Research

Question 1

Ethics Issues in Palliative Care Research

Answer 1

1. Validity
   - Studies must use valid techniques of design and data analysis and intend to produce knowledge that is generalizable
2. Value
   - Studies must offer value (a likelihood that the results will improve health and well-being of future patients)
3. Benefit to subjects (either during or after)
   - Consider using a crossover design, altering the standard 1:1 randomization to intervention:control in an RCT, such that more subjects stand to benefit from a potential intervention
   - Consider data collection in descriptive studies that may lead to better care (ie. more careful monitoring of pain)
   - Results may help a patient make decisions after the trial is over
   - Open label extension or reduced rate programs to participants after the trial is over
4. Minimization of risks and benefits
   - Consider impact of placebo/sham treatments
   - Minimize disruption to patient and caregivers (phone interviews, multiple options to schedule clinic visits, avoid unnecessary surveys, etc.)
5. Ensuring decision-making capacity
   - High prevalence of cognitive impairment in advanced illness and may be difficult to identify as capacity varies over time and treatment themselves may impact capacity
   - Brief assessment of understanding important, and if the study involves more substantial risk, a more structured capacity assessment may be appropriate
   - Involve an SDM if necessary, but still try to seek patients assent
   - Consider advanced consent if a patient may lose capacity or has only intermittent capacity
6. Protecting voluntariness
   - Ensure enrolment occurs with the full knowledge of available alternatives and option to withdraw at any tie with it impacting care

Question 2

Ethical Issues in Research: Validity and Value

Answer 2

Validity
- Studies must use valid techniques of design and data analysis and intend to produce knowledge that is generalizable

Value
- Studies must offer value (a likelihood that the results will improve health and well-being of future patients)

Question 3

Ethical Issues in Research: Benefit to Research Subjects

Answer 3

Benefit to subjects (either during or after)

• Consider using a crossover design, altering the standard 1:1 randomization to intervention:control in an RCT, such that more subjects stand to benefit from a potential intervention
• Consider data collection in descriptive studies that may lead to better care (ie. more careful monitoring of pain)
• Results may help a patient make decisions after the trial is over
• Open label extension or reduced rate programs to participants after the trial is over

Question 4

Ethical Issues in Research: Minimizing Risks and Burdens

Answer 4

Minimizing risks and benefits

• Ensure risks and burdens are minimized
• Minimize burden of additional interviews, investigations, and study visits (e.g. many options for clinic visits, data collection by phone, etc.)
• Tends to vary according to study - “DEMARCATED” or substantial risk may not occur to participants who receive a treatment that they would likely have received off protocol anyway, but study of an intervention outside of a typical indication poses risks that must be justified

The question of placebo

• All patients should have access to the best available standard of care, raising questions as to whether placebo is ever appropriate.
• In some scenarios, e.g. incident pain, a placebo response may be impressive and be ethically acceptable in a way that placebo control for antibiotic tx of meningitis would not be
• Access to an alternative ‘rescue’ treatment may also make placebo control justified, with results adjusted for such ‘rescue’ use later

The question of sham procedures

• Must ensures that the ‘sham’ control itself poses minimal risk above and beyond usual care
• A crossover design can be helpful to mitigate concerns around patient access

Question 5

Ethical Issues in Research: Consent and Capacity

Answer 5

Ensuring decision-making capacity

• High prevalence of cognitive impairment in advanced illness and may be difficult to identify as capacity varies over time and treatment itself (e.g. opioids etc.) may impact capacity
• Comorbidities, including dementia, depression, psychiatric illness, or critical
• Brief assessment of understanding important, and if the study involves more substantial risk, a more structured capacity assessment may be appropriate
• Involve an SDM if necessary, but still try to seek patients assent
• Consider advanced consent if a patient may lose capacity or has only intermittent capacity

Question 6

Ethical Issues in Research: Protecting voluntariness

Answer 6

Protecting voluntariness
- Ensure enrolment occurs with the full knowledge of available alternatives and option to withdraw at any tie with it impacting care

Question 7

Needs for future palliative care research

Answer 7

1. Groups of sufficient size and output to develop future research
2. National and international funding with successful collaboratives to ensure there are no significant gaps
3. Training of clinicians and scientists in palliative care research

Question 8

Planning a research study in Palliative Medicine

Answer 8

1. Describe clearly the clinical problem or observations prompting the idea for the study
2. Discuss relevance and validity with colleagues
3. Carry out a comprehensive lit review to assess prior knowledge
4. Formulate the research question and ensure the aim is clear, precise, and specific.
5. Define the patient population
6. Decide on the study design
7. Decide on the outcomes to be measured
8. Write the protocol

