Judith S. Lyles

Primary Care Clinicians Treat Patients with Medically Unexplained Symptoms: A Randomized Controlled Trial

AbstractOBJECTIVE: There is no proven primary care treatment for patients with medically unexplained symptoms (MUS). We hypothesized that a long-term, multidimensional intervention by primary care providers would improve MUS patients’ mental health. DESIGN: Clinical trial. SETTING: HMO in Lansing, MI. PARTICIPANTS: Patients from 18 to 65 years old with 2 consecutive years of high utilization were identified as having MUS by a reliable chart rating procedure; 206 subjects were randomized and 200 completed the study. INTERVENTION: From May 2000 to January 2003, 4 primary care clinicians deployed a 12-month intervention consisting of cognitive-behavioral, pharmacological, and other treatment modalities. A behaviorally defined patient-centered method was used by clinicians to facilitate this treatment and the provider-patient relationship. MAIN OUTCOME MEASURE: The primary endpoint was an improvement from baseline to 12 months of 4 or more points on the Mental Component Summary of the SF-36. RESULTS: Two hundred patients averaged 13.6 visits for the year preceding study. The average age was 47.7 years and 79.1% were females. Using intent to treat, 48 treatment and 34 control patients improved (odds ratio [OR]=1.92, 95% confidence interval [CI]: 1.08 to 3.40; P=.02). The relative benefit (relative “risk” for improving) was 1.47 (CI: 1.05 to 2.07), and the number needed to treat was 6.4 (95% CI: 0.89 to 11.89). The following baseline measures predicted improvement: severe mental dysfunction (P<.001), severe body pain (P=.039), nonsevere physical dysfunction (P=.003), and at least 16 years of education (P=.022); c-statistic=0.75. CONCLUSION: The first multidimensional intervention by primary care clinicians led to clinically significant improvement in MUS patients.

Exploration of DSM-IV criteria in primary care patients with medically unexplained symptoms.

Objectives: Investigators and clinicians almost always rely on Diagnostic and Statistical Manual of Mental Disorder, 4th edition’s (DSM-IV) somatoform disorders (and its derivative diagnoses) to characterize and identify patients with medically unexplained symptoms (MUS). Our objective was to evaluate this use by determining the prevalence of DSM-IV somatoform and nonsomatoform disorders in patients with MUS proven by a gold standard chart review. Methods: In a community-based staff model HMO, we identified subjects for a clinical trial using a systematic and reliable chart rating procedure among high-utilizing MUS patients. Only baseline data are reported here. The World Health Organization Composite International Diagnostic Interview provided full and abridged DSM-IV diagnoses. Patients with full or abridged DSM-IV somatoform diagnoses were labeled “DSM somatoform-positive,” whereas those without them were labeled “DSM somatoform-negative.” Results: Two hundred six MUS patients averaged 13.6 visits in the year preceding study, 79.1% were females, and the average age was 47.7 years. We found that 124 patients (60.2%) had a nonsomatoform (“psychiatric”) DSM-IV diagnosis of any type; 36 (17.5%) had 2 full nonsomatoform diagnoses, and 41 (19.9%) had >2; 92 (44.7%) had some full anxiety diagnosis and 94 (45.6%) had either full depression or minor depression diagnoses. However, only 9 of 206 (4.4%) had any full DSM-IV somatoform diagnosis, and only 39 (18.9%) had abridged somatization disorder. Thus, 48 (23.3%) were “DSM somatoform-positive” and 158 (76.7%) were “DSM somatoform-negative.” The latter exhibited less anxiety, depression, mental dysfunction, and psychosomatic symptoms (all p <.001) and less physical dysfunction (p = .011). Correlates of this DSM somatoform-negative status were female gender (p = .007), less severe mental (p = .007), and physical dysfunction (p = .004), a decreased proportion of MUS (p <.10), and less psychiatric comorbidity (p <.10); c-statistic = 0.77. Conclusion: We concluded that depression and anxiety characterized MUS patients better than the somatoform disorders. Our data suggested radically revising the somatoform disorders for DSM-V by incorporating a new, very large group of now-overlooked DSM somatoform-negative patients who were typically women with less severe dysfunction. HMO = health maintenance organization DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th edition DSM-V = planned for approximately 2010, the Diagnostic and Statistical Manual of Mental Disorders, 5th edition MUS = medically unexplained symptoms ECA = epidemiologic catchment area SD = somatization disorder SF-36 = Short-Form 36 MCS = Mental Component Summary of the SF-36 PCS = Physical Component Summary of the SF-36 SSAS = Spielberger State Anxiety Scale CES-D = Center for Epidemiological Studies Depression inventory PSC = Psychosomatic Symptom Checklist WHO-CIDI = World Health Organization Composite International Diagnostic Interview.

