Clinical Research Lecture 2 PDF

# Clinical Research ## Assoc. Prof. \ Engy Ahmed Wahsh Clinical pharmacy, Faculty of pharmacy, October 6 university ## Types of Research * Clinical Research * Basic Science Research * Translational Research ## Different Types of Clinical Research * **Treatment Research** Generally involv...

# Clinical Research ## Assoc. Prof. \ Engy Ahmed Wahsh Clinical pharmacy, Faculty of pharmacy, October 6 university ## Types of Research * Clinical Research * Basic Science Research * Translational Research ## Different Types of Clinical Research * **Treatment Research** Generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy. * **Prevention Research** Looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes. * **Diagnostic Research** Refers to the practice of looking for better ways to identify a particular disorder or condition. * **Screening Research** Aims to find the best ways to detect certain disorders or health conditions. * **Quality of Life Research** Explores ways to improve comfort and the quality of life for individuals with a chronic illness. * **Genetic Studies** Aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person's genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient's genetic make-up. * **Epidemiological Studies** Seek to identify the patterns, causes, and control of disorders in groups of people. **An Important Note:** Some clinical research is "outpatient," meaning that participants do not stay overnight at the hospital. Some is "inpatient," meaning that participants will need to stay for at least one night in the hospital or research center. Be sure to ask the researchers what their study requires. ## How to Make Clinical Research ### [1] Developing a Research Idea * Critical thinking * Clinical background * Being a keen observer during clinical practice * Reading clinical research ### [2] Reviewing the Literature * Finding the keywords of the research question * Developing the search strategy * Searching Medical Electronic databases (PubMed, Cochrane, Google Scholar, EBSCO, EMBASE, SCOPUS, Web of Knowledge, etc.) Because scientific research is a cumulative process in which each researcher starts from the point where other researchers stopped. Reviewing the literature plays an important role in structuring your research project, improving your ideas by answering the following questions: * Had anyone investigated this research question before? * Which research design did they use? * Which outcomes did they measure? * What were the key results? * What were the recommendations for future researchers? ### [3] Formulating the Hypothesis * Being aware of the types of hypotheses ### [4] Planning for the Study Planning is the most crucial step in the research process. Proper planning is critical for a successful research project. Poorly designed research studies are not likely to be published in top journals, are likely to be criticized by other scholars, and might not be informative for clinical practice. On the contract, poor research design can be misleading for clinical practice. ### [5] Piloting the Study After you finalize your protocol, you should start piloting the process of data collection, data entry, and data analysis. This may shed light on potential problems that were not considered in the study protocol. ### [6] Gaining Ethical Approval * Complying with the requirements and guidelines of your institution Ethics Committee (EC) or Institutional Review Board (IRB). ### [7] Study Implementation * Clinical skills if the interventional study ### [8] Data Collection * Data collection tools e.g. Redcap, Surveygizmo, ... etc. ### [9] Data Entry * Using MS Excel, Google sheets, Epiinfo®, etc. ### [10] Data Analysis * Interpretation of the statistical analysis results * Running the basics statistical tests on some statistical analysis software, e.g., SPSS, R, STATA, SAS, etc. ### [11] Writing Manuscript * Following the standard reporting checklists * Following the scientific writing rules * English language proficiency ### [12] Publication * Presentation skills * Experience in Journal selection * Experience in addressing reviewers' comments Highlights the importance of making your research available to others. The process of publication allows your work to be evaluated and criticized by healthcare physicians and decision-makers, and deposited in the scientific literature for future researchers. You can publish your work in a conference and/or an academic journal whether their coverage is national, regional, or international. ## Reviewing the Literature (Literature Search) What the difference between (literature review & literature search)? * **Finding** The keywords of the research question. Medical Subject Headings (MESH) * **Developing** The search strategy. Boolean operator * **Searching** Electronic databases (PubMed, Cochrane, CINAHL, EMBASE, Google Scholar, EBSCO, SCOPUS, Web of Knowledge, PsycINFO, etc....) ## Developing Research Questions * **Steps to Write Research Questions** 1. Select an Interesting Topic 2. Do Preliminary Research on the Topic 3. Consider Your Audience 4. Ask Questions 5. Start Your Research ## Reviewing the Literature (Literature Search) * **Finding** The keywords of the research question. Mesh terms * **Developing** The search strategy. Boolean operator * **Searching** Electronic databases (PubMed, Cochrane, CINAHL, EMBASE, Google Scholar, EBSCO, SCOPUS, Web of Knowledge, PsycINFO, etc....) # National Library of Medicine A screenshot of the website is presented here. The website of the National Library of Medicine, which is part of the National Center of Biotechnology Information, is a search engine that allows users to have access to the Medline database and selected life science journals. # National Center for Biotechnology Information A screenshot of the website is presented here. The website of the National Center for Biotechnology Information provides users with access to biomedical and genomic information. ## MeSH A screenshot of the website is presented here. MeSH stands for Medical Subject Headings. It is the controlled vocabulary thesaurus used for indexing articles for PubMed. ## Boolean Operators Boolean logic (named after mathematician George Boole) is a system of logic to designed to yield optimal search results. The Boolean operators, AND, OR, and NOT, help you construct a logical search. * **AND** This will retrieve citations that discuss all three concepts in each article. The more concepts you AND together, the fewer records you will retrieve. * **OR** This expands your search by retrieving