Consistency checks to improve measurement with the Hamilton Rating Scale for Anxiety (HAM-A).

BACKGROUND: Mitigating rating inconsistency can improve measurement fidelity and detection of treatment response. METHODS: The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that developed consistency checks for ratings of the Hamilton Anxiety Rating Scale (HAM-A) and Clinical Global Impression of Severity of anxiety (CGIS) that are widely used in studies of mood and anxiety disorders. Flags were applied to 40,349 HAM-A administrations from 15 clinical trials and to Monte Carlo-simulated data as a proxy for applying flags under conditions of inconsistency. RESULTS: Thirty-three flags were derived these included logical consistency checks and statistical outlier-response pattern checks. Twenty-percent of the HAM-A administrations had at least one logical scoring inconsistency flag, 4 % had two or more. Twenty-six percent of the administrations had at least one statistical outlier flag and 11 % had two or more. Overall, 35 % of administrations had at least one flag of any type, 19 % had one and 16 % had 2 or more. Most of administrations in the Monte Carlo- simulated data raised multiple flags. LIMITATIONS: Flagged ratings may represent less-common presentations of administrations done correctly. Conclusions-Application of flags to clinical ratings may aid in detecting imprecise measurement. Flags can be used for monitoring of raters during an ongoing trial and as part of post-trial evaluation. Appling flags may improve reliability and validity of trial data.

Consistency checks to improve measurement with the Hamilton Rating Scale for Depression (HAM-D).

BACKGROUND: Symptom manifestations in mood disorders can be subtle. Cumulatively, small imprecisions in measurement can limit our ability to measure treatment response accurately. Logical and statistical consistency checks between item responses (i.e., cross-sectionally) and across administrations (i.e., longitudinally) can contribute to improving measurement fidelity. METHODS: The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled flags indicating consistency/inconsistency ratings for the Hamilton Rating Scale for Depression (HAM-D17), a widely-used rating scale in studies of depression. Proposed flags were applied to assessments derived from the NEWMEDS data repository of 95,468 HAM-D administrations from 32 registration trials of antidepressant medications and to Monte Carlo-simulated data as a proxy for applying flags under conditions of known inconsistency. RESULTS: Two types of flags were derived: logical consistency checks and statistical outlier-response pattern checks. Almost thirty percent of the HAMD administrations had at least one logical scoring inconsistency flag. Seven percent had flags judged to suggest that a thorough review of rating is warranted. Almost 22% of the administrations had at least one statistical outlier flag and 7.9% had more than one. Most of the administrations in the Monte Carlo- simulated data raised multiple flags. LIMITATIONS: Flagged ratings may represent less-common presentations of administrations done correctly. CONCLUSIONS: Application of flags to clinical ratings may aid in detecting imprecise measurement. Reviewing and addressing these flags may improve reliability and validity of clinical trial data.

SIGH, what's in a name? An examination of the factor structure and criterion validity of the (Structured Interview Guide for the) Hamilton Anxiety scale (SIGH-A) in a sample of African American adults with co-occurring trauma experience and heavy alcohol use.

The Hamilton Anxiety Inventory (HAM-A) is one of the oldest and most commonly used anxiety rating scales in clinical research. Despite its ubiquity, no studies have examined the scale's underlying factor structure and criterion validity among Black and African American adults with psychopathology (Mage = 42.25, SD = 11.44). Therefore, we estimated a confirmatory factor analysis of the commercially available Structured Interview Guide for the Hamilton Anxiety scale (SIGH-A; Williams, 1996) among African American adults (n = 88; 43% female) with co-occurring heavy alcohol use and trauma-related symptoms. Next, we examined the criterion validity of its Psychic and Somatic factors and overall anxiety severity score from participants who completed a single screening session (i.e., cross-sectional analysis) for a larger study. Results indicated that a two-factor solution provided an adequate fit to the data. Regression analyses indicated that the total SIGH-A score, but not its subscales, significantly predicted posttraumatic stress disorder (PTSD) severity. Neither the SIGH-A subscales nor total scores were significant predictors of alcohol consumption. The current findings suggest that the SIGH-A factor structure among African American adults with alcohol and trauma-related conditions is similar to previous reports that have tested largely White samples but highlight potential shortcomings when its subscales are used independently. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

THE DEPRESSION INVENTORY DEVELOPMENT SCALE: Assessment of Psychometric Properties Using Classical and Modern Measurement Theory in a CAN-BIND Trial.

