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developing countries: fertility care pathway

case study for St. Michael Specialist hospital

in Ghana

January 2021

By

Inèz Sikkel

University of Amsterdam

Medical Informatics

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Designing and defining care pathways in

developing countries: fertility care pathway

case study for St. Michael hospital in Ghana

Master thesis

Period: June 2020 – December 2020 Student

Inèz Sikkel

Location

AMPC International Health Consultants

Mentor

Arjan van Bergeijk Partner

AMPC International Health Consultants

Tutor Marieke Sijm

Department of Medical Informatics University of Amsterdam

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Summary

Introduction The Saint Michael Specialist Hospital is a new private hospital in Ghana which is currently in the start-up phase. The first challenge is to design the new hospital from scratch, including the building and facilities, equipment as well as the information architecture. One of the services to be provided by Saint Michael is fertility care. The task to design and build the hospital including its services is assigned to a company called AMPC. The team of AMPC that is tasked with designing these new services has a clear view on how to design the building and facilities for the new hospital. However, the team is lacking insights on identifying the best approach to follow in order to design the care processes and related information flows for the new services in a developing country. This study is aimed at obtaining those insights, so that AMPC can use the insights to design the care processes and related information flows.

Methods This thesis answers three main questions, the first question is what characteristics are of an approach to design a care pathway and related information flows in a developing country. To answer this question, the relevant aspects of the context of care pathways are examined using a focus group and a literature review and the success criteria to an approach for designing care pathways are studied using a literature review. The other two main questions also answer the first main question. The second question is to what extent Design for Six Sigma (DFSS) fits the characteristics of the approach to design a care pathway in a developing country. Literature results of the success criteria are matched to the phases of DFSS to study how DFSS can be used to design a care pathway. The third question to be answered is how DFSS can be applied to design the fertility care pathway for Saint Michael using the fertility care pathway of the Netherlands and Belgium as a starting point. An optimal fertility care pathway for the Netherlands and Belgium is designed using interviews, project team meetings and literature reviews. The fertility care pathway for Saint Michael is adapted to the situation in Ghana on the basis of an interview with a Ghanaian fertility doctor.

Results Relevant aspects of the context of care pathways included regulations and legislations, the use of EMR’s and reimbursement systems. A fertility care pathway was designed for the Netherlands and Belgium and optimised using a DOTWIMP analysis. Points of attention included: defects in patient identification, errors in data input and reducing waiting times. Furthermore, it was examined what success criteria are to an approach for designing a care pathway in a developing country. They included the use of a multidisciplinary team, stakeholder interviews and continuous improvement. The DFSS characteristics of the approach to design a care pathway in a developing country were successfully matched to identified success criteria. DFSS was applied to design the fertility care pathway for Saint Michael hospital using the optimal fertility care pathway of the Netherlands and Belgium as a starting point. The two designed fertility care pathways were compared. The differences included that pregnancy tests and hormone injections were not done at home but at the hospital or a local clinic, psychological counselling is part of the fertility care pathway in Ghana and in Ghana genetic screening of embryos is optional whereas in the Netherlands and Belgium there must be a medical indication for genetic screening.

Discussion This study demonstrated that Design for Six Sigma was suitable for designing a completely new fertility care pathway and the related information flows in a developing country. The approach followed by this study, using Design for Six Sigma to design a care pathway in a developing country has been translated into a roadmap that can be used by AMPC to design other new services in developing countries. Furthermore, an optimal fertility care pathway is now available as a starting point for designing new services in developing countries.

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Samenvatting

Inleiding Saint Michael is een nieuw privé ziekenhuis in Ghana dat zich in de opstartfase bevindt. De eerste uitdaging is om het nieuwe ziekenhuis vanuit het niets te ontwerpen. Het ontwerp omvat het gebouw, de faciliteiten, diensten en de informatiearchitectuur. Eén van de diensten van het

ziekenhuis is fertiliteitszorg. De opdracht om het ziekenhuis te ontwerpen en te bouwen, inclusief de diensten, is toegewezen aan het bedrijf AMPC. Het team van AMPC heeft een duidelijke visie op het ontwerp van het gebouw en de faciliteiten voor het nieuwe ziekenhuis. Echter, de inzichten

ontbreken om te bepalen wat de beste benadering is om de zorgprocessen en bijbehorende

informatiestromen voor de nieuwe diensten in een ontwikkelingsland vorm te geven. Dit onderzoek richt zich op het verkrijgen van die inzichten, zodat AMPC met behulp van die inzichten de

zorgprocessen met bijbehorende informatiestromen kan gaan ontwerpen.

Methoden In deze thesis worden drie hoofdvragen beantwoord. Ten eerste wordt er onderzocht wat de kenmerken zijn van de benadering om een zorgpad en de daarbijbehorende informatiestromen te ontwerpen in een ontwikkelingsland. Deze vraag wordt beantwoord door middel van literatuur-onderzoek en een focusgroep. Ook worden de succescriteria van een aanpak om een zorgpad te ontwerpen bestudeerd in een literatuuronderzoek. De andere twee hoofdvragen beantwoorden ook de eerste hoofdvraag. De tweede vraag is, in hoeverre DFSS past bij de kenmerken van de

benadering om een zorgpad in een ontwikkelingsland te ontwerpen. De succescriteria worden vergeleken met de fasen van DFSS om te onderzoeken hoe DFSS kan worden gebruikt om een zorgpad te ontwerpen. De derde vraag is hoe DFSS kan worden toegepast om het fertiliteitszorgpad voor Saint Michael te ontwerpen met als basis het fertiliteitszorgpad van Nederland en België. Aan de hand van interviews, projectteambijeenkomsten en literatuuronderzoeken wordt een optimaal fertiliteitszorgpad voor Nederland en België ontworpen. Het fertiliteitszorgpad voor Saint Michael is door middel van een interview met een Ghanese fertiliteitssarts aangepast aan de situatie in Ghana. Resultaten Relevante aspecten van de context van zorgpaden waren onder meer regelgeving en het gebruik van EPD's. Voor Nederland en België is een fertiliteitszorgpad ontworpen en geoptimaliseerd met behulp van een DOTWIMP-analyse. Aandachtspunten waren: defecten in patiëntidentificatie, fouten in data-invoer en wachttijden verminderen. Verder is onderzocht wat succescriteria zijn voor een benadering voor het ontwerpen van een zorgtraject. De criteria omvatten het gebruik van een multidisciplinairteam, stakeholderinterviews en continue verbetering. De DFSS-kenmerken van de benadering om een zorgtraject in te ontwerpen, werden met succes gematcht met de succescriteria. DFSS is toegepast om het fertiliteitszorgpad voor Saint Michael te ontwerpen met als uitgangspunt het optimale fertiliteitszorgpad van Nederland en België. De twee ontworpen fertiliteitszorgpaden zijn vergeleken. De verschillen waren onder andere dat zwangerschapstesten en hormooninjecties niet thuis werden gedaan, maar in het ziekenhuis, psychologische begeleiding maakt deel uit van het zorgpad in Ghana en in Ghana is genetische screening van embryos optioneel, terwijl in Nederland en België daar een medische indicatie voor moet zijn.

