GENERIC + STATS Flashcards
1
Q
What is a risk ratio?
A
Aka relative risk
The risk of developing a disease associated with an exposure compared to the risk of developing the disease in the abscence of an exposure
Risk of disease in exposed/ risk in unexposed
2
Q
How do you interpret risk ratios?
A
Risk ratio of 1 = identical risk among the 2 groups
Risk ratio >1 indicates an increased risk of the group
Risk ratio <1 indicates a decreased risk for the group
3
Q
What is a rate ratio?
A
It compares the incidence rates, person-time rates, or mortality rates of two groups
Rate for group of primary interest / rate for comparison group
4
Q
How do you interpret rate ratios?
A
The interpretation of the value of a rate ratio is similar to that of the risk ratio. That is, a rate ratio of 1.0 indicates equal rates in the two groups, a rate ratio greater than 1.0 indicates an increased risk for the group in the numerator, and a rate ratio less than 1.0 indicates a decreased risk for the group in the numerator.
E.g. if rate ratio was 2.2 then people who smoke are 2.2 times more likely to get lung cancer than nonsmokers
5
Q
Whats the difference between risk and rate?
A
Risk is the number of new cases that occur during a specified time period divided by a population at risk of becoming a case.
Rate is the number of new cases that occur per the total amount of time a person is at risk of becoming a case.
6
Q
What is an odds ratio?
A
a statistic that quantifies the strength of the association between two events, A and B.
The odds ratio is defined as the ratio of the odds of A in the presence of B and the odds of A in the absence of B, or equivalently, the ratio of the odds of B in the presence of A and the odds of B in the absence of A. Two events are independent if and only if the OR equals 1, i.e., the odds of one event are the same in either the presence or absence of the other event. If the OR is greater than 1, then A and B are associated (correlated) in the sense that, compared to the absence of B, the presence of B raises the odds of A, and symmetrically the presence of A raises the odds of B. Conversely, if the OR is less than 1, then A and B are negatively correlated, and the presence of one event reduces the odds of the other event.
7
Q
How do you calculate odds ratio?
A
Odds that a case was exposed / odds that a control was exposed
E,.g. Odds of lung cancer in smokers / odds of lung cancer in non-smokers
8
Q
What is risk difference?
A
Aka attributable risk
The difference between the risk of an outcome in the exposed group and the unexposed group.
Incidence in exposed - incidence in unexposed
9
Q
How do you calculate absolute risk?
A
the number of events (good or bad) in a treated (exposed) or control (non-exposed) group, divided by the number of people in that group
10
Q
What is the inverse of absolute risk reduction?
A
Number needed to treat
11
Q
What is the inverse of absolute risk increase
A
Number needed to harm
12
Q
What is number needed to treat?
A
The number of people with a specified condition who need to be treated for a specified period of time in order to prevent one adverse or beneficial outcome (depending on if its NNT to harm or to benefit)
(Remember this is always a whole number!!)
13
Q
How do you calculate absolute risk reduction?
A
The AR of events in the control group rate of disease in unexposed group - the rate of disease in the exposed group
14
Q
Whats the difference between relative and absolute risk?
A
Absolute risk refers to the actual probability of an outcome occurring in a specific group regardless of any other factors. I.e. the risk of disease among the population. Being studies
Relative risk on the other hand, compares the risk of an outcome between exposed and unexposed groups.
15
Q
what is primary prevention?
A
intervening before health effects occur, through. measures such as vaccinations, altering risky behaviors (poor eating. habits, tobacco use), and banning substances known to be associated. with a disease or health condition
I.e. identifying modifiable risk factors
16
Q
what is secondary prevention?
A
Systematically detecting the early stages of disease and intervening before full symptoms develop – for example, prescribing statins to reduce cholesterol and taking measures to reduce high blood pressure.
17
Q
What is screening?
A
The systematic application of a test to identify individuals at sufficient risk of a specific disorder to warrant further investigation or direct preventive action, amongst persons who have not sought medical attention on account of symptoms of that disorder.
18
Q
What are the principles of screening?
A
the condition should be an important health problem
there should be a recognisable latent or early symptomatic stage
the natural history of the condition, including development from latent to declared disease, should be adequately understood
there should be an accepted treatment for patients with recognised disease
there should be a suitable test or examination that has a high level of accuracy
the test should be acceptable to the population
there should be an agreed policy on whom to treat as patients
facilities for diagnosis and treatment should be available
the cost of screening (including diagnosis and treatment of patients diagnosed) should be economically balanced in relation to possible expenditure on medical care as a whole
screening should be a continuing process and not a ‘once and for all’ project.
19
Q
What are the pros and cons of screening?
A
Pros - better prognosis, reassurance of a normal test, cost effective, may require less long term therapy
Cons - discomfort of tests, false reassurance of a false negatives, true positives and negatives, overdiagnosis (waste of resources, iatrogenic harm and stress), ethical issues, opportunity cost
20
Q
What is opportunistic screening>
A
Opportunistic screening happens when someone asks their doctor or health professional for a check or test, or a check or test is offered by a doctor or health professional. Unlike organised screening which is managed by a national health service to ensure everyone has an equal opportunity to participate and ensure that if the test results are abnormal, the pt receives the correct further testing/management/support.
21
Q
What is population screening?
A
A nationally delivered, proactive screening programme which aims to improve health outcomes in people with the condition being screened for, and/or offer information to enable informed choices. It is offered to a group of people identified from the whole population, and defined demographically such as by age or sex.
22
Q
What is targeted screening?
A
A nationally delivered proactive screening programme which aims to improve health outcomes in people with the condition being screened for, among groups of people identified as being at elevated/above average risk of a specific condition. Compared to the general population, the target population may be at higher risk because of lifestyle factors, genetic variants or having another health condition.
