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Introduction to RESEARCH World
Transcript of Introduction to RESEARCH World
RESEARCH... Alaa Obeida firstname.lastname@example.org THANK YOU :) Ground Rules - Mobiles silent
- Active participation
- Friendly environment
- Make NEW Friendships
- Have FUN :) Learning Objectives WHY RESEARCH?! What is scientific Research? In the broadest sense of the word, the definition of research includes any gathering of data, information and facts for the advancement of knowledge. The strict definition of scientific research is performing a methodical study in order to prove a hypothesis or answer a specific question.
Finding a definitive answer is the central goal of any experimental process. References:
Martyn Shuttleworth (Oct 3, 2008).
Index Medicus for the Eastern Mediterranean Region (IMEMR) Science is not perfect and does not claim to be. The Definition of the Scientific Method and Pseudoscience What we need to LEARN... -Research Ethics
- What research to do
- Planning the research
- Writing a Protocol
- Submitting a research Proposal
- Implementing the research project - Describing and analyzing research results
- Interpreting research results
- Communicating research
- Writing a scientific paper
- Making a scientific presentation
- Assessment and evaluation of research Research Ethics Guidelines for the responsible conduct of biomedical research.
It educates and monitors scientists conducting research to ensure a high ethical standard. 1946-1947 Nuremberg Trials
1. Research participants must voluntarily consent to research
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal testing
4. Research must avoid unnecessary physical and mental suffering
5. No research projects can go forward where serious injury and/or death are potential outcomes 6. The degree of risk taken with research participants cannot exceed anticipated benefits of results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified persons
9. Human subjects must be allowed to discontinue their participation at any time
10. Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death The 10 Nuremberg guidelines WHY?! Research with
Human Subjects Plagiarism Conflicts of
interest Peer Review Data management Research misconduct AUTHORSHIP Research with
animals An author on an article should have significantly contributed to both the research and writing Plagiarism is the act of passing off somebody else’s ideas, thoughts, pictures, theories, words, or stories as your own. The Indiana University website provides the following advice to avoid plagiarism.
A researcher preparing a written manuscript should cite the original source if he or she:
• “Quotes another person’s actual words, either oral or written;
• Paraphrases another person’s words, either oral or written;
• Uses another person’s idea, opinion, or theory;
• Borrows facts, statistics, or other illustrative material, unless the information is common knowledge.” To avoid unintentional or accidental plagiarizing of another person’s work, use the following tips from the Northwestern University website:
• Cite all ideas and information that is not your own and/or is not common knowledge,
• Always use quotation marks if you are using someone else’s words,
• At the beginning of a paraphrased section, show that what comes next is someone
else’s original idea (example: these bullet points start out by saying the information originated with Northwestern University),
• At the end of a paraphrased section, place the proper citation. Redundant publications constitute a special type of plagiarism.
The ICMJE defines redundant publication as follows:
“Redundant or duplicate publication is publication of a paper that
overlaps substantially with one already published.” http://plagiarism.org/ Peer review is the process in which an author (or authors) submits a written manuscript or article to a journal for publication and the journal editor distributes the article to experts working in the same, or similar, scientific discipline. The process involves the following:
1. Reviewers and editors read and evaluate the article
2. Reviewers submit their reviews back to the journal editor
3. The journal editor takes all comments, including their own, and communicates this feedback to the original author (or authors) According to an article on quality peer reviews in the Journal of the American
Medical Association, a high quality peer review should evaluate a biomedical article or publication on the following merits:
• Importance – Does the research impact health and health care?
• Usefulness – Does the study provide useful scientific information?
• Relevance – Does the research apply to the journal’s readers and content area of interest?
• Sound methods – Was the research conducted with sound scientific methods
that allowed the researchers to answer their research question?
• Sound ethics – Was the study conducted ethically ensuring proper protection for human subjects? Were results reported accurately and honestly?
• Completeness – Is all information relevant to the study included in the article?
