Your SlideShare is downloading. ×
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients

404

Published on

Published in: Health & Medicine
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
404
On Slideshare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. Differences in side-effect assessment between healthcare professionals and patients Lesley Fallowfield Brighton & Sussex Medical School
  • 2. Introduction
    • Many advancements and improvements made in breast cancer treatment in past 2 decades
    • Better imaging, surgical techniques, systemic therapies offer prospect of cure to many and longer lives for those with MBC
    • Not all treatments are risk free
    • Discussion of therapeutic options must include discussion of harms and benefits
    • Includes appreciation of routes of administration
  • 3. Patients and clinicians may have different values
    • Many novel breast cancer treatments offer PFS
    • Some also have at best unpleasant toxicities and at worst very serious side effects
    • True benefits may be modest or uncertain due to limited follow-up
    • Desirable benefits and acceptable costs may differ between individual patients and also between patients and healthcare professionals
  • 4. Decisions patients face
    • Is lengthier survival worth treatment side-effects or is a better QoL free from either toxicity of treatment or hospitalisation ‘worth’ potential decrease in survival ?
    • How much survival benefit is needed to trade off the disadvantages and side-effects ?
    • Research suggesting that patients will accept toxicity for minimal benefits is flawed
    • When no clear survival benefits exist between treatments then QoL information may be crucial and influence patient preferences
  • 5. Do we have the data patients need for optimal decision-making ?
    • Veracity of safety and side-effect data (mainly from trials) doubtful
    • Methods for collection and recording sometimes inadequate
    • Concordance between PROs and those collected by healthcare professionals poor
    • CTC assessment by HCPs maybe more subjective than patient ratings
  • 6. Common Terminology Criteria for Adverse Events (CTCAE)
    • All cancer studies of investigational products demand toxicity assessment
    • Standardisation of data capture via CTCAE vital
    • Grading categories sometimes odd, and rarely been subjected to reliability or validity testing
    • Differences found between raters, and toxicity criteria are often misunderstood (Kaba et al, 2004)
    • Proxy frequency and intensity ratings almost always less accurate than patients (Sneeuw et al, 1999)
  • 7. PROs v. physician reports using CTC for AE (Basch et al, Lancet Onc, 2006)
    • 400 patient physician pairs in lung and GU clinics completed ratings of 11 items:-
      • Fatigue, pain, nausea, vomiting, diarrhoea, constipation, anorexia, dyspnoea, cough, urinary frequency, hot flushes
    • Agreement highest for observable symptoms such as vomiting
    • Most discrepancy was non-observable such as fatigue and genitourinary function
  • 8. Concordance - clinician recorded v PROs
    • In trials levels of symptom burden collected from PROs often higher than physician reported CTC (Greimel, 2011)
    • Little concordance between life threatening rather than quality of life-threatening side effects (Savage et al, 2002, Fallowfield et al, 2004, Ruhstaller, 2009, Oberguggenberger, 2011)
    • Can lead to discontinuation of therapy or non-adherence and sub-optimal treatment
    • Hampers research into ameliorative interventions
  • 9. Benefit/harms of hormone therapy
    • RCTs demonstrate efficacy of drugs such as tamoxifen in preventing recurrence in ER+ EBC
    • AIs more effective than tamoxifen
    • Most women will have 5 or more years of therapy
    • Substantial proportion of women will derive no direct benefit and only experience iatrogenic harms
    • Many side-effects go under-reported, unrecognised and untreated
  • 10. Concordance of Symptom Reports of Any Severity (Coombes, 2003) Symptoms % Prevalence CRF PRO Kappa 95% CI Hot flushes 49.8 73.5 0.73 ** .70 - .75 Fatigue 21.0 71.5 0.72 ** .41 - .47 Insomnia 17.9 69.4 0.45 * .42 - .48 Headaches 15.8 48.7 0.66 ** .63 - .69 Dizziness 9.5 32.1 0.72 ** .69 - .75 Vaginal bleeding 2.7 5.4 0.97 *** .96 - .98
  • 11. What are the primary goals of MBC treatment ?
    • Surely to palliate worst symptoms of disease and to offer appropriate ameliorative interventions in a timely manner
    • Unlikely if symptoms and side-effects not identified
    • Studies show that physicians’ inter-rater pain assessments are disparate and lower than patients (Frost et al, 2005)
    • Survey of >1300 patients with metastatic disease showed discrepancies between patient and physician assessment predictive of inadequate pain management , (Cleeland et al, NEJM)
  • 12. Nurses’ assessments of advanced cancer patients (Stromgren et al, 2001)
    • Responses of patients to 3 standardised PRO measures compared with nursing notes
    • ‘ Nurses Symptom Recognition’ (NSR) % estimated
    • Previous study showed DSR to be low for all items except pain
    • Many unrecognised symptoms could be palliated
    Item NSR (%) pain 84 physical function 84 nausea 64 vomiting 58 anorexia 41 dyspnoea 46 fatigue 36 sleeplessness 0 poor QoL 0
  • 13. Why are there differences ?
    • Poor communication skills of HCPs eliciting information
      • Leading & multiple questions
      • Ascertainment bias
    • Reluctance of patients to admit to presence and/or severity of symptoms
      • Fear treatment maybe stopped
      • Embarrassment
      • No wish to appear ungrateful or complaining
  • 14. Conclusions
    • Toxicity assessments made by proxy raters provide different information from that provided by patients
    • Frequency and severity may differ
    • Patient experience of treatment is not available from CTCAE
    • Impact on general well-being - social, emotional and functional not captured as well as good PROs
    • Both types of assessment are needed and need analysis in an integrated manner
  • 15. Acknowledgements
    • Colleagues at Sussex Health Outcomes Research & Education in Cancer

×