Screening for Psychological Distress in Palliative Care: Performance of Touch Screen Questionnaires Compared with Semistructured Psychiatric Interview

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1 Vol. 38 No. 4 October 2009 Journal of Pain and Symptom Management 597 Original Article Screening for Psychological Distress in Palliative Care: Performance of Touch Screen Questionnaires Compared with Semistructured Psychiatric Interview Parvez Thekkumpurath, MRCPsych, Chitra Venkateswaran, MD, Manoj Kumar, MRCPsych, MD, Alex Newsham, MA, and Michael I. Bennett, MD, FRCP Psychological Medicine Research (P.T.), Edinburgh Cancer Research Centre, Edinburgh, United Kingdom; Amrita Institute of Medical Sciences and Research Centre (C.V.), Kerala, India; Leeds Partnerships Foundation NHS Trust (M.K.), Leeds, United Kingdom; Leeds Psychosocial Oncology and Clinical Practice Research Group (A.N.), Leeds Institute of Molecular Medicine, St. James University Hospital, Leeds, United Kingdom; and International Observatory on End of Life Care (M.I.B.), Institute for Health Research, Lancaster University, Lancaster, United Kingdom Abstract This study examined the criterion validity of computer-based screening tools (Distress Thermometer [DT], Brief Symptom Inventory-18 [BSI-18], and General Health Questionnaire-12 [GHQ-12]) in detecting any form of psychological distress in palliative care patients, compared with a semistructured psychiatric interview, Schedules for Clinical Assessment in Neuropsychiatry (SCAN). Patients aged 18 years or older referred to specialist palliative care services in Leeds completed the computer-based screening tools before SCAN interview by psychiatrists who were blind to screening results. SCAN interviews generated International Classification of Diseases, Tenth Revision (ICD-10) psychiatric diagnoses. Receiver operating characteristic (ROC) analysis compared the performance of screening tools with SCAN interview in identifying cases of distress. Sensitivity, specificity, positive and negative predictive values, and area under the curve (AUC) were calculated. Of the 226 eligible patients during the study period, 174 consented and 150 completed the study. Fiftyone (34%) patients satisfied ICD-10 criteria for a psychiatric diagnosis, adjustment disorder being the most common one (22%). On ROC analysis, DT, BSI-18, and GHQ-12 showed an AUC of 0.729, 0.729, and 0.755, respectively. At optimum cutoff values, sensitivity and specificity were 0.77 and 0.59 for DT, 0.78 and 0.62 for BSI-18, and 0.77 and 0.61 for GHQ-12, respectively. These data indicate that more than one-third of palliative care patients experience psychological distress. The three touch screen-based screening tools The study was funded by competitive grant support from the Rosemary Fellowship Trust, Leeds, and is endorsed by the UK Clinical Research Network (UKCRN ID: 2816). Dr. Chitra Venkateswaran s work was supported by a UICC American Cancer Society Beginning Investigators Fellowship (2006) funded by the American Cancer Society. The authors have no potential conflicts of interest. Ó 2009 U.S. Cancer Pain Relief Committee Published by Elsevier Inc. All rights reserved. Address correspondence to: Parvez Thekkumpurath, MRCPsych, Psychological Medicine Research, Edinburgh Cancer Research Centre, Western General Hospital, Crewe Road South, Edinburgh EH4 2XR, United Kingdom. Parvez.Thekkumpurath@ ed.ac.uk Accepted for publication: February 19, /09/$esee front matter doi: /j.jpainsymman

2 598 Thekkumpurath et al. Vol. 38 No. 4 October 2009 performed equally well in identifying distress compared with a psychiatric interview. The single-item DT is as good as longer screening tools, with an optimum cutoff of 5 in this population. Depressive disorders may be rarer in this population than commonly thought, in comparison to adjustment disorders. J Pain Symptom Manage 2009;38:597e605. Ó 2009 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. Key Words Sensitivity and specificity, diagnosis, screening, distress, depression, adjustment disorders, anxiety, palliative care, terminal care, cancer Introduction The term distress has emerged as a working concept based on expert consensus to refer to emotional or psychological problems in patients with cancer. The U.S. National Comprehensive Cancer Network (NCCN) defines distress as: A multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms and its treatment. Distress extends along a continuum, ranging from common normal feelings of vulnerability, sadness, and fears to problems that can become disabling, such as depressions, anxiety, panic, social isolation, and existential and spiritual crisis. 1 This unitary concept of distress is very attractive in its simplicity, pragmatism, and appeal to all. In a cancer context, emotional distress can be conceptualized as referring to anxiety, depression, and adjustment disorders related to the cancer experience. 