Consultation to Determine Priority Information Needs for the Canadian Multiple Sclerosis Monitoring System. Information Needs Workshop

Transcription

1 Consultation to Determine Priority Information Needs for the Canadian Multiple Sclerosis Monitoring System

2 Who We Are Established in 1994, CIHI is an independent, not-for-profit corporation that provides essential information on Canada s health system and the health of Canadians. Funded by federal, provincial and territorial governments, we are guided by a Board of Directors made up of health leaders across the country. Our Vision To help improve Canada s health system and the well-being of Canadians by being a leading source of unbiased, credible and comparable information that will enable health leaders to make better-informed decisions.

3 Table of Contents Acknowledgements... ii Disclaimer... ii Executive Summary... 1 Introduction... 2 The Workshop... 3 Welcome and Introductions... 3 Setting the Context... 3 Agenda and Workshop Process... 5 Priority Questions Identified During Workshop... 6 Final Comments From Participants Next Steps and Workshop Close Appendix A: List of Participants Appendix B: Discussion Themes and Example Questions Supplied by CIHI Appendix C: Results of Workshop Process Step 1 Individual Brainstorming Exercises (Index Cards) Appendix D: Results of Workshop Process Step 2 Key Messages From Small Group Discussions Appendix E: Other Questions, Associated Participant Feedback and Percentage of Available Resources Allocated to the Area During Step Appendix F: Other Questions and Associated Participant Feedback Receiving No Resources Allocated During Step

4 Acknowledgements The Canadian Institute for Health Information (CIHI) wishes to thank the participants at the Workshop on Priority Information Needs for the Canadian Multiple Sclerosis Monitoring System (CMSMS) who helped identify priority clinical and policy questions. The workshop was held in Ottawa, Ontario, on September 15, 2011, and was hosted by the Canadian Institute for Health Information. The input received was invaluable and forms the basis of these proceedings. Production of this workshop proceedings document has been made possible by a financial contribution from the Public Health Agency of Canada. Disclaimer The views expressed herein do not necessarily represent the views of the Public Health Agency of Canada. ii

5 Executive Summary Multiple sclerosis (MS) is a chronic, often debilitating disease that has a significant impact on many Canadians. Although regional data collection efforts have provided important information, data is not collected in the same way across the country. Information is fragmented, and a national perspective on MS is missing for Canada. The country needs high-quality information on MS to better inform those diagnosed with the disease, their health care providers and the health care system. In response to this information need, the Canadian Institute for Health Information (CIHI) is working collaboratively with a broad range of stakeholders on the development of the Canadian Multiple Sclerosis Monitoring System (CMSMS). As part of ongoing stakeholder engagement related to the development of the CMSMS, CIHI held a workshop in Ottawa, Ontario, on September 15, The workshop brought together 29 subject matter experts from across Canada to develop a list of priority clinical and policy questions that will enable CIHI to determine the minimum data set needed for a nationwide system to measure and monitor the evolution and treatment of MS in Canada. Workshop participants included clinicians, researchers, people living with MS and individuals from Health Canada, the Public Health Agency of Canada and provincial ministries of health. Participants worked individually and in small groups through a three-step, facilitated process to identify important information needs related to MS in Canada and a corresponding set of clinical and/or policy questions. Toward the end of the workshop, using a standardized methodology identified by CIHI, each participant individually allocated his or her equal allotment of finite resources as a means of identifying the priority questions that should be addressed through the CMSMS minimum data set. The following nine priority question areas received 71% of available resources: 1. Prevalence and incidence data 2. Treatment options and impacts 3. Effectiveness of different models of care 4. Effectiveness of treatment 5. Factors affecting access to health care (such as diversity and socio-economic status) 6. Outcome measures 7. Effect of MS on employability 8. Functional ability of persons with MS 9. Service delivery timelines (for example, effect on disease progression) The priority question area of prevalence and incidence data received one-quarter (25%) of available resources. The remaining eight priority question areas each received individual allocations of between 3% and 9%, amounting to 46% of the total amount of resources available for allocation. The nine key priority question areas identified by participants during 1

6 the workshop, as well as the underlying series of associated questions, contextual information and rationales, will provide the basis for further information gathering and technical analysis needed to design the minimum data set for the CMSMS. Introduction In March 2011, the development of the Canadian Multiple Sclerosis Monitoring System (CMSMS) was announced. The Canadian Institute for Health Information (CIHI) is working collaboratively with the Canadian Network of Multiple Sclerosis Clinics, the Multiple Sclerosis Society of Canada and federal, provincial and territorial governments on the development, implementation and operation of this monitoring system. As part of ongoing consultations related to the development of the CMSMS, CIHI held a workshop in Ottawa, Ontario, on September 15, The objectives of the workshop were to Bring together subject matter experts and clinicians who are eminent in the diagnosis, assessment and ongoing management of individuals living with multiple sclerosis (MS) to identify priority information required to monitor the natural history of MS, determine clinical effectiveness of treatment approaches and measure and/or improve the quality of care provided to individuals diagnosed with MS; and Develop a list of priority clinical and policy questions that will enable CIHI to determine the minimum data set needed for a nationwide system to measure and monitor the evolution and treatment of MS in Canada. The consultation was designed to initiate the process of identifying the priority questions that need to be addressed in the CMSMS minimum data set. Workshop results will inform ongoing stakeholder engagement and form the basis of CIHI s and its Technical Advisory Committee s discussions as they develop the CMSMS. The workshop was attended by 29 subject matter experts with expertise and experience in the diagnosis, assessment and ongoing management of individuals living with MS, including clinicians, researchers, people living with MS and individuals from Health Canada, the Public Health Agency of Canada and provincial ministries of health. A list of workshop participants is attached as Appendix A. This report summarizes information provided by CIHI to participants during the workshop and captures the individual and collective advice of workshop participants regarding the important clinical and policy questions that should be considered as the basis of the CMSMS minimum data set. 2

