[Study of the impact of a post-acute coronary syndrome pharmaceutical interview in hospital]. / Étude de l'impact d'un entretien pharmaceutique post-syndrome coronarien aigu à l'hôpital.

OBJECTIVES: Post-acute coronary syndrome pharmaceutical interviews were set up in our establishment. The objective of this study was to assess their impact on patient knowledge and their benefit at one year on medication compliance, cardiovascular risk factors (smoking, overweight, dyslipidemia) and the recurrence rate. METHODS: Two groups were formed, an experimental group of patients who had benefited from pharmaceutical interviews and a control group of patients who had not benefited from them. The knowledge of the patients was measured using a quizz carried out before the interview and one month after for the experimental group, then one year after hospitalization for the two groups. A one-year follow-up of medication compliance assessed, control of cardiovascular risk factors and the rate of recurrence of acute coronary syndrome was carried out in both groups. RESULTS: A significant increase in knowledge (P<0.001) after the pharmaceutical interview and its maintenance over time were observed in the experimental group. One year after hospitalization, in the experimental group, the average score on the knowledge quizz (9.2/10) was significantly higher (P<0.005) than that of the control group (6.6/10); medication compliance was significantly better (P<0.05) and greater smoking cessation was observed. CONCLUSIONS: These encouraging results should be highlighted in order to perpetuate and develop such approaches around patient care.

Cochrane Centralised Search Service showed high sensitivity identifying randomized controlled trials: A retrospective analysis.

BACKGROUND AND OBJECTIVES: The Cochrane Central Register of Controlled Trials (CENTRAL) is compiled from a number of sources, including PubMed and Embase. Since 2017, we have increased the number of sources feeding into CENTRAL and improved the efficiency of our processes through the use of application programming interfaces, machine learning, and crowdsourcing.Our objectives were twofold: (1) Assess the effectiveness of Cochrane's centralized search and screening processes to correctly identify references to published reports which are eligible for inclusion in Cochrane systematic reviews of randomized controlled trials (RCTs). (2) Identify opportunities to improve the performance of Cochrane's centralized search and screening processes to identify references to eligible trials. METHODS: We identified all references to RCTs (either published journal articles or trial registration records) with a publication or registration date between 1st January 2017 and 31st December 2018 that had been included in a Cochrane intervention review. We then viewed an audit trail for each included reference to determine if it had been identified by our centralized search process and subsequently added to CENTRAL. RESULTS: We identified 650 references to included studies with a publication year of 2017 or 2018. Of those, 634 (97.5%) had been captured by Cochrane's Centralised Search Service. Sixteen references had been missed by the Cochrane's Centralised Search Service: six had PubMed-not-MEDLINE status, four were missed by the centralized Embase search, three had been misclassified by Cochrane Crowd, one was from a journal not indexed in MEDLINE or Embase, one had only been added to Embase in 2019, and one reference had been rejected by the automated RCT machine learning classifier. Of the sixteen missed references, eight were the main or only publication to the trial in the review in which it had been included. CONCLUSION: This analysis has shown that Cochrane's centralized search and screening processes are highly sensitive. It has also helped us to understand better why some references to eligible RCTs have been missed. The CSS is playing a critical role in helping to populate CENTRAL and is moving us toward making CENTRAL a comprehensive repository of RCTs.

[Medical devices used in digestive system surgical procedures: What's the cost?] / Dépenses en dispositifs médicaux stériles dans certains actes de chirurgie hépatobiliaire et digestive : que resterait-il du Groupe Homogène de Séjour ?

OBJECTIVE: Medical devices innovations and associated procedures represent a large part of health facilities budget. The aim of this work was to evaluate the cost of medical devices used during different surgical procedures. This cost was compare with the revenue collected from hospital stay pricing. METHOD: A prospective analysis of the medical devices used in operating room was carried out for different types of programmed surgeries. For five weeks, references of sterile single-use medical devices used during the interventions were collected. RESULTS: Expenditure on medical devices used during surgical procedures represented 5.7 % of the hospitalization value for an inguinal hernia repair, 12 % for a cholecystectomy, 9.35 % for a colectomy, 14.5 % for a hepatectomy and 7 % for pancreatectomy, any severity index combined. The most important correlations existed between act duration and patient's level of severity and between operating times and consumables expenditure. CONCLUSION: Cost optimization opportunities are equivalence of some medical devices ranges, purchases with national groupings and potential decreases in operating times related to the use of innovative medical devices.

