Learning research methodology: Revisiting the evidence.

Abstract

Sound knowledge of research methodology is important for conducting a proper study. It is also important for submitting the research proposal to regulatory bodies and for submitting the manuscript for publication subsequently. The three major considerations of research are related to scientific, ethical and regulatory aspects.[1] The first clinical trial (‘open uncontrolled trial’) related to public health was probably conducted by King Nebuchadnezzar, who ruled Babylon in 6th Century BC. He ordered that his subjects eat only meat-wine diet, believing that they would be in best health in perpetuity. However, this was opposed by some population of royal blood and vegetarians who preferred legumes and water. He allowed them to have their way for 10 days and then assessed their health; the vegetarians appeared better nourished as compared to the meat eaters.[2] In modern era, James Lind (1716–94) is considered as the first physician to have conducted a controlled clinical trial. As surgeon on a ship, he noted high rates of mortality in sailors with scurvy. He assigned the affected to receive different types of food items and found that those who received lemon and oranges had best improvement. May 20th is designated the International Clinical Trials Day, because James Lind's celebrated controlled trial began on that day in 1747. The first ‘Double Blind Non-Randomised Controlled Trial’ was conducted in 1943 involving one thousand British office and factory workers suffering from colds by The Medical Research Council UK, using patulin (an extract of Penicillium patulum) as treatment.[3] The first randomised controlled trial was conducted in 1946 with pulmonary tuberculosis patients receiving either “streptomycin and bed-rest (S case) or bed-rest alone (C case)”. Both randomisation and allocation concealment were enforced by Austin Bradford Hill, the statistician in the trial and this trial is considered as the ‘pioneer’ for the modern day randomised controlled trials.[4] Considerations of protection of human rights during research have evolved over the past century as risks and burden to patient health were recognised. Ethical foundation related to medical research was first enunciated by the Nuremberg Code (1947) after the abuses by German doctors during 2nd world war; the voluntariness of consent was the hallmark of this Code, followed by the Declaration of Helsinki (1964) by the World Medical Association (WMA) on ethical principles of research. This is updated periodically, the last time in 2013 during WMA General Assembly.[5] The need for independent evaluation of medical products before marketing was felt in the background of many tragedies, especially the thalidomide incidence in Europe in the 1960s. Many countries developed their own laws and guidelines, but a common united approach among countries was felt with the industries seeking global markets, with large diversity in terms of regulations and requirements. Hence, the ‘Harmonisation’ of regulatory requirements was pioneered by the European Community in association with Japanese and American stakeholders from pharmaceutical industry (International Conference on Harmonisation) in the form of ‘Good Clinical Practice’ guidelines.[6] These have become the universal standards for ethical conduct of clinical trials. The concept of critical appraisal and evidence-based medicine was introduced in the 1970s and 1980s to highlight the need to apply the scientific literature for bedside management and need for ‘current’ best evidence to be applied for patient care.[78] Reporting and publication are the sine qua non of research. The guidelines for conduct, reporting, editing and publication of scholarly work to improve the quality of medical science and its reporting was published by the International Committee of Medical Journal Editors (ICMJE), a working group of medical journal editors and representatives of selected related organisations, including the World Association of Medical Editors.[9] The Indian Journal of Anaesthesia (IJA) (www.ijaweb.org/www.ijaweb.in) follows the ICMJE guidelines for reporting, editing and publications as do majority of the medical journals in the world. Registration of the research proposal of the trials is recommended with separate entities/bodies which are expected to be easily accessible, not-for-profit groups which do not charge fees and are electronically searchable with mechanism for validation of the registration data.[9] Registration of the research is necessary to allow for genuine reporting so that selective, duplicative, repetitive and motivated works are avoided. The research proposals would also be accessible to public and patients so that they have knowledge of the on-going trials and whether they want to enrol. The Institutional Ethical Committee (IEC) will also be guided by the registry to check for novelty of proposed research and relevance of data related to the proposals submitted to them. The World Health Organisation hosts the International Clinical Trials Registry Platform and those registries which meet the requirements as per the ICMJE are included in this list; Clinical Trials Registry - India is one of them (http://ctri.nic.in). At the institutional level, the IECs or Institutional Review Boards perform the duties of assessing the research proposal and the ethical aspects. The constitution of the IEC and its roles and responsibilities are well defined and no research is allowed to start before prior approval of these bodies.[1011] In India, the premier agency that regulates the biomedical research is the Indian Council of Medical Research (ICMR), with a history of over 100 years. The precursor of ICMR was the Indian Research Fund Association (1911) which was re-designated as ICMR in 1949. The ICMR supported many projects including research, over many decades; The Ethical Guidelines for Biomedical Research on Human Participants was first released in 2000 and later updated in 2006. A new updated draft is now available pending final approval.[1011] All aspects of biomedical research in India are governed by ICMR. There has been rekindling of interest in research and publications in the last few years in India. This has been so because of the recent regulations of central authority on medical education, the Medical Council of India, which has received both acclaim and criticism.[12] The authors feel that the regulations have indeed lighted up the research scenario in India, but opinion is that progress here is hindered by systemic lack of mandatory effective teaching and training in research methodology. A student-centric approach to teaching in research methodology has also been felt recently among the anaesthesia faculty and trainees as it is felt that many existing teaching modules include lecture-based approaches and are not speciality specific. Epidemiological studies are less frequent in anaesthesia and critical care practice and much of the research is related to short-term interventions in the perioperative period. Keeping these factors in mind, the Governing Council of the Indian Society of Anaesthesiologists (ISA) approved the preparation of a new workshop module on Research Methodology and Publications in 2015, with President, the Editor-in-Chief of the IJA and a three-member expert group as members. The module, since then, has been operationalised and successfully implemented in various workshops across India. This issue of the IJA is another effort by the ISA and IJA to promote research methodology and publications among anaesthesiologists which covers all the aspects of the research methodology; some of the chapters have links to additional material which is available online due to constraints of print pages.