Template for use in Traditional Chinese

Medicine Case Study Research Projects

Aleksandar Zivaljevic, Vahideh Toossi

Abstract
A case study research strategy is commonly used by both scientists and practitioners when reporting
on a single, or a small number of cases that provide information of significance to their field.
Although not traditionally a commonly used knowledge creation strategy in Traditional Chinese
Medicine (TCM), case study research has lately become a prominent strategy for reporting on TCM
phenomena. As a result, the output of TCM case study reports is becoming more frequently found in
journals and other currently used channels for knowledge dissemination. Consequently, written TCM
case study reports have grown in importance, which implies that ensuring scientific rigour by
imposing some requirements around the information presented, is of importance.

This work presents a set of guidelines that if followed, will bring presentation of TCM case studies
closer to the way in which Western medicine case studies are presented. We believe that this will
result in the two modalities of treatment being brought closer to one another. Moreover, similar
standards would allow for similar measures of success to be used and a comparison of the results of
the conducted case studies would be possible. Such a comparison would allow the best treatment
modalities to be recognised and adopted as the mainstream forms of treatment.

We understand that other TCM case study templates exist, but we believe that more discussion on
the subject results in more benefit to the field.

Keywords: TCM, case study, case study template

Introduction and Background

Case studies are a research strategy utilised in research projects whose focus is on “understanding
the dynamics present in the single settings” (Eisenhardt, 1989, p. 564). However, the “single
settings” constraint does not stop authors from covering multiple cases nor from utilising multiple
levels of analysis in one study. It is not uncommon for the authors of a case study to employ more
than one method and their findings are based on the data collected using both qualitative and
quantitative methods. Although some misunderstandings about its utility have arisen over time
(Flyvbjerg, 2006; Verschuren, 2003), the case study strategy is used on its own, distinguished from
other research strategies.

The use of the case study strategy has been well established in Western medicine. The object of
interest in the case study is usually a single patient, but it is not uncommon that a case study
observes a series of patients, an episode of care or the introduction of a new product, service or
policy in the medical environment (Crowe et al., 2011). The findings of a case study are expected to
be produced in a scientifically diligent manner, as erroneous results gained through conducting case
studies of low scientific rigour can be misleading for the community.
Case reports, as the written outputs of case studies, are valuable vehicles for dissemination of
information among both the communities of scientists and of practitioners. The significance of case
reports is supported by the fact that some significant discoveries in the medical field have been
communicated in the form of case study reports; examples are the first observations of HIV, a new
strain of rabies encephalitis and propranolol as a treatment for infantile haemangioma (Wardle &
Roseen, 2014).

Written documents depicting case reports are not unknown in TCM. One example is the scholarly
tradition of the Nei Jing Chinese medicine that produced many written documents outlining medical
practice in observed case studies (Ferrigno et al., 2006). However, in the past, case study reports
have had somewhat different forms in TCM. The information presented in a case study report may
not present all the information that Western experts would consider necessary to present the
research project as of sufficient trustworthiness. At the current time, the situation is changing, but it
appears that some more work is needed to raise the level of scientific rigour in the area of TCM case
study reports.

In this article, we put forward a template suitable for reporting results of TCM case studies for
consideration by the scientific community.

Firstly, we present the purpose of this work and present the reader with the reasons that led us to
produce another TCM case study report template. Secondly, we comment on the current situation in
TCM case study report writing and we mention existing case study report guidelines that are found
in the literature. And thirdly, we provide and justify a template that we recommend for future use in
producing TCM case study reports.

The purpose of the study

We believe that bringing the standards for TCM and Western medicine case study reports closer
together will bring the two modalities of treatment closer together. Similar standards would allow
for similar measures of success to be used and comparison of the effectiveness of treatments
described in the conducted case studies would be possible. This would further facilitate the use of
the best treatment techniques, regardless of the treatment modality to which they belong, being
recognised and adopted as the mainstream.

We focus on case study reports in this work and remind the scientific community that more can be
done to make TCM case studies more acceptable to Western readers, including discussions on how
to enhance the TCM case study process to increase the trustworthiness of TCM case reports.

We understand that other TCM case study templates exist, but we believe that more discussion on
the subject will be of benefit to the TCM field.