7 The Workshop Welcome and Introductions On behalf of CIHI, Francine Anne Roy, Director, Health Spending and Strategic Initiatives, welcomed participants to the workshop and thanked them for their willingness to participate in the development of the CMSMS. Ms. Roy briefly shared information regarding the conception and launch of the initiative. In March 2011, the Honourable Leona Aglukkaq, Minister of Health, announced the creation of the CMSMS to enhance understanding of MS by health care professionals, researchers and policy-makers. The CMSMS is a long-term initiative for collecting standardized MS-related information from across Canada. Over time, this data will help inform better decision-making related to MS to improve the treatment and delivery of services to individuals with MS and their families. Participation in the CMSMS will be voluntary, and it is expected that clinicians and others will be able to access the system to meet their deliverables. CIHI is working in collaboration with the Canadian Network of Multiple Sclerosis Clinics and the Multiple Sclerosis Society of Canada to develop the CMSMS. System design is being funded by the federal government. In addition, discussions between CIHI and appropriate funders are under way to obtain funding for long-term maintenance of the system. Ms. Roy also noted that provinces and territories support the CMSMS initiative and are engaged in discussions to explore cost-sharing opportunities. Setting the Context Brent Barber, Program Consultant, CIHI, presented a brief overview of the intent and potential benefits of the CMSMS, CIHI s role, the current status of system development and the role of the workshop in developing the CMSMS. The CMSMS is intended to complement and enhance current data efforts by providing a national, standardized data set. Mr. Barber pointed out that many provincial and regional data sources on MS currently exist across Canada. However, these data sets are not necessarily standardized, connected or consistent, and data is often stored in ways that make it inaccessible for analysis. It is expected that the CMSMS will address these issues. The development and implementation of the CMSMS will be multi-phased, beginning with design and development, moving to the initial launch of a minimum data set, and including ongoing development over time. In the current design phase, CIHI is seeking to better understand the desired scope and parameters of the system by conducting an environmental scan and seeking the advice of stakeholders and data providers. This work will help CIHI determine the most useful and relevant data to include in the initial launch of the system. Then, as stakeholders become more involved in reporting, knowledge and data are accumulated and data gaps are better understood, the initial data set will be enhanced over time. 3

8 CIHI is an independent, non-profit organization that currently maintains 27 data holdings. Mr. Barber provided two examples of data systems developed and managed by CIHI the National Trauma Registry and the Canadian Joint Replacement Registry that demonstrate the potential value of the CMSMS. Data from both of these systems has been used to directly improve the lives of Canadians. Mr. Barber reviewed the purpose of the workshop and outlined the way in which information and guidance collected at the workshop will be used by CIHI. He indicated that the workshop proceedings will be used to further the development of the CMSMS by CIHI s Technical Advisory Committee and the Project Advisory Committee and through further discussions and consultations with stakeholders, including data providers. The priority questions developed by workshop participants will be used by CIHI to identify the CMSMS minimum data set and to inform the monitoring system s design. Overall, Mr. Barber encouraged participants to raise any question about MS they deem important to address and to state the rationale for their choices so that CIHI can make informed decisions regarding the scope and parameters of the CMSMS. Following his presentation, Mr. Barber responded to several questions from participants, including the following: Q. Will patients be asked to provide data and, if so, how? A. Currently, there are no plans to collect information directly from patient sources. In future, it may be desirable to ask patients to provide information through, for example, a secure website using a code provided by their physicians. Regardless of the method by which such information may be collected, the issue of patient consent will be addressed. Q. There is a need to balance the desire and need for data with our practical ability to collect data. How will this balance be achieved? A. CIHI recognizes this challenge and has relevant past experience in addressing it. As part of the system design process, CIHI will explore a range of data sources and collection methods to ensure that needed data is appropriately collected. Q. It would be useful to add community neurologists, general practitioners, physiotherapists and other health care providers to the list of stakeholders being approached by CIHI. Are there plans to do so? A. CIHI intends to consult broadly and is planning to include these stakeholders as development of the CMSMS continues. 4