Discussie Dit onderzoek toont aan dat Design for Six Sigma geschikt is voor het ontwerpen van een volledig nieuw fertiliteitszorgpad en de gerelateerde informatiestromen. The benadering die gevolgd werd in dit onderzoek is vertaald naar een stappenplan dan gebruikt kan worden door AMPC om andere nieuwe diensten in ontwikkelingslanden te ontwerpen. Bovendien is in dit onderzoek een optimaal fertiliteitszorgpad ontwikkeld dat gebruikt kan worden als uitgangspunt voor het ontwerpen van nieuwe diensten in ontwikkelingslanden.

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Keywords

- Fertility care

- Developing countries - Care pathways - Design for Six Sigma - Information flows

Preface

This master thesis is the product of my seven month Scientific Research Project and the final result of my Master Medical Informatics at the University of Amsterdam. AMPC International Health

Consultants gave me the opportunity to choose my own topic within the operations of the new Saint Michael Specialist hospital they are building in Ghana. They even offered me the opportunity to visit Ghana, which was unfortunately not possible during the Covid-19 pandemic. Eventually I was able to design one of the care processes and its information flows using a care pathway for the new hospital. I hope that this thesis will contribute to the delivery of high quality care and to the development of an Electronic Medical record for Saint Michael. Even though I was only able to visit AMPC’s office during the summer period, I am grateful for everything I have learnt, the people that I have met and all the help I have received to obtain my results.

There are a number of people who have helped me during my project, for which I am very grateful. I would like to say a special thank you to Marieke Sijm, who has helped me a lot during every stage of my master thesis. Marieke has taught me everything I know about Design for Six Sigma and Lean, she also has helped me make my project a success.

I would also like to thank Arjan van Bergeijk for the opportunities you have given me, for teaching me how things work in a business, for making time to help me with my project and for making me feel part of AMPC.

I hope you will enjoy reading my Master thesis! Inèz Sikkel

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Table of Contents

Designing and defining care pathways in developing countries: fertility care pathway case study

for St. Michael Specialist hospital in Ghana ... 1

Chapter 1 ... 8 1.1 General Introduction ... 9 1.2 Fertility care ... 10 1.3 Infertility in Ghana ... 11 Chapter 2 ... 13 2.1 Research questions... 14

2.2 Methods and thesis outline ... 14

2.3 Study Design ... 16

2.4 Care pathways ... 17

2.5 Design for Six Sigma ... 18

Chapter 3 ... 19 3.1 Introduction ... 20 3.2 Methods ... 20 3.3 Results ... 22 3.4 Discussion ... 25 Chapter 4 ... 26 4.1 Introduction ... 27 4.2 Lean ... 28

4.3 Business Process modelling notation ... 29

4.4 Methods ... 30 4.5 Results ... 32 4.6 Discussion ... 36 Chapter 5 ... 38 5.1 Introduction ... 39 5.2 Methods ... 40 5.3 Results ... 42 5.4 Discussion ... 51 Chapter 6 ... 53 6.1 Findings ... 54

6.2 Relation to other work ... 55

6.3 Strengths & Limitations ... 56

6.4 Implications & Future research ... 57

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References ... 58

Appendix A: General flowchart of the diagnosis process and treatment options for a couple with fertility problems ... 63

Appendix B: Fertility care pathway for Netherlands and Belgium ... 64

Appendix C: Information flows Netherlands and Belgium ... 67

Appendix D: Fertility care pathway for Saint Michael Specialist Hospital ... 69

Appendix E: Information flows Saint Michael Specialist Hospital ... 72

Appendix F: Roadmap for designing a care pathway in a developing country using Design for Six Sigma ... 74

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Chapter 1

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1.1 General Introduction

The Saint Michael Specialist Hospital is a new private hospital in Ghana which is currently in the start-up phase. The first challenge is to design the new hospital from scratch, including the building and facilities, equipment as well as the information architecture.

The design phase will be followed by construction and implementation, and in the end should lead to a well operating hospital that provides cardiac care, fertility care and ambulatory care. The aim of this new private hospital is to provide high quality service and healthcare to patients.

The task to design and build the hospital including its services is assigned to a company called AMPC International health consultants located in Weesp (the Netherlands). AMPC supports the design, construction, equipping and operations of hospitals and other types of healthcare facilities. The team of AMPC that is tasked with designing these new services for Saint Michael Specialist Hospital consists of five Dutch AMPC consultants and a junior researcher. The experience of the participants ranged between two to fourteen years. One team member was a doctor, two

participants were consultants and one participant is partner at the AMPC. One of the consultants had an IVF treatment herself and is therefore a patient expert. The team has a clear view on how to design the building and facilities for the new hospital. However, the team is lacking insights on identifying the best approach to follow in order to design the care processes and related information flows in a new to build hospital in a developing country. In terms of the Nictiz layer model1, this

would mean the team is unclear on the approach for designing the process and information layer of the model. This is fundamental to be able to decide on the application and IT infrastructure needed to support the process and its information flows. According to one of the partners at AMPC, the fact that the team working on designing the new hospital does not have a structured approach to design the care processes and information flows yet, can be explained by the lack of electronic information usage in developing countries. Most patient data in Ghana so far is documented in hand-written paper files. Only recently the demand for more structured and electronic information came up due to private financial sponsors who want to get more business-related data on the care provided. Another development is that more and more patients own a smartphone which offers possibilities for

electronic data exchange and storage2. The expectation of the design team is that the role of

electronic medical information in Ghana will significantly increase in the near future. When building a new hospital, AMPC wants to prepare for the future and hence plan for electronic information system usage. Therefore it is essential to design the care processes and information flows for each new service to be provided.

Thus, the problem is twofold, being the lack of insight on what characteristics are of an approach to design a care pathway and the related information flows in a developing country and the absence of a fertility care pathway including the related information flows in the literature. Therefore, it is needed to find characteristics of an approach to design a care pathway in a developing country and to define a fertility care pathway with the related information flows for the new to build Saint Michael Specialist hospital in Ghana. The approach is defined as a structured method to obtain the requested outcome, which in this case is to design a care pathway in a developing country.

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1.2 Fertility care

In the entire world there are around 72 million people infertile of which around 40 million would like to be treated for it3. In the Netherlands, approximately 30% of the cases the cause of infertility is

found on the male and in approximately 30% of the cases the cause of infertility is found on the female. There are several reasons for infertility, for men this is often due to reduced sperm quality and for women this is often caused due to disorders in the menstruation cycle, problems with the oviducts or endometriosis4.

