151219P - HEALTH RESEARCH: RESEARCH IN NURSING AND MEDICINE 1: INTRODUCTION

Presented at a workshop on enhancing research and publications in universities in Eastern Africa held at Umma University Kenya 19^th December 2015 by Professor Omar Hasan Kasule Sr MB ChB(MUK), MPH (Harvard), DrPH (Harvard)

IMPORTANCE OF RESEARCH IN EDUCATION

• The purpose of research is not only to discover new knowledge
• Research complements the learning process
• The teacher engaged in research is intellectually active and up to date
• A student engaged in research has a thirst for knowledge 

QUR’AN AND RESEARCH 1: CONCEPTS OF RESEARCH IN THE QUR’AN

• Basic Qur’anic concepts relating to research are: intellect (aql), knowledge(ilm), fiqh, thinking(fikr), innovation and creativity. The Qur’an is not a textbook of science. It however contains many verses that train the mind to observe, analyze, think and act in a scientific manner.
• Intellect is correlated with signs and with knowledge. Failure to use the intellect and blind following are condemned. Knowledge is supreme. It removes blind following.
• Human knowledge is limited. Knowledge is acquired by study. Humans were ordained to read.
• The Qur’an has used the term fiqh to refer to understanding which is deeper than knowing.
• The Qur’an puts emphasis on thinking. Thinking is based on empirical observation. The Qur’an emphasizes freedom of thought in the form of freedom of belief.
• Innovations in religion are prohibited but creativity is encouraged.

QUR’AN AND RESEARCH 2: DESCRIPTIVE KNOWLEDGE IN THE QUR’AN

• Descriptive: describe things as they are
• The Qur’an described mountains, the barrier between two oceans, metal, the wind, plants, the sky, honey, and water.
• The Qur’an described the motion of the earth, the boats, the sun, the moon, the water, and of the wind.
• The Qur’an described processes such as making of iron, armor, dams, and boats.
• It described the creation of the human from dust. It describes the constant laws of nature, sunan al laah fi al kawn. The laws are fixed and stable and operate in various situations. Order is a law of nature. Recording of observations is emphasized.

QUR’AN AND RESEARCH 3: ANALYTIC KNOWLEDGE IN THE QUR’AN

• Analytic: discover the relationship (sababiyat) among events or phenomena
• Tarbiyat qur’aniyat
• The Qur’an calls for evidence. It rejects false evidence and condemns non evidence-based knowledge such as sorcery, consulting fortune tellers, speculation or conjecture.
• Human thought is a tool and not an end in itself. It operates on the basis of empirical observations and revelation, both objective sources of information, thought that is not based on an empirical basis or revelation is speculative and leads to wrong conclusions.
• The Qur’an calls for objectivity. It condemns following subjective feelings and turning away from the truth. Reliance is on observation and not speculation.
• The Qur’an calls upon humans to observe Allah’s signs in the universe and in humans. The Qur’an however made it clear that human senses have limitations.
• Rational thinking and logical operations were described. In many prohibitions the Qur’an provides logical reasons.
• The use of similitude, tashbiih, of two things and phenomena is seen several verses. The Qur’an also employed many examples, mithl, to illustrate concepts. Prudence in reaching conclusions is emphasized.

QUR’AN AND RESEARCH 4: ETIQUETTE OF SCIENTIFIC DISCOURSE IN THE QUR’AN

• Questions can be for finding out information.
• The opposing opinion should be respected. Differences on scientific matters can arise and are natural. Discussion and exchange of views is a necessity for humans.
• Discussion has its own etiquette: the truth must be revealed. Contradictions must be avoided. Arrogance is condemned.
• Attributes of good discussion: objectivity, truthfulness, asking for evidence, and knowledge. Purposeless disputation is frowned upon.  False premises should be abandoned once discovered Fear of people should be no reason for not revealing the truth. Deception is condemned. The truth of any assertion must be checked. Yaqeen is the basis of ‘ilm but dhann is not.

THE RESEARCH PROCESS

• Identifying and describing a problem
• Using the scientific method to formulate and test hypotheses
• Interpreting findings.

PHILOSOPHY OF RESEARCH

• Health research, following the scientific method, is empirical, inductive, and refutative.
• Empirical: Health research relies on and respects only empirical findings. Empiricism refers to reliance on physical proof.
• Inductive: Induction is building a theory on several individual observations.
• Refutative: Refutation is basically refusal of a supposition until it is proved otherwise. Deterministic vs relative

TYPES OF RESEARCH 1

• Theoretical
• Epidemiological
• Clinical
• Laboratory

ETHICO-LEGAL ISSUES IN HEALTH RESEARCH

• A study involving humans must get approval from a recognized body. For approval the study must fulfill certain criteria. It must be scientifically valid. It is unethical to waste resources (time and money) on a study that will give invalid conclusions.
• Among ethical considerations are: individual vs. community rights, benefits vs. risks, informed consent, privacy and confidentiality, and conflict of interest.

