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00005650-200908000-0000700005650_2009_47_866_sikorskii_administration_8article< 110_0_9_5 >Medical Care© 2009 Lippincott Williams & Wilkins, Inc.Volume 47(8)August 2009pp 866-874Differential Symptom Reporting by Mode of Administration of the Assessment: Automated Voice Response System Versus a Live Telephone Interview[Original Article]Sikorskii, Alla PhD*; Given, Charles W. PhD†; Given, Barbara PhD, RN, FAAN‡; Jeon, Sangchoon MS§; You, Mei MS‡From the *Department of Statistics and Probability, College of Natural Science, Michigan State University, East Lansing, Michigan; †Department of Family Medicine, College of Human Medicine, Michigan State University, East Lansing, Michigan; ‡College of Nursing, Michigan State University, East Lansing, Michigan; and §School of Nursing, Yale University, New Haven, Connecticut.Supported by Grant R01 CA79280 from the National Cancer Institute and in affiliation with the Walther Cancer Institute, Indianapolis Indiana.Reprints: Charles W. Given, PhD, Department of Family Medicine, Michigan State University, College of Human Medicine, B108 Clinical Center, East Lansing, MI 48824. E-mail: Automated voice response (AVR) systems have been used to collect patient-reported outcome data. Mode of administration of the assessment may affect patient reporting.Objective: To evaluate if there is a differential reporting of symptoms by the mode of assessment: AVR versus a live telephone interview among cancer patients with solid tumors undergoing chemotherapy.Research Design: Randomized clinical trial comparing a nurse-assisted symptom management with an automated telephone symptom management. After completing intake telephone interview administered by a person, patients were randomized to either nurse arm or AVR arm to receive a 6-contact 8-week symptom management intervention. Patients in the nurse arm were called by specially trained nurses, and patients in the AVR arm were contacted via automated system to assess their symptoms and deliver symptom management strategies.Subjects: Two hundred patients in nurse arm, and 186 patients in the AVR arm completed the first intervention contact.Measures: Severities of 14 cancer-related symptoms were rated by patients at intake interview and at first intervention contact before the receipt of any interventions.Results: When compared with patients contacted by a nurse, patients contacted by the AVR reported higher severity of nausea and vomiting, diarrhea, poor appetite, constipation, diarrhea, pain, and alopecia controlling for prior intake symptom assessment that was free of mode effect. Symptom reporting varied by age, with the oldest group of patients reporting higher severity to the nurse.Conclusion: Mode effect needs to be considered in designing trials for symptom management and in symptom monitoring in clinical practice.Interactive or automated telephone voice response (AVR) systems have been used to help clinicians provide care to patients experiencing chronic conditions including cancer.1–5 These systems merge computer software to a prerecorded voice and an automated telephone system to collect data from patients, monitor their health status, or deliver intervention strategies for the management of chronic conditions.6–11 Patients are called at specified times and intervals, their responses are entered using the touchtone pad of a telephone, and recorded. Patient evaluations indicate that automated systems have high usability and acceptability, and are more accurate than in-person interviews in obtaining sensitive information.12,13 The AVR systems seem equal to clinical interviews in obtaining data to make psychiatric diagnoses,14 in promoting diabetic self-care management skills,6,15 and in delivering pain coping strategies.7 This research compares cancer patients’ reports of symptoms using AVR systems with live telephone reports to nurses. Specifically, this research seeks to determine if there is an effect of the mode of symptom assessment, that is, if patients report the severity of their symptoms differently to the automated system versus to a person. Given the same underlying value of severity, is there a difference in patient severity rating reported to a person (nurse) versus an AVR?In randomized clinical trials, intake and follow-up assessments of patients usually involve the same mode of administration, for example paper-and-pencil, telephone interviewing, electronic devices such as personal digital assistant (PDA),16 a touch-screen computer,17,18 or patient web-based self-reporting.19,20 However, the technology for delivering interventions may differ by trial arm. For example, a nurse may deliver tailored cognitive-behavioral strategies via the telephone, whereas an AVR system may deliver preprogrammed information and self-care strategies. Thus, the exposure is the same, the content similar, but mode of delivery differs. In attempting to specify the processes through which elements of the intervention seek to change the outcome variable during the contacts, it is critical to distinguish between real changes and changes that may be due to mode effects. Thus, comparisons based on different methods of assessment must be capable of separating real differences from those due to possible mode effects. The purpose of this research is to compare patients’ assessments of symptom severity as reported during live telephone interviews compared with assessments using AVR techniques.The computerized modes of data collection such as AVR, PDA, or web-based reporting have been compared with paper-and-pencil self-administration and to live telephone interviews. Comparisons of a paper-and-pencil administration to a PDA revealed mode effects for