2 Rates of distress in cancer are measured either as self-reports, with cutoff scores signifying clinically significant distress, or as combined rates of psychological disorders, mainly anxiety, depression, and adjustment disorders, measured by psychiatric diagnostic interviews. Prevalence of distress reported as such in palliative care varies between 7% and 60% depending on the stage and type of the disease, study design, and measures used, with most studies suggesting that around one-third of patients experience clinically significant distress. 3e5 Estimates of specific diagnostic categories, such as depression, range from 6.7% 6 to 30%. 7 Specific rates of anxiety in advanced cancer reported from structured interviews are up to 13.9%. 4 Very few studies look specifically for adjustment disorder, although one study reported the prevalence of adjustment disorders to be 15.8%. 6 The most consistent rates are derived from structured or semistructured interviews that use operationalized diagnostic criteria, such as the International Classification of Diseases, Tenth Revision (ICD-10) 8 or the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV). 9 Higher rates of depression are seen in patients with advanced and metastatic disease and in patients with a poor prognosis. 10 At least 10%e15% of these patients warrant specialist psychological or psychiatric help. 11 Commonly, however, distress in these settings is not routinely identified, leading to significant burden to the individual and with potential impact on management of symptoms, such as pain. 3,12 Screening for distress is now recommended as an integral and primary step of psychosocial care in patients with advanced cancer. 11 Once identified, psychological distress in terminally ill patients is amenable to treatment through good psychological support and medications. Even patients with a life expectancy of only four to six weeks benefit from the use of appropriate intervention. 13 Numerous screening tools varying in length and complexity are available, but establishing the validity of a screening tool in a specific patient population is vital before it can be recommended for routine use. Although many studies have examined the validity of screening tools in patients with early-stage disease, research and, therefore, clinical guidance is lacking for patients with advanced disease. A recent review summarized the evidence in this area but concluded that there is a lack of

3 Vol. 38 No. 4 October 2009 Validity of Distress Screening Tools in Palliative Care 599 good quality evidence from methodologically sound studies to guide clinical practice. 14 The Expert Working Committee on Palliative Care recommends a psychiatric interview using operationalized diagnostic criteria, such as DSM-IV or ICD-10, as a gold standard for identifying distress. 15 It follows that criterion validity of screening tools must be based on such gold standard psychiatric interview rather than comparison with other tools if highquality evidence is to be generated. We conceptualized distress as any form of psychological disorder in advanced cancer as a meaningful clinical construct in evaluating measures of distress. This was measured as the presence of any ICD-10 psychiatric diagnosis in the last four weeks on a semistructured interview, the Schedules for Clinical Assessment in Neuropsychiatry (SCAN). The purpose of the study was to test the efficacy of three screening questionnaires in detecting all forms of psychological disorders (conceptualized as distress) in palliative care patients, most of whom had advanced cancer. This work was conceived as the first phase in a project to develop and test a care pathway for managing psychological distress in this population. Methods The study was approved by the Leeds East Research Ethics Committee, and all patients provided written informed consent. Patients Consecutive patients older than 18 years, who had advanced disease and were referred for inpatient care or outpatient support at two specialist palliative care units in Leeds, United Kingdom, were eligible for inclusion. Patients were excluded if they were not able to complete patient assessments and did not have mental capacity as judged by their physician according to British Medical Association guidance. 