A Centralized Clinical Outcome Measurement of Eating Disorders in

Clinical Outcome Measurement of Eating Disorders

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The Provincial Centre of Excellence for Child and Youth Mental Health at CHEO

Le centre d’excellence provincial au CHEO en santé mentale des enfants et des ados

Evaluation Implementation Grant EIG 1208

Final Report March 31st, 2011

A Centralized Clinical Outcome

Measurement of Eating Disorders in Youth across Ontario:

A Multi-Site Partnership

Written by: Dr. Katherine Henderson, PhD, C.Psych and Nicole Obeid, MA

Co-Principal Investigators:

Dr. Katherine Henderson and Dr. Annick Buchholz

Co-Investigators: Dr. Wendy Spettigue, Dr. Mark Norris, Dr. Nick Barrowman, Dr. Margus Heinmaa, Dr. Leora Pinhas, Dr. Debra Katzman,

Dr. Melissa Lieberman, Dr. Karin Jasper, Dr. Ahmed Boachie, Dr. Adele Lafrance


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Table of Contents Page Contents

3 Executive Summary

6 Introduction

12 Results and Lessons Learned

23 Conclusion and Recommendations/Next Steps

24 Knowledge Exchange

27 References

28 Appendices


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Executive Summary

Eating disorders are chronic and life threatening illnesses. Despite the morbidity and

mortality of this condition, these disorders remain understudied and underserved, and there

is an absolute paucity of research examining outcomes in pediatric clinical populations.

Three pediatric eating disorder programs located in tertiary care hospitals in Ontario worked

collaboratively together to create a multisite research partnership that would allow for the

creation of knowledge about the children and youth served in Ontario and an evaluation of

the services provided to our children and youth.

In Ontario, three specialized pediatric eating disorder teams; the Children’s Hospital of

Eastern Ontario (CHEO), Southlake Regional Health Centre (SHRC), and the Hospital for

Sick Children (HSC), made a commitment to take action to address the lack of research

available for this vulnerable population. The vision for this multi-site partnership was

conceptualized by members from all sites and with the leadership of Dr. Henderson and

Buchholz from CHEO, the members were able to successfully implement the vision. The

three centres created an interdisciplinary, multi-institutional partnership with the goals of

greater research collaboration, shared resources, and shared data to attempt to close the

knowledge gap in research on outcomes and treatment in children and youth suffering from

eating disorders. This multi-institutional partnership received a Provincial Centre of

Excellence Program Implementation Grant in June of 2010 to formally develop a Centralized

Multisite Database Partnership (CMDP) and to develop capacity for research with the

creation of a multisite database.

Over the course of the granting period, the partnership met monthly via teleconference,

as well as in-person on three separate occasions. Through these meetings this team has

accomplished four main goals: 1) the establishment of a solid partnership across the three

sites with one representative from each site acting as a Steering Committee member, 2) the

creation and approval of all relevant authorship and ownership documents necessary to


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operate a multi-site partnership, 3) the establishment of a web-based database and data

definition dictionary which explicitly lists and defines all variables that are to be part of the

multi-site database, and 4) has contributed to knowledge translation at both a provincial and

national level.

A strong partnership is the cornerstone to the success of any longitudinal multisite

research program. Drs. Henderson and Buchholz, with Ms. Obeid as a research coordinator

worked within a collaborative participatory framework to establish a formal partnership that

was inclusive and sustainable. Interdisciplinary representatives from each site were invited

to join the research partnership. Interdisciplinary and inter-site relationships were fostered

and strengthened through bi-monthly teleconferences and 3 full day in-person meetings.

These meetings provided a forum for an exchange of knowledge and expertise and the

development and refinement of our common vision for the partnership. During these

meetings the detailed authorship agreement, methodology for the study, data dictionary, and

future knowledge dissemination and research plans were developed, discussed, and agreed

upon by all involved. Furthermore, the web-based database structure was successfully

designed and developed over the course of the grant. Unfortunately there was a significant

delay in moving the data base to the secure server at CHEO. This delay resulted in an

inability to enter and store data in the centralized web-based database, which prevented any

outcomes analyses of the data.

Through the funding for this grant, Dr. Henderson and Dr. Buchholz with their co-

investigators were successful in creating a formal multisite partnership for outcomes

research on pediatric eating disorders with clear terms of agreement on the use of the data

and authorship, developing a centralized web-based data-base, and in successfully

engaging in knowledge translation and exchange. The development of this multisite

partnership is extremely important. Through this partnership the CMDP will finally be able to

start to address the paucity of research examining outcomes in pediatric eating disorders.


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The knowledge generated over the upcoming years from this partnership and centralized

database will provide missing evidence to better guide the prevention and treatment of this

serious and chronic mental health illness affecting many children and youth in Ontario. This

knowledge will also be essential to our national and international partners who work hard to

provide excellent care and treatment to youth suffering from eating disorders.

The CMDP has learned from the challenges faced in implementing this grant and

continues to work to build upon the successes achieved. The delay in being able to

implement the web-based data base, was turned into an opportunity to apply for further

funding to pilot test the data and the feasibility of data collection once the data base has

been established. The team was successful in receiving funds from the Sick Kids Psychiatry

Endowment Fund ($25,000). The team further used the strength of the partnership to apply

for a CIHR grant to hold a national meeting (CIHR meetings and plannings grant, $9,999).

The partnership has set a goal of building on the results and success of the Centre of

Excellence Grant and the Hospital of Sick Children grant. To this end we are committed to

submitting a grant to CIHR in January in 2012 to provide funds for an extensive 3 year

evaluation of programs in Ontario and possibly across Canada.


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Introduction

Eating disorders are chronic and life threatening illnesses. Despite the morbidity and

mortality of this condition, these disorders remain understudied and underserved, and there

is an absolute paucity of research examining outcomes in pediatric clinical populations. The

shared vision of the current project was to create a forum in which to conduct a quasi-

experimental, multi-site, repeated measures design to examine recovery trajectories of

medical and psychological outcome variables across a number of organizations within

Ontario. Initially, four pediatric eating disorder programs located in tertiary care hospitals

worked collaboratively to address the shared goals of creating a centralized web-based

database to examine the clinical profiles of patients, 6-month recovery trajectories, as well

as predictors of clinical outcome.

Throughout the course of the granting period, numerous tasks related to the

formation of a solid partnership were established, as was the creation of a secure web-

based database that has the capacity to store, disseminate, and retrieve data from various

sources was created. Due to unexpected challenges and delays in the Children’s Hospital of

Eastern Ontario (CHEO) IS department, the timely establishment of an operational and

secure centralized database was not possible. A thorough explanation of the challenges and

delays encountered will be described later in this report. Without the secure operational

centralized database it has not been possible to complete any analyses. It is anticipated that

with ongoing support of the current partnership and an ongoing commitment to finalize the

secure centralized database, that the data that each site has gathered, will be entered into

the centralized database as soon as possible, and that analysis of this data will provide

valuable information on clinical outcomes from services that are provided by eating disorder

programs within Ontario. The data base and partnership will also provide a measurement

framework upon which to build a larger, potentially national, partnership among programs

offering treatment to children and youth struggling with eating disorders.