• Accuracy – Is the written product a true reflection of the conduct and results of the research? The two most important ethical concepts in the peer review process are
2) Protection of intellectual property Conflicts of interest arise when a person’s (or an organization’s) obligations to a particular research project conflict with their personal interests or obligations Any conflict of interest especially regarding the funding organization should be revealed by the researcher. 1) The ethical and truthful collection of reliable data.
2) The ownership and responsibility of collected data.
3) Retaining data and sharing access to collected data with colleagues and the public. The three issues for data management (ethical and truthful data collection, responsibility of collected data, and data sharing) can be addressed by researchers before and during the establishment of a new research project. Research misconduct is defined as fabrication, falsification, or plagiarism
in proposing, performing, or reviewing research, or in reporting research
results. • Fabrication is making up data or results and recording or reporting them.
• Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
• Plagiarism* is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
• Research misconduct does not include honest error or differences of opinion. (1) To insure that animals intended for use in research facilities or for exhibition purposes or for use as pets are provided humane care and treatment.
(2) To assure the humane treatment of animals during transportation in commerce.
(3) To protect the owners of animals from the theft of their animals by preventing the sale or use of animals which have been stolen. --Respect for Persons – Informed Consent
a) know what they are getting involved with before they commit;
b) not be coerced or manipulated in any way to participate;
c) must consent to participate in the project as a subject
--Respect for Persons – Privacy and confidentiality
--Risk benefit and beneficence
--Justice The following should be considered:
• Human subjects must voluntarily consent to research and be allowed to discontinue participation at any time.
• Research involving human subjects must be valuable to society and provide a reasonably expected benefit proportionate to the burden requested of the research participant.
• Research participants must be protected and safe. No research is more valuable than human well being and human life.
• Researchers must avoid harm, injury, and death of research subjects and discontinue research that might cause harm, injury, or death.
• Research must be conducted by responsible and qualified researchers.
• No population of people can be excluded from research or unfairly burdened unless there is an overwhelming reason to do so. Tuskegee Syphilis Experiment
1932 and 1972 What Research to DO?! Selection of a field for research Drivers for health research Participation in collaborative
international research Participation in pharmaceutical
company research Where do research ideas come from? Criteria for a good research topic Categories of health research:
• Biomedical sciences: all biological, medical and clinical research, and biomedical product development and evaluation.
• Population sciences: epidemiology, demography and the socio-behavioural sciences.
• Health policy sciences: health policy research, health systems research and health services research. Economic analysis studies are now an important subcategory of health policy research. Multidisciplinary Research Research Type:
• Basic versus applied research
• Quantitative versus qualitative research
• Descriptive versus Experimental
• Action research
• Research in health economics
• Big science There are only two types of science: “applied” science, and “not yet applied” science. Qualitative and quantitative research are not alternatives. Rather than thinking of qualitative and quantitative strategies as incompatible, they should be seen as complementary. Curiosity-driven research Needs-driven research Profit-driven research Opportunity-driven research In many types of biomedical research, discovery is the prize in the research game There is no guarantee that research, actively and methodologically pursued, will lead to the discovery of what it set out to discover Minoxidil (the drug for male baldness) was originally developed and tested for the treatment of hypertension Sildenafil (Viagra), used for the treatment of erectile dysfunction, was discovered in a cardiovascular research programme “Keep on going and the chances are that you will stumble on something, perhaps when you are least expecting it. I have never heard of anyone stumbling on something sitting down.” --Heath, 1985 The seeds of great discovery are constantly floating around us, but that they only take root in minds well prepared to receive them Alexander Fleming in the summer of 1928
"Antibiotics" In 1889 in Strasbourg, while studying the function of the pancreas in digestion,
Joseph von Mering and Oscar Minkowski removed the pancreas from a dog. One day later, a laboratory assistant called their attention to a swarm of flies around the urine from this dog. Curious about why the flies were attracted to the urine, they analyzed it and found it was loaded with sugar, a common sign of diabetes. But it was only in 1921 that Canadian researchers Fredrick Banting (a young medical doctor), Charles Best (a medical student), and John Macleod (a professor) could extract the secretion from the pancreas of dogs, inject it into dogs rendered diabetic, and prove its effectiveness In the field of international health now, the burden of disease as a result of any health problem is commonly expressed as the disability-adjusted life years (DALYs) lost. This measure expresses both time lost through premature death and time lived with a disability. Industry has become a major actor in health research In the 1990s, seven countries—United States of America, Japan, United Kingdom, Germany, Switzerland, France and Italy (in decreasing order)—
conducted 97% of all worldwide pharmaceutical research and development (Murray et al. 1994). The recent top-selling drugs were mostly in this category, for example Eli Lilly’s Evista for osteoporosis, Merck’s Propecia for male pattern baldness, Pfizer’s erectile dysfunction pill Viagra (with estimated sales of US$ 2 billion by 2000), and Monasto’s Celebra for arthritic pain. The opportunity comes with the availability of funding, the chance to participate in collaborative international research, and working with the pharmaceutical industry Funding comes from;
1) Public sources: governments and United Nations intergovernmental organizations
2) Private sources: or-profit pharmaceutical industry and not-for-profit agencies - Research is an international activity.