16 Data Collection Eligible consenting patients underwent cognitive assessment, completion of distress screening tools, and then psychiatric interview by one of the two researchers within 72 hours of participation. The cognitive assessment and distress screening tools were completed in one sitting. After this, patients were given the option to complete the psychiatric interview immediately or at another time within 72 hours. Most patients completed all sections within 24 hours. Basic demographic information on age, gender, and ethnicity were obtained on a predesigned data collection form. Details of diagnosis, performance status (Eastern Cooperative Oncology Group), 17 past history, and treatment of mental health problems also were collected. At the end of the study, date of death was recorded for patients who had died. All study measures were adapted onto a touch screen laptop computer. The researcher explained the study process and set up the laptops for the patients to use. Although the researcher was at the patient s side for any clarifications and help, he or she was blind to the patient s responses. Information on time taken to complete each questionnaire and the number of explanations required was collected. Study Measures Patients initially completed a cognitive screening consisting of the Mini-Mental State Examination (MMSE) 18 and confusion assessment method (CAM). 19 MMSE is a well-researched and established screening questionnaire for cognitive decline. CAM is widely used as a brief screening questionnaire for delirium; it reflects DSM-1Vand ICD-10 diagnostic guidelines for delirium. Although a cutoff score of 24 on the MMSE is recommended for probable cognitive impairment, for the purpose of this study, mental capacity before and after study entry was based on clinician s judgment and not on MMSE or CAM score. Low scores on cognitive assessment helped to identify people with cognitive impairment and prompted reassessment of mental capacity. After cognitive screening, patients completed the three distress screening tools, which appeared in random order on the computer touch screen to reduce order effect. The computer touch screens developed by the Leeds Psychosocial Oncology and Clinical Practice Research Group were used in the study. Computer touch screen questionnaires are acceptable and easy to use in the cancer population, ensure good data quality, and

4 600 Thekkumpurath et al. Vol. 38 No. 4 October 2009 have shown to be valid for identifying clinically significant levels of distress in routine oncology practice. 20 The three questionnaires were adapted onto the touch screen portable laptops, which could be used at the bedside. Each questionnaire started with a set of simple instructions, and then individual items appeared on a single screen, with response buttons displayed in large font for easy readability (Fig. 1). Subsequent items appeared once a response was made, making it easy for patients to focus on one item at a time. Brief and ultra-short questionnaires are now widely used in cancer settings. 21 The three screening tools examined in the study, the Distress Thermometer (DT), 22 the Brief Symptom Inventory-18 (BSI-18), 23 and the General Health Questionnaire-12 (GHQ-12), 24 were selected after a literature review. Selection criteria included focus on psychological distress rather than single diagnostic category, such as depression; few or no somatic items; acceptance and ease of use for clinicians and patients; and reported use in a palliative care population. The DT is an 11-point visual analog scale measuring distress, where 0 ¼ no distress at all and 10 ¼ extreme distress, in the previous one-week period. DT as a screening tool is integral to the NCCN s distress management guidelines. 1 The BSI-18 is a multidimensional questionnaire with 18 items, developed specifically for use in a cancer population. The BSI- Fig. 1. Snapshot of Item 3 of GHQ-12 screening questionnaire on the touch screen. 18 items are divided into three dimensions of depression, anxiety, and somatoform, and the total score represents a global severity index. For each item, patients score on a 0e4 Likert scale. The total BSI score is used as a marker of global distress. The GHQ-12 is used in the general population to screen for general psychological morbidity and capture the construct of distress. Each item is scored on a scale of increasing severity (0e4). Schedules for Clinical Assessment in Neuropsychiatry The SCAN interviews were developed by the World Health Organization and have been used in a wide variety of settings with established reliability. 25 SCAN interviews follow a semistructured format to generate psychiatric diagnoses based on operationalized diagnostic criteria, such as ICD-10 and DSM-1V. ICD-10 criteria were used for this study, and we defined the presence of one or more psychiatric diagnoses in the last four weeks, based on SCAN interview, as the criterion definition of distress. Both researchers were trained in SCAN at an accredited training center (Department of Psychiatry, University of Leicester, United Kingdom). To ensure interrater reliability between the two researchers, 10% of the interviews were directly observed and rated by an expert third party (M. K.). Patients identified as having a psychiatric diagnosis after interview were reported to the clinical team (with the patient s permission), and the protocol for managing distress in the unit followed. Statistical Analysis The demographic and clinical parameters of patients who completed the study were compared with those of patients who did not. Chi-squared test was used to compare categorical data, and independent t-test was used for continuous data. The primary outcome measure was the validity of screening tools in detecting psychological distress compared with psychiatric interview. We compared total scores on each of the three tools against presence of psychological distress in a SCAN interview, using receiver operating characteristics (ROC) analysis. 26 The ROC analysis is a graphic display of sensitivity ( y-axis) over 1 specificity (x-axis) for

