Showing papers by "David R. Rubinow published in 2010"

Postmenopausal Hormone Therapy: An Endocrine Society Scientific Statement

Abstract: Objective: Our objective was to provide a scholarly review of the published literature on menopausal hormonal therapy (MHT), make scientifically valid assessments of the available data, and grade the level of evidence available for each clinically important endpoint. Participants in Development of Scientific Statement: The 12-member Scientific Statement Task Force of The Endocrine Society selected the leader of the statement development group (R.J.S.) and suggested experts with expertise in specific areas. In conjunction with the Task Force, lead authors (n = 25) and peer reviewers (n = 14) for each specific topic were selected. All discussions regarding content and grading of evidence occurred via teleconference or electronic and written correspondence. No funding was provided to any expert or peer reviewer, and all participants volunteered their time to prepare this Scientific Statement. Evidence: Each expert conducted extensive literature searches of case control, cohort, and randomized controlled tria...

Feasibility and diagnostic validity of the M-3 checklist: a brief, self-rated screen for depressive, bipolar, anxiety, and post-traumatic stress disorders in primary care.

Abstract: PURPOSE Mood and anxiety disorders are the most common psychiatric conditions seen in primary care, yet they remain underdetected and undertreated. Screening tools can improve detection, but available instruments are limited by the number of disorders assessed. We wanted to assess the feasibility and diagnostic validity of the My Mood Monitor (M-3) checklist, a new, 1-page, patient-rated, 27-item tool developed to screen for multiple psychiatric disorders in primary care. METHODS We enrolled a sample of 647 consecutive participants aged 18 years and older who were seeking primary care at an academic family medicine clinic between July 2007 and February 2008. We used a 2-step scoring procedure to make screening more efficient. The main outcomes measured were the sensitivity and specificity of the M-3 for major depression, bipolar disorder, any anxiety disorder, and post-traumatic stress disorder (PTSD), a specific type of anxiety disorder. Using a split sample technique, analysis proceeded from determination of optimal screening thresholds to assessment of the psychometric properties of the self-report instrument using the determined thresholds. We used the Mini International Neuropsychiatric Interview as the diagnostic standard. Feasibility was assessed with patient and physician exit questionnaires. RESULTS The depression module had a sensitivity of 0.84 and a specificity of 0.80. The bipolar module had a sensitivity of 0.88, and a specificity of 0.70. The anxiety module had a sensitivity of 0.82 and a specificity of 0.78, and the PTSD module had a sensitivity of 0.88 and a specificity of 0.76. As a screen for any psychiatric disorder, sensitivity was 0.83 and specificity was 0.76. Patients took less than 5 minutes to complete the M-3 in the waiting room, and less than 1% reported not having time to complete it. Eighty-three percent of clinicians reviewed the checklist in 30 or fewer seconds, and 80% thought it was helpful in reviewing patients’ emotional health. CONCLUSIONS The M-3 demonstrates utility as a valid, efficient, and feasible tool for screening multiple common psychiatric illnesses, including bipolar disorder and PTSD, in primary care. Its diagnostic accuracy equals that of currently used single-disorder screens and has the additional benefit of being combined into a 1-page tool. The M-3 potentially can reduce missed psychiatric diagnoses and facilitate proper treatment of identified cases.

Elevated Corticotropin Releasing Hormone (CRH) during Pregnancy and Risk of Postpartum Depression (PPD)

Abstract: Context: Perinatal depression has a prevalence of 10% with devastating consequences for mother and baby. The prospective identification of those at risk for postpartum (PPD) or prenatal (PND) depression has led to biomarker searches in pregnancy. There are conflicting reports of associations between midpregnancy placental CRH (pCRH) and PPD or PND. Objective: The objective of the study was to quantify the association of maternal pCRH with PPD and PND. Design: This was a prospective cohort study (the Pregnancy, Infection, and Nutrition Study). Setting: The study was conducted at a prenatal clinics at the University of North Carolina at Chapel Hill. Patients: Patients included 1230 pregnant women. Main Outcome Measures: The relationship between pCRH at less than 20 wk and 24–29 wk and maternal depression assessed in pregnancy [Center for Epidemiologic Studies Depression Scale (CES-D)] and postpartum (12 wk and 1 yr) with the Edinburgh Postnatal Depression Scale (EPDS). Results: At 24–29 wk, 24.8% of women had CES-D score of 17 or greater, and 9.7% had a CES-D score of 25 or greater. At 12 wk postpartum, 18.2% of women had an EPDS score of 10 or greater and 7.6% had an EPDS score of 13 or greater. CRH measures at less than 20 wk and 24–29 wk were inversely correlated with a CES-D score at 24–29 wk (n = 1080, P < 0.05 and P < 0.01, respectively). Pregnancy pCRH was not correlated with the EPDS score at 12 wk (n = 484) or 1 yr postpartum (n = 391). In covariate-adjusted models, higher pCRH was not associated with a CES-D of 17 or greater at 24–29 wk (odds ratio 0.88 per sd change in pCRH at 24–29 wk, 95% confidence interval 0.76–1.03). There was no association between log CRH at 24–29 wk and PPD (covariate-adjusted odds ratio per sd 0.99, 95% confidence interval 0.69–1.42). Conclusion: Higher midpregnancy pCRH was not associated with an increased risk of PND or PPD.

Depression in women with spontaneous 46, XX primary ovarian insufficiency.

Abstract: Primary ovarian insufficiency (POI) is associated with increased risk for depression, episodes of which frequently occur after the onset of menstrual irregularity and before the POI diagnosis.