9 Q. How does CIHI intend to standardize existing data for the purposes of the CMSMS (for example, by conversion and extraction)? A. CIHI recognizes the need for a flexible approach to meet the unique needs of individual data providers. It will be necessary to employ a range of methodologies, depending on factors such as the type of data collected, the way in which it is submitted and stored, and the data provider s readiness to share the data. Agenda and Workshop Process Participants worked individually and in small groups through a facilitated process designed to identify and prioritize information needs related to measuring and monitoring MS in Canada. They considered information needs in the following four main discussion themes, which were provided by CIHI: Disease presentation, progression, diagnosis and treatment; Patient levels of functioning, outcomes and quality of life; Access to care, delivery of services and health system improvement; and Other areas important to MS. For the first three themes, CIHI also presented a set of example questions to stimulate thinking and discussion (see Appendix B for a full list of themes and example priority questions provided by CIHI). It was made clear to participants at various times during the day that the themes and sample questions supplied by CIHI were provided solely for the purposes of structuring the workshop and initiating discussions and were not intended to limit discussion during the day. In general, CIHI encouraged participants to be visionary and consider both current and future data needs. For each discussion theme, participants worked through a three-step process to individually brainstorm and identify important information needs related to MS in Canada; develop a set of clinical and/or policy questions, with rationales, to meet those information needs; and identify a set of priority questions that should be addressed through the initial CMSMS minimum data set. The following process was followed: Step 1: The prioritization process began with an individual brainstorming exercise to support and prompt group discussions. Each participant identified information required to measure and monitor the evolution and treatment of MS in Canada. The information needs were recorded on index cards; the content of these cards is recorded in Appendix C. Step 2: Next, participants worked in small groups (five or six people) to discuss the information needs raised by individuals. Their task was to express the needs as clinical or policy questions that might provide the basis of the CMSMS. For each question, the group also articulated the rationale for including it in the deliberations. The group members then agreed on the top two to four priority questions, which were written on large sheets of notepaper, presented to the full workshop for consideration and posted around the meeting room for further consideration. In addition, each table group recorded the main points of its discussion on a worksheet (see Appendix D). 5

10 In the first two steps of the workshop, each theme area was addressed separately. Once a set of clinical and/or policy questions was developed for each theme, participants worked together in plenary to reduce overlap and duplication by grouping the full set of priority questions into theme areas, where possible. Step 3: Finally, participants were asked to identify the key priority questions that CIHI should address through the CMSMS minimum data set. CIHI used a standardized methodology to allow participants to individually identify the relative priority of the key questions. First, all participants were given equivalent quantities of finite resources to allocate to one or more priority questions, indicating their choice of a key priority. The total amount allocated to each priority question area was then tabulated, and areas with the highest allocation (above a minimum threshold agreed to by the group) indicated the key priority questions. Priority Questions Identified During Workshop Table 1 summarizes the key priority question areas identified during Step 3 of the workshop. Nine priority question areas received 71% of the total resources available to participants for allocation during Step 3. Priority questions about prevalence and incidence data received one-quarter (25%) of available resources, with the remaining eight priority question areas each receiving between 3% and 9% of available resources. Table 1: Summary of Priority Question Areas Identified by Participants During Step 3 Priority Question Areas Percentage of Available Resources Allocated to Area During Step 3 1. Prevalence and Incidence Data 25% 2. Treatment Options and Impacts 9% 3. Effectiveness of Different Models of Care 8% 4. Effectiveness of Treatment 8% 5. Factors Affecting Access to Health Care (for example, Diversity and Socio-Economic Status) 6. Outcome Measures 5% 7. Effect of MS on Employability 4% 8. Functional Ability of Persons With MS 3% 9. Service Delivery Timelines (for example, Effect on Disease Progression) 3% Total 71% Note The priority question area labels were created by CIHI for this report to summarize the main priority areas identified by workshop participants. 7% 6

11 Each priority question area has a number of associated key questions, contextual information and rationales, which were developed by workshop participants. This level of detail is available in Table 2. Table 2: Nine Priority Question Areas, Associated Participant Feedback by Area and Percentage of Available Resources Allocated to Area During Step 3 1. Prevalence and Incidence Data 25% Prevalence and incidence data (for example, by MS form/stage, region, age and gender, and presence of comorbidities) What are the incidence and prevalence and evolution of MS in Canada (for example, demographics, illness-related variables and comorbidities, evolution of disease)? What are the incidence and prevalence of MS, the regional differences and demographics (and are they changing)? What groups are at risk of developing MS in terms of age at onset, gender, geography, occupation and ethnicity (genetic and country of birth)? Are there changes/changes of trend over time? What causes MS? Lack of pan-canadian data to determine trends over time so we can make decisions about what services should be available and where Need to know the scope of the problem and geographic differences and if these are changing over time Need information to plan, organize and deliver patient care Need to know the natural history of MS Address the effects of immigration, gender, age and Vitamin D exposure Address access to diagnosis and testing Much is unknown about causes/factors implicated; this information is critical to possibly preventing MS in the future Identify exposures or comorbidities from earlier health issues, drug exposures or vaccinations 2. Treatment Options and Impacts 9% What is the impact of treatment (disease-modifying treatments, chronic cerebrospinal venous insufficiency treatment, occupational therapy, physiotherapy, etc.) on the disease path and quality of life for a person with MS? What is the scope of options across the country for MS and how do they differ between regions? What are the long-term side effects of drug treatment for MS? Can we identify patients at risk of developing a serious adverse drug reaction (ADR)? Can we identify ADRs to new drug treatments in a more timely fashion and effectively communicate this to patients and health care providers? Address patient demand for access and information Look at the impact of early treatment Address regional differences Monitor safety and side effects Does early access make a difference? What are the regional barriers to treatment variety and options? Treatment in broad scope all interventions, including medications, rehabilitation, wellness, prevention, equipment, psychosocial First do no harm ADRs result in unnecessary harm/hospitalizations Current reporting of ADRs is very poor (less than 1% of serious ADRs are reported) Newer drugs for MS might be more effective but also have unexpected and serious ADRs Monitoring of ADRs should be independent of pharmaceutical industry 7