5 Vol. 38 No. 4 October 2009 Validity of Distress Screening Tools in Palliative Care 601 each cutoff point on the tools being assessed. The area under the curve (AUC) indicates the discriminant ability of the tool. An AUC of 0.5 indicates no discriminant ability over chance and an AUC of 1 indicates a perfect screening test correctly identifying all cases and noncases as set by the criterion. Sensitivity, specificity, positive and negative predictive values (for each cutoff point, and the AUC are reported. Predictive values are good indicators of clinical usefulness of screening tools in a given population with known prevalence. Positive predictive value indicates the proportion of positively screened people who will have the condition in question. Negative predictive value, in contrast, will indicate the proportion of screen-negative people who will actually be free of the condition. A logistic regression examined any association between the predictor variables and the outcome of distress. A Kaplan-Meier survival analysis was performed to estimate median survival of participants after completion of questionnaires. All statistical analyses were performed with SPSS v14.0 for Windows (SPSS, Chicago, IL, USA). Results Patients were recruited between September 2006 and July During this period, 226 patients were considered eligible to take part and were approached; 174 consented and 150 completed all the rating instruments and the SCAN interview. Twenty-four patients did not complete the study (either dropped out or withdrawn) after consenting, at various stages of the study. The reasons for dropout are listed in Fig. 2. Three patients were withdrawn after the cognitive screening because of lack of mental capacity. All dropouts or withdrawals happened at various stages between consenting and before SCAN interview. Nine dropped out after giving consent and seven dropped out during completion of screening questionnaires. Eight patients Total patients referred for specialist palliative care during the study 723 Excluded: 497 Eligible patients, as identified by clinical team 226 Consented Opted out: All patient assessments completed Total drop outs and withdrawn: 24 Too ill: 14/24 Too drowsy: 4/24 Lacks capacity: 3/24 Physical disability: 2/24 No reason given: 1/ Fig. 2. Flowchart of patient recruitment and progress through the study.

6 602 Thekkumpurath et al. Vol. 38 No. 4 October 2009 dropped out after completion of screening and before the SCAN interview. These were mostly patients who had become ill before the scheduled SCAN interview the next day. Anonymized basic demographic data on age, gender, primary cancer diagnosis, and hospitalization status were available for noncompleters (patients who were eligible but opted out or dropped out and did not complete the study), allowing a comparison of these with completers. There was no significant age (t ¼ 0.931, degrees of freedom [df] ¼ 224, P ¼ 0.35) or gender (c 2 ¼ 0.235, df ¼ 1, P ¼ 0.67) difference, but more patients from the inpatient unit did not complete the study (either opted out or dropped out) compared with those from the outpatient center (c 2 ¼ 6.925, P ¼ 0.01, df ¼ 1). The characteristics of the sample are summarized in Table 1. The sample had an even representation between inpatient (73 [48%]) and outpatient (77 [52%]) centers. Forty-three (28.7%) patients reported a history of past psychiatric treatment, defined as answering yes to the question Have you ever been treated for nervous or emotional problems such as anxiety or depression in the past at any time? Survival analysis performed at the end of the study, when 50% (75) of the study population had died, showed a median survival of 45 days after the interview (standard error: 11, 95% confidence interval [CI]: 23, 67). Cognitive Screening The mean (standard deviation [SD]) MMSE score was 27 (2.8). Sixteen patients scored less than 24 on the MMSE scale but were judged to have clinical capacity and completed the study. Of these, three had a psychiatric diagnosis on SCAN interview (2 ¼ adjustment disorder, and 1 ¼ cognitive impairment). Only one person was diagnosed as having delirium by