Objective: The goal of the Depression Inventory Development (DID) project is to develop a comprehensive and psychometrically sound rating scale for major depressive disorder (MDD) that reflects current diagnostic criteria and conceptualizations of depression. We report here the evaluation of the current DID item bank using Classical Test Theory (CTT), Item Response Theory (IRT) and Rasch Measurement Theory (RMT). Methods: The present study was part of a larger multisite, open-label study conducted by the Canadian Biomarker Integration Network in Depression (ClinicalTrials.gov: NCT01655706). Trained raters administered the 32 DID items at each of two visits (MDD: baseline, n=211 and Week 8, n=177; healthy participants: baseline, n=112 and Week 8, n=104). The DID's "grid" structure operationalizes intensity and frequency of each item, with clear symptom definitions and a structured interview guide, with the current iteration assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain, and appetite. Participants were also administered the Montgomery- Åsberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) that allowed DID items to be evaluated against existing "benchmark" items. CTT was used to assess data quality/reliability (i.e., missing data, skewness, scoring frequency, internal consistency), IRT to assess individual item performance by modelling an item's ability to discriminate levels of depressive severity (as assessed by the MADRS), and RMT to assess how the items perform together as a scale to capture a range of depressive severity (item targeting). These analyses together provided empirical evidence to base decisions on which DID items to remove, modify, or advance. Results: Of the 32 DID items evaluated, eight items were identified by CTT as problematic, displaying low variability in the range of responses, floor effects, and/or skewness; and four items were identified by IRT to show poor discriminative properties that would limit their clinical utility. Five additional items were deemed to be redundant. The remaining 15 DID items all fit the Rasch model, with person and item difficulty estimates indicating satisfactory item targeting, with lower precision in participants with mild levels of depression. These 15 DID items also showed good internal consistency (alpha=0.95 and inter-item correlations ranging from r=0.49 to r=0.84) and all items were sensitive to change following antidepressant treatment (baseline vs. Week 8). RMT revealed problematic item targeting for the MADRS and QIDSSR, including an absence of MADRS items targeting participants with mild/moderate depression and an absence of QIDS-SR items targeting participants with mild or severe depression. Conclusion: The present study applied CTT, IRT, and RMT to assess the measurement properties of the DID items and identify those that should be advanced, modified, or removed. Of the 32 items evaluated, 15 items showed good measurement properties. These items (along with previously evaluated items) will provide the basis for validation of a penultimate DID scale assessing anhedonia, cognitive slowing, concentration, executive function, recent memory, drive, emotional fatigue, guilt, self-esteem, hopelessness, tension, rumination, irritability, reduced appetite, insomnia, sadness, worry, suicidality, and depressed mood. The strategies adopted by the DID process provide a framework for rating scale development and validation.

Consistency checks to improve measurement with the Montgomery-Asberg Depression Rating Scale (MADRS).

International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled consistency/inconsistency flags for the Montgomery-Asberg Depression Rating Scale (MADRS). Twenty-two flags were identified. Seven flags are believed to be strong flags that suggest that a thorough review of rating is warranted. The flags were applied to assessments derived from the NEWMEDS data repository. Almost 65% of ratings had at least one inconsistency flag raised and 22% had two or more. Application of flags to clinical ratings may improve reliability of ratings and validity of trials.

The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder.