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This final report will focus the four main objectives that were accomplished during the

granting period and will discuss how the principal investigators addressed the challenges

presented by the delays in the technology. While discussing each of the objectives in turn,

this report will highlight the accomplishments and lessons learned. Although it is recognized

that a multisite evaluation of clinical populations of youth with eating disorders was not

successfully completed, the solid partnership that has grown and evolved from this ongoing

collaboration has been paramount in securing a platform in which multisite outcomes

research is now possible. The four main achievements of this project were: 1) the creation of

a formal a provincial inter-disciplinary multi-site partnership, 2) researching and creating

authorship and ownership guidelines to direct the partnership 3) consensus on common

outcome indicators including a data definition dictionary that would be placed in a

centralized database to be developed and maintained at CHEO, and 4) contribution to

knowledge translation.

Background

Physical and emotional development is profoundly affected in children and youth

suffering from eating disorders. Physical complications of the illness include bradycardia,

hypotension, hypothermia, cardiac arrhythmias, heart failure, amenorrhea, osteopenia,

neurological impairments, hormonal imbalances, growth deceleration, and impaired bone

density and fertility (Katzman, 1999). Psychological sequelae of an eating disorder include

depression, suicidality, mood lability, social withdrawal, cognitive impairment, insomnia,

irritability, agitation, and marked deterioration in family relationships (Neiderman, 2000).

Sullivan (Sullivan, 1995) reported mortality rates in individuals with eating disorders that

exceeded the expected incidence of death from all causes in women 15 to 24 years of age

by twelve-fold. In short, eating disorders in youth are associated with potentially devastating

psychosocial and medical outcomes, impaired quality of life, premature mortality, and

exorbitant costs to the health care system (Nielson & Bara-Carrill, 2003). Many youth


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diagnosed with a severe eating disorder are no longer capable of functioning at school or

with their peers and may require intensive interventions such as hospitalization.

Current treatment for an eating disorder typically involves a multidisciplinary

approach including medical and nutritional rehabilitation as well as psychological

interventions (Wilson & Shafran, 2005). More recently, rehabilitation centers for eating

disorders have adopted a treatment approach which has come out of the Maudsley Hospital

in England, and which has been expanded, modified, and systematically detailed by Lock

and LeGrange (Lock & le Grange, 2005). In this approach, family therapy is provided to

empower and support parents in the refeeding process of their child, as well as to address

underlying psychosocial issues. In parallel to the emergence of the Maudsley family-based

therapeutic approach, relatively new pediatric day treatment programs for the treatment of

eating disorders in youth have emerged in many provinces. Both family-based outpatient

therapies and day treatment programs have been developed, in part, to address historically

lengthy hospital stays and repeat admissions for youth struggling with an eating disorder.

However, to date, there has been no long-term outcome measurement examining the

effectiveness of these approaches, or predications of best outcome based on types of eating

disorders. There is also a lack of research on clinical pathway management, even though it

is acknowledged that there is a wide range of eating disorders requiring different levels of

intervention.

The paucity of research on treatment outcomes in eating disorders is partly related to

the prohibitive expense of creating a randomized control trial to compare one intensive and

comprehensive treatment approach to another. Single site studies do not have the power to

complete the research and the generalizability of the results would be limited. The current

study was acknowledged to be limited by its lack of randomization; however, it was

established to overcome the issues concerning power and generalizability that is afforded by

use of a multi-site study. Data from the participating sites is thought to provide results to help


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researchers understand the profile of patients presenting to tertiary care hospitals, 6 month

recovery trajectories, and predictors of outcome.

Existing Partnerships

At the beginning of this grant informal partnerships were being developed between

the Children’s Hospital of Eastern Ontario’s (CHEO) eating disorder program, and the

pediatric eating disorders programs located at McMaster Children’s Hospital (MCH),

Southlake Regional Health Centre (SRHC), and the Hospital for Sick Children (HSC), to

explore how to become a multisite team to allow for the examination of clinical profiles and

recovery trajectories of youth suffering from eating disorders. When this grant was

developed, all four pediatric centers provided outpatient services in the form of

comprehensive assessments, medical management, psychopharmacology, nutritional

counseling, family therapy, individual therapy, and group therapies. All four tertiary care

centers also had specialized interdisciplinary teams to care for patients who are medically

unstable and must be admitted to hospital. In addition, CHEO, SRHC and HSC eating

disorder programs offer intensive day treatment programs for youth suffering from severe

eating disorders. Although the particular range and nature of services available for youth

differ within each program, the programs treat the same population (youth younger than

age18), and the family/team based treatment model and philosophy of each program are

similar. The four partners had already demonstrated a capacity for single site program

evaluation activities and each had established databases with common measures across

sites. The following provides a brief description of the single site program activities that each

site was engaged in at the time of the grant application:

1) CHEO EDP had been actively collecting and evaluating clinical outcomes from their Day

Treatment Program since the program began in January 2000; clinical outcome findings had

been presented at provincial, national, and international conferences. Similarly, all

assessment, outpatient, and tracking data had also been collected and managed in a


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database since the opening of the program, providing further evidence of this site’s abilities

to participate in program evaluation and outcomes management. In January 2007, CHEO

received funding for a provincial inpatient eating disorder program and implemented a

program evaluation component to this service in April 2008; since that time, a steering

committee for ED program evaluation activities met on a weekly basis to discuss

implementation successes, challenges and changes. Similarly, the Mental Health Patient

Service Unit (MHPSU) at CHEO is strongly committed to program evaluation and had

developed a steering committee for outcomes measurement for which a representative from

each of the service units (including eating disorders) met on a monthly basis for the

purposes of knowledge exchange and the development of a common database. The

MHPSU had prioritized program evaluation activities across the full continuum of its

services. The Eating Disorders Team had taken a leadership role in the capacity building of

its program evaluation activities since January 2000.

2) SRHC EDP had been formally measuring outcomes since September 2008 for all

patients presenting to the Program for an assessment. Other evaluation activities also

ongoing included the evaluation of new adjunct therapies (emotion-focused therapy; multi-

family therapy and reflecting team family therapy) and an assessment of needs identified by

family physicians and psychologists in the community.

3) HSC EDP had recognized the importance of maintaining consistent and ongoing program

evaluation activities and had been evaluating outcome from all components of their

program. The EDP employed psychologists and a psychometrist for ongoing program

evaluation activities, and had the program evaluation infrastructure necessary for this study.

4) MCH Pediatric EDP highly valued clinically relevant research such as program

evaluation. Staff members of the EDP all actively participated in program evaluation work

through assisting with data collection, providing suggestions and feedback regarding


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specific evaluation questions. MCH has had considerable success to date with implementing

program evaluation practices.

The initial four participating organizations also created strong ties with the Ontario

Community Outreach Program for Eating Disorders. It was anticipated that through the

partnership and the resulting multi-site centralized database, a framework for the

amalgamation of data with others sites in Ontario would be possible. The director of the

Ontario Community Outreach program for Eating Disorders, Dr. Gail McVey, was fully

supportive of this initiative, and was invited to provide consultation to the partnership

regarding the broader needs of the province. It was anticipated that this liaison would lead to

excellent knowledge exchange opportunities within the province.