HYPOTHESES AND THE SCIENTIFIC METHOD

• The scientific method consists of hypothesis formulation, experimentation to test the hypothesis, and drawing conclusions.
• Hypotheses are statements of prior belief. They are modified by results of experiments to give rise to new hypotheses. The new hypotheses then in turn become the basis for new experiments.
• The null or research hypothesis, H0, states that there is no difference between two comparison groups and that the apparent difference seen is due to sampling error.
• The alternative hypothesis, HA, disagrees with the null hypothesis.
• H0 and HA are complimentary and exhaustive. They both cover all the possibilities.
• A hypothesis can be rejected but cannot be proved.
• Although a hypothesis cannot be proved in a conclusive way, an objective measure of the probability of its truth can be given in the form of a p-value.

SAMPLE SIZE DETERMINATION

• The size of the sample depends on the hypothesis, the budget, the study duration, and the precision required.
• If the sample is too small the study will lack sufficient power to answer the study question. A sample bigger than necessary is a waste of resources.
• Power is ability to detect a difference. The bigger the sample size the more powerful the study. Beyond an optimal sample size, increase in power does not justify costs of larger sample.
• There are procedures, formulas, and computer programs for determining sample sizes for different study designs.

HEALTH RESEARCH: RESEARCH IN NURSING AND MEDICINE 2: STUDY DESIGN

CROSS SECTIONAL DESIGN

• Study of the status of disease and its causes at a point in time
• Cross-sectional studies are used in community diagnosis, preliminary study of disease etiology, assessment of health status, disease surveillance, public health planning, and program evaluation.
• Cross-sectional studies have the advantages of simplicity, and rapid execution to provide rapid answers.
• The disadvantages are: inability to study etiology because the time sequence between exposure and outcome is unknown, inability to study diseases with low prevalence, high respondent bias, poor documentation of confounding factors, and over-representation of diseases of long duration.

HEALTH SURVEYS

• Surveys involve more subjects than the usual epidemiological sample are used for measurement of health and disease, assessment of needs, assessment service utilization and care.
• Planning of surveys includes: literature survey, stating objectives, identifying and prioritizing the problem, formulating a hypothesis, defining the population, defining the sampling frame, determining sample size and sampling method, training study personnel, considering logistics (approvals, manpower, materials and equipment., finance, transport, communication, and  accommodation), preparing and  pre-testing the study questionnaire. Surveys may be cross sectional or longitudinal.
• The household is the usual sampling unit.
• Existing data may be used or new data may be collected using a questionnaire (postal, telephone, diaries, and interview), physical examinations, direct observation, and laboratory investigations. Structure and contents of the survey report is determined by potential readers. The report is used to communicate information and also apply for funding.

CASE-CONTROL DESIGN

• The case-control study is popular because of its low cost, rapid results, and flexibility. It uses a small numbers of subjects.
• Cases are sourced from clinical records, hospital discharge records, disease registries, data from surveillance programs, employment records, and death certificates.
• Controls must be from the same population base as the cases and must be like cases in everything except having the disease being studied.

FOLLOW-UP DESIGN

• A follow up study (also called cohort study, incident study, prospective study, or longitudinal study), compares disease in exposed to disease in non-exposed groups after a period of follow-up.
• Follow up can be prospective (forward), retrospective (backward), or ambispective (both forward and backward) follow-up.

RANDOMIZED DESIGN: COMMUNITY TRIALS

• A community intervention study targets the whole community and not individuals.
• The Salk vaccine trial carried out in 1954 had 200,000 subjects in the experimental group and a similar number in the control group.
• The aspirin-myocardial infarction study was a therapeutic intervention that randomized 4524 men to two groups. The intervention group received 1.0 gram of aspirin daily whereas the reference group received a placebo.
• The Women’s Health Study involved randomization of 40,000 healthy women into two groups to study prevention of cancer and cardiovascular disease. One group received vitamin E and low dose aspirin. The other group received a placebo.
• The alpha tocopherol and beta carotene cancer prevention trial randomized 19,233 mid-age men who were cigarette smokers.