the Center for Epidemiological Studies Depression scale,21 but no differences in responses to other instruments.22,23 Paper-and-pencil self-administration has been shown to result in higher average depressive symptomatology scores compared with in-person interviews.24 Among cancer patients who experience multiple symptoms related to cancer, its treatment and comorbid conditions, AVR systems have been used for symptom monitoring,1,17–19 but the mode effects of AVR versus other formats of symptom data collection have not been studied.In this research, cancer patients’ reports of severity of 14 symptoms are investigated to answer the following research questions: (1) is there a mode of administration effect on patients’ reports of severity of 14 cancer-related symptoms: pain, fatigue, insomnia, peripheral neuropathy, dyspnea, cough, poor appetite, constipation, diarrhea, nausea/vomiting, dry mouth, alopecia (hair loss), difficulty remembering, and weakness, according to live telephone interview with a nurse versus AVR; (2) are the mode effects in symptom reporting to a nurse versus AVR different by patient and disease characteristics such as age, sex, education, or site of cancer?METHODSSampleApprovals for the study were obtained from the Institutional Review Board of the sponsoring university, and the Institutional Review Boards of 2 comprehensive cancer centers, one community cancer oncology program, and 6 hospital-affiliated community oncology centers. Eligible patients (1) were 21 years of age or older, (2) had a diagnosis of a solid tumor cancer or non-Hodgkin lymphoma, (3) were undergoing a course of chemotherapy, (4) were able to speak and read English, and (5) had a touch-tone telephone. Patients agreeing to participate signed an informed consent form, and had all socio-demographic information entered into a web-based tracking system. Before entering the study, patients were screened for symptom severity using an AVR version of the M. D. Anderson Symptom Inventory.25 Patients who scored 2 or higher on a 0 to 10 scale on severity of any symptom at screening were entered into the study. All patients had an intake interview administered by trained interviewers live over the telephone. After the intake interview, patients received a printed copy of the Symptom Management Guide (SMG) that contained specific strategies for the management of each symptom. Computer minimization procedure26 was used for to randomize patients to receive either a cognitive-behavioral intervention delivered by oncology nurses, or information and self-care strategies delivered by the AVR.In each of the 2 trial arms, patients had 6 telephone contacts over 8 weeks, with the first intervention contact occurring on average about 2 weeks after the intake interview. Each telephone contact began with the assessment of severity of symptoms on a 0 to 10 rating scale. In the nurse-directed arm, tailored cognitive-behavioral symptom management strategies supplemented with the reference to the SMG were delivered for symptoms above threshold of 4 in severity. In the AVR arm, a prerecorded pleasant female voice queried patients regarding their severity for their symptoms. To rate symptom severity, patients pressed the appropriate numbers on their telephone keypads. For symptoms rated at 4 or higher, the AVR delivered information and self-care strategies: patients were directed to the sections of the SMG that informed them about strategies to manage the symptoms that were above threshold. Details regarding the trial can be found elsewhere.27Patients who completed the first intervention contact are included in this analysis. Data from their symptom severity assessment obtained before the delivery of any intervention strategies are used to test for mode effects. The assessments of severity conducted during intervention contacts 2 to 6 were done after the delivery of the different types of the interventions in nurse-directed and AVR arms at contact 1. In the symptom assessments at contacts 2 to 6, the mode effects were confounded with the effects of different interventions; therefore only contact 1 data are used in mode effect testing. Figure 1 summarizes the number of patients who entered and dropped out at each step, and the number analyzed.FIGURE 1. Flow chart of the trial.MeasuresIndependent variables included age, sex, level of education, and site and stage of cancer. Their values were obtained from the patients’ medical records, entered into the tracking system, and confirmed during intake interview. Drawing upon our own and others work age was categorized as <45, 45 to 74, and 75 and older. In earlier analyses these age categories were predictive of differences in response between nurse and AVR administered interventions; the youngest group favoring the AVR and the oldest group favoring the nurses. Thus, age categories needed to be considered in the analysis of mode effects. Second, differences in age may reflect variations in the aggressiveness of tumors, patient responses to treatment,28,29 and in treatment aggressiveness.30 Finally, age categories represent variations in cognitive neuro-processing and plasticity.31,32The level of education was collapsed into 2 categories: high school or less versus some college. Individuals with a high school level of education or less have been shown to be at risk for experiencing difficulties in comprehending medical information.33Site of cancer was summarized as lung versus nonlung. Although patients with sites of cancer other than lung form a heterogeneous population, the differences in symptom reporting were found for lung versus other cancer sites in earlier work.27Severity of symptoms was scored by patients on a scale ranging from absence (0) to the