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What’s new in Clinical Practice Guidelines (CPG) in Critical Care Kuwait , April 11, 2013. What is new in CPG in Critical Care Past, Present, Futur e. P rocess of CPG developm ent (GRADE ) Examples of new and / or controversia l recommendations Future tasks

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what s new in clinical practice guidelines cpg in critical care kuwait april 11 2013
What’s new in Clinical Practice Guidelines (CPG) in Critical CareKuwait, April 11, 2013
what is new in cpg in critical care past present futur e
What is new in CPG in Critical CarePast, Present, Future
  • Process of CPG development (GRADE)
  • Examples of new and / or controversial recommendations
  • Future tasks
  • Allow you to use those guidelines with more satisfaction
the evolution of power in medicine
The evolution of power in medicine
  • Clinical Experience and pathophysiological knowledge
  • RCTs
  • Meta-analyses, decision analyses, economic analyses
  • Above with recommendation  Practice guidelines
in the beginning
In the beginning...
  • Early 2000
    • CPG increasing in importance
    • Chaos all over the place, especially for ‘generalists’
    • Need to create order out of chaos
grade guideline development process
GRADE: Guideline development process
  • Step one
    • What is the question?
  • Step two
    • Find and summarize best evidence
  • Step three
    • Apply judgments (quality of evidence, strength of recommendations)

G

rade

grade defining feature
GRADE defining feature
  • Evidence: high or low quality?
      • quality of evidence: the likelihood that our estimates of effects are true and adequate to support given recommendation
  • Recommendation: weak or strong?
      • confidence that following the recommendation will cause more good than harm
recommendations weak or strong
Recommendations: Weak or strong?

strong recommendations

strong methods

AND

benefits clearly outweigh downsides

weak recommendations

weak methods

OR

balance of benefits and downsides unclear or close

R

ecommendation

slide10

Formulate

question

Select

outcomes

Rate

importance

of outcomes

Systematic Review

(outcomes across studies)

Evidence Profile (GRADEpro)

Pooled estimate of effect for each outcome

1

Quality of evidence for each outcome

2

High  Moderate  Low  Very low

High | Moderate | Low | Very low

Critical

Outcome1

action

PICO

start

RCT

observational

high

low

Critical

Outcome2

risk of bias

inconsistency

indirectness

imprecision

publication bias

Important

Outcome3

rate down

Not

Outcome4

important

large effect

dose-response

antagonistic bias

rate up

Guideline panel

systematic review of evidence

recommendation

  • Formulate recommendations
  • For or against an action
  • Strong or weak (strength)
  • Strong or weak:
  • Quality of evidence
  • Balance benefits/downsides
  • Values and preferences
  • Resource use (cost)

Rate overall quality of evidence

across outcomes

  • Wording
  • “We recommend…” | “Clinicians should…”
  • “We suggest…” | “Clinicians might…”
  • unambiguous
  • clear implications for action
  • transparent (values & preferences statement)
strength of recommendation
Strength of recommendation

degree of confidence that desirable effects of adhering to recommendation outweigh the undesirable effects.

  • Undesirable effects
  • harms
  • more burden
  • costs
  • Desirable effects
  • health benefits
  • less burden
  • savings
strong or weak recommendation
Strong or Weak Recommendation?
  • Quality of the evidence
  • Balance between desirable and undesirable effects
  • Values and preferences
  • Costs (resource allocation, feasibility)
strenght of recommendations
Strenght ofRecommendations
  • strong recommendation
      • authors confident that following the recommendation will cause more good than harm
  • weak recommendation (suggestion)
      • authors believe that following the recommendation will cause more good than harm, but are less confident
why grade recommendations implications
Why Grade Recommendations? Implications
  • strong recommendation
    • one size fits all
    • expect uniform clinician behavior
    • use as performance indicator
  • weaker recommendation
    • expect action to vary
strenght of recommendations1
Strenght ofRecommendations
  • do it or don’t do it
    • strong recommendation
  • probably do it, or probably don’t
    • weaker recommendation
how to present grades
How to present grades?
  • words only
    • recommendations versus suggestions
    • quality high, moderate, low, very low
  • numbers and letters
    • recommendation 1 and 2
    • quality A, B, C, D
grade pragmatic approach
GRADE pragmatic approach
  • If question appropriate, look for meta-analysis (MA)
  • If no published MA, identify main studies
  • If possible, do your own MA
  • If no MA, describe main studies and their results
  • Be explicit about the way you identified and summarized the evidence
  • Make sure there is explicit link between recommendation and evidence
surviving sepsis campaign
Surviving Sepsis Campaign
  • New or controversial recommendations
slide21

