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119 Cards in this Set
- Front
- Back
Identify the most influential event that led to the HHS Policy for Protection of Human Subjects:
-Nuremberg trials -Syphilis Study at Tuskegee -Jewish Chronic Disease Hospital Study -Willowbrook Study |
Syphilis Study at Tuskegee
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What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)?
Honesty, Trust, Respect Informed consent, IRB review, Research Integrity Respect for Persons, Beneficence, Justice Protections for Pregnant Women, Prisoners, Children |
Benificence
Respect for persons justice |
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Which entity has regulatory authority for the protection of human subjects for PHS-funded research?
OHRP NIH Institutions that receive Federal funds HHS |
OHRP
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True or False: All research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research.
True False |
False
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True or False: An institutionally designated authority, other than the investigator, should determine that proposed studies are exempt from regulatory requirements.
True False |
True
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Which of the following should be eliminated or minimized in the research design?
Coercion Research risks Repeated recruitment of research participants for new protocols All of the above |
All of the above
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When might human subjects research require investigators to obtain informed consent?
Investigators must obtain informed consent if the study involves interactions with research participants. Investigators must obtain informed consent if the study involves interventions with research participants. Investigators must obtain informed consent if the study involves collection of private information from or about research participants. All of the above |
All of the above
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True or False: After informed consent for a research study is given, a research participant must complete the study.
True False |
False
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True or False: In general, informed consent should be a process rather than a one-time event.
True False |
true
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In order to participate in research, children must …
Provide written informed consent 1 Provide written permission Provide assent, unless the IRB determines that they are too young Sign, or put an “X” on the assent document |
Provide written permission
Provide assent, unless the IRB determines that they are too young |
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For research involving pregnant women, participation requires ...
That women have completed the first trimester. That the study be conducted first in men. Permission of the father. Consideration of risks and potential benefits for the fetus and the pregnant woman. |
Consideration of risks and potential benefits for the fetus and the pregnant woman.
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Why might an individual have diminished autonomy?
They are a neonate. They are incarcerated or involuntarily confined. They are unconscious. All of the above. |
All of the above.
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True or False: Risks to research participants must be completely eliminated for the study to be considered ethical.
True False |
False
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When are researchers specifically required by NIH policy to describe Data and Safety Monitoring?
For all research involving human subjects For all research involving children as subjects in research For all clinical trials For all research with prisoners |
For all clinical trials
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True or False: There must be equipoise in order to justify conducting a clinical trial.
True False |
True
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What is an appropriate method for maintaining confidentiality of private information obtained from human subjects?
Keeping data in a password-protected database Storing images in a secured cabinet Coding data or specimens and keeping the key to the code in a separate, locked drawer All of the above are ways to maintain confidentiality |
All of the above are ways to maintain confidentiality
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True or False: If a researcher determines that his/her study poses no more than minimal risk as defined in 45 CFR 46, there is no need for the protocol to have IRB review and approval.
True False |
False
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Children must be included in all NIH-supported human subjects research unless:
The researcher is not a pediatrician Past experience has shown it is time-consuming and expensive to recruit children There are scientific and ethical reasons to exclude them The researcher does not possess the pediatric equipment necessary to involve children in the proposed research |
There are scientific and ethical reasons to exclude them
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True or False: For HIV antiretroviral treatment trials conducted in developing countries, the NIH expects investigators/contractors to address the provision of antiretroviral treatment to trial participants after their completion of participation in the clinical trial.
True False |
True
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Which of the following is TRUE regarding applications for NIH-funded research overseas?
It is illegal to spend NIH funds in research overseas Research conducted overseas is subject to HHS Human Subjects Regulations (45 CFR 46) and local regulations and policies Research conducted overseas is only subject to local regulations and policies Research conducted overseas need not address human subjects protections |
Research conducted overseas is subject to HHS Human Subjects Regulations (45 CFR 46) and local regulations and policies
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In localities where community consent is the norm,
A family member’s consent for another individual may be sufficient, as long as community consent is given Federal regulations preclude the conduct of PHS-funded research Community consent to participate in the research study is sufficient and no IRB approval is required In addition to the cultural norm, individual informed consent is required |
In addition to the cultural norm, individual informed consent is required
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Epidemiological
Cannot prove that a risk factor causes the condition or disease studied T/F |
True
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Epidemiological
Can only show that a risk factor is correlated with a higher incidence of the disease in the population exposed to the risk factor T/F |
True
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Incidence proportion
a- number of all individuals affected by the disease w/i a specified time. b- incidence/time. c- number of new individuals affected who contract a disease w/i a specified time. |
c- number of new individuals affected who contract a disease w/i a specified time.