Impact of long-term daylight deprivation on retinal light sensitivity, circadian rhythms and sleep during the Antarctic winter.

Long-term daylight deprivation such as during the Antarctic winter has been shown to lead to delayed sleep timing and sleep fragmentation. We aimed at testing whether retinal sensitivity, sleep and circadian rest-activity will change during long-term daylight deprivation on two Antarctic bases (Concordia and Halley VI) in a total of 25 healthy crew members (mean age: 34 ± 11y; 7f). The pupil responses to different light stimuli were used to assess retinal sensitivity changes. Rest-activity cycles were continuously monitored by activity watches. Overall, our data showed increased pupil responses under scotopic (mainly rod-dependent), photopic (mainly L-/M-cone dependent) as well as bright-blue light (mainly melanopsin-dependent) conditions during the time without direct sunlight. Circadian rhythm analysis revealed a significant decay of intra-daily stability, indicating more fragmented rest-activity rhythms during the dark period. Sleep and wake times (as assessed from rest-activity recordings) were significantly delayed after the first month without sunlight (p < 0.05). Our results suggest that during long-term daylight deprivation, retinal sensitivity to blue light increases, whereas circadian rhythm stability decreases and sleep-wake timing is delayed.

Proteasome Inhibitor Carfilzomib-Based Therapy for Antibody-Mediated Rejection of the Pulmonary Allograft: Use and Short-Term Findings.

We present this observational study of lung transplant recipients (LTR) treated with carfilzomib (CFZ)-based therapy for antibody-mediated rejection (AMR) of the lung. Patients were considered responders to CFZ if complement-1q (C1q)-fixing ability of their immunodominant (ID) donor-specific anti-human leukocyte antibody (DSA) was suppressed after treatment. Treatment consisted of CFZ plus plasma exchange and immunoglobulins. Fourteen LTRs underwent CFZ for 20 ID DSA AMR. Ten (71.4%) of LTRs responded to CFZ. DSA IgG mean fluorescence intensity (MFI) fell from 7664 (IQR 3230-11 874) to 1878 (653-7791) after therapy (p = 0.001) and to 1400 (850-8287) 2 weeks later (p = 0.001). DSA C1q MFI fell from 3596 (IQR 714-14 405) to <30 after therapy (p = 0.01) and <30 2 weeks later (p = 0.02). Forced expiratory volume in 1s ( FEV1 ) fell from mean 2.11 L pre-AMR to 1.92 L at AMR (p = 0.04). FEV1 was unchanged after CFZ (1.91 L) and subsequently rose to a maximum of 2.13 L (p = 0.01). Mean forced expiratory flow during mid forced vital capacity (25-75) (FEF25-75 ) fell from mean 2.5 L pre-AMR to 1.95 L at AMR (p = 0.01). FEF25-75 rose after CFZ to 2.54 L and reached a maximum of 2.91 L (p = 0.01). Responders had less chronic lung allograft dysfunction or progression versus nonresponders (25% vs. 83%, p = 0.04). No deaths occurred within 120 days and 7 patients died post CFZ therapy of allograft failure. Larger prospective interventional studies are needed to further describe the benefit of CFZ-based therapy for pulmonary AMR.

Association between high on-treatment platelet reactivity and occurrence of cerebral ischemic events in patients undergoing percutaneous coronary intervention.