Targeted screening differs from population screening as it aims to systematically offer screening to more specific groups of people with a higher risk of a condition. For example, age and sex are factors in the risk of lung cancer, but individuals who smoke are at even higher risk.
23
Q
What is stratified screening?
A
A nationally delivered, proactive screening programme, offering testing which varies in frequency and modality, according to the level of individual risk. This is designed to achieve a more favourable balance of benefits and harms at individual as well as population level.
Stratification is used in both targeted and population screening programmes, at the point of invitation as well as along the pathway. For example:
people with a family history of breast cancer can be identified and screened more often depending on their level of risk
24
Q
What is sensitivity and how do you calculate it?
A
The proportion of patients with disease who get a positive test
True positives / all with disease
TP / (TP+FN)
25
What is specificity and how do you calculate it?
Proportion of patients without the disease who get a negative test
True negatives / all those without disease
TN/ (TN+FP)
26
What is a positive predictive value and how do you calculate it?
The post-test probability that pt with a positive test result has the condition
True positives / all those test [positive
TP/(TP+FP)
27
What is a negative predictive value and how do you calculate it?
The post-test probability that pt with a negative test result does not have the condition
True negatives / all those who test negative
TN/TN+FN
28
How does prevalence affect sensitivity and specificity?
They remain constant as the test itself doesnt change
29
How does prevalence affect positive and negative predictive values?
As prevalence rises NPV falls and PPV rises
30
How does prevalence affect likelihood ratios?
As they rely on sensitivity and specificity
It doesn’t change with prevalence
31
What is a likelihood ratio?
the likelihood that a given test result would be expected in a patient with the target disorder compared to the likelihood that that same result would be expected in a patient without the target disorder.
Positive LR - how much more likely the person is to receive a positive result
Negative LR - how much more likely the person is to receive a negative result
32
How do you calculate a likelihood ratio for a positive test result?
Chance of a positive test if disease is present / chance of a positive test if disease is absent
Sensitivity / (1- specificity)
33
How do you calculate a likelihood ratio for a negative test result?
Chance of a negative test if disease is present / chance of a negative test if disease is absent
(1- sensitivity) / specificity
34
Whats the difference between odds and risk?
Odds is a ratio of the number of people who develop an outcome to the number of people who dont. E.g. odds of rolling a 4 on a dice is 20% 1:5
Risk is the ratio of the number of people who develop an outcome to the total number of people e.g. 1:6 which is 16.6%
35
What is a hazard ratio?
A measure of how often a particular event happens in one group compared to how often it happens in another group, over time.
36
What is a null hypothesis?
the hypothesis that there is no significant difference between specified populations, any observed difference being due to sampling or experimental error.
37
What is a p value?
the probability of obtaining a result by chance at least as extreme as the one that was actually observed, assuming that the null hypothesis is true
38
What is a 95% confidence interval?
A range of values that is 95% likely to contain the true value
39
What is a type 1 error?
Rejecting the null hypothesis when it is true (false positive)
40
What is a type 2 error?
Accepting the null hypothesis when it is false e.g. false negativbe
41
Healthy and unhealthy adjustment responses to physical symptoms, and the impact of personal family and cultural influences
Healthy - seeking medical attention, self-care, seeking social support, developing coping strategies
Unhealthy - substance misuse, denial, avoidance, catastrophizing
Family - those with supportive families are more likely to adhere to medical treatments, engage in healthy behaviours and have a more positive outlook on their recovery. Criticism amd negalect from family can lead to more stress and poorer health outcomes
Culture - some cultures may see it as a punishment, some cultures may encourage natural remedies and holistic approaches to healing
42
Whats the impact of MUS on life?
the need to feel understood
struggling with isolation
‘sense of self’ in strain
facing uncertainty
searching for explanations
ambivalence about diagnosis
disappointed by healthcare
Feel as though they can’t fully adopt the sick role
43
What is a post-mortem examination? What contributions can it make to understanding and influencing care of the living?
Also known as an autopsy, is the examination of a body after death, carried out by a pathologist. The aim of a post-mortem is to determine the cause of death.
They angle pathologists to obtain a better understanding of how diseases spread and the pathophysiology of diseases which allows more effective treatment in the future
In thr past they help provide a foundation for understanding the brain e.g. Broca and Wernicke used it, improved medical knowledge and helps generate hypothesis for further study
44
What are the legal requirements for a coroner’s post-mortem?
In accordance with the Human Tissue Act 2004, consent is needed in order for a hospital post-mortem to take place, either from the patient before death, or from the appropriate next of kin.
Where a coroner deems a post-mortem examination necessary as part of their investigation into the patient's death, consent is not needed. Where a patient or their next of kin object to a post-mortem, the coroner will take this into account but can, even in the face of this objection, proceed to a post-mortem if they consider that it is necessary.
The coroner may, however, agree to a limited post-mortem in some cases, if this is appropriate and provides the necessary information. In rare circumstances, the coroner may agree to an MRI scan of the body being performed as an alternative to a post-mortem.
45
What are the legal issues surrounding a post mortem examination?
Coroners and justice Act 2009:
a. A post mortem examination can be authorised by the coroner.
b. The choice of pathologist is to be made by the coroner but, in cases of suspected homicide, he must consult the police.
d. The pathologist undertaking the examination must preserve, as far as possible, all material which bears upon the cause of death or the identification of the deceased.
e. The pathologist must notify the coroner of the material being retained and the reason for the retention.
f. The coroner must notify the pathologist of the period for which the material may be retained.
h. The coroner must notify the next-of-kin of the retention of material and seek their views as to the appropriate treatment for the material when it is no longer required for his purposes.
Human Tissue Act 2004
post mortem examination must take place on premises covered by a licence from the Human Tissue Authority.
A licence in relation to post mortem examination also covers the removal of relevant material for the purposes of the examination; removal for other purposes (e.g. research) would require a separate licence.