12 3. Effectiveness of Different Models of Care 8% What model of care (community-based versus facilitybased) has the best outcomes (for example, affecting disease progressions and treatment)? What service delivery models are most cost-effective and provide highest-quality care across the disease continuum (for example, chronic disease management model, selfmanagement or regular bursts/tune-ups of care/early and repeated)? Who is the best gate-keeper to access the model? How can we enhance integration of care (health care providers, caregivers, clinics)? Is the MS clinic model really the best way to deliver services across the continuum of care? What types of MS care models exist across the country (interdisciplinary/multi-disciplinary) and how do they impact patient outcomes (for example, psychosocial, functional, quality of life)? Who is the first responder for an MS relapse? What kinds of services show better outcomes (for example, location, hours of operation)? What are various models of care (for example, university teaching hospital versus community)? Are there delays in care? Impact on relapse rate and progression Integration of the range of services (sharing of information, care planning) Understand/clarify what is most effective These models enhance self-efficacy and give people the tools to succeed Which services should be integrated? How do we implement it? The clinic was developed in the 1950s and situated in urban areas Does this address needs of those in remote areas? Can we better use technology/telemedicine/innovative care practices? Minimum model of care Evaluate how each discipline contributes to the right person and right time Impact on prognosis or outcome for delayed care Inefficiency in cost/time to get necessary care (for example, wasted resources at emergency department) Patient perception and utilization of available care and lack thereof 4. Effectiveness of Treatment 8% What treatments (including alternative treatments, disease-modifying treatments/therapies and complementary and alternative medicine) are people having? What are the side effects? What are the outcomes? What information exists regarding drug therapy safety, off-label use, over-the-counter medications, alternatives, switches and compliance (adherence)? How do we identify responders and non-responders through clinical and biomarkers? What are the variability and disparities in treatment across settings and across Canada? To be able to provide people with information with which to make decisions To provide best practices Note: Treatment has a wide definition that includes rehab, counselling, etc. Long-term effect of diseasemodifying therapy must be monitored. Data gap Impact on progression, relapse and quality of life To improve treatment and patient outcomes To improve/aid disease diagnosis To improve overall understanding of the disease Need this information to develop and monitor practice guidelines 8

13 5. Factors Affecting Access to Health Care (for Example, Diversity and Socio-Economic Status) 7% How might services be provided to address diversity? Culturally diverse groups (such as Mennonites) Gay/lesbian/transgender people (sexual orientation) Economic diversity (poor people) Geographic diversity (northern, remote) What are the barriers to accessing health care? Are we reaching the most vulnerable populations (immigrants, Aboriginals)? How does access to MS care vary by province and within the province, particularly in remote areas and with underserviced populations? What is the profile of health care utilization in MS (emergency room, family medicine physicians, clinic)? What are the geographic or demographic determinants of access? Does timely access to care and delivery of service from family medicine physicians, neurologists, neuropsychologists, social workers, physiotherapists, occupational therapists, etc. have an impact on the person with MS? How can we ensure universality and comprehensive services? How do we ensure that delivery of services is equitable among the MS community? Population is changing but provide services uniformly everyone fits in Is this the best or are some left out (for example, treatment compliance, stigma and satisfaction with services)? Disparities Lack of consistency in provincial priorities and geographic variations We can identify barriers to care and impact on prognosis We can measure cost of different utilization By showing that should the person with MS have access to said services, will lead to a reduction in long-term medical costs What are the barriers to disease-modifying treatments and other rehabilitation services from a patient s perspective and provincial variations in funding? This will benefit a broader group of individuals and add to the information collected (making it more complete) Advanced data on MS patients who leave clinics will no longer be available 6. Outcome Measures 5% What are the scales/tools currently in use? Particularly other than expanded disability status scale To assess other indicators besides mobility Is there a regular time for periodic reassessments? How can the presence of symptoms be uniformly measured and routinely collected? What are the outcome measures that must be used across Canada to monitor outcomes? Because MS is a disease with broad and variable symptoms, how do we capture the breadth of this? Need to capture the global impact of MS (for example, social, emotional, physical, cognitive and on life roles) Having symptom data at one point in time will inform incidence in the population, allowing service planning to focus on highest-frequency symptoms (fatigue, cognition, mobility, etc.) Help in the development and monitoring of care guidelines 9