The Depression Inventory Development project is an initiative of the International Society for CNS Drug Development whose goal is to develop a comprehensive and psychometrically sound measurement tool to be utilized as a primary endpoint in clinical trials for major depressive disorder. Using an iterative process between field testing and psychometric analysis and drawing upon expertise of international researchers in depression, the Depression Inventory Development team has established an empirically driven and collaborative protocol for the creation of items to assess symptoms in major depressive disorder. Depression-relevant symptom clusters were identified based on expert clinical and patient input. In addition, as an aid for symptom identification and item construction, the psychometric properties of existing clinical scales (assessing depression and related indications) were evaluated using blinded datasets from pharmaceutical antidepressant drug trials. A series of field tests in patients with major depressive disorder provided the team with data to inform the iterative process of scale development. We report here an overview of the Depression Inventory Development initiative, including results of the third iteration of items assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain and appetite. The strategies adopted from the Depression Inventory Development program, as an empirically driven and collaborative process for scale development, have provided the foundation to develop and validate measurement tools in other therapeutic areas as well.

Comparison of Site-Based Versus Central Ratings in a Study of Generalized Anxiety Disorder.

Lack of standardization across sites and raters, poor interrater reliability, and possible scoring bias affecting the primary outcome measure contribute to a high failure rate in anxiety trials. Remote centralized raters who are blinded to protocol inclusion and exclusion criteria as well as visit number may standardize assessments across raters and eliminate scoring bias, decreasing placebo response and thereby increasing signal detection. The purpose of the primary study was to test the safety and efficacy of an anxiolytic in a double-blind, placebo-controlled (no active comparator), multicenter trial. However, there was an additional prospective objective to explore site ratings compared with remote centralized ratings in the cohort of subjects on placebo. Site raters assessed subjects 6 times over an 8-week period. The primary outcome measure was the week 8 site-rated Hamilton Anxiety Scale (HAM-A). Remote centralized raters by telephone independently rated these subjects on the HAM-A at baseline and week 6. Of the 122 subjects selected by site raters and therefore randomized, remote centralized raters would have admitted 59 (48%) and excluded 63 (52%), based on their HAM-A ratings. The mean change from baseline in HAM-A total score in the placebo group admitted to the study by site raters was 9.3, significantly higher than the 5.9 point mean change on placebo as measured by the remote centralized raters.The data are consistent with the potential for qualification bias at baseline when rated by sites. The results make a strong case for using strategies to ensure that baseline scoring is truly independent of the pressure to enroll.

Transcultural Adaptation of GRID Hamilton Rating Scale For Depression (GRID-HAMD) to Brazilian Portuguese and Evaluation of the Impact of Training Upon Inter-Rater Reliability.

UNLABELLED: GRID-HAMD is a semi-structured interview guide developed to overcome flaws in HAM-D, and has been incorporated into an increasing number of studies. OBJECTIVES: Carry out the transcultural adaptation of GRID-HAMD into the Brazilian Portuguese language, evaluate the inter-rater reliability of this instrument and the training impact upon this measure, and verify the raters' opinions of said instrument. METHODS: The transcultural adaptation was conducted by appropriate methodology. The measurement of inter-rater reliability was done by way of videos that were evaluated by 85 professionals before and after training for the use of this instrument. RESULTS: The intraclass correlation coefficient (ICC) remained between 0.76 and 0.90 for GRID-HAMD-21 and between 0.72 and 0.91 for GRID-HAMD-17. The training did not have an impact on the ICC, except for a few groups of participants with a lower level of experience. Most of the participants showed high acceptance of GRID-HAMD, when compared to other versions of HAM-D. CONCLUSION: The scale presented adequate inter-rater reliability even before training began. Training did not have an impact on this measure, except for a few groups with less experience. GRID-HAMD received favorable opinions from most of the participants.

A 6-week randomized, double-blind, placebo-controlled, comparator referenced trial of vabicaserin in acute schizophrenia.

