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\begin{document}

\title{Translation And Adaptation Of CF R.I.S.E Transition Program To Turkish}



\author[1]{Merve Selcuk}%
\author[1]{Yasemin Gokdemir}%
\author[1]{Ela Erdem Eralp}%
\author[1]{Almala  Ergenekon}%
\author[1]{Cansu Yılmaz Yegit}%
\author[1]{Mürüvvet Yanaz}%
\author[1]{Aynur Guliyeva}%
\author[1]{Mine Kalyoncu}%
\author[1]{Seyda Karabulut}%
\author[1]{Neval Metin Cakar}%
\author[2]{Burcu Uzunoglu}%
\author[2]{Gamze  Tastan }%
\author[3]{Damla Kocamaz }%
\author[3]{Ozge Kenis-Coskun}%
\author[4]{Ilknur Gorgun}%
\author[5]{Randall Messier}%
\author[5]{Pamela Mertz}%
\author[1]{Fazilet Karakoc}%
\author[1]{Bulent Karadag}%
\affil[1]{Marmara Universitesi Tip Fakultesi}%
\affil[2]{TC Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi}%
\affil[3]{Marmara Universitesi Egitim ve Arastirma Hastanesi}%
\affil[4]{KIFDER}%
\affil[5]{Institute for Excellence in Health and Social Systems (IEHSS}%


\vspace{-1em}



  
  \date{June 17, 2024}


\begingroup
\let\center\flushleft
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\selectlanguage{english}
\begin{abstract}
\textbf{Background:} Previously, Cystic Fibrosis (CF) patients faced a
limited life expectancy, but significant medical advances now highlight
the need for successful transition programs from pediatric to adult
care. \textbf{Methods:} The aim of this project was to implement the CF
R.I.S.E. program, a structured transition program, in a CF center with
limited resources at Marmara University. The program was adapted and
translated into Turkish with the permission of the Cystic Fibrosis
Foundation. A multidisciplinary team collaborated in the translation and
adaptation process and educational materials were developed for patients
and families. \textbf{Results:} Successful implementation of the CF RISE
program was achieved within six months. A pilot study with randomly
selected patients revealed positive feedback indicating the
effectiveness and understandability of the program. The program
facilitated strong collaboration between pediatric pulmonologists, CF
nurses, dietitians and patient representatives. However, challenges were
encountered due to the lack of a designated social worker, which
affected patients' access to expert guidance on social security and
disability rights. \textbf{Conclusions}: The CF S.O.B.E. program was
successfully adapted and implemented at the Marmara University CF Center
in Turkey. The program is expected to have a positive impact on
patients' knowledge and self-care skills over a period of 1.5 years. It
is aimed to make the program a routine practice in the center and to
expand the collaboration with adult clinics. Further studies are needed
to assess its long-term impact and applicability in different health
settings. The ultimate goal is to disseminate the program's resources
and promote structured transition practices nationwide.%
\end{abstract}%



\sloppy


\textbf{1. INTRODUCTION}

Cystic Fibrosis (CF) is a genetic disorder with an incidence rate of
1/3000-1/6000 live births \textsuperscript{1-3}. In the 1930s life
expectancy for people with CF (pwCF) was limited to just a few years,
but medical advancements have increased life expectancy, with modulatory
drugs targeting specific gene defects being effective in a majority of
the CF population \textsuperscript{4}.

Currently, more than half of the CF population in Europe, Canada and
North America is over 18 years old, a significant increase is expected
in the number of pwCF transitioning from pediatric to adult
care\textsuperscript{5,6}. The transition period can be a stressful time
for young adults with chronic diseases and can result in poor health
outcomes\textsuperscript{7}. A structured transition program can help
prepare pwCF and their caregivers and lead to higher patient
satisfaction, lower anxiety, and greater
self-esteem\textsuperscript{8,9}.

When developing a successful framework for transitioning healthcare
services for pwCF, it is important to consider strategies that will help
prepare pwCF and their caregivers, as well as tools that can track and
measure transition progress at various stages \textsuperscript{10}.