INTRODUCTION: Percutaneous coronary angioplasty (PCI) has become a routine treatment in symptomatic patients with coronary artery disease. The use of new generation drug eluting stents (DES) and dual antiplatelet therapy has significantly improved treatment outcomes and increased patients' safety by reducing the risk of stent thrombosis. AIMS: The goal of this study was to assess whether high on treatment platelet reactivity (HTPR), despite clopidogrel treatment, measured with Multiplate Electrode Aggregometer (MEA) is associated with the risk of adverse ischemic cerebral events. METHODS: Symptomatic patients with coronary artery disease admitted for coronary angiography and angioplasty (PCI) were consecutively enrolled in this study. 249 consecutive patients underwent coronary artery stenting for stable angina (n=215) or non-ST-elevation acute coronary syndrome (n=34). Inhibition of platelet aggregation was assessed by MEA. Genetic polymorphism of CYP2C19 was tested by HRM Real-Time PCR method in 150 patients. RESULTS: Patients with HTPR were more frequently diagnosed with ischemic stroke (p=0.0351, OR=16.818, 95% CI [1.464-193.23]) and other ischemic cerebral events (stroke or TIA, p=0.0339, OR=6.5, 95% CI [1.36-31.07]). Cumulative assessment of all ischemic and hemorrhagic events showed no statistical significance. Cerebral ischemic event was the only adverse event that correlated with CYP2C19 (*2/*2) allele (p=0.0489, OR=10; 95% CI [1.39-71.80]). CONCLUSIONS: HTPR assessed by MEA, in patients treated with clopidogrel after coronary artery stenting was found to be an important risk factor of ischemic cerebral events. In concordance, the carriers of CYP2C19*2/*2 allele showed an increased rate of ischemic cerebral events.

Techno-economic analysis of CHP system supplied by waste forest biomass.

Poland, as for Europe, is a country with an average forest cover of approximately 30%. In these forests, more than 37M m3 of wood, mostly coniferous (over 80%), is harvested per year. In 2012, 4.2M m3 of sawn timber was produced (sawn timber without factory lumber). At the same time, in Poland there are over 8000 sawmills, whereas only about 700 of them saw over 90% of the harvested timber. So much fragmentation is a major cause of low sawmills innovation, particularly of those small ones. However, in recent years, a trend of development in this sector is noticeable, and it is through rationalisation of material and energy economy. One of the methods to increase the technical and economic effectiveness of enterprises involved in woodworking is to build in the combined heat and power system (CHP) plant with the ORC system into the existing infrastructure, which will be matched to the needs of the company. This article presents an analysis of the profitability of the investment based on the example of a medium-sized company sawing approximately 50,000 m3 of timber per year, and the economic analysis was performed for prices and costs valid in Poland. The analysis made for the 1650 kW(el) organic Rankine cycle (ORC) system, has resulted in a profitability index PI = 1.3, on the assumptions that the ORC system operates for 6000 h y(-1), will be purchased at the price of 4500 € kW(el)(-1) and at the price of electricity sales of 130 € MWh(-1).

Aging of retrieved gel breast implants: a comparison between two product generations.

In order to get a marketing authorization, breast implants (BI) must meet a number of standard requirements. French and European standards ISO 14607 list a number of official tests to be performed before an implant can be used clinically. However, the BI material characteristics evolution over implantation time remains a research field which is unexplored. The goal of the present study is to compare the mechanical ageing of two breast implant generations and assess if the use of one generation rather than the other is advantageous in terms of durability. For that purpose, 21 explanted BI were analyzed in terms of biomechanical characteristics and compared. Twelve BI were textured anatomic specimens of 5th generation and 10 BI were round textured specimens of 4th generation. All the specimens were produced by the same manufacturer. Implantation time ranged from 3 to 130 months. Both the shell and the gel of every specimen were analyzed. Results show that the mechanical properties go down with the implantation time for all the implants. Moreover, the shell of round implants appear to be less resistant than the shell of anatomic specimens with 25% lower rupture forces. With regard to the gel, whatever the specimen, results show that the properties change with implantation time. The color changes from transparent to milky to finally become yellow, while the cohesion goes down especially for the round specimens. Globally, the study brings out that BI get degraded with implantation time and provides information which could help predicting the durability of the implant.

Impact of fatigue on outcome of selective serotonin reuptake inhibitor treatment: secondary analysis of STAR*D.

