Dr Ben Britton

A range of anxiety measures is used in oncology but their comparability is unknown. We examined variations in measurement across three commonly used instruments: Hospital Anxiety and Depression-Anxiety subscale (HADS-A); Depression, Anxiety, Stress Scale - Anxiety subscale (DASS-A); and Generalised Anxiety Disorder scale (GAD-7). Participants (n = 164) completed the self-report measures and the Generalised Anxiety Disorder module of the Structured Clinical Interview for DSM-IV (SCID). We performed Rasch analysis and calculated diagnostic accuracy statistics. Instruments measured similar constructs of anxiety, but had different ranges of measurement, with the HADS-A including lower severity symptoms than the other two measures. Anxiety severity was similar for GAD-7 ¿mild¿ and HADS-A ¿possible¿ categories, but ¿mild¿ anxiety on the DASS-A represented more severe symptoms. Conversely, DASS-A ¿severe¿ anxiety represented less intense symptoms than GAD-7 ¿severe¿ anxiety. Co-calibration indicated a score of eight on the HADS-A was equivalent in anxiety severity to scores of three on the DASS-A and six on the GAD-7. Area under the curve (AUC) was just acceptable for HADS-A and GAD-7 but not DASS-A. The HADS-A, DASS-A and GAD-7 displayed important differences in how they measured anxiety. In particular, categorical classifications of anxiety severity (mild/moderate/severe) were not equivalent across instruments. Thus, prevalence estimates of anxiety symptoms will vary as a consequence of the instrument used. The GAD-7 and HADS-A obtained more similar results and better AUC than the DASS-A. Our co-calibration could be used in future studies and meta-analyses of individual participant data to set cut-off points that provide more consistent classification of anxiety severity.

Background: Detecting anxiety in oncology patients is important, requiring valid yet brief measures. One increasingly popular approach is the Patient Reported Outcomes Measurement Information System (PROMIS); however, its validity is not well established in oncology. We assessed the convergent and criterion validity of PROMIS anxiety measures in an oncology sample. Methods: 132 oncology/haematology outpatients completed the PROMIS Anxiety Computer Adaptive Test (PROMIS-A-CAT) and the 7 item (original) PROMIS Anxiety Short Form (PROMIS-A-SF) along with six well-established measures: Hospital Anxiety and Depression Scale-Anxiety (HADS-A); Generalised Anxiety Disorder-7 (GAD-7); Depression, Anxiety and Stress Scale-Anxiety (DASS-A) and Stress (DASS-S); Distress Thermometer (DT) and PSYCH-6. Correlations, area under the curve (AUC) and diagnostic accuracy statistics were calculated with Structured Clinical Interview as the reference standard. Results: Both PROMIS measures correlated with all legacy measures at p <.001 (Rho =.56¿.83). AUCs (>.80) were good for both PROMIS measures and comparable to or better than all legacy measures. At the recommended mild cut-point (55), PROMIS-A-SF had sensitivity (.67) comparable to or better than all the legacy measures, whereas PROMIS-A-CAT sensitivity (.59) was lower than GAD-7 (.67) and HADS-A (.62), but comparable to PSYCH-6 and higher than DASS-A, DASS-S and DT. Sensitivity for both was.79. A reduced cut-point of 51 on both PROMIS measures improved sensitivity (.83¿.84) although specificity was only adequate (.61¿.62). Conclusions: The convergent and criterion validity of the PROMIS anxiety measures in cancer populations was confirmed as equivalent, but not superior to, established measures (GAD-7 and HADS-A). The PROMIS-A-CAT did not demonstrate clear advantages over PROMIS-A-SF.

Background: Patients undergoing (chemo) radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC) are at high risk of malnutrition during and after treatment. Malnutrition can lead to poor tolerance to treatment, treatment interruptions, poor quality of life (QOL) and poten-tially reduced survival rate. Human papillomavirus (HPV) is now known as the major cause of OPSCC. However, research regarding its effect on nutritional outcomes is limited. The aim of this study was to examine the relationship between HPV status and nutritional outcomes, including malnutrition and weight loss during and after patients¿ (chemo) radiotherapy treatment for OPSCC. Methods: This was a longitudinal cohort study comparing the nutritional outcomes of HPV-posi-tive and negative OPSCC patients undergoing (chemo) radiotherapy. The primary outcome was nutritional status as measured using the Patient Generated-Subjective Global Assessment (PG-SGA). Secondary outcomes included loss of weight, depression, QOL and adverse events. Results: Although HPV-positive were less likely to be malnourished according to PG-SGA at the beginning of treatment, we found that the difference between malnutrition rates in response to treatment was not significantly different over the course of radiotherapy and 3 months post treatment. HPV-posi-tive participants had significantly higher odds of experiencing >10% weight loss at three months post-treatment than HPV-negative participants (OR = 49.68, 95% CI (2.7, 912.86) p = 0.01). Conclu-sions: The nutritional status of HPV positive and negative patients were both negatively affected by treatment and require similarly intense nutritional intervention. In acute recovery, HPV positive patients may require more intense intervention. At 3-months post treatment, both groups still showed nutritional symptoms that require nutritional intervention so ongoing nutritional support is essential.

