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\begin{document}

\title{IMPLEMENTATION OF A FORMALIZED EVALUATION AND PLANNING TOOL TO IMPROVE
PEDIATRIC ONCOLOGY OUTCOMES IN KENYA}



\author[1]{Jaime Libes}%
\author[2]{Doreen Mutua}%
\author[3]{Ayomide Omotola}%
\author[3]{Miguel Bonilla}%
\author[3]{Nickhill Bhakta}%
\author[3]{Paola Friedrich}%
\author[4]{David Wata}%
\author[5]{Sarah Nyaboke O-Muma}%
\author[6]{Michael Ganey}%
\author[2]{Carol Muriithi}%
\author[7]{Martin Mwangi}%
\author[7]{Alfred Karagu Maina}%
\affil[1]{University of Illinois Chicago College of Medicine at Peoria Department of Internal Medicine}%
\affil[2]{Gertrude Children’s Hospital}%
\affil[3]{St Jude Children's Research Hospital Department of Oncology}%
\affil[4]{Kenyatta National Hospital}%
\affil[5]{AIC Kijabe Hospital}%
\affil[6]{Tenwek Hospital}%
\affil[7]{Kenya Ministry of Health}%


\vspace{-1em}



  
  \date{May 27, 2024}


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\selectlanguage{english}
\begin{abstract}
Survival from pediatric cancers in low-middle-income countries is often
very low compared to that of high-income countries due to multifactorial
etiologies, including late presentation, delayed diagnosis, difficulty
with accessing health care, drug unavailability and treatment
abandonment. The St. Jude Pediatric Oncology Facility Integrated Local
Evaluation Tool (PrOFILE) was developed to identify the strengths and
weaknesses of individual institutions, as well as whole countries.
Following the completion of data analysis from Kenyan institutions, the
first PrOFILE hybrid in-person and virtual workshop was held.
Multi-disciplinary stakeholders prioritized recommendations for
improving care and developed smart objectives to accomplish identified
goals over the following 2 years. Strengths and weaknesses of conducting
a hybrid global workshop were identified.%
\end{abstract}%



\sloppy


\textbf{Introduction}

Survival from pediatric cancers in low-middle-income countries (LMICs)
is much lower than higher income countries (HICs) due to late
presentation, delayed diagnosis, difficulty with accessing health care,
drug unavailability and treatment abandonment{[}1-13{]}. There is often
an extreme shortage of trained health care providers and the referral
pathway to a hospital equipped to care for children with cancer is
burdened by long wait times, travel time and distance and financial
barriers. Within Kenya, financial barriers, lack of standardized
treatment protocols and inconsistent family education about the planned
treatment, as well as concerns with treatment delays within the
hospitals have been shown to lead to abandonment of curative
therapy{[}14-19{]}.

The Pediatric Oncology Facility Integrated Local Evaluation Tool
(PrOFILE) assessment was developed to identify the strengths and
weaknesses of individual institutions within a country, as well as the
pediatric oncology services on a national level. Following an extensive
needs assessment, workshops are conducted with key stakeholders to
identify actionable goals to be achieved over the next few years to
improve pediatric oncology care.

The PrOFILE tool provides comprehensive, modular and self-guided
institutional self-assessments. PrOFILE had already been conducted in 61
pediatric oncology units in 16 countries. Each institution and country
received score-based reports and then workshops were conducted either
in-person or completely virtual. Outcome based goals were then set by
each country to improve care within pre-determined time frames. Due to
timing around an improving, but still ongoing pandemic, the Kenyan
PrOFILE workshop was the first one conducted in a hybrid format.

\textbf{Methods}

\emph{Foundational Pre-Workshop Activities}

\emph{PrOFILE Assessments}

To assess the current situation of the participating hospitals, as well
as identify strengths and opportunities at the national level, the
abbreviated version of the St. Jude Pediatric Oncology Facility
Integrated Local Evaluation (PrOFILE) self-assessment tool was
implemented in seven hospitals where pediatric oncology services are
offered in Kenya. These hospitals were identified by Gertrude Children's
Hospital and the National Cancer Institute (NCI) and as estimated by
GLOBOCAN 2018, have an average of number of 6,000 new patients per year.
PrOFILE provides a snapshot of the pediatric hematology and oncology
landscape and care continuum at both country and facility levels over
the following 12 modules: national context, facility and local context,
finances and resources, personnel, service capacity, service
integration, diagnostics, chemotherapy, supportive care, surgery,
radiation therapy and patients and outcomes. These modules are grouped
into five specific components, including Context, Workforce,
Diagnostics, Therapy, and Patients \& Outcomes. One outcome of the tool
is a comprehensive list of strengths and opportunities, as well as
suggested collaborators and St. Jude support packages corresponding to
each of them.