Diagnosis

During the first visit to a fertility centre the situation of the visiting person is discussed. When a couple visits a fertility centre together they are asked for how long they have been trying to get pregnant and the chances of getting pregnant in a natural way is being calculated5. The rest of the

information about the diagnosis and treatment of infertility is discussed based on a heterosexual couple trying to get pregnant due to Ghanaian culture. After an orienting conversation with a medical specialist both men and women undergo blood tests to check among others their general health, hormone levels and if they ever had a sexually transmitted disease. Thereafter women have an ultrasound to check the number of oocytes and the general anatomy of the oviducts and uterus. Men undergo a semen analysis to assess the quality and forward movement of their sperm. After these examinations the second consult is scheduled to discuss treatment options6.

Treatment options

The woman’s menstruation cycle is monitored to see if there are any problems regarding the natural cycle. If a problem with the natural menstruation cycle of the woman is observed, a hormone treatment is being prescribed and the couple is assisted in planning their next attempt in the natural way (if there are no problems with the man’s sperm quality). When another attempt of the natural way fails or when a problem is found with the forward movement of the man’s sperm insemination is being used as a treatment. When multiple insemination’s failed or when a medical procedure is needed to obtain sperm of enough quality IVF or an ICSI procedure is used7,8.

Intrauterine Insemination (IUI)

During an insemination a sperm sample is being transferred to the uterus of the woman. This can also be donated sperm. Insemination can increase the chances of getting pregnant because at the exact right time of the menstruation cycle a sperm sample is directly transferred to the upper part of the uterus. That way the sperm cells do not have to pass the cervix9. If there is no medical reason for

not using insemination this option is preferred over IVF or ICSI. The reason for this is that it is ethically preferred to fertilize the woman in a more natural way, because the medication needed before an IVF/ICSI treatment can have unwanted secondary effects and because the harvesting of oocytes is a very painful medical procedure which can also have unwanted secondary effects10.

However, if multiple inseminations failed or if a MESA/TESA procedure is needed, IVF/ICSI is being used as the final treatment option.

MESA/TESA

Microsurgical epididymal sperm aspiration (MESA) and testicular sperm aspiration (TESA) are surgical procedures used when sperm is absent in a man’s ejaculate. This can be due to for example

obstruction of the tubes. During the MESA procedure, the vas deferens of the man is exposed and motile sperm is retrieved from the epididymis. If sperm is not being produced at all or not correctly, there is still a change that it can be retrieved from the testicles. In that case a TESA procedure can be

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11 performed. The sperm are then retrieved directly from the tissue of the testicles. Both procedures happen under general anaesthetic11.

IVF and ICSI

In Vitro Fertilization (IVF) is an assisted fertilization procedure where the oocyte and sperm cell merge in a test tube in the laboratory. An IVF procedure starts with hormone stimulation using medication so that multiple oocytes are matured simultaneously. When the oocytes are matured they are retrieved with a small procedure using a needle to retrieve the oocytes from the ovaries. In the laboratory the oocytes and sperm cells are brought together in a test tube. The sperm can either be retrieved in a natural way, via a MESA or TESA procedure or from a donor. The sperm must fertilize the oocytes without further assistance. After one day it is checked if the oocytes are fertilized. After three to five days (depending on the woman’s cycle) the fertilized oocytes are transferred to the uterus of the woman. The fertilized oocytes can also be cryopreserved.

Intracytoplasmic sperm injection (ICSI) is a form of IVF, the process works exactly the same however, during an ICSI procedure the sperm cells are assisted to fertilize the oocytes. The sperm cells are injected directly into the cytoplasm of the oocyte. It is used when multiple IVF procedures fail or when the man’s sperm quality is severely impaired12.

Cryopreservation

Cryopreservation is a technique that can be used to store oocytes, sperm cells, fertilized oocytes, embryos and tissue for a long period of time. They are frozen and stored in liquid nitrogen at -196 degree Celsius. There are multiple reasons for cryopreservation, for example as part of an IVF or ICSI procedure, to store fertilized oocytes for a future attempt of pregnancy, age or before the treatment of a severe illness. It is under discussion if cryopreservation has adverse effects or not13,14.

1.3 Infertility in Ghana

In the Ghanaian culture married couples are expected to have children. Procreation is commonly believed to be the meaning of life for both women and men. The general perception of residents of Ghana is that a couple needs to have children in order to give marriage a meaning and purpose. Having children is also important to be respected as a human being and to get socially accepted. Data collected during a survey in 2009 by the Ghana Statistical service shows that women between the age of 15 to 49 on average have four children15.

Another health survey conducted by the Ghanaian Statistical service in 2008 showed that the prevalence of infertility among Ghanaian women was around 15%16. This is quite high as it has been

estimated that worldwide the infertility rate among women is between 8% and 12%. Two potential reasons for the high infertility rate among African women are a high incidence of sexually

transmitted diseases and pregnancy related infections due to unhygienic home delivery

circumstances17. According to the World Health Organisation the definition for infertility is: ‘A couple

is considered infertile if no pregnancy has been achieved after 12 months or more of unprotected intercourse’18.

It has been estimated that infertility is primarily caused by the men in 40% of the infertility cases, however women are often blamed. Childless women often suffer terribly from the social

consequences. A study that interviewed women who were seeking treatment in a fertility care centre found that women with infertility problems were facing severe social stigma and for example, had been crying for long periods and suffered from insomnia19. A similar study in Ghana found that 53%

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12 Some individuals who were not able to handle the social consequences of not having children ended up taking their own life20. Finally, infertility is also the most important reason for divorce in Ghana21.

Because of the cultural importance of procreation in Ghana, the national policy which encourages the establishment of private healthcare centres and the economic middle class growing in the country, private fertility care clinics have been founded in the country. In 1995 the first In Vitro Fertilization clinic opened and now there are fourteen fertility care centres in Ghana15.

There are no legislations or regulations present in Ghana regarding fertility care15. There are no

regulations for IVF or ICSI. Sperm donation, egg donation and surrogate mothers are commercially available. It is even possible to select a donor based on eye colour, hair colour, educational level etcetera22 . In the Netherlands age restrictions apply for IVF services, this is due to the success rate

decreasing when a woman ages and enforces by limiting healthcare costs23. In Ghana however, age

restrictions do not exist and the fertility service is being paid for out of pocket24. Preimplantation

genetic diagnosis (PGD) makes it possible to screen the genetics of the fertilized egg cell before it is placed inside the womb of a woman25. In many countries there exist restrictions and regulations for

PGD because of ethical reasons. For example the Indian government has prohibited PGD26 and in

Germany it is only allowed when there is a strong likelihood that parents will transfer a genetic disease to the unborn child27. Nonetheless, no regulations exist in Ghana for PGD.