- Knowledge is created and built up incrementally through the work of scientists of different nations.
- There is no such thing as self-reliance in science.
- Science is international.
- There is no national science; there is a national contribution to the pool of science. Different models for participation in international health research:
1) Participation in multi-centre clinical trials
2) The network approach (human genome project)
3) The twinning approach International health research provides good opportunities for developing country researchers BUT Country priorities for research should not be distorted Another concern is the internal brain drain problem. The brain drain is not simply geographical.
Brain drain can take place while the scientists are in their own countries, if their interests and scientific pursuits are completely irrelevant to their country’s problems. Research should not be done in one country for the benefit of another country.
Research subjects and/or their communities, should stand to benefit from the research conducted on them. NO “safari research" Collaboration between industry and academia more than 30% of their research and development budget and all or part of their clinical research and development (Burrill, 1998) The advantage of participation in industry-sponsored
research is that it is usually well funded, and is more likely to be pursued for clinical application. Concerns: 1) Discovery research (patent and licensing rights)
2) Clinical testing (Good Clinical Practice (GCP))
3) Post-marketing research (a promotional objective, scientific rigour) Searching the medical literature • Read the medical literature, including reviews which outline gaps in research
• Attend scientific meetings
• Teach—questions asked by students can often give ideas for research
• Be a team player—ideas can come from colleagues or mentors, in the same or different disciplines
• Acquaint herself/himself with the lines of interest of funding research organizations • Develop specific areas of scientific interest—it is a good idea to be an expert in
a small field, it is better to be a big fish in a small pond than a small fish in a large lake
• Get new ideas out of her/his own previous research
• Be a good observer
• Be imaginative
• Have a skeptical attitude when reading scientific findings—science should not be admired, science should be questioned There are over 2 million articles published every year in over 20,000
biomedical journals. Initiatives for expanding access to the scientific literature Open access Health InterNetwork Access to Research Initiative (HINARI) Eastern Mediterranean Region Virtual Health Sciences Library PubMed Central Eastern Mediterranean Region Index Medicus http://www.biomedcentral.com/openaccess WHO and 5 leading publishers http://www.who.int/hinari/en/ http://www.emro.who.int/information-resources/vhsl/ BY United States National Library of Medicine (NLM) http://www.ncbi.nlm.nih.gov/pmc/ http://www.emro.who.int/information-resources/imemr/ A good research topic should be feasible (can be done), interesting, novel, ethical and relevant (has an implication). These criteria have been collectively called the FINER formula (Hulley et al., 2001) Sir Peter Medawar, a British Nobel Laureate, used to describe scientific research as “the art of the soluble”, in an analogy to Otto von Bismarck’s description of politics as “the art of the possible” (Medawar, 1979) Feasibility • It should be possible to recruit the number of subjects required to provide the answer
to the research question within the timeframe of the planned research.
• The research facility available to the investigators should have the equipment, supplies
and other requirements to undertake the research.
• The investigators must have the required expertise.
