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Radiotherapy Year 3 > Assorted > Flashcards

Assorted Flashcards

1
Q

What is a clinical trial?

A

A research project that compares 2 or more treatments in patients with a particular condition, to help generate high quality evidence about which is more effective

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2
Q

Who manages/coordinates a clinical trial?

A

Clinical trial unit of hospital

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3
Q

What is the hierarchy of evidence?

A
  1. Systematic reviews and meta-analyses
  2. RCTs with definitive results
  3. RCTs with non-definitive results
  4. Cohort studies
  5. Case-controlled studies
  6. Cross-sectional surveys
  7. Case series
  8. Case reports
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4
Q

What are the three phases of clinical trials and their main consideration?

A

Phase 1 - is the new treatment safe?
Phase 2 - is the new treatment effective?
Phase 3 - is the new treatment better than current SoC?

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5
Q

What are the features of phase 1 trials/

A

Small, typically less than 30 patients
Designed to find safe dose of new treatment and learn about side effects

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6
Q

What are the features of a phase 2 trial?

A

Typically up to 100 patients
May be randomised
Designed to find more information on side effects and how the treatment works for certain types of cancer

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7
Q

What are the features of a phase 3 trial?

A

Typically 100s of patients
Randomised
Designed to compare new treatment with standard and check which is better

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8
Q

Why is randomisation done?

A

Avoids bias: stops doctors assigning arms depending on how they fit the patient for example

Usually done by computer

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9
Q

What is blind and double blind randomisation?

A

Blind, patient doesn’t know what they are getting
Double blind, clinician doesn’t know either

Usually can’t blind RT trials

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10
Q

What kind of things would you need to consider if setting up a clinical trial?

A

Trial design. Do systematic review, has anyone else done this?
Practicalities: costing, staff planning
Collaborator negotiations: discuss with collaborators and funders
Set up permissions, ethics, MHRA

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11
Q

What might you need to do to participate in trial?

A

Facility questionnaire
Trial set up and permissions
Accreditation - trial QA
Site initiation visit
Delegation log
Recruitment
Data collection

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12
Q

What is trial accreditation and what does it involve?

A

Makes sure that patients entering the trial have same standards and quality of treatment

Questionnaire
Process document (how you will treat)
Benchmarking exercises (do some plans/contouring, they check it)
Site visit
Ongoing data collection

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13
Q

What can go wrong in a clinical trial?

A

Series adverse effects (these are reviewed, study may be terminated early)
Failing to recruit patients in an acceptable time frame
Failure to follow protocol

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14
Q

What is an example of trial protocol not being followed?

A

POG 8346 trial
Ewing sarcoma study, irradiate whole bone or just involved bone
Found no difference in LC between the two groups
Did find quality of RT made a difference,
No deviations from protocol, LC 5yrs 80%
Major deviation, 16%

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15
Q

What does being in a clinical trial involve for the patient?

A

Informed consent
Additional tests (potentially)
Additional data collection
Extra visits
Extra follow up

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16
Q

What are some advantages that patients could perceive of being in a CT?

A

Trial will advance cancer research and benefit future patients
May have access to treatment not widely available
May benefit if treatment is more effective
May think more appointments is reassuring and provide more support

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17
Q

What are some disadvantages that a patient might perceive of being in a CT?

A

New treatment could be worse
Could have severe side effects which haven’t been realised
Probably need more appointments
Might have extra costs associated with appointments, childcare/accomodation
Randomisation means no choice in treatment

18
Q

What is PPI?

A

Patient and public involvement
Have patients/public involved in design and running of research, not being a research subject
PP should be involvd in all aspects of project

19
Q

What are some practice defining trials?

A

CHHiP trial
PACE trial

START trial
FAST trial

20
Q

What is the case for hypofractionation in prostate cancer?

A

Evidence that PC has low alpha beta ratio (~1.5 Gy), lower than surrounding tissues
Hypofractionating should produce good tumour control with late effects that are as good or better than standard

21
Q

What did the CHHiP trial find?