Treating Patients with Medically Unexplained Symptoms in Primary Care

BACKGROUND: There are no proven, comprehensive treatments in primary care for patients with medically unexplained symptoms (MUS) even though these patients have high levels of psychosocial distress, medical disability, costs, and utilization. Despite extensive care, these common patients often become worse.OBJECTIVE: We sought to identify an effective, research-based treatment that can be conducted by primary care personnel.DESIGN: We used our own experiences and files, consulted with experts, and conducted an extensive review of the literature to identify two things: 1) effective treatments from randomized controlled trials for MUS patients in primary care and in specialty settings; and 2) any type of treatment study in a related area that might inform primary care treatment, for example, depression, provider-patient relationship.MAIN RESULTS: We developed a multidimensional treatment plan by integrating several areas of the literature: collaborative/stepped care, cognitive-behavioral treatment, and the provider-patient relationship. The treatment is designed for primary care personnel (physicians, physician assistants, nurse practitioners) and deployed intensively at the outset; visit intervals are progressively increased as stability and improvement occur.CONCLUSION: Providing a comprehensive treatment plan for chronic, high-utilizing MUS patients removes one barrier to treating this common problem effectively in primary care by primary care personnel.

Efficacy of a one-month training block in psychosocial medicine for residents : a controlled study

Study objective:To determine the efficacy of a comprehensive, one-month psychosocial training program for first-year medical residents.Design:Nonrandomized, controlled study with immediate pre/post evaluation. Limited evaluation of some residents was also conducted an average of 15 months after teaching.Setting:Community-based, primary care-oriented residency program at Michigan State University (MSU).Subjects:All 28 interns from the single-track MSU residency program during 1986/87–88/89 participated in this required rotation; there was no dropout or instance of noncompliance with the study. In the follow-up study in 1989, all 13 available trainees participated. Of 20 untrained, volunteer controls, ten were second/third-year residents in the same program during 1986/87 and ten were interns from a similar MSU program in Kalamazoo, MI, during 1988/89.Teaching intervention:An experiential, skill-oriented, and learner-centered rotation with competency-based objects focused on communication and relationship-building skills and on the diagnosis and management of psychologically disturbed medical patients.Measurements and main results:The two subsets of the control group were combined because residents and training programs were similar and because means and standard deviations for the subsets were similar on all measures. By two-way analyses of variance (group×gender), the trainee group showed significantly greater gains (p<0.001) on questionnaires addressing knowledge, self-assessment, and attitudes; a mean of 15 months following training, there was no significant deterioration of attitude scores. All trainees were also able to identify previously unrecognized, potentially deleterious personal responses using a systematic rating procedure. Residents’ acceptance of the program was high.Conclusions:Intensive, comprehensive psychosocial training was well accepted by residents. It improved their knowledge, self-awareness, self-assessment, and attitudes, the latter improvement persisting well beyond training.

Using nurse practitioners to implement an intervention in primary care for high-utilizing patients with medically unexplained symptoms

Patients with medically unexplained symptoms (MUS) often are a source of frustration for clinicians, and despite high quality biomedical attention and frequent diagnostic tests, they have poor health outcomes. Following upon progress in depression treatment approaches, we developed a multidimensional treatment protocol for deployment by primary care personnel. This multi-faceted intervention for MUS patients emphasized cognitive-behavioral principles, the provider-patient relationship, pharmacological management, and treating comorbid medical diseases. We deployed it in an HMO using nurse practitioners (NP) to deliver the intervention to 101 patients, while 102 controls continued to receive medical care from their usual primary care physician. Successful deployment of the intervention required training the NPs, continuing support for the NPs in their management of this difficult population, and establishing strong communication links with the HMO. This paper addresses the practical considerations of using primary care personnel to implement a complex intervention in primary care, and it includes a discussion of special challenges encountered as well as solutions developed to overcome them.

IMPROVING RESIDENTS CONFIDENCE IN USING PSYCHOSOCIAL SKILLS

OBJECTIVE: To evaluate an intensive training program’s effects on residents’ confidence in their ability in, anticipation of positive outcomes from, and personal commitment to psychosocial behaviors.DESIGN: Controlled randomized study.SETTING: A university- and community-based primary care residency training program.PARTICIPANTS: 26 first-year residents in internal medicine and family practice.INTERVENTION: The residents were randomly assigned to a control group or to one-month intensive training centered on psychosocial skills needed in primary care.MEASUREMENTS: Questionnaires measuring knowledge of psychosocial medicine, and self-confidence in, anticipation of positive outcomes from, and personal commitment to five skill areas: psychological sensitivity, emotional sensitivity, management of somatization, and directive and nondirective facilitation of patient communication.RESULTS: The trained residents expressed higher self-confidence in all five areas of psychosocial skill (p<0.03 for all tests), anticipated more positive outcomes for emotional sensitivity (p=0.05), managing somatization (p=0.03), and nondirectively facilitating patient communication (p=0.02), and were more strongly committed to being emotionally sensitive (p=0.055) and managing somatization (p=0.056), compared with the untrained residents. The trained residents also evidenced more knowledge of psychosocial medicine than did the untrained residents (p<0.001).CONCLUSIONS: Intensive psychosocial training improves residents’ self-confidence in their ability regarding key psychosocial behaviors and increases their knowledge of psychosocial medicine. Training also increases anticipation of positive outcomes from and personal commitment to some, but not all, psychosocial skills.

