Guid Lines

Clinical Practice Guidelines
Clinical practice guidelines

• “Clinical practice guidelines are systematically
developed statements to assist practitioner
and patient decisions about appropriate
health care for specific clinical
circumstances.”(Institute of Medicine, )
• Guidelines define the role of specific
diagnostic and treatment modalities in the
diagnosis and management of patients.
• The statements contain recommendations
that are based on evidence from a rigorous
systematic review and synthesis of the
published medical literature.
Guidelines:
• Synthesize and translate the highest quality of
evidence into practice recommendations
• Optimize treatment outcomes and reduce the use of
any harmful or unnecessary interventions
• Establish standards of care and reduce inappropriate
practice variations
• Facilitate shared decision making among physicians,
patients and their caregivers
• Inform policy makers in their decisions about the
allocation of health care resources.
Scientific Research in Medicine
 Primary Research
• Basic research
• Clinical Research
• Epidemiological research
 Secondary research
• Meta-analysis
• Review
Scientific research in medicine
Research types
• Descriptive studies
• Analytical studies
Analytical Studies
• Observational studies
• Experimental Studies
Clinical Research
Experimental
 Clinical study
• Phase I study
• Phase II study
• Phase III study
• Phase IV study
Clinical Research
Observational
 Therapy study without intervention
 Prognostic study
 Diagnostic study
 Observational study with drugs
 Secondary data analysis
 Case series
 Single case report
Secondary Research
 Meta-analysis
 Review
• Systematic
• Simple (narrative)
• Different types of clinical questions are best
answered by different types of research
studies.
• You might not always find the highest level of
evidence (i.e., systematic review or meta-
analysis) to answer your question. When this
happens, work your way down the Evidence
Pyramid to the next highest level of evidence.
Clinical Question Suggested Research Design(s)
All Clinical Questions Systematic review, meta-analysis
Therapy
Randomized controlled trial (RCT), meta-analysis
Also: cohort study, case-control study, case series
Etiology
Randomized controlled trial (RCT), meta-analysis, cohort study

Also: case-control study, case series
Diagnosis
Randomized controlled trial (RCT)
Also: cohort study
Prevention
Randomized controlled trial (RCT), meta-analysis

Also: prospective study, cohort study, case-control study, case series
Prognosis
Cohort study
Also: case-control study, case series
Meaning
Qualitative study
Quality Improvement
Randomized controlled trial (RCT)

Also: qualitative study
Cost
Economic evaluation
The stages of the Guideline development
• Establish a Guideline Development Group