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Incidence rate
a- number of all individuals affected by the disease w/i a specified time. b- incidence/time. c- number of new individuals affected who contract a disease w/i a specified time. |
b- incidence/time.
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Prevalence
a- number of all individuals affected by the disease w/i a specified time. b- incidence/time. c- number of new individuals affected who contract a disease w/i a specified time. |
a- number of all individuals affected by the disease w/i a specified time.
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Example of Incidence proportion
a- Measure probability of disease b- Number of new cases/ size of population at risk x 100 c- total # of cases in the population/ the # of individuals in the population x 100 d- used to estimate how common a condition is w/i a population over a certain period time |
Number of new cases/ size of population at risk x 100
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Example of Incidence rate
a- Measure probability of disease b- Number of new cases/ size of population at risk x 100 c- total # of cases in the population/ the # of individuals in the population x 100 d- used to estimate how common a condition is w/i a population over a certain period time |
a- Measure probability of disease
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Example of Prevalence
a- Measure probability of disease b- Number of new cases/ size of population at risk x 100 c- total # of cases in the population/ the # of individuals in the population x 100 d- used to estimate how common a condition is w/i a population over a certain period time |
both
c- total # of cases in the population/ the # of individuals in the population x 100 d- used to estimate how common a condition is w/i a population over a certain period time |
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Incidence proportion
Incidence rate (calculation) |
incidence proportion - If a population initially contains 1,000 non-diseased persons and 28 develop a condition over 2 years of observation. (28/1000 x 100)
Incidence rate - 14 cases per years b/c the incidence (28 per 1,000) is divided by the # of years (2) |
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High Prevalence and High Incidence example
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If the condition takes a long time to cure, and if 22 cases were recorded in year 1, but only 6 cases were recorded in year 2, then in year one of the condition.
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Cause Interference
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a conclusion based on evidence and reasoning that an event or process brought about a certain consequence.
The use of date and biomedical and psychosocial theories in a repeatable fashion to make educated, informed assertions about which relationships are causal and how they are causal. |
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1960's
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– NCA becomes the modern ACA
– National Board of Chiropractic Examiners is established (1963) – FCER focuses money on training faculty in science and research |
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1963
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– AMA states objective:
– “…The complete elimination of the chiropractic profession |
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1964
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- Committee on Quackery
– Primary goal of the committee: to contain and eliminate chiropractic – (evidence from the Wilk trial 1976) |
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1967
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- Committee on Quackery established that it was unethical for a medical physician:
– To associate professionally with a chiropractor – To make referrals to a chiropractor – To teach a chiropractor – To practice with a chiropractor |
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1970's
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– FCER focuses money on training faculty in science and research
• Scott Haldeman, D.C., M.D., PhD. • Reed Phillips, D.C., PhD • John Triano, D.C., PhD |
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1973
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– Chiropractic included in Medicare
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1974
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- US Office of Education recognizes the CCE Students get federal Funding to attend Chiropractic College
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1971
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- National College gets regional accreditation
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1975
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- National Institute of Neurological Diseases and Stroke (NINDS) conference on spinal manipulation
– First formal interaction between chiropractors and medical physicians in an academic forum |
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1976
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– Wilk et al. case
– The AMA was charged of violating the Sherman Anti-Trust act in its efforts to “contain and eliminate” the chiropractic profession |
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1978
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- Journal of Manipulative and Physiological Therapeutics (JMPT) was the first successful chiropractic scientific journal
JMPT has: – Good editing methods – Scientific contents – Peer reviewers from outside and inside chiropractic - Blinded peer review process |
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A. Human Participant Protection Education for Research Teams
1. Identify the three fundamental ethical principles that guide ethical human subject research as identified by the Belmont report and codified by the 45CFR 46 |
Respect for Persons, Beneficence, and Justice
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2. Identify the criteria for human research as outlined by 45 CFR 46.120
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§46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
(a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the department or agency through such officers and employees of the department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. (b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one. |
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3. Define informed consent and describe the elements that should be included in an informed consent document
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Informed consent —
A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study. |
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The Belmont principle of respect for persons is primarily applied by requiring that all human subjects research participants provide voluntary ________ ________ to participate in research.
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informed consent
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The three fundamental aspects of informed consent are:
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Voluntariness, Comprehension, Disclosure
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Voluntariness
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Individuals’ decisions about participation in research should not be influenced by anyone involved in conducting the research: “...consent must be freely given or truly voluntary.”