• The cost of doing the research must be affordable and the financial resources available.
• The research objectives must not be too many or too ambitious. It is always advisable
to establish a single primary objective around which to focus the development of
the study plan. This can be supplemented with secondary objectives that may also
produce valid conclusions. Interest topic must be of interest to the investigators and to the scientific community Novelty The research must be expected to contribute new information. Novel does not necessarily mean that the research has not been done before. The prefix “re” in the word research implies searching again. Ethics Ethical issues must be addressed at the early stage of selecting the research topic.
Other ethical issues will need to be addressed in planning the research. Some ethical problems may indicate that the research should not be considered from the beginning. Relevance This criterion can be called: the “so-what?” test. For the research to be considered relevant, it must have the potential to advance scientific knowledge, influence clinical management, influence health policy, or guide further research. 1 2 Planning the Research 3 Types of research design Selecting a research design Defining and refining the research question Generating the research hypothesis Study Sample Sample Size Measurement Planning Qualitative Research A note on questionnaire design A note on research in health economics Ethics in research design Observational Studies Experimental or Intervention Studies Descriptive Analytical An observational study that simply describes the distribution of a characteristic. An observational study that describes associations and analyzes them for possible cause and effect. Cross-sectional Longitudinal measurements are made on a single occasion measurements are made over a period of time;
Retrospective or Prospective Case–control studies A type of observational-analytical-retrospective studies over time in which a group of subjects with a specified outcome (cases) and a group without that outcome (controls) are identified.
Used for studying rare conditions and conditions with long intervals between exposure and outcome.
Efficient and economical, but do not have the strength of evidence of a prospective study. Cohort Studies In clinical and epidemiological research, a longitudinal observational study is usually called a cohort study.
The word cohort was the ancient Roman term for a group of soldiers who marched together into battle.
The prospective cohort design is generally considered to be the “crème de la crème” of observational methodologies. One of the best examples of a prospective cohort study was initiated by Austin Bradford Hill and Richard Doll, to investigate the relationship between smoking and lung cancer. In the experimental or intervention study, the investigators test the effect of an intervention on the events taking place in the study. Controlled Non-controlled In the late 1920s, a group of researchers at the Western Electric Hawthorne Works in Chicago were investigating the effects of lighting, heating and other physical conditions upon the productivity of workers. Much to the surprise of the researchers, the productivity of the workers kept improving even when the actual physical conditions were not improved. The Hawthorne effect can be manifested in clinical research settings.
Even “inert” treatments might result in significant improvements in the patient’s condition (Polgar and Thomas, 2000). Giving a treatment to a patient or group of patients and finding that the treatment works gives only preliminary and non-definitive information.
No control group!! Randomized Non-randomized In testing the outcome in a group of patients who receive the treatment and another group who do not, we are still not sure whether any difference observed is because of the treatment or because the characteristics of the patients in the two groups were different. Intervention studies characterized by the prospective assignment of subjects, through a random method, into an experimental group and a control group. Intervention studies in which allocation to either experimental or control group is not based on randomization, making assignment subject to possible biases that may influence study results. A crossover study a special design of controlled intervention study that is
sometimes used in drug trials.
Half and half then cross. Time consuming. Better comparison. A before-and-after study (historic controls): results from experimental subjects are compared with outcomes from patients treated before the new intervention was available. The term double-blind is used when neither researchers not subjects are aware of the type of intervention.
A trial in which there is no attempt at blinding may be called open or open label. A research question may be answered by more than one research design. The researcher has to select the appropriate design for the particular study. In the traditional hierarchy of evidence, randomized controlled
studies are generally ranked high, followed by cohort and case–control studies, while observational descriptive studies are ranked at a lower level. The investigators may, however, not be able to select the design that gives a high level of evidence, because it will not be feasible to do, or will not be ethical to do. In this case, their selection of another design will be acceptable and justified. In order to develop the research design, the research topic often has to be changed to a research question, and the research question should be defined and refined so that it can be answered with precision. Does post-menopausal hormone replacement therapy predispose women to develop endometrial cancer? For the purpose of the research design, the question needs to be better defined. (type of therapy, duration, cancer confirmed or not...) For the purpose of the research design, the question also needs to be refined.
