Psychosomatics 47:304-311, August 2006
doi: 10.1176/appi.psy.47.4.304
© 2006 Academy of Psychosomatic Medicine
Evaluation of General Practitioners' Training: How to Manage Patients With Unexplained Physical Symptoms
Winfried Rief, Ph.D.,
Alexandra Martin, Ph.D.,
Elisabeth Rauh, M.D.,
Thomas Zech, Dipl.Psych., and
Andrea Bender, Dipl.Psych.
Received February 14, 2005; revised June 28, 2005; accepted August 9, 2005. From the Dept. of Clinical Psychology and Psychotherapy, Philipps-Univ. of Marburg, Marburg, Germany. Send correspondence and reprint requests to Dr. W. Rief, Dept. of Clinical Psychology and Psychotherapy, Philipps-Univ. of Marburg, Gutenbergstr. 18, 35032, Marburg, Germany. e-mail: rief{at}staff.uni-marburg.de
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ABSTRACT
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Patients with unexplained physical symptoms ("somatoform disorders") tend to overuse the healthcare system. Therefore, the authors aimed to assess whether a training session for general practitioners (GPs) on managing patients with unexplained physical symptoms would be acceptable to GPs and lead to improvements in patient care. In a randomized clinical trial (GPs randomized), GPs got a 1-day training session and additional materials. Included were 26 GP offices in primary care and 295 patients with unexplained physical symptoms (minimum of two symptoms required). Outcome measures were healthcare utilization (number of doctor visits) 6 months before and 6 months after the index visit to the GP, somatization severity, depression, and hypochondriacal fears at the index visit to the GP’s office and 6 months later. Training GPs to manage these patients led to significant reductions in healthcare utilization; patients of untrained GPs showed comparable attendance rates in the 6 months before and after the index visit. Differences in depression, somatization, and hypochondriacal fears, however, could not be attributed to the GP training. GPs rated the training as being highly relevant for their everyday practices, underlining the need for and acceptance of the training. Training GPs in managing patients with unexplained physical symptoms seems to be helpful for the reduction of excessive healthcare utilization. These 1-day workshops have high acceptability, so this approach could be a good model for empirically-validated continuing-education programs.
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INTRODUCTION
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For patients with mental and psychosomatic disorders, primary-care offices are the first port-of-call in seeking medical help. Depression, anxiety disorders, and unexplained physical symptoms (somatoform disorders) are extremely frequent in primary-care settings, yet they are typically unrecognized.1 Ansseau and others2 report rates of up to 42% of patients in primary care with threshold or subthreshold psychiatric disorders. Because mental disorders, especially depression, are associated with dissatisfaction with medical care,3 many doctors find these patients difficult to treat and difficult to manage in primary-care offices. Therefore, a series of primary-care intervention trials have been conducted to increase the detection rate for mental disorders and to improve their management and treatment.
Some studies have shown that training physicians in diagnosis of depression, anxiety, and other mental disorders in primary care leads to improvements in the detection of these disorders.4 The detection of mental disorders in primary-care patients can also be improved by routinely administering screening questionnaires;5,6 however, improvement in the detection of mental disorders in primary care does not necessarily lead to improvements in treatment. Furthermore, improvement in diagnosis and treatment strategies does not necessarily lead to improvements in treatment outcome of patients’ symptoms.1,4 For example, Goldberg and others7 randomized 95 practitioners to either continued quality-improvement routines or routine clinical care. However, they were unable to demonstrate improvement in patient outcomes for the active-intervention groups. In sum, primary care has a central role for the management and treatment of patients with mental and psychosomatic disorders, but there are substantial problems in detecting and managing these patients in this setting. Powerful solutions for these problems are needed.
One of the most challenging problems in primary-care patients is seeing those with unexplained physical symptoms for which no clear organic pathology can be found ("somatoform disorders"). Although this problem has been neglected for a long time, the last 15 years have revealed some successful approaches for these patients. The most difficult subgroup are those patients with multiple, persisting somatoform symptoms.8,9 A recently-published metaanalysis has shown that cognitive-behavioral therapy can be a successful treatment option for these patients.10 For the most severely disabled patients with somatization syndrome, even inpatient treatment can be cost-effective if powerful psychological interventions are included.11,12 Because these treatment options are too expensive to be provided for the whole sample of patients with unexplained symptoms, the improvement of low-cost, primary careoriented interventions for these patients is necessary. Khan and others13 emphasized that "developing better management strategies for prevalent, medically unexplained, persistent somatic symptoms is a healthcare priority."13 Therefore, we will focus on the primary-care approaches.
