TOOLKIT 36. Research. About this Toolkit. By Lisa Esmonde, MRSS

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1 TOOLKIT 36 Research About this Toolkit By Lisa Esmonde, MRSS This toolkit provides guidance on what constitutes research, what a trained researcher does and what is possible to achieve without a prior training or background in research. It is not a complete how to of research. Research is a vast topic and this toolkit should be viewed as a most basic starter kit and hopefully encourage collaboration with either a professional body involved in research such as a University Department involved in researching complementary therapies or some other group that is suitably qualified. It will provide some literacy in the terms commonly used in research and which the reader will find in academic papers reporting on research studies. By understanding some of the fundamental basics, the reader will hopefully be encouraged to begin steps to record their practice and perhaps even undertake some research or become involved in ongoing research in a way that is safe and relevant to appropriately researching Shiatsu. Shiatsu is not presently statutorily regulated as other complementary and alternative medicine (CAM) therapies are that have what is termed an evidence base for how effective they are. In the UK, as in many other developed nations, decisions about health technologies are determined largely by what is termed as Evidence-Based-Medicine (EBM). Technology is the term used to describe anything that can be used to treat an individual in a healthcare setting. A technology, once researched and published in a peer review publication can be counted among the evidence base to be reviewed among other related technologies and treatments for a condition that would be evaluated for inclusion among treatments to be offered in the NHS by the National Institute for Health and Clinical Excellence (NICE). As Shiatsu therapists we treat people using some or all of the varied techniques in our training that will be helpful to our clients. We are not trained to be professional researchers but yet, there may be questions that arise in our minds about what we do in Shiatsu, who is it most beneficial for, how our clients experience our treatments, the impact of consecutive treatments alongside conventional care etc. We may be concerned that there are various streams of treatment and some are more conventional Shiatsu and others not. How do we go about finding answers? Our interest in research is likely to be about what happens and what effects outcome in a Shiatsu treatment rather than the molecular construction of a substance or issues regarding other areas of scientific research. That by way of saying, the field of research is vast and spans every academic discipline but because our interest is going to concern areas of health and well-being, this toolkit will be confined to the basics of this field. And this field is very large on its own with many disparate strands. The most well known is the randomised controlled trial and the guidelines which dictate how it is conducted provide important safety checks for all the other types of health research strategies. Short mention is made of the necessity of guidelines under quantitative research.

2 Am I doing research, audit or evaluation? Important distinctions need to be drawn between areas that have apparent overlap with research but which have relevance to many common questions that arise such as those given in example above. The areas are: audit and evaluation. First, research may be defined as the discovery or testing of a new approach or technology in our clinical practice. The different types of research approaches are described later on. Research will always have a specific question that is being asked and will have stated boundaries around what it is exploring or measuring. Audit is measurement or assessment of what we already know but finding out whether it happens in routine practice. No new approach or technology is being tested but it is more of a check such as whether each new Shiatsu client is explicitly asked whether any or our profession s red flags for contraindicating treatment are asked before first treatment (do they have any fever or raised or lowered temperature, do they suffer with seizures, sudden unexplained weight changes etc.). Another audit might be whether or if an active practitioner regularly attends peer or other professional supervision for their practice. More information on audit can be obtained from the Research Council for Complementary Medicine s website It is free to become a member and download their information resources. We conduct audit to ensure safe, best and effective practice. The first steps in audit are to record factors such as: Sociodemographic data Numbers and type of conditions presented The average number of treatments before discharge How patients come to the practice Closely related to research and audit is the activities that are under the umbrella of evaluation. Again, as with audit, evaluation is not seeking to make a new discovery or particularly add to knowledge but to measure or assess how well something is working in practice. Often a service or activity is put in place in the healthcare setting because it is assumed that it will be of benefit. An example might be Shiatsu therapy services for people with chronic musculoskeletal problems in a particular catchment area where there are a high proportion of people suffering from this complaint. A simple agree or disagree questionnaire with specific symptoms listed before and after treatment will allow us to evaluate how well the service is working clinically but it will also need additional questions regarding access to the service (including ability to pay if required), whether the time of the service are appropriate, whether other local services are used in addition to or instead of the new shiatsu service etc. However, in an evaluation, no new discovery is being made. Whatever our area of investigation, before we begin, we must consult with an appropriate ethics committee. If we are working with NHS patients, we must consult with the National Research Ethics Service and satisfy their requirements for the area in question by submitting an ethics application. Further information may be found on their website at: If your work is not considered to be research but rather audit of evaluation, it is invaluable to go through this process to ensure that all is as it is required to be so no future problems will hinder your research, audit or evaluation findings becoming published in the public arena. Each area; audit, research and evaluation, has merit and serves an important function. A researcher is likely to be able to and to also conduct all three. This toolkit focuses on research. Types of Research There are different academic disciplines that will employ different research emphasis and give weight to different kinds of research. This toolkit describes the broad distinctions between quantitative (questions such as how much, how many, how effective a treatment is?), qualitative