The pathologist undertaking the post mortem examination must act under the authority of a licence from the Human Tissue Authority authorising post mortem examinations on those premises.
Samples may only be taken for the purpose of determining the cause of death if the post mortem has been authorised by the coroner.
The performance of the post mortem examination must be in accordance with the Codes of Practice and other guidance, information and advice issued by the Human Tissue Authority
46
What are the ethical issues surrounding a post mortem examination?
respect for the dead body
retaining tissues from the body for study
the applicability autopsy information has when examining the quality of care provided by a medical institution.
47
What is the biopsychosocial model of health and illness?
Suggests that to understand a person's medical condition it is not simply the biological factors to consider, but also the psychological (thoughts, emotions, behaviours) and social factors (socio-economic, socio-environmental, cultural)
48
What examples can you give of the impacts of chronic ill health has had on psychological processes?
1/3rd of pt with chronic ill health experiences symptoms of depression
Learning to deal with and make sense of distressing sympotms
Learning to cope with new healthcare environments/procedures
Comping with impact of symptoms on own physical/emotional healthy, family roles, work, finances
Grieving for the loss of previous health
No clear diagnosis can make adjustment more challenging and symptoms may be unpredictable
Stress and anxiety can exacerbate physical symptoms
49
What is a coping style?
the cognitive and behavioural changes that result from the management of an individual's specific external/internal stressors
50
What are the 3 types of coping styles?
Problem-focused coping
Emotion focused coping
Avoidance coping
51
What is problem-focused coping?
a problem-solving technique in which an individual addresses a problem or stressor directly in an attempt to alleviate or eliminate it. It is also referred to as problem-centered coping. For example, a student who is nervous about giving a presentation at a research event may cope by practicing the presentation each night before the event, attending seminars on how to give presentations, or asking friends to listen to the presentation in order to provide feedback to make sure they are fully prepared for the event.
(Considered to be the most effective coping strategy as it’s associated with lower stress levels)
52
What is emotion0-focused coping?
Emotion-focused coping involves regulating your feelings and emotional response to the problem instead of addressing the problem e.g. mindfulness meditation or journaling
53
What is avoidance coping?
cognitive and behavioral efforts oriented toward denying, minimizing, or otherwise avoiding dealing directly with stressful demands e.g. procrastination
54
What act means patients are legally allowed to request to see their medical records?
The Data Protection Act 1988
55
What is a prevalence ratio?
The prevalence in the exposed group vs the prevalence in the non-exposed group
E.g. a prevalence ratio of 5 indicates that the proportion of the disease is 5 times greater amongst the exposed group than the non-exposed group
56
What is proportional mortality?
a measure of the percentage of deaths in a specified population that are attributable to a particular cause. It is calculated by dividing the number of deaths due to a specific cause by the total number of deaths in the population, and then multiplying the result by 100.
57
What is measurement bias?
Where information collected within a Study is not accurate due to an error in data collection during measurement
It’s a systemic bias so is retained across the data set
58
How do meta-analysis and systematic review differ?
A meta analysis synthesises and combines multiple pieces of pre-existing research in order to investigate a specific topic. Statistical methods are then used to collectively analyse the results and reach a statistically powerful conclusion.
A systemic review is similar but instead answers a specific question purely through synthesis ans summary of a variety of pre-existing studies, without the use of statistically analysis.
59
What is sampling bias?
The selection of participants for analysis in such a way that proper randomisation is not achieved, thereby ensuring that the sample obtained is not representative of the population intended to be analysed
60
Which measure of association is best for cross sectional studies?
Odds ratio or prevalence ratio
61
Which measure of association is best for a cohort study?
Relative risk or rate ratio
62
What is attrition bias?
A type of selection bias due to systemic differences between study groups due to loss of members during study conduct i.e. loss of participants
63
How can you reduce attrition bias?
Intention to treat analysos
64
What is power?
The ability to correctly reject a null hypothesis that is indeed false
65
How can you increase the power of a study?
Greater sample size
More precise measuring instruments
Higher significance value
66
What is a type 1 error?
Rejecting them null hypothesis when it is actually true
A false psoitive
67
What is a type 2 error?
Accepting the null hypothesis when its actually false
False negative
68
What do most researchers agree an acceptable power for a study is?
80%
69
how do you calculate the power of a study?
1 - the probability of type 2 error (beta)
70
Outline the link between P values and type 1/2 errrs?
The higher the P value the greater the chance the null hypothesis will be rejected = the greater the chance of a type 1 error
71
What is a clinical audit?
A quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria. Where indicated changes are implemented and further monitoring is used to cornfirm improvement in healthcare delivery
72
What are the main stages of the clinical audit?
1. Identify problem
2. Set criteria and standards
3. Observe practice
4. Compare performance with criteria and standards
5. Implement change
73
what do you achieve from an audit cycle?
A way to find out if healthcare is being provided in line with standards and lets care providers and patients know where their service is doing well, and where there could be improvements.
74
What are the strengths and limitations of an audit?
Pros:
it may help you to meet requirements. For example, all NHS organisations are required to carry out audits
Professional benefits - may increase staff enthusiasm
Benefits to patient care and service delivery
Cons:
Diminished clinical ownership
Fear of litigation
Hierarchical and territorial suspicions
Professional isolation
Increased workload
Restriction of clinical freedom
75
Outline healthy and unhealthy adjustment responses to physical symptoms
Healthy adjustment responses:
- Seeking medical advice and treatment for physical symptoms
- Adopting healthy lifestyle behaviors such as regular exercise, good nutrition, and adequate sleep
- Developing coping strategies, such as relaxation techniques, mindfulness, or social support, to manage symptoms and reduce stress
- Engaging in activities and hobbies that bring joy and a sense of purpose
- Maintaining a positive outlook and focusing on personal strengths and resilience
Unhealthy adjustment responses:
- Ignoring physical symptoms or delaying medical attention
- Adopting unhealthy lifestyle behaviors such as smoking, excessive alcohol consumption, or a poor diet
- Avoiding social interaction or withdrawing from activities and hobbies
- Becoming overly anxious, depressed, or hopeless about the future
- Developing negative coping mechanisms, such as substance abuse, self-harm, or overeating
76
How do personal factors influence adjustment responses to physical symptoms?
