Introduction 1 2 5 6 8 9 14 15 10 16 13 9 17 20 9 10 9 10 18 20 20 http://www.epidemic.org 21 22 28 29 30 20 The aims of the study were twofold: the first was to assess the effectiveness of real-time computerized measurement of HRQoL in various patients with CLD and presentation of the results to physicians before the consultation in terms of improvement in patient HRQoL, patient management, and patient satisfaction with the consultation by means of a randomized trial with repeated measurements. The second aim was to assess hepatologists’ experiences with the availability of real-time HRQoL patient data and to measure the possible effect(s) it had on their consultations. Patients and methods Patient recruitment This study was performed at the Department of Gastroenterology and Hepatology of the Erasmus Medical Centre, Rotterdam, where HRQoL measurement on a regular basis was implemented for the duration of 1 year. All patients older than 17 years of age with CLD visiting the department between September 2004 and January 2005 were invited to participate. Written information about the study was sent to the patients 3 days before their consultation at the outpatient department. Patients interested in participating informed their physician, who consequently directed them to the researcher for further explanation of the study and to sign informed consent. For this effectiveness study, we included all patients with two or more measurement moments. All physicians working at the Department of Hepatology participated. The protocol was in accordance with the ethical guidelines of the modified 1975 Declaration of Helsinki and approved by the Medical Ethics Committee of the Erasmus MC. Study objectives The primary aim of this study was to assess the effectiveness of computerized measurement of HRQoL in clinical practice. The primary outcome measures were patients’ generic HRQoL (physical and mental component score separately) and disease-specific HRQoL. Secondary outcome measures were patient satisfaction with the consultation and patient management. The secondary aim of this study was to assess hepatologists’ experiences with the availability of real-time HRQoL patient data. Study design and intervention Physicians Physicians were randomly assigned to either the experimental or control group by means of a restricted randomization procedure called blocking. To ensure an equal number of physicians in each group, it was decided to include six in the experimental group and five in the control group. We used a random sequence table to assign physicians to one of the conditions. Due to the nature of the intervention, it was impossible to blind physicians to group assignment. 1 Fig. 1  dashed line  Patients Through the random assignment of physicians, patients were indirectly allocated to either group. Patients were initially blinded to the group assignment. All patients participating in the study completed a computerized generic- and disease-specific HRQoL questionnaire and the first part of a pen-and-paper questionnaire on patient satisfaction with the consultation before each consultation at the outpatient Department of Hepatology for 1 year. They also completed the second part of the satisfaction questionnaire after the consultation. More specific information on the content of the questionnaires is provided in “Study measures”. To ascertain good questionnaire completion, a researcher was always available to answer questions about the computer and/or questionnaires at the patient’s request. Study measures HRQoL 24 n 30 n 29 31 r r 32 Patient satisfaction with the consultation n r P 33 Patient management The effect of the intervention on patient management was measured by means of a checklist that physicians completed after each consultation with a study participant, including the question: “Have you changed your treatment in any way?” and a subquestion: “If so, what have you done?” followed by several options: “Prescription of antidepressants,” “Referral to psychosocial care,” “Altering the frequency of consultations,” and “Other.” Physicians’ experiences Experiences of physicians with the experimental condition were assessed through the checklists that they completed after each consultation with a study participant, asking the question: “Did you find the HRQoL information useful? Why?” with the answering options: “Yes, it provided new information,” “Yes, it saved time,” “Yes...,” “No, the patient is doing well,” “No, I know this patient well enough,” “No, the patient tells me a lot,” “No...”