
- Cocaine use disorder is the continued use of cocaine despite clinically
significant distress or impairment.
- Typically includes a strong desire to take the drug, difficulties in controlling
its use, persisting in its use despite harmful consequences, a higher priority
given to drug use than to other activities and obligations, increased tolerance,
and sometimes a physical
withdrawal state.
Prediction
Episodic or continuous for years
Problems
Occupational-Economic Problems:
- Causes significant impairment in academic or occupational functioning
- Economic problems caused by squandering money or drug-related unemployment
- Works poorly with others
Antagonistic (Antagonism):
- Suspiciousness, social withdrawal
Disinhibited (Disinhibition):
- Intoxicated (sometimes violent) behavior, impaired driving
- Impulsivity, dangerous risk taking, irresponsibility
- Prostitution or drug-dealing, theft, other law-breaking, violence
- Marital (or child) abuse/neglect
Psychotic (Impaired Intellect):
- Intoxication sometimes causes psychosis with delusions and/or hallucinations
- Intoxication sometimes causes delirium:
- Disturbance in attention (ie, reduced ability to direct focus, sustain, and
shift attention) and awareness (reduced orientation to the environment)
- Disturbance in cognition (ie, memory deficit, disorientation, language,
visuospatial ability, or perception)
Sociable (High Extraversion):
- Intoxication causes:
- Increased alertness, feelings of well-being and euphoria, energy and motor
activity, feelings of competence and sexuality
- Individuals to go for long periods without food or sleep, followed by
exhaustion and fatigue, giving way to long periods of sleep and periods of
extreme hunger
Emotional Distress (Negative Emotion):
- Can cause anxiety, depression, suicidal behavior, anger
Medical:
- Intoxication can cause sudden death, even in first time users
- Causes denial of addiction and denial of the physical illnesses it causes
- Can cause HIV (if using needles); weight loss & malnutrition; seizures; heart
attack, stroke
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Click Here For Free Diagnosis
Limitations of Self-Diagnosis
Self-diagnosis of this disorder is often inaccurate. Accurate diagnosis of this disorder
requires assessment by a qualified practitioner trained in psychiatric diagnosis and
evidence-based treatment.
However, if no such professional is available, our free computerized diagnosis is
usually accurate when completed by an informant who knows the patient well.
Computerized diagnosis is less accurate when done by patients (because they often lack
insight).
Example Of Our Computer Generated Diagnostic Assessment
Stimulant Use Disorder (Cocaine) 304.20
This diagnosis is based on the following findings:
- Abused cocaine/crack in the past 5 years (still present)
- Greater use of cocaine/crack than intended (still present)
- There is a persistent desire or unsuccessful efforts to cut down or control
use of cocaine/crack (still present)
- A great deal of time is spent in obtaining cocaine/crack, using it, or
recovering from its effects (still present)
- Craving, or a strong desire or urge to use cocaine/crack (still present)
- Recurrent use of cocaine/crack resulting in a failure to fulfill major role
obligations at work, school or home (still present)
- Continued use of cocaine/crack despite having persistent social problems
that it made worse (still present)
- Important social, occupational, or recreational activities are given up or
reduced because of use of cocaine/crack (still present)
- Developed tolerance to cocaine/crack (still present)
- Developed withdrawal symptoms to cocaine/crack (still present)
Treatment Goals:
- Goal: stop cocaine/crack use because using more than
intended.
- Goal: stop cocaine/crack use because it is getting out of
control.
- Goal: stop cocaine/crack use in order to prevent wasting so much
time using a stimulant, or recovering from its use.
- Goal: stop cocaine/crack use in order to decrease craving for
this stimulant.
- Goal: stop cocaine/crack use so that she can better fulfill
major role obligations at work, school or home.
- Goal: stop cocaine/crack use in order to improve the
stimulant-related social problems.
- Goal: stop cocaine/crack use in order to increase time spent on
important social, occupational, or recreational activities.
- Goal: stop cocaine/crack use in hazardous situations in order to
prevent injury.
- Goal: stop cocaine/crack use in order to prevent further
worsening of current stimulant-related physical or emotional
problems.
- Goal: stop cocaine/crack use because tolerance to this stimulant
is developing.
- Goal: stop cocaine/crack use because withdrawal symptoms are
developing.