68 international authors

  • 30 international organizations
  • 19 reviewers
  • Attention to COI
  • GRADE system
  • Emphasis on meta-analyses (636 references)
    • If you can't dazzle them with brilliance, baffle them with bs
slide22

Formulate

question

Select

outcomes

Rate

importance

of outcomes

Systematic Review

(outcomes across studies)

Evidence Profile (GRADEpro)

Pooled estimate of effect for each outcome

1

Quality of evidence for each outcome

2

High  Moderate  Low  Very low

High | Moderate | Low | Very low

Critical

Outcome1

action

PICO

start

RCT

observational

high

low

Critical

Outcome2

risk of bias

inconsistency

indirectness

imprecision

publication bias

Important

Outcome3

rate down

Not

Outcome4

important

large effect

dose-response

antagonistic bias

rate up

Guideline panel

systematic review of evidence

recommendation

  • Formulate recommendations
  • For or against an action
  • Strong or weak (strength)
  • Strong or weak:
  • Quality of evidence
  • Balance benefits/downsides
  • Values and preferences
  • Resource use (cost)

Rate overall quality of evidence

across outcomes

  • Wording
  • “We recommend…” | “Clinicians should…”
  • “We suggest…” | “Clinicians might…”
  • unambiguous
  • clear implications for action
  • transparent (values & preferences statement)
controversies and changes team work
Controversies and changes – team work
  • Sepsis management requires a multidisciplinaryteam (physicians, nurses, pharmacy, respiratory,dieticians, and administration) and multispecialty collaboration(medicine, surgery, and emergency medicine) to maximize thechance for success.
calibrating the level of your enthusiasm
Calibrating the level of your enthusiasm
  • There will be one week of extra paid vacation for all attending this conference
  • Kuwait and UAE meet in the opening match of the World Cup in Qatar 2022
  • New personal income tax is introduced to pay the football team players for winning more games
controversies and changes plus some gossiping
Controversies and changes (plus some gossiping)
  • The administration of effective intravenous antimicrobialswithin the first hour of recognition of septic shock (grade1B) and severe sepsis without septic shock (grade 1C)should be the goal of therapy.
  • Remark: Although the weightof the evidence supports prompt administration of antibioticsfollowing the recognition of severe sepsis and septicshock, the feasibility with which clinicians may achieve thisideal state has not been scientifically evaluated.
controversies and changes plus some gossiping1
Controversies and changes (plus some gossiping)
  • The administration of effective intravenous antimicrobialswithin the first hour of recognition of septic shock (grade1B) and severe sepsis without septic shock (grade 1C)should be the goal of therapy.
  • Remark: Although the weightof the evidence supports prompt administration of antibioticsfollowing the recognition of severe sepsis and septicshock, the feasibility with which clinicians may achieve thisideal state has not been scientifically evaluated.
slide28

surviving

patients

[%]

time from onset of hypotension [hours]

controversies and changes plus some gossiping2
Controversies and changes (plus some gossiping)
  • The administration of effective intravenous antimicrobialswithin the first hour of recognition of septic shock (grade1B) and severe sepsis without septic shock (grade 1C)should be the goal of therapy.
  • Remark: Although the weightof the evidence supports prompt administration of antibioticsfollowing the recognition of severe sepsis and septicshock, the feasibility with which clinicians may achieve thisideal state has not been scientifically evaluated.
controversies and changes protocolized care
Controversies and changes – protocolized care
  • EGDT (targets BP, CVP, UO, Scvo2) with the use of fluids, pressors, transfusion, dobutamine (1C)
    • CVP too low (high PEEP)
    • one protocol versus another
    • Transfusion and dobutamine
jama feb 24 2010 jan 2007 jan 2009
JAMA Feb 24, 2010 (Jan 2007-Jan 2009)