. Also, a semistructured interview was conducted 6 months into the study and at the end of the study. The interview included questions about the effort to request HRQoL information, the usefulness of the information, whether the availability of HRQoL information increased the duration of the consultation, and whether participating patients addressed HRQoL issues more often than patients who did not participate. Physicians were also asked whether there were certain subgroups of patients whose HRQoL information they found particularly useful. Opinions of physicians in the control group toward possible future availability of HRQoL information during the consultation were assessed by means of the same semistructured interview at 6 months only. Statistical analysis Sample size D Data selection n n Data analysis 2 t 34 Univariate analyses of variance were performed for each outcome variable (disease-specific HRQoL and generic HRQoL MCS and PCS) separately. A forward technique was used in which the main effects of the fixed factors were assessed in the first block, and the interactions between feedback of HRQoL data and each of the other fixed factors (age, gender, severity of the disease) were explored in the second block. Differences between the two groups on patient management variables and satisfaction with the consultation were assessed by means of Mann–Whitney tests. Hepatologists’ experiences with the availability of real-time patient HRQoL data was assessed by means of semistructured interviews and checklists. These data were of a descriptive nature and are presented as such. Results Characteristics of patients and physicians in the study n n 2 1 2 2 n Fig. 2 Patients in the study  Table 1 Differences in age, gender, diagnosis, and disease severity between patients in the study and nonrespondents  n n P n P Age, mean (range) 47.5 (20–75) 48.6 (20–81) 0.52 47.6 (18–80) 0.92 n     Male 96 (59) 87 (53) 0.24 136 (52) 0.21     Female 66 (41) 78 (47) 124 (48) n     Hepatitis B 22 (13) 25 (15) 0.04 49 (19) 0.00     Hepatitis C 23 (14) 24 (15) 56 (22)     Cholestatic liver disease 11 (7) 22 (13) 32 (12)     Pretransplantation 11 (7) 7 (4) 1 (0)     Posttransplantation 62 (38) 48 (29) 55 (21)      Autoimmune hepatitis 12 (8) 11 (7) 18 (7)      Other 21 (13) 28 (17) 49 (19) n     No cirrhosis 101 (62) 105 (64) 0.43 159 (61) 0.96     Compensated cirrhosis 42 (26) 45 (27) 69 (27)      Decompensated cirrhosis 19 (12) 15 (9) 32 (12) 2 t P Table 2 Characteristics of patients included in the data analysis  n n P n     Women 38 (48) 28 (34) 0.08     Men 42 (52) 54 (66) Age, mean (range) 47.5 (21–74) 47.6 (20–74) 0.98 n     Hepatitis B 1 (1) 20 (25) 0.00     Hepatitis C 7 (9) 16 (19)     Cholestatic liver disease 4 (5) 6 (7)     Pretransplantation 5 (6) 3 (4)     Posttransplantation 43 (54) 23 (28)     Autoimmune hepatitis 6 (7) 6 (7)     Other 14 (18) 8(10) n     No cirrhosis 44 (55) 56 (68) 0.01     Compensated cirrhosis 16 (20) 22 (27)     Decompensated cirrhosis 20 (25) 4 (5) 2 t Descriptives 3 4 Table 3 Questionnaire completion rate of patients in the control and experimental groups  Number of times questionnaires were completed n 2 3 4 5 6 8 9 11 n 22 29 11 7 7 1 2 1 80 n 45 18 9 5 2 2 1 0 82 Table 4 Patients’ adjusted means and 95% confidence intervals at T1 and T2−Ti  T1 P T2−Ti P Control  Experimental Control Experimental Overall SF-12 PCS 41.5 (39.0–43.9) 45.6 (42.0–49.3) 0.06 42.0 (39.6–44.4) 44.8 (41.4–48.3) 0.19 SF-12 MCS 43.4 (40.3–46.5) 46.0 (41.4–50.6) 0.35 43.8 (41.0–46.5) 44.8 (40.8–48.8) 0.69 LDSI 2.0 21.2 (19.0–23.4) 18.9 (15.7–22.2) 0.27 20.4 (18.6–22.2) 18.8 (16.1–21.4)  0.31 Male patients SF-12 PCS 10.2 (37.1–43.3) 47.0 (42.9–51.2) 0.10 41.3 (38.2–44.2) 45.7 (41.7–49.7) 0.29 SF-12 MCS 41.6 (37.7–45.4) 45.6 (40.4–50.8) 0.49 41.2 (37.8–44.6) 46.7 (42.1–51.2) 0.02 LDSI 2.0 22.8 (20.0–25.5) 18.1 (14.4–21.8) 0.10 21.4 (19.2–23.6) 18.0 (15.0–21.0) 0.14 Female patients SF-12 PCS 42.7 (39.2–46.3) 44.2 (39.8–48.7)  42.8 (39.4–46.2) 44.0 (39.7–48.2)  SF-12 MCS 45.2 (40.7–49.6) 46.4 (40.8–52.0)  46.3 (42.4–50.2) 42.9 (37.9–47.8)  LDSI 2.0 19.6 (16.4–22.8) 19.8 (15.8–23.8)  19.4 (16.9–22.0) 19.5 (16.3–22.7)  Older patients SF-12 PCS 41.5 (38.4–44.6) 44.6 (40.7–48.6) 0.49 40.4 (37.4–43.3) 43.4 (39.9–47.5) 0.72 SF-12 MCS 41.5 (37.6–45.4) 46.3 (41.4–51.3) 0.26 41.2 (37.8–44.7) 45.9 (41.6–50.3) 0.03 LDSI 2.0 22.8 (20.0–25.5) 19.1 (15.6–22.7) 0.31 22.1 (19.9–24.3) 18.1 (15.3–21.0) 0.04 Younger patients SF-12 PCS 41.4 (37.9–44.9) 46.7 (42.2–48.6)  43.6 (40.3–47.0) 45.9 (41.6–50.3)  SF-12 MCS 45.3 (40.9–49.7) 45.7 (40.0–51.3)  46.3 (42.5–50.2) 43.6 (38.7–48.6)  LDSI 2.0 19.6 (16.5–22.7) 18.7 (14.7–22.8)  18.8 (16.2–21.3) 19.4 (16.1–22.6)  The means at T1 and T2−Ti were obtained from the univariate analyses of variance with fixed factors: age, gender, severity of the disease, study group (control or experimental), and interactions between these variables. Differences in diagnoses between patients in both groups were controlled for. The significance level reflects the group for which the largest difference on the variable was found SF-12  PCS  MCS  LDSI Effects of the experimental condition on patients’ HRQoL and satisfaction with the consultation Disease-specific HRQoL 5 Adj F P Adj D 35 Table 5 Interaction effects between age, gender, disease severity, and feedback on the outcome variable disease-specific HRQoL, controlled for diagnosis Source F df P R 2 Corrected model 2.11 10 0.03  Intercept 599.83 1 0.00  Diagnosis (propensity score) 1.80 1 0.18 0.08 Gender 0.04 1 0.85 Disease severity 3.39 2 0.04 Age 0.84 1 0.36 Feedback 1.05 1 0.31 Gender * Feedback 2.17 1 0.14 0.12 Severity * Feedback 0.15 2 0.86 Age * Feedback 4.18 1 0.04 Dependent variable: mean total score of the Liver Disease Symptom Index   2.0 [disease-specific health-related quality of life (HRQoL)] for the measurement moments T2...Ti Generic HRQoL Mental Component Summary score Adj  F P Adj  6 Adj  F P Adj  6 Table 6 Univariate analysis of variance with the variables age, gender, disease severity, and feedback on