The research will only be able to determine if there is an association or not.
The refined question should therefore be: Is post-menopausal hormone replacement therapy, as defined, associated with a subsequent increased risk of endometrial cancer?
The association, if found, will need an explanation, but cannot be taken as meaning causation without further questioning. Another example for practice:
“Is passive smoking harmful to
the foetus?” “Are the children born to women whose husbands smoke more than 20 cigarettes a day, of lower birth weight than children born to women whose husbands do not smoke?”
This research question is now suitable to turn into a specific hypothesis that can provide a good basis for the development of an appropriate design and calculation of the sample size needed. If the research question is concerned with relationships between observations or
variables, a research hypothesis will need to be developed. Target population and accessible population Types of sampling An important issue in the design of the research is the question of sampling. Ideally, the study design should include all the target population.
The term population in scientific methodology refers to the material of the study, whether it is human subjects, animals or inanimate objects.
Including all the target population is generally not possible, because of the large numbers, the cost and the time.
A subset of the population is studied instead, from which conclusions (or inferences) are drawn as applying to the target population.
The sample has to be selected to be as representative as possible of the target population, and in enough numbers to provide valid answers. Instead of the “target population”, the investigator often depends on the “accessible population”. The accessible population must be representative of the target population, in order to draw conclusions about the target population. ELECTIONS Polls Population Census The sample selected from the accessible population should be representative of the accessible population. Random sampling is not haphazard sampling. It is sampling done in a systematic way to ensure, as far as possible, complete objectivity in the selection of the sample. Now, it is usually done using a computer program. Stratified random sampling: a special type of sampling to ensure that all subgroups in the accessible population are represented in the sample Cluster sampling: It is based first on the random selection of certain subgroups, from which the sample can be taken. Systematic sampling: a simple periodic process, for example selecting every second or third patient. Consecutive sampling: taking every subject who presents herself/himself over a specified time period. These are not strictly random techniques, but they avoid bias in the selection. The desired sample size is now easily calculated with the help of computer statistical programs. It is not necessarily true that the bigger the sample, the better the study.
Beyond a certain point, an increase in sample size will not improve the study.
It is also better to ensure that the sample is representative, rather than being very large. We decide beforehand on a level of probability or uncertainty that we are willing to accept for the study, and then we find the desired sample size to provide that level of statistical probability. Traditionally, most studies set this level of statistical significance at 0.05, that is accepting a chance of 5% of finding an association that is not actually there. In this case, we still want to calculate statistical probability that we may have missed a difference or an association that exists in the population, but was not found in the sample. This so-called statistical power of the study. Usually 0.8 is acceptable. Avoid false-negative error avoid false-positive error An important question in the research design is the decision on how measurements are made to ensure reliability and validity. To test for validity of the measurement, it has to be compared to a “gold standard”. If for example, we are using a diagnostic test as an indicator of breast cancer, it should be compared to the gold standard of a breast biopsy. Quantitative Research Three main methods are commonly used in qualitative research: Observation In-depth Interviews Focus Groups Depending on the objective of the study, observation can be made from an outsider or insider perspective, or somewhere in between.
Outsider observers maintain a distance.
Insider observers interact. Intensive one-on-one interviewing is a classical method in qualitative research.
Unlike questionnaires interview (Quantitative method), the questions flowing from the answer of the respondent, as a follow-up to the answer, or to probe further into the answer. Open-ended questioning is a basic tool in qualitative research. A focus group discussion is not a group interview. It is based on the exchange of information, ideas and views among the participants themselves. The researcher is playing the role of a moderator, and not an interviewer. The group should be relatively homogeneous, for example in age and sex and sociocultural background. A two-hour discussion (ideally 8-10 people) is likely to generate 25 to 40 pages of transcript. Self-administered
Administered by interviewers The open-ended and Closed-response types TIPS:
- Questions should be well worded to avoid any ambiguity.