RANDOMIZED DESIGN: CLINICAL TRIALS

• The aim of randomization in controlled clinical trials is to make sure that there is no selection bias and that the two series are as alike as possible by randomly balancing confounding factors.
• Patients are allocated randomly either to the new drug or the old drug and rates of cure or improvement are compared

HEALTH RESEARCH: RESEARCH IN NURSING AND MEDICINE 3: DATA COLLECTION

SOURCES OF INFORMATION 1

• Existing data or Studies (observational or experimental).
• Existing data is from census, medical facilities, government, and private sector, health surveys, and vital statistics.
• Experimental studies, natural or true experiments, involve deliberate human action or intervention whose outcome is then observed.
• The advantage of experimental studies is that of controlled conditions
• The disadvantage of experimental studies is the ethical problems of experimenting on humans.

SOURCES OF INFORMATION 2

• Observational studies allow nature to take its course and just record the occurrences of disease and describe the what, where, when, and why of a disease.
• Observational epidemiological studies are of 3 types: cross-sectional, case-control, and follow-up/cohort studies. Special surveys cover a larger population that epidemiological studies and may be health, nutritional, or socio-demographic surveys.
• The advantage of observational studies is low cost and fewer ethical issues.
• They suffer from 3 disadvantages: disease etiology is not studied directly because the investigator does not manipulate the exposures, unavailability of information, and confounding.

SOURCES OF SECONDARY / EXISTING DATA

• Secondary data is from decennial censuses, vital statistics, routinely collected data, epidemiological studies, and special health surveys.
• Census data is reliable. It is wide in scope covering demographic, social, economic, and health information.
• The census describes population composition by sex, race/ethnicity, residence, marriage, socio-economic indicators.
• Vital events are births, deaths, Marriage & divorce, and some disease conditions.
• Routinely collected data are cheap but may be unavailable or incomplete. They are obtained from medical facilities, life and health insurance companies, institutions (like prisons, army, schools), disease registries, and administrative records.

PRIMARY DATA COLLECTION BY QUESTIONNAIRE

• Questionnaire design involves content, wording of questions, format and layout.
• The reliability and validity of the questionnaire as well as practical logistics should be tested during the pilot study.
• Informed consent and confidentiality must be respected.
• A protocol sets out data collection procedures.
• Questionnaire administration by face-to-face interview is the best but is expensive.
• Questionnaire administration by telephone is cheaper.
• Questionnaire administration by mail is very cheap but has a lower response rate.
• Computer-administered questionnaire is associated with more honest responses.

PHYSICAL PRIMARY DATA COLLECTION

• Data can be obtained by clinical examination, standardized psychological/psychiatric evaluation, measurement of environmental or occupational exposure, and assay of biological specimens (endobiotic or xenobiotic) and laboratory experiments.
• Pharmacological experiments involve bioassay, quantal dose-effect curves, dose-response curves, and studies of drug elimination.
• Physiology experiments involve measurements of parameters of the various body systems.
• Microbiology experiments involve bacterial counts, immunoasays, and serological assays.
• Biochemical experiments involve measurements of concentrations of various substances.
• Statistical and graphical techniques are used to display and summarize this data.

DATA ENTRY INTO THE COMPUTER

• Self-coding or pre-coded questionnaires are preferable.
• Data is input as text, multiple choice, numeric, date and time, and yes/no responses.
• In double entry techniques, 2 data entry clerks enter the same data and a check is made by computer on items on which they differ.
• Data in the computer can be checked manually against the original questionnaire.
• Interactive data entry enables detection and correction of logical and entry errors immediately.
• Data editing is the process of correcting data collection and data entry errors.

DATA EDITING / MANAGEMENT

• The data is 'cleaned' using logical, statistical, range, and consistency checks. All values are at the same level of precision (number of decimal places) to make computations consistent and decrease rounding off errors.
• Data editing identifies and corrects errors such as invalid or inconsistent values. Data is validated and its consistency is tested.

THE MAIN DATA PROBLEMS

• Missing data
• Coding and entry errors
• Inconsistencies
• Irregular patterns
• Digit preference
• Out-liers
• Rounding-off / significant figures
• Questions with multiple valid responses
• Record duplication.

DATA TRANSFORMATION

• Data transformation is the process of creating new derived variables preliminary to analysis
• Data transformation includes mathematical operations such as division, multiplication, addition, or subtraction; mathematical transformations such as logarithmic, trigonometric, power, and z-transformations.

DATA ANALYSIS

• Data analysis consists of data summarization, estimation and interpretation.
• Simple manual inspection of the data is needed before statistical procedures.
• Preliminary examination consists of looking at tables and graphics.
• The tests for association are the t, chi-square, linear correlation, and logistic regression tests or coefficients.
• The common effect measures Odds Ratio, Risk Ratio, Rate difference.
• Measures of trend can discover relationships that are not picked up by association and effect measures.