Foundational pre-work included an introductory online meeting with
Kenyan NCI officials, Gertrude Children's Hospital in Nairobi, an
American twinning partner to University of Nairobi, and the St. Jude
PrOFILE and Sub-Saharan Africa Regional Teams. During the meeting, St.
Jude presented the PrOFILE tool, its methodology, and previous
experiences using the tool. Within Kenya, this initiative was
coordinated by representatives from Gertrude Children's Hospital, NCI
and WHO.

\emph{Data Analysis}

Using the REDCap tool, data collection and entry took place from October
2021 to December 2021. The PrOFILE team analyzed the data and prepared
the reports in January 2022. The aggregate report was used in the Kenya
National Stakeholder Workshop on Childhood Cancer activities
(Supplemental File S1).

\emph{Workshop Planning}

After the local results were disseminated, each participating
institution was encouraged to present their results -- strengths and
weaknesses/reflections/impression at the weekly St. Jude Sub-Saharan
Africa tumor board meeting. At this meeting, each site had the
opportunity to present their impressions to a larger audience which led
to thoughtful conversations, better insight of the situation of the
institution and feedback from their colleagues.

To ensure the correct stakeholders were present at the national
workshop, the core planning team (St. Jude, an American twinning partner
at University of Illinois (UIC), NCI and Gertrude Children's Hospital)
met to conduct a stakeholders analysis using the C5 (C-2) tool developed
by St. Jude Global. During this meeting, the team met to identify,
assess, and prioritize partners involved in the care of children with
cancer in Kenya. The meeting outcome informed the invitation list which
was sent by the NCI (Ministry of Health (MoH)). After this, the team
reviewed the stakeholders list and using the objectives, drafted the
meeting agenda. The agenda allowed time for both the care providers and
the funding agencies/foundations to discuss ways they can collaborate to
ensure improved outcomes for children with cancer in Kenya.

\emph{Workshop agenda}

Essentially, the purpose of the workshop was to build consensus on
opportunities and barriers to assist stakeholders with prioritizing
projects that accelerate progress in health care for children with
cancer in Kenya based on the Kenya Cohort Aggregate Results. The
workshop aimed to connect national priorities to commitments and global
targets. The aims included conducting a broad, multidisciplinary
assessment of facility-based childhood and adolescent cancer care
services in Kenya with the intent of identifying priorities for future
work. To help address the priorities identified, we aimed to engage
local, national, and external stakeholders through a series of data-
driven prioritization exercises. We also aimed to identify
challenges/barriers to pediatric hematology-oncology (PHO) care locally
and define key strategies to bridge these in Kenya based on national,
regional, and global priorities

\textbf{Results}

\emph{Workshop Attendees and Agenda}

A total of 18 hybrid sessions were held over a 2-day period with
approximately 57 on-site and virtual participants representing a
diverse, multi-disciplinary group of national, regional, and
international stakeholders. The participants included frontline
healthcare workers (physicians providing medical oncology care, nurses,
surgeons, radiation oncologists, pharmacists) from seven Kenyans
hospitals, as well as representatives from civil society partners,
international collaborators, and other multi-national implementation
partners. There were 13 general sessions and one panel discussion with
the participation of all the attendees. Participants were also separated
into five working groups, each of which aligned with one of the five
specific components of PrOFILE, including Context, Workforce,
Diagnostics, Therapy, and Patients \& Outcomes. Each group conducted
four PrOFILE activities, including the categorization exercise (Table
1), collaboration exercise (Table 2), impact-effort matrix exercise
(Figure 1), and action plan and timeline development (Table 3). Each
activity was built on outputs from the previous exercise.

\emph{Session Output}

\emph{Context working group}

The projects designated as priorities for the context working group
include improving drug procurement and increasing childhood cancer
awareness. The first objective developed is to increase by 90\%
uninterrupted supply of essential pediatric oncology medicines in public
health facilities in Kenya within 2 years, with a 9-month milestone of
developing a tracking system to identify the proportion of patients
getting treatment as per protocol. The second actionable objective is to
increase awareness of childhood cancers in selected communities by 50\%
within 2 years, with a 9-month milestone of training champions for this
effort.

\emph{Workforce working group}

The projects designated as priorities for the Workforce working group
include increasing treatment adherence by implementing appointment
scheduling call backs and improving or upgrading hospital
infrastructure. The first actionable objective is to establish systems
and procedures to track missed appointments in the pediatric oncology
unit and increase patient attendance to 100\% by the end of 2 years,
with an 8-month milestone of having established a process and completed
training. The second objective is to establish a functional, dedicated,
and comprehensive regional PHO center that will provide care to 100\% of
children presenting with cancer by the end of 2 years, with a 6-month
milestone of construction of improved facilities and a 12-month
milestone of establishment of human resource teams and treatment
guidelines.