Recognizing that a centralized multi-site database requires expertise in technology,

privacy legislation, and ethics, the principal investigators had been in consultation with

experts on behalf of the partnership group. Mr. Tyson Roffey the Director of Information

Services and the Privacy Officer at CHEO and Dr. Khaled El-Emam, principal investigator

for the Electronic Health Information Laboratory at the University of Ottawa and CHEO

Research Institute had been consulted to ensure that the database could be created with

the appropriate security dimensions, with enough sophistication to handle at least four

separate sites, to be able to be enhanced over the years, and that all privacy legislation

could be considered. Finally, Dr. Carole Gentile, chair of the Research Ethics Board at

CHEO was a key consultation partner providing expert ethical guidance.

The proposed evaluation activities (see Appendix A and B for the Program Logic

Model and the Evaluation Plan) resulting from the development of this multi-site partnership

will have direct impact on child and youth mental health, with a focus on eating disorder

programs for children and youth at hospitals in Ontario. Eating disorders continue to be

chronic and life threatening illnesses for the children and youth of Ontario, with an ongoing

paucity of research examining clinical outcomes. This study was designed to build on the


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existing capacity for strong outcomes research in youth with eating disorders, by creating a

partnership in outcomes management between four provincial organizations who provide

intensive interdisciplinary treatment for eating disorders.

Results and Lessons Learned

In Ontario, four specialized pediatric eating disorder teams; the Children’s Hospital of

Eastern Ontario (CHEO), Southlake Regional Health Centre (SHRC), McMaster Children’s

Hospital (MCH) and the Hospital for Sick Children (HSC), made a commitment to take action

to address the lack of research available for this vulnerable population. The vision of this

multi-site partnership was conceptualized by members from all sites and with the leadership

of Dr. Katherine Henderson and Dr. Annick Buchholz at CHEO this vision has been realized.

At this time, only Dr. Katherine Henderson remains as the principal lead on this project, as

Dr. Buchholz has taken a leave of absence from her role on the Eating Disorder Team.

These initial four centres created an interdisciplinary, multi-institutional partnership with the

goals of greater research collaboration, shared resources, and shared data to attempt to

close the knowledge gap in research on outcomes and treatment in children and youth

suffering from eating disorders. This multi-institutional partnership received this Provincial

Centre of Excellence Program Implementation Grant in June of 2010 to formally develop a

Centralized Multisite Database Partnership (CMDP) and develop capacity for research with

the creation of a multisite database.

Over the course of the granting period, the partnership met monthly via

teleconference, as well as met in-person on four separate occasions. Through these

meetings this team has accomplished four major goals: 1) the establishment of a solid

partnership across the three sites with one representative from each site acting as a

Steering Committee member, 2) the creation and approval of all relevant authorship and

ownership documents necessary to operate a multi-site partnership, 3) the establishment of


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a web-based database and data definition dictionary which explicitly lists and defines all

variables that are to be part of the multi-site database, and 4) has contributed to knowledge

translation both provincially and nationally.

1) Evolution of the Partnership

A strong partnership is the cornerstone to the success of any longitudinal multisite

research program. Thus, a primary objective of this project was to formalize a multisite

partnership between the four interested pediatric eating disorder programs in Ontario. Prior

to being granted funding from the Centre of Excellence, colleagues from the initial four sites

discussed informally over the phone and met once face-to-face (during an annual provincial

network meeting) in order to establish interest in forming this partnership. With confirmed

interest, the four sites worked together to draft the proposal for the current grant. It was

agreed that CHEO would lead this research initiative with Dr. Henderson and Dr. Buchholz

as principal investigators.

Drs. Henderson and Buchholz, with Ms. Obeid as a research co-ordinator worked

within a collaborative participatory framework to establish a formal partnership that was

inclusive and sustainable. Interdisciplinary representatives from each site were invited to

join the research partnership. Interdisciplinary and inter-site relationships were fostered and

strengthened through bi-monthly teleconferences and 3 full-day in-person meetings. These

meetings provided a forum for an exchange of knowledge and expertise and the

development and refinement of our common vision for the partnership. During these

meetings the detailed authorship agreement, methodology for the study, data dictionary, and

future knowledge dissemination and research plans were developed, discussed, and agreed

upon (this will be reviewed in more detail in later sections).

Through their participation in the regular meetings and the development of the

structure of the partnership and the research program, the MCH representatives had to

make the very difficult decision that due to a lack of protected time and financial resources,


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they would not be able to collect the minimum data required to be part of the partnership.

They continue to be committed to joining the partnership should they or the partnership be

successful in securing more funds to provide the resources required.

The CMDP partnership currently consists of 3 pediatric eating disorder programs in

Ontario with a strong interdisciplinary representation. The CHEO program has 4 co-

investigators involved: 2 psychologists, 1 psychiatrist, 1 adolescent health physician, and

the support of 1 research coordinator and 1 software consultant. HSC has 4 co-investigators

including 2 psychologists, 1 psychiatrist, 1 adolescent health physician, and the support of a

psychometrist. SRHC has 2 co-investigators 1 Clinical Mental Health Specialist and 1

psychiatrist, and the support of a PhD student who helps with data entry and database

maintenance. A further partner to this collaboration is Dr. Adele Lafrance who originally held

the lead at SRHC, but in September 2010 she accepted a position at Laurentian University.

She has remained a co-investigator on the project, and has become an academic partner

(see Appendix C for a list of study partners).

In addition to the direct partners involved in the partnership, the CHEO site

investigators have also fostered important relationships with staff members with a breadth of

expertise within CHEO who have an ongoing central role in the maintenance and

sustainability of this partnership. The MHPSU Operations Director and the Chief Information

Officer at CHEO have committed to the development and on-going maintenance of the

provincial database for eating disorders beyond the timelines of this initiative. Although

funding from the current grant was sought to support software development and consultation

fees, CHEO has committed to supporting this proposal with in-kind funds for the

development and sustainability of this database (to be housed at CHEO). For example,

CHEO currently pays the $2000 fee for annual maintenance of the website server. Given

that the multi-site data collection process developed for this study has been designed to be

sustained beyond the terms of the current grant (i.e., resource infrastructures and web-


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based database), the partnering sites have also agreed to collect the common data set at

12-months post-assessment, speaking to the long-term collaboration created by this grant.

Furthermore, the Software Consultant, provided by Dr. Khaled El-Emam’s E Health

Information lab, has agreed to continue to provide in-kind support for the maintenance of the

web-based database.

The work and time dedicated to ensuring a strong, formal partnership between the

three sites will provide the foundation for a larger provincial and national partnership

between pediatric eating disorder programs. Following the presentation provided by Dr.

Henderson and Dr. Buchholz at the November 2010 annual provincial network meeting for

eating disorders in Ontario, the London Health Sciences Centre has contacted the CMDP to

express an interest in joining the partnership.