UNLABELLED: Vabicaserin, a potent 5-HT2C receptor agonist, decreases nucleus accumbens extracellular dopamine levels in rats, without affecting striatal dopamine, indicating mesolimbic selectivity. This is the first study of efficacy, safety and tolerability of vabicaserin in adults with acute schizophrenia. Three hundred fourteen hospitalized subjects were randomized to: Vabicaserin 200 or 400 mg/day, olanzapine 15 mg/day or placebo. Central raters assessed the PANSS and CGI-S. Site raters performed the BPRS and CGI-I. Central rated PANSS Positive (PANSS-PPS) was the primary endpoint. Two hundred eighty-nine subjects were included in the mITT efficacy analysis. Vabicaserin was well tolerated with no major safety concerns. Olanzapine, but not vabicaserin, caused weight gain. Vabicaserin 200 mg/day and olanzapine demonstrated significant improvement at week 6 vs. placebo on PANSS-PSS. A non-significant decrease vs. placebo was observed for 400 mg/day. Both vabicaserin groups demonstrated significant improvement over baseline on PANSS Negative while placebo worsened. Vabicaserin 200 mg/day and olanzapine demonstrated significantly greater improvement over placebo on PANSS Total whereas 400 mg/day showed a trend toward improvement. There was no significant improvement vs. placebo for either vabicaserin group on site-rated BPRS. Vabicaserin 200 mg/day and olanzapine demonstrated significant improvement vs. placebo on CGI-I and CGI-S but not 400 mg/day vabicaserin. Vabicaserin demonstrated efficacy on primary and secondary endpoints at 200 mg/day, but not at 400 mg/day which showed a trend for efficacy. The 200 mg/day vabicaserin group achieved proof of concept using central ratings. Both vabicaserin doses were well tolerated with no significant safety signals and no weight gain. TRIAL REGISTRATION: clinicaltrials.gov. Identifier: NCT00265551.

Trauma exposure and posttraumatic stress disorder in primary care patients: cross-sectional criterion standard study.

OBJECTIVE: Posttraumatic stress disorder (PTSD) is one of the most common but least recognized anxiety disorders in primary care. This study aimed to describe the association of PTSD and trauma exposure with somatic symptoms, psychiatric comorbidity, functional impairment, and the actual treatment of PTSD in primary care. METHOD: This cross-sectional criterion standard study included 965 consecutive primary care patients from 15 civilian primary care clinics in the United States. The Structured Clinical Interview for DSM-IV (SCID) was used to establish diagnosis of PTSD and other anxiety disorders. Somatic symptoms, depression, and anxiety were measured with the Patient Health Questionnaire (PHQ), and functional impairment was measured with the Medical Outcomes Study Short-Form General Health Survey (SF-20). The study was conducted from November 2004 to June 2005. RESULTS: PTSD was diagnosed in 83 patients (8.6%; 95% CI, 7.0%-10.5%), and trauma exposure without fulfilling DSM-IV criteria for PTSD was reported by 169 patients (17.5%; 15.2%-20.0%). With odds ratios ranging between 2.1 (95% CI, 1.2-3.6) for headache and 9.7 (3.8-24.8) for chest pain, PTSD patients had markedly elevated somatic symptom rates compared to the reference group of patients with no PTSD or trauma exposure. PTSD was significantly associated with elevated rates of psychiatric comorbidity, pain, and impaired functioning. Patients reporting trauma but no PTSD had rates of somatic symptoms, psychiatric comorbidity, and functional impairment that were intermediate between PTSD and reference group patients. Adjusting for depression substantially attenuated the association of PTSD and trauma with somatic symptoms, suggesting that depression may be an important mediator of the PTSD-somatic symptoms relationship. CONCLUSIONS: The high frequency of PTSD in primary care and its association with psychiatric comorbidity and functional impairment underscore the need to better detect and treat PTSD in primary care. Recognizing the frequent somatic presentation of PTSD and appreciating the salience of comorbid depression may be especially important in optimizing PTSD care.

Attitudes toward borderline personality disorder: a survey of 706 mental health clinicians.

