Measures In Patients Research Articles

Randomized trial of a meditation-based stress reduction program and cognitive behavior therapy in generalized social anxiety disorder

Mindfulness-based stress reduction (MBSR) has been reported to reduce anxiety in a broad range of clinical populations. However, its efficacy in alleviating core symptoms of specific anxiety disorders is not well established. We conducted a randomized trial to evaluate how well MBSR compared to a first-line psychological intervention for social anxiety disorder (SAD). Fifty-three patients with DSM-IV generalized SAD were randomized to an 8-week course of MBSR or 12 weekly sessions of cognitive–behavioral group therapy (CBGT). Although patients in both treatment groups improved, patients receiving CBGT had significantly lower scores on clinician- and patient-rated measures of social anxiety. Response and remission rates were also significantly greater with CBGT. Both interventions were comparable in improving mood, functionality and quality of life. The results confirm that CBGT is the treatment of choice of generalized SAD and suggest that MBSR may have some benefit in the treatment of generalized SAD.

0449 INSOMNIA AND EXCESSIVE DAYTIME SLEEPINESS IN PSYCHOTIC PATIENTS TAKING TRADITIONAL OR ATYPICAL ANTIPSYCHOTIC MEDICATIONS

The Patient-Rated Troubling Symptoms of Depression (PaRTS-D) instrument assesses the presence and troublesomeness of 8 commonly reported depression-related symptoms from the patient's perspective. A post hoc analysis of a double-blind, randomized risperidone augmentation to antidepressant therapy trial in patients with major depressive disorder explored the relationship between the PaRTS-D instrument and other clinician- and patient-rating scales.Patients completed the PaRTS-D; the Patient Global Improvement Scale (PGIS), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and the Sheehan Disability Scale (SDS), while clinicians completed the Hamilton Rating Scale for Depression (HRSD-17), and the Clinical Global Impressions of Severity (CGI-S) at baseline and at pre-determined study weeks.In the PaRTS-D instrument, the four most frequently reported and troublesome symptoms were sadness (73.5%, severity 6.8), trouble concentrating (70.9%, 7.3), reduced involvement in pleasurable activities (61.9%, 7.3), and being tense or uptight (56.0%, 6.7). The improvement in PaRTS-D total score was significantly greater in risperidone-augmented compared with placebo-augmented patients at week 4 (p = 0.034) and week 6 (p = 0.007). Pearson correlations between the PaRTS-D scores and the measures of HRSD-17, CGI-S, PGIS, Q-LES-Q, and SDS were significant at both baseline and at week 6 LOCF (p < 0.001 for each comparison).Results are from a post hoc analysis.Significant correlations were observed between the PaRTS-D and other clinician- and patient-rated measures, with PaRTS-D being sensitive to the effects of treatment. These findings suggest that the PaRTS-D instrument is a reliable scale to assess antidepressant activity as experienced by the patients.

Randomized Trial of a Telephone Care Management Program for Outpatients Starting Antidepressant Treatment

Randomized Trial of a Telephone Care Management Program for Outpatients Starting Antidepressant Treatment

Does personalized feedback improve the outcome of cognitive‐behavioural guided self‐care in bulimia nervosa? A preliminary randomized controlled trial

Feedback has long been a part of psychosocial and health behaviour interventions and with the advent of computerised assessment and treatment tools, is gaining greater importance. The aim of the present study was to evaluate the addition of personalized feedback to a guided cognitive-behavioural (CBT) self-help programme for patients with bulimia nervosa. Randomised-controlled trial. 61 patients with DSM-IV bulimia nervosa or eating disorder not otherwise specified (EDNOS) were randomly allocated to receive 14 sessions of cognitive behavioural guided self-care with or without added personalised feedback on current physical and psychological status, risk and problems, and variables facilitating or hindering change. Feedback to patients was delivered in a number of ways: (a) personalised letters after assessment and at the end of treatment, (b) a specially designed feedback form administered half-way through treatment, (c) computerised feedback about bulimic and other symptoms, such as anxiety, depression and interpersonal functioning repeated at intervals throughout treatment and follow-up. Outcome was assessed using patient-rated measures of bulimic symptoms at the end of treatment and at 6-month follow-up. The data were analysed using maximum likelihood methods of assess group differences at the follow-up. Added feedback did not have an effect on take-up or drop-out from treatment. However, it improved outcome by reducing self-induced vomiting and dietary restriction more effectively. The findings lend support to the notion that the addition of repeated personalised feedback improves outcome from guided CBT self-help treatment and deserves further study.