2) Creation of the authorship and ownership guidelines

Over the course of the grant the multi-site team focused on developing a solid

partnership, and an important component of formalizing the partnership was the creation of

authorship and ownership agreements. These agreements are complex and have been

designed to address the time frame of the current grant from the Centre of Excellence and

the long term vision for the database, which includes the current research proposal and the

possibility of the partnerships and database thriving for many years. Each site has

demonstrated incredible commitment to ensuring the success of this research project, and

with this level of commitment also comes a need to ensure that ownership and credit are

attributed fairly to all involved. Through the early stages of this partnership, it came to the

attention of the collaborators that the need for formalized agreements was necessary. The

process of establishing these agreements was lengthy and complicated. CMDP members

invested time in researching and consulting with other multi-site projects and teams, to

determine all of the important components to address when developing an authorship

agreement for a longitudinal multisite research program. Each site dedicated some time to


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this initiative, and together several relevant documents were shared with the partnership.

Through research and many lengthy discussions and debates, the CMDP was able to

establish the guidelines through consensus and collaboration. The formalization of the

authorship agreement represents a significant accomplishment of this partnership, and

forms the foundation for the ongoing success of the partnership.

The following documents were drafted and approved by the CMDP partnership (see

Appendix D):

1. Authorship, Acknowledgements, and Manuscripts Agreement

2. General Authorship and Manuscripts

3. Single Site versus Central Shared Dataset

4. Requesting Secondary Use of Data

5. Ancillary Studies

6. Designating a New Partner on the CMDP of PEDP of Ontario

7. Maintaining the Integrity of the Database

8. Intellectual Property and Data Sharing Agreement

Furthermore, the CMDP partners collaboratively prioritized the top 9 research papers that

would address the overall goals of the research program. It was agreed that each site would

take the lead on 3 separate projects that would follow from either the assessment data or

the follow-up data. The assignment of site and title of the 9 projects are available in

Appendix E.

3) Centralized Database

The third central objective that was achieved over the course of the grant was the

development of the web-based centralized database. This objective was achieved through

three steps: (a) achieving consensus on the central indicators to be evaluated, (b)

development of a detailed data definition dictionary, and (c) the software development of a

web-based database.


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Common Indicators

During the in-person meetings, the CMDP partners had extensive discussions and

engaged in knowledge exchange about which indicators were most appropriate for this

research initiative (based on research and clinical expertise) and how to best measure these

indicators. The common outcome indicators that were selected to be part of this centralized

database were agreed upon by all participating sites. Specifically, medical indicators include

body mass index and percent of healthy weight, including items to define how these are

calculated for each child and youth. Eating disorder behaviour and attitudes indicators are

measured using an internationally recognized and standardized self-report measure of

eating disorders and a relatively new clinician-report measure validated by CHEO

investigators (EDS3). Psychological indicators have been chosen to reflect the two most

common comorbidities in patients with eating disorders and include internationally

recognized and standardized self-report measures of depression (CDI) and anxiety (MASC)

in youth. Parents are also asked to complete a validated measure of self-efficacy in their

ability to support their child through recovery. Other predictor variables agreed upon include

demographic information (age, gender, region) and clinical variables (e.g., diagnosis,

chronicity of illness). Data collection is well underway at all three remaining sites, and is

currently being collected at the time of the initial assessment (a patient’s first presentation to

the treatment program, Time 1) and identical medical, eating disorder and psychological

outcome data is also currently being collected at six months post-assessment (Time 2).

Further, this study is also measuring whether the programs are providing family- and youth-

friendly services, by assessing parent and youth satisfaction with the treatment they receive

(Time 2 only). Finally, the feasibility of the data collection process is to be evaluated by all

those involved in the data collection process using a feasibility questionnaire (via web-based

survey-monkey). This feasibility survey will be distributed once the web-based data base is

operational.


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All programs have the resource infrastructure available to collect the data through

medical/dietetic appointments and/or follow-up appointments with therapists. Trained

therapists and psychometrists are administering and scoring the psychological measures,

and physicians/nurses/dieticians are collecting the medical data. The psychological

measures take approximately 20 minutes for patients to complete. The medical and

psychological data are also being used clinically to track the patient’s progress. Research

assistants (an existing resource at each site) at the respective sites have been involved in

scoring and entering the data into each site’s database, while waiting for the instalment of

the shared web-based statistical database. Raw data remains secured in psychology and

medical files at the respective sites.

Data Definition Dictionary

Once the common indicators were decided upon, a very detailed data definition

dictionary was created. This consisted of detailing the name of the variable as it appeared in

SPSS, the data type, the descriptive variable label, the value number, and the value labels.

This dictionary was created in Excel and describes all 835 variables contained in the

database. An excerpt of the data definition dictionary is provided in Appendix F. Generating

the data definition dictionary required collaboration across sites about each sites existing

data base and the best definition for the new multi-site data base that would still be feasible

for each site.

Web-based database

The centralized database and web application has been developed by the IT

professionals from the E-health Information Lab at CHEO’s Research Institute led by Dr.

Khaled El Emam at CHEO’s Research Institute and supported by Tyson Roffey, Chief

Information and Privacy Officer at CHEO. It has been designed so that each partner is able

to log into the web application through a web browser and then upload and enter all of their


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data into the centralized database. Data may be viewed and retrieved from the database,

via the web application, by those with the correct privileges. Data will be anonymized at the

user end as necessary and sent to the centralized database via a secure channel (i.e. using

128-bit SSL encryption). The database itself will be stored on a server within CHEO. The

server will have the appropriate security, monitoring, and backup systems in place. This set

up will ensure that only the study partners will be able to read and modify the database. The

IT professionals from the E-health Information lab have committed to continuing to provide

support during the pilot testing of the database to ensure that it is stable, user friendly and

secure. Given that the web-based database is maintained at CHEO, credentials and access

will be provided by CHEO researchers to the appropriate people (i.e., study investigators

and trained research assistants), and the CMDP partnership has agreed that CHEO will act

as a gatekeeper to this database. Data within the database will be identified by coded IDs

that correspond to participants at the respective sites. There will be no names or identifying

information stored within the centralized database. Privacy specialists from the E-Health

Information Lab at CHEO have been consulted to ensure that the data stored within the

database meets all privacy standards.

While the data base structure was successfully designed and developed over the

course of the grant, there was a significant delay in moving the data base to the secure

server at CHEO. We have been waiting for 12 months for the implementation of a secure

server that is to house the web-based database. This delay was due to the launch of an

electronic documentation (eclin Doc) system at CHEO which took priority of CHEO IS

resources. IS was unable to provide any personnel due to the time commitment required for

the launch of eClin Doc, resulting in a fairly significant delay in the installation of a secure

server devoted to this project. At this point in the time, the secure server has been

configured, passwords and access have been provided to our software developer, so it

appears reasonable to expect that the web-based database will be secured on the CHEO


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server by the end of April 2011. Once the secure server is established, data from each

respective site will be uploaded into the multi-site database in order for analyses to start.

Outcomes Evaluation

Although unique challenges arose throughout the course of the granting period that

delayed the acquisition of a secure multi-site database to be populated with data that would

allow for evaluative analyses, the vision and objectives for the partnership are still clear and

pressing. The paucity of research on pediatric treatment outcomes in eating disorders has

been noted by researchers over the last decade, and in order to optimize the power and

generalizability of outcomes data, the partnership agreed to work collaboratively to address

three shared objectives.