Personality traits
Cognitive styles
Emotional regulation skills
For example, a person who is generally optimistic and has strong problem-solving skills may be better equipped to cope with physical symptoms and adjust to changes in their health.
77
How do family factors influence adjustment responses to physical symptoms?
Family support can play a crucial role in an individual's ability to adjust to physical symptoms. Family members can provide emotional support, practical assistance, and help the individual maintain a sense of social connectedness. However, family conflict or lack of support can be a source of stress and negatively impact adjustment.
78
How do cultural factors influence adjustment responses to physical symptoms?
Culture can influence how an individual interprets and expresses physical symptoms, as well as their beliefs about illness and treatment. For example, some cultures may view illness as a punishment for past behaviors, while others may see it as a result of an imbalance in the body's energy. These beliefs can affect an individual's willingness to seek medical care, comply with treatment, and cope with physical symptoms.
79
What is a clinical audit?
A systematic review of healthcare practices to determine whether they are consistent with established standards or guidelines
80
What is the purpose of an audit?
To identify areas where healthcare providers can improve their practices and enhance the quality of care they provide to patients
81
What are the steps involved in conducting an audit?
- identify standards - what should be happening
- collect data on current practice
- analyse and assess against standards set
- identify steps to improve
- implement changes
- re-evaluate
82
What are the benefits of conducting an audit?
- improved pt care and increases numbers of satisfied pt
- can improve clinical education
- enhances healthcare practices
- increased compliance with regulations and guidelines
- financial benefits
- encourages teamwork
- fulfills contractual obligations
- can make practice more efficient
83
What are some challenges/limitations associated with conducting an audit?
- difficulty in obtaining accurate and complete data
- lack of resources (they cost time, money and resources)
- resistance from healthcare providers
- difficulty in implementing recommendations
- if it doesnt change anything then resources have been wasted
- is only a snapshot so may not be representative or could be influenced by confounding factors
84
Outline the complaints system within the NHS?
Patient Advice and Liaison Service - available in most hospitals for urgent issues and immediate action or just to offer advice about the process or help resolve issues informally
NHS complaints advocates can help you to make a complaint
First step is normally raising the matter directly - local resolution
You can either complain to the NHS service provider directly or to the commissioner of the services within 12 months of incident
If the pt is not satisfied with the response to their formal complaint they can escalate it to the independant review stage - review for the Parlimentary and Health Service Ombudsman (an independant body that will investigate and make recommendation to the NHS on how to resolve the issue)
Patients can also take legal action but this is a last resort
85
What are adverse events?
An event or incident that results in harm or injury to a patient, either due to healthcare-related activities or in spite of them.
86
What is a near miss?
an event or situation that could have resulted in harm to a patient but did not, either by chance or through timely intervention
87
What is a critical event?
An adverse event that is severe or life-threatening, requiring immediate action to prevent harm or death to the patient
88
What are examples of adverse events?
Medication errors
Healthcare associated infections
Falls
Pressure ulcers
Diagnostic errors
Surgical errors
Miscommunication
89
What are the most frequent adverse events in primary care?
Prescription errors
Drug administration errors by patients
Clinical assessment errors
90
What are the most frequent adverse events in secondary care?
Surgical errors
Healthcare associated infections
Medication errors
91
How does monitoring adverse and critical events improve pt safety and healthcare quality?
It can help identify areas where pt safety can be improved. By tracking adverse events, they can identify patterns and trends which can help inform targeted interventions to reduce the risk of future adverse events
Enhances healthcare qua;ity by identifying areas where care processes can be improved
Increases accountability among healthcare providers (avoiding blame culture)
92
What systems are in place in the NHS to monitor adverse and critical events?
National Reporting and Learning system
Medicines and Healthcare products Regulatory Agency
Care Quality commission
Clinical audits
incident reporting systems
Learn from Patient Safety Events service
93
What is the National Reporting and Learning System?
a web-based system used by healthcare organizations in the UK to report and learn from patient safety incidents, including adverse and critical events. The system allows healthcare organizations to analyze incident data, identify trends, and share information to improve patient safety.
94
What is the Medicines and Healthcare products Regulatory Agency?
a government agency responsible for regulating medicines and medical devices in the UK. The agency operates a Yellow Card Scheme, which allows healthcare professionals and patients to report adverse drug reactions and medical device incidents. The scheme is used to monitor the safety of medicines and medical devices and to inform regulatory decisions.
95
What is Care Quality Commission?
an independent regulator of healthcare services in England
They monitor healthcare organizations to ensure they are meeting quality and safety standards, including monitoring adverse and critical events.
96
What are Incident Reporting Systems?
Many healthcare organizations in the UK have their own incident reporting systems, which allow healthcare professionals to report adverse and critical events within their organization. These systems can be used to monitor trends and patterns of incidents within an organization, identify areas for improvement, and implement changes to improve patient safety.
97
What is a serious incident
vents in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant, that they warrant using additional resources to mount a comprehensive response
98
What is a never event?
serious incidents that are entirely preventable because guidance or safety recommendations providing strong systemic protective barriers are available at a national level, and should have been implemented by all healthcare providers.
99
What are the principles of serious incident management?