Outcome scores in spinal surgery quantified: excellent, good, fair and poor in terms of patient-completed tools

Outcome scores are very useful tools in the field of spinal surgery as they allow us to assess a patient's progress and the effect of various treatments. The clinical importance of a score change is not so clear. Although previous studies have looked at the minimum clinically important score change, the degree of score change varies considerably. Our study is a prospective cohort study of 193 patients undergoing discectomy, decompression and fusion procedures with minimum 2-year follow-up. We have used three standard outcome measures in common usage, the oswestry disability index (ODI), the low back outcome score (LBOS) and the visual analogue score (VAS). We have defined each of these scores according to a global measure of outcome graded by the patient as excellent, good, fair or poor. We have also graded patient perception and classified excellent and good as success and fair and poor as failure. Our results suggest that a median 24-point change in the ODI equates with a good outcome or is the minimum change needed for success. We have also found that different surgical disorders have very different minimal clinically important differences as perceived by patient perception. We found that for a discectomy a minimum 27-point change in the ODI would be classed as a success, for a decompression the change in ODI needed to class it as a success would be 16 points, whereas for a fusion the change in the ODI would be only 13 points. We believe that patient-rated global measures of outcome are of value and we have quantified them in terms of the standard outcome measures used in spinal surgery.

Long-term outcome of cognitive behaviour therapy clinical trials in central Scotland

To establish the long-term outcome of participants in clinical trials of cognitive behaviour therapy (CBT) for anxiety disorders and psychosis, examining the effectiveness and cost-effectiveness associated with receiving CBT in comparison with alternative treatments. An attempt was made to contact and interview all of the participants in eight randomised, controlled, clinical trials of CBT for anxiety disorders and two randomised, controlled, clinical trials of CBT for schizophrenia conducted between 1985 and 2001. Case note reviews of healthcare resources used in the 2 years prior to entering the trials and the 2 years prior to follow-up interview were undertaken. Mixed rural and urban settings in five localities in central Scotland. Anxiety disorder trials were conducted mainly in primary care and included three with generalised anxiety disorder, four with panic disorder and one with post-traumatic stress disorder (PTSD). The psychosis studies (one on relapse prevention and one with chronic disorder) were conducted in secondary care. Of the 1071 entrants to the 10 studies, 489 agreed to participate (46% of original entrants, 52% of those available to contact). Follow-up interviews took place between 1999 and 2003, 2-14 years after the original treatment. Interviews for Trials 1-8 were conducted by a research psychologist blind to original treatment condition. Interviews for Trials 9 and 10 were conducted by community psychiatric nurses also blind to treatment condition. Case note reviews were completed following the interview. For Trials 1-8 the main interview-based outcome measures were: Anxiety Disorders Interview Schedule-DSM-IV for diagnosis and co-morbidity, Clinical Global Severity (0-8) and the Hamilton Anxiety Rating Scale. The main patient-rated measures were: Brief Symptom Inventory, SF-36 II, Clinical Global Improvement (1-7), and the Positive and Negative Affect Scale. For Trials 9 and 10 the primary outcome measure was the interview-based Positive and Negative Syndrome Scale (PANSS). For the anxiety disorder studies (Trials 1-8), over half of the participants (52%) had at least one diagnosis at long-term follow-up, with significant levels of co-morbidity and health status scores comparable to the lowest 10% of the general population. Only 36% reported receiving no interim treatment for anxiety over the follow-up period with 19% receiving almost constant treatment. Patients with PTSD did particularly poorly. There was a 40% real increase in healthcare costs over the two time periods, mainly due to an increase in prescribing. A close relationship was found between poor mental and physical health for those with a chronic anxiety disorder. Treatment with CBT was associated with a better long-term outcome than non-CBT in terms of overall symptom severity but not with regard to diagnostic status. The positive effects of CBT found in the original trials were eroded over longer time periods. No evidence was found for an association between more intensive therapy and more enduring effects of CBT. Long-term outcome was found to be most strongly predicted by the complexity and severity of presenting problems at the time of referral, by completion of treatment irrespective of modality and by the amount of interim treatment during the follow-up period. The quality of the therapeutic alliance, measured in two of the studies, was not related to long-term outcome but was related to short-term outcome. The cost-effectiveness analysis showed no advantages of CBT over non-CBT. The cost of providing CBT in the original trials was only a very small proportion (6.4%) of the overall costs of healthcare for this population, which are high for both physical and mental health problems. In the psychosis studies (Trials 9 and 10), outcome was generally poor with only 10% achieving a 25% reduction in total PANSS scores from pretreatment to long-term follow-up, also cost-effectiveness analysis showed no advantages of CBT over non-CBT, although healthcare costs fell over the two time periods mainly owing to a reduction in inpatient costs. Psychological therapy services need to recognise that anxiety disorders tend to follow a chronic course and that good outcomes with CBT over the short term are no guarantee of good outcomes over the longer term. Clinicians who go beyond standard treatment protocols of about 10 sessions over a 6-month period are unlikely to bring about greater improvement. Poor outcomes over the long term are related to greater complexity and severity of presenting problems at the time of referral, failure to complete treatment irrespective of modality and the amount of interim treatment during the follow-up period. The relative gains of CBT are greater in anxiety disorders than in psychosis. Longitudinal research designs over extended periods of time (2-5 years), with large numbers of participants (500+), are required to investigate the relative importance of patient characteristics, therapeutic alliance and therapist expertise in determining the cost-effectiveness of CBT in the longer term.