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Diagnostic Features
Cocaine is the world's most addictive drug, and one of the most destructive. Cocaine Use
Disorder is a condition characterized by the harmful consequences of repeated cocaine
use, a pattern of compulsive cocaine use, and (sometimes) physiological dependence on
cocaine
(i.e.,
tolerance
and/or symptoms of withdrawal). This disorder is only diagnosed when cocaine use becomes
persistent and causes significant academic, occupational, social or medical impairment.
Cocaine and amphetamine-like drugs have identical intoxication and withdrawal symptoms;
hence
are
grouped
together under the diagnosis of Stimulant Use Disorders.
Cocaine Intoxication causes significant psychological and social impairment (e.g.,
euphoria or emotional blunting; gregariousness; hypervigilance; interpersonal
sensitivity; anxiety, tension or anger; stereotyped behaviors; impaired judgment; or
impaired social or
occupational
functioning). This intoxication has two or more of the following physical signs:
rapid/slowed pulse, widening of the pupils, increased/decreased blood pressure,
perspiration/chills, nausea/vomiting, weight loss, psychomotor agitation/slowling,
muscular
weakness/respiratory
depression/chest pain/cardiac arrhythmias,
confusion/seizures/dyskinesias/dystonias/coma. Stimulant effects such as euphoria,
increased pulse and blood pressure, and psychomotor activity are most commonly seen.
Depressant effects such as sadness, slowed pulse, decreased
blood
pressure,
and decreased psychomotor activity are less common and generally emerge only with
chronic high-dose use.
Cocaine Withdrawal only occurs after the cessation of (or reduction in) heavy and
prolonged cocaine use. This withdrawal syndrome is characterized by dysphoric mood
(i.e., anxious, tense, depessed, or angry mood) and two or more of the following:
fatigue; vivid,
unpleasant
dreams;
insomnia/hypersomnia; increased appetite; psychomotor agitation/slowing. This withdrawal
syndrome usually requires several days of rest. Depressive symptoms with suicidal
ideation or behavior can occur during cocaine withdrawal.
Psychological Complications
Users on a cocaine binge can spend thousands of dollars in a few days, resulting in
financial catastrophes. Cocaine users may become involved in theft, prostitution, or
drug dealing in order to support their cocaine habit. Acute intoxication can cause:
rambling speech,
headache,
ringing
in the ears, brief spells of paranoia, auditory hallucinations (in a clear sensorium),
and tactile hallucinations ("coke bugs"). Mood changes such as extreme anger,
depression, suicidal ideation, irritability, anhedonia, Emotional Instability, and
disturbances in attention
and
concentration
are common. Long-term cocaine users often develop erratic behavior, social isolation,
sexual dysfunction, and promiscuous sexual behavior.
Medical Complications
Users that snort cocaine often develop sinusitis, nose bleeds, and a perforated nasal
septum. Users that smoke cocaine develop coughing, bronchitis, and pneumonitis. Users
that inject cocaine have puncture marks ("tracks") on their forearms. Frequent
injections and unsafe
sex
increases
the risk of HIV. Other sexually transmitted diseases, hepatitis, tuberculosis, and other
lung infections are also seen. Chest pain, weight loss and malnutrition are common.
Myocardial infarction, palpitations and arrhythmias, sudden death from respiratory or
cardiac arrest, stroke, and seizures have been associated with cocaine use among young
and otherwise healthy individuals. Traumatic injuries due to violent behavior are common
among
individuals
trafficking drugs.
Cocaine use is associated with abruptio placentae, premature labor and delivery, and an
increased prevalence of infants with very low birth weights.
Psychological Comorbidity
Cocaine Use Disorder has increased rates of other Substance Use Disorders (especially
alcohol, marijuana, heroin, benzodiazepines), Major Depressive Disorder, repeated Panic
Attacks, social phobic-like behavior, generalized anxiety-like syndromes, Eating
Disorders,
Post-traumatic
Stress
Disorder, Antisocial Personality Disorder, Attention Deficit - Hyperactivity Disorder,
and Pathological Gambling.
Medical Comorbidity
Cocaine Use Disorder has increased rates of hepatitis, sexually transmitted diseases
including HIV/AIDS, tuberculosis, pneumonitis, and pneumothorax.
Associated Laboratory Findings
Cocaine is detected on routine urine toxicology testing. It remains in the urine for 1-3
days after a single dose and may be present for 7-12 days after repeated high doses.