A comprehensive transition program should involve a well-coordinated
approach that includes a clinical summary with contributions from all
members of the pediatric multidisciplinary team (nurses, doctors,
dieticians, psychologists, social workers, and physiotherapists), an
opportunity to meet the adult care team at the adult CF center, and
ensuring timely access to an adult care provider\textsuperscript{11,12}.
In cystic fibrosis (CF) transfer programs, the involvement of social
workers is paramount for a seamless transition from pediatric to adult
care. These professionals, form a multidisciplinary transition team,
with social workers often serving as the ''transition coordinator'' for
individual patients\textsuperscript{12,13}. As the number of adults with
CF increases, comprehensive transition programs and clinics are becoming
more common in many countries \textsuperscript{14-16}.

CF R.I.S.E. (Responsibility, Independence, Self-Care, Education) is a
planned, structured transition program created to improve quality of
life, maximize independence, and minimize interruptions in care as a
patient transitions from pediatrics to an adult
subspecialist\textsuperscript{12,16}. This program has been successfully
implemented in the United States since 2015 providing tools and
resources to help patients and caregivers understand the disease and
develop skills for managing it independently. CF R.I.S.E. aims to
provide a gradual and purposeful transition of responsibility over time
from support person to patient, while facilitating communication among
pediatric and adult care teams, patients, and caregivers
\textsuperscript{17}. The program has the potential to address the
deficits in transition and has been positively evaluated by CF
healthcare providers during its implementation period
\textsuperscript{10,12}.

Although adult patients have been increasing steadily over the years,
the number of adults with cystic fibrosis in Turkey is relatively lower
compared to Europe and North America. Being the largest center in
Turkey, there are 424 individuals with CF in Marmara CF center and only
103 (24.3\%) are adults. Since there was no structured transition
program in our center, we decided to implement the CF RISE program by
making the necessary translations and adaptations during the Cystic
Fibrosis Foundation (CFF) Virtual Improvement Program-F7 (VIP-F7)
training program. We named our transition program CF S.O.B.E, which
consists of the first letters of responsibility, self-care, independence
and education in Turkish.

Our aim was to convey our experience of the adaptation and
implementation process of the CF RISE program in a CF center with
limited resources. To our knowledge, this is the first implementation of
CF RISE program outside of the US and in another language other than
English.

\textbf{2 MATERIALS AND METHODS}

\textbf{2.1 Setting and design}

This is a quality improvement project created within the VIP-7 program
in March 2022 at Marmara University (MU) Faculty of Medicine Selim
Coremen CF Center. The study was approved by the respective ethics
review board of the participating institutes the Ethics committee of
Marmara University. (Project No: 07.10.2022.1359). A total of 81
individuals between the ages of 16-25 are followed in our center, 40
people residing in Istanbul who could regularly come to CF clinics were
selected for implementation CF RISE. Permission was obtained from the
CFF for the translation and usage of CF-R.I.S.E. materials. Written
consent was obtained from the participants and their families.

\textbf{2.2 MU CF Team}

MU CF team consists of 5 pediatric pulmonologists, 6 pediatric
pulmonology fellows, 2 CF nurses, 1 dietitian, 1 physiotherapist, and 1
patient representative from the Turkish Cystic Fibrosis Association
(KIFDER). As part of the CFF QI project, all transition team members
regularly attended weekly quality improvement meetings with 2 QI coaches
from October 2021-October 2022. A social worker and psychologist are not
part of the CF team.

\textbf{2.3 Step 1: Translation and adaptation}

\textbf{2.3.1 CF R.I.S.E Program}

The CF R.I.S.E. program includes 13 Knowledge Assessment Questionnaires
(KAQ) and 6 Responsibility Checklists (RCL) forms\textsuperscript{18}.
The purpose of the KAQ is to evaluate the individual's basic knowledge
about CF. It covers topics related to lung and liver health, infection
prevention methods, pancreatic insufficiency, nutritional principles,
endocrinology problems, school, work, financial, and social security.
These assessments are introduced gradually. Each module is completed
independently by the pwCF without parental or team assistance, to
accurately assess areas for knowledge improvement. Once completed, the
responsible CF care team member devises a plan to address identified
knowledge gaps. After providing the necessary trainings, the modules are
reassessed in subsequent visits or in 6 to 12 months to measure
progress\textsuperscript{18}.