Measuring Atopic Eczema Severity Visually

There is wide variation in the objective visual variables used to measure atopic eczema severity in clinical trials, making comparison and interpretation of results difficult. To provide a rationale for simplifying and standardizing objective atopic eczema scoring by investigating which visual variables provide the best measure of disease severity from the patient's perspective. The dermatology outpatient department at the Queen's Medical Centre, University Hospital in Nottingham, and 5 local general practices. One hundred eighty individuals with atopic eczema. Clinical examination with scoring of 7 clinical signs and disease extent, followed by regression analyses of visual variable scores against a patient-rated measure of current disease severity. Objective measurements account for only a quarter of the variation in patient-rated disease severity. Three clinical signs were independent predictors of patient-rated disease severity: excoriations, erythema, and edema/papulation. Disease extent measurements do not reflect patient-rated disease severity in a linear manner, with mean severity scores increasing little above 30% body surface area involvement. From the patient's perspective, the measurement of 3 clinical signs-excoriations, erythema, and edema/papulation-provides as much information about current atopic eczema severity as more complex scoring systems that measure multiple clinical signs and disease extent. The simplicity of the Three Item Severity score, a previously published atopic eczema score based on measurement of these 3 clinical signs, makes it a suitable tool for research studies or clinical practice.

Pain Dominates Measurements of Elbow Function and Health Status

Elbow function can be quantified with use of physician-based elbow-rating systems and health status questionnaires. Our hypothesis was that pain has a strong influence on these scores, which overwhelms the influence of objective factors such as motion. One hundred and four patients were evaluated, at a minimum of six months (average, forty-six months) after the latest surgery for an intra-articular fracture of the elbow, with use of three physician-based evaluation instruments (Mayo Elbow Performance Index [MEPI], Broberg and Morrey rating system, and American Shoulder and Elbow Surgeons Elbow Evaluation Instrument [ASES]), an upper-extremity-specific health status questionnaire (Disabilities of the Arm, Shoulder and Hand [DASH]), and a general health status questionnaire (Short Form-36 [SF-36]). Multivariate analysis of variance and regression modeling were used to identify the factors that account for the variability in scores derived with these measures-in other words, which factors have the strongest influence on the final score. Pain alone accounted for 66% of the variability in the MEPI scores, 59% of the variability in the Broberg and Morrey scores, and 57% of the variability in the ASES scores. Models that included other factors accounted for only slightly more variability (73%, 79%, and 79%, respectively), and those that did not include pain accounted for only 22%, 41%, and 41% of the variability. Thirty-six percent of the variability in the DASH scores could be accounted for by pain alone, and 45% could be accounted for by pain and range of motion. Models not including pain accounted for only 17% of the variability in the DASH scores. Pain has a very strong influence on both physician-rated and patient-rated quantitative measures of elbow function. Consequently, these measures may be strongly influenced by the psychosocial aspects of illness that have a strong relationship with pain, and objective measures of elbow function such as mobility may be undervalued. It may be advisable to evaluate pain separately from objective measures of elbow function in physician-based elbow ratings.