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Chapter 2

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2.1 Research questions

Following from the problem statement as described in chapter one, the key problem to address in this research is the lack of insights in an optimal approach to design the new-fertility care service in the new to build hospital in Ghana. Therefore the aim of this study is examine the characteristics of an approach to design a care pathway in a developing country.

The main- and sub-questions research questions studied in this thesis are:

1: What are characteristics of an approach to design a care pathway and related information flows in a developing country?

1.1: What aspects of the context of care pathways are relevant for designing care pathways in developing countries?

1.2: What are success criteria to an approach for designing a care pathway in a developing country?

2: To what extent does Design for Six Sigma fit the characteristics of the approach to design a care pathway in a developing country?

2.1: How can Design for Six Sigma be used to design a care pathway?

3: How can Design for Six Sigma be applied to design the fertility care pathway for Saint Michael Specialist hospital in Ghana with the optimal fertility care pathway of the Netherlands and Belgium as a starting point?

3.1: What is the optimal fertility care pathway for the Netherlands and Belgium?

2.2 Methods and thesis outline

St. Michael Specialist hospital aims to provide high quality service and care to their patients. A tool with a proven track of record for realizing this envisioned high quality services is the care pathway. A care pathway is a detailed visual presentation of the essential steps in the care of patients with a specific clinical problem28–30. Care pathways are effective for improving patient outcomes and

increasing efficiency from the perspective of the healthcare provider. Care pathways are already widely used in healthcare and defining care pathways is a proven method for organising care in an optimal way31. The approach of using care pathways is still a new concept within the healthcare

sector in developing countries. In Ghana for example, the use of care pathways to develop new services or to improve existing clinical practice is not common. In a private hospital in South Africa they were probably one of the first hospitals to use care pathways in Africa. They have used care pathways to represent the best practices for non-invasive ventilation (NIV) treatment for the

management of respiratory failure. The second reason for using care pathways was to make the care around NIV more efficient and cost effective32.

Hence, care pathways for the fertility care service to be provided at Saint Michael Specialist hospital, could not be found in the literature. Fertility care pathways mentioned in the literature are based on documenting and then optimizing an existing care path rather than designing a completely new care pathway which is required for St. Michael Specialist hospital. Hence current research on care pathways does not provide insight to the design team on how to design the new processes and information flows for the fertility care service. Moreover, fertility care pathways mentioned in the literature are based on the situation in developed countries and not on the situation in developing countries. Therefore, this study examines the characteristics of an approach to design a care pathway

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15 and the related information flows in developing countries. The reason for using care pathways for designing the new fertility care service line is because there has been a lot of published research supporting the successfulness of using care pathways. A study by the University of Leuven showed that care processes with care pathways were 2.6 times more likely to be well organized29. Care

pathways also ensure that continuum of care around the needs of a health service are obtained and that all the processes are streamlined to ensure efficiency33. Designing a care pathway will also help

the researcher to identify the required information flows in the process.

To be able to design a care pathway for fertility care, it is examined to what extend the Design for Six Sigma approach fits characteristics of the approach to design a care pathway in a developing country. Design for Six Sigma was chosen because research has shown that the Six Sigma methods are the best for new product/service development and for quality improvement34,35. Design for Six Sigma

(DFSS) is an approach that is used to develop new products or services or redesign products and services at a high level of quality. DFSS aims to design the new products or services right at the first time with minimal defects. DFSS ensures that the product or service meets the customer’s

requirements. One of the most common used DFSS systems is DMADV. The acronym DMADV stands for Define, Measure, Analyse, Design and Verify36. Design for Six Sigma originates from the

manufacturing industry but has already proven success in healthcare for example to reduce patient length of stay and billing errors37. In a hospital in New England Design for Six Sigma was used to

design a new healthcare process, they concluded that DFSS was effective to design an efficient process for the vaccination of employees38.

To be able to use the Design for Six Sigma method one or more concepts are needed to discuss with the project team. Therefore, a care pathway that represents the current situation in two developed countries (the Netherlands and Belgium) and the fertility care pathway in Ghana will be defined. The reason for defining the fertility care pathway for the Netherlands and Belgium was that it was the most feasible option because the researcher and project team were based in the Netherlands. Therefore, the project team had a network in fertility care in the Netherlands and Belgium.

Furthermore, fertility care is very similar in both countries. The designed care pathways were limited to the scenario of a female and a male looking for a fertility treatment where a clear cause of

infertility can be diagnosed. The stakeholders in the project were AMPC, the fertility care doctors in Ghana and the patients that will receive fertility care in the future.

The fertility care pathway for the Netherlands and Belgium has to be defined before the interview with the Ghanaian doctor takes place. The reason for first defining the fertility care pathway for the Netherlands and Belgium is because one of the experienced consultants from AMPC mentioned that healthcare providers in a developing country are not always directly reachable. The reasons that healthcare providers are not always directly reachable is that healthcare providers are very busy in general, they might not always have an internet connection and it is not easy to come over being in a different country. Therefore, a conversation with a healthcare provider in a developing country should be very well prepared. Hence, the fertility care pathway for the Netherlands and Belgium is firstly defined.

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Figure 1: Overview of the study design

2.3 Study Design

This study was performed from June 2020 to December 2020. Figure 1 shows an overview of how the study has been composed and how the chapters have been built. Figure 1 also shows the mixed methods used in this study.

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2.4 Care pathways

A care pathway is a detailed visual presentation of the essential steps in the care of patients with a specific clinical problem28–30. In this study, the definition of a care pathway includes the information

flows associated with the care pathway. The information flows are the data that is needed for a certain activity, and the data that is produced in a certain activity (information input and output). The concept of care pathways originally derived from quality improvement methods designed by the Japanese car manufacturer, Toyota, such as LEAN and Total Quality Management. The goal of these Japanese approaches is to improve quality and to eliminate waste39. These methods were applied to

healthcare for the first time between 1985 and 1987 in the United States of America40. They used

care pathways when Diagnosis-Related Groups (DRGs) were introduced as a new reimbursement system41 for the reorganisation of care.

Nowadays, designing and implementing care pathways are considered as one of the main methods to organise and reorganise a care process. There are many different applications in healthcare for the use of clinical pathways, for example designing care processes, implementing clinical governance, structuring delivered care, improving the quality of care and to make sure that healthcare is based on the latest developments in research42.