Prevalence
The 12-month prevalence in the American population is 0.2% among 12- to 17-year-olds and
0.3% among individuals 18 years and older. The male:female ratio is 4:1. Rates are
highest among 18- to 29-year-olds (0.6%) and lowest among 45- to 64-year-olds (0.1%).
Course
Cocaine smoking and intravenous use rapidly lead to addiction in a few short weeks or
months. Snorting cocaine usually takes months to years to lead to addiction. With
continued use, there is a loss of pleasurable effects (due to tolerance) and an increase
in unpleasant
effects
(e.g.,
anxiety, depression, anger).
Outcome
Little research has been done on the long-term course of Cocaine Use Disorder.
Comparative Lethality
Chronic users of cigarettes lose 13% of their expected lifespan, chronic users of alcohol lose 29%, chronic users of cocaine lose
44%, chronic users of methadone lose 49%
, chronic users of heroin lose 52%, and chronic
users of methamphetamine lose 53% of their expected
lifespan.
Familial Pattern
Part of the risk of developing Cocaine Use Disorder is genetic; since many individuals
with this disorder have behavioral disinhibition (a highly heritable tendency towards
impulsivity, novelty-seeking, dangerous risk-taking and rule-breaking).
Effective Therapies
Currently there is no effective psychosocial or pharmacological treatment for Cocaine Use Disorder that has been
proven effective in replicated, randomized, placebo-controlled clinical trials. Thus
there are no FDA-approved
pharmacotherapies for stmulant use disorder.
It is possible to stop using cocaine. To do this you must: (1) totally divorce yourself
from drug-using or drug-supplying people, (2) not use alcohol or any other illegal drug,
(3) be socially active and help others, (4) talk to other people who have successfully
stayed
off drugs, (5) devote yourself to important activities that give meaning and purpose to
life (e.g., family, friends, sports, work, helping others, church etc.). Therapists know
that these 5 steps work, but our therapies often are ineffective in motivating patients
to
complete these essential steps to recovery.
Top 20 Most Harmful Drugs In Britain In 2008
Professor David Nutt published in the Lancet the following rating of Britain's most
dangerous drugs. They are listed in descending order from the most harmful.
1. Heroin
Class A drug. Originally used as a painkiller and derived from the opium poppy.
There were 897 deaths recorded from heroin and morphine use in 2008 in England
and Wales, according to the Office of National Statistics (ONS). There were
around 13,000 seizures,
amounting to
1.6m
tonnes of heroin.
2. Cocaine
Class A. Stimulant produced from the South American coca leaf. Accounted for 235
deaths -- a sharp rise on the previous year's fatalities. Nearly 25,000 seizures
were made, amounting to 2.9 tonnes of the drug.
3. Barbiturates
Class B. Synthetic sedatives used for anaesthetic purposes. Blamed for 13
deaths.
4. Street methadone
Class A. A synthetic opioid, commonly used as a substitute for treating heroin
patients. Accounted for 378 deaths and there were more than 1,000 seizures of
the drug.
5. Alcohol
Subject to increasing concern from the medical profession about its damage to
health. According to the ONS, there were 8,724 alcohol deaths in the UK in 2007.
Other sources claim the true figure is far higher.
6. Ketamine
Class C. A hallucinogenic dance drug for clubbers. There were 23
ketamine-related deaths in the UK between 1993 and 2006. Last year there were
1,266 seizures.
7. Benzodiazepines
Class C. A hypnotic relaxant used to treat anxiety and insomnia. Includes drugs
such as diazepam, temazepam and nitrazepam. Caused 230 deaths and 1.8m doses
were confiscated in more than 4,000 seizure operations.
8. Amphetamine
Class B. A psychostimulant that combats fatigue and suppresses hunger.
Associated with 99 deaths, although this tally includes some ecstasy deaths.
Nearly 8,000 seizures, adding up to almost three tonnes of confiscated
amphetamines.
9. Tobacco
A stimulant that is highly addictive due to its nicotine content. More than
100,000 people a year die from smoking and tobacco-related diseases, including
cancer, respiratory diseases and heart disease.
10. Buprenorphine
An opiate used for pain control, and sometimes as a substitute to wean addicts
off heroin. Said to have caused 43 deaths in the UK between 1980 and 2002.
11. Cannabis
Class B. A psychoactive drug recently appearing in stronger forms such as
"skunk". [Since this video was made; there is now conclusive proof that cannabis
causes a 6.7 fold increase in the risk of developing schizophrenia.] Caused 19
deaths and there were 186,000
seizures,
netting 65 tonnes of the drug and 640,000 cannabis plants.