Discussion and guidelines

It is not uncommon that TCM research has been criticised for methodological and interpretative
limitations (O’Connell et al., 2009). This raises the issue of the credibility of TCM research results and
impacts on opinions about the effectiveness of TCM treatment methods and TCM as a treatment
modality. As a result, the progress of TCM, as well as its acceptance and adoption in the Western
world are being put in danger.
A good part of the criticism can be attributed to the presentation of the reports produced as
research output. Authors who have surveyed TCM case study literature, found that large number of
the TCM case studies have been published offering rich content on subjects, but they conclude that
“the quality of the reports was generally poor” and recommend that “case reports should be
published in a structured manner” (Liu et al., 2011). In the majority of cases, the message conveyed
is that “Systematic reporting recommendations are urged to develop for improving the contents and
format of case reports in TCM” (S. Fu et al., 2016).

Literature on how to write TCM case study reports is readily available in the body of knowledge. The
literature provides guidelines on how a case report should be written and gives some indications on
what should be reported. The literature we assessed comprised of journal articles (Ferrigno et al.,
2006; S.-F. Fu et al., 2016; Leung & Seely, 2009; White, 2004) and journal guidelines (CARE, 2016;
Vinjamury, 2015). After critically reviewing the guidelines, we concluded that all of the guidelines fail
to instruct the author to provide information that will relate the material presented in a TCM case
study to Western medicine phenomena and which would allow it to be appreciated and understood
by a reader with a Western medicine background.

We expect that TCM case studies will increasingly be read by readers new to TCM, but familiar with
Western medicine, including medical practitioners, allied healthcare workers, policy makers and
individuals with interest in their health. Our recommendation in this work is our reaction to that
observation and we offer a structure to be followed in writing TCM case studies that will satisfy that
need.

We suggest that the document should include at least the following sections: Introduction and
Background, Case, Treatment, Discussion and Conclusion. The model lists the Case section and the
Treatment section separately to ensure a clear separation the patient’s status before, during and
after treatment has been completed. More information on this will be given at a later point in this
document. We next provide the guidelines for each of the suggested report sections.

The introduction and Background section

Some of the common misconceptions about case studies are that they cannot be used for theory
generation and scientific advancement, that generalisation is not possible or that they are good for
hypothesis generation only. Although it is known that these are only misconceptions (Flyvbjerg,
2006), case studies where the cases are selected without much consideration can easily fall into all
these categories. This makes the selection of the case an important step in the process and we
suggest that some guidelines to support case selection are put in place. However, as the broader
discussion on the case study as a research method falls outside of the scope of this work, we will
limit our discussion to basic information only.

The onus is on the author to provide good evidence that the case described is of importance to
science. A good discussion on how to select a case is shown in Seawright and Gerring (2008). Their
classification of types of cases consists of the following: typical, diverse, extreme, deviant, influential,
most similar and most different. For them, a typical case is representative and exemplifies a stable
relationship with other cases. Diverse cases include cases that between themselves, feature the
maximum variance along all relevant dimensions. If diverse cases are observed, a case study will
investigate at least two cases. To be classified as an extreme case, a case needs to feature extreme
values of one of its variables, either dependent or independent. A deviant case shows a surprising
value of one of its variables, while an influential case is a case that influenced a definition of a model
of a causal relation. Finally, the most similar or most different cases are those cases exhibiting either
most similar or most different values in one or more dimensions of interest.

We suggest that the specifics of the clinical representation of the case as well as of the treatment
and its success or failure are taken into consideration when reasons for selecting case studies are
described. The questions that can be asked at this stage are: are the symptoms typical in their
manifestation for a given condition (typical case)? Has the reaction to treatment been typical (typical
case)? Are the values of the characteristics of these two cases in terms of symptoms and/or reaction
to treatment located on opposite ends of the spectrum (diverse cases)? Are the symptoms shown
and/or the reaction to treatment of this case far from usual in the same circumstances (extreme
case)? Are the symptoms and/or the reaction to treatment surprisingly different than those
expected (deviant case)? Is the set of symptoms and/or the reaction to treatment in this case used
for defining a relation of interest (influential case)? Are the symptoms or therapy outcome
treatment in the two cases observed the most similar/different in the group of cases observed (most
similar/different cases)?