14 7. Effect of MS on Employability 4% What employment issues are there (for example, employer flexibility in terms of willingness to adapt to part-time work or working from home)? How quickly do people go on disability insurance versus working part-time? Are people with MS in the workforce in Canada? What keeps them there? What are the barriers and facilitators (technology, services, transport) to employment? Support advocacy to governments regarding employment and taxation policies Loss of employment leads to loss, poverty, lost identity This has an impact on individuals, families, community and government costs What impact does MS have on employment status People are valuable contributors to the workforce and occupation? 8. Functional Ability of Persons With MS 3% What is the functional ability of persons with MS as related to maintaining themselves and their environments and maintaining or entering paid employment? A standardized measure is needed to identify these functions across the country, as these are issues that affect resources, family and community participation Determine funding (MS Society, government) or access to those that have the greatest impact on quality of life What data is there on level of functioning, progression Decisions about care and service and functional impact across the country? 9. Service Delivery Timelines (for example, Effect on Disease Progression) 3% What are the wait times for access to care (for example, To understand disparities to get a consult, to get an MRI exam, to get treatment)? What is the access to MRI and other tests for diagnosis and follow-up? What are the factors that affect the geographic differences in service delivery models across the country and access to this care (for example, regional)? Do delays to diagnosis (due to access) affect patient prognosis? What is the best pathway of care from symptom onset to system access (for example, family medicine physicians, neurologists, rehab, nurse practitioners)? Can family medicine physicians diagnose? Are there early access programs? What is the access to diagnostic services (for example, 2T MRI scanner, gadolinium-enhanced MRI), specialized teams, rehabilitation services (inpatient and outpatient) and appropriate long-term care? What is the access to standard treatments and superspecialized treatments such as baclofen pump, deep brain stimulation or plasma exchange therapy (PLEX)? What are the timelines? From onset to neurologist consult From onset to MRI From onset to diagnosis From onset to treatment Impact on early diagnosis and treatment Impact on monitoring and changing medical prescriptions Geographic differences in access We know there are differences What is the minimum standard of care? Access problems between areas (city/rural) Knowing factors will help with improvement Access problems across country Primary care overrun Multiple disciplines can affect care How long do people wait for services? Do delays affect MS function, quality of life satisfaction? Will assist in appropriate allocation of services Geographical differences and impact on prognosis Impact on managing adverse drug events (PLEX for progressive multifocal leukoencephalopathy) Understand trends Inequitable treatment options across the country 10

15 Priority questions that received total participant allocations below the designated minimum threshold or no participant contributions during Step 3 can be found in Appendix E and Appendix F, respectively. Final Comments From Participants After briefly reviewing the results of the prioritization exercise, participants raised the following additional questions and comments: A participant asked if a biological repository was being considered (for example, collection of blood or serum samples). Ms. Roy responded that CIHI is not equipped to manage biological repositories. However, clinical data that is based on the collection of biological samples can be collected. A participant encouraged CIHI to consider the need to provide funding to support initial collection of CMSMS-related data by data providers (such as rehab centres and MS clinics) where resources may not be readily available to meet CMSMS requirements. In response to a question regarding the expected timeline to implement the CMSMS, Madelaine Cherry, Senior Program Consultant, CIHI, indicated that a phased, or modular, approach to development of the overall system is planned. Ms. Cherry noted that the draft data set is expected to be released by March 31, 2012 (an external field review of the draft will occur prior to this release). The business requirements for the system are being developed and are expected by the end of the fiscal year. The business requirements will continue to be developed over time as the CMSMS is expanded and refined. CIHI was also encouraged to consider ways in which access to the CMSMS by researchers, clinicians and others can be managed in a timely way that is not unduly restrictive (while remaining accountable to privacy and security requirements). Ms. Roy noted that CIHI s corporate aim is to create a data access strategy that is seamless, timely and responsive. Next Steps and Workshop Close On behalf of CIHI s MS team, Ms. Roy thanked participants for their helpful and valuable input. Ms. Roy assured participants that all of the information provided will be used by CIHI (including all index cards and worksheets). The key priority questions that were identified will provide the basis for further information gathering and technical analysis needed to design the minimum data set for the CMSMS. She noted that the rationale provided with each priority question will be particularly important in ensuring that a useful, relevant data set is created. In addition, CIHI will conclude the environmental scan that is currently under way and continue to consult with relevant stakeholders to refine the CMSMS. In closing, Ms. Roy invited participants to view the environmental scan, the workshop proceedings and other relevant project information on CIHI s website and/or to contact CIHI directly to discuss the project. 11