Data collection commenced at all sites in January of 2010, and ongoing collection is

still underway. Once the web-based database is secured on the CHEO server (expected

date: April 2011), data from each respective site will be uploaded into the multi-site

database in order for analyses to start.

The specific goals of this study were:

(1) To examine the clinical profiles of youth presenting for an eating disorder

assessment in tertiary care hospitals in Ontario;

(2) To examine recovery trajectories of medical and psychological outcome markers of

youth struggling with an eating disorder for six months following their initial

assessment;

(3) To evaluate predictors of outcome based on clinical profiles and treatment services

received over six months.

It is anticipated, that with the ongoing multisite partnership and the dedication of the

remaining sites that are currently committed to the partnership, that the above objectives will

be met in the upcoming months. At the current time, the establishment of the web-based

database on a secure server should be completed by the end of April 2011, and data from


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the respective sites will be imported into the database within the month of May 2011.

Analyses on the data, once available, are set to commence over the summer of 2011.

Feasibility of data collection

In addition to the communal indicators that are collected at each site, the partnership

is also committed to learning about the feasibility of this data collection. Specifically, the

CMDP is interested in knowing the estimation of the rates for patient/parent participation,

enrolment, and adherence/compliance at each of the three sites. In order to collect this

information, a mixed methods survey created through a participatory approach with all co-

investigators was created. Quantitative data will be collected on the number of participants

invited, the number who choose to participate, the number who decline, and the number lost

to attrition at the six-month follow-up time. Qualitative data regarding types of barriers and

facilitators that were felt by each member of the partnership will also be collected, as well as

a rank-ordering of which were felt to be the top 3 barriers or facilitators. Each site will be

asked to complete open-ended questions regarding suggestions to overcome any barriers

and how they felt the facilitators were helpful. This data will be analyzed to determine any

common or site specific themes. All feasibility surveys will be administered by the research

coordinator once the web-based database goes live. In order to evaluate the user-friendly

interface, security, and sustainability of the centralized database over time, as well as

assessing the feasibility of uploading the data in a timely manner, a survey will be

administered to all end-users and investigators at each site. Further, the survey will be

designed to collect the following information about the centralized web-based data base: a)

number of times unable to access the server; b) median time to upload data to the server;

and c) number of mistakes encountered at each site in the uploads. Any ongoing issues

detected from these feasibility surveys will be followed-up by our IT consultant.


22

4) Contribution to KT

One of the final objectives of this project was to promote and contribute to knowledge

translation in this field. Thus, the interdisciplinary, multi-institutional provincial partnership of

the CMDP proposed, secured funding for, and executed a national meeting for specialized

pediatric eating disorder teams in tertiary care hospitals across Canada, with the goals of

connecting, collaborating, and ultimately creating a national outcomes research agenda in

pediatric eating disorders. The meeting, which was CIHR funded, directly addressed child

and youth mental health, with a focus on outcomes research on the treatment of eating

disorders in children and youth. Building on lessons learned and the strength of the

provincial partnership, the CMDP proposed a day that focused on knowledge sharing and

exchange, catalyzing new research initiatives, and creating a national consensus on the

research needs, gaps and opportunities in outcomes management of eating disorders in

children and youth. One of the aims of the meeting was that it would act as a catalyst for the

development of a national interdisciplinary, multi-institutional partnership that will work

toward a national research agenda on outcomes research in the treatment of pediatric

eating disorders. Using the lessons learned from the already formed provincial multi-site

partnership, it was felt that the knowledge gained through a multi-institute national research

initiative would create crucial evidence for the provincial, national, and international

communities regarding the effectiveness of the current standards of care for youth with

eating disorders, and enhance eating disorder treatment for children and youth in Canada

and the international community. Paramount to this initiative was the leadership that the

CMDP Steering Committee provided for the full-day meeting, and the vision that the

provincial partnership held to solidify and create firm stepping stones and guidelines for a

provincial partnership that could then be applied to a larger national platform.


23

Conclusion and Recommendations/Next Steps

In conclusion, through the funding for this grant, Dr. Henderson and Dr. Buchholz

with their co-investigators were successful in creating a formal multisite partnership for

outcomes research on pediatric eating disorders with clear terms of agreement on the use of

the data and authorship, in developing a centralized web-based database, and in

successfully engaging in knowledge translation and exchange.

The development of this multisite partnership is extremely important. Through this

partnership the CMDP will finally be able to start to address the paucity of research

examining outcomes in pediatric eating disorders. The knowledge generated over the

upcoming years from this partnership and centralized database will provide missing

evidence to better guide the prevention and treatment of this serious and chronic mental

health illness affecting many children and youth in Ontario. This knowledge will also be

essential to our national and international partners who work hard to provide excellent care

and treatment to youth suffering from eating disorders.

As noted earlier, the success of the CMDP has allowed the partnership to be

successful in receiving a CIHR grant to hold a national meeting on outcomes research in

pediatric eating disorders. This meeting will help generate much needed interdisciplinary

and inter-site collaborations to enhance outcomes research in pediatric eating disorders

across Canada. The next steps from this meeting include regular working groups and a bi-

annual national meeting to continue to maintain and improve on a national research agenda

for outcomes research in pediatric eating disorders.

The CMDP has learned from the challenges faced in implementing this grant. The

delay in being able to implement the web-based database, was turned into an opportunity to

apply for further funding to pilot test the data and the feasibility of data collection once the

database was established. The team was successful in receiving funds from the Sick Kids

Psychiatry Endowment Fund ($25,000, January 2011- January 2012). The partnership also


24

worked to strengthen the relationship and formal agreement with the CHEO IS department

to ensure the long term sustainability of the web-based database and to prevent future

challenges (as much as possible). The partnership has set the goal of building on the

results and successes of the Centre of Excellence Grant and the Hospital of Sick Children

grant. To this end we are committed to submitting a grant to CIHR in January of 2012 to

provide funds for an extensive 3 year evaluation of programs in Ontario and possibly across

Canada.

Knowledge Exchange

Knowledge exchange and dissemination from this project has focused on ensuring

the success of this centralized multi-site database, with the long term vision that its

successes will be the seed for the development of a province wide centralized multi-site

database for all pediatric eating disorder programs, greatly enhancing knowledge exchange

across the province. Knowledge gained through the process of creating a collaborative

network and a web-based centralized multi-site database has been shared between the

partnering agencies, within their hospitals, with the full Ontario network for eating disorder

providers, and at regional, provincial, and national meetings. It is anticipated that knowledge

and skills gained as a result of the data within this program evaluation project will be used to

better understand the presentation and treatment trajectories of youth with eating disorders

at specialized interdisciplinary eating disorder programs in the province. Having the large

multi-site sample size will allow important questions to be asked and answered regarding

the prognosis of different patients and how to best match treatment to youth at assessment

and throughout their treatment journey, to ensure the best success for each individual and

youth with an eating disorder. The expectation is that the innovative knowledge gained

through these research activities will be shared in the form of presentations, discussions,

face-to-face meetings, publications, etc, and may also lead to the creation of a community of

practice focused on pediatric eating disorders.