Background: It is unknown how many distressed patients receive the additional supportive care recommended by Australian evidence-based distress management guidelines. The study identifies the (1) distress screening practices of Australian cancer services; (2) barriers to improving practices; and (3) implementation strategies which are acceptable to service representatives interested in improving screening practices. Method: Clinic leads from 220 cancer services were asked to nominate an individual involved in daily patient care to complete a cross-sectional survey on behalf of the service. Questions related to service characteristics; screening and management processes; and implementation barriers. Respondents indicated which implementation strategies were suitable for their health service. Results: A total of 122 representatives participated from 83 services (51%). The majority of respondents were specialist nurses or unit managers (60%). Approximately 38% of representatives¿ services never or rarely screen; 52% who screen do so for all patients; 55% use clinical interviewing only; and 34% follow referral protocols. The most common perceived barriers were resources to action screening results (74%); lack of time (67%); and lack of staff training (66%). Approximately 65% of representatives were interested in improving practices. Of the 8 implementation strategies, workshops (85%) and educational materials (69%) were commonly selected. Over half (59%) indicated a multicomponent implementation program was preferable. Conclusions: Although critical gaps across all guideline components were reported, there is a broad support for screening and willingness to improve. Potential improvements include additional services to manage problems identified by screening, more staff time for screening, additional staff training, and use of patient-report measures.

Aim: The routine use of prophylactic percutaneous endoscopic gastrostomy (PEG) tubes for nutrition support during radical chemoradiation for head and neck cancer has been suggested to result in PEG dependency. This research aimed to determine the rates of gastrostomy dependency at the Calvary Mater Newcastle (CMN) where PEGs are routinely used and to identify potentially modifiable risk factors. Methods: All patients with head and neck cancer planned for curative chemoradiation with a prophylactic PEG inserted were included in this review. Medical records of 250 patients treated between 2000 and 2015 were examined. Results: Overall, eight patients (3%) were unable to wean. At 12 months following treatment, 16 patients (6%) still required PEG tubes for feeding. A greater T extent (T4 or synchronous head and neck tumors) and number of days Nil By Mouth (NBM) remained as significant independent risk factors for PEG dependency at 12 months (Textent OR 6.96 P¿'.001; NBM OR 1.01 P¿=.004) and overall (Textent OR8.04 P¿=.02; NBM OR1.01 P¿=.001). Associations with NBM were investigated, which demonstrated that patients had less NBM days with intensity-modulated radiation therapy (IMRT) (ß-13.3, P¿=.007) and seeing a speech pathologist during treatment (ß-11.9, P¿=.026). More NBM days were associated with tumors with greater T extent (ß+22; P¿'.001). Conclusion: The routine use of prophylactic PEGs has not resulted in significant rates of PEG dependency at the CMN. Seeing a speech pathologist during treatment and IMRT may decrease time NBM, which was identified as a potentially modifiable risk factor for PEG dependency.

Background: A key challenge in behavioural medicine is developing interventions that can be delivered adequately (i.e., with fidelity) within real-world consultations. Accordingly, clinical trials should (but tend not to) report what is actually delivered (adherence), how well (competence) and the distinction between intervention and comparator conditions (differentiation). Purpose: To address this important clinical and research priority, we apply best practice guidelines to evaluate fidelity within a real-world, stepped-wedge evaluation of ¿EAT: Eating As Treatment¿, a new dietitian delivered health behaviour change intervention designed to reduce malnutrition in head and neck cancer (HNC) patients undergoing radiotherapy. Methods: Dietitians (n = 18) from five Australian hospitals delivered a period of routine care and following a randomly determined order each site received training and began delivering the EAT Intervention. A 20% random stratified sample of audio-recorded consultations (control n = 196; intervention n = 194) was coded by trained, independent, raters using a study specific checklist and the Behaviour Change Counselling Inventory. Intervention adherence and competence were examined relative to apriori benchmarks. Differentiation was examined by comparing control and intervention sessions (adherence, competence, non-specific factors, and dose), via multiple linear regression, logistic regression, or mixed-models. Results: Achievement of adherence benchmarks varied. The majority of sessions attained competence. Post-training consultations were clearly distinct from routine care regarding motivational and behavioural, but not generic, skills. Conclusions: Although what level of fidelity is ¿good enough¿ remains an important research question, findings support the real-world feasibility of integrating EAT into dietetic consultations with HNC patients and provide a foundation for interpreting treatment effects.

