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Descriptive Correlation studies Case reports Cross-sectional surveys Analytic Case-control Cohort prospective historical Case study Participant observation Interviewing Naturalistic study Narrative research Phenomenology Life history Oral history Field research/study Encephalopathy Interpretive research Ethnography Intervention True experiment pretest-posters factorial design repeated measures ARC Quasi-experimental one-group prophetesses nonequivalent control group, pretest-posters time-series Writing an Effective Research Proposal 4 Will have been chosen based on: 1 .
Research question/hypothesis. 2. Strengths and weaknesses of alternative designs. 3. Feasibility, resources, time frame, ethical considerations. Examples: 1 . The purpose of this study is to determine the major physiologic, psychosocial and lifestyle concerns of women two weeks and eight weeks after an unplanned cesarean delivery. Methods We will use a descriptive survey design in which all patients at weeks two and eight following an unplanned cesarean delivery will be mailed a questionnaire designed to assess physiologic, psychosocial and epistyle concerns. Example: 2.
Patients residing in rural areas of Alberta are less likely than urban patients to undergo a oscilloscope within 18 months of a curative resection for collaborate cancer. Methods This will be a cross-sectional survey. Patients with a diagnosis of collaborate cancer who underwent a curative resection will be mailed a questionnaire 18 months following surgery asking about diagnostic tests performed since surgery. Or This will be a historical cohort-study. Patients with a diagnosis of collaborate cancer will be identified using the Alberta Cancer Registry and divided into woo groups based on place of residence.
Subsequent oscilloscopes will be detected by linkage to the Alberta Health Insurance Claims Database for the 18 months following surgery. Example: 3. Does the administration of analgesic by nurses vs.. By patients themselves affect pain intensity during postoperative recovery in older adults? Methods This will be a two-group randomized clinical trial. Operatively patients will be randomized to nurse-administered or patient administered post-operative analgesia. 15 Keys to Success * Clearly identify and label study design using standard terminology.
Quantitative/qualitative * Intervention/descriptive * Cross-sectional/longitudinal * Prospective/retrospective * True Experiment/Quasi-Experiment * Must * * * specify the major elements of the design Variables, instruments Subjects: sampling frame, sample size, selection procedures Timing of testing/intervention Use a diagram if needed Must be consistent with objectives/hypotheses. Must * * * * * justify choice of design: appropriate choice to answer question lack of bias/validity precision/power feasible ethical Examples of Problems in Describing Research Designs A randomized quasi- experimental design. Quasi-experimental studies are not randomized) The primary objective is to determine if coffee drinking causes pancreatic cancer. A case-control study will be conducted. (case-control studies can determine associations but not causation) 16 SUBJECTS 1. Who will be studied? 2. How will they be recruited? 3. How will they be allocated to study groups? (if appropriate) 1 . Who Will be Studied A. Specify eligible subjects * Target population: clinical & demographic characteristics * Accessible population: temporal & geographic characteristics Inclusion/Exclusion Criteria Examples
Women following an unplanned cesarean delivery at the Foothills hospital between January 1 and March 30, 1997. Inclusion Criteria: 1. Age > 16 2. English-speaking 3. Calgary resident Exclusion Criteria: 1 . Refuse to give informed consent 2. Concomitant severe medical problem preventing participation All patients undergoing elective orthopedic surgery of the knee, ankle or shoulder at the Peter Laughed Centre. Inclusion Criteria: Age > 18 Able to understand instructions Exclusion Criteria: Allergy to study medications Drug/alcohol dependence Surgery completed after EH Refuse to give informed consent 7 B.
How will they be selected Sampling: the process of selecting a portion of the population to represent the entire population of interest (target population). Types of Sampling 1. Probability: each element in the population has an equal, independent chance of being selected. The goal is to obtain a sample representative of the target population. Inviolability samples may differ in important ways from the target population because of how they were selected (selection bias).
This is of greatest concern when the study is defining the characteristics of a population (I. E. Survey). Examples: * Simple random sampling * Stratified random sampling * Cluster sampling 2. Inviolability * Consecutive sampling: commonly used in intervention studies. * Convenience sampling * Purposive sampling: commonly used in qualitative research. Keys to Success * Clear description of study population. * Appropriate inclusion/exclusion criteria. * Justification of study population and sampling method (bias). * Clear description of sampling methods.
Examples 1. Consecutive patients admitted to the Peter Laughed Hospital for orthopedic surgery. 2. The survey will be ailed to a random sample of 100 women who underwent a Cesarean section from January 1 to December 31, 1996. Sampling will be stratified based on the hospital where they delivered. 3. All patients who underwent curative surgery for collaborate cancer between April 1, 1985 and March 30, 1994 in the Province of Alberta. 4. We will recruit a convenience sample of 25 patients attending the prenatal clinic.
Writing an Effective Research Proposal 18 2. How Will They Be Recruited? Describe what methods will be used to recruit subjects. Important to document that the study will be feasible and that there will be o ethical problems. Examples 1 . Patients admitted for orthopedic surgery will be asked by their attending surgeon for permission to be contacted about the study. Those who agree will be seen by the study nurse who will explain the nature of the study to the patient and assess eligibility for the study.
Willing patients will then be seen by the principal investigator and informed consent obtained. 2. A poster will be placed in the prenatal clinics requesting people who are interested in participating in a research study to complete and return a stamped, self-addressed card. 3. How Will They Be Allocated To Study Groups? Random Allocation: The assignment of subjects to treatment conditions in a manner determined by chance alone. Goal of Randomization: to maximize the probability that groups receiving differing interventions will be comparable.
Goals of the Randomization Technique * True random allocation * Temperature * Allocation concealment Methods of randomization * Drawn from a hat * Random number table * Computer generated Methods that are NOT Random Alternate days of the week Alternate patients 19 In the protocol: * Describe the randomization technique in detail * Justify any special cuisines used stratification blocking disproportionate randomization Example Subjects will be allocated to study groups using simple randomization performed using a computer-generated randomization list and sequentially-number, sealed, opaque envelopes.
After a subject has signed informed consent, the next envelope will be opened to determine which treatment the subject will receive. Subjects will be allocated to active treatment or placebo in a 2:1 ratio. It is believed that this ratio will increase the likelihood that patients will be willing to participate in he study and therefore increase recruitment rates. Example of Problems in Describing Allocation to Study Groups We will randomize 50 patients to either treatment or control group. During the 4 weeks of the study, it is anticipated that approximately 60 patients will be eligible.
Therefore, a random sample of fifty will be chosen. (mixing up creating a random sample and random allocation. Must randomized control trials recruit consecutive patients who are then randomly allocated to the different study groups. ) INTERVENTION In experimental research, the experimental treatment or manipulation. The literature review should have provided a Justification for the use of this application, including information on dosing, expected benefits and the risk of side effects. In the methods section, how intervention should be described in terms of when and how it will be administered, dosing, etc.