23% mortality

17% mortality

controversies and changes new protocol
Controversies and changes – new protocol
  • We suggest targeting resuscitation to normalize lactate inpatients with elevated lactate levels as a marker of tissuehypoperfusion (grade 2C)
  • Text: If Scvo2 is not available, lactate normalization maybe a feasible option in the patient with severe sepsis-inducedtissue hypoperfusion. Scvo2 and lactate normalization may alsobe used as a combinedendpoint when both are available.
controversies and changes new diagnostic possibilities plus gossiping
Controversies and changes – new diagnostic possibilities (plus gossiping)
  • We suggest the use of low procalcitonin levels or similarbiomarkers to assist the clinician in the discontinuationof empiric antibiotics in patients who appeared septic, buthave no subsequent evidence of infection (grade 2C).
controversies and changes vasopressors
Controversies and changes - vasopressors
  • We recommend norepinephrine as the first-choice vasopressor(grade 1B).
  • We suggest epinephrine (added to and potentially substitutedfor norepinephrine) when an additional agent isneeded to maintain adequate blood pressure (grade 2B).
  • We suggest dopamine as an alternative vasopressor agent tonorepinephrine only in highly selected patients (eg, patientswith low risk of tachyarrhythmias and absolute or relativebradycardia) (grade 2C).
  • A trial of dobutamine infusion up to 20mcg/kg/min be administered or added to vasopressor (if in use) in the presenceof (a) myocardial dysfunction as suggested by elevated cardiac filling pressures and low cardiac output, or (b) ongoing signs ofhypoperfusion, despite achieving adequate intravascular volume and adequate MAP (grade 1C)
controversies and changes
Controversies and changes

2008: We suggest that intravenous hydrocortisonebe givenonly to adult septicshock patients after it has been confirmedthat their blood pressure ispoorly responsive to fluid resuscitationand vasopressor therapy (grade2C)

2012: We suggest not using intravenoushydrocortisone as a treatmentof adult septic shock patients if adequate fluidresuscitationand vasopressor therapy are able to restore hemodynamicstability. If thisis not achievable, we suggest intravenous hydrocortisonealone at a dose of 200 mg per day (grade 2C)

controversies and changes ards
Controversies and changes - ARDS
  • We recommend target a tidal volume of 6 mL/kg predicted body weight in patients with sepsis-induced ARDS (grade 1A vs. 12 mL/kg).
  • We suggest strategies based on higher rather than lower levelsof PEEP for patients with sepsis-induced moderate tosevere ARDS (grade 2C).
  • We suggest recruitment maneuvers in sepsis patients withsevere refractory hypoxemia due to ARDS (grade 2C).
  • We suggest ashort course of NMBA of not greater than 48 hours for patients with early sepsis-induced ARDS and a Pao2/Fio2< 150 mm Hg (grade 2C).
  • We suggest prone positioning be used in sepsis-induced ARDS patients with a Pao2/Fio2 ratio ≤ 100 mm Hg in facilities that haveexperience with such practices (grade 2B).
controversies and changes less sedation
Controversies and changes – less sedation
  • We recommend that either continuous or intermittentsedation be minimized in mechanically ventilated sepsispatients, targeting specific titration endpoints (grade 1B).
controversies and changes1
Controversies and changes
  • 2008:We recommend that stress ulcer prophylaxisusing H2 blocker (grade 1A)or proton pump inhibitor (grade 1B)be given to patients with severe sepsisto prevent upper gastrointestinal (GI)bleed.
  • 2012:We recommend that stress ulcer prophylaxis using H2 blockeror proton pump inhibitor be given to patients with severesepsis/septic shock who have bleeding risk factors (grade 1B).
  • When stress ulcer prophylaxis is used, we suggest the use ofproton pump inhibitors rather than H2 receptor antagonists(H2RA) (grade 2C).
  • We suggest that patients without risk factors should notreceive prophylaxis (grade 2B).
stress ulcer prophylaxis1
Stress ulcer prophylaxis
  • The balance of benefits and risks may thus depend on the individual patient’s characteristics (including the presence of enteral feeding) as well as on the local epidemiology of VAP and C. difficileinfections.
controversies and changes dvt
Controversies and changes – DVT
  • We recommend that patients with severe sepsis receivedaily pharmacoprophylaxis against VTE (grade 1B).
  • We recommend that this be accomplishedwith daily subcutaneous LMWH (grade 1B versusUFH twice daily and grade 2C versus UFH given thricedaily).

