2016 Bi-Regional Annual Conference Mountain and Western States

2016 Bi-Regional Annual Conference Mountain and Western States

2016 Bi-Regional Annual Conference Mountain and Western States Regional Hemophilia Treatment Centers Evidence Based Practice Alfonso Iorio, MD, PhD, FRCPC McMaster University Canada Learning objectives 1. Understand the NHF/McMaster Clinical Guideline projects intent, status and next steps. 2. Identify three evidence based practices we are currently using in HTC clinical care. 3. Identify at least one area where more evidence is

needed. 4. Determine method of data capture that would facilitate QI approaches. What are Guidelines? "Guidelines are recommendations intended to assist providers and recipients of health care and other stakeholders to make informed decisions. Recommendations may relate to - clinical interventions, - public health activities, or - government policies." WHO 2003, 2007

Motivation for Developing Clinical Practice Guidelines in Hemophilia Mission of MASAC Changing Healthcare Environment Hemophilia Strategic Summit May 2012 Need assessment: Strengthening Evidence-base for Hemophilia Care Promote Comprehensive Hemophilia Care Recommendation: Generate and Maintain Evidence-Based Guidelines Complete comprehensive assessment of existing guidelines and

resolutions Identify gaps and prioritize standards for updating Update guidelines following a systematic process Scoping 9 priority topics (10/2013)

Laboratory diagnosis Sustained adult prophylactic factor replacement Management of aging hemophilia patients / long-term care Management of MSK complications / related therapies Management of comorbid conditions Inhibitor mitigation, treatment, management Stem cell/gene therapy Comprehensive care model Data/evidence needs Scoping 9 priority topics (10/2013)

Laboratory diagnosis Sustained adult prophylactic factor replacement Management of aging hemophilia patients / long-term care Management of MSK complications / related therapies

Management of comorbid conditions Inhibitor mitigation, treatment, management Stem cell/gene therapy Comprehensive care model Data/evidence needs Why a CPG on Models of care for Hemophilia importance of a range of coordinated services to most patients with hemophilia establish a foundation upon which more specific CPGs addressing other aspects of care may be developed. define comprehensive care as it relates to the haemophilia patient;

specify the coordinated set of diagnostic, therapeutic, and auxiliary services involved identify best-practices and evidence-based standards of comprehensive / coordinated care for haemophilia treatment centers (HTCs) and individual clinical practices. The National Haemophilia Program Standards, Evaluation and Oversight Systems in the United States of America, M Skinner, JM Soucie, K McLaughlin, Blood Transfus 2014; 12 Suppl 3: s542-8 Which kind of CPG? Project grounded in a transparent, internationally accepted process 1.

Establishing transparency 2. Management of conflict of interest (COI) 3. Guideline development group composition 4. Clinical practice guidelinesystematic review intersection

5. Establishing evidence foundations for and rating strength of recommendations 6. Articulation of recommendations 7. External review 8.

Updating A Systematic Workplan What is GRADE? Grading of Recommendations, Assessment, Development and Evaluation Method of grading quality of evidence and strength of recommendations in guidelines. Used by over 80 international organizations to produce GRADE can beandapplied

to rare rigorous, transparent sensible clinical practice guidelines andlike other hemophilia health care recommendations. diseases Developed by an international working group with over 300 contributors. GRADE for dummies Appraisal of evidence Study limitations

Precision Consistency Directness Publication bias Evidence to Recommendations Priority? Certainty on value of outcome? Overall certainty? Large desirable effects? Small undesirable effects? Desirable relative to undesirable effects? Resources required?

Effect size Dose effect Plausibility Incremental cost relative to net benefits? Health inequalities? Acceptability? Feasibility? Evidence profile EtR framework

GRADE for rare diseases GRADE for rare diseases 3 specific components: 1. Systematic elicitation of expert opinions 2. Use of indirect evidence from other diseases 3. Generation of qualitative evidence as needed Haemophilia, submitted Integrated multidisciplinary care for the management of chronic conditions in adults: an overview of reviews and an example of using indirect evidence to inform

clinical practice recommendations in the field of rare diseases. 7 reviews on 3 chronic conditions. Cindy Yeung, Nancy Santesso, Dena Zeraatkar, Alice Wang, Menaka Pai, Integrated care results in: Iorio Michelle Sholzberg, Holger J Schnemann, Alfonso

a reduction in mortality a probable reduction in emergency visits an improvement in function little to no difference in quality of life shorter hospital stays little to no difference in missed days of school/work No studies reported educational attainment, or

patient adherence and knowledge. Generating qualitative evidence Additional information required to make good recommendations: What outcomes are valued by stakeholders? What is the impact of different options on health inequities? What options are acceptable to stakeholders? What options are feasible to implement?

