Principles And Step Of Clinical Research In General Surgery Notes

Principles And Steps of Clinical Research In General Surgery

Clinical Research In General Surgery Introduction

The dictionary defines research as “the systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions”.

The Keywords In This Definition Are:

1. ‘Systematic investigation’ meaning an orderly and methodical investigation;
2. ‘Establish facts’ meaning that you are collecting new data, and
3. ‘Reach new conclusions’ meaning that you are adding to the already existing knowledge.

Read And Learn More: Basic Principles Of Surgery Notes

Clinical research is research in the field of health sciences particularly clinical sciences. The National Cancer Institute defines clinical research as follows:

• “Research in which people, or data or samples of tissue from people, are studied to understand health and disease.
• Clinical research helps find new and better ways to detect, diagnose, treat, and prevent disease.
• Types of clinical research include clinical trials, which test new treatments for a disease, and natural history studies, which collect health information to understand how a disease develops and progresses over time”.
• We live in the era of evidenced-based surgery. Society at large expects us to practice scientific surgery.
• As long ago as 1853, Ruskin described the concept of science as follows: “The work of science is to substitute facts for appearances and demonstrations for impressions”.
• Any field, including surgery, can claim to be scientific only when the body of its knowledge is backed by reliable and honest data that is collected and analysed in good research studies. Thus it is essential that practicing clinicians understand the principles that underlie.

Principles Of Clinical Research

Clinical research is governed by several important principles. Some of these principles are highlighted hereunder.

1. Ethical Conduct Of Clinical Research:
   • The utmost importance must be given to ethical conduct in carrying out clinical research. The researcher must exercise total honesty and integrity.
   • The significant qualities of an ethical researcher was laid out by Salter and has been listed in the researcher must always have in mind the physical and emotional comfort of the subject of clinical research.
   • The ethical principle of “do no harm” must be the primary principle while undertaking research.
2. Clinical Research How Usefulness To Society:
   • Clinical research must address common clinical problems. It should try and answer the controversies or difficult questions that a clinician faces in everyday practice.
   • It would be incorrect to undertake research only for the sake of research and publishing papers.
3. Proprieties Of Clinical Research :
   • The researcher must always show propriety in whatever he/she does.
   • This takes several forms including financial regularity, communication with his colleagues and his subjects, proper maintenance of records and transparency in sharing data with others.
4. Address Biases Of Clinical Research:
   • The researcher must be careful to make sure that biases or prejudices do not compromise the conclusions that are drawn from the data.
   • Several kinds of biases exist. The important ones are:
   • Selection bias where the subjects in each of the study groups are chosen in such a manner that the results may be skewed;
   • Observer bias where the person tabulating the end result may skew the results deliberately or even unwittingly; and
   • Confounding factor/s where an intervention or a condition other than the one being studied may influence the outcome.

Steps Of Clinical Research

Clinical research is undertaken in a systematic manner involving several steps. These steps are summarised.

Clinical Research Step 1. Recognise a clinical problem and carry out a literature search to understand what is known thus far about the subject.

• Once this is determined, one can go about asking a research question. An example of a common clinical question would be whether a drain has to be used after a cholecystectomy or not.

Clinical Research Step 2. Asking the correct research question and putting forth a sensible hypothesis is an important step in research. One talks of the ‘null hypothesis’ in research.

• This essentially means that the researcher starts by saying that the intervention proposed does not have an influence on the outcome. If the data proves otherwise, then a conclusion is drawn that the intervention is indeed helpful.
• Continuing the above example, the null hypothesis would be that the use of a drain would not be useful after cholecystectomy.

Clinical Research Step 3. Draw up a protocol. A protocol is a detailed document that describes several aspects of the study including the aim of the study with the research question, the methods that are being used to answer this question, and all the administrative issues that go with the study.