Objective Many patients who experience distress do not seek help, and little is known about the reasons for this. We explored the reasons for declining help among patients who had significant emotional distress. Methods Data were collected through QUICATOUCH screening at an Australian hospital. Oncology outpatients scoring 4 or more on the Distress Thermometer were asked if they would 'like help' with their distress. Those who declined help were asked their reasons. Demographic variables and a clinical measure of anxiety and depression (PSYCH-6) were used to identify factors associated with reasons for declining help. Results Of 311 patients with significant distress, 221 (71%) declined help. The most common reasons were 'I prefer to manage myself' (n = 99, 46%); 'already receiving help' (n = 52, 24%) and 'my distress is not severe enough' (n = 50, 23%). Younger patients and women were more likely to decline help and were more likely to already be receiving help. Distress score and PSYCH-6 scores were significantly lower among patients who rated their distress as not severe enough to require help. Nevertheless, there were patients who had maximal scores on distress and PSYCH in each group. Conclusions Two common patient barriers to help with distress are a preference for self-help and a belief that distress is not sufficiently severe to warrant intervention. These beliefs were held by a sizeable proportion of individuals who reported very high levels of distress. Qualitative research and subsequent interventions for overcoming these barriers are required to obtain the most benefit from distress screening programs.

Background: Active Surveillance (AS) is recommended for the treatment of localised prostate cancer; however this option may be under-used, at least in part because of expectations of psychological adverse events in those offered or accepting AS. Objective: (1) Determine the impact on psychological wellbeing when treated with AS (non-comparative studies). (2) Compare AS with active treatments for the impact on psychological wellbeing (comparative studies). Method: We used the PRISMA guidelines and searched Medline, PsychInfo, EMBASE, CINHAL, Web of Science, Cochrane Library and Scopus for articles published January 2000-2014. Eligible studies reported original quantitative data on any measures of psychological wellbeing. Results: We identified 34 eligible articles (. n=. 12,497 individuals); 24 observational, eight RCTs, and two other interventional studies. Studies came from North America (16), Europe (14) Australia (3) and North America/Europe (1). A minority (5/34) were rated as high quality. Most (26/34) used validated instruments, whilst a substantial minority (14/34) used watchful waiting or no active treatment rather than Active Surveillance. There was modest evidence of no adverse impact on psychological wellbeing associated with Active Surveillance; and no differences in psychological wellbeing compared to active treatments. Conclusion: Patients can be informed that Active Surveillance involves no greater threat to their psychological wellbeing as part of the informed consent process, and clinicians need not limit access to Active Surveillance based on an expectation of adverse impacts on psychological wellbeing.

Background: The use of different depression self-report scales warrants co-calibration studies to establish relationships between scores from 2 or more scales. The goal of this study was to examine variations in measurement across 5 commonly used scales to measure depression among patients with cancer: Hospital Anxiety and Depression Scale-Depression subscale (HADS-D), Centre for Epidemiologic Studies Depression Scale (CES-D), Patient Health Questionnaire-9 (PHQ-9), Beck Depression Inventory-II (BDI-II), and Depression Anxiety and Stress Scale-Depression subscale (DASS-D). Methods: The depression scales were completed by 162 patients with cancer. Participants were also assessed by the major depressive episode module of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition. Rasch analysis and receiver operating characteristic curves were performed. Results: Rasch analysis of the 5 scales indicated that these all measured depression. The HADS and BDI-II had the widest measurement range, whereas the DASS-D had the narrowest range. Co-calibration revealed that the cutoff scores across the scales were not equivalent. The mild cutoff score on the PHQ-9 was easier to meet than the mild cutoff score on the CES-D, BDI-II, and DASS-D. The HADS-D possible cutoff score was equivalent to cutoff scores for major to severe depression on the other scales. Optimal cutoff scores for clinical assessment of depression were in the mild to moderate depression range for most scales. Conclusions: The labels of depression associated with the different scales are not equivalent. Most markedly, the HADS-D possible case cutoff score represents a much higher level of depression than equivalent scores on other scales. Therefore, use of different scales will lead to different estimates of prevalence of depression when used in the same sample.

Background: The confidence with which researchers can comment on intervention efficacy relies on evaluation and consideration of intervention fidelity. Accordingly, there have been calls to increase the transparency with which fidelity methodology is reported. Despite this, consideration and/or reporting of fidelity methods remains poor. We seek to address this gap by describing the methodology for promoting and facilitating the evaluation of intervention fidelity in The EAT (Eating As Treatment) project: a multi-site stepped wedge randomised controlled trial of a dietitian delivered behaviour change counselling intervention to improve nutrition (primary outcome) in head and neck cancer patients undergoing radiotherapy. Methods/Design: In accordance with recommendations from the National Institutes of Health Behaviour Change Consortium Treatment Fidelity Workgroup, we sought to maximise fidelity in this stepped wedge randomised controlled trial via strategies implemented from study design through to provider training, intervention delivery and receipt. As the EAT intervention is designed to be incorporated into standard dietetic consultations, we also address unique challenges for translational research. Discussion: We offer a strong model for improving the quality of translational findings via real world application of National Institutes of Health Behaviour Change Consortium recommendations. Greater transparency in the reporting of behaviour change research is an important step in improving the progress and quality of behaviour change research. Trial registration number:ACTRN12613000320752(Date of registration 21 March 2013)