A

60/20 is non inferior to 74/37 and could be new SoC
No significant difference in acute/late urinary toxicity
increase in grade 2+ bowel toxicity but this disappeared after 18 weeks

22
Q

What did the PACE trial investigate?

A

36.25/5 vs surgery and vs 62 in 20

Suggests that patients don’t have worse toxicity, SBRT performs as well as standard RT

23
Q

What did START trial investigate?

A

Moderate hypofractionation

START A and B
A: 13f in 5 weeks (41.6Gy and 39Gy) vs 50 in 25 over 5 weeks

START B: 50 in 25 over 5 weeks vs 40 in 15 over 3 weeks

At least as favourable as conventional fractionation

24
Q

What did FAST and FAST FORWARD trials look at?

A

compared 50/25 over 5 weeks with 28.5/5 and 30/5 over five weeks
No significant difference in late effects

FAST FORWARD then looked at 5f in one week (26 or 27 in 5) vs 40 in 15
Non-inferior to 40 in 15

25
Q

What factors resulted in an increase in radiation induced incidents and lead to RAGE?

A

Limited radiobiological understanding
Poor technique
Lack of consistent standards
Move to MV linacs

26
Q

What is RAPPER?

A

Trial aiming to identify genetic varients associated with increased risk of side effects

27
Q

Why is RT change good for the patient and NHS?

A

Patient:
increased cure rates
reduced side effects
improved experience

NHS, improved efficiency through:
faster work
fewer staff
upskilling cheaper staff
use of technology

28
Q

What could lead change?

A

Patients
Research and technology
Capital
Government (legislative changes)
Competitor

29
Q

What might we see that would make us want to change?

A

Peer reviewed literature
Presentations at conferences
Local evidence eg audits
Sharing evidence between centres
Developments from manufacturer
Learning from incidents

30
Q

What literature discusses change?

A

On target 2 discusses change implementation
IPEM 81 has section on project management
NHS improvement guidance

31
Q

What are the steps in On target 2 guidance?

A

Define goals
Establish baseline
Design and prepare
Testing before full implementation
Risk assessment following change
Implementation and review

32
Q

What is stakeholder analysis?

A

Considering power and influence of different groups vs their interest

Determines how closely they are involved, keep satisfied vs manage closely etc

33
Q

What considerations do we make for end to end testing?

A

Where has the change impacted? Should E2E test that entire section, start from step beforehand

Involve those usually involved at every step

eg Using RS for H&N planning, scan D4, contour PTV on it, export to R&V system and check, treat

34
Q

What are we considering for information governance?

A

Data Protection Act
Caldicott principles/ Caldicott guardian
GDPR
Computer mistrust act
Research ethics

35
Q

What legislation is relevant to the use of software within healthcare?

A

EU/UK medical device regulations
ISO
IEC
DCB

36
Q

What are VR and VM?

A

Value representation - what type of data you are expecting (words, numbers)

Value multiplicity - how many things you can have there (1 name)

37
Q

What services can DICOM allow?

A

C-STORE
C-FIND
C-GET
C-MOVE (copy)
C-ECHO (used to check communications)

The standard defines transfer of information via messages

38
Q

What is HL7?

A

Health Level 7

Standard for exchange of electronic health information
Messages sent in simple text format between systems, each message contains multiple segments or sub segments

Reduces data entry workload, patients registered once on central system and synchronised with other systems

39
Q

Advantages of HL7 FHIR over v2/3

A

Shorter learning curve as it uses familiar concepts
More versatile
Potential to be used in development of mobile apps
Exchange information between wider variety of systems (eg wearables)

40
Q

What is interoperability?

A

Enable seamless and secure access to health information that is usable whenever and wherever needed

Shouldn’t have equipment that is standalone

Radiotherapy Year 3 (12 decks)

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