Scientific Statement: Postmenopausal Hormone Therapy

Abstract: Objective: Our objective was to provide a scholarly review of the published literature on menopausal hormonal therapy (MHT), make scientifically valid assessments of the available data, and grade the level of evidence available for each clinically important endpoint. Participants in Development of Scientific Statement: The 12-member Scientific Statement Task Force of The Endocrine Society selected the leader of the statement development group (R.J.S.) and suggested experts with expertise in specific areas. In conjunctionwiththeTaskForce,leadauthors(n25)andpeerreviewers(n13)foreachspecifictopicwereselected.Alldiscussions regardingcontentandgradingofevidenceoccurredviateleconferenceorelectronicandwrittencorrespondence.Nofundingwas provided to any expert or peer reviewer, and all participants volunteered their time to prepare this Scientific Statement. Evidence: Each expert conducted extensive literature searches of case control, cohort, and randomized controlled trials as well as meta-analyses, Cochrane reviews, and Position Statements from other professional societies in order to compile and evaluate available evidence. No unpublished data were used to draw conclusions from the evidence. Consensus Process: A consensus was reached after several iterations. Each topic was considered separately, and a consensus was achieved as to content to be included and conclusions reached between the primary author and the peer reviewer specific to that topic. In a separate iteration, the quality of evidence was judged using the GRADE (Grading of Recommendations Assessment, Development,andEvaluation)systemincommonusebyTheEndocrineSocietyforpreparingclinicalguidelines.Thefinaliteration involved responses to four levels of additional review: 1) general comments offered by each of the 25 authors; 2) comments of the individual Task Force members; 3) critiques by the reviewers of the Journal of Clinical Endocrinology & Metabolism; and 4) suggestions offered by the Council and members of The Endocrine Society. The lead author compiled each individual topic into a coherent document and finalized the content for the final Statement. The writing process was analogous to preparation of a multiauthored textbook with input from individual authors and the textbook editors. Conclusions: The major conclusions related to the overall benefits and risks of MHT expressed as the number of women per 1000 taking MHT for 5 yr who would experience benefit or harm. Primary areas of benefit included relief of hot flashes and symptoms ofurogenitalatrophyandpreventionoffracturesanddiabetes.Risksincludedvenothromboticepisodes,stroke,andcholecystitis. In the subgroup of women starting MHT between ages 50 and 59 or less than 10 yr after onset of menopause, nonstatistically significant trends suggested additional benefit including reduction of overall mortality and coronary artery disease. In this subgroup,estrogenplussomeprogestogensincreasedtheriskofbreastcancer,whereasestrogenalonedidnot.Beneficialeffects oncolorectalandendometrialcancerandharmfuleffectsonovariancanceroccurredbutaffectedonlyasmallnumberofwomen. Data from the various Women’s Health Initiative studies, which involved women of average age 63, cannot be appropriately applied to calculate risks and benefits of MHT in women starting shortly after menopause. At the present time, assessments of benefit and risk in these younger women are based on lower levels of evidence.

DSM-V: an opportunity to embrace the future of psychiatric diagnosis.

Abstract: As originally conceived, the DSM represented a great diagnostic advance because it introduced a symptomand syndrome-based conceptual framework to supplant theoretical, metapsychological beliefs about psychopathology. Thereafter, the nature and association of symptoms trumped their inferred, psychological meaning, signifying a triumph of descriptive psychiatry. The underlying assumption was that the provision of a common, operationalized, nosological language would translate into more rational use of available therapeutic agents. Moreover, through its systematic approach to disease, the DSM promised to offer practitioners critical insights into the nature and prognosis of psychiatric illnesses. However, as currently formulated, the DSM is limited by a number of shortcomings, including the omission of certain critical contextual specifiers that are essential to the proper conception and management of disease. Re-formulation of the DSM offers an opportunity to realize its intended broad clinical utility, thereby far exceeding its role as an effective tool for the delivery of healthcare dollars from insurance companies. The explicit intent of the DSM is to provide predictive value regarding illness course and treatment-response characteristics. Implicitly, however, it instructs practitioners how to think about psychiatric disorders; the way in which one conceptualizes illness will influence the clinical information that one elicits and attends to, with corresponding effect on treatment choices. Current practices in pharmacologic therapy are characterized by the use of single agents (e.g., SSRIs) to treat a wide range of diagnostic categories, as well as by the prolific admixture of pharmacological agents from multiple categories for the treatment of major psychological illnesses. Such practices belie a lack of conceptual clarity that may derive in part from the absence of crucial clinical specifiers in the DSM. Failure to identify important contextual modifiers tacitly conveys a lack of relevance and likely will result in the exclusion of these variables from both the clinical evaluation and conceptualization of a patient’s illness. Psychiatric illnesses are heterogeneous in both etiology and presentation, and they mandate attention to other physiologic systems. In the case of depression, for example, the etiologically relevant effects of thyroid status and medication use are routinely evaluated. Failure to consider the contribution of such variables could result in substantial diagnostic, prognostic, and treatment errors. Notably, however, the DSM overlooks key contextual modifiers specific to reproductive state, despite the clear association between mood disorders and changes in gonadal steroid exposure. The postpartum state already appears in the DSM IV, but both the perimenopause and the luteal phase of the menstrual cycle similarly may influence the course and treatment response profile of mood disorders. For example, three independent studies now demonstrate that estradiol is an effective antidepressant in the perimenopause but not in the postmenopause (Schmidt et al. 2000; Soares et al. 2001; Morrison et al. 2004). Consequently, failure to consider menopausal state may result in the formulation of a suboptimal therapeutic algorithm. Further, the omission of perimenopause as a specifier conveys a lack of relevance to the clinician, irrespective of the conviction D. R. Rubinow (*) :A. Miller Department of Psychiatry, University of North Carolina Chapel Hill School of Medicine, UNC, Chapel Hill, NC, USA e-mail: David_rubinow@med.unc.edu