The Foundation for Holistic Medical Research has developed its own unique and reliable process for choosing and conducting basic science and clinical holistic medical research. The steps outlined below are greatly abridged but still given in some detail for your interest.
Step 1: Identify the General Question
The first step in the research process is develop a research question. Interest in a particular topic usually begins the research process, but it is existing knowledge of the subject that helps create an appropriate research question for a study. Questions then arise out of a perceived knowledge deficit within a specific field of study. The mark of an excellent study is if it focuses at the extreme frontier between where current knowledge ends and total ignorance begins.
Step 2: Systematic Reviews:
A systematic review is a comprehensive survey of a topic that carefully examines all relevant studies of the highest level of evidence, both published and unpublished, assesses each study, synthesizes the findings from individual studies in an unbiased way and presents a balanced and impartial summary of the findings with due attention to any flaws.A systematic review is more rigorous than a traditional literature review and attempts to reduce the influence of bias. In order to do this, a systematic review itself follows a formal process:
- Articulate a clearly formulated research question
- Review published research (systematic literature search)
- Review unpublished research (attending conferences, personal communications with colleagues etc.)
- Identified research is rated for quality according to an explicit methodology
- Results of the critical assessment of the individual studies are merged
- Final results are stated addressing: issues of quality of the included studies, impact of bias and the applicability of the findings
Step 3: Refinement of the Question
Often the initial question identified in the Step 1 of the process is found to be too broad in scope or otherwise ambiguous. We now further clarify the question and narrow the scope of the study. This can only be done after the literature search and systematic review have been completed. The knowledge gained through these reviews guide the researcher in refining and focusing the research.
At this point, the investigator should be able to also predict an answer to the question. This will be the hypothesis to be tested by the investigation. A proper hypothesis is based on the investigator’s previously knowledge, the literature and systematic reviews, prior personal or other’s research and must be supported by available scientific evidence. The independent and dependent variables should also now be clearly identified. The independent variable (the presumed “cause”) is the variable that is varied or manipulated by the researcher. The dependent variable (the measurable response or “effect”) is the variable observed or measured for change.
There must also be a formulation of the study objective. The study objective is an active statement about how the study is going to answer the specific research question. Objectives can (and often do) state exactly which outcome measures are going to be used within their statements. They are important because they not only help guide the development of the protocol and design of study but also play a role in sample size calculations and determining the statistical power of the study.
Here is a fictional example of the relationship between the research question, hypothesis and study objective:
Study: Jones, M., et al. Treatment of Mild to Moderate Hypertension in Adult Men and Women with Convolvulus pluricaulis Chois (Shankhapushpi). Journal X, 20–; 01:1–10.
Research question: How does the herb Convolvulus pluricaulis Chois (Shankhapushpi) compare with a placebo in managing mild to moderate hypertension in adult men and women?
Research hypothesis: Blood pressure levels in individuals with mild to moderate hypertension are reduced in patients who receive daily Convolvulus pluricaulis Chois (Shankhapushpi) for 12 weeks compared with those who receive placebo.
Objective: To investigate the clinical efficacy of Convolvulus pluricaulis Chois (Shankhapushpi) in the management of mild to moderate adult hypertension.
Step 4: Clearly Define Terms and Concepts
Terms and concepts are words or phrases used in the purpose statement of the study or the description of the study. These items need to be specifically defined as they apply to the study. Terms or concepts often have different definitions depending on who is reading the study. To minimize confusion about what the terms and phrases mean, the researcher must specifically define them for the study. For example, a study which looks at the effect of a specific herb on “mild to moderate depression” must define that term as narrowly as possible. By defining the terms or concepts more narrowly, the scope of the study is more defined, making it easier to collect the necessary data for the study. This also makes the study more understandable and easier to interpret.
Step 5: Develop the Methodology
The protocol for the study is referred to as the methodology. The methodology serves as the road map for the entire study, specifying who will participate in the study; how, when, and where data will be collected; and the very specific details of the program. This protocol is composed of numerous decisions and considerations and specifies all the steps that must be completed for the study. This ensures that the investigator has carefully thought through all these decisions, knows where the funds for the study need to be allocated, and that a step-by-step plan will be followed.
Step 6: Collect Data
Once the methodology is completed, the actual study begins with the collection of data. The collection of data is a critical step in producing the information needed to answer the research question. Every study includes the collection of some type of data—whether it is from the literature, from a test tube, or from people—to answer the research question. In basic science or clinical research, investigators collect data on the defined dependent variables at defined time intervals.
Once the data are collected on the dependent variables, the researcher is ready to move to the final steps of the process, which are the data analysis and interpretation.
Step 7: Analyze the Data
All the time, effort, and resources dedicated to steps 1 through 6 of the research process culminate in this penultimate step. The importance of statistics, especially in holistic medical research, cannot be overstated and starts at the planning stage to establish the design and size of an experiment that will ensure a good probability of detecting effects of clinical or scientific interest. Statistics is again used during the analysis of data to make inferences valid in a wider population. FHMR is fortunate to have two experienced statisticians on its team. The results of this statistical analysis are then reviewed and summarized in a manner directly related to the research questions. The data is analyzed to determine if the results are statistically significant. If the differences are statistically significant, the study validates the hypothesis that was the focus of the study. Even if the hypothesis is refuted, the world of science has learned something new.
Step 8. Interpretation of findings
A statistically significant finding simply means that it is probably caused by something other than chance. Significant does not mean important. Results need to be interpreted in an objective and critical way, before assessing their implications and before drawing conclusions. Interpretation of research results is not just a concern for researchers. Health professionals and lay people reading or hearing research results should be able themselves to interpret them correctly, and to assess their implications for their work and individual health.
As you can see, conducting high-quality research requires dedication of much time and effort to every step of the planning process, implementation phase, data collection, and final analysis and interpretation.
“The best-laid schemes o’ mice an’ men gang aft agley” (poet Robert Burns) As well as research is planned, it has to be a fluid, dynamic process. Inevitably, along the way there are many unforeseen issues and obstacles and modifications are always required. You cannot conduct a study using a true scientific research process when time is limited or the study is done under other constraints. Though adjustments along the way can be expected, research that does not adhere to a formal protocol such as this FHMR process, results in either false conclusions or conclusions that are not of any real value to the scientific community or society.