applying the CAM diagnostic algorithm for delirium. Prevalence of Psychological Distress Fifty-one (34%) of the 150 patients who completed SCAN satisfied ICD-10 criteria for a psychiatric diagnosis. The distribution of psychiatric diagnoses is shown in Table 2. Fifteen (10%) interviews were directly observed and rated by the expert (M. K.). Of these, eight were by Researcher 1 (C. V.) and seven by Researcher 2 (P. T.). The agreement Table 1 Demographic Details of the Sample (n ¼ 150) Characteristics n Mean age in years (SD) 70 (12) Gender Male 64 (43%) Female 86 (57%) Primary cancer site Gastrointestinal 45 Lung 31 Genitourinary 30 Breast 13 Hematological 8 Head and neck 4 Skin and soft tissue 4 Primary unknown 11 Nonmalignant illness 4 Inpatient 73 (48%) Outpatient 77 (52%) ECOG Performance Status Ambulatory and managing self-care, 0e2 80 (53%) Nonambulatory, limited self-care, 3e4 69 (46%) Past psychiatric history Present 43 Absent 107 ECOG ¼ Eastern Cooperative Oncology Group. on presence and type of psychiatric diagnosis was 100% between the expert and the researchers. Younger age (B ¼ 0.037, df ¼ 1, P ¼ 0.04) and a history of psychiatric treatment (B ¼ 1.384, df ¼ 1, P ¼ 0.01) were significant independent variables associated with any form of psychological distress. No other variables were associated with the presence of psychological distress. Performance of Screening Questionnaires Most patients completed all three screening questionnaires in less than 10 minutes, with Table 2 ICD-10 Psychiatric Diagnosis From SCAN Interview (n ¼ 150) Diagnosis n (%) Adjustment disorder 33 (22) Depressive disorders 11 (7.3) Mild 5 Moderate 5 Severe 1 Anxiety disorders 4 (2.7) Generalized anxiety disorder 2 Panic disorder 1 Agoraphobia 1 Nonorganic psychotic disorder 1 (0.67) Alcohol dependence syndrome 1 (0.67) Dementia, unspecified type 1 (0.67)

7 Vol. 38 No. 4 October 2009 Validity of Distress Screening Tools in Palliative Care 603 a median (range) time of 1 (1e5), 3 (2e11), and 3 (1e8) minutes to complete DT, BSI-18, and GHQ-12, respectively. The mean (SD) scores were 4.46 (3.14) on the DT, (9.41) on the BSI-18, and 5.26 (4.02) on the GHQ-12. The ROC curve (Fig. 3) compares the performance of all three screening questionnaires in identifying any form of psychiatric diagnosis in the last four weeks, generated by the SCAN interview. Comparison of AUC values for each of the questionnaires showed values of (95% CI: 0.643, 0.815) for DT, (95% CI: 0.641, 0.816) for BSI-18, and (95% CI: 0.676, 0.833) for GHQ-12. An AUC of around 0.75 for all three questionnaires shows clear discriminant value as screening tools. Sensitivity, specificity, and positive and negative predictive values for various cutoff scores were calculated from ROC analysis. These values at three potential cutoff scores for each questionnaire are presented in Table 3 along with the AUC for each questionnaire. Discussion In a palliative care population, we found that adjustment disorder was the most prevalent diagnosis of psychological distress and that the performance of the three screening tools was very similar in identifying distress. The DT, with a cutoff score of 5, was as good as the more detailed screening tools. Computerized, short screening questionnaires were acceptable and easily completed in this frail population. The three questionnaires performed almost equally in this setting, with sensitivities between 75% and 80% and specificities of around 60%. At the optimum cutoff, all three questionnaires Sensitivity ROC Curve 0.4 Source of the Curve Distress Thermometer BSI-18 GHQ-12 Reference Line show positive predictive values of around 50% and negative predictive values of above 85%. This would mean that only 50 of 100 patients scoring above the cutoff on a screening questionnaire will have a diagnosable psychological condition. However, these rates are comparable to the performance of screening questionnaires in this context. 6,7 This is an important issue to consider for clinicians using screening questionnaires. Essentially, screening questionnaires are better at excluding distress rather than identifying its presence. Choice of an ideal cutoff is based on a trade-off between sensitivity and specificity and is essentially a clinical question rather than a statistical one. The clinical context in which the questionnaire is used, the purpose Specificity Diagonal segments are produced by ties. Fig. 3. ROC analysis of performance of DT, BSI-18, and GHQ-12 against any psychiatric diagnosis from the SCAN interview. 1.0 Table 3 Sensitivity, Specificity, PPVs, and NPVs for Individual Questionnaires at Various Cutoffs Questionnaire AUC (95% CI) Cutoff Sensitivity Specificity PPV NPV DT (0.643e0.815) $ $ $ BSI (0.641e0.816) $ $ $ GHQ (0.676e0.833) $ $ $ NPV ¼ negative predictive value; PPV ¼ positive predictive value. Optimum cutoffs are given in boldface.

