Hi XXXXXXX

Well, I suppose the research design being used here is a randomized controlled trial (RCT). As part of the intervention, we are studying a medication which has proposed benefits in treating patients with substance dependence. So, here there would two different groups - one being the "treatment" group (i.e. those patients who recieve the proposed medication to treat addiction problems) and the other being the "control" group (i.e. those patients who recieve a placebo medication). A comparison will then be made if the treatment group shows a better results than the control group, which will mean that the treatment is really effective.

Yes, of course, this research will involve a multi-diciplinary tem. Usually this team will comprise of a doctor, nurses, social workers, data analysts or statisticians, etc. Depending on the setting the study is being done, the team members should be given adequate training.

I would consider the following points vital in the training of the team members:

1) The whole team should be educated about the aims of the study and the methodology of the study. They should know what type of study this is, what is the research design and how is it going to be carried out.

2) They should be made aware of the ethical guidelines of the study, especially regarding what is the expected ethical code of conduct to be followed throughout the study.

3) The team members have to be trained on how to obtain consent from the participants in the study. Written consent by means of signing a form will be required, but before that the participants need to be explained what the study is, what is the proposed medication, they have to be made aware that half of the participants will be receiving a placebo (dummy) pill, etc, etc. So, the person doing this needs adequate training in giving these explanations and clarifying any doubts.

4) The on-site team members i.e. wherever the study is being carried out (e.g. hospital setting or community setting) should be trained on how to select and seggregate patients into the two different groups - treatment group and control group. This will involve first training them in how to enroll patients in the study based on the specified 'inclusion criteria'. For example the research workers may have to identify patients with substance abuse using certain specified criteria - may be DSM criteria or other questionnaires like CAGE questionnaire, etc. So, the team members who are doing this need clinical training on applying these diagnostic or inclusion criteria.

5) Once selected for the study, the research worker who is in-charge of administering the medication (e.g. the hospital or community nurse) will have to alloctae the patients randomly into each of the two groups, i.e. some patients may be recieving the medication and some may be receiving the placebo. So, person administering should know when, how and in what dosage to administer the medication (usually the the medication being tested as well as the placebo will be of the same size, colour and appearance to avoid any bias) and the person administering them should be knowledgeable and careful as to which is being administered to which patient. In some cases (called a double-blinded RCT), both the patient as well as the person administering the medication will be unaware as to which patient is receiving what medication.

6) After administering the drug, the patients have to be periodically followed up to track the results. They have to be assessed periodically whether they are abstinent from the substance, or how many relapses they had, etc. So, the team needs to be trained on how and using what tools this assessment has to be done.

7) Now, all the above steps require meticulous and careful record keeping. So, the team members should be trained on record keeping methods. Sometimes, computerized data entry may be required, and so, appropriate training needs to be given for that also.

8) The data collected should be kept confidential and safeguarded from tampering. So, the team needs to be educated on data storage methods also. Often, patients may be alloted numbers and the administered medication may be notified by alphabets like Drug A and Drug B. So, this involves very careful record keeping and data storage.

9) The final step would be the data analysis. The team members in-charge of statistical analysis should be properly trained in statistical methods and tests which have to be employed. They also have to be made knowledgeable in interpreting the data in an appropriate and unbiased manner.

10) Most importantly, the primary researcher or the research team leader should be able to co-ordinate the efforts and inputs of all the team members and serve as mentor to train, guide, clarify and monitor the rest of the team members.

So, from the above example we can see that the research involves human expertise and skill throughout the different steps in the study and so, unless the entire research team is well trained and properly co-ordinated, there will be possibilities for human errors, bias and wrong results. So it is indeed the reponsibility of the researcher to ensure that muti-disciplinary team is well trained is well treined and guided properly.

Wish you all the best.

Regards,
Dr. Jonas Sundarakumar
Consultant Psychiatrist

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Hi XXXXXXX

Since the questions are multiple and long, I shall give you the salient points alone, and you can build up on them.

Research validation of clinical methods has become almost universally practiced now. Evidenced Based Medicine, as it is called, is application of scientific research in evaluating and validating clinical methods and treatments, thereby ensuring that clinical decisions are based on strong scientific evidence.

STRENGTHS:
- Evidence based medicine has the strength of knowledge. For example, most clinical guidelines like the NICE guidelines or the Maudsley guidelines are based on a stockpile of knowledge, obtained from huge databases of research data.
- Ensures conscientious, explicit and judicious use of current best evidence in making decisions.
- Minimizes human error and bias in clinical decisions.
- Ensures that the clinical methods or treatment recommendations are up-to-date.
- Assures standard of quality.
- Universally acceptable.

LIMITATIONS:
- It may undermine a clinician's personal experience and expertise. For example, a clinician may have years of valuable experience in treating a particular problem or may have developed a particular clinical method based on years of practice. But just because it is not validated by research and published, it does not mean that his clinical methods or treatment strategies are useless.
- The evidence admitted is based on clinical trials – and these are expensive.
- It may sometimes take too long for properly designed RCT to be done and the results to be obtained
- Rare scenarios, like rare diseases may not always have a strong research evidence
- Finally, some critics argue that Evidence Based Medicine is, in a way, conservative and restrictive. If we were to go by only what has been proven we wouldn’t do any research at all. There won't be room for creativity or new ventures.


ROLE OF RESEARCH IN THE ADDICTION PROFESSION:
- Epidemiological research has been instrumental in determining the nature, prevalence and distribution of various substance use disorders all over the world.

- Research has been immensely useful in understanding the etiology and pathogenisis of addiction disorders.

- Regarding treatment also, it is only with the help of numerous RCTs, that treatment options have been studied and validated. The effectiveness of medication and psychotherapeutic interventions used today have to be owed to the systematic and meticulous research which have been done in the earlier years.

So, it would be a good idea to apply research support for therapeutic interventions in any clinical setting. Before a medication can be tried, it has to first be seen whether it has been studied before and whether RCTs have been done to prove the efficay of the medication. Systematic reviews (for example, Cochrane reviews) can be obtained from established databases (like the Cochrane Database), which will give a clear picture regarding the effectiveness of the medication. Clinical Practice Guidelines, like the NICE guidelines, which are strongly evidence-based can be utilized to implement appropriate treatment recommendations. Periodic updation with journals and other research updates will help in keeping the clinician well informed and equipped regarding the various treatment options available for treating addiction-related problems.

Regards,
Dr. Jonas Sundarakumar
Consultant Psychiatrist

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