worst severity possible(10) at intake interview and at each of the intervention contacts. Because the lists of symptoms were slightly different in intake interview and intervention contacts, we conducted the analyses on the 14 symptoms common to both assessments. Symptom severity reported at the first intervention contact was used as a dependent variable, and symptom severity reported during intake interview was used as a covariate as described later.Data AnalysisUnadjusted arm comparisons of symptom severity scores at intake interview and first intervention contact were performed using t tests. At intake into the trial, all patients were interviewed by trained interviewers over the telephone; thus, no mode effect was present. The severity score of each symptom as reported in the intake interview was used to control for the underlying value of severity in mode effect analysis. For each symptom, a regression model that related severity of a symptom reported at the first intervention contact to severity reported at intake interview, trial arm, and the number of days since intake interview was fit. To answer the question about differential reporting, that is, if the underlying value of severity is the same, but patient reports to a person versus AVR differ, a measure of the underlying value of severity needs to be included in the model. In the absence of a true value of severity, several different estimates have been used,34 which may be problematic to use with symptoms due to dimensionality issues.35 In this study, a value free of mode effects was available from the intake interview, which was used along with the adjustment for the number of days between 2 symptom assessments. Further, trial arm by severity at intake interaction was added to the model. Models with and without the interaction terms were compared using a likelihood ratio test. Nonuniform mode effect, that is, mode effect with varying direction across levels of the underlying symptom severity, would be present if the model was better with the interaction term. Comparison of models with severity and severity and trial arm produced a test for a mode effect uniform with respect to the underlying value of severity as reflected by severity measured at intake.The influences of patient age, sex, level of education, and site of cancer on symptom reporting were investigated by adding the appropriate variables as covariates and in interaction with trial arm to the regression models. To avoid a potential problem with colinearity, age, sex, education, and site of cancer were investigated separately in relation to mode effect. The adjusted means36 of symptom severity by levels of covariates and trial arm were derived from the regression models, and differences by trial arm were tested. Effect sizes for between trial arm differences were calculated by subtracting the adjusted means and dividing the difference by the standard deviation at intake. To illustrate the direction of the differences, effect sizes are reported as positive if severity was greater in the AVR arm and as negative when severity was greater in the nurse arm. Because the distribution of symptom severity was skewed to the left, the regression models were implemented as generalized linear models with gamma-distributed errors.37 Bonferroni adjustments were used to control for probability of type I error in tests for 14 symptoms with test results deemed significant if P value was less than 0.0036. The selection of Bonferroni adjustment to control type I error was informed by the fact that Bonferroni method is not based on any additional assumptions, and that it has been shown to result in almost the same conclusions as obtained with cross-validation.38 On the other hand, Bonferroni adjustment may be much too stringent.39 To control for the false discovery rate, Benjamini-Hochberg procedure was implemented,40 which is valid under the assumption of positive dependence of P values.41 Because the list of symptoms was prespecified in advance of testing, and because adjustments for multiplicity may result in an inflated type II error,39 both adjusted and unadjusted results are presented. The conclusions derived using Bonferroni and Benjamini-Hochberg procedures were very similar, and both are presented in Tables and results. The analyses were performed using SAS 9.1.42RESULTSTable 1 contains the summary of socio-demographic and disease information by arm of the trial for those randomized and for those analyzed. No significant differences were found between the arms of the trial at intake according to patient or disease characteristics. There were no significant differences by trial arm among those who dropped out after the intake interview, or among those who skipped intervention contacts.TABLE 1. Characteristics of the Sample by Trial Arm: Those Randomized and Those AnalyzedTable 2 provides the results of trial arm comparisons of symptom severity at intake for those who skipped the intervention contacts, or dropped out of the study before the first intervention contact, and thus were not analyzed (first panel). Even though the percent of those not analyzed was higher in the AVR arm compared with the nurse-directed arm (15% vs. 8.3%), their patient and disease characteristics (Table 1), and symptom severity (Table 2) were not different by trial arm.TABLE 2. Severity of Symptoms at Intake Interview and the First Contact of Intervention Contact by Trial ArmPanels of Table 2 display the severity of symptoms for those not analyzed, and for those analyzed as reported by at the intake interview, and approximately 2 weeks later when patients in the AVR arm were called by the automated system, and patients in the nurse arm were queried by the nurse interveners. The