Background In the UK, demonstration of patient and public involvement (PPI) is now a funding requirement. Despite advice being available to researchers regarding PPI, levels of engagement are variable. Patient involvement has been at the core of the Leeds Psychosocial Oncology and Clinical Practice Research Group since 2007 when a local Research Advisory Group (RAG) was established. In addition, we work with experienced patient advocates from national groups. Methods The RAG is led by designated researchers who manage and communicate with members. The RAG is invited to twice yearly meetings with the full research team when study findings are disseminated and advice sought. The meetings are also an opportunity to socialise and thank members. Effective partnerships and engagement require good communication, building relationships over time and tailoring involvement to individuals’ skills and experience. Results Patients have been involved in design, planning new projects and assisting with grant proposals; development, pilot testing of interview strategies and question generation, project steering groups and management teams, development of self-management advice for online patient portals; implementation, extensive beta testing of new questionnaire builder software to enable collection of online patient-reported outcomes (PRO) and study websites, cognitive interviews to develop PRO items; dissemination, co-authorship of papers and presentations, attendance/representation of the group at conferences. Conclusion The involvement of patient advocates is integral to ensuring PRO development remains patient-centred. Having a co-operative, well-established local PPI group and nationally active patient collaborators has had a rewarding and significant impact on our research programmes.

The Hospital Anxiety and Depression Scale (HADS) has been used extensively in cancer patients to identify psychological distress. Reports of the factor structure and screening performance of the instrument vary. Rasch models allow an assessment of the structure of a questionnaire by identifying item fit. Removal of misfitting items may improve both the dimensionality and efficacy of screening questionnaires.A Rasch analysis of the HADS-T and subscales was used to explore the factor structure, dimensionality and screening efficacy. A total of 1855 patients completed a touchscreen version of the HADS, including 381 patients who had received a psychiatric interview (SCAN/PSE). These data were analysed using Rasch models, and the screening efficacy at identifying cases of psychological distress and anxiety and depression evaluated.The results demonstrated that the structure of the HADS-T and subscales was unidimensional. Three items from the HADS-T, and one from each of the subscales demonstrated misfit. Screening efficacy for the HADS-T and subscales was modest. However, removal of misfitting items had little impact on screening, demonstrating that items could potentially be omitted, if required. The item range covered a narrow spectrum of psychological distress, predominantly higher levels of distress. Additional items have to be added if screening for moderate to mild distress is to be improved for cancer patients. Copyright (c) 2005 John Wiley & Sons, Ltd.

Purpose: To develop and preliminarily evaluate a Social Difficulties Inventory (SDI) for use in oncology practice. Methods: Item generation from patients (n=96), staff (n=49) and the literature. Questions constructed and pre-tested (n=42) resulting in a 22-item questionnaire. Psychometric evaluation (n=271) assessed frequency of endorsement, factor structure, summated scales and construct validity followed by randomisation to criterion validity or test-retest arms. Results: Items met preset frequency of endorsement criteria. Factor analysis revealed a four-factor structure, three clearly definable, (1) Physical ability, (2) Providing for the family and (3) Contact with others, explaining 45.8% variance. Summated scales developed from these demonstrated good reliability (Cronbach’s alpha > 0.7) and were used to test and confirmed construct validity. Several comparators from the Life Events and Difficulties Schedule (LEDS) and CAncer Rehabilitation Evaluation System Short Form (CARES-SF) tested criterion validity and majority agreements were moderate to good. Test–retest reliability was good with most kappa values > 0.6. One item was eliminated resulting in a 21-item questionnaire. Conclusion: The SDI is relevant and easy to understand. Initial psychometric evaluation was encouraging. Ongoing work to evaluate the clinical meaning and utility of the instrument and to examine the relationships between SDI scores and clinical outcomes will provide guidance about its usefulness as an assessment tool in routine oncology practice.