25

Also, the partnering agencies and the director of the outreach program, Dr. McVey,

have been engaged in regular knowledge exchange over the course of the granting period,

and she has been kept abreast of the progress and outcomes of this partnership.

Knowledge exchange has occurred through regular teleconference calls and face-to-face

meetings. Further, the multisite partners have and will continue to share knowledge and

anecdotal experiences with one another regarding the process of creating and starting a

multi-site database, by means of regular conference calls which have allowed for the

exchange of new and creative ideas and ensure that each site learns from the experience of

the other sites. These opportunities for exchange have ensured the success of the

centralized database and the longevity of the partnership.

Knowledge and skills gained as a result of this project has been disseminated

through formal and informal presentations and written documents:

• Findings regarding the ongoing multi-site program evaluation project have been

shared with members of the eating disorder teams at each organization, during

weekly/monthly research meetings and bi-annual/annual team retreats.

• Acquired knowledge and skills related to program evaluation generally, the creation

of a multi-site partnership, and of the programs specifically, have been presented to

key hospital staff across the country during a national meeting of all eating disorder

programs. It has also been presented to all pediatric and adult eating disorder

programs at the Annual Provincial Outreach Conference in November 2010.

• It is also anticipated that information will be disseminated through The Provincial

Centre for Excellence’s required Final Outcomes Report and Plain Language

Summary of project outcomes.


26

• As the results of the outcomes evaluation become available, further knowledge

exchange will occur in the form of manuscripts in applied scholarly journals and

presentations at provincial, national, and international conferences.

• Teams at London Health Sciences Centre, the Central West Eating Disorder

Program and an eating disorder team in Newfoundland have consulted the CMDP

principal investigators on outcomes research for children and youth with eating

disorders.


27

References

Katzman, D. K. (1999). Preventing Eating Disorders: A handbook of interventions and

special challenges. Philidelphia, PA: Taylor & Francis Group.

Lock, J. & le Grange, D. (2005). Family-based treatment of eating disorders. Int.J

Eat.Disord., 37 Suppl, S64-S67.

Neiderman, M. (2000). Anorexia Nervosa and Related Eating Disorders in Childhood and

Adolescence. (2nd edition ed.) East Sussex, UK: Psychology Press.

Nielson, S. & Bara-Carrill, N. (2003). Family, Burden of Care and Social Consequences. In

J.Treasure, U. Schmidt, & E. van Furth (Eds.), Handbook of Eating Disorders (2nd

ed., West Sussex: John Wiley & Sons.

Sullivan, P. F. (1995). Mortality in Anorexia Nervosa. American Journal of Psychiatry, 152,

1073-1076.

Wilson, G. T. & Shafran, R. (2005). Eating Disorder guidelines from NICE. The Lancet, 365,

79-81.


28

APPENDIX A

___________________________________

Program Logic Model


29

Evaluation Outcomes ► Medical

stabilization

► Reduction in eating disorder symptoms

► Improved psychological functioning: reduced depression

► Improved psychological functioning: reduced anxiety

► Increase in parent’s self-efficacy in ability to support child/youth

Process Outcomes ► Demographics/

patient profile

► Satisfaction

► Feasibility of outcomes measurement

I N P U T S O U T C O M E S

► Resources specific to program evaluation activities within overall fiscal resources:

○ Children’s Hospital of Eastern Ontario

(CHEO): 0.2 FTE psychologist/psychiatrist; 0.2 FTE psychometrist

○ Hospital for Sick Children (HSK): 0.2 FTE psychologist/psychiatrist; 0.4 FTE psychometrist

○ Southlake Regional Health Centre (SRHC): 0.4 FTE psychologist

► Human Resources:

○ Specialized interdisciplinary team at each of the four sites. Core clinical disciplines include:

- Psychologists - Nurses - Psychiatrists - Dietitians - Pediatricians/Adolescent Health Specialists - CYCs

Program Goals: Improved medical and mental health through specialized pediatric family-based services across the continuum of care for eating disorders

Program Logic Model An evaluation of pediatric eating disorder programs in Ontario:

A multisite approach

• Regular

appointments for nutritional & medical monitoring

• Individual &

group therapy provided in intensive (inpatient & day hospital) and outpatient settings

• Parents/ caregivers & family therapy & education groups

O U T P U T S

Activities Target Group

• Children/

Youth under 18 years of age

• Children/

Youth under 18 years of age

• Parents/

caregivers & families

CO

MPO

NEN

TS

▪ Men

tal h

ealth

ser

vice

s

▪ M

edic

al in

terv

entio

n an

d

n

utrit

iona

l man

agem

ent


30

APPENDIX B

____________________________________

Evaluation Plan


31

Evaluation Plan

● Outcome indicators: Focus on medical stabilization, reduction in eating disorder symptoms, mental health improvement, and increase in parental feelings of self-efficacy toward recovery from eating disorders.

Outcomes Indicator(s) Source of data

Method to collect data

Who collects data

When collects data

E V A L U A T I O N O U T C O M E S

Medical stabilization

Movement toward targeted ideal BMI

Scale & stadiometer

Weight and Height

Team nurse, physician or

team clinician

Assessment and 6 months post-

assessment

Reduction in eating disorder symptoms

Decrease in scores on a self-report &

clinician measures of eating disorder

symptoms

EDI 3 (child/youth)

EDS3 (clinician)

Validated self-report

questionnaire EDS3:

validated clinician rating

scale

Team clinician, psychometrist;

or research assistant


assessment

Improved psychological functioning: Reduced Depression

Decrease in scores on a validated self-report measure of child & adolescent

depression

CDI (child/youth)


questionnaire

Team clinician, psychometrist,



assessment

Improved psychological functioning: Reduced Anxiety

Decrease in scores on a validated self-report measure of child & adolescent

anxiety

MASC (child/youth)


questionnaire




assessment

Increase in parent’s self-efficacy in ability to support child/youth

Increase in scores on a measure of self-efficacy for

parents/caregivers

PVA (parent/

caregiver)


questionnaire



Assessment and 6-months post-

assessment

P R O C E S S O U T C O M E S

Demographics/patient profile

Demographic & clinical patient

profiles

Interview checklist

Clinician completes intake form

Team clinician Assessment

Satisfaction Scores on

Satisfaction Measure: CSQ

CSQ (youth & parents)


questionnaire



6 months post-assessment


32

APPENDIX C ____________________________________

Centralized Multi-site Database Partners


33

Partners

Site Partner Title

Children’s Hospital of Eastern Ontario

Dr. Katherine Henderson Psychologist Dr. Annick Buchholz Psychologist Dr. Mark Norris Pediatrician Dr. Wendy Spettigue Psychiatrist Dr. Nick Barrowman Senior Statistician

Southlake Regional Health Centre

Dr. Karin Jasper Clinical Mental Health Specialist

Dr. Ahmed Boachie Psychiatrist

Hospital for Sick Children

Dr. Leora Pinhas Psychiatrist Dr. Margus Heinmaa Psychologist Dr. Melissa Lieberman Psychologist Dr. Debra Katzman Adolescent Health Physician