12. Solvents
Fumes inhaled to produce a sense of intoxication. Usually abused by teenagers.
Derived from commonly available products such as glue and aerosol sprays. Causes
around 50 deaths a year.
13. 4-MTA
Class A. Originally designed for laboratory research. Releases serotonin in the
body. Only four deaths reported in the UK between 1997 and 2004.
14. LSD
Class A. Hallucinogenic drug originally synthesised by a German chemist in 1938.
Very few deaths recorded.
15. Methylphenidate
Class B drug. Brand name of Ritalin. A psychostimulant sometimes used in the
treatment of attention deficit disorders.
16. Anabolic steroids
Class C. Used to develop muscles, notably in competitive sports. Also alleged to
induce aggression. Have been blamed for causing deaths among bodybuilders. More
than 800 seizures.
17. GHB
Class C drug. A clear liquid dance drug said to induce euphoria, also described
as a date rape drug. Can trigger comas and suppress breathing. Caused 20 deaths
and 47 seizures were recorded.
18. Ecstasy
Class A. Psychoactive dance drug. Caused 44 deaths, with around 5,000 seizures
made.
19. Alykl nitrites
Known as "poppers". Inhaled for their role as a muscle relaxant and supposed
sexual stimulant. Reduce blood pressure, which can cause fainting and in some
cases death.
20. Khat
A psychoactive plant, the leaves of which are chewed in east Africa and Yemen.
Also known as qat. Produces mild psychological dependence. Its derivatives,
cathinone and cathine, are Class C drugs in the UK.
Ineffective therapies
Some argue that cocaine use should be decriminalized, and that cocaine addiction should
be treated "like any other medical disorder". They forget that there is no treatment for
Cocaine Use Disorder that has been proven effective.
Legalizing Illicit Drugs
Some people argue that illicit drugs should be legalized to decrease the crime
associated with these drugs. Historically, tobacco and alcohol were once illegal drugs.
Tobacco smoking is now the leading cause of death in America, and alcoholism is the
third leading cause
of death. Thus legalizing illicit drugs does not make them any less medically and
socially harmful. In fact the opposite is true; legalizing illicit drugs increases their
use and the harm they cause. The Government of Finland is passing legislation that will
gradually ban
all tobacco use by 2040.
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 The Drug Scene In Vancouver, Canada
in 2003 (It Is 100 Times Worse Today)
22 of 26 Canadians Who Wanted a High-Paying Mining Job Failed
Their Drug Screening
Test
- Cocaine Use Disorder - Google
- Cocaine Abuse - Epocrates Online
- Overview of substance abuse and overdose - Epocrates Online
- Cocaine intoxication - PubMed Health
- Cocaine withdrawal - PubMed Health
- Cocaine
dependence - Wikipedia
- Cocaine Abuse -
DSM-IV Diagnostic Criteria, American Psychiatric Association
- Cocaine
Dependence - DSM-IV Diagnostic Criteria, American Psychiatric Association
- Cocaine
Intoxication - DSM-IV Diagnostic Criteria, American Psychiatric Association
- Cocaine Intoxication Delirium - DSM-IV Diagnostic Criteria,
American Psychiatric Association
- Cocaine-Induced Sleep Disorder - DSM-IV Diagnostic Criteria,
American Psychiatric Association
- Cocaine-Induced Anxiety Disorder - DSM-IV Diagnostic
Criteria, American Psychiatric Association
- Cocaine-Induced Mood Disorder - DSM-IV Diagnostic Criteria,
American Psychiatric Association
- Cocaine-Induced Psychotic Disorder - DSM-IV Diagnostic
Criteria, American Psychiatric Association
- Cocaine
Withdrawal - DSM-IV Diagnostic Criteria, American Psychiatric Association
- Predictors of
depressive symptomatology among rural stimulant users. Moderate to severe
depressive symptomatology was reported by 43.0% of a rural, American,
multistate sample of
not-in-treatment 710
stimulant drug users. Crack use as well as the daily use of cocaine increased the
odds of depressive symptoms. Methamphetamine use had no significant association with
depression.
- 5 Myths About Addiction - CBC
Stories
Rating Scales
Stages of Learned Behavior
Our survival involves learning what to avoid (i.e., fear) and what to approach (i.e.,
crave). Both fear and craving are essential for our survival, but both can spiral out of
control.