Alternative terms for care pathways

There are more than 20 different synonyms used in the literature when referring to a care pathway. Table 1 lists seven of the most commonly used terms43–45:

Table 1: Seven most common used synonyms for 'care pathways'

• Clinical pathway • Clinical protocol

• Integrated care pathway • Critical pathway

• Care plan • Care tracks • Care map

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2.5 Design for Six Sigma

Design for Six Sigma (DFSS) is an approach that is used to design new products or services or redesign products and services at a high level of quality. DFSS aims to design the new products or services right at the first time with minimal defects. Design for Six Sigma uses the DMAIC (Define, Measure, Analyse, Improve, Control) steps to improve existing processes or to design a new process. Define

This is the first phase in DFSS. During the define phase it is necessary to identify the customer requirements, the goals and objectives, the scope, the team members and to divide the roles and responsibilities for the project. Thereafter the process is identified and documented and a preliminary project plan can be set up. The first step is to create a project charter. Thereafter the customer and business needs have to be identified. Customers are identified and their requirements are collected and analysed.

Measure

In the measure phase data is collected to evaluate the performance of the current process. The current processes can be measured using a data collection plan.

Analyse

In the analyse phase the collected data and the process is analysed in order to find how the process can be improved.

Design

In the design phase the process is improved and/or designed. Verify

In the verify phase the designed process is verified. It is also important to keep track of the process after the improvements have been implemented36.

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Chapter 3

Relevant aspects of the context of care pathways in

developing countries

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3.1 Introduction

Designing and implementing care pathways are known to be effective to organise healthcare in an efficient way31. Care pathways have not been designed and implemented very often in developing

countries. Though, the designing and implementation of care pathways has also shown to be effective to organise healthcare efficiently in developing countries32. Therefore, AMPC wants to

design (and implement in the future) a care pathway to organise the care around the new fertility care service line in Ghana efficiently. It is presumably that the best way to design and implement a care pathway efficiently is slightly different in a developing country. Bergström et al. found that the context in which a care pathway is designed and implemented affects the best approach to develop a care pathway efficiently. The context in which a care pathway is developed includes the culture in which patients and healthcare providers live, and how healthcare is generally organised in a country. The context in which a care pathway is designed is different between developing countries and developing countries46. The first step to design a care pathway for a developing country is to

understand what aspects of the context of care pathways are relevant for designing care pathways in developing countries47. These relevant aspects of the context of care pathways are important input

for designing any care pathway in a developing country.

The focus of this chapter is therefore to examine what aspects of the context of care pathways are relevant for developing countries (see figure 2). This information is applied to the development of the care pathway for Ghana in chapter 5 and for future implementation of the care pathway.

Figure 2: The differences in context that influence the care pathways between developing and developed countries

3.2 Methods

To examine what aspects of the context of care pathways are relevant for developing countries, first the opinions of experts were asked during a focus group. This research method was chosen because the opinions of the experts could be asked in a less time consuming manner, for both the participants as the investigator, compared to one-to-one interviews. Thereafter a literature review was

conducted to find other research that identified relevant aspects of the context of care pathways in developing countries. Finally the relevant aspects of the context of care pathways for developing countries were compared to the aspects of the context of care pathways in developed countries.

Focus group

The aim of the focus group was to study the relevant aspects of the context of care pathways for developing countries and to reach consensus on what aspects of the context of care pathways relate to the (fertility) care pathway. The participants were five AMPC consultants, who have been selected

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21 based on their previous experience with working in healthcare organisations in developing countries. One participant is a doctor, two participants are consultants and one participant is a partner at the AMPC. One of the consultants had an IVF treatment herself and is therefore a patient expert. The experience of the participants with healthcare in developing countries ranged between two to fourteen years.

The researcher took the role of moderator and note taker during the focus group. The group

discussion was hosted in the meeting room of the AMPC office. One of the participants attended the presentation via the Microsoft Teams software. A study that examined the experiences of young people that had cancer, proved that online focus groups are still effective48.

The focus group started with a ten minute presentation that covered the subject of the entire research project, an explanation of care pathways in general including an example of a basic care pathway and an example of a care pathway for a fertility care centre in the Netherlands. The presentation continued with the research methods of this sub-study and the research methods of the entire research project. The importance of the input from the focus group participants was emphasized. After the ten minute presentation the group discussion started. The focus group was asked about what aspects of the context of care pathways they found relevant for developing countries. The moderator kept the discussion moving forward and made sure all participants contributed to the group discussion.

The focus group was recorded via the Microsoft Teams software. The moderator used the notes and the recording of the group discussion to document the relevant aspects of the context of care pathways in developing countries, mentioned during the focus group. The recording of the focus group was transcribed and coded in Microsoft Word. All words that seemed to be a relevant aspect of the context of care pathways were labelled.

Literature review

A literature review is a written presentation of a critical and strategic analysis of what has been published on a certain topic. Cooper wrote the guidelines for a literature review adopted by this study, his work can be used for further reading on the theory behind literature reviews49,50.

The literature review was conducted to obtain more information about relevant aspects of the context of care pathways in developing countries. Keywords for the search strategy were: process, mapping, developing country, developing countries, low income countries, Africa, Ghana, healthcare, care pathway and clinical pathway, differences. Various combinations with AND and OR were used. The databases that were searched were PubMed and Google Scholar. Also, reference lists of relevant articles were inspected. First, all the titles of the articles were reviewed. Secondly, the abstracts of the articles with a title that seemed relevant for the study were examined. Finally, the full text of the articles that still seemed relevant after reading the abstract were reviewed. When the searching terms resulted in too many hits, the pages were reviewed until there were more than three subsequent pages without relevant titles.

The inclusion criteria were broad because research mentioning relevant aspects of the context of care pathways in developing countries could not be identified. Therefore articles mentioning

processes mapping, process definition, clinical pathways, implementation of new health technology, optimization projects and challenges in a developing country were included. The following inclusion criteria were used:

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22 - Implementation of a new healthcare technology in a developing country

- Mentioning challenges, barriers and differences in healthcare in developing countries - Optimization projects of healthcare in a developing country

3.3 Results

Focus group discussion

Because of the general presentation at the start of the discussion the participants were aware of the subject of this study, therefore the answers of the focus group participants were related to fertility care. The duration of the focus group was one hour. The participants were experienced in working in healthcare in developing countries. However, they had no previous experience with designing care pathways. The identified codes of the focus group have been presented in table 2.

The first aspect of the context of care pathways in developing countries that the focus group

participants mentioned was that procedures might differ. Often procedures in western countries like The Netherlands, are designed in a way to cut costs. However, in developing countries people are likely to pay out of pocket for the procedures and cutting costs is not necessarily the first priority resulting in differences in procedures.

‘Regarding to the services that you want to offer, it is for a specific population group. You would not use insemination if the chances of pregnancy are higher with IVF. The IVF procedure is more

expensive but people have to pay out of their own pocket and if the clinic wants to maximize revenue it will be doing IVF procedures. The higher success rate will also make patients who can afford this clinic happier.’