Laurentian University Dr. Adele Lafrance Psychologist


34

APPENDIX D

____________________________________

CMDP Partnership Agreements


35

CENTRALIZED MULTI-SITE PARTNERSHIP OF PEDIATRIC EATING DISORDERS PROGRAM’S IN ONTARIO

- AUTHORSHIP GUIDELINES, ROLE DEFINITIONS AND PROCEDURES MANUAL -

Background/Reference Material Regarding Authorship

The Committee on Public Ethics Report on Authorship Disputes recommends that authorship issues should be discussed right at the start. “Start gathering views of all team members and if possible discuss authorship at a face-to-face meeting. Even before a study is finished, you should have some idea of the publications that might come out of it, such as a conference abstract, the full paper, then some supplementary papers, and who is likely to be most involved in these. Continue to discuss ideas about authorship as the project evolves, and especially if new people get involved. Keep a written record of your decisions.” Decide authorship before you start each article. Many authorship difficulties arise because of misplaced expectations and poor communication. So it is important that, before you start to write up your project, you confirm in writing who will be doing what and by when. Ideally you should do this face to face, though this may not always be possible. Keep everyone informed of any changes with a written note. (http://publicationethics.org/files/u2/2003pdf12.pdf) According to the International Committee of Medical Journal Editors (ICMJE) (www.icmje.org), “…an author is generally considered to be someone who has made substantive intellectual contributions to a published study”. Authorship applies to all publications, abstracts and presentations and any other published or presented material (will be referred to as papers throughout this agreement). As detailed in the ICMJE’s Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (2008):

• Authorship credit should be based on 1. substantial contributions to conception and design, acquisition of data, or

analysis and interpretation of data; 2. drafting the article or revising it critically for important intellectual content;

and 3. final approval of the version to be published.

Authors should meet conditions 1, 2, and 3. • When a large, multi-center group has conducted the work, the group should

identify the individuals who accept direct responsibility for the manuscript. • Acquisition of funding, collection of data, or general supervision of the research

group alone does not constitute authorship. • All persons designated as authors should qualify for authorship, and all those

who qualify should be listed. • Each author should have participated sufficiently in the work to take public

responsibility for appropriate portions of the content.

According to Tri Council Policy on Integrity in Research and Scholarship (www.nserc-crsng.gc.ca)

• All papers will recognize the substantive contributions of collaborators and students.

http://publicationethics.org/files/u2/2003pdf12.pdf

http://www.icmje.org/

http://www.nserc-crsng.gc.ca/

http://www.nserc-crsng.gc.ca/


36

• All papers will ensure that authorship of published work includes all those who have materially contributed to, and share responsibility for, the contents of the publication, and only those people.

Background/Reference Material Regarding Contributors Listed in

Acknowledgments All contributors who do not meet the criteria for authorship should be listed in an acknowledgment section. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chair that provided only general support. Corresponding authors should declare whether they had assistance with study design, data collection, data analysis, or manuscript preparation. If such assistance was available, the authors should disclose the identity of the individuals who provided this assistance and the entity that supported it in the published article. Financial and material support should also be acknowledged. Groups of persons who have contributed materially to the paper but whose contributions do not justify authorship may be listed under such headings as “clinical investigators” or “participating investigators,” and their function or contribution should be described—for example, “served as scientific advisors,” “critically reviewed the study proposal,” “collected data,” or “provided and cared for study patients.” Because readers may infer their endorsement of the data and conclusions, these persons must give written permission to be acknowledged. As recommended by the Council of Science Editors’ Recommendations for Group Author Articles in Scientific Journals and Bibliometric Databases, the CMDP team will use the following byline style when the number of contributing authors exceeds that requested by a specific journal. Byline: Steven Q Smith, MD, Yoko Suzuki, MD, J T Mann, PhD, Klaus T Schulze, MD, Christine DeAngelo, MD, Charles Davis, MD, PhD, Katherine J Jones, MD, and CMDP of PEDP in Ontario.


37

Centralized Multi-Site Partnership of Pediatric Eating Disorders Program’s in Ontario’s

Additional Processes Regarding Authorship, Acknowledgements, and Manuscripts Agreement

Our approach to authorship is inclusive in that all partners/investigators will have the opportunity to be co-authors on papers and presentations. Decisions about lead authorship on papers that address primary research questions are/were discussed when the CMDP group met/meets on XXX and are documented in the “People & Projects” document. Any changes to the documented decisions will be made by the research team by 100% consensus. Decisions about lead authorship on papers that address secondary research questions will also be made by the research team by consensus. The CMDP investigators will establish a PI lead group. The investigators will each choose ____ from each site to sit on the PI lead group committee. This committee will meet regularly to review research proposals, authorship, and timelines for research papers.

• The investigator team will prepare and approve a list of potential manuscripts and presentations, lead authors and timeframes that will be approved by all investigators.

• The list of proposed manuscripts will identify a corresponding “lead” author who will meet the criteria above and will hold responsibility for drafting the first version, managing input from other authors, manuscript submission and editorial process.

• Investigators who take a key role in the writing of any paper of the full study findings will be listed according to their contribution following the lead author. If contributions are equal, authors will be listed alphabetically.

• Site Investigators will have the first option to be the lead author on papers that report results from an individual site.

• All authors have the right to opt-out of any paper where they feel they have not contributed by informing the lead author in writing at the time of the first manuscript review.

• The lead author should inform any co-authors who have not participated or contributed to the paper or to the review process following the designated review timeline that they will be removed from the author list and included in the Acknowledgments.

• The PI Lead Group and all co-investigators will be informed of any proposed manuscripts or presentations stemming from the CMDP’s database that have not already been vetted by the team. All proposed papers will be submitted to the PI Lead Group with a title, proposed list of authors, short abstract, intended journal and timeframe for submission. This will be circulated to the investigator team for review and approval. The PI Lead Group will provide written permission via email to the investigative team to proceed with manuscript submission, after an in-person or conference call discussion. Manuscripts will be prepared and submitted in a 12 month period from the time of outline approval, unless otherwise indicated in the Application for Requesting Secondary Use of Data.

• All authors involved with a paper will be responsible for reviewing and making


38

contributions within a timely manner including: o 2 weeks for manuscripts o 1 week for abstracts

Students and Learners

• All students and other learners who have contributed to the project will be acknowledged in the Acknowledgement section.

• If a student or learner assumes a major role in a secondary project associated with the CMSP database, under the supervision of a Partner, the student or learner may request to co-lead authorship. Under this circumstance, the student or learner would have to play a major role in the initial draft.

Any concerns regarding authorship decisions should be discussed with the PI Lead Group.

Designating a New Partner on the CMDP of PEDP of Ontario To be considered as a partner the candidate must meet the following criteria:

• Be nominated by a partner of the CMDP • Be a clinician/treatment provider with one of the partnering organizations

Decision making regarding the designation of a new partner will include the following;

• Information is presented to the PI Lead Group for discussion and a recommendation.

• If the PI Lead Group agrees on a recommendation, the information and PI Lead Group’s recommendation is shared with all partners via email and feedback is requested (options: agree with recommendation or prefer to discuss with all partners).

• If the PI Lead Group do not agree on a recommendation, the information is shared with the all partners and is discussed during a teleconference or in-person meeting.