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Comprehension
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Individuals must have the mental or decisional capacity to understand the information presented to them in order to make an informed decision about participation in research.
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Disclosure
HHS regulations (45 CFR 46.116(a)) require that researchers disclose: |
1. The purpose of the study
2. Any reasonably foreseeable risks to the individual 3. Potential benefits to the individual or others 4. Alternatives to the research protocol 5. The extent of confidentiality protections for the individual 6. Compensation in case of injury due to the protocol 7. Contact information for questions regarding the study, participants’ rights, and in case of injury 8. The conditions of participation, including right to refuse or withdraw without penalty |
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This disclosure must be made in such a way that it provides a ________ _________the information she or he would need in order to make an informed decision.
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reasonable person
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B. Psychological
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Possible ways to protect against psychological risks include reminding participants of their right to withdraw from research or limit their participation if they become uncomfortable, providing counseling or psychological support for participants who experience distress, or thoroughly debriefing research participants after research sessions are completed.
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C. Social
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Often, minimizing social risks to participants involves protecting confidential data, including not only the data collected, but the fact of participation in the research project itself.
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Types of Risk
Because research involves risks, __________, Institutional Review Boards (IRBs), and other members of the research team must take responsibility for protecting participants against the risks of participating in research. Protections vary according to the kind of risk: |
investigators
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matching
1900 Practice>>theory>>limited science>>no clinical research 1950 Science>>theory>>clinical research>>practice 2000 Theory>>science>>practice >>clinical research |
1900 Practice>>theory>>limited science>>no clinical research
1950 Theory>>science>>practice >>clinical research 2000 Science>>theory>>clinical research>>practice |
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T/F
1. There were approximately 1,000 scientists in 1800 2. This grew to nearly 1,000,000 in 1900 3. And to more than 3,200,000 by 1975 |
1. True
There were approximately 1,000 scientists in 1800 2. False This grew to nearly 100,000 in 1900 3. False And to more than 3,200,000 by 1972 |
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Scientific investigation was carried out in order to prove or disprove a theory
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Most involved belief systems
If discs herniated, then pain originates from the disc, Therefore, proper treatment is removal of the disc If abnormal posture and aberrant spinal mechanics cause pain, then adjusting and postural exercises are proper treatment |
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1949 – “Good intentions” from NCA Council On Education to increase research
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Assigned research projects to faculty members at chiropractic colleges
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1953 – “Good intentions” from Henry Higley, M.A., D.C. organizes NCA to:
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Create a research center
intended to collect data gathered by students observing in practitioners’ offices |
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NCA’s “Good intentions” of 1949 failed
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Faculty had few skills in science and research
No training was provided Chiropractic colleges were in a poverty state No resources were available (equipment, labs, etc.) Few colleges were non-profit to receive grant money |
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1953 “Good intentions” fails due to:
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Poor participation from students and colleges
Lack of training Lack of funding |
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UCA
what it is why is was created |
In 1906 The “Universal Chiropractic Association (UCA)” was created to help fight for the legalization of chiropractic
Money was needed for legal, not research, purposes > 25,000 prosecutions of DC’s in first 30 years |
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Problems with Early
Chiropractic Research |
No valid measurements
Poor methodology Not a reproducible study Data not published in a scientific journal |
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1938 What Chiropractic is Doing (a hard bound book):
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A collection of testimonials
Published for marketing "chiropractic science“ |
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Problems with What Chiropractic is Doing:
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Not experimental nor sound observational studies
No outcome measures |
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Lillard Marshall, D.C.