The CF RISE program covers six responsibility checklists: 1) Working
with the CF care team and other healthcare professionals, 2)
Responsibility of CF Treatments, 3) Living with CF, 4) CF Transition, 5)
School and Career Plan, 6) Finance and Insurance. These are designed to
facilitate the acquisition of age-related self-care skills for everyone.
Although KAQs are applied only to patients, RCL forms are collaborative
assessments involving a designated support individual and the CF
healthcare team to assess and monitor the patient's current level of
responsibility. In the RCL forms, patients/parents are required to
respond to each question using a Likert scale ranging from 1 to 5. The
results of each question are compared between the parent and pwCF, and
if there is inconsistency, the individual's level of responsibility for
that question is reevaluated \textsuperscript{18}.

A target responsibility is identified for the next meeting between the
transition clinic (TC) representative and the pwCF based on the RCL
results. The assigned tasks are recorded in a progress report, signed by
both parties, and a copy of the progress report is given to the pwCF.
The assigned responsibility is determined based on the individual's
needs and level, and the interaction between the TC representative and
the pwCF is contractual in nature\textbf{.} The progress of patients is
reassessed one year later with renewed RCLs \textsuperscript{18}.

\textbf{2.3.2 Translation of CF R.I.S.E materials in Turkish}

1- Translation and adaptation: All materials of the CF R.I.S.E program
were translated into Turkish by the MU team. Necessary changes were made
in the health and finance, business, and college program contents
according to the conditions in our country.

2- Translated materials were evaluated for comprehensibility and content
by senior team members and a team of volunteers from KIFDER, including a
pwCF, a Turkish grammar teacher and two other members of KIFDER.
Materials were designed to be understandable at the 3rd or 5th grade
level. All translated and newly created materials were shared with CFF.

After the translation of all CF R.I.S.E materials into Turkish, the
contents were reviewed by the team members, and adaptations were made
according to our country's conditions. Since the College-Business Life
and Finance-Social Security KAQs in CF RISE contain questions about the
educational and social security system in US, we have created new KAQs
suitable for the conditions of our country and the rights of the
disabled. The two KAQs of Lifestyle and Mental Health were combined into
a new KAQ called ''Lifestyle and Mental Health'' (Table 1).

\textbf{2.3.3 Patient Education Materials}

Educational resources including patient leaflets, webinars and videos
were produced on all topics covered by the Knowledge Assessment
Questions (KAQ). As part of the CF S.O.B.E initiative, webinars, patient
leaflets and videos, were available online through a website created
specifically for this project (16).

\textbf{2.4 Step 2: Timeline}

We planned to reassess patients' knowledge levels regarding the
completed topics every 6 months via KAQs. We also planned to identify
wrong answers and focus on these subjects in their following clinical
appointments provide the correct answers face to face. We created 4
training modules and determined dates for online meetings every 3 months
to cover the related content of these training modules. We also aimed to
apply two different RCLs at each appointment and reapply RCLs after 12
months. The timeline created within this scope is provided in detail in
Figure 1.

\textbf{2.5. Step 3: Pilot Study}

A pilot study was conducted with a 16-year-old male and a 21-year-old
female patient randomly selected by TC team members. During the pilot
study, BOTH patients were asked to complete 11 core KAQs and 2
responsibility checklists. Both patients confirmed that the materials
were understandable and informative. They expressed their excitement
about the implementation of such a program. The pilot visits lasted 30
and 40 minutes respectively. Feedback from the CF team revealed that
patients would need an extra 30-40 minutes of in addition to their
routine clinical procedures. After the pilot study, the program was
introduced to all families and patients through an online meeting.

\textbf{3. DISCUSSION}

In this quality improvement program we aimed to report our experiences
regarding the adaptation and implementation process of the CF RISE
program in a CF center with limited resources. The successful
translation and implementation of the program were accomplished within a
six-month period.

The pilot study provided positive feedback from patients, demonstrating
their favorable evaluations regarding the content and comprehensibility
of the program. Young pwCF described the education they received as
''exciting and necessary,'' stating that it allowed them to better
understand their condition and take responsibility for their care. This
program was implemented through strong collaboration among pediatric
pulmonologists, CF nurses, dietitians, and volunteer patient
representatives. We had no financial support or social worker.