Qualitative, interview-based study was done to address these issues Recruitment through NHF website, facebook posts, tweets, and emails to key groups of stakeholders Guideline Questions in PICO Format PICO questions allow us to define clinical questions in terms of a specific patient problem, so we can find clinically relevant evidence in the literature. Selecting outcomes of interest Mortality / survival

Missed days from work or school Number of ER visits Length of in-patient stay Quality of life Functional outcomes - joint damage / joint disease Educational attainment Patient adherence Patient knowledge Final questions 1. Should integrated care versus non-integrated care be used for people with hemophilia? 2. For individuals with hemophilia, should a hematologist, a specialized hemophilia nurse, a

physical therapist, a social worker, or round-theclock access to a specialized coagulation laboratory be part of the integrated care team, versus an integrated care team with a lesser complement? Final recommendations (Q1) For persons with hemophilia, the Guideline Panel suggests that the integrated care model be used over non-integrated care models. Conditional recommendation, moderate certainty in the evidence For persons with hemophilia with inhibitors, and

those at high risk for inhibitor development, the Guideline Panel recommends that the integrated care model be used over non-integrated care models Strong recommendation, moderate certainty in the evidence STRENGTH OF RECOMMENDATIONS Stakeholder Strong Conditional Policy maker

Adopt in most situations Adoption might involve specific debate Clinicians Most patients should receive the intervention Different patients might

require different choices Patient Most patients would like to adopt Many patients, but not all, would adopt Evidence profiles: mortality QUALITY ASSESSMENT No of studies

1 Study design observational Risk of bias Not serious Inconsistency Not serious

Indirectness Not serious Imprecision Not serious Other considerations None

NUMBER OF PATIENTS Integrated care 149/1979 (7.5%) Non-integrated care 86/971 (8.9%) EFFECT Relative (95% CI) Absolute (95% CI) Quality 0.60 (0.50-0.80) 35 fewer per 1000 (from 18 fewer to 44 fewer)

LOW Evidence to Recommendations CRITERIA JUDGMENT Is there a problem priority? Is there important uncertainty about how much people value the main outcome? What is the overall certainty of evidence for benefits and harms? Are the desirable anticipated effects large?

Are the undesirable anticipated effects small? Yes No Are the desirable effects large relative to undesirable anticipated effects small? Are the resources required small? Is the incremental cost small relative to the net benefits? What would be the impact on health inequalities? Is the option acceptabe to key stakeholders? Is the option feasible to implement? Yes

Moderate Probably yes Yes Yes Yes Probably reduced Probably yes Yes Evidence to Recommendations CRITERIA

JUDGMENT Is there a problem priority? Is there important uncertainty about how much people value the main outcome? What is the overall certainty of evidence for benefits and harms? Are the desirable anticipated effects large? Are the undesirable anticipated effects small? Yes No Are the desirable effects large relative to undesirable anticipated

effects small? Are the resources required small? Is the incremental cost small relative to the net benefits? What would be the impact on health inequalities? Is the option acceptabe to key stakeholders? Is the option feasible to implement? Yes Moderate Probably yes Yes Yes

Yes Probably reduced Probably yes Yes Final recommendations (Q2) For individuals with hemophilia, the Panel suggests that a hematologist, a specialized hemophilia nurse, a physical therapist, a social worker, and round-theclock access to a specialized coagulation laboratory be part of the integrated care team, over an integrated care team that does not include all of these components Conditional recommendation, very low certainty in the

evidence Public commenting Timeline update Publication and dissemination Poster presented at THSNA Poster accepted for presentation at WFH 6 articles submitted to Haemophilia supplement to be available for WFH / NHF in Orlando Once Main Guideline Paper accepted by

Haemophilia will submit to National Guidelines Clearinghouse 1. Evidence-based guidelines support integrated disease management as the optimal model of hemophilia care Pipe and Kessler 2. NHF-McMaster Guideline on care models for hemophilia management Pai et al