16 Appendix A: List of Participants Anthony Traboulsee, University of British Columbia Brent Lawlor, Health Canada Carol Fredrek, Calgary and Area Chapter, Multiple Sclerosis Society of Canada Christine Guérette, Neuro Rive-Sud MS Clinic Colleen Harris, University of Calgary Cristina Toporas, Multiple Sclerosis Society of Canada Deborah Malazdrewicz, Manitoba Health Diane Lowden, McGill University Health Centre François Grand Maison, Neuro Rive-Sud MS Clinic Helen Tremlett, University of British Columbia Janet Palm, B.C. and Yukon Division, Multiple Sclerosis Society of Canada Jay Onysko, Public Health Agency of Canada Joan Ozimy, person living with MS and volunteer board member with the Multiple Sclerosis Society of Canada, Alberta Division Jo-Anne Howe, University of Toronto and Toronto Rehabilitation Institute Jutta Hinrichs, Foothills Medical Centre, Alberta Health Services Laurie Cucheran-Morris, Ottawa Chapter, Multiple Sclerosis Society of Canada Louise Pelletier, Public Health Agency of Canada Marilyn Lenzen, Multiple Sclerosis Society of Canada Melissa McGowan, Canadian Pediatric Demyelinating Disease Program, The Hospital for Sick Children (Toronto) Michelle Ploughman, Memorial University of Newfoundland/Eastern Health Nadine Prévost, Société canadienne de la SP, Division du Québec Paul Martin, person with MS and MS self-help coordinator Pierre Duquette, Hôpital Notre-Dame du Centre hospitalier de l Université de Montréal Regan Spencer, Winnipeg Health Sciences Centre Susan Forwell, University of British Columbia Susan Martin, Multiple Sclerosis Society of Canada, Atlantic Division HRM Chapter Communication Coordinator Tanya Packer, Dalhousie University Trudy L. Campbell, Dalhousie Multiple Sclerosis Research Unit Vanina Dal Bello-Hass, McMaster University 12

17 Appendix B: Discussion Themes and Example Questions Supplied by CIHI To stimulate discussion, CIHI provided participants with a set of sample questions related to each theme area. It was made clear to participants at various times during the day that the themes and sample questions supplied by CIHI were provided solely for the purposes of structuring the workshop and initiating discussions and were not intended to limit discussion during the day. Themes and questions were projected at the front of the room during the associated agenda time. Theme 1: Priority Questions About MS: Disease Presentation and Progression, Diagnosis and Treatment Beginning the discussion... examples of priority questions may include 1. What is the scope of therapy options currently in use in Canada, and does it vary by province/territory? 2. What are main risk factors for disease progression? 3. What factors impact patient compliance with disease-modifying medications? 4. How many patients with MS are referred to psychological services? 5. What key factors impact disease progression in the first five years after diagnosis? Theme 2: Priority Questions About MS: Patient Level of Functioning, Outcomes and Quality of Life Beginning the discussion... examples of priority questions may include 1. How does MS impact home and family life? 2. Are there specific sequences or combinations of treatments that delay the onset of specific impairments (e.g. fatigue, bladder problems, spasticity)? 3. What impact does MS have on employment status? 4. What level of impairment and activity limitations are associated with the different subtypes of MS? 13

18 Theme 3: Priority Questions About MS: Access to Care, Delivery of Services and Health System Improvement Beginning the discussion... examples of priority questions may include 1. What are the social and environmental factors that impact the use of social, health and other services? 2. What are the wait times between referral and initial assessment by a neurologist? 3. What are the characteristics and service delivery approach of MS clinics with the lowest wait times? 4. Does location of residence (e.g. province/territory) impact the assessment and treatment approaches offered to Canadians? 5. What are the most cost effective protocols for investigating people presenting with potential MS? Theme 4: Other Priority Questions About MS Did we miss anything? 14

19 Appendix C: Results of Workshop Process Step 1 Individual Brainstorming Exercises (Index Cards) The workshop prioritization process began with an individual brainstorming exercise to support and prompt group discussions. Each participant identified information required to measure and monitor the evolution and treatment of MS in Canada and recorded this information on a set of index cards (one question/issue per card). The information gathered during this exercise has been recorded below by theme. The sequential numbering (1.1, 1.2, etc.) is included for ease of reference and no order of priority should be assumed. Theme 1: Priority Questions About MS: Disease Presentation and Progression, Diagnosis and Treatment 1.1 What are the implications of stopping a disease modifying treatments? 1.2 What are the criteria for stopping disease modifying treatment? 1.3 What are the symptoms of when patients stop disease modifying treatment? 1.4 What scales and tools (other than the expanded disability status scale) are used for those to measure ability (i.e. government disability form)? 1.5 What are the outcomes from secondary clinicians? 1.6 How do we track disease progression? 1.7 What treatments are patients accessing? (i.e. Nova Scotia covered therapies versus British Columbia coverage) 1.8 When patients present with few physical symptoms, can there be another scale developed other tan the expanded disability status scale to reflect their disability? 1.9 Many patients have disabilities that are not physical disabilities. What other tools are being used to measure patients abilities? 1.10 What is the incidence and prevalence of MS across Canada? : Need to know scope of problem Number of people affected Is this changing over time Provide data to plan organize and deliver care 15