For example, an individual can develop a phobia about snakes in which the fear becomes
excessive. This phobia can develop into an obsession in which the individual spends much of
the time thinking about snakes, and how to avoid them.
This obsession can develop into a compulsion in which the individual spends much of the time
doing superstitious, compulsive, ritual behaviors aimed at avoiding snakes.
Likewise, an individual can develop an excessive craving for alcohol which causes
significant distress or disability.
This excessive craving for alcohol can develop into an obsession in which the individual
spends much of the time thinking about alcohol, and how to get it.
This obsession can develop into a compulsion in which the individual spends much of the time
compulsively drinking, and feeling powerless to resist this craving.
Four Stages of Fear and Craving
4 STAGES OF FEAR |
4 STAGES OF CRAVING |
Normal Fear:
Is in proportion to the actual danger, and doesn't cause significant
distress or disability.
|
Normal Craving:
Doesn't cause significant distress or disability.
|
Excessive Fear (Phobia):
Is out of proportion to the actual danger posed, and causes significant
distress or disability.
|
Excessive Craving:
Is not socially acceptable, and causes significant distress or disability
(e.g., "I'm using [cocaine] too much").
|
Obsessional Fear:
Persistent, unwanted or obsessional thoughts about the fear develop, which
cause significant distress or disability.
|
Obsessional Craving:
Persistent, unwanted or obsessional thoughts about the craving develop,
which cause significant distress or disability (e.g., "I spend much of my
time thinking about [cocaine], and how to get it").
|
Compulsive Fear:
Compulsive behaviors develop (aimed at reducing the anxiety associated with
the obsession), which the individual finds very hard to resist doing.
|
Compulsive Craving:
Compulsive behaviors develop (aimed at satisfying the craving), which the
individual finds very hard to resist doing (e.g., "I can't stop myself from
using [cocaine]").
|
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Dependence Syndrome Due To Use Of Cocaine F14 - ICD10 Description,
World Health Organization
Repeated use of cocaine that typically includes a strong desire to take the drug,
difficulties in controlling its use, persisting in its use despite harmful consequences,
a higher priority given to drug use than to other activities and obligations, increased
tolerance,
and
sometimes a physical
withdrawal state.
Cocaine Use Disorder -
Diagnostic Criteria, American Psychiatric Association
An individual diagnosed with Cocaine Use Disorder needs to meet all of the following
criteria:
- A problematic pattern of cocaine use leading to clinically significant
impairment or distress, as manifested by at least two of the following,
occurring within a 12-month period:
- Cocaine is often taken in larger amounts or over a longer period than was
intended.
- There is a persistent desire or unsuccessful efforts to cut down or control
cocaine use.
- A great deal of time is spent in activities necessary to obtain cocaine, use
cocaine, or recover from its effects.
- Craving, or a strong desire or urge to use cocaine.
- Recurrent cocaine use resulting in a failure to fulfill major role
obligations at work, school, or home.
- Continued cocaine use despite having persistent or recurrent social or
interpersonal problems caused or exacerbated by the effects of cocaine.
- Important social, occupational, or recreational activities are given up or
reduced because of cocaine use.
- Recurrent cocaine use in situations in which it is physically hazardous.
- Cocaine use is continued despite knowledge of having a persistent or
recurrent physical or psychological problem that is likely to have been
caused or exacerbated by cocaine.
- Tolerance, as defined by either of the following:
- A need for markedly increased amounts of cocaine to achieve intoxication
or desired effect.
- A markedly diminished effect with continued use of the same amount of
cocaine.
- Withdrawal, as manifested by either of the following:
- The characteristic withdrawal syndrome for cocaine:
- Cessation of (or reduction in) prolonged cocaine use.
- Dysphoric mood and two (or more) of the following physiological
changes, developing within a few hours to several days after the
cessation of (or reduction in) cocaine use:
- Fatigue.
- Vivid, unpleasant dreams.
- Insomnia or hypersomnia.
- Increased appetite.
- Psychomotor retardation or agitation.
- Cocaine is taken to relieve or avoid withdrawal symptoms.
- Specify if:
- In early remission: After full criteria for Cocaine Use Disorder
were previously met, none of the criteria for Cocaine Use Disorder have
been met for at least 3 months but for less than 12 months (with the
exception that the criterion, "Craving, or
a
strong desire
or urge to use cocaine," may be met).
