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Differences in side-effect assessment between healthcare professionals and patients Lesley Fallowfield Brighton & Sussex M...
Introduction <ul><li>Many advancements and improvements made in breast cancer treatment in past 2 decades </li></ul><ul><l...
Patients and clinicians may have different values <ul><li>Many novel breast cancer treatments offer PFS </li></ul><ul><li>...
Decisions patients face <ul><li>Is lengthier survival worth treatment side-effects or is a better QoL free from either tox...
Do we have the data patients need for optimal decision-making ? <ul><li>Veracity of safety and side-effect data (mainly fr...
Common Terminology Criteria for Adverse Events (CTCAE) <ul><li>All cancer studies of investigational products demand toxic...
PROs v. physician reports using CTC for AE   (Basch et al, Lancet Onc, 2006) <ul><li>400 patient physician pairs in lung a...
Concordance - clinician recorded v PROs <ul><li>In trials levels of symptom burden collected from PROs often higher than p...
Benefit/harms of hormone therapy <ul><li>RCTs demonstrate efficacy of drugs such as tamoxifen in preventing recurrence in ...
Concordance of Symptom Reports of Any Severity  (Coombes, 2003) Symptoms % Prevalence CRF  PRO Kappa 95% CI Hot flushes 49...
What are the primary goals of MBC treatment ? <ul><li>Surely to palliate worst symptoms of disease and to offer appropriat...
Nurses’ assessments of advanced cancer patients  (Stromgren et al, 2001) <ul><li>Responses of patients to 3 standardised P...
Why are there differences ? <ul><li>Poor communication skills of HCPs eliciting information </li></ul><ul><ul><li>Leading ...
Conclusions <ul><li>Toxicity assessments made by proxy raters provide different information from that provided by patients...
Acknowledgements <ul><li>Colleagues at Sussex Health Outcomes  Research & Education in Cancer </li></ul>
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ABC1 - L. Fallowfield - Differencies in side effects assessment among doctors, nurses and patients

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

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

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