1. Psychosocial difficulties in head and neck cancer; the development of an evidence based measurement instrument Lucy Ziegler Rob Newell

2. Justification for development of new instrument. Psychosocial consequences of disease and treatment are often extensive and profound. QoL measures currently used to identify and monitor psychosocial difficulties do not reflect extent and range of psychosocial issues that exist. Existing measures are based on professional opinion and patient consultation and ranking of item relevance. Traditional concept of QoL measurement may not be the best measurement technique in the head and neck cancer population?

3. 4 phase study design Systematic review of psychosocial difficulties. Systematic review of existing measurement instruments Development of conceptual model and development of new measurement instrument. Validation study

4. Systematic review 1 Psychosocial issues identified were related to : Fear of recurrent disease Eating and communication Maintaining Social interaction Pain Disfigurement Personality Depression and anxiety

5. Systematic review of existing measurement instruments Necessary to assess each existing instrument against standard criteria or format. No appraisal tool available. Developed appraisal tool to provide a standard format to evaluate the following elements of existing instruments:

6. Measurement instrument appraisal criteria. Name of instrumentFormat Developed by and where?User centredness Intended purposeFeasibility Justification for measureResponsiveness ValidityCoverage of psychosocial areas identified by systematic review 1. Reliability

7. Developing New questionnaire Informed by systematic review of existing questionnaires Learned from systematic review 1 what issues the questionnaire should focus on. Format must be easy to understand and quick to complete. Reading age of 12 or less

8. Questionnaire items Eating (both functional and social) Role in family Employment Appearance Others perception of appearance Pain Relationships Fear of cancer coming back Meeting new people Support from family and friends anger Anxiety and depression

9. Questionnaire Layout 1. I worry about the cancer coming back. Disagree 0 1 2 3 4 5 6 7 8 9 10 Agree

10. Validation Study Types of validity explored: Convergent validity Construct validity. Internal consistency Internal association Practical utility and application.

11. Method … Inclusion criteria, must have diagnosis of head and neck cancer Exclusion criteria less than 3 months post diagnosis 210 questionnaires sent out Response rate of 73% achieved 154 returned

12. Internal consistency and internal association of questionnaire Factor analysis led to the identification of 4 sub scales of the questionnaire: Interaction Appearance Emotional Functional

13. Factor analysis also led to the following elements being discarded from the questionnaire Taste Tobacco and alcohol use, Loneliness Family support

14. Convergent validity Extent to which a questionnaire yields the same results as a questionnaire measuring similar phenomena. Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith 1983 ) chosen as a well established measure that focuses on similar issues yet is not disease specific. High levels of convergent validity were seen between the anxiety subscale of HADS and Emotion and Appearance subscales of HNCPIQ. The Depression subscale of the HADS and the subscales of Function and Interaction showed equally high convergence.

15. Test-retest 40 respondents were sent the same questionnaire 2 weeks after completing the first to determine the extent to which the questionnaire was able to yield consistent results under consistent conditions. Intraclass correlation coefficient.972 (0.7 considered high correlation)

16. Feasibility Questionnaire must be feasible for clinical practice and acceptable to respondents 3 additional questions at end of questionnaire about feasibility (only for validation study) Was it upsetting to complete? Did it take too long? Was it easy to understand? stats

17. Results relating to feasibility 92% of respondents claimed they did not find the questionnaire upsetting to complete 98% thought the questionnaire did not take too long to complete. 96% thought the questionnaire was easy to understand.

18. Summary The head and neck psychosocial impact questionnaire has demonstrated good initial reliability and validity. Clinical applicability: To further our understanding of the existence and severity of psychosocial difficulties. To determine need for psychosocial intervention. To facilitate further research study of this area.

19. Conclusion The study represents a different approach to instrument development than previously used in this field. The study challenges quality of life measurement as the only, and perhaps best approach for capturing information about psychosocial wellbeing in the head and neck cancer population.