After the selection of the case(s) has been explained and elaborated on in the case study report, we
suggest that some description of the relevant Western medical conditions and TCM syndromes are
given. This is just general information on both perspectives that will inform the reader, regardless of
her/his expertise or level of experience. At the end of the section, a parallel between the two
perspectives should be given and, if applicable, references to the different philosophies that
underpin the two views should be included.

This section should answer questions such as: What are the Western medical conditions relevant to
this case and their descriptions? What are the TCM syndromes/patterns relevant to this case and
their descriptions? What are the similarities and differences between the perspectives taken by
Western medicine and TCM in relation to the conditions/syndromes in this case?

The Case section

The Case section of the report starts with a description of why the patient has come to the
practitioner. This description includes current and past symptoms, risk factors, a description of the
treatment the patient has had in the past, how the patient reacted on the treatment and anything
else that the patient has disclosed as relevant to the condition. It is important that all information is
recorded as given by the patient, without the practitioner’s opinion, conclusions or any subjective
content.

If the patient has provided the practitioner with information that might have been collected in past
episodes of care, that information should be shown next in the case study report. This should
include all relevant information from the patient’s file that the patient might provide to the
practitionerbefore, during or after their appointment. This might include lab and x-ray data, medical
practitioners’ opinions and recommendations and any other factual data provided by the patient. Of
great importance is that only facts are presented and no assumptions are made yet.

Other valuable information to be included in the report is information about the socio-economic
factors that might have affected the patient’s condition. Therefore, we suggest that the information
on the patient’s life, work, habits and family be collected and presented in the report. However, only
the relevant information is to be shown; providing more information than necessary could result in
the increased length of the report as well as an increase in the possibility of identifying the patient
and breaching her/his right to privacy.

The information collected by the practitioner after conducting a visual inspection should be shown
next. The question answered in this section should be “What did the TCM practitioner see?”.
Although the TCM point of view, communicated through the use of TCM terminology is expected to
be the basis of the report, it would be of value if the results of the visual inspection are
communicated in language acceptable to non-TCM readers, most of most of whom should be
assumed to have basic knowledge of Western medicine. This can be done by relating observations
made of the signs and symptoms used in Western medicine. An example of good practice could be
mentioning breathlessness and voice alterations (weak voice) as an explanation for an observation
of Lung Qi Deficiency.

In addition to the visual inspection, the practitioner will also examine the patient using several other
methods. It is important that those methods are described here. The reader should be able to gain a
good understanding of the examination methods used as well as the reasons for undertaking them.

Not all information collected from the patient and produced during the examination will influence a
practitioner’s decision on the state of the patient. For that reason, it is important to list and describe
the factors that influenced the practitioner in the process of examination as well as the reasons that
influenced the diagnosis and the course of treatment. Here, a reference to Western medicine would
help the non-TCM reader to understand the reasons behind the process and the evidence for the
conclusions. Although the focus is on TCM, the work must demonstrate its validity to a reader from a
Western medicine background as well.

The information on the treatment should follow. It is important to provide all information about the
treatment, including methods, types of treatment, the exact action taken and the timeframes.
Examples of what should be considered under the types of treatment here are one of the TCM
therapies or a combination of TCM therapies and Western medicine. Examples of TCM therapies are:
acupuncture or acupressure, moxibustion, tuina or herbal medicine. The actions taken should
include a description of the exact herbal formula(s) prescribed, the points used for acupuncture or
acupressure, the body parts treated with tuina and similar. The timeframes should not just state the
length of treatment, but the periods between the treatment instances, the length of treatment
sessions, etc. It is important that all the actions are supported by the inclusion of reasons and
evidence for talking them.

It is not uncommon that patients treated by TCM practitioners also undergo non-TCM treatment at
the same time. They may be undergoing a course of treatment prescribed by a Western medical
practitioner, that might include medications (drugs) or other invasive or non-invasive therapies
(radiation therapy, physical therapy, surgery, etc.). They may also be undergoing an alternative
therapy treatment that includes dietary supplements, herbs or similar. As all these can influence the
course and the outcomes of TCM treatment, it is important that it is documented in the case study
report.