In this citation, another aspect of the context of care pathways is also mentioned, being the payment for services by the patients themselves rather than by an insurance company.

Another aspect of the context of care pathways is the regulations and legislations regarding clinical procedures. Developing countries often have much less legislations and regulations compared to developed countries51. For example the maximum age to receive fertility treatment. In many

developing countries there are no age restrictions on IVF services. In the Netherlands the maximum age to receive a IVF treatment is 50 years (if the oocytes have been retrieved latest at the age of 4323).

‘When you create a flowchart more questions regarding regulations and legislation might arise. For example, cryopreservation. When would you do this and for how long? Are there regulations for that? Are there international guidelines for that? Creating a flowchart can raise ethical questions. ’

Finally the participants mentioned that the healthcare providers in a developing country are not always directly reachable. The reasons that healthcare providers are not always directly reachable is that healthcare providers are very busy in general, they might not always have an internet

connection and it is not easy to come over being in a different country. Therefore, a conversation with a healthcare provider should be very well prepared.

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23

‘You have to be practical because you can’t just have the conversation tomorrow. You have to be very well prepared and define your questions and what you are looking for. If you have thought about this beforehand it will make it much easier to have the conversation and to find the gaps in the pathway.’

Table 2: Codes for relevant aspects of the context of care pathways

Codes Theme

Procedures Context aspect

Regulations and legislations Context aspect Availability healthcare

providers

Recommendation

Literature results

In the literature more relevant aspects of the context of care pathways in developing countries were found. 19 articles were analysed by full text reading and 7 articles were included in the results. The search terms and hits are shown in table 3.

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24

Table 3: Search terms and number of hits

The seven articles described the following relevant aspect of the context of care pathways: the use of Electronic Medical Records, the reimbursement systems and clinical roles. These aspects of the context of care pathways are described under the corresponding headings below.

Electronic Medical Records (EMRS)

In 2008, the use of EMRs in the United Kingdom, Netherlands, Australia and New Zealand was already more than 90% among general practictioners52. In developing countries EMRs are often

non-existent, and medical records are often still paper-based53. This limits the data available for the

Search terms Database Hits Read

abstract

Read full article

((("process"[All Fields]) AND ("mapping"[All Fields])) OR ("process mapping"[All Fields])) AND (("developing country"[All Fields]) OR ("developing countries"[All Fields]) OR ("low income countries"[All Fields]))

PubMed 62 11 7

((("process"[All Fields]) AND ("mapping"[All Fields])) OR ("process mapping"[All Fields])) AND (("developing country"[All Fields]) OR ("developing countries"[All Fields]) OR ("low income countries"[All Fields]) OR "africa"[All Fields] OR "ghana"[All Fields] OR "nigeria"[All Fields] OR "ivory coast"[All Fields] OR "burkina faso"[All Fields]) AND "differences"[All Fields])

Pubmed 20 5 2

((("process"[All Fields]) AND ("mapping"[All Fields])) OR ("process mapping"[All Fields])) AND (("developing country"[All Fields]) OR ("developing countries"[All Fields]) OR ("low income countries"[All Fields]) OR "africa"[All Fields] OR "ghana"[All Fields] OR "nigeria"[All Fields] OR "ivory coast"[All Fields] OR "burkina faso"[All Fields]) AND ("barriers"[All Fields] OR "challenges"[All Fields])

PubMed 44 6 3

(("differences"[All Fields]) OR ("barriers"[All Fields]) OR ("challenges"[All Fields])) AND (("developing

countries"[All Fields]) OR ("developing country"[All Fields]) OR ("low income countries"[All Fields])) AND (("high income countries"[All Fields]) OR ("developed countries"[All Fields]) OR ("western countries"[All Fields])) AND (("process"[All Fields]) AND ("mapping"[All Fields]) OR ("process mapping"[All Fields]))

PubMed 2 2 0

(("care pathway"[All Fields]) OR ("clinical pathway"[All Fields])) AND (("developing country"[All Fields]) OR ("developing countries"[All Fields]) OR ("low income countries"[All Fields]) OR "africa"[All Fields] OR "ghana"[All Fields] OR "nigeria"[All Fields] OR "ivory coast"[All Fields] OR "burkina faso"[All Fields]) AND ("barriers"[All Fields] OR "challenges"[All Fields] OR "differences"[All Fields]))

PubMed 11 4 1

(("differences"[All Fields]) OR ("barriers"[All Fields]) OR ("challenges"[All Fields]) OR ("comparison"[All Fields])) AND (("developing countries"[All Fields]) OR

("developing country"[All Fields]) OR ("low income countries"[All Fields])) AND (("high income countries"[All Fields]) OR ("developed countries"[All Fields]) OR ("western countries"[All Fields])) AND (("care pathway"[All Fields])) OR ("clinical pathway"[All Fields]))

PubMed 0 0 0

(differences OR barriers OR challenges) AND (developing countries OR developing country OR africa OR ghana OR ivory coast OR burkina faso OR nigeria) AND (care pathway OR clinical pathway)

Google Scholar

24000 12 4 (differences OR barriers OR challenges) AND

(Developing countries OR developing country OR low income countries) AND (high income countries OR developed countries OR Western Countries) AND (care pathway OR clinical pathway)

Google Scholar

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25 information flows in the care pathway. Operational data for the analysis of the process steps is lacking and research infrastructure is also limited available. Therefore visual observations of the process are even more important in developing countries54. The use of paper records can also cause

errors because of for example misreading handwritten text55.

Reimbursement systems

Although National Health Insurance Systems are being introduced more often In developing countries, healthcare is still often paid for out-of-pocket56,57. In developed countries healthcare is

often paid for by coverage schemes and insurance58. This has consequences on the care pathway

because services might be organised differently because of insurance roles and the billing process is also differently organised.

Clinical roles

In western countries, doctors and nurses have specified tasks and roles. In developing countries this is not always the case. Jobs are not always clearly defined and this causes inefficiency in the care pathway54.

3.4 Discussion

The focus of this chapter was to examine what aspects of the context of care pathways are relevant for developing countries.

During a focus group discussion with consultants that were experienced with working in healthcare in developing countries two relevant aspects of the context of care pathways were described. Thereafter a literature review was conducted where three more relevant aspects of the context of care pathways were identified. One of the relevant aspects identified during the literature review was that medical records are often still paper based in developing countries. An article that studied the challenges of infertility management in Nigeria mentioned that healthcare providers in Nigeria were still using paper based medical records and in their case 44.7% of the paper based medical records got lost59.