OBJECTIVE: To explore relationships between baseline and changes in fatigue during treatment with outcomes in patients with major depressive disorder (MDD) receiving citalopram monotherapy. RESEARCH DESIGN AND METHODS: Secondary analyses of data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Level 1 treatment phase (≤14 weeks citalopram monotherapy). Fatigue was assessed with item 14 on energy level from the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16; scored 0-3: 0 = no fatigue, 3 = maximal fatigue); prospective fatigue: assessment of fatigue at Level 1 entry and exit (no fatigue, treatment-emergent fatigue, remitted fatigue, or residual fatigue). CLINICAL TRIAL REGISTRATION: Http://clinicaltrials.gov, NCT00021528. MAIN OUTCOME MEASURES: Remission of depressive symptoms (17-item Hamilton Rating Scale for Depression ≤7 or QIDS-SR16 ≤5); Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form; Short-Form Health Survey Mental and Physical subscales; and Work and Social Adjustment Scale (WSAS). RESULTS: At baseline, of 2868 patients included in the analyses, 5.5% had a QIDS-SR16 item 14 score of 0; 22.9%, a score of 1; 53.6%, a score of 2; and 18.0%, a score of 3. During Level 1 treatment, 3.5% of patients had no prospective fatigue, 2.1% had treatment-emergent fatigue, 33.6% had fatigue remitting during treatment, and 60.8% had residual fatigue. Female gender, unemployment, fewer years of education, and lower monthly income were significantly associated with higher rates of baseline fatigue (all P < 0.0001). Higher levels of baseline or prospective fatigue were associated with reduced likelihood of remission, decreased overall satisfaction (P < 0.0001), and reduced mental and physical function at outcome (P ≤ 0.05). Patients with higher baseline or prospective fatigue reported higher WSAS total scores (P < 0.0001), indicative of more severe functional impairment. CONCLUSIONS: Lower baseline fatigue and remission of fatigue during antidepressant treatment in patients with MDD are associated with higher rates of remission of depressive symptoms and better function and quality of life. Study limitations include use of the STAR*D Level 1 sample (citalopram as only antidepressant), use of a proxy measure of energy/fatigue (item 14 from the QIDS-SR16), and the secondary post-hoc analysis design.

Does early-onset chronic or recurrent major depression impact outcomes with antidepressant medications? A CO-MED trial report.

BACKGROUND: Prior studies have suggested that major depressive disorder (MDD) with pre-adult onset represents a distinct subtype with greater symptom severity and higher rates of suicidal ideation. Whether these patients have poorer response to various types of antidepressant treatment than those with adult-onset MDD is unclear. Method A total of 665 psychiatric and primary care out-patients (aged 18-75 years) with non-psychotic chronic or recurrent MDD participated in a single-blind, randomized trial that compared the efficacy of escitalopram plus placebo, bupropion sustained-release plus escitalopram, or venlafaxine extended-release plus mirtazapine. We compared participants who self-reported MDD onset (before age 18) to those with a later onset (adult onset) with respect to baseline characteristics and treatment/outcome variables at 12 and 28 weeks. RESULTS: Early-onset chronic/recurrent MDD was associated with a distinct set of sociodemographic (female, younger age) and clinical correlates (longer duration of illness, greater number of prior episodes, greater likelihood of atypical features, higher rates of suicidality and psychiatric co-morbidity, fewer medical problems, poorer quality of life, greater history of child abuse/neglect). However, results from unadjusted and adjusted analyses showed no significant differences in response, remission, tolerability of medications, quality of life, or retention at 12 or 28 weeks. CONCLUSIONS: Although early-onset chronic/recurrent MDD is associated with a more severe clinical picture, it does not seem to be useful for predicting differential treatment response to antidepressant medication. Clinicians should remain alert to an increased risk of suicidality in this population.

Increased CSF concentrations of myelin basic protein after TBI in infants and children: absence of significant effect of therapeutic hypothermia.

BACKGROUND: The objectives of this study were to determine effects of severe traumatic brain injury (TBI) on cerebrospinal fluid (CSF) concentrations of myelin basic protein (MBP) and to assess relationships between clinical variables and CSF MBP concentrations. METHODS: We measured serial CSF MBP concentrations in children enrolled in a randomized controlled trial evaluating therapeutic hypothermia (TH) after severe pediatric TBI. Control CSF was obtained from children evaluated, but found not to be having CNS infection. Generalized estimating equation models and Wilcoxon Rank-Sum test were used for comparisons of MBP concentrations. RESULTS: There were 27 TBI cases and 57 controls. Overall mean (± SEM) TBI case MBP concentrations for 5 days after injury were markedly greater than controls (50.49 ± 6.97 vs. 0.11 ± 0.01 ng/ml, p < 0.01). Mean MBP concentrations were lower in TBI patients <1 year versus >1 year (9.18 ± 1.67 vs. 60.22 ± 8.26 ng/ml, p = 0.03), as well as in cases with abusive head trauma (AHT) versus non-abusive TBI (14.46 ± 3.15 vs. 61.17 ± 8.65 ng/ml, p = 0.03). TH did not affect MBP concentrations. CONCLUSIONS: Mean CSF MBP increases markedly after severe pediatric TBI, but is not affected by TH. Infancy and AHT are associated with low MBP concentrations, suggesting that age-dependent myelination influences MBP concentrations after injury. Given the magnitude of MBP increases, axonal injury likely represents an important therapeutic target in pediatric TBI.