3. Methodology for the development of the NHF-McMaster guideline on care models for hemophilia management Yeung et al 4. Care models in the management of hemophilia: a systematic review Yeung et al 5. Integrated multidisciplinary care for the management of chronic

conditions in adults: an overview of reviews and an example of using indirect evidence to inform clinical practice recommendations in the field of rare diseases. Yeung et al 6. Outcomes, Equity, Acceptability and Feasibility: a qualitative study to understand stakeholder perceptions and experiences of a care model for the management of hemophilia in the U.S. Lane et al Potential next / follow-on steps

1. Implementation standardization of performance metrics (e.g., process heading to self-audit or accreditation for HTCs) 2. Research prioritize high-value research to fill data gaps or strengthen evidence base 3. Scoping initiate another guideline Where do we go from here? IMPLEMENTATION CONSIDERATIONS Identify and address barriers to accessing care Geographic location, race/ethnicity, insurance status, capacity of centres, stable funding streams for centres

Standardize components of integrated care model across the U.S. Develop and track performance measures to ensure PWH get the resources and care they need Train, recruit and retain specialized health care team members Where do we go from here? IMPLEMENTATION CONSIDERATIONS Formal research into the impact of models of care on patient-important outcomes must continue How can care models respond to changing natural history of hemophilia and the changing U.S. healthcare

system? Integrated care centres must respond to needs of their patient population in a dynamic way this will ensure their long-term sustainability Where do we go from here? RESEARCH PRIORITIES Qualitative research may address barriers to care, particularly in non-HTC patients. Can U.S. HTCs build their data collection and analysis capacity, to conduct high quality, well-organized studies? Where do we go from here?

RESEARCH PRIORITIES Gaps in data exist! Populations to study: geriatric populations; populations with poor access to care; PWH who access care outside of HTCs. Interventions to study: which aspects of the integrated care model are a value add; impact of telemedicine and other remote care delivery systems as an alternative/add-on. Where do we go from here?

RESEARCH PRIORITIES Gaps in data exist! Outcomes to study: cost of care outside of HTCs; factor utilization within and outside of HTCs; impact of care on lost days of school/work, educational attainment, employment attainment; impact of patient characteristics on outcomes. Implementation - HTC certification systems optional or optimal choice? NHF foresees that the development of the comprehensive care CPG will provide a catalyst to promote harmonization of care delivery and reduce

practice variations among the US HTC system. An agreed evidence-based benchmark would allow for both internal and external evaluation of adherence to best practices and benchmark available services with an HTC. Ultimately, it will serve as an important starting point for establishment of a US HTC self-audit or accreditation system. The National Haemophilia Program Standards, Evaluation and Oversight Systems in the United States of America, M Skinner, JM Soucie, K McLaughlin, Blood Transfus 2014; 12 Suppl 3: s542-8 Learning objectives 1. Understand the NHF/McMaster Clinical Guideline projects intent, status and next steps. 2. Identify three evidence based practices we are

currently using in HTC clinical care. 3. Identify at least one area where more evidence is needed. 4. Determine method of data capture that would facilitate QI approaches. Acknowledgements for this presentation Mark Skinner Menaka Pai and Cindy Yeung Holger Schunemann, Nancy Santesso All the panel members Tamara Navarro, Shannon Lane

Guideline panel members Kari Atkinson Parent of PWH, NHF Chapter President Maria Martins-Lopes Chief Medical Officer, CDMI/Magellan, payer representative Marianne Clancy Executive Director of HHT Foundation, patient with a rare disease Ruth Mulvany Physical therapist Randall Curtis PWH, hemophilia researcher

Sue Geraghty Hemophilia nurse Alfonso Iorio Canadian hemophilia clinic director Jeanne Lusher Former U.S. hemophilia clinic director Mike Makris U.K. hemophilia clinic director Craig Kessler U.S. hemophilia clinic director Nigel Key (Clinical Chair) U.S. hemophilia clinic director Kristy Lee Genetic counsellor Holger Schunemann (Chair) Clinical epidemiologist, internist

Michelle Sholzberg Canadian hemophilia physician, American Society of Hematology representative Mark Skinner PWH, WFH and NHF Past President Mike Soucie Hemophilia researcher, CDC representative Douglas Stratton Chairman and CEO, Foundation for Complex Healthcare, payer representative Vicky Whittemore - Program Director (Epilepsy), NIH/NINDS

Thank you !!! Download these slides at: Hemophilia.mcmaster.ca

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