8104 Background Psychological distress (PsyD) is common in cancer patients (CP). Self-report screening instruments are disappointing in detecting CP needing specialist intervention for PsyD, and CP with increased PsyD below psychiatric disorder, needing support within cancer care. Items assessing PsyD may fit on a single scale, so we may reduce the number of items CP must answer and tailor questions to CP own level of PsyD. We aim to apply Rasch analyses to instruments measuring PsyD, to develop a bank of items, and to evaluate how these items fit a unidimensional scale across the range of severity of PsyD (in logits). Methods A Rasch common-item equating analysis was applied to our database. The Beck Depression Inventory, General Health Questionnaire, Mental Health Inventory, State-Trait Anxiety Inventory, FACT Emotional Well-being scale, Patient Health Questionnaire, Hospital Anxiety and Depression Scale, and EORTC QLQ-C30 Emotional Functioning scale were analysed separately. Items that misfit the single scale (infit mean square >1.4) were removed. Then items from each instrument were added with common items as anchor points. Results A sample of 4923 CP provided an initial bank of 83 items. When 18 items were removed due to misfit, 65 items had infit and outfit mean square <1.4. No factor structure was evident in the residuals on principal components analysis, confirming a good unidimensional structure. Internal reliability was high (person separation index 0.85). Item locations ranged from -5 to +3 logits. Therefore many items assessed high levels of PsyD. Person abilities ranged from -5 to +1. Many CP reported low levels of PsyD. Limited overlap between item and person locations indicates a need to develop further items. Conclusions In a large sample of CP we have applied a Rasch model to items from widely used previously validated self-report PsyD questionnaires. Many items fit a single continuum of PsyD. Additional items may improve the item bank, leading in future to a fixed questionnaire and computer adaptive testing to measure PsyD in CP on a single continuum, using fewer items, tailored to the patient. No significant financial relationships to disclose.

PURPOSESystematic quality-of-life (QOL) assessment may have value in oncology practice by increasing awareness of a wide range of issues, possibly increasing detection of psychologic morbidity, social problems, and changes in physical status, and improving care and its outcomes. However, logistic problems are substantial. Automated systems solve many of these problems. We field-tested the feasibility and compliance that can be achieved using a computer touchscreen system in two consecutive studies.PATIENTS AND METHODSIn study 1, a prospective cohort of 272 patients was offered QOL assessment at each clinic appointment for 6 months. In study 2, all patients (N = 1,291) were offered QOL assessment as part of clinic routine during a 12-week period.RESULTSIn study 1, 82% of patients agreed to take part, but over time, compliance was poor (median, 40%; mean, 43%) and deteriorated with longer follow-up. In study 2, the overall compliance was greatly increased (median, 100%; mean, 70%), and compliance was retained over multiple visits. In study 1, compliance was better in younger patients, males, and socially advantaged patients, but was not affected by the presence of depression or anxiety, or QOL. In the second study, building on experience in the first study, data collection and storage in the computer system was excellent, achieving 98% of collected data stored in one center. In general, patients were comfortable with the computers and the approach. Data collection on the wards was more difficult and less complete than in clinics, especially for patients undergoing acute admissions.CONCLUSIONFeasibility with higher compliance was demonstrated in study 2, in which the data collection was integrated into routine care, and can be improved with further technical initiatives and education of staff.

Health-related quality of life (QL) is a recognised and important patient-related outcome of anti-cancer treatment, which can be measured by carefully developed, psychometrically robust, questionnaires. Although the validity and sensitivity of the cancer QL questionnaires is now widely accepted and they are frequently used in therapeutic clinical trials, they have yet to impact fully on patients’ care and are little used by practising oncologists. Several barriers have hampered the practical use of QL measures for individual patients, including the logistic barrier of collection and analysis of large amounts of data, the conceptual barrier of determining the clinical meaning of QL scores, the theoretical concerns over whether instruments developed for group comparisons can be used for individual patients, and the lack of research data on the possible benefits for individual patients. Thus, whilst oncology professionals are broadly convinced of the value of the concept and measurement of QL and its utilisation in clinical trials is increasing, its impact on routine clinical practice remains small.