A Method for Rating Charts to Identify and Classify Patients with Medically Unexplained Symptoms

Background: As part of conducting a randomized control trial (RCT) to treat chronically high utilizing patients with medically unexplained symptoms (MUS), we developed the chart rating method reported here to identify and classify MUS subjects. Method: Intended at this point only as a research tool, the method is comprehensive, uses explicit guidelines, and requires clinician raters. It distinguishes primary organic disease patients from those with primary MUS, quantifies medical comorbidities in primary MUS patients, and also distinguishes subgroups among MUS patients that we call somatization (resembles DSM-IV somatoform disorders) and minor acute illness (MAI) which differs from DSM-IV somatoform definitions. Scoring rules are used to generate the diagnoses above. The rules may be set according to the investigator’s needs, from highly sensitive to highly specific. Results: We found high levels of agreement with the gold standard for MUS vs. organic disease (97.6%) and among raters for the key individual chart elements rated (92–96%). The method identified 206 MUS subjects and the extent of their medical comorbidities for entry into a RCT. It also identified somatization and MAI; the latter supports the validity of this newly reported MAI syndrome. Conclusion: We concluded that this method offered research potential for identifying MUS patients, for quantifying their medical comorbidities, and for classifying MUS subgroups.

In their own words: qualitative study of high-utilising primary care patients with medically unexplained symptoms

BackgroundHigh utilising primary care patients with medically unexplained symptoms (MUS) often frustrate their primary care providers. Studies that elucidate the attitudes of these patients may help to increase understanding and improve confidence of clinicians who care for them. The objective of this study was to describe and analyze perceptions and lived experiences of high utilising primary care patients with MUS.MethodsA purposive sample of 19 high utilising primary care patients for whom at least 50% (69.6% in this sample) of visits for two years could not be explained medically, were encouraged to talk spontaneously about themselves and answer semi-structured questions. Verbatim transcripts of interviews were analyzed using an iterative consensus building process.ResultsPatients with MUS almost universally described current and/or past family dysfunction and were subjected to excessive testing and ineffective empirical treatments. Three distinct groups emerged from the data. 1) Some patients, who had achieved a significant degree of psychological insight and had success in life, primarily sought explanations for their symptoms. 2) Patients who had less psychological insight were more disabled by their symptoms and felt strongly entitled to be excused from normal social obligations. Typically, these patients primarily sought symptom relief, legitimization, and support. 3) Patients who expressed worry about missed diagnoses demanded excessive care and complained when their demands were resisted.ConclusionHigh utilising primary care patients are a heterogeneous group with similar experiences and different perceptions, behaviours and needs. Recognizing these differences may be critical to effective treatment and reduction in utilisation.

Screening for high utilizing somatizing patients using a prediction rule derived from the management information system of an HMO: a preliminary study.

Background.Somatization is a common, costly problem with great morbidity, but there has been no effective screening method to identify these patients and target them for treatment. Objectives.We tested a hypothesis that we could identify high utilizing somatizing patients from a management information system (MIS) by total number of visits and what we termed “somatization potential,” the percentage of visits for which ICD-9 primary diagnosis codes represented disorders in the musculoskeletal, nervous, or gastrointestinal systems or ill-defined complaints. Methods.We identified 883 high users from the MIS of a large staff model HMO as those having six or more visits during the year studied (65th percentile). A physician rater, without knowledge of hypotheses and predictors, then reviewed the medical records of these patients and identified somatizing patients (n = 122) and nonsomatizing patients (n = 761). In two-thirds of the population (the derivation set), we used logistic regression to refine our hypothesis and identify predictors of somatization available from the MIS: demographic data, all medical encounters, and primary diagnoses made by usual care physicians (ICD-9 codes). We then tested our prediction model in the remaining one-third of the population (the validation set) to validate its usefulness. Results.The derivation set contained the following significant correlates of somatization: gender, total number of visits, and percent of visits with somatization potential. The c-statistic, equivalent to the area under the ROC curve, was 0.90. In the validation set, the explanatory power was less with a still impressive c-statistic of 0.78. A predicted probability of 0.04 identified almost all somatizers, whereas a predicted probability of 0.40 identified about half of all somatizers but produced few false positives. Conclusions.We have developed and validated a prediction model from the MIS that helps to distinguish chronic somatizing patients from other high utilizing patients. Our method requires corroboration but carries the promise of providing clinicians and health plan directors with an inexpensive, simple approach for identifying the common somatizing patient and, in turn, targeting them for treatment. The screener does not require clinicians’ time.