3 (explorative questions such as how people feel receiving Shiatsu, how they see their condition after having had Shiatsu or is there any difference between receiving Shiatsu alongside conventional care? etc) and mixed methods, a combination of both of the above to better ascertain the effect and impact of a treatment. What counts as information in research Emphasis is placed on using different strategies or approaches depending on what a researcher regards as reality and their world view such as whether what a person perceives as real to be inside their head or something unchanging regardless of how they see it (their ontological perspective) and what is regarded as knowledge numbers of how many or how much or information on what way one thing may affect another (their epistemological perspective). To begin with we are probably going to conduct smaller scale research in which fundamental questions such as our world view and what we regard as knowledge, although inherent in how we not only conduct research but perhaps even make decisions, are not explicitly dealt with. But they are nonetheless important to be aware of. What is advised is that some grasp of the possibilities of different perspectives is important for when we interpret our results, whether they be quantitative or qualitative or mixed and therefore the conclusions that can be fairly drawn from them. We could ask, why bother doing research? I know the Shiatsu I provide works for people but it will not be seen as a candidate to become a viable health technology without evidence that is regarded as robust and to provide information that is considered within EBM. EBM rates the strength of research evidence in a hierarchy according to the absence of bias and application of a study s results from inferential statistical tests that allow interpretation of findings to be inferred from the particular results of study to a whole population or group of a population. (See the table of evidence according to the hierarchy of evidence used by NICE. ) This is done by the use of clinical trials, trials which employ strict research design that ensures a certain and specific minimum number of participants are recruited to a study, who those participants should be (e.g. men or/and women, adults or/and children), what their illness is etc such that a level of equivalence is possible to ascertain among all participants. This is so that any changes from the beginning of the study across participants has a less likelihood of being due to chance. Table 1: Hierarchy of evidence taken from Helen Barret s 2009 electronic paper in the publicly available online resource Health Knowledge available at: The hierarchy of research evidence - from well conducted meta-analysis down to small case series, publication bias Epidemiology: The Hierarchy of Research Evidence and Publication Bias 1. Systematic reviews and meta-analyses 2. Randomised controlled trials (RCT) with definitive results (confidence intervals that do not overlap the threshold clinically significant effect) 3. Randomised controlled trials with non-definitive results (a point estimate that suggests a clinically significant effect but with confidence intervals overlapping the threshold for this effect) 4. Cohort studies 5. Case-control studies 6. Cross sectional surveys 7. Case reports