Open and transparent - needs of those affected should be the primary concern of those involved (duty of candour)
Preventative - investigations must be done to identify what went wrong, how it went wrong and what can be done to prevent similar incidents occurring again
Objective - those involved in the investigation process must not be involved with the direct care of those pt affected
Timely and responsive - serious incidents must be reported without delay and no longer than 2 working days after the incident
Systems based - use the systems-based investigation methodology
Proportionate - scale and scope of the investigation should be proportionate to the incident to ensure resources are effectively used
Collaborative - serious incidents often involve several organisations and these should work in partnership to ensure incoidents are effectively managed
100
What are the professional responsibilities of a doctor involved in a serious or never event?
Provide immediate care to ensure pt safety and wellbeing e.g. initiating first aid
Report the event
Cpommiunoicate with pt and families
Participate in root cause analysis
Learn from the event
101
Review the different methods for collecting and analyzing adverse event data?
Incident reporting systems
Electronic health records
Patient surveys
Chart review
Root cause analysis
102
Why is it important to monitor adverse events?
They are common, have important consequences and up to 50% are preventable!
We can learn from them and reduce adverse event sin the future, improving care
103
What are barriers to learning from adverse events?
Lack of communication
Lack of responsibility taken
Focus on the immediate event not the root cause
Pride and rigid attitudes of staff
104
Why does it matter who is recruited to clinical trials?
They have to be representative of the total population and adhere to all inclusion criteria to increase reliability of the study
105
Outline the phases of a clinical trial?
Phase I: In this phase, a small group of healthy volunteers (20-100) are given the drug being tested to determine its safety, dosage range, and potential side effects. The study also aims to evaluate how the drug is absorbed, metabolized, and eliminated from the body.
Phase II: In this phase, a larger group of patients (100-300) with the targeted disease receive the drug to assess its efficacy and safety. This phase helps determine the optimal dose and potential side effects of the drug.
Phase III: In this phase, a larger group of patients (1000-3000) with the targeted disease receive the drug to confirm its effectiveness, monitor side effects, and compare it with standard treatments or placebo.
Phase IV: This phase takes place after the drug has been approved by the regulatory authorities and is on the market. Phase IV studies aim to gather more information about the drug's long-term effects, risks, and benefits.
106
What are the ethical issues regarding recruitment to a clinical trial?
Ensuring fully informed consent - pt must understand the nature of the study, the risks and benefits and their right to withdraw at any time
Voluntary participation
Fair selection of participants
Researchers must ensure the potential benefits of the study outweighs the risks for the participants. They must also ensure the risk/harm is minimised as much as possible
Protect vulnerable populations
Ensure participants privacy and confidentiality are protected throughout the study
Equity - they must be conducted to ensure participants are not discriminated against
Placebo use - participants may not receive the best possible treatment for their conditons
107
Outline how you would seek a pt consent to participate in a clinical trial?
Provide the patient with an informed consent document that includes a detailed description of the study, the risks and benefits, and the patient's rights as a participant.
Discuss the study with the patient and answer any questions they may have. Make sure they understand the purpose of the study, the procedures involved, and the potential risks and benefits.
Give the patient adequate time to consider their decision and consult with their family or other healthcare providers as needed.
Obtain the patient's written consent to participate in the study. The consent document should be signed and dated by the patient, and a copy should be provided to them for their records.
Reiterate the patient's right to withdraw from the study at any time and provide them with contact information for the research team if they have any questions or concerns.
108
How can attitudes towards older patients can affect the delivery of healthcare?
Ageism: Negative stereotypes and prejudices about older patients can lead to ageism, which can result in healthcare providers not taking their concerns seriously, dismissing their symptoms, or failing to provide appropriate care.
Underdiagnosis and undertreatment: Ageist attitudes can also lead to underdiagnosis and undertreatment of health conditions in older patients. Healthcare providers may assume that certain symptoms or conditions are simply a result of aging, rather than conducting a thorough evaluation to identify and treat underlying health problems.
Communication barriers: Attitudes towards older patients can also affect communication between healthcare providers and patients. Providers may speak in a condescending or patronizing manner, assuming that older patients are less capable of understanding complex medical information.
Reduced access to care: Negative attitudes towards older patients can also result in reduced access to care, as healthcare providers may be less likely to refer them for specialized care or offer certain treatments or interventions.
109
How can attitudes towards patients with mental illness can affect the delivery of healthcare?
Stigma: Stigmatizing attitudes towards patients with mental illness can lead to negative stereotypes, misconceptions, and discrimination. Healthcare providers may view patients with mental illness as being less deserving of care or less capable of recovery.
Misdiagnosis: Attitudes towards patients with mental illness can also lead to misdiagnosis or underdiagnosis of mental health conditions. Healthcare providers may dismiss certain symptoms or fail to recognize the severity of mental health issues.
Limited treatment options: Stigmatizing attitudes towards patients with mental illness can also result in limited treatment options, as providers may be less likely to refer patients for specialized care or offer certain treatments or interventions.
Communication barriers: Negative attitudes towards patients with mental illness can also affect communication between healthcare providers and patients. Providers may use stigmatizing language or assume that patients with mental illness are unable to understand complex medical information.
110
Define advocacy in relation to mental illness?
Advocacy refers to efforts to promote the rights, needs, and interests of individuals with mental health conditions.
It can take many forms, such as raising awareness of mental health issues, promoting access to mental health services, and advocating for policy changes to improve the lives of individuals with mental illness.
Advocacy efforts in mental health may be aimed at reducing stigma, discrimination, and social exclusion experienced by individuals with mental illness. Advocates may work to challenge negative attitudes and stereotypes about mental illness, promote a greater understanding of the causes and treatments of mental illness, and encourage people with mental health conditions to seek treatment and support.
Advocacy can also involve efforts to improve access to mental health services and resources, such as promoting the availability of affordable and effective treatments, and advocating for greater investment in mental health research and services.