The impact of local anesthetic distribution on block onset in ultrasound-guided interscalene block.

BACKGROUND: Recent investigations of local anesthetic distribution in the lower extremity have revealed that completely surrounding the sciatic nerve with local anesthetic provides the advantage of more rapid and complete anesthesia in the territory served by the nerve. We hypothesized that a pattern of distribution that entirely envelops the targeted nerve roots during interscalene block would provide similar benefits of more rapid anesthesia onset. METHODS: During interscalene block guided by ultrasound with nerve stimulator confirmation, the pattern of local anesthetic distribution was recorded and later classified as complete or incomplete envelopment of the visible nerve elements in 50 patients undergoing ambulatory shoulder arthroscopic surgery. The pattern was then compared with the extent of block setup at pre-determined intervals, as well as to post-operative pain levels and block duration. RESULTS: Twenty-two patients (44%) had complete envelopment of the nerves in the plane of injection during ultrasound imaging of the interscalene block. There was no difference in the fraction of blocks that were fully set-up at 10 min with regards to complete or incomplete envelopment of the nerves by local anesthetic. All of the patients had complete setup of the block by 20 min. In addition, the post-operative pain levels and duration of block did not vary among the two groups with complete vs. incomplete local anesthetic distribution around the nerves. CONCLUSION: The presence or absence of complete envelopment of the nerve elements in the interscalene groove by local anesthetic did not determine the likelihood of complete block effect at pre-determined time intervals after the procedure.

A rare heterozygous TRAF6 variant is associated with hypohidrotic ectodermal dysplasia.

BACKGROUND: Mutations in the genes encoding components of the tumour necrosis factor (TNF)-α-like pathway cause hypohidrotic ectodermal dysplasia (HED). It has been postulated that the TNF receptor-associated factor 6 (TRAF6) is also involved in this pathway. OBJECTIVES: To investigate mutations in the TRAF6 gene in an individual with HED. METHODS: Genetic analysis was performed on TRAF6 in a patient with HED, her parents, her sister and 150 ethnically matched, healthy individuals. RESULTS: In the patient, sequencing analysis of one DNA strand revealed a deletion of eight nucleotides (c.1074-1081delCAATTTG) in the 5' fragment of the last exon of TRAF6, while no deletion was detected in the other DNA strand indicating a heterozygous mutation. No such sequence abnormality was detected in the patient's parents and her sister. CONCLUSION: This is the first report of a heterozygous TRAF6 sequence variant associated with symptoms typical of HED.

Is prior course of illness relevant to acute or longer-term outcomes in depressed out-patients? A STAR*D report.

BACKGROUND: Major depressive disorder (MDD) is commonly chronic and/or recurrent. We aimed to determine whether a chronic and/or recurrent course of MDD is associated with acute and longer-term MDD treatment outcomes. METHOD: This cohort study recruited out-patients aged 18-75 years with non-psychotic MDD from 18 primary and 23 psychiatric care clinics across the USA. Participants were grouped as: chronic (index episode >2 years) and recurrent (n = 398); chronic non-recurrent (n=257); non-chronic recurrent (n=1614); and non-chronic non-recurrent (n = 387). Acute treatment was up to 14 weeks of citalopram (≤ 60 mg/day) with up to 12 months of follow-up treatment. The primary outcomes for this report were remission [16-item Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR(16)) ≤ 5] or response (≥ 50% reduction from baseline in QIDS-SR(16)) and time to first relapse [first QIDS-SR16 by Interactive Voice Response (IVR) ≥ 11]. RESULTS: Most participants (85%) had a chronic and/or recurrent course; 15% had both. Chronic index episode was associated with greater sociodemographic disadvantage. Recurrent course was associated with earlier age of onset and greater family histories of depression and substance abuse. Remission rates were lowest and slowest for those with chronic index episodes. For participants in remission entering follow-up, relapse was most likely for the chronic and recurrent group, and least likely for the non-chronic, non-recurrent group. For participants not in remission when entering follow-up, prior course was unrelated to relapse. CONCLUSIONS: Recurrent MDD is the norm for out-patients, of whom 15% also have a chronic index episode. Chronic and recurrent course of MDD may be useful in predicting acute and long-term MDD treatment outcomes.