HEALTH RESEARCH: RESEARCH IN NURSING AND MEDICINE 4: READING AND WRITING SCIENTIFIC LITERATURE

6 LITERATURE SEARCH

• The best source of on-line documents is pubmed.gov.
• Articles are searched for by key words
• The search can be limited by subject matter, language, type of publication, and year of publication.

            CRITICAL READING OF A JOURNAL ARTICLE

For critical reading of scientific literature, the reader must be equipped with tools to be able to analyze their methodology and data analysis critically before accepting their conclusions. Common problems in published studies are incomplete documentation, design deficiencies, improper significance testing and interpretation.

The main problem of the title is irrelevance to the body of the article. Problems of the abstract are failure to show the focus of the study and to provide sufficient information to assess the study (design, analysis, and conclusions).

Problems of the introduction are failures of the following: stating the reason for the study, reviewing previous studies, indicating potential contribution of the present study, giving the background and historical perspective, stating the study population, and stating the study hypothesis.

Problems of study design are the following: going on a fishing expedition without a prior hypothesis, study design not appropriate for the hypothesis tested, lack of a comparison group, use of an inappropriate comparison group, the Berkson's fallacy, selection of cases and controls from different populations, and sample size not big enough to answer the research questions. The following terms are often confused with one another. ‘Measurement’ is using instruments. ‘Calculation’ deals with numbers and formulas. ‘Estimation’ is used in two senses as an approximation in measurements or as computation of statistical parameters. ‘Determination’ is a general term for getting to a conclusion by use of the 4 methods above. The term ‘study’ is generic and can be confused with experiment that refers to only some types of studies.

Problems in data collection are: missing data due to incomplete coverage, loss of information due to censoring and loss to follow-up, poor documentation of data collection, and methods of data collection inappropriate to the study design.

Problems of data analysis are failures in the following: stating type of hypothesis testing (p value or confidence interval), use of the wrong statistical tests, drawing inappropriate conclusions, use of parametric tests for non-normal data, multiple comparisons or multiple significance testing, assessment of errors, assessment of normality of data, using appropriate scales and tests, using the wrong statistical formula, and confusing continuous and discrete scales.

Problems in reporting results are: selective reporting of favorable results, numerators without denominator, inappropriate denominators, numbers that do not add up, tables not labeled properly or completely, numerical inconsistency (rounding, decimals, and units), stating results as mean +/- 2SD for non-normal data, stating p values as inequalities instead of the exact values, missing degrees of freedom and confidence limits.

Problems of the conclusion are failures in the following: repeating the results section, discussion of the consistency of conclusions with the data and the hypothesis, extrapolations beyond the data, discussing short-comings and limitations of the study, evaluation of statistical conclusions in view of testing errors, assessment of bias (misclassification, selection, and confounding), assessment of precision (lack of random error), and assessment of validity (lack of systematic error).

Internal validity is achieved when the study is internally consistent and the results and conclusions reflect the data. External validity is generalizability (i.e. how far can the findings of the present study be applicable to other situations) and is achieved by several independent studies showing the same result. Inability to detect the outcome of interest due to insufficient period of follow-up, inadequate sample size, and inadequate power.

ABUSE or MISUSE OF STATISTICS

Statistics can be abused by incomplete and inaccurate documentation of results as well as selection of a favorable rate and ignoring unfavorable ones. This is done by 'playing' either with the numerator or the denominator. The scales of numerators and denominators can be made artificially wider or narrower giving false and misleading impressions. Statistical results are misleading in the following situations: (a) violating the principle of parsimony, (b) study objective unclear and not reflected in the study hypothesis (c) fuzzy, inconsistently, and subjective definitions (of cases, non-cases, the exposed, the non-exposed, comparison groups, exposure, method of measurement), (f) incomplete information on response rates and missing data.

SCIENTIFIC WRITING

The goal of scientific writing is clarity. The following must be observed about sentences: short concise sentences, use of personal pronouns, subject-verb agreement is a common mistake, using active and avoiding passive sentences, proper organization of parallel ideas, and proper use of parentheses.

A paragraph must start with a short and simple topic sentence that is an overview of the message contained in that paragraph. Each paragraph should convey only one message. The sentences following the topic sentence provide details and support for the topic sentence. Ideas in a paragraph should be presented in the right order with no missing steps using one of the following alternatives: least to most important, most to least important, concise to the detailed, time chronological order, problem followed by solution, or solution followed by the problem. Links and transitions such as ‘which is’ should be used when moving from one group of ideas to another to ensure continuity in the paragraph. There must be consistency in the order in which information is mentioned. If certain objects were mentioned in a certain order in the introduction, they must be mentioned in the same order all through the writing. The writer should maintain a consistent viewpoint all through the paper and not appear to be jumping from point to point. Important messages must be given emphasis.