Severe Obsessive-Compulsive Disorder With and Without Comorbid Hair Pulling

Chronic hair pulling and trichotillomania are putative obsessive-compulsive spectrum disorders. This study determined the prevalence of hair pulling in an inpatient obsessive-compulsive disorder (OCD) population and compared clinical characteristics and treatment response between subgroups with and without comorbid hair pulling. Patients with severe DSM-IV-diagnosed OCD (N = 154) who were consecutively admitted to an OCD residential treatment facility between August 2000 and July 2003 were included. Clinician-rated (Yale-Brown Obsessive Compulsive Scale) and patient-rated (Massachusetts General Hospital Hairpulling Scale, Beck Depression Inventory, and Posttraumatic Diagnostic Scale) measures were administered at index evaluation. OCD patients with and without moderate to severe hair pulling were statistically compared on clinical and treatment characteristics and treatment response. Of the OCD subjects, 18.8% (N = 29) endorsed any hair pulling, 15.6% (N = 24) had moderate to severe hair pulling, and 7.8% (N = 12) had severe hair pulling comparable to that of a specialty trichotillomania clinic population. OCD patients with moderate to severe hair pulling were more likely to be women (p < .001), endorse > 1 comorbid tic (p < .05), and have earlier-onset OCD (p = .001). This cohort also had fewer contamination obsessions (p = .04) and checking compulsions (p = .04) and was more likely to be receiving stimulant (p = .006) or venlafaxine (p = .02) medication than those patients without hair pulling. Posttraumatic Diagnostic Scale scores were nearly significantly higher in the OCD + hair pulling group (p = .08). OCD treatment response was unaffected by the presence of comorbid hair pulling. Hair pulling is a highly common comorbidity in severe OCD. Women and early-onset OCD patients appear to be more vulnerable to comorbid hair pulling. OCD sufferers with comorbid hair pulling also exhibit an increased risk for tics and may present with different OCD symptomatology.

Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study

BackgroundLate-life depression is a common, chronic and recurring disorder for which guidelines recommend long-term therapy. The safety and efficacy of duloxetine for the treatment of major depressive disorder (MDD) were evaluated using data from elderly patients (age ≥ 65 years; n = 101) who participated in a large, multinational, open-label study.MethodsPatients meeting DSM-IV criteria for MDD received duloxetine 80 mg/d (40 mg twice daily (BID)) to 120 mg/d (60 mg BID) for up to 52 weeks. Efficacy measures included the Clinical Global Impression of Severity (CGI-S) scale, the 17-item Hamilton Rating Scale for Depression (HAMD17), the Beck Depression Inventory-II (BDI-II), the Patient Global Impression of Improvement (PGI-I) scale, and the Sheehan Disability Scale (SDS). Safety and tolerability were evaluated using discontinuation rates, spontaneously reported adverse events, and changes in vital signs, ECG, and laboratory analytes.ResultsMean changes in HAMD17 total score at Weeks 6, 28, and 52 were -13.0, -17.4 and -17.5 (all p-values <.001). Significant improvement (p < .001) in both clinician- (CGI-S) and patient-rated (PGI-I) measures of improvement were observed at Week 1 and sustained throughout the study. Observed case response rates at Weeks 6, 28, and 52 were 62.9%, 84.9%, and 89.4%, respectively, while the corresponding rates of remission were 41.4%, 69.8%, and 72.3%. Adverse events led to discontinuation in 27 (26.7%) patients. Treatment-emergent adverse events reported by >10% of patients included dizziness, nausea, constipation, somnolence, insomnia, dry mouth, and diarrhea. Most events occurred early in the study. Mean changes at endpoint in blood pressure and body weight were less than 2.0 mm Hg, and -0.1 kg, respectively.ConclusionsIn this open-label study, duloxetine was effective, safe, and well tolerated in the long-term treatment of MDD in patients aged 65 and older.