20 1.11 What are the rehabilitative treatments that are considered (i.e. physiotherapy, occupational therapy, psychology, speech and language pathologist, social worker, etc.) and at what point are patients referred? : We need to look at a broad range of treatments, not just medical/ pharmaceutical treatments How did the disease first present itself? What were the initial symptoms that prompted the person to seek medical attention and obtain the diagnosis? : Increase understanding of what clinicians (i.e. family medicine physicians, etc.) should note about the onset of MS What is the disease course at onset, after years (i.e. secondary progressive MS) 1.14 What is the natural history of MS before and after the advent of diseasemodifying therapies? : Do they make a difference? Is this sustained? For how long? Are there cohorts of patients who benefit more? 1.15 What is the scope of therapy options to financial coverage in Canada? Access should be equal? How to achieve universal health care for MS Can coverage be standardized? 1.16 How does disease progression correlate to accessibility to MS clinic services? : If you don t have access to information and services such as physiotherapy, occupational therapy specialized to MS, do you progress more quickly? Should there be a broader net cast by the services available through clinics in major centres versus rural areas? 1.17 How many patients with MS are referred to what kinds of services and by whom? And how? And to what outcomes? Understanding the trajectory of people with MS through the services system, road blocks faced, and facilitating factors 1.18 What barriers do people with MS face in accessing treatment and services? Understanding what prevents people with MS to access treatment and services, understanding disparities across Canada and funding solutions/help formulate solutions to overcoming such barriers 16

21 1.19 What influences choice of diagnosis from a physician and patient perspective? 1.20 What are the health care system factors that impact patient adherence with disease modifying medications and other treatment? There are multiple variables to patient adherence: Delivery of health care Relationship with health care providers Hours of operation Location 1.21 How can we gain access to information about needs for rehabilitation, health practitioners, and their treatment outcomes? 1.22 Many needs of patients for treatment are decided by physicians. How do physicians decide who will benefit? 1.23 Health practitioners could enter data into a standard database Time between diagnostic test request (e.g. MRI) and diagnosis of MS or clinically isolated syndrome. Difference regional/provincial 1.25 Which professional does the patient have access to at different stage of the disease, based on expanded disability status scale? 1.26 Long-term outcomes The long-term impact of current treatments is questionable, at best. We need to monitor treatment outcomes in the long-term, especially regarding prevention of progression 1.27 Us of MRI Facilities We have to develop guidelines for the use of MRI in diagnosis (easy), disease monitoring (problematic) 1.28 (1) What are the main clinical elements that must be collected to describe disease, presentation and diagnosis? Important to collect the data right elements (2) How often should patients be seen to re-evaluate progression? So that we identify in the system the right time frames to collect the data (3) What are the different treatments offered and how do they match the current state? To make sure we collect information about best practice guidelines (4) What are the recommended practice guidelines for treatment? So that we can monitor variability and present evidence 1.29 Relapse data on pregnancy and post-partum and breast feeding 17

22 1.30 Access to Rehabilitation Psychology/psychiatry MRI (delay) 1.31 Access to disease modifying therapies according to form of MS/Region 1.32 Long-term follow-up of radiological isolated syndrome Incidence and prevalence data: According to region Long-term trends Relation to vitamin D 1.34 Off-label medical prescriptions for progressive forms of MS Usefulness of cerebrospinal fluid analysis in diagnosis Data on treatment switches: Results Reasons 1.37 Delay from symptom onset to neurologist consult; delay from symptom to diagnosis Data on drug safety What are the top 3 comorbid conditions for people living with MS? Understand the burden of disease 1.40 What are the current treatments for MS being implemented across Canada and their outcomes for patients? Better understanding of existing and new treatments and long-term outcomes 1.41 What is the incidence and prevalence of MS by geography, in Canada? Inform hot spots of MS and possible burden to population and health care system 1.42 What are the risk factors for developing MS? Better understanding of the disease and factors influencing progression of the disease 18

23 1.43 What treatment is available to a patient and has their ability to access treatment been limited because They see a community family medicine physicians or neurologist and not a clinic Because a provincial government will not cover costs of some treatments : Available and funded treatment is inconsistent across a province or the country as a whole. (The same could be asked about diagnosis too.) 1.44 How long between first attack and diagnosis, and eventually treatment? Initiating early treatment so important to prevent disease progression 1.45 Do people diagnosed with MS have equitable and reasonable access to services? For example: exercise programs; accessible transportation; equipment; renovations; home support. Do those services impact disability? These factors impact living with MS in the long-term, quality of life, and caregiver quality of life? 1.46 How many people have MS? (Seems like an easy question to answer, but it is not!) Each province collects data in different ways Not all people have equal access to diagnostic services What is the gap between symptom, onset, and diagnosis? Does that vary between provinces, rural/urban, socio-economic? 1.47 Do other co morbid conditions such as cardiovascular disease, arthritis, etc. affect the progression of MS? Why? 1.48 (1) Where in the health care system continuum do individuals experiencing their first neurological event present themselves? (2) How long does the process around obtaining a diagnosis of clinically isolated syndrome or MS take in various regions of Canada? (3) How soon is rehabilitation (occupational therapy, physiotherapy, etc.) introduced to individuals once they are diagnosed with MS? 1.49 (1) What is the scope of rehabilitation options and services available to people with MS and how/why do these vary by provinces/territories? (2) Disease management is key to enhanced quality of life, caregiver support, enhancing activities and participation. Do all Canadians have similar availability of services? 1.50 (1) What role do health promotion, wellness and prevention (i.e. exercise, nutrition, stress management, have in Disease prevention Disease progression Disease treatment 19