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Define stigma in relation to mental illness?
Stigma refers to negative attitudes, beliefs, and stereotypes that people hold about individuals who have mental health conditions
These attitudes can be deeply ingrained and can lead to discrimination, social exclusion, and other forms of unfair treatment.
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How should you manage adults who want to stop smoking?
Offer referral to local smoking cessation services or inform the person who they can access local NHS Stop Smoking Services which can offer evidence-based interventions including behavioural support and NRT
Discuss ways the person can manage cravings using distraction strategies
NRT
Varenicline or bupropion
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What has been shown to be the most effective treatment to stop smoking?
varenicline or combination NRT (a patch plus a short-acting preparation)
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What are examples of theories of behavioural change?
Health belief model
Transtheoretical model/stages of change model
Social cognitive theory
Theory of planned behaviour
Self determination theory
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What is the health belief model and link it to smoking cessation?
It is a psychological model that explains and predicts health-related behaviors by focusing on the attitudes and beliefs of individuals. It proposes that an individual's decision to take action to prevent or control a health problem is based on several factors, including their perceived susceptibility to the problem, the perceived severity of the problem, the perceived benefits of taking action, and the perceived barriers to taking action.
In the context of smoking cessation, the HBM suggests that an individual's decision to quit smoking is influenced by their beliefs about the risks of smoking (perceived susceptibility and severity), their beliefs about the benefits of quitting smoking (perceived benefits), and their beliefs about the challenges of quitting smoking (perceived barriers).
For example, a smoker who perceives themselves to be susceptible to the health risks associated with smoking, such as lung cancer and heart disease, and perceives these risks to be severe, may be more motivated to quit smoking. Similarly, a smoker who believes that quitting smoking will lead to improved health and quality of life may be more likely to make a quit attempt. On the other hand, a smoker who believes that quitting smoking will be difficult or that they lack the necessary support to quit may perceive high barriers to quitting and may be less likely to make a quit attempt.
Healthcare providers can use the HBM to develop smoking cessation interventions that address the individual beliefs and attitudes of smokers. For example, they can provide information on the risks of smoking and the benefits of quitting, offer support to help smokers overcome perceived barriers to quitting, and encourage smokers to build their self-efficacy in quitting. By addressing the beliefs and attitudes that underlie smoking behavior, healthcare providers can help smokers to make informed decisions about quitting smoking and increase their chances of successful smoking cessation.
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What is the transtheoretical model and link it to smoking cessation?
This model proposes that people go through a series of stages when making behavior changes, including precontemplation, contemplation, preparation, action, maintenance, and termination. This model suggests that people do not simply change their behavior all at once but rather move through a series of stages before achieving lasting change.
In the context of smoking cessation, the TTM proposes that smokers go through a series of stages before successfully quitting smoking. The precontemplation stage is characterized by a lack of intention to quit smoking, while the contemplation stage involves considering the pros and cons of quitting smoking. The preparation stage involves making a plan to quit smoking, while the action stage involves actively quitting smoking. The maintenance stage involves sustaining the behavior change over time, and the termination stage involves complete cessation of smoking with no desire to return to the behavior.
Healthcare providers can use the TTM to tailor smoking cessation interventions to the individual stage of change of each smoker. For example, they can provide information and support to smokers in the contemplation stage to help them weigh the pros and cons of quitting, offer assistance in developing a quit plan for those in the preparation stage, and provide ongoing support to smokers in the maintenance stage to help them sustain their quit attempt. By understanding the stage of change of each smoker, healthcare providers can tailor their interventions to the specific needs and challenges of each individual and increase the likelihood of successful smoking cessation.
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What is the social cognitive theory and link it to smoking cessation?
This is a psychological model that emphasizes the importance of both individual factors, such as knowledge, beliefs, and attitudes, and environmental factors, such as social norms and peer influence, in behavior change. The SCT proposes that people learn from observing and imitating the behaviors of others, and that their behaviors are influenced by their perceptions of the outcomes of those behaviors and their beliefs about their ability to perform them.
In the context of smoking cessation, the SCT suggests that individual factors, such as knowledge and attitudes about smoking, as well as environmental factors, such as social norms around smoking, influence smoking behavior. The theory proposes that effective smoking cessation interventions should aim to change the individual's attitudes and beliefs about smoking, as well as the social norms and environmental factors that contribute to smoking behavior.
Healthcare providers can use the SCT to develop smoking cessation interventions that address both individual and environmental factors. For example, they can provide education about the risks of smoking and the benefits of quitting, offer support to help smokers build their self-efficacy in quitting, and encourage smokers to seek out supportive social networks and environments that promote smoke-free lifestyles. By addressing the individual and environmental factors that influence smoking behavior, healthcare providers can help smokers make sustained behavior changes and improve their overall health outcomes.
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What is the theory of planned behaviour and link it to smoking cessation?
This is a psychological model that proposes that people's behavior is influenced by their intentions to perform that behavior, which in turn are influenced by their attitudes toward the behavior, subjective norms, and perceived behavioral control.
In the context of smoking cessation, the TPB suggests that an individual's intention to quit smoking is influenced by their attitudes toward quitting, subjective norms around smoking and quitting, and their perceived ability to quit. Attitudes toward quitting refer to an individual's beliefs and evaluations of quitting smoking, including their beliefs about the health benefits of quitting and their enjoyment of smoking. Subjective norms refer to an individual's beliefs about the social pressure to smoke or quit smoking, including the influence of family, friends, and society. Perceived behavioral control refers to an individual's beliefs about their ability to successfully quit smoking, including their confidence in their ability to quit and the availability of resources and support to help them quit.