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(President and founder of the NCA) published a pamphlet:
Case series Several hundred adolescent inmates 10-20 yrs old Volunteer doctors provided chiropractic care |
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Problems with the Pamphlet
Distributed by Lillard Marshall |
Problems with Marshall's pamphlet:
Poor study methods No detailed records Type of care and outcomes not described Due to these problems, the “study” was poorly received by the government and health care community thus did not reflect well on chiropractic |
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Important Date
1935 |
1935 - 1961 B.J. Palmer Chiropractic Clinic:
Two divisions: a medical side for diagnosis only and a chiropractic side for diagnosis and treatment Patients were required to go through both to fight against claims of misdiagnosis |
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Problems with the B.J. Palmer
Chiropractic Clinics |
No controlled studies
Little critical thought in study design Although a lot of data was collected, nothing was done with it Information was not collected in a scientific way to evaluate a theory, but instead to “prove that chiropractic works” No publication in scientific journals |
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1930
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- American Chiropractic Association (ACA) and UCA combine to form the National Chiropractic Association (NCA)
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1935
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– NCA member C.O. Watkins (a Palmer graduate) proposed the creation of the Committee on Education (the forerunner of today's CCE)
He proposed that educational standards be set for the chiropractic colleges 1938 - Watkins viewed clinical research as the missing link in chiropractic's scientific development |
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In 1944
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Watkins inspired the creation of the Chiropractic Research Foundation (CRF)
Today's Foundation for Chiropractic Education and Research (FCER) |
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Chiropractin Research Foundation - CRF’s purpose
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To receive monies for research purposes
To promote science of chiropractic To promote infrastructure: facilities, equipment, etc. To promote chiropractic hospitals and clinics To gather and disseminate scientific information |
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Problems with CRF
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Focused on marketing and fundraising not on research
Money went more to the colleges than research Lack of fundraising goals and poor public relations resulted in failures (often expensive ones) |
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Important Names in Research
1970s |
FCER focuses money on training faculty in science and research
Scott Haldeman, D.C., M.D., PhD. Reed Phillips, D.C., PhD John Triano, D.C., PhD |
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NINDS
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National Institute of Neurological Diseases and Stroke (NINDS)
Conference on spinal manipulation 1975 – between Chiropractors and MDs |
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1982
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JMPT received status in Index Medicus (Pub Med)
First RCT of chiropractic for any health problem Index to chiropractic literature begun |
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1987
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Judge Getzendanner orders permanent injunction against the AMA on September 25th requiring it to publish the court's judgment in the Journal of the American Medical Association (JAMA)
follow up from the Wilk trial |
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1991
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– First RAND* Study published. Additional studies in 92, 94, 98
*Research ANd Development Health insurance experiment |
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1994
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“Federal Guidelines for Low Back Pain” published
Association of Chiropractic Colleges holds first Educational Conference Proceedings published in the “Journal of Chiropractic Education” |
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Epidemiology DEFINITION:
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The study of what is upon the people
Epi-upon + Demos-people + logos-study of Study of disease in a populations in order to determine – How, when, and where- they occur |
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What Epidemiology Studies
CAN & CANNOT do |
Epidemiological studies:
Cannot prove that a risk factor causes the condition or disease studied Can only show that a risk factor is correlated with a higher incidence of the disease in the population exposed to the risk factor The higher the correlation, the more certain the association |
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Example of what Epidemiology
CAN and CANNOT do |
EXAMPLE
The discovery of the link between cigarette smoking and lung cancer was based on comparisons of lung cancer rates in smokers and non-smokers This only showed a higher rate of cancer in smokers, but did not prove the link To prove the link, controlled studies exposing animals to smoke against animals not exposed to smoke were performed |
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Incidence proportion
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– number of new individuals who contract a disease within a specified time
Number of new cases/size of population at risk X 100 |
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Incidence rate
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– incidence/time
Measures probability of disease |
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Prevalence
|
- number of all individuals affected by the disease within a specified time
total number of cases in the population/ the number of individuals in the population X 100 used to estimate how common a condition is within a population over a certain period of time |
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Causal Inference
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Correlation does not imply causation
A conclusion based on evidence and reasoning that an event or process brought about a certain consequence The use of data and biomedical and psychosocial theories in a repeatable fashion to make educated, informed assertions about which relationships are causal and how they are causal |
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Causal Inference
Simpler view |
Even simplest of interaction of bodies physical system are complex.
