013 - focus on efficacy and/or effectiveness with most attention going to the allocation method of study participants
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/transparency-neuropathy_research-protocol.pdf
September 01, 2016 - ClinicalTrials.gov captures several data
elements including number of enrolled and completed trial participants … the intervention was the same AND 1
or more groups in the trial had an identical number of study participants … Reasons for delays (if any)
Population Total enrollment, sample size in each arm, drop-outs
Participants
-
effectivehealthcare.ahrq.gov/products/hip-fracture-pain/research-protocol
December 09, 2009 - Even though there is a consensus that the average age of participants will be over 60 to 65 years old … nonrandomized controlled trials, cohort studies (prospective or retrospective), case-control studies
Participants … Observational study designs with no comparison group (case reports, case series, cross sectional studies)
Participants … Majority (>80%) of participants <50 years, as stated by the study investigators or evident from the … trial characteristics (e.g., mean/SD of patient population); participants with underlying pathological
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/pharma-nonpharma-ptsd-2022-update-app-g2-3.xlsx
January 01, 2022 - Bias Due to Deviations From Intended Interventions (Cochrane) or Performance Bias (AHRQ); Masking Participants … 1.2) Was the allocation sequence concealed until participants were enrolled and assigned to interventions … 2.2) Were carers and people delivering the interventions aware of participants' assigned intervention … RoB judgement 3.1) Were data for this outcome available for all, or nearly all, participants randomized … PN/NI to both previous questions) Were outcome assessors aware of the intervention received by study participants