2008:

  • We recommend that patients with severesepsis receiveDVT prophylaxis with either a) lowdoseUFH administeredtwice or three times per day;or b) daily LMWH unless there arecontraindications(grade 1A).
  • We suggest that in patients at veryhigh risk, LMWH be used rather thanUFH as LMWH is proven superior inother high-risk patients (grade 2C).
controversies and changes sweet is good
Controversies and changes – sweet is good!
  • A protocolized approach to blood glucose management in ICU patients with severe sepsis commencing insulin dosing when2 consecutive blood glucose levels are >180 mg/dL.
  • This protocolized approach should target an upper blood glucose≤180 mg/dL rather than an upper target blood glucose ≤ 110 mg/dL (grade 1A).
  • 2008

We suggest use of a validated protocolfor insulin dose adjustments and targetingglucose levels to the 150mg/dL range (grade 2C).

controversies and changes platelets
Controversies and changes - platelets
  • 2012: In patients with severe sepsis, we suggest that platelets beadministered prophylactically when counts are ≤ 10,000/mm3 (10 × 109/L) in the absence of apparent bleeding,as well when counts are ≤ 20,000/mm3 (20 × 109/L) if thepatient has a significant risk of bleeding. Higher plateletcounts (≥ 50,000/mm3 [50 × 109/L]) are advised for activebleeding, surgery, or invasive procedures (grade 2D).
  • 2008: In patients with severe sepsis, we suggestthat platelets be administeredwhen counts are 5000/mm3 (5x109/L) regardless of apparent bleeding.
  • Platelet transfusion may beconsideredwhen counts are 5000–30,000/mm3(5–30 109/L) and there is a significantrisk of bleeding. Higher plateletcounts (50,000/mm3 [50 109/L])are typically required for surgery orinvasive procedures (grade 2D).
controversies and changes don t push calories
Controversies and changes – don’t push calories...
  • 1. We suggest administering oral or enteral (if necessary) feedings,as tolerated, rather than either complete fasting or provisionof only intravenous glucose within the first 48 hrsafter a diagnosis of severe sepsis/septic shock (grade 2C).
  • 2. We suggest avoiding mandatory full caloric feeding in thefirst week, but rather suggest low-dose feeding (eg, up to500 kcal per day), advancing only as tolerated (grade 2B).
  • 3. We suggest using intravenous glucose and enteral nutritionrather than total parenteral nutrition (TPN) alone or parenteralnutrition in conjunction with enteral feeding in the first 7days after a diagnosis of severe sepsis/septic shock (grade 2B).
  • 4. We suggest using nutrition with no specificimmunomodulatingsupplementation in patients with severe sepsis (grade 2C).
  • Translation: Atempt feeding as patient tolerates, don’t push full caloric intake for its own sake, underfeeding (2/3) / trophic feeding (up to 500 kcal) is OK/even better (but may increase it if fast recovery), don’t use TPN early, do not use supplements (all 2C)
controversies and changes communication
Controversies and changes - Communication

2012

Setting Goals of Care

  • 1. We recommend that goals of care and prognosis be discussedwith patients and families (grade 1B).
  • 2. We recommend that the goals of care be incorporated intotreatment and end-of-life care planning, utilizing palliativecare principles where appropriate (grade 1B).
  • 3. We suggest that goals of care be addressed as early as feasible,but no later than within 72 hrs of ICU admission (grade 2C).