number of days between the intake interview and first intervention contact did not differ by trial arm (nurse arm: mean of 15.05 [standard deviation 6.31], AVR arm: 13.60 days [standard deviation 5.53]). The comparison of intake symptom severity reported by those who completed the first intervention contact and those who did not revealed no differences between or within trial arms. For those analyzed, the severity of poor appetite was higher in the AVR arm (P = 0.02) at intake interview, but this difference was not significant with either Bonferroni or Benjamini-Hochberg adjustment for multiplicity. Severity of all other symptoms was balanced by trial arm at intake even without applying adjustments for multiple testing (P > 0.05, Table 2). However, at first intervention contact before the delivery of any intervention strategies, patients in the AVR arm reported significantly higher severity of several symptoms: alopecia (hair loss), poor appetite, nausea/vomiting, constipation, and pain (significant with Benjamini-Hochberg adjustment). Note that the means of symptom severity at live intake interview and at first nurse-administered intervention contact are similar.Further analyses were performed controlling for the symptom severity reported at intake interview to detect differential reporting of symptoms given the same underlying value of severity. The comparisons of models with and without trial arm by symptom severity at intake interaction revealed that models without the interaction term were better for all symptoms, thus nonuniform mode effect was absent. After the interaction term between trial arm and intake symptom severity was removed from the model, the uniform mode effect as reflected by the trial arm coefficient was tested. The coefficients of the models with intake severity and arm as explanatory variables for the outcome of symptom severity reported at the first intervention contact are presented in Table 3.TABLE 3. Results of Regression Analyses Relating Severity at the First Intervention Contact to Trial Arm and Severity at Intake Interview Adjusting for the Number of Days Between Intake Interview and First Intervention ContactFrom these models, a significant uniform mode effect after either multiplicity adjustment was found for alopecia, poor appetite, nausea/vomiting, and constipation. For symptoms of pain, and diarrhea, mode effect was significant with Benjamini-Hochberg adjustment for multiplicity. For fatigue, dyspnea, and peripheral neuropathy the P values for mode effect were less than 0.05, but not significant after either multiplicity adjustment. Remarkably, the direction of the mode effect was the same across symptoms, with higher levels of severity reported to the AVR compared with a nurse.When site of cancer, sex, or level of education were added to the model in interaction with trial arm, no significant mode effects that were differential by these characteristics were observed. The findings for age suggested that for several symptoms, the mode of administration effect was differential by age group. The adjusted means by trial arm and age categories are presented in Table 4.TABLE 4. Least Square Means of Symptom Severity at the First Intervention Contact by Age and Trial Arm Adjusted for Symptom Severity at Intake Interview and the Number of Days Between Intake Interview and First Intervention ContactPatients in the middle age group (45–74 years) reported higher levels of severity of alopecia, poor appetite, constipation, diarrhea, fatigue, nausea/vomiting, pain, and peripheral neuropathy to the AVR. In contrast, oldest age group (75+ years) reported higher levels of severity of dyspnea, fatigue, pain, peripheral neuropathy, and insomnia to the nurse. Because of the sample sizes of 17 and 20 for patients 75 years of age or older in the nurse and AVR arm respectively, the magnitude of the effect size was used to assess the differences between trial arms. The effect size of 0.33 is recommended as a lower bound for clinically important difference.43 In the oldest age group, the effect sizes for dyspnea, fatigue, pain, peripheral neuropathy, and insomnia was greater than or equal to 0.35 favoring nurse. In the youngest age group (25–44 years), only 3 symptoms, alopecia, dyspnea, and pain, exhibited mode effects with effect sizes exceeding 0.33 in magnitude with higher levels of severity reported to the AVR. Alopecia was the only symptom for which the effect sizes in all 3 age groups were clinically significant favoring AVR arm. For pain, the magnitude of the effect size for the differences in all 3 groups was clinically significant with youngest and oldest age groups favoring the nurse, and the middle age group favoring the AVR.DISCUSSIONThe results highlight the importance of accounting for mode effects in designing trials of interventions for symptom management. When different types of interventions are delivered using different modes, and symptom assessments are used to determine which symptoms should and which should not be targeted with interventions, mode effects need to be considered. For example, according to the National Comprehensive Cancer Network guidelines,44 scores of 4 or higher in severity indicate the need for symptom management. However, if given the same underlying level of severity, patients report this severity differently to an AVR versus a nurse, then adjustments to the thresholds that trigger intervention delivery are needed. In addition, if mode effects are present early on, but diminish over time, the reported decrease in severity over time should be distinguished from the response to the interventions delivered. AVR systems are just one example of the computer technology used to assess patient-reported outcomes