Formal transition processes for pwCF have been implemented worldwide
since 1982, primarily in the United States and
Canada\textsuperscript{16,19}. The United Kingdom has been at the
forefront of establishing a transition program in Europe, and studies
conducted in in several countires have reported positive outcomes
regarding structured transition programs \textsuperscript{15,20,21}.
Among these transition protocols, the CF RISE program, developed as part
of quality improvement initiatives with resources from the CFF, has been
successfully implemented in the United States for many years
\textsuperscript{17}. Therefore, the CF RISE program was chosen as a
global example to be implemented in our country, representing the first
translation and adaptation of the CF RISE program into a language other
than English.

The success of establishing the CF S.O.B.E. program can be attributed to
various factors. Active participation of a multidisciplinary team,
expertise of subject specialists in developing educational resources,
and the inclusion of patient representatives and language educators
played crucial roles. Additionally, regular meetings between the
transition team and QI coaches from the CFF VIP-F7 program, as well as
valuable feedback from patients and families, facilitated continuous
improvements and adaptations to meet the needs of patients and the
healthcare system.

During the development of this program, a significant challenge
encountered was the absence of a designated social worker as a project
coordinator. The establishment of transition protocols for adult clinics
and their continuous implementation within the hospital setting are
critical, and social workers, typically serving as program coordinators
in centers where CF R.I.S.E has been successfully implemented for years,
play a vital role within the transition team \textsuperscript{12,16,22}.
Due to limited availability of social workers and psychologists in our
hospital, it was not possible to assign a social worker to the
transition project. As a result, a significant portion of our patients
did not have access to expert guidance on social security and disability
rights. Consequently, pwCF and their families lacked awareness of
government regulations concerning social security and disability rights,
and their knowledge on this topic was limited. As part of this project,
collaboration was established with volunteer experts through the CF
patient and family association (KIFDER) to review government regulations
regarding social security and disability rights and prepare written
materials. A comprehensive online meeting was conducted with the entire
transition team to ensure an inclusive approach and facilitate the
dissemination of information to all team members.

Collaborative consultations and joint clinics involving professionals
from both the pediatric and the adult clinic are often preferred over
direct handovers \textsuperscript{12,22}. The next phase of our research
involves integrating the adult clinic into the transition program and
establishing a fully structured joint transitional outpatient clinic
aimed at optimizing the transition process for patients. These clinics
would be dedicated to patients who are prepared to transition from the
pediatric clinic to the adult clinic at our center.

However, the implementation of the program in a single center may have
certain limitations regarding its generalizability to other centers in
Turkey. In order to gain a deeper understanding of the program's
effectiveness, future studies should emphasize the assessment of its
long-term impact on patient outcomes, as well as its suitability for
different centers and the healthcare system in our country. With this
objective in mind, following the initial evaluations of the CF SOBE
program at our center, our aim is to distribute the resources we have to
CF centers nationwide and promote the implementation of structured
transition practices throughout the country.

\textbf{4. CONCLUSION}

CF R.I.S.E was successfully translated and adapted in our center. The
success of the adaptation of CF RISE program can be attributed to the
participation of a multidisciplinary team, utilization of educational
resources, and regular meetings for feedback and compliance. Based on
the program's outcomes, the aim is to share all materials and surveys
with other centers, ensure their utilization, and benefit all pwCF.

In the coming period, our center will enroll pwCF aged 16-25 years in
the CF SOBE program. The enrolled patients will be reassessed for their
knowledge and skills after KAQs and RCLs. People with CF and their
families who receive personalized education within the scope of the
project are expected to increase their knowledge and skills about CF at
the end of 1.5 years. Periodically throughout the project, the
individual deficiencies of the patients will be identified through
interim information assessments and individual and collective trainings
(webinars, etc.) will be organized to overcome the information
deficiencies (see Figure 1).

It is aimed that the project will become a routine practice of our
center in the coming period. In addition, within the scope of the
project, joint visits with adult clinics with limited experience in CF
are aimed to increase their expertise in CF disease and active
participation of transfer clinics in the project.

\textbf{5. ACKNOWLEDGMENTS}

The authors would like to thank the CFF VIP-7 team, KIFDER volunteers,
patients for participating and for their feedback and assistance in
conducting the study.

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