Introduction
Health-related quality of life (HRQoL), or psychological, social, and physical functioning [
1], has become an important outcome measure in medical care. Standardized assessment of HRQoL preceding each consultation may potentially provide physicians with valuable information. Several studies have shown that physicians vary in their ability to elicit psychosocial information or that they underestimate patients’ HRQoL [
2‐
5]. Furthermore, various studies have shown that when communication with the physician encompasses both physical and psychosocial issues, patients have better treatment compliance, are more satisfied with the consultation, and report less symptoms [
6‐
8].
Nevertheless, relatively few studies have assessed the value of HRQoL measurement in clinical practice. Some have shown positive results with regard to acceptance by patients and physicians or a significant increase in the identification and/or discussion of HRQoL issues [
9‐
14]. Less consistent and favorable results have been obtained with regard to the effectiveness of standardized HRQoL measurement in actually improving HRQoL or psychosocial outcomes. Even though decreased depression [
15], improved overall and emotional functioning [
10], improved mental health [
16], and a decrease in disease-specific debilitating symptoms of patients undergoing chemotherapy [
13] have been associated with HRQoL measurement in clinical practice, several other studies found no significant improvement in HRQoL or psychosocial outcomes [
9,
17‐
20]. A possible explanation might be that the majority of existing studies assessing the effectiveness of HRQoL measurement in clinical practice with regard to patients’ psychosocial functioning or HRQoL have included oncological patients or patients from general practice. Oncological patients can be considered a special group due to the life-threatening nature of the disease. Patients from general practice, on the other hand, may be too diverse and often present with generally minor complaints, which may hamper the discovery of beneficial effects. Both groups impede generalization of results to other chronic patient populations.
Two important studies [
9,
10] used designs in which physicians were part of both the control and the experimental group, either by using a crossover design (physicians were first assigned to one group, then crossed over to the other group halfway through the study) [
9] or by assigning patients rather than physicians to the different groups [
10]. This may possibly have caused bias. Two systematic reviews have stressed the need for further research evaluating the effectiveness of repeated measurements of HRQoL in clinical practice [
18,
20] and the need for further research to help health care professionals identify patients who would benefit most from such interventions [
20].
The study reported here differs from previous studies by including a patient population with chronic liver disease (CLD) in order to study the effects of HRQoL use in clinical practice in a population that is more representative of other patients with a chronic disease. CLD is one of the most prevalent diseases in the world. The most common causes of CLD, hepatitis B virus (HBV) and hepatitis C virus (HCV), have been estimated to affect 360 million and 200 million people worldwide, respectively (
http://www.epidemic.org, 4-12-2006). In addition, alcohol is another main cause of end-stage liver disease worldwide and the second most common reason for liver transplantation in the United States [
21]. CLD is a serious disease that is associated with significant physical and psychological symptoms such as impaired cognition, hepatic coma, fluid in the abdomen, abdominal pain, joint pain, fatigue, depression, and anxiety [
22‐
28]. Not surprisingly, HRQoL in patients with CLD has been shown to be impaired [
29,
30]. CLD is an appropriate example of a typical chronic disease, with patients experiencing substantial comorbidity and possibly mortality, as is the case in other chronic diseases such as kidney disease and chronic obstructive pulmonary disease.
Our study also differs from previous studies by assessing the benefits of HRQoL measurement for patients with different demographic characteristics (e.g., men and women, young and old), which is essential for determining which patients are most likely to benefit from HRQoL measurement in clinical practice, a point recently reiterated in a systematic review on this topic [
20]. In addition, in our study, physicians rather than patients were assigned to the control or the experimental group. This assigning of physicians to only one group prevents bias of physicians being focused on discussing HRQoL when seeing patients in the control group.
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.
Discussion
Computerized, real-time measurement of HRQoL at our busy outpatient Department of Hepatology and presentation of the results to physicians before each consultation did not show a main effect on patients’ overall HRQoL. However, secondary analyses showed that the HRQoL measurements positively affected disease-specific HRQoL and generic mental HRQoL of older patients (>48 years of age) with CLD and also generic mental HRQoL of male CLD patients. The results of our study are among the first to show a beneficial effect of presenting HRQoL data to physicians in clinical practice. Most other studies have failed to show evidence for the actual improvement in HRQoL or psychosocial outcomes [
9,
17‐
20]. Of the studies that did find a beneficial effect, one showed a decrease in disease-specific debilitating symptoms [
13], and another showed improved emotional functioning [
10], which is in line with findings of our study. It should be noted that due to the cross-sectional data analyses, a causal relationship between intervention and HRQoL could not be demonstrated. Future studies should address this in further detail.
Our study found no differences between patients in the experimental and control groups with regard to satisfaction with the consultation, which is in line with findings from previous studies [
9,
36,
37]. The lack of observed differences between the study groups may have been due to high levels of satisfaction, resulting in a ceiling effect.
This study was among the first to show a significant difference in patient management between experimental and control groups, with physicians in the experimental group mostly reporting a significant increase in the frequency of consultations. Our findings were statistically significant and in accordance with the findings of a systematic review [
20] and subscribe to the increasingly acknowledged importance of using HRQoL information for the improvement of physician consultations [
38]. However, it should be noted that even though the differences in patient management between control experimental groups were statistically significant, the absolute numbers were small. Therefore, the results should be interpreted cautiously, and further studies using more elaborate methods of data collection—for instance, monitoring patients’ medical records or administering more detailed checklists—are recommended.
Physicians’ experiences with using HRQoL information during the consultation were generally positive; requesting the information was not considered an extra effort on their part, and they found the information especially useful for certain groups of patients, such as those awaiting liver transplantation, those with hepatitis C, and nonnative speakers. All physicians but one found the information useful for at least some (45%) of their patients. Physicians indicated finding the information least useful when patients were doing well in terms of HRQoL or when they knew the patient well. These generally positive experiences are in accordance with findings from previous studies [
9‐
14], which assessed oncologists’ attitudes toward using HRQoL information in clinical practice. The confirmation of these results in hepatologists suggests that HRQoL information may also be well accepted by physicians treating patients with other chronic conditions. Another result of our study was that when HRQoL information was available, more time was spent discussing psychosocial issues and more treatments were altered. Interview and checklist data were contradictory regarding the duration of consultations when HRQoL information was available. In a previous study in which the duration of consultations was timed, no increase in consultation time was found [
14]. Future studies should shed more light on whether the availability of HRQoL information increases the length of consultations in hepatology.
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.