Outcomes on the pharmacopsychometric triangle in bupropion-SR vs. buspirone augmentation of citalopram in the STAR*D trial.

OBJECTIVE: To compare within the framework of a novel pharmacopsychometric triangle, augmentation treatment with bupropion vs. buspirone in the acute therapy of major depression in the STAR*D study. The triangle provides a composite view in three domains of antidepressive activity, side effects, and quality of life. METHOD: Within the pharmacopsychometric triangle, the short six-item subscales of the Hamilton Depression Scale (HAM-D(17)) and of the Inventory of Depressive Symptomatology (IDS-C(30)), referred to as HAM-D(6) and IDS-C(6), were focussed on pure antidepressive effect. Side-effects (tolerable vs. intolerable) and quality of life were measured using patient-administered questionnaires. A modified intention to treat sample was used. RESULTS: Within the pharmacopsychometric triangle, bupropion-SR (sustained release) was superior to buspirone when augmented to the current citalopram treatment. Thus, in the domain of pure antidepressive effect, bupropion-SR was superior (P = 0.05) on the HAM-D(6), IDS-C(6), and IDS-C(30), but not on the HAM-D(17). In the domain of side effects, the total scores on the Patient Rated Inventory of Side Effects (PRISE) were reduced significantly more by bupropion-SR than by buspirone (P = 0.03). In the domain of quality of life, the total scores on the Quality of Life Enjoyment and Satisfaction Questionnaire (QLES-Q) showed a trend (P = 0.10) from baseline to endpoint of a superiority for bupropion-SR compared with buspirone. CONCLUSION: In all domains of the pharmacopsychometric triangle, bupropion-SR was superior to buspirone as augmentation therapy in depressed outpatients not responding to citalopram.

Factor structure and dimensionality of the two depression scales in STAR*D using level 1 datasets.

BACKGROUND: The factor structure and dimensionality of the HAM-D(17) and the IDS-C(30) are as yet uncertain, because psychometric analyses of these scales have been performed without a clear separation between factor structure profile and dimensionality (total scores being a sufficient statistic). METHODS: The first treatment step (Level 1) in the STAR*D study provided a dataset of 4041 outpatients with DSM-IV nonpsychotic major depression. The HAM-D(17) and IDS-C(30) were evaluated by principal component analysis (PCA) without rotation. Mokken analysis tested the unidimensionality of the IDS-C(6), which corresponds to the unidimensional HAM-D(6.) RESULTS: For both the HAM-D(17) and IDS-C(30), PCA identified a bi-directional factor contrasting the depressive symptoms versus the neurovegetative symptoms. The HAM-D(6) and the corresponding IDS-C(6) symptoms all emerged in the depression factor. Both the HAM-D(6) and IDS-C(6) were found to be unidimensional scales, i.e., their total scores are each a sufficient statistic for the measurement of depressive states. LIMITATIONS: STAR*D used only one medication in Level 1. CONCLUSIONS: The unidimensional HAM-D(6) and IDS-C(6) should be used when evaluating the pure clinical effect of antidepressive treatment, whereas the multidimensional HAM-D(17) and IDS-C(30) should be considered when selecting antidepressant treatment.

Painful physical symptoms and treatment outcome in major depressive disorder: a STAR*D (Sequenced Treatment Alternatives to Relieve Depression) report.