\emph{Diagnostics working group}

The projects designated as priorities for the diagnostics working group
include reducing time from first evaluation to diagnostic confirmation
and increasing access and timelines for leukemia and solid tumor
diagnostics. The first objective is to reduce the time from suspicion to
confirmation to 4 weeks in 70\% of children by implementing an effective
referral system within a 24-month period, with a 2-month milestone of
defining the referral pathway to be implemented, and a 9-month milestone
of monitoring the number and percentage of patients in the pathway. The
second objective is to reduce to 2 weeks the time for reporting flow
cytometry or immunohistochemistry results in 70\% of samples submitted
for analysis within a 24-month period, with a 10-month milestone of
evaluating percentage of samples reported timely.

\emph{Therapy working group}

The projects designated as priorities for the therapy working group
include standardizing chemotherapy protocols and guidelines and
prioritizing PHO surgery, including improving post-operative
care\emph{.} The first actionable objective is to develop PHO
chemotherapy protocols for Kenya by April 2023 and to implement those
protocols by April 2024, with a 1-year milestone of developing the
protocols and obtaining approval from the MOH. The second objective is
to create a PHO surgery group by 2023 and to establish a PHO surgery
training program by 2024, with a 1-year milestone of establishing a PHO
surgery working group.

\emph{Patients and outcomes working group}

The projects designated as priorities for the patients and outcomes
working group include tracking and reducing treatment abandonment and
increasing the number of patients with a confirmed diagnosis. The first
actionable objective is to reduce the treatment abandonment rate of
patients with Acute lymphoblastic leukemia (ALL) and Wilms tumor (WT) by
50\% within 2 years, with a 1-year milestone of establishing a registry
to track patients in each PHO institution. The second objective is to
establish a correct diagnosis in greater than 80\% of children being
treated for cancer, with a 1-year milestone of creating diagnostic
algorithms for PHO diseases and establishing hospital-based pediatric
cancer registries

\textbf{Discussion}

The PrOFILE tool provided a baseline assessment of childhood cancer
services in Kenya which was the first of its kind in the country. It
allowed multidisciplinary teams from various locations in Kenya to work
collaboratively. The workshop participants assumed an active role in
identifying barriers and opportunities to achieve the common goal of
improving the cure rate of children with cancer in Kenya. They were able
to identify goals and develop actionable objectives that they can take
ownership of accomplishing. Kenya was the first country to conduct this
workshop in hybrid format, which was successfully completed, with
demonstrated benefits and challenges.

The hybrid setting allowed participation of global collaborators and
Kenyan teams from different regions with diverse access to resources,
some of whom were not able to travel. To facilitate participation of
on-line participants in this hybrid setting, an on-line presentation
about concept definitions related to the respective activity and
instructions was incorporated prior to each of the 4 PrOFILE activities.
However, one limitation of the hybrid setting includes virtual
participants having limited interactions with in-person participants.
The potential for less effective exchange of ideas and experiences when
discussed virtually also exists. The focus of plans for the upcoming
years was based on results from small group sessions, which were
predominantly attended by in-person participants due to the availability
and time differences of virtual attendees, especially the international
collaborators.

The initiative and hybrid format were felt to be highly valuable by
participants, with results able to encompass all the health systems that
are needed to improve the survival of children with cancer in the
country. The various members at the workshop were voluntarily assigned
to each of the working groups after the conclusion of the workshop, with
a team leader appointed for each; the National Context, Diagnostic,
Workforce, Therapeutic and Patient Outcomes working groups. The working
groups agreed to meet individually to accomplish their group objectives
and monitor the milestones of their objectives at key time points to
ensure that they are achieved before the 2-year period. The team leaders
of each working group agreed to meet every 3 months to coordinate their
activities.

Subsequent to this workshop, the Kenyan NCI developed a
Multi-disciplinary Advisory Committee with 5 subcommittees, including 1)
Awareness and Diagnosis, 2) Treatment, 3) Palliative Care, survivorship
and rehabilitation, 4) Training, and 5) Commodities and oncology drugs.
The plan is to incorporate the working group members who volunteered at
the Profile workshop and then meet monthly initially to work toward the
identified goals. A follow-up PrOFILE assessment 2 years after the
action points will be conducted to evaluate childhood cancer services
after the interventions made by the working groups.

Changing the outcomes of children with cancer in LMICs requires a
stepwise approach that focuses on tackling specific problems over time.
A formal way of evaluating the major challenges in each work environment
is necessary to address the threats that effect each facility, but also
on a national context, enabling them to foster collaborations that
leverage on the strengths of each hospital. It is therefore our hope
that in the 2-year period, the working groups will be collaborating and
developing practical solutions to the major challenges impacting
childhood cancer services.

\textbf{Conflicts of Interest}

None of the authors have conflicts of interest to declare.

\textbf{Acknowledgements}

The authors would like to acknowledge American Lebanese Syrian
Associated Charities (ALSAC) for funding this work and the St. Jude
PrOFILE team for instruction and assistance with implementing this tool
and analyzing the data. We would especially like to thank the
participating hospital teams, Ministry of Health and global
collaborators for helping to make the workshop a success.

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