Goldberg and colleagues14,15 have developed a teaching package for general-practice trainees. Smith and others16 evaluated psychiatric consultation for primary-care physicians on how to manage patients with somatization disorders. Their suggested use of recommendation letters showed beneficial effects, and the results were partly replicated in subsequent studies.17 Morriss and Gask18 delivered an 8-hour reattribution training program to eight family doctors and evaluated the effects on patients before and after doctors took part in this program. They could show that patients were more satisfied with the treatment after the doctors’ training, although clinical improvements for patients were not reported. In other studies, pre–post comparisons were presented, which makes it difficult to interpret the results.19,20 Attempts to encourage primary-care patients with somatoform symptoms to engage in emotional writing yielded contradictory results.21,22 Finally, in a study by Larisch and others,23 GPs were trained to provide six 20-minute sessions of reattribution training. The authors report small and limited effects of this intervention. First attempts were also suggested to combine evaluated interventions to a "stepped-care approach."24 A Cochrane review of psychosocial intervention trials delivered by general practitioners rated these interventions as having limited or conflicting results.25 Therefore, it is still an open question whether training general practitioners can lead to clinical improvement in patients with somatoform disorders.
In this study, we also developed a training package for primary-care physicians on managing patients with unexplained physical symptoms. In this training, we included recently published results on feasible assessment and diagnostic routines, management and treatment strategies for somatoform disorders, and indication guidelines for referrals to medical and psychological specialists, and we trained general practitioners (GPs) to use management strategies in interaction with these patients.
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METHOD
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Inclusion of General Practitioners
We wrote a letter of invitation to more than 200 GPs in the area of Marburg, Germany. For their participation and in compensation for a day away from work, doctors were offered 500 Euros. By offering financial compensation, we aimed to include not only "psychologically-minded" GPs, but also to motivate other GPs to participate. After further information about the study was given by telephone, 26 GPs agreed to participate (mean age: 48 years; age range: 32 to 58 years; 17 men, 9 women; mean time since board-certification: 19.5 years; (standard deviation [SD]: 7). These 26 GPs were randomized to two doctor groups, one receiving the training package after 4 months, the second one receiving the training package after 8 months. Therefore, this design corresponds to a cluster-randomization procedure.
Patients
Patients with a history of multiple unexplained physical symptoms (at least two symptoms) not fully explained by a well-known organic etiology were the focus of our approach. The inclusion criterion of two symptoms was chosen because of its relevance as a predictor for persistence of symptoms.8 We planned to include three waves of 100 patients, which means 4 to 5 patients per GP per sample selection wave. The first wave (first cohort) was collected in the first 4 months of the study; the second cohort of patients was selected between Month 5 and Month 8 (when Doctor Group #1 had received training, whereas Doctor Group #2 had not); and the third cohort of patients was selected during Month 9 to Month 12 (after Doctor Group #2 had also received the training package). We included 295 patients with multiple unexplained symptoms (65% women; mean age: 50.6 years; age range: 17–82); however 6 patients were excluded because organic diseases were detected during the follow-up period that explained their symptoms at their first assessment. We obtained complete interview results at the 6-month follow-up from 208 of the remaining 289 patients (72%), and self-rating scales at the 6-month follow-up were available from 204 patients. Table 1 gives further information on the sample.
Study Design
The design of the study is outlined in Table 2, also including information according to the CONSORT Statement. GPs were instructed on identifying patients fulfilling the inclusion criteria; they were also given screening scales to facilitate the detection of patients. For each cohort, every GP was visited for 1 to 2 days; during this time, GPs would motivate five patients fulfilling the inclusion criteria to participate. Afterwards, a research assistant continued with the first assessment. The second (4 weeks later) and third patient assessments (6 months later) were done by telephone interview as well as mailed self-rating scales. Patients were excluded if investigations revealed organic reasons for the complaints during the 6-month period between Assessments #1 and #3. The study was approved by the university ethics committee.