Most outcomes are caused by a chain or web consisting of many component causes One to one relationships very rare |
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Establishing a
Cause-Effect Relationship |
Temporal Precedence
Must show CAUSE happened BEFORE the EFFECT chicken or egg? Co-variation of the Cause and Effect Must show that there is a relationship Not by chance or coincidence No Plausible Alternative Explanations |
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Types of Causality
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Many Cause for the same effect
Increase in X increase in Y Increase in Z increase in Y Cause dependency on Time Increase in X increase in Y, after 30 minutes of exposure to X, or increase in summer but not fall Same cause different outcomes Increase in X increase in Y and Z Outcomes are effect of various interdependent causes Different Values of V + W + X increase in Y Circular Causality Increase in X <- -> increase in Y |
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IMRaD
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Abstract- Summary of the research
Introduction- Importance, literature review, hypothesis Methods- Design, sample selection, data collection Results- Data summarized, analysis of data, tables and charts Discussion- Conclusions supported, no exaggerations, weakness stated |
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Introduction
Of an Abstract |
Discusses the importance and purpose of the research
Reviews previous related research Demonstrates how study contributes to literature Relates contents of study to previously published data Defines unusual terms or words that are essential to the understanding of the paper States hypothesis being tested |
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Methods
Of an Abstract |
Subject or population used
Subject selection Inclusion and exclusion criteria Sample size Procedures Outcome measures Statistical analysis (Descriptive and analytic) |
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Results
Of an Abstract |
Summarizes all pertinent data
Tables and graphs Results of statistical analysis Reports all research outcomes related to the stated hypothesis Does not include any discussion or commentary |
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Discussion
Of An Abstract |
Interprets data and discusses the importance of the research
Only area where author may express opinion DOES NOT restate results Identifies limitations to the study Outlines need for future research |
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Conclusion
Of an Abstract |
Short in length, approximately one paragraph long
Based on data presented in the study Relates to the purpose of the study |
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MEDLINE
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17 Million records
Covers broadly all areas of biomedicine Paid for by U.S. tax dollars (approx $250 million last year) “free” Widely available through most major database sources Despite size, only indexes 18% of literature |
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Manual, Alternative, & Natural Therapy Index System - MANTIS
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Largest index of scientific Alt. Med. Literature
Indexes ALL chiropractic and osteopathic scientific literature Used by virtually all chiropractic colleges worldwide 280,000 articles indexed |
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Types of
Indexes/Journals Discussed |
M.A.N.T.I.S. (Manual, Alternative, & Natural Therapy Index System)
Medline EMbase CINAHL Biosis Aidsline, Toxline, Cancerlit |
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Types of Keyword
Searches |
Keyword search
MeSH term search |
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Cons of Keyword Searches
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Keyword searches bring up ANY article with that keyword
Does not find ALL articles on a subject Not all the articles would have been within the specific guidelines we wanted |
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MeSH Terms &What Journals Use Them
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National Library of Medicine developed a restricted vocabulary for indexers to use… called MeSH for Medical Subject Headings (MeSH)
There are approximately 35,000 index words used Indexes like Mantis & the nursing index CINAHL, like Medline, use these terms. |
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Indexing
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Process of assigning a very uniform and restrictive vocabulary or set of words to an article.
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Terms used for
Indexing |
Medical Subject Headings (MeSH)
Subheadings Check Tags Publication Types |
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Boolean Arguments
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Provides powerful method of pulling from a large set of information....only the information you need.
Primarily uses “AND”, “OR” & “NOT” statements “Sprains and strains” is not valid |
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Reproducibility
Of Research |
Where –the search was conducted
When –the search was conducted How –the search was conducted What Mesh or keywords were used How were the boolean arguments created Were there any other search restrictions (e.g. language, journal, etc.) |
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Hierarchy
Of Knowledge |
Experiments
Quasi-experiment Observations Antidotal Reports Testimonials Rumors/Assertions |
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Qualitative Research/Design
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Method of investigation used to gain insight into people's attitudes, behaviors, value systems, concerns, motivations, aspirations, culture or lifestyles.
Used as a precursor to Quantitative research Seeks out the ‘why’, not the ‘how’ through the analysis of Unstructured information |
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Quantitative
Design |
The systematic scientific investigation of quantitative properties and phenomena and their relationships.
A quantitative attribute is one that can be measured. Expressed as a specific quantity (unit) that can be multiplied by a number. ie. distance, mass, time, etc. |
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Categories of
Quantitative Design |
1. Correlational
Uses statistical tests of association/agreement 2. Intervention/Experimental Uses statistical tests of difference |
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Correlation
Design (define) |
Observes and Examines a number of instances and variables
Asserts whether there is a co-relationship between variables |
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Correlation Designs
(Types) |
Prospective studies of agreement
Prospective studies of association Retrospective Studies of agreement/Association |
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Correlation Design
Types order of Strongest to Weakest |
Strongest to weakest
1 Prospective studies of agreement 2 Prospective studies of association 3 Retrospective Studies of agreement/Association |
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Prospective Studies
Of Agreement |
i.e. Reliability, validity studies
*Studies gathering data in the present |
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Prospective Studies
Of Association |
Quantify the strength of association between two variables
(i.e. Age and BP) |
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Retrospective Studies of Agreement/Association
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Use of pre-existing records for data
** Studies reviewing past records or events |
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Intervention/Experimental
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Tries to prove or disprove a hypothesis with statistical analysis
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Classifications of Design
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1 Qualitative
- Observational (Pre-experimental) 2 Quantitative - Quasi-experimental - True Experimental |