BACKGROUND: Painful physical symptoms (PPS) are both common and reduce the likelihood of remission in major depressive disorder (MDD), based upon results of clinical trials in selected populations. Whether PPS significantly contribute to poorer treatment outcome overall in primary or specialty psychiatric care settings remains unclear. METHOD: Out-patients (n=2876) with MDD were treated in the first step of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial with citalopram up to 60 mg/day for up to 14 weeks. Presence of painful symptoms, as well as severity of depression, physical illness, and demographic and treatment factors were examined. Time to and overall rates of remission were analysed in relation to the presence of PPS. RESULTS: Of the participants, 80% complained of PPS. These patients, both in primary and specialty psychiatric settings, had significantly lower remission rates and took longer to remit. Increasing severity of PPS was associated with greater physical illness burden, lower socio-economic status, absence of private insurance and being female, African-American or Hispanic. After adjustment for these factors, patients with PPS no longer had significantly poorer treatment outcomes. CONCLUSIONS: Presence and severity of PPS is an indicator of MDD that may have poorer treatment outcome with an initial selective serotonin reuptake inhibitor. These poorer treatment outcomes are multifactorial, however, and are not explained by the presence and severity of pain per se.

Indicators of pretreatment suicidal ideation in adults with major depressive disorder.

OBJECTIVE: In order to evaluate the presence of treatment emergent suicidal ideation (SI), it becomes necessary to identify those patients with SI at the onset of treatment. The purpose of this report is to identify sociodemographic and clinical features that are associated with SI in major depressive disorder (MDD) patients prior to treatment with a selective serotonin reuptake inhibitor. METHOD: This multisite study enrolled 265 out-patients with non-psychotic MDD. Sociodemographic and clinical features of participants with and without SI were compared post hoc. RESULTS: Social phobia, bulimia nervosa, number of past depressive episodes, and race were independently associated with SI by one or more SI measure. CONCLUSION: Concurrent social phobia and bulimia nervosa may be potential risk factors for SI in patients with non-psychotic MDD. Additionally, patients with more than one past depressive episode may also be at increased risk of SI.

Residual symptoms after remission of major depressive disorder with citalopram and risk of relapse: a STAR*D report.

BACKGROUND: Many patients with major depressive disorder (MDD) who experience full symptomatic remission after antidepressant treatment still have residual depressive symptoms. We describe the types and frequency of residual depressive symptoms and their relationship to subsequent depressive relapse after treatment with citalopram in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. METHOD: Participants in primary (n=18) and psychiatric (n=23) practice settings were openly treated with citalopram using measurement-based care for up to 14 weeks and follow-up for up to 1 year. We assessed 943 (32.8% of 2876) participants who met criteria for remission to determine the proportions with individual residual symptoms and any of the nine DSM-IV criterion symptom domains to define a major depressive episode. At each visit, the 16-item Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR16) and the self-report Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale were used to assessed depressive symptoms and side-effects respectively. RESULTS: More than 90% of remitters had at least one residual depressive symptom (median=3). The most common were weight increase (71.3%) and mid-nocturnal insomnia (54.9%). The most common residual symptom domains were sleep disturbance (71.7%) and appetite/weight disturbance (35.9%). Those who remitted before 6 weeks had fewer residual symptoms at study exit than did later remitters. Residual sleep disturbance did not predict relapse during follow-up. Having a greater number of residual symptom domains was associated with a higher probability of relapse. CONCLUSIONS: Patients with remission of MDD after treatment with citalopram continue to experience selected residual depressive symptoms, which increase the risk of relapse.

Irritability is associated with anxiety and greater severity, but not bipolar spectrum features, in major depressive disorder.

OBJECTIVE: Irritability is common during major depressive episodes, but its clinical significance and overlap with symptoms of anxiety or bipolar disorder remains unclear. We examined clinical correlates of irritability in a confirmatory cohort of Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study participants with major depressive disorder (MDD). METHOD: Logistic regression was used to identify features associated with presence of irritability on the clinician-rated Inventory of Depressive Symptomatology. RESULTS: Of 2307 study participants, 1067(46%) reported irritability at least half the time during the preceding week; they were more likely to be female, to be younger, to experience greater depression severity and anxiety, and to report poorer quality of life, prior suicide attempts and suicidal ideation. Bipolar spectrum features were not more common among those with irritability. CONCLUSION: Irritable depression is not a distinct subtype of MDD, but irritability is associated with greater overall severity, anxiety comorbidity and suicidality.