Assessment instruments
The assessment of healthcare use (which was a primary outcome measure in our study) was done through a structured interview asking for healthcare utilization during the last 6 months. To increase the validity of this interview, we asked about specific healthcare use in detail (e.g., one specific item for each of 17 doctors’ specialties), and memory cues were used to avoid under-reporting of healthcare use. Patients had to report the number of doctor visits for each specialty, without our asking the reasons for the doctor visits. The mean number of doctor visits during the previous 6 months was 16.3 (SD: 15.7). The GPs were also asked about the number of doctor visits they knew of for this patient; these GP-based data were 10.7 (SD: 7.4) doctor visits, again confirming increased healthcare use, but lower than the patients’ ratings. Because GPs are not automatically informed by other doctors about their patients, we used the patients’ ratings to assess healthcare use. To reach valid psychiatric diagnoses, we used a structured clinical interview26 with sufficient interrater reliability.27 The administered self-rating scales were the Screening for Somatoform Symptoms (SOMS),28 the Beck Depression Inventory (BDI),29 the Whiteley Index (to assess health anxiety),30 and the Beck Anxiety Inventory (BAI).31
The training package: "How to Manage Patients With Unexplained Physical Symptoms"
The training package for GPs was provided during a 1-day session. It included information on the diagnosis of somatoform disorders, anxiety disorders, and depression. Screening instruments (such as the SOMS or BDI) were presented to the participants; then behavioral, cognitive, and affective features of these patients were described. The core of the training package was the presentation and discussion of management guidelines, and, if necessary, role-playing to become familiar with them. The management guidelines (see Table 3) were a synthesis of those used in other studies,16,32 further research results, and our own experience. Topics included how to communicate with these patients, when to start and when to stop medical examinations, how to handle the organic health beliefs of the patients, their need for reassurance, and their avoidance of physical activity. Finally, further treatment options were presented, as well as indication rules and ways to inform patients that referral is necessary. To support the training goals, we also provided information forms for physicians and patients.
Hypothesis, statistical procedures
Previous primary-care–oriented studies have shown that the goals of these trials have to be modest. Therefore, our principal goal was not to improve the outcome of somatization, depression, or anxiety substantially, but to improve and optimize healthcare use. One crucial aspect of such a training package is acceptance by the general practitioners. Therefore the first analysis will focus on satisfaction ratings of the GPs after the training sessions.
As a more general approach to data analysis, we initially planned to compare results for patients of trained and untrained GPs. This approach might yield general tendencies, but it is confounded by nonspecific time-dependent changes (e.g., improvement though experience of GPs). A more specific approach for data analysis is the following: Because GP Group 1 got training before the acquisition of the second cohort, we expected better results in the patients of Cohort 2 and Cohort 3, compared with Cohort 1 in this GP group. In GP Group 2, we expected a better outcome in Cohort 3 than in Cohort 1 and Cohort 2, because this group got the training between the acquisition of Cohort 2 and Cohort 3.
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RESULTS
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GPs’ satisfaction ratings
After the 1-day training session, the participating GPs answered a self-rating scale including 12 items asking for different aspects of doctors’ satisfaction with the training (e.g., on theoretical background, diagnostic usefulness, applicability, provided material, possibility of discussing problems with patients, competence of trainers, relevance for everyday practice, general rating, recommendation for other GPs). These 12 items revealed highly similar results; therefore we will primarily report the data of the key item "How relevant was the workshop for your everyday practice in your GP office?" The answers were the following (all ratings on a 5-point Likert scale): extremely relevant, 48%; highly relevant, 39%; partially relevant, 9%; with low relevance, 4%; and very low relevance, 0%. It is obvious that the GPs found the education very useful. Highest ratings were for Opportunity to Ask Questions (mean: 1.18), Competence of Trainers (1.47), "I would recommend this training to other GPs." (1.76), and Quality of Provided Materials (1.71), whereas ratings were lowest for practical exercises during the training session (2.54).