Assessment of mood states in patients receiving long-term corticosteroid therapy and in controls with patient-rated and clinician-rated scales

Corticosteroids have been used for many years for inflammatory diseases. Mood changes are common during short-term, high-dose, corticosteroid therapy. Virtually no data are available on the mood effects of long-term corticosteroid therapy. To evaluate mood during corticosteroid therapy using standard clinician-rated and patient-rated measures. Outpatients receiving prednisone therapy (7.5 mg/d for 6 months) and similar controls were enrolled. Current mood was evaluated using the Hamilton Rating Scale for Depression (HRSD), Young Mania Rating Scale (YMRS), Brief Psychiatric Rating Scale (BPRS), Internal State Scale (ISS), and a diagnostic interview. Twenty patients and 14 controls were enrolled in the study. Depressive symptom severity as evaluated by the HRSD and ISS depression and well-being subscales and global psychiatric symptom severity as evaluated by the BPRS and ISS perceived conflict subscale were greater in patients receiving prednisone than controls. Manic symptom severity as evaluated by the ISS activation subscale but not the YMRS was higher in patients receiving prednisone. Twelve (60%) of 20 corticosteroid-treated patients met diagnostic criteria for a lifetime prednisone-induced mood disorder. Activation subscale scores did not correlate with YMRS scores. Other ISS subscales showed expected correlations with clinician-rated assessments. Mood symptoms and disorders are common in corticosteroid-dependent patients. Unlike short-term prednisone therapy, long-term therapy may be more associated with depressive than manic symptoms based on the clinician-rated assessments. The ISS may be more sensitive to mood symptoms with prednisone than clinician-rated scales.

A comparison of the efficacy and acceptability of group versus individual cognitive behaviour therapy in the treatment of panic disorder and agoraphobia in primary care

AbstractPanic disorder and agoraphobia is a prevalent clinical condition which places heavy demands on treatment resources in primary care. The efficient delivery of evidence‐based psychological treatment for this disorder is therefore important. Previous research has investigated both individual and group treatment formats for cognitive behaviour therapy (CBT) for panic disorder and agoraphobia. These two modalities of treatment delivery are, however, rarely compared within the same study format. Also little is known of patients' preferences regarding treatment delivery formats. The present study investigated the relative efficacy of a group treatment CBT and an individual treatment CBT in comparison with a waiting list control group in the treatment of panic disorder with or without agoraphobia in primary care. Ninety‐seven patients suffering from DSM‐IV panic disorder with or without agoraphobia were randomly allocated to receive either group CBT, individual CBT, or waiting list control. All patients were seen by the same therapist and all received an identical treatment manual. Treatment response was measured by blind assessor, therapist and patient‐rated measures of anxiety, depression, and agoraphobic avoidance, and was analysed in terms of both traditional statistical significance and clinical significance of outcome. At treatment end‐point, in terms of traditional statistical significance, both the group and individual CBT were significantly superior to waiting list control but did not differ significantly from each other. When clinical significance of outcome at treatment end‐point was considered, individual CBT showed a significant advantage over both group CBT and waiting list control. At 3‐month follow‐up, however, the individual CBT treatment group showed significant superiority to the group CBT treatment on clinical significance of outcome on one outcome measure only. This was principally due to a reduction in the proportion of patients achieving criteria of clinically significant change in the individual CBT treatment group over the 3‐month follow‐up period. When given a free choice of group or individual CBT at the end of the waiting list period, the overwhelming majority (95%) of the waiting list patients chose individual CBT. The implications of these findings for future research and for wider clinical practice are discussed. Copyright © 2004 John Wiley &amp; Sons, Ltd.

Chronic pediatric asthma and chiropractic spinal manipulation: A prospective clinical series and randomized clinical pilot study