Healthcare providers can use the TPB to develop smoking cessation interventions that address the individual attitudes, subjective norms, and perceived behavioral control of smokers. For example, they can provide education about the health benefits of quitting and the availability of resources and support for quitting, address common misperceptions about smoking and quitting, and provide strategies for building self-efficacy and confidence in quitting. By addressing the attitudes, subjective norms, and perceived behavioral control that influence smoking behavior, healthcare providers can help smokers develop strong intentions to quit smoking and increase their chances of successful smoking cessation.
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What is the self-determination theory and link it to smoking cessation?
This is a psychological theory that emphasizes the importance of three basic psychological needs: autonomy, competence, and relatedness. The theory proposes that people are more likely to engage in behaviors that satisfy these basic needs and that behavior change is more likely to be sustained when individuals feel a sense of autonomy, competence, and relatedness in the behavior change process.
In the context of smoking cessation, the SDT suggests that smokers are more likely to be successful in quitting smoking if they feel a sense of autonomy, competence, and relatedness in the behavior change process. Autonomy refers to an individual's sense of control over their own behavior, while competence refers to an individual's belief in their ability to successfully quit smoking. Relatedness refers to an individual's sense of connection to others and the social environment.
Healthcare providers can use the SDT to develop smoking cessation interventions that address these basic psychological needs. For example, they can provide education about the health benefits of quitting and the availability of resources and support for quitting, while also respecting the individual's autonomy to make their own decisions about quitting. They can also provide strategies for building competence in quitting, such as developing personalized quit plans and providing feedback and support throughout the quitting process. Finally, they can promote relatedness by encouraging smokers to seek out supportive social networks and environments that promote smoke-free lifestyles.
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What is the duty of care?
The obligation of healthcare professionals to act in the best interests of their patients and to provide them with a standard of care that is reasonable, appropriate, and competent.
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What is medical negligence?
substandard care that’s been provided by a medical professional to a patient, which has directly caused injury or caused an existing condition to get worse.
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How do you prove medical negligence?
You must have had a duty of care to the patient
You must have breached that duty by failing to provide appropriate care
The breach of duty must have resulted in harm or injury to the patient
The harm or injury must have been a direct result of the breach of duty
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What are the legal implications of medical negligence?
patients who have been harmed as a result of medical negligence may be entitled to compensation for their injuries. This compensation may include damages for medical expenses, lost income, pain and suffering, and other related losses.
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What are the ethical implications of medical negligence?
It can erode the doctor-patient relationship and lead to feelings of betrayal, anger, and mistrust. Healthcare professionals have an ethical obligation to act in the best interests of their patients, to provide a high standard of care, and to take appropriate steps to prevent harm or injury.
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How can HCP avoid medical negligence?
remain up-to-date with current medical knowledge and best practices
communicate effectively with patients and their families
obtain informed consent
take appropriate steps to prevent medical errors.
They must also be willing to admit mistakes, take responsibility for their actions, and work to rectify any harm or injury that may have occurred.
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What are the 4 key principles of medical ethics?
Autonomy: This principle emphasizes the importance of respecting patients' rights to make their own decisions about their medical care. It requires healthcare professionals to provide patients with all the information they need to make informed decisions, and to respect their choices even if they do not agree with them.
Beneficence: This principle emphasizes the obligation of healthcare professionals to act in the best interests of their patients. It requires them to provide care that maximizes the patient's benefits and minimizes harm.
Non-maleficence: This principle emphasizes the obligation of healthcare professionals to do no harm to their patients. It requires them to avoid actions that may cause harm or increase the risk of harm.
Justice: This principle emphasizes the importance of fairness and equity in healthcare. It requires healthcare professionals to treat patients fairly and equitably, and to allocate resources in a way that maximizes benefits and minimizes harm for all patients.
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Explain how the principles of medical ethics apply to the duty of care in medical practice?
utonomy is an important principle in the duty of care because patients have the right to make their own decisions about their medical care. Healthcare professionals must provide patients with all the information they need to make informed decisions and respect their choices, even if they do not agree with them.
Beneficence and non-maleficence are also important principles in the duty of care. Healthcare professionals have an ethical obligation to provide care that maximizes the patient's benefits and minimizes harm. They must take reasonable steps to prevent harm or injury to the patient and avoid actions that may cause harm or increase the risk of harm.
Justice is also an important principle in the duty of care. Healthcare professionals have an obligation to treat patients fairly and equitably and to allocate resources in a way that maximizes benefits and minimizes harm for all patients.
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Discuss the importance of informed consent in medical practice, and explain how it is related to the duty of care and medical ethics.
Informed consent can protect patients' autonomy, or their right to make their own decisions about their medical care. It is a fundamental principle of medical ethics that patients have the right to be informed about their medical treatment and to make decisions about their care based on that information.
Obtaining informed consent is also a key component of the duty of care in medical practice. Healthcare professionals have an ethical and legal obligation to provide patients with information about their medical treatment and to respect their right to make decisions about their care. By obtaining informed consent, healthcare professionals can ensure that they are providing care that is consistent with the patient's wishes and that respects their autonomy.
In addition to protecting patients' autonomy and fulfilling the duty of care, informed consent also helps to prevent medical malpractice and liability. If a patient is not properly informed about the risks and benefits of a medical procedure or treatment, they may be more likely to experience harm or injury. By obtaining informed consent, healthcare professionals can demonstrate that they took reasonable steps to prevent harm and acted in accordance with ethical and legal standards.
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What is cultural competence?
the ability of healthcare professionals to understand and appreciate the cultural beliefs, values, and practices of their patients, and to provide medical care that is respectful, sensitive, and appropriate to the patient's cultural background. Cultural competence is essential in medical practice because it can help to improve the quality of care, increase patient satisfaction, and reduce health disparities.
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What statistical test is used to compare before and after studies on the same population?
Wilcoxon signed-rank test
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Whats the usual outcome measure of cohort studies?
Relative risk
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Whats the usual outcome measure of case control studies?