and deliver interventions to patients experiencing symptoms due to chronic conditions.In this trial, randomization procedure allocated patients to trial arms that were equivalent at intake with regard to socio-demographic characteristics and reported symptom severity. However, at the time the intervention began, this equivalence was affected by the mode of administration of the symptom assessment with groups being no longer equivalent with respect to primary outcome of symptom severity burden.27 This arm imbalance can be handled analytically by adjusting for the severity reported at first contact when evaluating severity at later contacts, however, once different intervention strategies are delivered using different modes, the mode effect cannot be separated from the effect of the intervention.The analyses were carried out on a symptom by symptom basis using generalized linear models that controlled for each symptom's severity that was reported a week earlier free of mode effects. Other methodological approaches to detection of mode effects that are based on classical test theory or item response theory, and differential item functioning analyses have been used.21,24,34 These approaches rely on dimensionality structure, for example, established factor structure of the construct being measured. In the application to cancer-related symptoms, the dimensionality issue remains open to question.35 Among breast cancer patients who are not undergoing active treatment, Stanton et al45 have shown the stability of factor-analytic results across multiple samples, but stability of subscales remains an issue and an open question among cancer patients undergoing treatment. One proposed explanation for such instability is that the results of factor analyses depend on correlations among symptoms, and those in turn may depend on specific sites of cancer, treatments, and timing of administration of the symptom assessment relative to treatment and disease course. Notably, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)46 has 6 single items that assess symptoms reported by cancer patients that do not form subscales. The approach for the detection of mode effects implemented in this study does not rely on factor structure. Instead, we used a prior assessment of symptoms that was conducted over the telephone by the interviewers with all patients to control for the underlying value of severity. The observed stability of means of symptom severity scores between 2 assessment times was reflective of the fact that cancer-related symptoms persist over time,47 and may have multiple etiologies linked to chemotherapeutic agents, comorbid conditions, or affective states.48A potential explanation of why patients reported higher levels of severity to the AVR compared with a person could lie in the neutrality of the AVR. With no interaction and no comments from the interviewer, patients may be more candid and truthful about the severity of their symptoms. This explanation would be consistent with the fact that patients report more severe symptoms to others than to oncologists or nurses.49 The breakdown of the mode effects by age revealed that the age group of 45 to 74 years made the largest contribution to the overall mode effect. Except for 3 symptoms (alopecia, dyspnea, and pain), no mode effects were found in the youngest group, while patients who were 75 years of age or older, reported higher severity of several symptoms to the nurse compared with the AVR. These symptoms are mostly physical in nature (dyspnea, pain, fatigue, peripheral neuropathy, and insomnia), and the effect sizes for the mode effect in the oldest age group were moderate to large suggesting clinically important differences. The literature on aging and plasticity is not clear. However, the oldest group of patients clearly was more willing to report severity to the nurse, just as the middle age group was more comfortable reporting greater severity to the AVR. The oldest group of patients may, based on some evidence, possess less adaptability32 and, therefore, may value interactions with nurses who inquire about their symptoms. Further, shifts that require patients to use AVR technology may be easier for younger patients where they encounter these systems in their daily lives.Although the mechanisms behind these age-related mode effects remain speculative, we believe that age is an important characteristic in assessing possible mode effects and needs to be considered carefully in future assessment of differences in delivery as interventions are moved to computer and web-based modes of delivery. It should be noted that the sample size for the oldest age group was relatively small, and further research is needed to confirm this finding. Also, further research is needed to assess if mode effects persist over time, which was not possible to do in this study as from contact 2 on, the mode effects were confounded with the effects of different interventions administered in AVR and in nurse arms.Limitations of this research include slight differences in symptom lists evaluated at intake interview and first intervention contact. In intake interview, nausea and vomiting were asked as 2 items but combined into one for the purposes of comparison with the intervention contact where both symptoms were inquired about in one question. There were approximately 2 weeks between intake interview and the first intervention contact, during which the severity of symptoms may have changed. 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Assessment: Automated Voice Response System Versus a Live Telephone InterviewSikorskii, Alla PhD; Given, Charles W. PhD; Given, Barbara PhD, RN, FAAN; Jeon, Sangchoon MS; You, Mei MSOriginal Article847