The purpose of the title is to identify the main topic or message of the paper so as to attract readers. A good title is unambiguous, concise, and contains important words. It should contain the following: independent variable(s), dependent variable(s), the study subjects or materials, and statement of the main message like ‘to study the effect of’, ‘to determine’ etc.

The abstract is an overview of the report with a few significant details. It should be written to be read by both those who read the full paper and those who do not read the full paper. Normally the abstract should not exceed 250 words. The abstract should mirror the sections of the paper: introduction, materials & methods, results, and discussion. The present tense is used to state the research hypothesis and the answer. The past tense is used for the experiment. An abstract is accompanied by keywords that are used for indexing.

The introduction should be short. It should start with stating the research question or research hypothesis and then go on to elaborate. The transition should be from the known to the unknown and from the big picture to the detail. The introduction should mention the type of study, the study subjects or materials (substances, animals, and persons). In some cases the introduction may briefly mention the proposed experimental approach to answering the research question. Results should not be mentioned in the introduction.  The introduction should state whether the work is new or original.

The aim of the materials and methods section is to describe the experimental techniques in detail sufficient for another trained scientist to replicate the procedures. The order of presentation is different for animal and clinical studies. For animal studies the order is: materials and animals, preparation, study design, interventions, methods of measurement, calculations, and data analysis. For clinical studies the order is: study subjects, inclusion criteria, exclusion criteria, study design, interventions, method of measurement, calculations, and data analysis. Independent and dependent variables should be identified. Intermediate results can be put in the materials and methods section. Final results should be put only in the results section. Details of sample size determination should be provided.

The results section presents the findings of the procedures carried out in the methods section. It should be brief and to the point. A distinction must be made between results and data. Result refers to summary information obtained from data analysis. Results of hypothesis-based studies should be in the past tense. Data of descriptive studies should be in the present tense. Data is the actual numerical information often presented in a summarized form. The result is presented followed by presentation of supporting data. Data are presented in the form of tables and diagrams (figures, bar diagrams, graphs, pie-charts, maps etc). Presentation of numerical data in text should be kept to a minimum. Only results relevant to the research hypothesis should be presented. Both negative and positive results are presented. It is considered scientific fraud to present only those results that the author thinks favor a particular hypothesis. The results section is written in chronological order. The most important results are presented before the least important. Magnitude of change should be presented as a summary statistic such as percentage change instead of presenting the raw data. Summary statistics normally used as the mean, the median, and the the proportion. The mean should be presented properly as mean +/- standard deviation or standard error of the mean (SD or SE) with units of measure indicated. Measures of effect are normally the chisquare and the t statistics. Actual p values should be given instead of indicating <0.05 or >0.05. When specifying the sample size the type of sample should be explained for example ‘the sample was 20 rats’ instead of the sample size was 20’. Emphasis can be put on some results and not others. Not all the data from the study need be reported. Citing data in the text takes less space but is more difficult to read. A topic sentence is used to give an overview. Important results are put first.

Figures used to present results must have a strong visual impact and must be simple. The following types of figures are used: line graph, scatter-gram, bar graph, histogram, and the frequency polygon. The title of the figure should reflect its contents. It must be labeled correctly. Symbols must be defined. The names of variables and units of measurement must be labeled appropriately. Tables must be properly titled and column headings clearly indicated. Footnotes, subscripts, and superscripts can be used.

The discussion section states the research hypothesis, answers it, and supports the answers using data from the current study and other studies. It provides reasons to show that the answer to the question is reasonable. It explores and explains possible sources of error and bias. It also identifies and explains differences between the study results and published results. As part of intellectual honesty it discusses the strengths as well as the weaknesses of the study and how they impact on the interpretation of the results. Issues of validity and precision are also addressed. Also discussed is whether the result is new and how important it is.

References are used to acknowledge information obtained from others. The references must be the most recent and most easily available on the subject. Review articles are better than original articles. They may be journal articles, books, PhD theses, abstracts of meetings, or conference proceedings. The reference should be put immediately after the relevant text. If there are several references in a sentence, cite each reference at the relevant point and do not wait to put all of them at the end of the sentence. References should be written using the Vancouver style which is: Author. Title. Journal Year; Volume (number): starting page – ending page.