Patients’ diagnoses
As expected, in most patients the unexplained physical symptoms were not fully accounted for by an organic condition or by anxiety or affective disorders: 242 patients (82%), therefore, received a diagnosis of somatoform disorder (52 [17.6%], somatization disorder; 107 [36.3%], undifferentiated somatoform disorder; 79 [26.8%], somatoform pain disorder; 6 [2%], conversion disorder; 32 [10.8%], hypochondriasis). All patients not fulfilling the criteria for a somatoform disorder fulfilled criteria either for depression or anxiety disorder. Forty-five percent of the total sample had anxiety disorders (44 [14.9%], panic disorder), 36% had affective disorders (60 [20.3%], major depression; 17 [5.8%], dysthymia). A mean BDI score of 13 indicated that most patients were mildly-to-moderately depressed. In the diagnostic interview, patients reported a mean of seven different somatic symptoms (see Table 1 for scores).
Specific Training Effects on Patient Outcome
To evaluate specific training effects, patients of the two GP groups were analyzed separately, expecting differences between Cohort 1 versus Cohorts 2 and 3 in GP Group 1, respectively, differences between Cohort 1 and 2 versus Cohort 3 in GP Group 2. However, this specific result was only found for number of doctor visits during the last 6 months (Table 5). In both subgroups, we found a significant interaction of cohort x time in the expected direction.
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TABLE 5. Healthcare Utilization (Number of Doctor Visits) 6 Months Before and After the General Practitioner (GP) Index Visit
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For more general analysis, we summarized all data of patients from untrained physicians and those from trained physicians. Table 4 demonstrates that for most variables, the mean patient outcome is better in the trained GP groups than in the untrained GP groups. However, a significant interaction between training of GPs x time-point was only found for the number of doctor visits, the number of somatoform symptoms (assessed by interview), and anxiety. Table 4 also reports the effect sizes comparing index visit and 6-month follow-up data for the single groups; again, effect sizes are typically higher in the intervention group than in the group of patients of untrained GPs.
Further Analyses
We further analyzed a possible effect of the subgroups of somatoform disorders on healthcare use. Therefore, the patients were re-grouped into those with undifferentiated somatoform disorders, somatoform pain disorder, somatization disorder, and others. As expected, we found the highest scores for healthcare use in the somatization-disorder group (F[3, 199]=4.3; p <0.01), and a significant effect for assessment-point (index visit versus 6-month follow-up: F[1, 199]=6.5; p <0.02), but the interaction was not significant (F[3, 199]=1.7; NS), indicating no differential course in the subgroups of somatoform disorders. Also, we repeated these analyses with anxiety disorders (panic, social phobia, generalized anxiety disorder) as well as with depression (major depression, dysthymia) as grouping factors. Both analyses confirmed a significant time factor, but no effects for the grouping variable or for the interaction of group with assessment-point. The course of patients with versus without depression, respective to anxiety, was not significantly different.
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DISCUSSION
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Patients with unexplained physical symptoms are a major challenge in primary care. Previous results have demonstrated that these patients are frequently "high users" of the healthcare system. The patient sample in this study certainly fulfilled the criterion of abnormal healthcare use, with an average of 16 doctor visits during the last 6 months before study entry. Therefore, the reduction and normalization of healthcare usage is a major goal in the management of patients with unexplained physical symptoms/somatoform disorders, at least in the sample examined in this study.
The present study demonstrated that training general practitioners to manage patients with unexplained physical symptoms leads to a reduction in excessive doctor visits. Although the number of doctor visits in the 6 months before and after the index visit was nearly identical when GPs were untrained, in those patients with trained GPs, the number of encounters decreased by about 6 visits. We have to acknowledge that the healthcare utilization of these patients is still unsatisfactorily high, even when GPs have been trained; yet the training was obviously cost-effective. In another study,16 psychiatric consultation of GPs has led to some improvements in patients, but not to reductions in doctor visits; however, in that study, healthcare utilization was not as abnormally high as in our sample.