Objectives: The first objective was to determine if chiropractic spinal manipulative therapy (SMT) in addition to optimal medical management resulted in clinically important changes in asthma-related outcomes in children. The second objective was to assess the feasibility of conducting a full-scale, randomized clinical trial in terms of recruitment, evaluation, treatment, and ability to deliver a sham SMT procedure. Study Design: Prospective clinical case series combined with an observer-blinded, pilot randomized clinical trial with a 1-year follow-up period. Setting: Primary contact, college outpatient clinic, and a pediatric hospital. Patients: A total of 36 patients aged 6 to 17 years with mild and moderate persistent asthma were admitted to the study. Outcome Measures: Pulmonary function tests; patient- and parent- or guardian-rated asthma-specific quality of life, asthma severity, and improvement; am and pm peak expiratory flow rates; and diary-based day and nighttime symptoms. Interventions: Twenty chiropractic treatment sessions were scheduled during the 3-month intervention phase. Patients were randomly assigned to receive either active SMT or sham SMT in addition to their standardized ongoing medical management. Results: It is possible to blind the participants to the nature of the SMT intervention, and a full-scale trial with the described design is feasible to conduct. At the end of the 12-week intervention phase, objective lung function tests and patient-rated day and nighttime symptoms based on diary recordings showed little or no change. Of the patient-rated measures, a reduction of approximately 20% in β2 bronchodilator use was seen (P =.10). The quality of life scores improved by 10% to 28% (P <.01), with the activity scale showing the most change. Asthma severity ratings showed a reduction of 39% (P <.001), and there was an overall improvement rating corresponding to 50% to 75%. The pulmonologist-rated improvement was small. Similarly, the improvements in parent- or guardian-rated outcomes were mostly small and not statistically significant. The changes in patient-rated severity and the improvement rating remained unchanged at 12-month posttreatment follow-up as assessed by a brief postal questionnaire. Conclusion: After 3 months of combining chiropractic SMT with optimal medical management for pediatric asthma, the children rated their quality of life substantially higher and their asthma severity substantially lower. These improvements were maintained at the 1-year follow-up assessment. There were no important changes in lung function or hyperresponsiveness at any time. The observed improvements are unlikely as a result of the specific effects of chiropractic SMT alone, but other aspects of the clinical encounter that should not be dismissed readily. Further research is needed to assess which components of the chiropractic encounter are responsible for important improvements in patient-oriented outcomes so that they may be incorporated into the care of all patients with asthma. (J Manipulative Physiol Ther 2001;24:369-77)

Comparing discriminative validity between a disease-specific and a general health scale in patients with moderate asthma

Health-related quality of life scales such as the Asthma Quality of Life Questionnaire and the Medical Outcomes Study Short-form General Health Survey SF-36 have become important measures of health status in clinical asthma trials. The discriminative properties of these scales, however, have not been extensively evaluated and compared. The purposes of this study were to assess and compare scale and discriminative properties of the Asthma Quality of Life Questionnaire (AQLQ) and the SF-36 in a group of patients with moderate asthma using a patient-rated global measure of disease activity as the criterion variable. Patients were interviewed in-person with a series of questionnaires including the AQLQ and the SF-36, and were also asked the global question “How active is your asthma now?” with possible responses of “extremely,” “very,” “moderately,” “mildly” or “not active.” Discriminative properties were determined using receiver operating characteristic (ROC) curves with responses to the global question as the criterion variable and mean domain scale scores as the independent variables. Relative validities for the AQLQ and SF-36 domains were also compared. A total of 230 patients, mean age of 41 years, were enrolled. Scores were lower and ranges were narrower for the AQLQ compared to the SF-36. In general, the AQLQ and the SF-36 were highly correlated, with r = 0.69 for the AQLQ overall score and the SF-36 Physical Component Summary (PCS) score. According to ROC analyses, both scales had excellent discriminative properties; however the area under the ROC curve was higher for the AQLQ overall score (0.81) than for the PCS (0.75). When ranked according to ROC area, the symptoms domain (0.83) had the greatest area under the ROC curve, followed by the emotional (0.76) and activities (0.76) domains of the AQLQ. However, in some cases, the area under the curve was less for an AQLQ domain (for example, 0.71 for the environmental domain) than for SF-36 domains (for example, 0.75 for the role physicial, and 0.75 for the social domain). Similarly, the AQLQ overall had a higher relative validity (5.2) compared to the PCS (2.2), and the symptoms domain of the AQLQ had the highest relative validity (6.0). Thus, both the Asthma Quality of Life Questionnaire and the SF-36 were able to characterize patients with moderate asthma in our cross-sectional study. In addition, both scales had strong discriminative properties when assessed with a global patient rating of current disease activity.

Therapist contact in cognitive behaviour therapy for panic disorder and agoraphobia in primary care