If Western medicines or complementary therapies are also used during the course of TCM treatment,
it is advisable that the author discloses whether that has been taken into account or considered to
have no impact when the TCM treatment was prescribed and administered. If other treatments have
been taken into account, the information on how that affected the prescription of the TCM
treatment should be given as well. For example, the TCM practitioner might have adjusted the
formula(s) prescribed, or the frequency of the treatments. It would be of value to know whether the
TCM treatment was prescribed so as to be complementary to the other therapy that the patient is
taking, for example, to minimise side effects, to decrease a patient’s anxiety or pain, or whether the
TCM treatment was prescribed with goals in mind that were unrelated to the other current
treatments.

The outcomes of the treatment should be presented next. Information should also be included on
how the treatment strategy worked in relation to any other treatments ongoing at the same time. In
particular, any assumptions and conclusions related to any complementary use of TCM and Western
medicine should be described and explained.

Although it is not common practice, reporting on unsuccessful treatments can be of value to science
and should be considered for publication. Both successes and failures are of interest to science and
can provide guidance to future similar projects and authors are encouraged to report on all
outcomes.

A patient’s opinion matters. It is crucial evidence in determining the quality of care, and as a part of
collecting information on outcomes and should be included in the report. It can also provide
valuable evidence of a patient’s attitude towards TCM which can later be taken into consideration
when deciding on the reasons behind the success or failure of the treatment. The questions
answered in this section of the report should be: What did patient say about the process of the
treatment? How did the patient see the result of the treatment? Did the patient see the outcomes
as the result of the TCM treatment or of some other treatment that the patient might have had at
the same time? As patient safety is one of the dimensions of the quality of care and it is of
importance to communicate this to the reader, a patient’s remarks on how safe he/she has felt
during the treatment process should be included in the report at this point as well.

The Discussion section

The author should elaborate on the reasons underpinning the outcomes of the case. The discussion
on why the case was a success or a failure should take place in this section. This is the section where
all information should be put together in one meaningful whole, starting from the early assumptions
based on initial perceptions and available evidence, through to the reasons for selecting the specific
treatment and the patient’s reactions to the treatment and outcomes. The specifics of the case
should be highlighted again and the value of the particular case to science should be re-emphasized.
All points addressed in the discussion need to be based on evidence and medical literature should be
cited to support the points of importance made in this section.

This is the section where conclusions should be made and offered to the scientific community for
criticism. Although the author is assumed to be an expert in the field, opinions that are not
supported by evidence should be avoided. Including personal opinions that are not based on
evidence could result in a biased report and would minimise its value.

It is not uncommon that research either does not provide clear answers to research questions or
creates new questions that could be addressed in future research. If that is the case, some guidelines
should be given to future researchers who may undertake to further explore the topics raised.
Instead of using the standard phrase “more research is needed…”, more specific guidelines could be
of value. An example could be to provide directions in relation to the research methods to be
utilised (for example, clinical trials or multiple case studies), the types of patients who may be
invited to participate (for example, based on participation in specific social groups or based on the
stage of progress of the condition) or the evaluation method that could be put in place to assess the
research process and its findings.

Lastly in the discussion section, the benefits of the research in this case study report should be
highlighted. Benefits to science previously mentioned, should be elaborated on and further
explained. Any practical application of the knowledge discovered during the research, as well as any
benefits of the research to the health industry and to practitioners should also be discussed.

The Conclusion section

The conclusion section sums up all points of relevance to the research raised in the previous sections.
The author should re-state the facts that will enable the reader to understand why this research is of
value to him/her as well as the implications of the research findings to science in general. Rather
than just repeating what has been said in previous sections, the author should provide a synthesis of
the key points and suggest a way forward. The reason(s) for using a case study research method
should also be given and any limitations of this research method should be included. Lastly,
suggestions for possible future research can be provided, followed by a brief reference to methods
that the author suggests could be utilised in that future research.

Conclusion
In this work we provide a set of guidelines to be followed in writing case study research reports. The
guidelines are structured so that the presentation of information in TCM case study research reports
can be similar to that found in stern medicine case studies. We suggest that presenting TCM case
study research reports in a format with which readers with a Western medical background are
familiar will result in faster adoption of TCM as a treatment modality. We acknowledge that other
similar works exist, but we suggest that we are adding a new dimension to the discussion.

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