OBJECTIVE: We sought to determine attitudes toward patients with borderline personality disorder (BPD) among mental health clinicians at nine academic centers in the United States. METHODS: A self-report questionnaire was distributed to 706 mental health clinicians, including psychiatrists, psychiatry residents, social workers, nurses, and psychologists. RESULTS: The study showed that most clinicians consider BPD a valid diagnosis, although nearly half reported that they preferred to avoid these patients. The clinician's occupational subgroup was significantly related to attitude. Staff nurses had the lowest self-ratings on overall caring attitudes, while social workers had the highest. Social workers and psychiatrists had the highest ratings on treatment optimism. Social workers and psychologists were most optimistic about psychotherapy effectiveness, while psychiatrists were most optimistic about medication effectiveness. Staff nurses had the lowest self-ratings on empathy toward patients with BPD and treatment optimism.DiscussionNegative attitudes persist among clinicians toward BPD, but differ among occupational subgroups. Overall, caring attitudes, empathy, and treatment optimism were all higher among care providers who had cared for a greater number of BPD patients in the past 12 months. CONCLUSION: These findings hold important implications for clinician education and coordination of care for patients with BPD.

The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review.

BACKGROUND: Depression, anxiety and somatization are the most common mental disorders in primary care as well as medical specialty populations; each is present in at least 5-10% of patients and frequently comorbid with one another. An efficient means for measuring and monitoring all three conditions would be desirable. METHODS: Evidence regarding the psychometric and pragmatic characteristics of the Patient Health Questionnaire (PHQ)-9 depression, generalized anxiety disorder (GAD)-7 anxiety and PHQ-15 somatic symptom scales are synthesized from two sources: (1) four multisite cross-sectional studies (three conducted in primary care and one in obstetric-gynecology practices) comprising 9740 patients, and (2) key studies from the literature that have studied these scales. RESULTS: The PHQ-9 and its abbreviated eight-item (PHQ-8) and two-item (PHQ-2) versions have good sensitivity and specificity for detecting depressive disorders. Likewise, the GAD-7 and its abbreviated two-item (GAD-2) version have good operating characteristics for detecting generalized anxiety, panic, social anxiety and post-traumatic stress disorder. The optimal cutpoint is > or = 10 on the parent scales (PHQ-9 and GAD-7) and > or = 3 on the ultra-brief versions (PHQ-2 and GAD-2). The PHQ-15 is equal or superior to other brief measures for assessing somatic symptoms and screening for somatoform disorders. Cutpoints of 5, 10 and 15 represent mild, moderate and severe symptom levels on all three scales. Sensitivity to change is well-established for the PHQ-9 and emerging albeit not yet definitive for the GAD-7 and PHQ-15. CONCLUSIONS: The PHQ-9, GAD-7 and PHQ-15 are brief well-validated measures for detecting and monitoring depression, anxiety and somatization.

Site versus centralized raters in a clinical depression trial: impact on patient selection and placebo response.

The use of centralized raters who are remotely linked to sites and interview patients via videoconferencing or teleconferencing has been suggested as a way to improve interrater reliability and interview quality. This study compared the effect of site-based and centralized ratings on patient selection and placebo response in subjects with major depressive disorder. Subjects in a 2-center placebo and active comparator controlled depression trial were interviewed twice at each of 3 time points: baseline, 1-week postbaseline, and end point--once by the site rater and once remotely via videoconference by a centralized rater. Raters were blind to each others' scores. A site-based score of greater than 17 on the 17-item Hamilton Depression Rating Scale (HDRS-17) was required for study entry. When examining all subjects entering the study, site-based raters' HDRS-17 scores were significantly higher than centralized raters' at baseline and postbaseline but not at end point. At baseline, 35% of subjects given an HDRS-17 total score of greater than 17 by a site rater were given an HDRS total score of lower than 17 by a centralized rater and would have been ineligible to enter the study if the centralized rater's score was used to determine study entry. The mean placebo change for site raters (7.52) was significantly greater than the mean placebo change for centralized raters (3.18, P < 0.001). Twenty-eight percent were placebo responders (>50% reduction in HDRS) based on site ratings versus 14% for central ratings (P < 0.001). When examining data only from those subjects whom site and centralized raters agreed were eligible for the study, there was no significant difference in the HDRS-17 scores. Findings suggest that the use of centralized raters could significantly change the study sample in a major depressive disorder trial and lead to significantly less change in mood ratings among those randomized to placebo.