• The protocol is required to make sure that the researcher and his colleagues know exactly what is to be done. The steps described in the protocol are never violated.
• The important components of a protocol are listed below:
• A Title that adequately describes the study and does enough to arouse the curiosity of the reader.
• Summary of the project. This is required to be submitted for various approvals that are required before the study is undertaken.
• Rationale of the study which describes the logic behind undertaking the study, leading up to why a particular research question had to be asked.
• Objectives of the study—lay down the research questions in detail and explain the outcomes that are going to be measured to get answers.
• Methods section of the protocol is the most important part that describes in detail what is going to be done. This has several subsections as under: 3e1. Subjects involved: Describes the characteristics of the group of patients who are going to be studied.
• Sample size: Explains the number of patients in the groups being studied. The sample size is important to determine the ‘power’ of the study and whether the conclusions of the study can be applied to all the patients at large, or not.
• Study design: Study design is the pre-eminent component of a research project. A detailed explanation of the various kinds of studies is outside the purview of this chapter. Only the very basic principles involved will be explained.
• Choosing the appropriate study design for a given research question is important. The value of the research project and the conclusions drawn therefrom depend on the choice of a proper study design.
• Anecdotal experiences reported as case reports or small numbers of patients (series) are of limited value because the information from these studies cannot be realistically extrapolated to a population in general.
• Retrospective studies collect data from patients who have already been treated or operated on.
• These studies are not as valuable as prospective studies because the methodology used is not standardized, there may be several data points that may be missing, and the interventions may vary from one patient to another.
• Prospective studies are a lot more reliable because the methods employed, the interventions undertaken, the tests done and the collection of data are all well controlled.
• The researcher can implement further safeguards against biases in the form of randomisation and blinding. Randomisation is a process where the researcher has no role in assigning the patients to the various study groups. The allocation is generally done through computer generated numbers.
• This process eliminates selection bias. Blinding is a process where the observer who measures the outcomes of the study is not aware of the intervention that has been undertaken in the study subject. Blinding eliminates observer bias.
• The randomised controlled trial (RCT) is perhaps the highest form of unbiased scientific study. Conclusions drawn from an RCT are rated to have the highest scientific value. However, it is not easy to conduct an RCT with sufficient numbers of patients particularly in surgical disciplines.
• Interventions involve a detailed description of the tests and procedures that are going to be undertaken on the patients. These may be biochemical or radiological tests. It also includes interventions in the form of administration of the study drug or an operative procedure.
• In the example taken, one may consider measuring pain through regular Visual Analogue Scale (VAS) scores, get a chest X-ray to rule out atelectasis and an abdominal ultrasound to detect collections.
• Outcome measurements describe the endpoints that are going to be measured in the study.
• Defining the endpoints and determining the correct metrics to measure them form an important part of the protocol.
• In the cholecystectomy example, one can consider postoperative pain, incidence of subhepatic collections, length of stay in hospital, postoperative infection, incidence of atelectasis as possible and points of the study.

Clinical Research Step 4. Obtain the necessary permissions from the regulatory authorities/bodies. Armed with the protocol, the researchers start with getting clearance from the head of the unit/the head of the department and the medical administrator.

• The protocol will then be scrutinized by the scientific and ethical committees of the institution. Once cleared by these committees, the study has to be registered with an authority like the Clinical Trial Registry of India.

Clinical Research Step 5. Conduct the study with honesty and diligence and collect data. Step

Clinical Research Step 6.  Analyse the data using the previously decided set of statistical methods.

Clinical Research Step 7. Draw conclusions based on the analysis of the data collected.

Clinical Research Step 8. Share the results and conclusions of the study either in the form of a presentation read at a conference or paper published in a good journal.

• It is quite possible that the results of this study are so significant that one might have to change ones’ clinical practice based on the study.
• In the example given above, many studies have shown that using a drain after a routine cholecystectomy is actually not required at

Clinical Secondary Research

The processes described so far are considered to be primary research. There is another form of research called secondary research. Examples of secondary research include systematic reviews, meta-analysis and clinical guidelines. In secondary research, data from several studies of primary research are collated and conclusions are drawn to help clinicians carry out high-quality evidence-based practice.