Panic disorder with or without agoraphobia is a prevalent clinical disorder which places heavy demands on treatment resources in primary care. The efficiency of delivery of psychological treatments for this disorder is therefore important. Previous research has focused on psychological treatments delivered with reduced therapist contact but methodological problems preclude firm conclusions. The present study investigated the relevance of therapist contact in cognitive behaviour therapy for panic disorder and agoraphobia, taking account of previous methodological problems. One hundred and four patients suffering from DSM III-R panic disorder with or without agoraphobia were randomly allocated to receive cognitive behaviour therapy with either, ‘standard’ therapist contact, ‘minimum’ therapist contact or as a bibliotherapy. All patients were seen by the same therapist and all received an identical treatment manual. Treatment response, as measured by patient and therapist report scales of anxiety, depression, and agoraphobic avoidance, was analysed in terms of both traditional statistical significance and clinical significance of outcome. At treatment end-point the ‘standard’ therapist contact and ‘minimum’ therapist contact groups showed significant reductions pre- to post-treatment on all measures. Pre- to post-treatment reductions for the bibliotherapy group were significant on therapist- and patient-rated measures of anxiety only. The ‘standard’ therapist contact group was consistently significantly improved in comparison to the bibliotherapy group. Significant differences between the ‘standard’ and ‘minimum’ therapist contact groups were found on therapist-rated anxiety only. Assessment of clinical significance of treatment outcome showed further differences between treatment groups with the ‘standard’ therapist contact group showing the largest proportion of patients achieving clinically significant change on all measures both at treatment end-point and at 6-month follow-up. Copyright © 2000 John Wiley & Sons, Ltd.

The Therapeutic Realizations Scale-Revised (TRS-R): psychometric characteristics and relationship to treatment process and outcome.

Therapeutic realizations are one of five universal, session-level change processes explicated in the Generic Model of Psychotherapy. Realizations refer to session impacts, the moment-to-moment accomplishments that patients experience within sessions. This study establishes the psychometric characteristics and factor structure of a modified patient-rated measure of session-level effects, the Therapeutic Realization Scale-Revised (TRS-R). In addition, it shows the relationship of the TRS-R to treatment process and outcome from the perspective of both patients and therapists. The findings provide support for the TRS-R as a reliable and valid, multidimensional index of session-level treatment effects.

Evaluation of the feasibility of and results of measuring health-status changes in patients undergoing surgical treatment for skeletal metastases.

The goal of treating patients with skeletal metastases is to decrease pain and improve or maintain physical function. Assessment of the effectiveness of treatment should therefore include evaluation of patient-rated measures of quality of life. The primary objective of the study was to determine the feasibility of studying the effect of surgical treatment of skeletal metastases on quality of life. The secondary objective was to provide data that begin to characterize this effect. The characteristics of patients with skeletal metastases are heterogeneous, patient enrollment in the study may be low, high attrition occurs secondary to death, and well accepted health-status measures (such as the Short Form-36) may be ineffective at detecting changes in health status; therefore, it is difficult to study these patients. High attrition and adjuvant treatment with radiation or chemotherapy made it impractical to draw firm conclusions about the effect of surgical treatment, but a trend toward improvement in selected health-status measures for both physical and mental health was noted. Analysis of patient-rated health-status scores as predictors of survival indicates that improvement in these scores 6 weeks after surgery is associated with an increase in the length of survival following surgery.

An international survey of cancer pain characteristics and syndromes

The optimal assessment of cancer pain includes a detailed description of pain characteristics and classification by both syndrome and likely mechanisms. In the clinical setting, the interpretation of this information is aided by knowledge of the available clinical experiences on these aspects of the pain. Unfortunately, existing data are limited. There have been few large surveys of cancer pain characteristics and syndromes, and comparative data from patients in different parts of the world are entirely lacking. To better define the characteristics of cancer pain syndromes the Task Force on Cancer Pain of the International Association for the Study of Pain (IASP) conducted a prospective, cross-sectional, international, multicenter survey of pain specialists and their patients. From a total of 100 clinicians who described themselves as cancer pain practitioners in the IASP membership directory, 51 agreed to participate in the survey and a total of 58 provided data. These clinicians resided in 24 countries and evaluated a total of 1095 patients with severe cancer pain mostly requiring opioid medication, using a combination of patient-rated and observer-rated measures. The patient-rated scales comprised a pain intensity measure chosen from the brief pain inventory. The observer-rated information included demographic and tumor-related data, and responses on checklists of pain syndromes and pathophysiologies. Patients were heterogeneous in terms of demographics and tumor-related information. More than 76% had a Karnofsky performance status score ≤70. Almost one-quarter of the patients experienced two or more pains. A large majority of the patients (92.5%) had one or more pains caused directly by the cancer; 20.8% of patients had one or more pains caused by cancer therapies. The average (SD) duration of pain was 5.9 (10.5) months. Approximately two-thirds of patients (66.7%) reported that the worst pain intensity during the day prior to the survey was ≧7 on a 10-point numeric scale. The factors that were univariately associated with higher pain intensity included the presence of breakthrough pain, somatic pain or neuropathic pain, age younger than 60 years, and lower performance status score. A multivariate model suggested that the presence of breakthrough pain, somatic pain, and lower performance status were the most important predictors of intense pain. Pains that were inferred by the treating clinician to be nociceptive and due to somatic injury occurred in 71.6% of the patients. Pains labeled nociceptive visceral were noted in 34.7% and pains inferred to have neuropathic mechanisms occurred in 39.7%. In a broad classification, the major pain syndromes comprised bone or joint lesions (41.7% of patients), visceral lesions (28.1%), soft tissue infiltration (28.3%), and peripheral nerve injuries (27.8%). Twenty-two types of pain syndromes were most prevalent. Large differences in the diagnosis of breakthrough pain by clinicians of different countries suggest that this phenomenon is either defined or recognized differently across countries. These data confirm, in segment of the cancer population experiencing severe pain, in different parts of the world, that cancer pain characteristics, syndromes and pathophysiologies are very heterogeneous. Predictors of worsening pain can be identified. The data provide a useful context for the interpretation of pain-related information acquired in both clinical and research settings. They suggest the need for future studies and the potential usefulness of a written checklist for cancer pain syndromes and pathophysiologies.