A limitation of this study is that the results were only based on interviews and literature. More relevant aspects could have been identified if the researcher had visited healthcare facilities in a developing country and a developed country. However, this was not possible during the time of this study and due to the COVID-19 pandemic. Another limitation of this study is that the participants of the focus group were aware of the fertility case study, therefore their answers were mainly related to the aspects of the context of fertility care pathways and not necessarily care pathways in general. A strength of this study was that experts with different backgrounds and experience in working in developing countries, were interviewed during a focus group. Another strength of this study is that after an hour had passed in the focus group discussion, none of the participants had anything else to add. Therefore the scheduled time for the focus group discussion was sufficient.

In conclusion, this chapter provides what aspects of the context of care pathways are relevant in developing countries. Five relevant aspects of the context of care pathways were identified during a focus group and a literature review. The identified aspects included different procedures,

regulations, (electronic) medical records, reimbursement systems and the definition of clinical roles. The relevant aspects of the context of care pathways identified in this chapter have been applied to the development of the fertility care pathway in chapter 5. Future research should include visits to healthcare facilities in developing countries to find more relevant aspects of the context of care pathways.

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Chapter 4

Optimal care pathway fertility care in a developed

country based on two case studies (NL and BE)

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4.1 Introduction

For several reasons, including the raising costs of healthcare, it is becoming increasingly important to organise healthcare as efficiently as possible. Care pathways are an important tool to organise healthcare efficiently because the tool provides insights for improvement by mapping out and reviewing the total process29. Traditionally, care pathways map the care processes derived from

clinical guidelines. Clinical guidelines do not mention best practices for the use of technologies in healthcare such as electronic medical records60,61, while the use of electronic medical records (EMR’s)

in hospitals continues to increase52. Data derived from care processes such as lab results or, diagnosis

and treatment plans are collected in EMR’s. Information flows present the exchange of data between care processes and EMRs. Because of the increasing role of EMR’s in healthcare, the information flows that are exchanged between care processes and electronic medical records is considered an important part of care pathways in this study. By including information flows in care pathways, care pathways are improved and best practices for the use of electronic medical records can be

developed61.

Fertility care in Western countries follows a certain chain of activities and interactions with patients as well as EMR’s. The procedures for the diagnosis and treatment of fertility problems have been described in clinical guidelines in for example the Netherlands62, United Kingdom63 and in the United

States64. Furthermore, many websites of fertility care clinics describe the steps that patients follow

during their fertility treatment65–67. However, no examples of care pathways for fertility care covering

the full chain of activities from the first consultation of a patient till the final treatment can be found. A partial care pathway for diagnosing fertility problems and defining the recommended treatment plan for each-diagnosis has been defined by the Royal College of Obstetricians and Gynaecologists in the United Kingdom. This care pathway does not describe the processes from the starting point, when a patient or couple first sees a doctor to the point where their treatment is finalized. Furthermore, the information flows that relate to the care processes described in the fertility care pathway are missing68.

The first aim of the research presented in this chapter is to define a complete fertility care pathway for Western countries with related information flows. With complete we mean that it starts with the first consultation of a patient or a couple with a care provider, it ends when the treatment is finalized and it includes information flows. The second aim of the research presented in this chapter is to optimize this care pathway. With optimization we adopt the definition from Lean, meaning the pathway is capable of meeting patient expectations while using as little resources (time and materials) as possible. The optimal care pathway for Western countries can be used to design new fertility care service lines as efficiently as possible and to improve existing fertility care services. In the case of the research described in this thesis, it will be used as a concept to design the new fertility care service for the Saint Michael Specialist hospital in Ghana (Chapter 5).

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4.2 Lean

Lean is a methodology to eliminate unnecessary steps in a process. The unnecessary process steps are called ‘waste’. Waste from the perspective of Lean is anything that is done in a process that does not add value to the customer69. The Lean methodology was developed by Toyota to improve the

production system in 1990. Lean focuses on mapping out all the process steps to identify which steps create value for the customer. By mapping out the process steps and identifying the steps that create value, waste can be eliminated from the process. The process steps that add value to the customer are streamlined to improve the quality of the process and the cost-effectiveness70.

The Lean methodology has often been applied to healthcare. For example in the Netherlands, Lean was successfully used to improve the efficiency of a care pathway for the treatment of hip

fractures71. Lean has not often been applied to healthcare in developing countries. However, In two

Brazilian hospitals, Lean methodologies were used to improve their operations47.

DOTWIMP

DOTWIMP is a Lean waste analysis tool focussing on identifying sources of waste in a process – in the case of this study the care pathway for fertility care – from a Lean perspective. The acronym

DOTWIMP stands for seven types of waste: defects, overproduction, transport, waiting, inventory, motion and extra processing. In figure 3, the seven types of waste are explained.

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4.3 Business Process modelling notation

In a care pathway the process steps are represented with a semantic description and semantic relationships between the process steps. The relationships between the process steps affect the outcomes of every process step in the care pathway and therefore the quality and efficiency of the processes. Because of the complexity of care pathways it is important to use a validated method to model the care pathway. The Business Process Modelling Notation (BPMN) is a validated method to map a care pathway72. BPMN is a semi-formal modelling language that describes complex processes

in a relatively easy graphical notation73. The BPMN workflow also ensures that clinical data can be

connected to the care pathway. For this reason, BPMN is a very useful tool in this study as it aims to map the care processes for fertility care and the related information flows with health data72.

Another benefit of using BPMN as a modelling tool for care pathways is that the meaning of the symbols is easy to interpret, even for people who are not familiar with BPMN, this is because it is similar to for example the legend of a map73.

Business Process Modelling Notation consists of four element types: - Flow objects

- Connecting objects - Swim lanes

- Artifacts

Flow objects can be events, activities. An event defines the starting and ending points of the diagram, activities describe activities in the process or tasks. A sequence flow is a connecting object that shows the relationship between the activities and the order, another connecting object is an

annotation flow, shown with a dotted line, which shows that an activity is related to another activity. Swim lanes show the participants in the process. Finally, an example of an artifact is an annotation. An annotation gives extra information on a part of the diagram, figure 4 shows the symbols used for the elements74.

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4.4 Methods

Defining an optimised fertility care pathway, requires a multi-step approach. Based on available time and resources for this research, it was decided to use mixed methods to first define a general

flowchart which is then reviewed and adjusted with experts from different perspectives and countries and then optimised. In this way the time spent with busy consultants and medical specialists was kept to a minimum.

A multidisciplinary project team was set up to evaluate the concept versions of the care pathway. The project team members were selected based on their previous experience with working in healthcare organisations in developing countries, their availability at the time of the research and past experience with undergoing fertility care. The flowchart and care pathways were created using the Lucidchart software.

The steps followed to develop the optimized fertility care pathway are described below. An overview of the development process of the care pathway is shown in figure 5. The steps in figure 5 have been categorized with the letters a, b, c, d, e, f ,g ,h. The letters correspond to the text that elaborates on the step in figure 5.