The Hospital Anxiety and Depression Scale (HADS) is widely used as a tool for assessing psychological distress in patients and non-clinical groups. Previous studies have demonstrated conflicting results regarding the factor structure of the questionnaire for different groups of patients, and the general population. This study investigated the factor structure of the HADS in a large heterogeneous cancer population of 1474 patients. It also sought to investigate emerging evidence that the HADS conforms to the tripartite model of anxiety and depression (Clark & Watson, 1993), and to test the proposal that detection rates for clinical cases of anxiety and depression could be enhanced by partialling out the effects of higher order factors from the HADS (Dunbar et al., 2000). The results demonstrated a two-factor structure corresponding to the Anxiety and Depression subscales of the questionnaire. The factor structure remained stable for different subgroups of the sample, for males and females, as well as for different age groups, and a subgroup of metastatic cancer patients. The two factors were highly correlated (r =.52) and subsequent secondary factor analyses demonstrated a single higher order factor corresponding to psychological distress or negative affectivity. We concluded that the HADS comprises two factors corresponding to anhedonia and autonomic anxiety, which share a common variance with a primary factor namely psychological distress, and that the subscales of the HADS, rather than the residual scores (e.g. Dunbar et al., 2000) were more effective at detecting clinical cases of anxiety and depression.

A study was undertaken to describe, evaluate and categorise the social problems experienced by cancer patients. Ninety-six adult cancer patients at all stages of disease participated in either a telephone focus group discussion, a face to face focus group or an individual interview which were tape recorded and transcribed. Six experts analysed the transcripts. A total of 32 social problems were identified categorized under eight headings plus four single items. The categories were: problems with (1) managing in the home, (2) health and welfare services, (3) finances, (4) employment, (5) legal matters, (6) relationships, (7) sexuality and body image and (8) recreation. Problems with relationships and communication were the most frequently reported with financial, employment, body image and domestic problems also being widely endorsed. Female groups, younger patient groups and groups where the aim of treatment was palliative reported more social problems than other groups. Social problems are common and important to cancer patients. The social problems identified in this study will contribute to an item pool generated for developing a Social Problems Inventory that may be included in patient centred assessment as part of routine oncology practice.

Diagnosis of and treatment for cancer may not only create physical and emotional difficulties for patients but may also have an impact on social aspects of patients' lives. Screening for social problems has not become part of routine oncology practice. This may be due to lack of a suitable questionnaire. This paper presents a psychometric analysis of the Problems Checklist with a view to assessing its usefulness as a screening tool for social problems in oncology. Evaluation was undertaken using data from an earlier study of 505 patients who completed the checklist. Frequency of endorsement, missing values, factor analysis and reliability and validity analysis of the summated scales were carried out. Missing data rates ranged from 4 to 18% over the 16 items. Fourteen items were well endorsed. Factor analysis produced a four-factor structure with components labelled daily living, relationships, economics and emotions. Reliability and validity tests endorsed the factor structure with the components on economics and emotions being particularly credible. Difficulties with relationships are harder to measure and results from the analysis suggest that this is an area that warrants further investigation. The checklist is a useful tool for highlighting problems. As a tool for screening for social problems it has some limitations.

PURPOSE:To evaluate alternative automated methods of collecting data on quality of life (QOL) in cancer patients. After initial evaluation of a range of technologies, we compared computer touch-screen questionnaires with paper questionnaires scanned by optical reading systems in terms of patients' acceptance, data quality, and reliability.PATIENTS AND METHODS:In a randomized cross-over trial, 149 cancer patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, version 2.0 (EORTC QLQ-C30), and the Hospital Anxiety and Depression Scale (HADS) on paper and on a touch screen. In a further test-retest study, 81 patients completed the electronic version of the questionnaires twice, with a time interval of 3 hours between questionnaires.RESULTS:Fifty-two percent of the patients preferred the touch screen to paper; 24% had no preference. The quality of the data collected with the touch-screen system was good, with no missed responses. At the group level, the differences between scores obtained with the two modes of administration of the instruments were small, suggesting equivalence for most of the QOL scales, with the possible exception of the emotional, fatigue, and nausea/vomiting scales and the appetite item, where patients tended to give more positive responses on the touch screen. At the individual patient level, the agreement was good, with a kappa coefficient from 0.57 to 0.77 and percent global agreement from 61% to 97%. The electronic questionnaire had good test-retest reliability, with correlation coefficients between the two administrations from 0.78 to 0.95, kappa coefficients of agreement from 0.55 to 0.90, and percent global agreement from 56% to 100%.CONCLUSION:Computer touch-screen QOL questionnaires were well accepted by cancer patients, with good data quality and reliability.