An ultra-brief screening scale for anxiety and depression: the PHQ-4.

BACKGROUND: The most common mental disorders in both outpatient settings and the general population are depression and anxiety, which frequently coexist. Both of these disorders are associated with considerable disability. OBJECTIVE: When the disorders co-occur, the disability is even greater. Authors sought to test an ultra-brief screening tool for both. METHOD: Validated two-item ultra-brief screeners for depression and anxiety were combined to constitute the Patient Health Questionnaire for Depression and Anxiety (the PHQ-4). Data were analyzed from 2,149 patients drawn from 15 primary-care clinics in the United States. RESULTS: Factor analysis confirmed two discrete factors (Depression and Anxiety) that explained 84% of the total variance. Increasing PHQ-4 scores were strongly associated with functional impairment, disability days, and healthcare use. Anxiety had a substantial effect on functional status that was independent of depression. CONCLUSION: The PHQ-4 is a valid ultra-brief tool for detecting both anxiety and depressive disorders.

Sources of unreliability in depression ratings.

BACKGROUND: Good interrater reliability is essential to minimize error variance and improve study power. Reasons why raters differ in scoring the same patient include information variance (different information obtained because of asking different questions), observation variance (the same information is obtained, but raters differ in what they notice and remember), interpretation variance (differences in the significance attached to what is observed), criterion variance (different criteria used to score items), and subject variance (true differences in the subject). We videotaped and transcribed 30 pairs of interviews to examine the most common sources of rater unreliability. METHOD: Thirty patients who experienced depression were independently interviewed by 2 different raters on the same day. Raters provided rationales for their scoring, and independent assessors reviewed the rationales, the interview transcripts, and the videotapes to code the main reason for each discrepancy. One third of the interviews were conducted by raters who had not administered the Hamilton Depression Rating Scale before; one third, by raters who were experienced but not calibrated; and one third, by experienced and calibrated raters. RESULTS: Experienced and calibrated raters had the highest interrater reliability (intraclass correlation [ICC]; r = 0.93) followed by inexperienced raters (r = 0.77) and experienced but uncalibrated raters (r = 0.55). The most common reason for disagreement was interpretation variance (39%), followed by information variance (30%), criterion variance (27%), and observation variance (4%). Experienced and calibrated raters had significantly less criterion variance than the other cohorts (P = 0.001). CONCLUSIONS: Reasons for disagreement varied by level of experience and calibration. Experienced and uncalibrated raters should focus on establishing common conventions, whereas experienced and calibrated raters should focus on fine tuning judgment calls on different thresholds of symptoms. Calibration training seems to improve reliability over experience alone. Experienced raters without cohort calibration had lower reliability than inexperienced raters.

The PHQ-8 as a measure of current depression in the general population.

BACKGROUND: The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. Our objectives were to assess the PHQ-8 as a depression measure in a large, epidemiological population-based study, and to determine the comparability of depression as defined by the PHQ-8 diagnostic algorithm vs. a PHQ-8 cutpoint > or = 10. METHODS: Random-digit-dialed telephone survey of 198,678 participants in the 2006 Behavioral Risk Factor Surveillance Survey (BRFSS), a population-based survey in the United States. Current depression as defined by either the DSM-IV based diagnostic algorithm (i.e., major depressive or other depressive disorder) of the PHQ-8 or a PHQ-8 score > or = 10; respondent sociodemographic characteristics; number of days of impairment in the past 30 days in multiple domains of health-related quality of life (HRQoL). RESULTS: The prevalence of current depression was similar whether defined by the diagnostic algorithm or a PHQ-8 score > or = 10 (9.1% vs. 8.6%). Depressed patients had substantially more days of impairment across multiple domains of HRQoL, and the impairment was nearly identical in depressed groups defined by either method. Of the 17,040 respondents with a PHQ-8 score > or = 10, major depressive disorder was present in 49.7%, other depressive disorder in 23.9%, depressed mood or anhedonia in another 22.8%, and no evidence of depressive disorder or depressive symptoms in only 3.5%. LIMITATIONS: The PHQ-8 diagnostic algorithm rather than an independent structured psychiatric interview was used as the criterion standard. CONCLUSIONS: The PHQ-8 is a useful depression measure for population-based studies, and either its diagnostic algorithm or a cutpoint > or = 10 can be used for defining current depression.