Odd ratios
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A study of 1000 participants aims to determine the normal range for a number of parameters in a South East London population.
It is found in the analysis there is a strong positive correlation between height and forced expiratory volume (FEV1).
Which statistical technique may be used to predict FEV1 at any given height in this cohort?
Linear regression - can predict how much one variable changes when a second variable is changed
Y=mx+c
(Looks at correlation)
134
What can summarise linear regression?
Pearsons correlation - parametric
Spearman’s rank correlation coefficient - non-parametric
135
What does The Kaplan-Meier estimate measure?
Survival overtime
136
A 49-year-old man comes to see you for advice on smoking cessation. He is interested in trying an electronic cigarette to help him stop smoking. You recently read about a trial comparing electronic cigarettes with nicotine replacement therapy for smoking cessation. Patients attending appointments in primary care were alternately allocated to the intervention group and control group.
What bias?
Selection bias - due to non-random assignment of pts to study group
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What is the external validity of a study?
The degree to which the conclusions in a study would hold for other persons in other places and at other times
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antibiotics show a 2% absolute risk reduction in the rate of complications.
How can this be expressed to the patient in terms of the number of people that need to be treated in order to get a benefit from antibiotics?
50
(1/o.o2)
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What are the ideal characteristics of a screening test?
High sensitivity and high specificity
Acceptable cost
Non-invasive
Safe
Validated
Easy
Early detection
Public acceptance
Shold be effective treatments available
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What bias does an asymmetric funnel plot suggest?
Publication bias
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What is variance?
a measure of the variability of a set of numbers in a dataset. It is closely related to the standard deviation (SD) in the following way: Variance=SD²
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Whats the difference between accuracy and precision?
Accuracy is defined as 'closeness of the measurements to a specific value'.
Precision is the 'closeness of the measurements to each other'.
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What is standardised mortality ratio?
Compares mortality within 2 different populations whilst taking into account the effect of confounding factors
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What is length time bias?
an overestimation of survival duration due to the relative excess of cases detected that are asymptomatically slowly progressing, while fast progressing cases are detected after giving symptoms
I.e. slow growing and less aggressive diseases have more of an opportunity to be picked up on screening tests
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Whats the difference between retrospective cohort studies and case-control studies?
While retrospective cohort studies try to compare the risk of developing a disease to some already known exposure factors, a case-control study will try to determine the possible exposure factors after a known disease incidence.
146
Outline the effect of prevalence on PPV/NPV, sensitivity and specificity?
PPV and NPV are affected by prevalence as if prevalence falls the number of true positives falls
Sensitivity and specificity are not affected by prevalence
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How do you calculate the standard error of the mean?
SD / square root of number of pt
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How does population size affect standard error of the mean?
as population size increases, SEM decreases indicating that the estimated sample mean value better approximates the population mean
149
What are the Oxford Centre for Evidence-Based Medicine levels of evidence system?
1a Systematic reviews (with homogeneity) of randomized controlled trials
1b Individual randomized controlled trials (with narrow confidence interval)
1c All or none randomized controlled trials
2a Systematic reviews (with homogeneity) of cohort studies
2b Individual cohort study or low quality randomized controlled trials (e.g. <80% follow-up)
2c 'Outcomes' Research; ecological studies
3a Systematic review (with homogeneity) of case-control studies
3b Individual case-control study
4 Case series (and poor quality cohort and case-control studies)
5 Expert opinion without explicit critical appraisal, or based on physiology, bench research or 'first principles'
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What is GRADE?
Used for rating the quality of evidence in systematic reviews and guidelines but now is used to grade the quality of primary research
151
what is a significance level?
The value that you set at the beginning of your study to assess the statistical probability of obtaining your results (p value). The significance level is usually set at 0.05 or 5%. This means that your results only have a 5% chance of occurring, or less, if the null hypothesis is actually true.
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Whats the main difference between sensitivity and specificity?
Sensitivity - how good the test is at finding the disease
Specificity - how good the test is at excluding disease
153
What is Overdiagnosis?
When screen-detected diseases are either non-growing or so slow-grow f that they would never cause medical problems in the future
154
What are common complaints in the NHS?
Safety issues
Insufficient information
Ineffective clinical practice e.g. poor coordination of discharge
Poor handling of complaints
Lack of respect/dignity
Poor staff attitudes
Failure to follow consent procedure
Poor environment e.g. poor hygiene
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What are some of the common issues in handling complaints?
Failure to acknowledge validity of complaint
Failure to apologise
Responses to complaints not explaining what has been done to prevent recurrence
Responses to complaints containing medical jargon
Failure to involve the staff directly concerns n the complaint into the investigation
156
What are the 3 possible aims for a clinical trial comparing a new drug to an existing treatment?
Superiority - issue with this is it requires a large sample size
Equivalence (-delta to +delta)
Non-inferiority
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What is reliability in research?
Consistency of the measure i.e. there will be less variability
158
What is validity in research?
The extent to which a concept is accurately measured in a study
Determined by whether a test accurately measures what its supposed to
159
How do you interpret a standardised mortality ratio?
SMR of 100 indicates the mortality in study group = standard population
SMR >100 indicates a higehr than expected amount of mortality
E.g. SMR of 140 indicates there were 40% mr=ore fatalities in the sample population than expected
160
What is a fixed effects meta analysis?
assumes 1 true effect size underlies all the studies in the meta-analysis so any observed effects are due to sampling error
161
What is a meta-synthesis?
bringing together qualitative data to form a new interpretation of the research field
162
What is a random effects meta analysis?
assumes the observed estimates of treatment effect can vary across studies because of real differences in the treatment effect in each study as well as sampling variability (chance). Thus, even if all studies had an infinitely large sample size, the observed study effects would still vary because of the real differences in treatment effects