the outcome variable mental generic HRQoL, controlled for diagnosis Source F df P R 2 Corrected model 1.65 10 0.10  Intercept 1337.05 1 0.00  Diagnosis (propensity score) 1.34 1 0.25 0.03 Gender 0.14 1 0.71 Disease severity 0.40 2 0.67 Age 0.65 1 0.42 Feedback 0.16 1 0.69 Gender * Feedback 6.10 1 0.02 0.10 Severity * Feedback 0.13 2 0.88 Age * Feedback 4.62 1 0.03 Dependent variable: mean total score of Short Form-12 Mental Component Summary (SF-12 MCS) [generic mental-health-related quality of life (HRQoL)] for the measurement moments T2...Ti Physical Component Summary score No significant main effect or interaction effects were found for the variables feedback of HRQoL data and age, gender, and disease severity on the SF-12 PCS. Patients’ satisfaction with the consultation z P Effects of the experimental condition on the consultation and on patient management z P z P n 3 4 1 1 2 Physicians’ experiences with the availability of HRQoL information in clinical practice Experiences of physicians in the experimental group at 6 months and at the end of the study did not differ. All physicians in the experimental condition found the HRQoL information useful, except for one older physician who claimed to know his patients very well. They indicated being better able to understand some of their patients through the extra information that was provided by the questionnaires. These physicians did not perceive requesting the information as an extra effort on their part. Furthermore, they did not think that using the information lengthened their consultations. All physicians in the experimental group indicated that they wanted to continue using the HRQoL information in the future. Physicians in the control group were similarly positive toward the possible availability of HRQoL information during their consultations in the future, on the condition that it would not be time consuming. This specifically concerned patients awaiting liver transplantation, patients with hepatitis C, and nonnative speakers (mostly patients with hepatitis B). Discussion 9 17 20 13 10 9 36 37 20 38 9 14 14 The strength of our study lies in the analyses performed, where benefits for specific groups of liver patients were explored by entering interactions between gender, age, disease severity, and feedback of HRQoL data, rather than solely investigating main effects between the intervention and control groups. Also, this study included patients with CLD rather than patients with cancer or patients from general practice, making it especially relevant to a more general population of patients with a chronic illness. We are aware of several limitations of this study. First, physicians rather than patients were randomly assigned to either the intervention or control group. Randomization is a complicated issue in these kinds of implementation studies, and both methods are subject to limitations. An important advantage of the randomization of physicians is that the control group was not biased toward mentioning HRQoL topics more often than usual. Future studies using the same design but including more physicians are needed to further explore possible main effects of HRQoL measurement on patients’ overall HRQoL. A second limitation was the high number of nonparticipants. Part of the explanation may lie in the fact that patients were responsible for contacting their physician if they were interested in participating in the study. In addition, the number of non-Dutch-speaking patients visiting the department is relatively large (hepatitis B, for example, is most common among people from North Africa). These patients were also invited to participate but were less likely to respond. The relatively large number of patients who completed the questionnaires only once may be explained by the small window of opportunity to complete the questionnaires before each consultation. In addition, for such implementation endeavors, cooperation of all staff members is essential, and future research should explore this further. A last limitation of this study was that the checklists used to assess consultation content were not very detailed. This was done on purpose, as longer inventories would have compromised physician participation. However, considering the positive outcomes of this study, it is advisable that future studies consider ways to obtain a more detailed view of how the HRQoL information affects consultation content, for example, by recording consultations. In conclusion, although a main effect of the intervention was not found, this study showed a beneficial effect of implementation of HRQoL measurement in clinical practice on the HRQoL of older and male patients with CLD and on patient management. Nevertheless, the study had several shortcomings, and further studies are needed to substantiate these findings. Physicians’ experiences with the availability of HRQoL information were positive, especially for patients awaiting liver transplantation, patients with hepatitis C, and nonnative speakers. They expressed an interest in continued use of HRQoL information. These results advocate the continued use of measuring HRQoL in a clinical practice of hepatology. Including older patients and male patients, who have been shown to benefit most from such a procedure, should be aimed for.