24 (2) Understandably focus in on cure of MS. However, we also need to shift focus to a chronic disease management model certainly with regard to programs and treatment and potentially with regard to primary prevention What proportion of people with MS has access to or do access approved disease modifying agents? Disease modifying agents are available, but it is unclear if all people with MS who might benefit have the financial/educational/support mechanisms that allow them to access these disease modifying agents or if they do actually access disease modifying agents, i.e.: What are the issues around non-access? 1.52 Does the time from onset of symptoms to diagnosis/treatment vary by province/territory and within provinces depending on the patients first point of contact for presentation with neurological symptoms? What is the average time from MS symptom onset to diagnosis and the (medical prescriptions) treatment initiation? When do patients with a new diagnosis access a multi-disciplinary team? 1.53 (1) What is the incidence and prevalence of MS in Canada and are there pockets/provinces with higher incidence/prevalence than the national average? (2) Is the prevalence of MS increasing? (3) Does it vary by factors and what would those be (gender, ethnicity, etc.)? And does the ratio female:male vary in subgroups of the population or subtypes of the disease? 1.54 How is the decision made to switch a person with MS from disease modifying medical prescriptions to no treatment? Patients started on treatment are often discontinued on disease modifying medical prescriptions once their disease is considered to be a progressive form What are the outcomes of stopping treatment for those with progressive disease? 1.55 What are the incidence and prevalence rates of MS in Canada/across provinces? Changing demographics/profiles : We don t have very precise estimates at the moment with described demographic Will need to know what proportion of the population the MS monitoring system represents 20

25 1.56 What sorts of co morbidity and/or multi-morbidity profiles do MS patients have in Canada? Comorbidities create management challenges chronic cerebrospinal venous insufficiency treatment or chronic venous disorder relationship Starting point for understanding burden of disease 1.57 Are the demographics of MS changing (age of onset and gender ration)? Changes in demographic may help us understand the cause or triggers for MS 1.58 What is the delay from onset to testing and diagnosis of MS? Are there regional differences in access to specialists and MRI for the diagnosis of MS? 1.59 What is the role of vitamin D exposure in prevention of MS? Could compare the rates of MS across regions versus use of vitamin D pre-diagnosis to address need for Canadians to take vitamin D to lower risk of MS 1.60 What medications are currently prescribed? Vitamin D considered prescriptive rather than over-the-counter Number of therapies available 1.61 Therapy options and escalation from acquired demyelinating syndromes, relapses and access to treatment Diagnosis changing with new criteria and varying provincial rules New therapies coming online Outcomes of therapy success 1.62 To identify responders/non-responders to various treatments available. Why? Because we would put money in the right place Is there a change in the population affected by MS gender in terms of: age at onset? geography? ethnicity (ethnic origin, country of birth)? occupation? Since the causes of MS are still unclear, it is important to identify group at risk and if there are changes in epidemic over time New therapies coming online 1.64 What are the main risk or protective factors influencing disease progression? In order to delay or slow down progression of disease, it is important to know what the key factors are influencing its course 1.65 Progression, primary and secondary, is currently the biggest therapeutic/ socio-environment challenge 21

26 1.66 Will this change care? Please make sure the final outcome actually captures quality of life. Often our medical community woks with the tools they have, but this does not always capture quality of life. By this I mean expanded disability status scale (EDSS) only measures the physical part of the disease not how ell someone actually is. Specific to the chronic cerebrospinal venous insufficiency treatment treatment provided to people I know will indicate improvement in their quality of life even though their expanded disability status scale (physical measurement) remains the same or in some cases diminished 1.67 What complementary/alternative treatments have been most beneficial at the various stages of MS? : To better inform or guide patients/clients To develop programming that complements or is consistent with these modalities 1.68 What side effects occur short term and long-term with disease modifying therapies? Patients complain of side effects in the long-term contrary to what s in the published literature. How should these e managed? How do they affect compliance? 1.69 How is the transition from relapsing/remitting to secondary progressive evaluated? Is this reliable? This is important because it affects access and choice of drugs 1.70 What is the relationship between social determinants of health and long-term outcomes (outcomes are broadly defined not just medical)? Are the most vulnerable receiving what they need, or should medical prescription treatments be different? 1.71 How long have people been diagnosed with MS? 1.72 What are the treatments (medical and alternative) that people with MS are taking? And what are the side-effects? I want to know which treatments people are taking and what are the side-effects to be able to provide them information to help them to take the best decisions 1.73 What are the indicators of disease progression? To better inform or guide patients/clients for planning or continuum of care Does participation in preventive programs (education, self-management, etc.) influence the long-term quality of life of people? 22