Relationship between quality of life and depression in patients with head and neck cancer.

This study describes the relationship between health-related quality of life (HRQOL) and depression in patients following major surgery for head and neck cancer. Cross-sectional study using medical chart review, patient interview, and test administration. Fifty patients were evaluated 6 months to 6 years following surgery using one global HRQOL measure (The Functional Assessment of Cancer Therapy-General [FACT-G]); three disease-specific measures of HRQOL (the HN module of the FACT [FACT-HNS], The University of Washington Quality of Life Scale [UWQOL], and The Performance Status Scale for Head and Neck Cancer); and one measure of depression (The Beck Depression Inventory [BDI]). The study population showed a high occurrence of depressive symptoms (22%). A negative correlation existed between the BDI and HRQOL as measured by the FACT-G (r = -0.49, P < .001) and the UWQOL (r = -0.44, P = .003). When somatic symptoms of depression were removed, the BDI remained correlated with HRQOL and was most highly correlated with the Emotional Well-Being (EWB) subscale of the FACT-G (r = -0.42, P = .003). There was no correlation between clinician judgments of EWB and any patient-rated measures of HRQOL or depression. Results demonstrate an inverse relationship between patient-reported HRQOL and depression. The lack of correlation between physician and patient ratings of HRQOL and EWB stresses the importance of obtaining patient ratings in addition to traditional clinician ratings when assessing outcomes. Finally, the multidimensional construction of the FACT with its specific subscales may make it a useful clinical tool for assessing patient status and augmenting patient interviews.

A cost-effectiveness analysis of cognitive behavior therapy and fluoxetine (prozac) in the treatment of depression

Depression affects at least 11 million Americans per year and costs the U.S. economy an estimated 44 billion dollars annually. Comprehensive review of the existing scientific evidence suggests that psychotherapy, particularly cognitive behavior therapy (CBT), is at least as effective as medication in the treatment of depression, even if severe (Antonuccio, Danton, & DeNelsky, 1995). These conclusions hold for both vegetative and social adjustment symptoms, especially when patient-rated measures are used and long-term follow-up is considered. In addition, several well-controlled studies with long-term follow-up (Evans et al., 1992; Shea et al., 1992; Simons, Murphy, Levine, & Wetzel, 1986) suggest that CBT may be more effective than drug treatment at preventing relapse. The relative effectiveness of psychotherapy for depression, particularly CBT, has been reinforced by meta-analyses reported in both psychiatry (Hollon, Shelton, & Loosen, 1991; Wexler & Cicchetti, 1992) and psychology journals (Dobson, 1989; Robinson, Berman, & Neimeyer, 1990; Steinbrueck, Maxwell, & Howard, 1983). In the era of managed care, it is not enough to be effective; treatments must be cost-effective. This paper considers the outcome studies as the basis for a cost-effectiveness comparison of drugs and psychotherapy in the treatment of unipolar depression. The analysis shows that over a 2-year period, fluoxetine alone may result in 33% higher expected costs than individual CBT treatment and the combination treatment may result in 23% higher costs than CBT alone. Supplemental analysis shows that group CBT may only result in a 2% ($596) cost savings as compared to individual treatment.