2008

Consideration for Limitation

of Support

  • 1. We recommend that advance careplanning, including the communicationof likely outcomes and realisticgoals of treatment, be discussed withpatients and families (grade 1D).
controversies and changes fluids
Controversies and changes - Fluids

2008 We recommend fluid resuscitationwitheither natural/artificial colloidsor crystalloids (1B)

2011 We recommend not using ‘200 starch’ (Grade 1A) and suggest not using 130 starches (2B)

controversies and changes fluids1
Controversies and changes fluids

2011We suggest to include some albumin over crystalloids alone in the initial fluid resuscitation regimen(2B) and recommend albumin be combined with crystalloids in the initial fluid resuscitation regimen when serum albumin concentration is known to be low (1B)

In the initial volume management of septic patients we suggestcrystalloids with supplemental discretionary use of albumin over other management strategies (2B)

controversies and changes fluids2
Controversies and changes - fluids

2012 We recommend crystalloids be used as the initial fluid ofchoice in the resuscitation (1B)

2012 We recommend against the use of hydroxyethyl starches(HES) for fluid resuscitation (grade 1B).

2012 We suggest the use of albumin in the fluid resuscitation ofsevere sepsis and septic shock when patients require substantialamounts of crystalloids (grade 2C)

controversies and changes fluids3
Controversies and changes - fluids

2013administration of saline should be limited in septic shock (2C) (proposal)

pad guideliness
PAD guideliness
  • Process
    • 20 people
    • 6 year long work
    • Developing questions, review/evaluate/sumarize evidence
    • Develop descriptive statements and actionable recomendation
    • Evaluated and compared pain, agitation/sedation and delirium measurement tools
pad guideliness1
PAD guideliness
  • Differences from previous 2002 guidelines:
    • Use of GRADE (connecting evidence with recommendations)
    • Use of professional librarian (19,000 papers, 472 references)
    • Scope (Pain, Agitation, Sedation, Delirium)
    • Anonymous pooling of opinions and assessments
    • Multidisciplinary approach (MD (9), RN (6), pharmacy (2), geriatrics)
pad guidelines1
PAD guidelines

Descriptive statement

Actionable recommendation

We recommend that pain be routinely monitored in all adult ICU patients (+1B)

We recommend that IV opioids be considered as the first-line drug class of choice to treat non-neuropathic pain in critically ill patients (+1C)

We suggest that analgesia-first sedation be used in mechanically ventilated adult ICU patients (+2B)

  • Adult medical, surgical, and trauma ICU patients routinely experience pain, both at rest and with routine ICU care (B)
  • Pre-procedural analgesia used in about 20% (B)
  • All available IV opioids, when titrated to similar pain intensity endpoints, are equally effective (C).
pad guidelines pain
PAD guidelines - Pain
  • Pain frequent (especially in cardiac surgery, especially in women) (B)
  • All opioids, when titrated, are equally effective (C)
  • Preemptive analgesis prior to chest tube removal (1C)
  • Opioids first class of drugs (1C)
  • The Behavioral Pain Scale (BPS) and the Critical-Care Pain Observation Tool (CPOT) are the most valid and reliable behavioral pain scales (B).
pad guidelines pain1
PAD guidelines - Pain