4 EXPLAIN HOW EACH STUDY DESIGN IS DONE Measuring effects Quantitative research Good clinical practice guidelines in trials Anyone who engages in clinical trials, although less likely given their costs and legal requirements, the proper conduct of this kind of healthcare research is regarded as important enough to require statutory regulation in the form of Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation. Although most of the guidance pertains to the conduct of testing of pharmacological and potentially life threatening technology, GCP training is a requirement to undertake before engaging in clinical trials as it aids the researcher in fulfilling all possible necessary steps to ensure participants are safe, their data is appropriately protected and if a study should be formally registered, that is clarified for the researcher. (The registration process is a formal process for every clinical trial conducted anywhere in the world). A breach of requirements of GCP, constitutes a legal offence carrying up to two years custodial sentence. Although we do not want to be put off, it is important to accept that correct and ethical conduct is important as there is a long history of improper research that has led to such stringent guidance. Another point to ponder is that although legal requirements in clinical research, these guidelines benefit all other health care research as they are aimed at protecting trial participants. The reader is encouraged to investigate this further by consulting with a few helpful sources. The emphasis and most fundamental aspect of research, is to formulate either a research question or a research area that is possible to answer using a research strategy which is appropriate for that area or question and using research tools that will provide the answers or bring the area under investigation into focus. In other words, these methods must be valid. The integrity of research is judged by the concepts of validity and reliability. Validity is whether we are measuring what we think we are measuring; reliability is whether our measurement of a concept is stable. Validity is the key quality to relevant research. Much detail is given to the trainee researcher on what are termed threats to validity such that the researcher can be reasonably secure that their time and efforts are correct to allow for appropriate examination of a question. The reader is encouraged to undertake additional reading on this topic as it is crucial to ensure the validity of a piece or research. A good accessible text is by Bryman (2004). Where there are one or several threats to validity, the results obtain from that study can be rendered irrelevant. It is especially important to have some understanding of what those threats can be. Researchers talk about internal and external validity, the former referring to whether the measurement instrument is the appropriate measure and the latter whether the results of the study can be generalised to a wider population. Qualitative research Some would argue, from an epistemological point of view, that measurement using the methods required in trial research cannot possibly capture the holistic approach that is encapsulated within a Shiatsu treatment and hierarchy of evidence notwithstanding, the only approach that has relevance to studying Shiatsu is qualitative (Mason et al. 2002, Verhoef et al and Lewith, 2002) or some mixture of methods of quantitative and qualitative. Qualitative research is the exploration of phenomenon using smaller samples but examining a topic in great detail. Several methods of collecting data are available but very broadly speaking these are generally speaking one of three types of data that are collected: 1. Taped interviews with participants 2. Video observation of phenomena 3. Analysis of secondary resources such as comments on a feedback form or analysis of other printed matter

5 There are several ways to analyse the data but the most common is using some form of thematic analysis where general themes are analysed. DEVELOP Many criticisms have been levied at qualitative research, no least the inherent bias of the researcher as s/he attempts to interrogate the qualitative data and thus impost his/her perspective on it. Beginning your research Typically when a person starts out doing research, their question or area tends to lack focus and be too broad. The reader is encouraged not to be put off by this but simply keep the research topic under investigation very simple and in that way, there is less likelihood of there being any threats to validity. To begin with a defined area must be pinned down. DEVELOP GIVE EXAMPLES OF RESEARCH STUDIES OF SHIATSU WHAT IS POSSIBLE WITHIN OUR PRACTICE References Bryman, A. 2004, Social Research Methods 2nd Edition edn, Oxford University Press, New York. Mason, S., Tovey, P. & Long, A.F. 2002, "Evaluating complementary medicine: methodological challenges of randomised controlled trials", British Medical Journal, vol. 325, pp Verhoef, M.J., Lewith, G., Ritenbaugh, C., Boon, H., Fleishman, S. & Leis, A. 2005, "Complementary and alternative medicine whole systems research: Behond identification of inadequacies of the RCT", Complementary Therapies in Medicine, vol. 13, pp Lewith., G.T., Nickens, W. & Walach, H., (eds) 2002, Clinical Research in Complementary Therapies: Principles, Problems and Solutions, 1st edn, Churchill Livingstone, London.

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