kdigo and the global guideline process · 2020. 8. 13. · vascular access! s16-s19! priming,...

KDIGO and the Global Guideline Process

Bertram Kasiske, MD

Mandaluyong City April 24, 2014

Kidney Disease: Improving Global Outcomes USRDS 2013 Annual data Report

• Global incidence and prevalence of ESRD • Clinical practice guidelines in nephrology •  The emergence of KDIGO •  Pros and cons of guideline globalization • Where do we go from here?

Global solutions for global problems

Kidney Disease: Improving Global Outcomes

Global incidence of ESRD in 2011

USRDS 2013 Annual data Report

Quintiles (per million pop.)


Quintiles (per million pop.)

Incidence of ESRD in 2011


Increasing global incidence & prevalence of ESRD (per million pop.)

Incidence Prevalence


Incidence of ESRD in 2011


Percentage of incident patients with ESRD due to diabetes in 2011


Percentage of prevalent patients by dialysis modality in 2011


Transplant rates in 2011


Prevalent rates of functioning transplants in 2011


• Global incidence and prevalence of ESRD • Clinical practice guidelines in nephrology



First guideline – Banff?

The Banff Conferences on Allograft Pathology: 1991 Centre For Conferences - Banff, AB Canada 1993 Centre For Conferences - Banff, AB Canada 1995 Centre For Conferences - Banff, AB Canada 1997 Banff Springs Hotel - Banff, AB Canada 1999 Banff Springs Hotel - Banff, AB Canada 2001 Rimrock Resort Hotel - Banff, AB Canada 2003 University of Aberdeen – Aberdeen, Scotland 2005 Fairmont Hotel - Edmonton, AB Canada 2007 La Coruña, Spain 2009 Rimrock Resort Hotel - Banff, AB Canada 2011 Enghien-les-Bains, France


1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 | | | | | | | | | | | | | | | | | | | |

RPA: HD

Adequacy 1993

AST: Living Donors

1996

DOQI: Guidelines

1997

1. HD Adequacy 2. PD Adequacy 3. Vascular Access 4. Anemia Treatment

KDOQI: Updates

2001

KDOQI: CKD 2002

KDOQI: Lipids 2003

KDOQI: HTN 2004

KDOQI: CVD 2005

United States

AST: Tx. Eval.

1995

KDOQI: Anemia

2006

KDOQI: Updates

2006

KDOQI: Diabetes in CKD 2007

KDOQI: Diabetes in CKD Update

2012

AST: Tx. Eval.

2001

Commentaries on KDIGO Guidelines

RPA: Shared Decision-

Making Update 2010


Canada

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 | | | | | | | | | | | | | | | |

Dialysis Initiation

1999

Elevated Serum Cr

1999

CSN Guidelines

2006

Dialysis Initiation

Update 2014

Anemia 2008

Iron 2008

ESAs 2008

Supplemental Treatment 2008

1. HD Adequacy 2. BP in HD 3. Mineral Metabolism 4. Vascular Access 5. Frequent HD

PD Adequacy

2011



Europe

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 | | | | | | | | | | | | | | | |

Transplant Part 2 2000

Transplant Part 1 2000

Anemia 2000

Anemia 2004

Vascular Access

2007

Hemodynamic Instability

2007

Nutrition 2007

Dialysis Strategies

2009

Crush Injuries

2012

Transplant Recip. & Donors

2013

Hyponatremia 2014



Europe

EBPG


Europe


United Kingdom

Clinical Practice Guidelines Committee


United Kingdom


Chronic Kidney Disease Guidelines

Dialysis Guidelines

Transplant Guidelines

Australia / New Zealand


India


India – Guidelines for HD Units Table of Contents

Introduction S1-S2 Setting up of HD Unit S3-S4 Personnel S5-S6 Machine and Dialyzer S7-S11 Dialysate S12-S12 Water Treatment S13-S15 Vascular Access S16-S19 Priming, Connecting and Disconnecting S20-S21 Anticoagulation S22-S23 Dialyzer Reuse S24-S27 Dialysis Dose S28-S28 Prevention of Infection S29-S34 Emergency Services S35-S35 Laboratory Support S36-S36 Nutrition S37-S38 Cardiovascular Disease Monitoring and Therapy S39-S39 Mineral and Bone Disorder Monitoring and Therapy S40-S41 Hypertension S42-S42 Diabetes S43-S43 Dialysis in Intensive Care Unit S44-S45


Nephrology guidelines: Pillar of wisdom or Tower of Babel?


Anemia guidelines

14

13

12

11

10

9

8 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

DOQI 1997

EBPG 1999

CSN- Canada

1999 CARI 2000

CVD

No CVD

KDOQI 2001

UK 2002

CARI 2003

CVD

No CVD EBPG 2004

KDOQI 2006 2007

Hb (g/dl)

JSDT 2004

young patients


• Global incidence and prevalence of ESRD • Clinical practice guidelines in nephrology •  The emergence of KDIGO



In December 2003, 30 nephrologists, from 20 countries and six continents, met in Amsterdam

to review the plans for a new organization, whose proposed mission was to develop and coordinate clinical practice guidelines for the care of kidney patients on a global basis. The

organization was christened “KDIGO”.