Patients described a small reduction in general psychopathology between the index visit and the 6-month follow-up. Although some data indicate better outcomes for patients of trained GPs (number of somatoform symptoms [interview data], anxiety), the attribution of this effect to the GP training is less clear and can be confounded by time-effects (i.e., GPs becoming more experienced or more sensitive to patients with unexplained physical symptoms). Interestingly, we found divergent results for the number of somatoform symptoms in the interview versus the self-rating scale. However, taking into consideration the results of former primary-care studies, we could not expect more pronounced benefits of our training program than we found. In a review of the literature by Kroenke and colleagues,4 only 4 of the 11 interventions to improve provider treatment of mental disorders in primary care led to significant decreases in psychiatric symptoms in patient samples. Rosendal and others, from Denmark,33 found that a GP training in assessment and treatment of somatization was well accepted by the GPs, even though clinical improvement for patients was unclear. Moreover, especially for patients with multiple somatoform symptoms (as in our sample), long-term outcome of more intense treatments is still a critical point.34 Since our intervention was just 1 day, a substantial benefit for general patient-outcome variables would be unrealistic. Greater effects might be found if GPs were trained to provide multi-session psychosocial interventions. In the study by Larisch et al.,23 GPs provided each patient with attribution therapy over six 20-minute sessions.
The question arises whether the selection of general practitioners might have influenced the results. A doctor-participation rate of 1 in 10 is quite typical in primary-care studies, but might have led to a selection bias. Participating doctors got a financial reimbursement of 500 Euros for attending the 1-day GP training and supporting patient acquisition in their office. Therefore, not only "psychologically-minded doctors" were included; some of the participating GPs argued during the training session that physical symptoms cannot be caused by psychological distress. In further analyses to be reported later, we will examine associations between the attitudes of GPs and the outcome in patients with unexplained physical symptoms.
We also have to discuss patient-selection processes. Although we expected more patients with "acute" symptoms, the sample selected from our participating GPs was obviously highly disabled, had a long history of multiple somatic complaints, and extraordinary levels of healthcare utilization. It might be possible that the GPs changed their patient-selection principles during the trial, leading to different patient characteristics in the cohorts. The pre-selection of patients from GPs was a precondition defined by the ethics committee, although, from a scientific point of view, a standardized case definition (e.g., by screening-questionnaires) would have been preferable. Although there were no signs of substantial cohort differences, the central analyses depend on intra-individual measures (e.g., healthcare use 6 months before index visit versus 6 months after the index visit of the same patient), and should be less prone to patient-selection bias. Some selection processes are also reflected in the healthcare-use data presented in Table 3: Patients from the three cohorts of the two GP groups report somewhat differing healthcare usage, leading to one sub-cohort of untrained GPs with a reduction in doctor visits comparable to two other cohorts from trained groups. Therefore, differences in physician groups, training effects of GPs on patient selection, and differences in initial values between patient groups may have caused some confounding effects, although our analyses were mainly based on intra-individual comparisons.
Finally, another shortcoming of our study is the small number of general practitioners involved. It would be desirable to have many more GPs involved and randomized to a training versus non-training group. However, such an approach is based on the assumption that patients from different doctors, different physician offices, different physician specialties, and different treatments would be comparable; this might be a critical point. Therefore we have used a "within-doctors" design to compare possible consequences of the GP training for one and the same doctor, and to avoid comparing offices with different patient characteristics. The inclusion of more doctors and more patients might have led to significant effects, not only for the number of doctor visits, but also for some other psychopathological variables. The problems through the selection of GPs and patients are typically related: many studies including high numbers of doctors included only very few patients per doctors (e.g., four patients per doctor, in Larisch et al.23, whereas others included few offices, but many patients per doctor (e.g., three offices included in the Dickinson et al. study.17 In our study, the mean patient number per doctor was 15.
Although training GPs is possibly an important step toward improving treatment for patients with unexplained physical symptoms, it is also obvious that it is not sufficient for many of them. Therefore, it is still necessary to evaluate more intense interventions.10,35 Despite these shortcomings, our results encourage continuation of this line of research.
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ACKNOWLEDGMENTS
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This study was funded by a grant from the German Ministry of Education and Research (BMBF) to W. Rief.
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ABSTRACT
INTRODUCTION