Goal – 5 or less; 6 or more not acceptable

pad guidelines agitation and sedation
PAD guidelines – Agitation and Sedation
  • Maintaining light levels of sedation :
    • is associated with shorter duration of MV and a shorter ICU LOS [B)
    • increases the physiologic stress response, but not myocardial ischemia (B)
    • its association with psychological stress remains unclear (C).
  • We recommend that sedative medications be titrated to maintain a light rather than a deep level of sedation in adult ICU patients, unless clinically contraindicated (+1B).
    • RASS and SAS (Richmond Sedation Agitation Scale and Reiker SAS) are valid sedation assesment tools (B)
pad guidelines agitation and sedation2
PAD guidelines – Agitation and sedation
  • Prompt identification and treatment of possible underlying causes of agitation, such as pain, delirium, hypoxemia, hypoglycemia, hypotension, or withdrawal from alcohol and other drugs, are important
  • Maintenance of patient comfort, provision of adequate analgesia, frequent reorientation, and optimization of the environment to maintain normal sleep patterns, should be attempted before administering sedatives
pad guidelines agitation and sedation3
PAD guidelines – Agitation and Sedation
  • We suggest that sedation strategies using nonbenzodiazepine sedatives (either propofol or dexmedetomidine) may be preferred over sedation with benzodiazepines (either midazolam or lorazepam) to improve clinical outcomes in mechanically ventilated adult ICU patients (+2B).
pad guidelines delirium
PAD guidelines – Delirium
  • Delirium:
    • syndrome of acute onset of cerebral dysfunctionwith change or fluctuation in baseline mental status
    • disorganized thinking or an altered level of consciousness
    • inattention, inability to sustain or shift attention
    • reduced awareness of the environment
    • perceptual disturbance (i.e., hallucinations, delusions) are frequent but neither required for diagnosis
    • Other symptoms : sleep disturbances, emotional disturbances (i.e., fear, anxiety, anger, depression, apathy, euphoria)
    • may be agitated (hyperactive delirium), calm or lethargic (hypoactive delirium), or may fluctuate between the two subtypes.
pad guidelines delirium1
PAD guidelines – Delirium

Delirium is associated with:

  • increased mortality (A)
  • prolonged LOS (A)
  • development of post-ICU cognitive impairment (B)
  • Risk factors (baseline): dementia, hypertension, alkoholism, severity of ilness (B)
  • Risk factors (later): coma, benzodiazepine use (in comparison to dex) (B)
  • Confusion Assesment Method (CAM-ICU) and Intensive Care Delirium Screening Checklist most valid for monitoring (A)
  • We recommend routine monitoring for delirium in adult ICU patients (+1B)
pad guidelines delirium2
PAD guidelines – Delirium
  • Delirium prevention:
    • early mobilization (1B)
  • Delirium treatment:
    • No evidence to support haloperidol (0)
    • Atypical may reduce duration (in comparison to placebo (all patients on haloperidol) (C)
    • Against ryvastigmine (1B)
    • Early mobilization (+1B)
    • If sedation required (and no benzos or alkohol withdrawal), suggest dexmedetomidine vs. benzos (2B)
    • No magic bullet drug, more in way of delivering care
pad guidelines management strategies
PAD guidelines – Management Strategies
  • Strategies for management:
    • Measure PAD
    • Analgesia first sedation (2B)
    • Daily sedation interruption OR light target sedation (with sedation only if required and goal to allow responsiveness and awarness) (1B)
    • Promoting and protecting sleep cycles (1C)
    • We recommend using an interdisciplinary ICU team approach that includes provider education, preprinted and/or computerized protocols and order forms, and quality ICU rounds checklists to facilitate the use of pain, agitation, and delirium management guidelines or protocols in adult ICUs (+1B)
future challenges for method center
Future challenges for method center
  • training of GRADE resource individuals;
  • training of content area experts in GRADE methodology (rise and usefulness of webinars);
  • planning for the future updates and reiterations (succession plans);
  • continuous struggle to link the recommendation to evidence;
slide85

Proton Pump Inhibitors Versus Histamine 2 Receptor Antagonists for Stress Ulcer Prophylaxis in Critically Ill Patients: A Systematic Review and Meta-Analysis.

WaleedAlhazzani,FarhanAlenezi, et al

Neuromuscular blocking agents in acute respiratory distress syndrome: a systematic review and meta-analysis of randomized controlled trials.

AlhazzaniW, AlshahraniM, et al

The Effect of Selenium Therapy on Mortality in Patients With Sepsis Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

WaleedAlhazzani, et al