KDIGO Beginnings


KDIGO – A Simple Idea

•  Although local practice differs, evidence is global

•  Avoiding redundancy and streamlining the efforts:

à  Increased output (more guidelines) à  Expanded scope (more topics) à  Robust, consistent quality à  Based on broader expertise à  Greater impact à  Improvement of the knowledge base


KDIGO – Guideline Process


KDIGO Guidelines

| | | | | | | | |

2006 2007 2008 2009 2010 2011 2012 2013 2014

Hepatitis C 2007

CKD MBD 2009

AKI 2012

Transplant recipients

2009

GN 2012

Anemia 2012

Blood Pressure

2012

Lipids 2013

CKD 2012




• Global incidence and prevalence of ESRD • Clinical practice guidelines in nephrology •  The emergence of KDIGO •  Pros and cons of guideline globalization

Kidney Disease: Improving Global Outcomes Kidney Disease: Improving Global Outcomes

“The time has come for guideline development to again be centralized …”

TM Shaneyfelt & RM Centor. Reassessment of clinical practice guidelines: go gently into that good night. JAMA. 2009;301:868.

“This committee recognizes value in a diverse community of developers and the unique relation-ships each has with its constituency, relevant experts, practitioners, and funding sources.”

IOM (Institute of Medicine). Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011.

Should guideline development be centralized? Two viewpoints.


The pluralistic approach creates …

•  Inconsistencies and confusion •  More competition for limited funding

•  Easier access to local funding •  Easier access to career development •  Guidelines tailored to local practice

but also

•  Threats to reliability and quality


The centralized approach creates …

•  Greater consistency

•  Less access to career development

•  Better use of limited resources

•  Improved reliability and quality

but also

•  More difficult fund raising

•  Less relevance to local practice


Evidence is global, but clinical practice is local.

How can we optimize the guideline development process?

Evidence is global


What do we need?

• Consistent state-of-the-art methods • Up-to-date evidence reviews • Up-to-date guideline recommendations • Global participation and ownership •  Local dissemination and implementation


The need for ongoing surveillance

• New topics −  A new treatment (also implies new evidence) −  A new disease or condition

• New evidence −  A new treatment −  New evidence for old topics

• Changes in interventions −  Interventions become safer and more effective −  Interventions become more affordable

• Changes in health care priorities −  Changes in importance of outcomes, e.g. QOL


Methods to update guidelines

1. Planned periodic updates −  Resource intense but robust

2. “Living Guideline” model −  Constantly update everything −  Popular Up-to-date® model

3. Selective ad hoc updates −  Ongoing surveillance −  Targeted PICO* evidence reviews −  Selective updates as needed

*Population/patient; Intervention; Comparator/control; Outcome


Approach to ongoing evidence surveillance and guideline updates

• PICO*s are defined by a GL Work Group and ERT −  Not all recommendations have a PICO −  Not all PICOs have recommendations

• Each PICO is assigned to an ERT −  The ERT is responsible for surveillance −  Frequency of searches vary, but generally yearly

• Reports are submitted to KDIGO co-chairs −  Co-chairs report to EC

• Need for update is suggested by: −  Strength of the new evidence −  Need for change



Ongoing interaction of the ERT and WG Co-Chairs

Evidence Review Team

Guideline Work Group Co-Chairs

Evidence Review Team

Guideline Work Group Co-Chairs

New Topics

New Evidence


Ongoing evidence surveillance and guideline updates

Five steps in a possible guideline update process.


Step 1. The guideline Work Group & ERT define searchable PICO recommendations

PICO1

PICO2

PICO3

No PICO

Work Group Co-Chairs

Guideline Work Group

ERT


Step 2. PICO topics are searched by a global evidence surveillance team (ST)

ST1

ST2

ST3

PICO1

PICO2

PICO3

No PICO Global

Surveillance Team


Global Evidence Surveillance Team

ST1 ST3

ST2

Central Database


Step 3. New evidence is referred to the original Work Group Co-Chairs

ST1

ST2

ST3

PICO1

PICO2

PICO3

No PICO

New Evidence Work Group Co-Chairs

Global Surveillance

Team

No New Evidence

No New Evidence


Step 4. The EC can continue surveillance or start a minor or major guideline revision


Executive Committee

Continue Surveillance

Minor Revision

Major Revision


ERT



Step 5. The Guideline Work Group & ERT produce a minor guideline revision

PICO1

PICO2

PICO3

No PICO


ERT



Example: Care of the Kidney Transplant Recipient Guideline surveillance


PICO* Topic 1: Induction Therapy

Am J Transplant Jan 2009; 9 (Suppl 3): S1



Step 1. The guideline Work Group & ERT define searchable PICO recommendations

Topic: Induction Therapy Population Kidney transplant recipients

Intervention Biologic agent

Comparator/control Placebo or another biologic

Outcome Patient survival, graft survival, acute rejection, DGF

Additional Search Criteria: Randomized trial. Minimum sample size 100 per group.


Step 2. PICO topics are searched by a global evidence surveillance team

Surveillance team finds only one new randomized trial with adequate statistical power.

MJ Hanaway, et al. N Engl J Med 2011;364:1909


Step 3. New evidence is referred to the original Work Group Co-Chairs

The Work Group Co-chairs conclude that there is no new evidence that would likely change the original guideline recommendation.


Step 4. The EC can continue surveillance or start a minor or major guideline revision


Executive Committee

Continue Surveillance

Minor Revision

Major Revision


ERT


The EC elects to continue surveillance.


• Resources to maintain a central database •  Volunteers (?) to update evidence reviews

• Work Group Co-chairs who can present recommendations for guideline updates to the KDIGO Executive Committee

•  Electronic guideline publication that allows modular updates

What is needed to implement timely global guideline updates?


Thank you!

kdigo and the global guideline process · 2020. 8. 13. · vascular access! s16-s19! priming,...

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