Question 9

Core inputs to evidence based medicine

Answer 9

1. Best Research Evidence
2. Clinical expertise
3. Patient’s values/experiences

Question 10

Evidence hierarchy for primary clinical research

Answer 10

1. RCT
2. Pseudo RCT
3. Cohort study
4. Case Control study
5. Case study/series

Question 11

Critical appraisal skills

Answer 11

1. Assess the patient/problem
2. ASK - ask the question (well-constructed clinical question)
3. ACQUIRE - conduct a search, choose the most relevant resources
4. APPRAISE - is the evidence valid and applicable?
5. APPLY - talk with the patient, integrate evidence, clinical expertise, and patient preferences
6. EVALUATE - evaluate the patient’s outcomes and performance

Question 12

Barriers to EBM in Palliative Care

Answer 12

• Paucity of evidence for palliative care
• Limited skills of palliative care practitioners
• Lack of motivation
• Lack of easy access to evidence

Question 13

P-Value (Type I Error rate)

Answer 13

• Probability of finding a difference in the treatment effect of the size detected in the study or larger by chance alone when there is NO true effect (typically 0.05)

Question 14

Qualitative Research: Phenomenology

Answer 14

• Aims to understand the lived experiences of individuals or groups
• Typically uses interviews or focus groups

Question 15

Qualitative research: Grounded theory approaches

Answer 15

• Aims to generate analytical categories and dimensions and analyse the relationships between them to understand social processes

Data collection

• Observation, participant observation
• Focus groups
• Interviews

E.g. Grounded theory study to explore attitudes and believes among emergency care providers regarding the provision of palliative care in the emergency department

Question 16

Qualitative Research: Ethnography

Answer 16

• Aims to understand the social world of people from a cultural perspective

Data collection

• Observation
• Interviews
• Documentary analysis
• Case studies

E.g. ethnographic study tracing the changing notions of a good death held by hospice/palliative care providers

Question 17

Limitations of using proxy ratings in palliative care research

Answer 17

1. HCP tend to overestimate patient anxiety, depression, and general psychological distress
2. Agreement regarding QOL between HCPs and patients is better in the absence of distress
3. Pain and other symptos are often underestimated by proxies
4. Proxy rating is more accurate when the domains are concrete and observable

Additionally:

• Lack of understanding of when and why proxy/patient ratings differ
• Lack of short and intuitively understandable assessment tools
• Uncertainty regarding psychometric properties of tools when used by proxies
• Uncertainty re: comparability between patients and proxies ratings

Question 18

Domains of QOL at EOL

Answer 18

1. Symptom management
2. Avoiding inappropriate prolongation of dying
3. Achieving a sense of control
4. Relieving burden
5. Strengthening of relationships between loved ones

Question 19

Health services research

Answer 19

Study of how social factors, financing systems, organization structures and processes, technologies, and personal behaviours affect:

• Access to care
• Quality of care
• Cost of care
• Health outcomes and well-being

Question 20

Dimensions of care relevant to quality

Answer 20

1. Effectiveness
2. Acceptability
3. Efficiency
4. Access
5. Equity
6. Relevance

Question 21

Types of Audit that may be used in Palliative Care

Answer 21

1. Key Indicators
   - Routinely collected data (e.g. visits, re-admission rates, etc.)
   - Recorded prospectively and examined at specific intervals
2. Topic Review
   - Topic is chosen and reviewed prospectively or retrospectively
   - Provides a baseline for future comparison
   - E.g. review of prescribing practice
3. Random Case Review
   - Notes are selected at random and reviewed by other physicians
   - May lose direction if aims and criteria for quality are not clear
   - Can be linked with key indicators
4. Patient/family satisfaction
   - Simple approach done via survey
   - Patients may die before they are able to complain
5. Adverse patient events
   - E.g. SIMS reports
   - Systematically identifies events that may indicate lapse in quality
   - Records reviewed retrospectively by clerk or other designate for examples of agreed adverse events
   - More vluable in specialties where adverse events are routinely recorded
   - In Palliative Care, may be difficult as adverse events are more difficult to routinely identify

Question 22

Major knowledge resources for palliative care on the Internet

Answer 22

1. Canadian Virtual Hospice
   - Tools for practice
2. Cochrane library
   - Systematic reviews regarding pain, supportive care measures
3. UpToDate
   - Evidence based summaries (though no data provided on how specific guidelines are chosen)
4. Caresearch.com.au
   - Provides summaries of clinical evidence