- In sustained remission: After full criteria for Cocaine Use
Disorder were previously met, none of the criteria for Cocaine Use
Disorder have been met at any time during a period of 12 months or
longer (with the exception that the criterion,
"Craving,
or a strong
desire or urge to use cocaine," may be met).
- Specify if:
- In a controlled environment: This additional specifier is used if
the individual is in an environment where access to cocaine is
restricted.
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World Health Organization Drug Use Disorder Treatment
Guidelines
Treatment Guidelines
Treatment Research
Treatment Evaluation
Crime
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Overcoming Drug Addiction

Self-Help Groups for Drug Addiction
Monitoring Your Progress
NOTE: When each of the following presentations finish; you must exit
by manually closing its window in order to return to this webpage.
The Healthy Social Behavior Scale lists social behaviors that research has
found to be associated with healthy social relationships. You can keep score (totaling its
4-point scale answers) on a separate piece of paper to monitor your progress.
The Mental Health Scale lists behaviors and symptoms that research has found
to be associated with mental health (or disorder). You can keep score (totaling its 4-point
scale answers) on a separate piece of paper to monitor your progress.
The Life Satisfaction Scale lists the survey questions often used to measure
overall satisfaction with life. You can keep score (totaling its 4-point scale answers) on a
separate piece of paper to monitor your progress.

Life
Satisfaction Scale (5-Minute Video)
The "Big 6" Dimensions of Mental Health
Research has shown that there are 5 major dimensions (the "Big 5 Factors" or
Five-Factor
Model) of personality disorders and other mental
disorders.
This website uses these 5 major dimensions of human behavior (i.e., Agreeableness,
Conscientiousness, Openness/Intellect, Extraversion/Sociability, and Emotional
Stability) to describe all mental disorders. This website adds one more dimension,
"Physical Health", to create the "Big 6" dimensions of mental health.
The behaviors of the "Five Factor Model of Personality" represent five adaptive functions
that are vital to human survival. For example, when one individual approaches another, the
individual must: (1) decide whether the other individual is friend or foe [
"Agreeableness"
], (2) decide if this represents safety or danger [
"Emotional Stability"
], (3) decide whether to approach or avoid the other individual [
"Extraversion/Sociability"
], (4) decide whether to proceed in a cautious or impulsive manner [
"Conscientiousness"
], and (5) learn from this experience [
"Openness/Intellect"
].

Desiderata
(5-Minute Video)

The following "Morning Meditation" allows you to plan your day using these "Big 6"
dimensions of mental health.
The following "Evening Meditation" allows you to review your progress on these "Big 6"
dimensions of mental health.
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"In physical science a first essential step in the direction of learning any
subject is to find principles of numerical reckoning and practicable methods for
measuring some quality connected with it. I often say that
when you can measure what you are speaking about and express it in
numbers you know something about it; but when you cannot measure it,
when you cannot express it in numbers, your knowledge is of a meagre and
unsatisfactory kind: it may be the beginning of knowledge,
but you have scarcely, in your thoughts, advanced to the stage of science,
whatever the matter may be."
Lord Kelvin (1824 – 1907)
- The best
summary on bad research is given by Laura Arnold in this TEDx lecture.
If you read nothing else about research, you owe it to
yourself to watch this short video - it is excellent!
- Economist in grim battle against deceptive scholarship
- List of Predatory
Journals and Publishers
- The power
of asking "what if?"
- The active placebo effect: 2300 years ago, the Greek Stoic philosophers
taught that it is not the objective event, but our subjective
judgment about the event, that determines our behavior. The active placebo
effect bears witness to this ancient wisdom.
- Criteria For High Quality Research Studies
It is
troubling that a recent study found that two-thirds of important psychological research studies couldn't
be replicated. High quality research must meet the following
criteria:
-
Randomized Controlled Trial:
Ask: Was the trial randomized? Was the randomization
procedure described and was it appropriate?
The best research design is to have research subjects randomly assigned
to an experimental or control group. It is essential that confounding
factors be controlled for by having a control group or comparator condition
(no intervention, placebo, care as usual etc.).
-
Representative Sample:
Ask: Do the research subjects represent a normal
cross-section of the population being studied?
Many psychological research studies using university students are
flawed because their subjects are not representative of the normal
population since they are all W.E.I.R.D. (White, Educated, Intelligent,
Rich, and living in a Democracy).
-
Single Blind Trial:
Ask: Was the treatment allocation concealed?