Gastrointestinal symptoms in primary care: prevalence and association with depression and anxiety.

OBJECTIVE: Results from general population studies suggest a relationship between gastrointestinal (GI) symptoms, depression, and anxiety. However, no primary care study has investigated this issue. This study investigates the prevalence of GI symptoms in primary care and their association with depression and anxiety. METHOD: Within a cross-sectional survey, 2091 consecutive patients from 15 primary care clinics in the United States completed self-report questionnaires regarding GI symptoms [15-item Patient Health Questionnaire (PHQ-15)], anxiety [seven-item Generalized Anxiety Disorder Scale (GAD-7)], and depression (PHQ-8). Of those, 965 randomly selected patients additionally underwent a criterion standard diagnostic telephone interview (Structured Clinical Interview for DSM-IV) for the most common anxiety disorders. RESULTS: A total of 380 [18% (95% CI, 16.3% to 19.3%)] patients reported to be substantially bothered by at least one GI symptom in the previous 4 weeks. The prevalence of severe levels of depression (PHQ-8 score > or =15) was nearly fivefold in patients with GI symptoms compared to patients without GI symptoms (19.1% vs. 3.9%; P<.001), and the prevalence of severe levels of anxiety (GAD-7 score > or =15) was nearly fourfold in patients with GI symptoms compared to patients without GI symptoms (19.4% vs. 5.6%; P<.001). Similarly, with each additional GI symptom, the odds for an interview-based diagnosis of specific anxiety disorders increased significantly: For example, compared to patients with no GI symptom, the odds ratio (OR) (95% CI) for generalized anxiety disorder in patients with one GI symptom was 3.7 (2.0 to 6.9); in patients with two GI symptoms, OR=6.5 (3.1 to 13.6); and in patients with three GI symptoms, OR=7.2 (2.7 to 18.8). CONCLUSION: GI symptoms are associated significantly with depression and anxiety in primary care. It is suggested to screen as a routine for anxiety and depression in patients with GI symptoms and, if indicated, to initiate specific treatment.

Depression, anxiety and somatization in primary care: syndrome overlap and functional impairment.

OBJECTIVE: To determine diagnostic overlap of depression, anxiety and somatization as well as their unique and overlapping contribution to functional impairment. METHOD: Two thousand ninety-one consecutive primary care clinic patients participated in a multicenter cross-sectional survey in 15 primary care clinics in the United States (participation rate, 92%). Depression, anxiety, somatization and functional impairment were assessed using validated scales from the Patient Health Questionnaire (PHQ) (PHQ-8, eight-item depression module; GAD-7, seven-item Generalized Anxiety Disorder Scale; and PHQ-15, 15-item somatic symptom scale) and the Short-Form General Health Survey (SF-20). Multiple linear regression analyses were used to investigate unique and overlapping associations of depression, anxiety and somatization with functional impairment. RESULTS: In over 50% of cases, comorbidities existed between depression, anxiety and somatization. The contribution of the commonalities of depression, anxiety and somatization to functional impairment substantially exceeded the contribution of their independent parts. Nevertheless, depression, anxiety and somatization did have important and individual effects (i.e., separate from their overlap effect) on certain areas of functional impairment. CONCLUSIONS: Given the large syndrome overlap, a potential consideration for future diagnostic classification would be to describe basic diagnostic criteria for a single overarching disorder and to optionally code additional diagnostic features that allow a more detailed classification into specific depressive, anxiety and somatoform subtypes.