Formalizing the designation of a new partner will include the following;

• A member of the PI Lead Group will invite the candidate to join the partnership via email and outline anticipated contributions and collaborations, and send the candidate relevant documents (e.g. this manual, Research Projects & People, and Application for Requesting Secondary Use of Data).

• Once the candidate confirms this agreement to join the partnership, a member of the PI Lead Group will ensure that the candidate completes the Partnership Letter of Agreement.

• The Research Projects & People document will be updated.


39

Background/Reference Material Regarding Intellectual Property and Data Sharing According to Tri Council Policy Statement: Ethical Conduct for Research Involving Humans 1998(TCPS) www.pre.ethics.gc.ca, the following principles will be followed. Article 11.11 With respect to research findings:

(a) Institutions and research ethics boards should take necessary measures to ensure that researchers and institutions share research results and publish or otherwise disseminate the analysis and interpretation of research findings in a timely manner without undue restriction.

Article 11.11 further states: 4. Provide that all confidentiality and publication clauses: (a) Are consistent with the researcher’s duty to share new information from

clinical trials with REBs and trial participants in a timely manner (Section D [“Sharing New Information”]);

(b) Are reasonable in terms of any limitations or restrictions on the publication or other dissemination or communication of information; and

(c) Permit researchers to access study data.

Centralized Multi-Site Partnership of Pediatric Eating Disorders Program’s in Ontario’s

Intellectual Property and Data Sharing Agreement All data will be shared with co-investigators through remote access to the centralized

multi-site database. Note that this does not permit an investigator to publish from this data unless agreed upon in the process detailed in this document.

Each site will send a copy of raw data to the research team lead at the Children’s Hospital of Eastern Ontario’s Eating Disorders Program.

http://www.pre.ethics.gc.ca/


40

Application for Requesting Secondary Use of Data Compiled by the

Centralized Multi-Site Partnership of Pediatric Eating Disorders Program’s in Ontario

The Centralized Multi-Site Partnership (CMSP) of Pediatric Eating Disorders Program’s in Ontario fosters a collaborative atmosphere. This self-governing group makes decisions based on 100% consensus. While the group operates on an honor system, there are requirements and conditions of participation that have evolved and which must be met if the privileges of access to CMSP data sets are to be granted. These conditions are outlined in this document, the Partnership Letter of Agreement, and the Authorship Guidelines, Role Definitions, and Procedures Manual, each of which must be read before signing this Application. Partner use of data from the CMSP database is contingent upon adherence to the following stipulations: 1. A brief research proposal outlining the title, proposed list of authors, a short abstract (detailing the research question(s), relevant hypotheses, sub-sample or groups, variables, and proposed statistical methods), intended journal for submission, and a timeframe must be submitted to the CMSP PI Lead Group for approval. The PI Lead Group may work to refine the research topic and questions to prevent duplication or overlap with existing projects. 2. The proposal must also identify how this study adheres to the purposes of CMSP and might be of benefit to youth struggling with an eating disorder. 3. Ethics review must be obtained from an accredited Research Ethics Board at the partner’s institution, prior to submission to the Research Ethics Board at the Children’s Hospital of Eastern Ontario. 4. All data analyses must be conducted by remote access to the Centralized Multi-Site Database housed by the Children’s Hospital of Eastern Ontario. No dataset or subset may be copied or removed. 5. Partners agree to hold all data as confidential, and will neither conduct analyses nor report data in such a way that individual participants could be identified or identifiable. 6. Any reports, manuscripts, presentations, or posters must be approved in writing by the PI Lead Group of the CMSP prior to submission; requests for review and approval must be made at least 3 weeks before the submission deadline. 7. Acknowledgment of the CMSP as the source of the data must be made in any reports, manuscripts, presentations, or posters. 8. Approval is for a particular purpose and research question(s) and cannot be transferred to another person or extended to include other uses. If you wish to expand the scope of the project to include other questions, you must first discuss this with the PI Lead Group, have the approval of all partners, and have approval in writing from the CMSP Lead. 9. CMSP encourages the dissemination of research to the wider community. It is expected that each project will conclude with a brief fact sheet or abstract of results for general audiences that the CMSP can distribute to policymakers, professionals who work with this population, and youth themselves.


41

10. Permission for the use of data is given for a specified period of time. If the project is not completed during this time period, the permission is rescinded, unless an extension has been approved by the CMSP. The specific time period will be discussed and agreed on by all partners of the CMSP. 11. In order to promote timely reporting of research, if a partner contracts to submit a manuscript for publication from their project, and such a manuscript is not submitted within the approved timeline, the PI Lead Group reserves the right to approve/assign a new lead to that particular project who will prepare this manuscript for publication on the partners behalf. In such a circumstance, author order may need to be renegotiated to reflect the efforts of the CMSP partner who assumes the lead role on this project. 12. A copy of any reports, manuscripts, presentations, posters, or fact sheets must be given to all CMSP partners.

The Centralized Multi-Site Partnership of Pediatric Eating Disorders Program’s in Ontario gives permission to:

Name ______________________________________________________________________ To use the following variable(s) from the data set _____________________________________ For the proposed project entitled: _____________________________________________________________________________________________________________________________ which has been submitted to the Centralized Multi-Site Partnership (see attached) and has been approved by all partners of the Centralized Multi-Site Partnership on (date) ________________ The permission is given for the time period of __________ to _____________________ I have read all the requirements in this contract and I agree to adhere to them. Signature ________________________________ Date _________________________ Name ___________________________________ Title _________________________ Partnering Site __________________________________


42

As a member of the PI Lead Group, my signature below indicates that I have agreed to allow the data from my site to be included in the data analyses conducted by the above stated partner, for the above stated purpose(s). Signature _______________________________ Date _________________________ Dr. Annick Buchholz, Children’s Hospital of Eastern Ontario, Eating Disorders Program Signature ________________________________ Date _________________________ Dr. Sherry Van Blyderveen, McMaster Children’s Hospital, Pediatric Eating Disorders Program Signature ________________________________ Date _________________________ xxx Signature ________________________________ Date _________________________ xxx


43

APPENDIX E

____________________________________

Assignment of Research Studies


44

Research Projects

Project Lead Site Brief Description Publications

Assessment Data

CHEO

Clinical profile by diagnostic category (AN-R, AN-BP, etc.) of youth presenting for an eating disorder assessment at a tertiary care hospital in Ontario.

CHEO Examining parent variables at assessment.

Southlake Satisfaction with assessment services provided.

Southlake Presence of abuse at assessment.

HSK Using assessment data for the purposes of improving the system of diagnostic classification, using latent class analysis.

Follow-up Data

CHEO Trajectory of different diagnostic category (psychological focus).

Southlake

Exploration of how assessment results relate to treatment recommendations and how recommendations map onto services offered and accepted.

HSK Predictors of short term medical outcomes.

HSK Determination of ideal body weight.


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APPENDIX F

____________________________________

Excerpt from Data Definition Dictionary


46

A Centralized Clinical Outcome Measurement of Eating Disorders in

Documents

Transcript of A Centralized Clinical Outcome Measurement of Eating Disorders in