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31 General flowchart

a) The first step was to gain general knowledge on what fertility care is, what sorts of treatments exist, what sorts of fertility problems exist, how fertility problems are diagnosed and how the decision for a certain treatment is made. To obtain general knowledge on fertility care an

unstructured interview with a fertility care patient expert from AMPC was conducted. This interview took place via jitsi.org on request of the participant and was recorded using the jitsi.org software. Transcribing and coding the interview was not possible because the sound of the participant was missing in the recording for most of the time. After the interview, the fertility clinic websites were consulted to identify the diagnosis process and the treatment options. The websites that were consulted in the first stage were: Fertility clinic Leiderdorp65,

Fertility centre HagaZiekenhuis66 and Freya67.

b) With the information obtained from the interview with the patient expert from AMPC and the fertility clinic websites , a general flowchart of the diagnosis process and treatment options for a couple with fertility problems was created. A flowchart was used to visualize the general knowledge obtained because flowcharts are widely used in multiple fields to represent a process in a clear and easy understandable diagram (appendix a)75. The general flowchart was reviewed by the project team.

Draft version care pathway

The general flowchart of the diagnosis process and treatment options for a couple with fertility problems was presented to the project team for review and adjustment.

c) Thereafter, a guideline for good practice in IVF laboratories68

and a video of an IVF lab tour created by the Reproductive Medicine Associates of New York69 were consulted.

d) The guideline and video were used to create a draft version of the care pathway using the Business Process Modelling Notation (BPMN). BPMN is a validated method to map a care pathway72,

therefore the general flowchart created in the first step was translated to BPMN. BPMN is a semi-formal modelling language that describes complex processes in a relatively easy graphical notation. The BPMN workflow also ensures that clinical data can be connected to the care pathway73. This draft version of the

fertility care pathway was presented again to the project team in a brainstorm session. The project team provided feedback on information that was missing. After the brainstorm session with the project team the websites of One Fertility Kitchener

Waterloo70, CNY Fertility71 , Cape Fertility72 and the public forum

on the Freya website73 were consulted for background

information to process the feedback provided by the project team during the brainstorm session.

Detailed Concept care pathway

e) The draft version of the fertility care pathway was presented to a fertility care doctor from the Oost-Limburg hospital in Genk

(Belgium) during a Skype session. The fertility doctor from Genk was contacted by the junior

Figure 5: Overview of development process care pathway

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32 researcher of this study because the fertility doctor was involved with the Walking Egg foundation. The junior researcher contacted the Walking Egg foundation because the researcher was interested in the fertility care service line that has been developed by the Walking Egg foundation that makes fertility care cheaper and therefore available to more people in the world17. The Skype session could

unfortunately not be recorded due to technical problems.

f) The missing activities and errors pointed out by the fertility care doctor were used to create a detailed concept of the fertility care pathway. The detailed concept of the fertility care pathway was reviewed with the project team.

Final version care pathway and SIPOC

g) The detailed concept version of the care pathway was used to identify the information flows related to the fertility care pathway. SIPOC diagrams were used to present the information that goes in an activity from the fertility care pathway (inputs) , and the information

that goes out of an activity from the fertility care pathway (outputs), see figure 6. The reason for choosing SIPOC diagrams to present the information flows was because SIPOC diagrams present information in a simple and high-level way so that it is easy understandable to the project team76. Suppliers

and Customers were left out of the diagrams. A SIPOC was created for every event in the fertility care pathway that had information inputs and outputs. The SIPOC diagrams were created in Microsoft Excel. Besides from the detailed concept version of the care pathway, screenshots from a fertility care electronic medical record77 and the website of the Tergooi fertility centre78 were used to find

more detail in the information flows related to the activities in the fertility care pathway.

h) The SIPOC diagrams were used to identify irrelevant activities (activities without input or output). The activities without information inputs and outputs were seen as irrelevant for the fertility care pathway. Therefore, the events without information inputs and outputs were left out of the final version of the care pathway.

DOTWIMP

After the development of the fertility care pathway and related information flows, the care pathway was optimised using a ‘DOTWIMP’ analysis. DOTWIMP is a waste analysis tool which is part of the toolbox of the Lean methodology. To develop the final version of the fertility care pathway there have not been any visits to a fertility clinic to see the process in practice. Instead, the fertility care pathway is based on literature and interviews. Therefore, it was hard to identify waste in the fertility care pathway developed in this study. Hence, the DOTWIMP analysis was performed to identify potential wastes and points of attention for the implementation of the fertility care pathway.

4.5 Results

The project team consisted of five Dutch AMPC consultants who are involved in setting up a fertility care service line and a junior researcher with some Lean experience and knowledge on DOTWIMP. The experience of the participants in working in healthcare ranged between two to fourteen years. One team member was a doctor, two participants are consultants and one participant is a partner at the AMPC. One of the consultants had an IVF treatment herself and is therefore a patient expert.

The information retrieved from fertility clinic websites, the IVF guidelines and interviews provided insight in the process for designing the fertility care pathway. A total of eight iterations were needed

Figure 6: SIPOC diagram with information input and output

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33 to develop the fertility care pathway for the Netherlands and Belgium (see figure 5). Every step of the fertility care pathway was discussed with the fertility care doctor. The fertility care doctor pointed out some missing activities and errors in the care pathway that were adjusted. Using the BPMN tool, the fertility care pathway was categorised into three swim lanes namely: at home, in the clinic and at the laboratory. One of the adjustments by the project team was that the team found it more clear to categorise the swim lanes based on location instead of categorising the swim lanes based on persons in the process, which is how the swim lanes were categorized in the first draft version of the care pathway. The starting point of the fertility care pathway was defined as the first moment the patient enters the fertility clinic. Some discussion took place before agreeing on the exact start- and

endpoint of the care pathway. Even though beforehand the research objective was to start at the first consultation of a patient or couple with a doctor and to end when the treatment is finalized, to describe the exact activities and information flows for the start- and endpoint was not

straightforward. The team reached consensus on the ending point of the care pathway defined as the moment when the patient stops with the treatment or when the patient gets pregnant and receives the ultrasound after 13 weeks. The starting and ending point of the fertility care pathway were based on the experience of the patient expert. A high-level representation of the fertility care pathway for the Netherlands & Belgium has been presented in figure 7, the detailed version of the fertility care pathway is presented in appendix B. The information flows have been presented in appendix C. The care pathway has four different paths that can be followed and two sub-paths

1. Decision is made for IVF or ICSI – Man needs MESA or TESA treatment

2. Decision is made for IVF or ICSI – Donor semen used or no male treatment needed 3. Decision is made for insemination – Donor semen used

4. Decision is made for insemination – No donor semen needed The sub-paths were:

1. Woman is pregnant yes/no

2. There is a risk for overstimulation yes/no

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