- Jargon should not be used.
- Not be phrased in a way that influences the response in one direction or another
- Should always be pre-tested in a pilot study before the main survey. A questionnaire typically includes the following components:
- An introductory statement
- Demographic questions
- Factual questions
- Opinion questions
- Closing statement All methods of economic evaluation in health care have one principle in common:
they examine one (or more) possible interventions and compare the costs of inputs or
resources necessary to carry out such interventions with their effects or economically
assessed benefits (Jefferson et al., 2000). In economic evaluation, the cost of an illness generally includes:
• Direct costs: borne by the health care system, community and patients’ families in addressing the illness (for example, diagnosis or treatment costs);
• Indirect costs, which may be tangible or intangible;
- Indirect tangible costs are mainly productivity losses, caused by the disease condition, and borne by the individual, family, society, or by the employer;
- Indirect intangible costs include the costs of pain, grief and suffering, and the loss of leisure time. From an ethical standpoint, four categories of health research can be distinguished. 1) Research involving human experimentation
- a) research of therapeutic or diagnostic nature
- b) research of a purely scientific nature
2) Research involving human subjects but not experimentation
3) Research involving experimentation on animals
4) Research not involving human subjects or animal experimentation Writing the Research Protocol 4 After proper and complete planning of the study, the plan should be written down.
The protocol is the detailed plan of the study.
Every research study should have a protocol, and the protocol should be written. WHY TO WRITE IT?! A well-thought out and well-written protocol can be judged according to three main criteria.
• Is it adequate to answer the research question(s), and achieve the study objective?
• Is it feasible in the particular set-up for the study?
• Does it provide enough detail that can allow another investigator to do the study and arrive at comparable conclusions? Format for the protocol • Project Title (descriptive and concise)
• Project Summary (concise, and should summarize all the elements of the protocol and stands on its own) • Project description:
− - Rationale (equivalent to the introduction in a research paper -why and what-)
− - Objectives: research question(s) (simple (not complex), specific (not vague), and stated in advance (not after the research is done), 1ry then 2ry objectives)
− - Methodology: (Full details, include information on the research design, the research subjects, interventions introduced, observations to be made and sample size)
− - Data management and analysis: (data coding for computer analysis, monitoring and verification)
• Ethical considerations: (should be written)
• Gender issues
• References: (relevant references on the subject) Many sciences cannot follow the scientific method exactly, due to the difficulty of defining reliability and validity. This, more than anything, will begin to dampen down the animosity between scientists and non-scientists and also make scientists much more approachable.
Pseudoscience is a belief that masquerades as a real science, despite failing to follow the scientific method. The definition of the scientific method is a strict protocol dictating the underlying philosophy behind scientific research. The Rosenthal effect Rosenthal and his colleagues in 1976 performed an experiment involving the training of two groups of rats in a maze learning task. A bright strain and a dull strain of rats especially bred for the purpose were trained by undergraduate student experimenters to negotiate the maze. After a suitable training interval, the relative performances of the groups were compared. Not surprisingly, the bright strain significantly outperformed the dull strain. What was surprising, however, was that the two strains were actually not different. The two groups of rats were actually genetically identical. The researchers had deceived the student experimenters for the purposes of the study, and the students’ expectations of the rats had resulted in different methods of treatment, which had affected the rats’ learning ability. These results have been confirmed time and time again in a variety of experimental settings, and with a variety of subjects. They confirm the need for blinding (Polgar and Thomas, 2000). Hawthorne effect
• Post-menopausal women who received hormone replacement therapy, of a specified type and duration, are more likely to develop endometrial cancer than post-menopausal women who did not receive such therapy. • Children born to women whose husbands smoke more than 20 cigarettes a day are of lower birth weight than children born to women whose husbands do not smoke.
The research hypothesis is a tentative statement that can be tested by a scientific research design. Using the previous two examples, the research hypotheses could be as follows. Reliability (reproducibility) means that the observer repeating the test, or someone else using the same method should be able to obtain the same findings.
Validity means that the measurement should actually represent what it is intended to measure.