citations in which either or both terms appear. The more concepts or keywords you Or together, the more records you will retrieve. * **Not** Allows to exclude concepts not relevant to your search. ## Literature Search vs. Literature Review * **Literature Search** It is a well-organized search for all the literature published on a specific topic. * Process of search * A step in any research project * **Literature Review** A summary of published literature. * Collection of information about a specific topic * Obtained through a literature search * Written article ## Literature Search has other benefits as follows: * To learn more about a medical topic (educational) * To find an answer for a case-related question (clinical practice) * To determine current best practice * To learn about the most recent advanced in your area * To improve the methodology of your research project ## What is Meant by "Medical Literature"? The term "Medical literature" refers to all scientific information in the field of medicine. This information includes: * Published articles in scholarly journals * Information in textbooks. * Abstracts of international conferences. ## Electronic Databases ### Medical Databases * **PubMed** PubMed is a search engine that was developed by the National Center for Biotechnology Information (NCBI) as a part of the US National Library of Medicine® (NLM). PubMed provides access to the Medline database, and it includes selected life science journals. PubMed adds citations daily, and it currently includes about 25 millions citations. * **CINAHL** Cumulative Index to Nursing and Allied Health Literature (CINAHL). CINAHL is a database that covers research paper related to nursing and allied health. * **EMBASE** EMBASE is a European database that is considered a good alternative to PubMed. It includes international research about drug and diseases since 1974. * **Cochrane Library** Cochrane is an international research collaborative of researchers around the world. Cochrane library offers the option to search for medical evidence to guide decision making in clinical practice. ### Multidisciplinary Databases * **Web of Science** A multidisciplinary database that is developed by Thomson Reuters and is highly selective for journals. It maintains a level of quality requirements and technical requirements for medical journals to be indexed in the Web of Science. * **Scopus** Scopus is a large multidisciplinary database that includes abstract and citation of peer-reviewed literature with tools that track authors, analyse research output and visualize research trends over time in a specific topic. * **Google Scholar** An interdisciplinary search engine that includes scholarly articles, abstracts, books, and dissertations. Google scholar is a free engine to use. However, it should be used cautiously because, unlike scopus and web of science, Google scholar archives scholarly material from various sources, including non-peer reviewed articles and low quality scientific publications. * **PsycINFO** This database includes medical articles related to psychology and the psychological aspects of nursing, sociology, business, and education. We use this database if we are investigating a medical topic that is related to psychology, attitudes, and behaviours. ## What Makes a Proper Literature Search? * Good keywords * Good search strategy * Relevant database ## Characteristics of the Research Question * Feasible * Interesting to the investigator * Novel * Ethical * Relevant ## Criteria for Each Characteristic | ITEM | CRITERIA | |:---------------------|:-----------------------------------------------------------------------------------------------------------------------| | Criteria for FEASIBILITY | * Adequate number of subjects <br> * Adequate technical expertise <br> * Affordable in time and money <br> * Manageable in scope | | Criteria for INTERESTING | * To practicing physician <br> * To scientific community <br> * To policy makers <br> * Something to be expert in | | Criteria for NOVELTY | * Confirms or refutes previous findings <br> * Extends previous findings <br> * Provides new findings | | Criteria for ETHICAL | * Respect for human rights <br> * Respect for confidentiality <br> * Respect for informed consent <br> * Respect for beneficence, non-maleficence, social justice | | Criteria for RELEVANCE | * To scientific knowledge <br> * To clinic, public health or health policy <br> * To future research directions | ## Problems with the Research Question | Problem | Suggested solution | |:--------------------------------------------|:-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Not feasible | NEXT SLIDES | | * A- Too broad | * Smaller set of variables <br> * Narrow the question | | * B- Not enough subjects available | * Expand inclusion criteria <br> * Modify exclusion criteria <br> * Add other sources of subjects <br> * Lengthen the time frame for entry into study <br> * Use strategies to decrease sample size | | * C- Methods beyond skill of investigator | * Talk with your mentor and Collaborate with colleagues who have skills <br> * Consult experts and review literature for alternative methods <br> * Learn the needed skills yourself | | * D- Too expensive | * Consider less costly study design <br> * Fewer subjects and measurements <br> * Less extensive measurement <br> * Fewer follow-up visits | | Not interesting, novel or relevant | * Consult with mentor <br> * Modify the research question | | Uncertain ethical suitability | * Consult with institutional review board (ethics committee) <br> * Modify the research question | ## Long-Term Effectiveness and Safety of Quadruple Combination Therapy with Empagliflozin Versus Dapagliflozin in Patients With Type 2 Diabetes: 3-Year Prospective Observational Study This study was conducted to investigate the long-term effectiveness and safety of empagliflozin versus dapagliflozin in patients with type 2 diabetes that was inadequately controlled despite a combined administration of metformin, glimepiride and dipeptidyl peptidase-4 inhibitor. The research included 362 patients with T2D who were enrolled in a 3-year open-label, prospective observational study. Patients were given either empagliflozin or dapagliflozin in addition to their existing triple drug regimen. The results showed that both medications were effective in controlling blood sugar, though empagliflozin group had a greater overall incidence of beneficial effects and overall results showed generally well tolerance. In general, the use of empagliflozin performed better than dapagliflozin.