and Leadership
• Define Scope and purpose
• Define the clinical problem
• Assemble a multidisciplinary systematic
review team
• Conduct a systematic review of the literature
• Establish recommendation
Level of Evidence
Class of Recomendations
Review (narrative)
Review
Cardiovasc Drugs Ther
. 2020 Aug;34(4):555-568.
doi: 10.1007/s10557-020-06981-3.
Anticoagulants for Stroke Prevention in Atrial
Fibrillation in Elderly Patients
Andreas Schäfer 1, Ulrike Flierl 2, Dominik Berliner
2
, Johann Bauersachs 2
• Ischaemic stroke and systemic embolism are the major potentially
preventable complications of atrial fibrillation (AF) leading to severe
morbidity and mortality. Anticoagulation using vitamin K antagonists (VKA)
or non-vitamin K oral anticoagulants (NOACs) is mandatory for stroke
prevention in AF. Following approval of the four NOACs dabigatran,
rivaroxaban, apixaban, and edoxaban, the use of VKA is declining steadily.
Increasing age with thresholds of 65 and 75 years is a strong risk factor when
determining annual stroke risk in AF patients. Current recommendations
such as the "2016 Guidelines for the management of atrial fibrillation" of the
European Society of Cardiology and the "2019 AHA/ACC/HRS Focused
Update" by the American College of Cardiology, the American Heart
Association, and the Heart Rhythm Society strengthen the importance of
anticoagulation and detection of bleeding risks, of which older age is an
important one. While patients aged ≥ 75 years are usually underrepresented
in randomised clinical trials ……………..
Meta-Analysis
• Novel Oral Anticoagulants
for the Prevention of Stroke in Patients with
Atrial Fibrillation and Hypertension: A
Meta-Analysis.
• Zheng Y, Liu Y, Bi J, Lai W, Lin C, Zhu J, Yao W,
Chen Q.Am J Cardiovasc Drugs. 2019
Oct;19(5):477-485. doi: 10.1007/s40256-019-
00342-8.PMID: 30931494
•
• Introduction
• Hypertension is associated with increased risk of stroke and bleeding in
patients with atrial fibrillation (AF). In the present study, we aimed to
investigate the influence of hypertension status in patients with AF
receiving treatment with non-vitamin K antagonist oral anticoagulants
(NOACs).
• Methods
• PubMed, Embase, and Cochrane Library were searched from the
inception of each database to November 2017. Randomized controlled
trials (RCTs) that evaluated NOACs versus warfarin in patients with AF
and hypertension were identified. A meta-analysis was performed
using random- or fixed-effects models according to the Preferred
Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
guidelines.
• Results
• Five trials (72,967 patients, including 51,378 patients with hypertension)
were enrolled. NOACs significantly reduced the risk of stroke and
systemic embolism (hazard ratio [HR] 0.87, 95% confidence interval [CI]
0.81–0.94, n = 51,378 patients), hemorrhagic stroke (HR 0.55, 95% CI
0.41–0.74, n = 28,818 patients), death from any cause (HR 0.91, 95% CI
0.85–0.97, n = 43,101 patients), major bleeding (HR 0.78, 95% CI 0.74–
0.83, n = 51,378 patients) and intracranial bleeding (HR 0.50, 95% CI
0.38–0.67, n = 27,185 patients). The benefits of NOACs in comparison
with warfarin were consistent in AF patients with or without
hypertension (Pinteraction for all outcomes > 0.05).
• Conclusions
Our findings suggest that NOACs can be recommended for the prevention
of stroke or systemic embolism in patients with AF and hypertension.
Systematic review
• Systematic review of societal costs associated
with stroke, bleeding and monitoring in atrial
fibrillation
• Amber L Martin
• ,Alessandra G Reeves
• Materials & methods
• Study selection
• The SLR was conducted according to the preferred reporting items for systematic reviews and meta-
analyses (PRISMA) guidelines [27] and the Cochrane Handbook for Systematic Review of Interventions [
28]. Details on data sources and study selection criteria are provided below.
• Data sources
• Systematic searches were conducted in the MEDLINE (via PubMed) and Embase electronic databases to
identify articles published in English between 1 January 2008 and 9 March 2018. The search algorithms
used a combination of indexing terms (medical subject heading [MeSH] terms in MEDLINE and Emtree
terms in Embase) and free-text keywords for NVAF, as well as terms for the broader AF indication. The
indication string was paired with terms for economic burden and for stroke, bleeding and INR
monitoring (Supplementary Table 1). Articles indexed as case reports, editorials,
comments/commentary, guidelines, news or narrative reviews were excluded from the searches. A
manual check of references from recent SLRs and meta-analyses identified through Cochrane Database
of Systematic Reviews was also conducted to ensure optimal and complete literature retrieval.
• Abstracts and poster presentations from the 2016 to 2017 International Society of Pharmacoeconomic
and Outcomes Research scientific meetings were also reviewed. Any abstracts of studies identified
through the conference searches reporting economic models and cost and resource use outcomes were
included in the review as grey literature
• Due to the heterogenous nature of the data, a qualitative
synthesis was performed to summarize the SLR results
and no statistical analyses were conducted. As part of
this synthesis, study and population characteristics, as
well as the manner of reporting indirect costs were
assessed both individually and across studies, to compare
results. All indirect costs were captured as reported and
broken out into monetary costs and nonmonetary costs.
The nonmonetary costs were categorized as productivity
loss, time loss or caregiver-related.
• Cochrane Database of Systematic Reviews (CDSR)
Regularly updated full text Systematic Reviews and Protocols (uncompleted reviews).
Database of Abstracts of Reviews of Effects (DARE)

Abstracts of critical assessments of systematic reviews.
Cochrane Central Register of Controlled Trials (CENTRAL/CCTR)

Controlled trials identified by Cochrane Review Groups.
NHS Economic Evaluation Database (NHS EED)

Abstracts of National Health Service economic evaluations of health care interventions.
Health Technology Assessment Database (HTA)

Abstracts of assessments of healthcare technologies.
The Cochrane Methodology Register (CMR)

Articles and books on the methodology of the systematic review process.

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Clinical Practice Guidelines

Clinical practice guidelines

All Clinical Questions Systematic review, meta-analysis

Randomized controlled trial (RCT), meta-analysis, cohort study

Randomized controlled trial (RCT), meta-analysis

Randomized controlled trial (RCT)

• Establish a Guideline Development Group

Database of Abstracts of Reviews of Effects (DARE)

Cochrane Central Register of Controlled Trials (CENTRAL/CCTR)

NHS Economic Evaluation Database (NHS EED)

Health Technology Assessment Database (HTA)

The Cochrane Methodology Register (CMR)

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