It is essential that the research subjects are kept "blind" as to
whether they are in the experimental or control group (in order to control
for any placebo effects).
-
Double Blind Trial (Better Than Single Blind Trial):
Ask: Were blind outcome assessments conducted?
In a double blind study, neither the research subjects nor the outcome
assessors know if the research subject is in the experimental or control
group. This controls for both the placebo effect and assessor bias.
-
Baseline Comparability:
Ask: Were groups similar at baseline on prognostic
indicators?
The experimental and control groups must be shown to be comparable at
the beginning of the study.
-
Confounding Factors:
Ask: Were there factors, that weren't controlled for,
that could have seriously distorted the study's results?
For example, research studies on the effectiveness of mindfulness cognitive therapy in
preventing depressive relapse forgot to control for whether the research
subjects were also simultaneously receiving antidepressant medication or
other psychological treatments for depression.
-
Intervention Integrity:
Ask: Was the research study protocal strictly
followed?
The research subjects must be shown to be compliant (e.g., taking their
pills, attending therapy) and the therapists must be shown to be reliably
delivering the intervention (e.g., staying on the research protocol).
-
Statistical analysis:
Ask: Was a statistical power calculation described?
The study should discuss its statistical power analysis; that is
whether the study size is large enough to statistically detect a difference
between the experimental and control group (should it occur) and usually
this requires at least 50 research subjects in the study.
Ask: Are the results both statistically
significant and clinically significant?
Many medical research findings are statistically significant
(with a p-value <0.05), but they are not clinically significant
because the difference between the experimental and control groups is
too small to be clinically relevant.
For example, the effect of a
new drug may be found to be 2% better than placebo. Statistically (if
the sample size was large enough) this 2% difference could be
statistically significant (with a p-value <0.05). However,
clinicians would say that this 2% difference is not
clinically significant (i.e., that it was too small to really
make any difference).
Statistically, the best way to test for
clinical significance is to test for effect size (i.e., the
size of the difference between two groups rather than confounding
this with statistical probability).
When the outcome of
interest is a dichotomous variable, the commonly used measures of
effect size include the odds ratio (OR), the relative risk (RR), and
the risk difference (RD).
When the outcome is a continuous
variable, then the effect size is commonly represented as either the
mean difference (MD) or the standardised mean difference (SMD)
.
The MD is the difference in the means of the treatment
group and the control group, while the SMD is the MD divided by the
standard deviation (SD), derived from either or both of the groups.
Depending on how this SD is calculated, the SMD has several versions
such, as Cohen's d, Glass's Δ, and Hedges' g.
Clinical Significance: With Standard Mean Difference, the
general rule of thumb is that a score of 0 to 0.25 indicates
small to no effect, 0.25-0.50 a mild benefit, 0.5-1 a moderate
to large benefit, and above 1.0 a huge benefit. It is a
convention that a SMD of
0.5
or larger is a standard threshold for clinically
meaningful benefit. The statistical summary
should report what percentage of the total variance of the dependent
variable (e.g., outcome) can be explained by the independent
variable (e.g., intervention).
In clinical studies, the study
should report the number needed to treat for an additional
beneficial outcome (NNTB), and the number needed to treat for
an additional harmful outcome (NNTH).
Number Needed To Benefit (NNTB): This is defined as the
number of patients that need to be treated for one of them to
benefit compared with a control in a clinical trial. (It is
defined as the inverse of the absolute risk reduction.)
Note: Statistically, the NNTB depends on which control group is used for
comparison - e.g., active treatment vs. placebo
treatment, or active treatment vs. no
treatment.
Number Needed To Harm (NNTH): This is
defined as the number of patients that need to be treated for
one of them to be harmed compared with a control in a clinical
trial. (It is defined as the inverse of the absolute increase in
risk of harm.)
Tomlinson found “an NNTB of 5 or less was probably associated
with a meaningful health benefit,” while “an NNTB of 15
or more was quite certain to be associated with at most a small
net health benefit.”
Ask: Does the researcher accept full
responsibility for the study's statistical analysis?
The researcher should not just hand over the study's raw
data to a corporation (that may have $1,000 million invested in the
study) to do the statistical analysis.
-
Completeness of follow-up data:
Ask: Was the number of withdrawals or dropouts in each
group mentioned, and were reasons given for these withdrawals or
dropouts?
Less than 20% of the research subjects should drop out of the study.
The intervention effect should persist over an adequate length of time.