8 604 Thekkumpurath et al. Vol. 38 No. 4 October 2009 of screening, and available resources to manage identified distress inform this choice. Lower cutoff scores result in greater sensitivity but lower specificity, leading to higher rate of false positives. We chose an optimum cutoff based on achieving maximum sensitivity, with a reasonable specificity of around 60% for clinical use. Significant strengths of this study include the large sample size of patients who were recruited at the end of life, the use of SCAN interview as a gold standard comparator rather than other screening tools, and the novel use of computer touch screen technology in this setting. Although the study was conducted in a population that was very limited functionally (43% was capable of limited self-care or confined to bed most of the time), the completion rate and relatively quick completion times suggest a high degree of acceptability of the touch screen questionnaire format in patients at the end of life. In this setting, we expected and found that a large proportion of patients did not meet eligibility criteria, and this may limit the ability to generalize our findings. A significant proportion of referrals to specialist palliative care inpatient units is for terminal care, and this is reflected in the 497 (68%) patients who were ineligible for study participation. We also observed that around a quarter of eligible patients chose not to take part, and an additional 15% withdrew, mostly because of failing health. However, as the main aim was to examine the criterion validity of questionnaires and not the prevalence of distress, we believe our findings are representative of this population. We attempted to minimize bias by randomly ordering the questionnaires, by ensuring that researchers conducting SCAN interviews were blind to the questionnaire responses, and by conducting checks of interrater reliability. However, we cannot exclude the effects on researchers, of observing patients responding to the questionnaires, and we did not randomly order the sequence of interview and questionnaires. The prevalence of psychological problems in this population is within reported ranges. 27 However, adjustment disorder (22%) and not depression (7.3%) emerges as the most common form of distress. This questions the validity of high rates of depression often quoted in this population, which is often based on self-report questionnaires. A recent study by Akechi et al. reports similar rates of adjustment disorder (16%) and depression (7%). 6 The same study reports similar findings on screening questionnaires, with positive predictive values of around 50% and high negative predictive values. However, the study was in a different culture (Japan) and did not use touch screen-based questionnaires, limiting further comparability. Many studies of psychological morbidity in palliative care have not looked specifically for adjustment disorder and might have included those cases under another diagnosis, such as depression. The concepts of depression and adjustment disorders are fundamentally different if the original psychiatric roots are traced. The more severe forms of clinical depression or major depression have been traditionally seen to be more biological entities, with specific symptom constellations, usually long-term course and variable prognosis. Adjustment disorders, however, are conceptualized as reactions to stress, with no specific symptom pattern, lasting for short periods and having a better prognosis. Our findings suggest that the DT, a singleitem visual analog scale, which can be easily completed and interpreted, performs equally well as the GHQ-12 or BSI-18, both of which are lengthier and require some expertise to interpret. This is especially relevant in a population that is very ill and close to death. There is evidence that this may be true across languages and cultures. 6 It is interesting to speculate whether a ceiling effect operates in relation to the performance of screening questionnaires. Despite variation in number and breadth of items, no questionnaire exceeded AUC value of around Based on this, we would recommend the DT as a quick and efficient method of screening for psychological distress in this population. Future research should focus on integration of psychological screening into routine palliative care clinical practice and development of care pathways based on this. Acknowledgments The authors gratefully acknowledge the assistance of Professor Galina Velikova, Dr. Penny Wright, and Dr. Adam Smith of the Psychosocial and Clinical Practice Research

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