-
Handling of missing data:
Ask: Was the statistical analysis conducted on the
intention-to-treat sample?
There must be use of intention-to-treat analysis (as opposed to a
completers-only analysis). In this way, all of the research subjects that
started the study are included in the final statistical analysis. A
completers-only analysis would disregard those research subjects that
dropped out.
-
Replication of Findings:
Ask: Can other researchers replicate this study's
results?
The research study's methodology should be clearly described so that
the study can be easily replicated. The researcher's raw data should be
available to other researchers to review (in order to detect errors or
fraud).
-
Fraud:
Ask: Is there a suspicion of fraud?
In a research study, examine the independent and dependent variables
that are always measured as a positive whole number (e.g., a variable
measured on a 5-point Likert-type scale ranging from "1 = definitely
false to 5 = definitely true" etc.). For each of these
variables, look at their sample size (
n
), mean (
M
) and standard deviation (
SD
) before they undergo statistical analysis. There is a high suspicion of
fraud in a study's statistics:
- If the M is mathematically impossible (online
calculator): This is one of the easiest ways to
mathematically detect fraud. The mean (
M
) is defined as "the sum (
Sum
) of the values of each observation divided by the total number
(
n
) of observations". So:
M
=
Sum
/
n
. Thus: (
Sum
) = (
M
) multiplied by (
n
). We know that, if a variable is always measured as a positive
whole number, the sum of these observations always has to be a whole
number. For these variables to test for fraud: calculate (
M
) multiplied by (
n
). This calculates the
Sum
which MUST be a positive whole number. If the calculated
Sum
isn't a positive whole number; the reported mean (
M
) is mathematically impossible - thus the researcher either
cooked the data or made a mistake. A recent study of 260 research papers
published in highly reputable psychological journals found that
1 in 2 of these research papers reported at
least one impossible value
, and 1 in 5 of these research papers reported multiple
impossible values. When the authors of the 21 worst offending
research papers were asked for their raw data (so that its
reliability could be checked) - 57% angrily refused. Yet such
release of raw data to other researchers is required by most
scientific journals. (Here is an example of a research paper filled with mathematically
impossible means.)
- If the SD is mathematically impossible (online
calculator): When researchers fraudulently "cook" their
data, they may accidently give their data a mean and standard
deviation that is mathematically impossible.
- If the
SD/M is very small
(i.e., the variable's standard deviation is very small compared
to the mean suggesting data smoothing).
- If the
SD's are almost identical
(i.e., the variables have different means but almost identical
standard deviations).
- If the 4th digit of the values of the variables aren't uniformly
distributed - since each should occur 10% of the time (Benford's Law).
- If the researcher is
legally prevented from publishing negative
findings
about a drug or therapy because that would violate the
"nondisclosure of trade secrets" clause in the research contract
(i.e., it is a "trade secret" that the drug or therapy is
ineffective - hence this can not be "disclosed"). Approximately half of all registered clinical
trials fail to publish their results.
- If the
researcher refuses to release his raw data to
fellow researchers
(so that they can check its validity). In order to be published
in most scientific journals, a researcher must promise to share his
raw data with fellow researchers. Thus a researcher's refusal to do
so is almost a sure indicator of fraud.
- If the
research study's data contradicts the study's
own conclusions
- surprisingly, this often occurs.
- Calling Bullshit
In The Age of Big Data - "Bullshit is language, statistical figures,
data graphics, and other forms of presentation intended to persuade by
impressing and overwhelming a reader or listener, with a blatant disregard for
truth and logical coherence." Reading the syllabus of this university course
should be required reading for every student of mental health. This syllabus is
absolutely fantastic!
- Statistical Methods in Psychology Journals: Guidelines and
Explanations - American Psychologist 1999
- Not All Scientific Studies Are Created Equal - video
- The
efficacy of psychological, educational, and behavioral treatment
- Estimating the reproducibility of psychological science
- Psychologists grapple with validity of research
- Industry sponsorship and research outcome (Review) -
Cochrane Library
- 'We've been deceived': Many clinical trial results are
never published - (text and video)
- Junk
science misleading doctors and researchers
- Junk science under spotlight after controversial firm buys
Canadian journals
- Medicine with a side of mysticism: Top hospitals promote
unproven therapies - Are some doctors becoming modern witchdoctors?
- When Evidence Says No, But Doctors Say Yes
- Cochrane Reviews (the best evidence-based, standardized
reviews available)
Research Topics
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