Protocol change improves live birth and recurrent cycle cancellation rates after a previous IVF cycle cancellation: an analysis of 13 000 autologous cycles reported to SART CORS.

STUDY QUESTION: After an IVF cycle cancellation, does changing the stimulation protocol affect the odds of live birth and recurrent cancellation in the subsequent cycle? SUMMARY ANSWER: After IVF cycle cancellation, compared to those who repeated the same stimulation protocol, those who changed their protocol had higher odds of live birth and lower odds of recurrent cycle cancellation. WHAT IS KNOWN ALREADY: There is limited data addressing the effect of changing the stimulation protocol after an IVF cycle is cancelled during initial stimulation. The odds of live birth outcomes are not known so far in studies addressing the effect of changing the protocol. STUDY DESIGN, SIZE, DURATION: Retrospective Cohort Study using the 2014-2017 Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) database. PARTICIPANTS/MATERIALS, SETTING, METHODS: The data included 13 135 patients with a first autologous IVF cycle that resulted in a cycle cancellation and was followed by a second autologous cycle within the study period. We excluded fertility preservation cycles, supernumerary cycle attempts after the second IVF cycle attempt, and cycles with more than one stimulation protocol documented per cycle start. Patients who received the same protocol for both cycles (n = 6434) were compared to those who changed their protocol in the second cycle (n = 6701). Multivariable logistic regression analyses were performed to estimate the adjusted odds of live birth and recurrent cancellation. MAIN RESULTS AND THE ROLE OF CHANCE: Changing the protocol in the second cycle resulted 14% lower odds of recurrent cycle cancellation (P = 0.01) and 17% higher odds of live birth after fresh transfers (P = 0.04). When stratifying the data by specific combinations of protocol change (agonist flare, agonist suppression, antagonist), there was an increase in live birth when switching from antagonist to agonist suppression (odds ratio (OR) = 1.36, P = 0.03) and from agonist suppression to antagonist (OR = 1.73, P = 0.01) compared to those who repeated their same stimulation protocol. Specifically in poor responders, outcomes were worse when using the agonist flare protocol and significantly improved with the agonist suppression protocol. LIMITATIONS, REASONS FOR CAUTION: Comparison of response to stimulation between first and second cycles cannot be made in this study because the index IVF cycle was cancelled during ovarian stimulation, and thus there is no reportable outcome data for that cycle. Additionally, SART only tracks the three stimulation protocols addressed in this study and does not have data on more contemporary protocols that are used in poor responders thus limiting the generalizability of our findings. WIDER IMPLICATIONS OF THE FINDINGS: Using the SART CORS database, which includes >90% of all reported IVF cycles in the USA, provides generalizability to the demographically diverse IVF populations found here. In agreement with prior studies assessing change in IVF protocols, the agonist flare protocol seems to result in worse IVF outcomes, and based on our results, we believe that there is no role for the agonist flare protocol in patients with a prior poor response to stimulation. STUDY FUNDING/COMPETING INTEREST(S): None declared. TRIAL REGISTRATION NUMBER: N/A.

Twelve-month service use, suicidality and mental health problems of European adolescents after a school-based screening for current suicidality.

Suicide is one of the leading causes of death in adolescents and help-seeking behaviour for suicidal behaviour is low. School-based screenings can identify adolescents at risk for suicidal behaviour and might have the potential to facilitate service use and reduce suicidal behaviour. The aim of this study was to assess associations of a two-stage school-based screening with service use and suicidality in adolescents (aged 15 ± 0.9 years) from 11 European countries after one year. Students participating in the 'Saving and Empowering Young Lives in Europe' (SEYLE) study completed a self-report questionnaire including items on suicidal behaviour. Those screening positive for current suicidality (first screening stage) were invited to an interview with a mental health professional (second stage) who referred them for treatment, if necessary. At 12-month follow-up, students completed the same self-report questionnaire including questions on service use within the past year. Of the N = 12,395 SEYLE participants, 516 (4.2%) screened positive for current suicidality and were invited to the interview. Of these, 362 completed the 12-month follow-up with 136 (37.6%) self-selecting to attend the interview (screening completers). The majority of both screening completers (81.9%) and non-completers (91.6%) had not received professional treatment within one year, with completers being slightly more likely to receive it (χ2(1) = 8.948, V = 0.157, p ≤ 0.01). Screening completion was associated with higher service use (OR 2.695, se 1.017, p ≤ 0.01) and lower suicidality at follow-up (OR 0.505, se 0.114, p ≤ 0.01) after controlling for potential confounders. This school-based screening offered limited evidence for the improvement of service use for suicidality. Similar future programmes might improve interview attendance rate and address adolescents' barriers to care.

[The right to die and assisted suicide: Review and critical analysis]. / Droit à mourir et suicide assisté : état des lieux et analyse critique.

OBJECTIVES: In the context of the present re-examination of the French bioethical laws by the National Advisory Ethics Committee ("Comité consultatif national d'éthique": CCNE), a recent survey indicated a request of the public opinion to obtain a medical aid in end of life and a so-called "assisted suicide". This led psychiatrists to re-consider their role and deontological position which usually led them to consider a request for an assistance in suicide as - a priori - a pathological demand, occurring within a suicidal crisis. The present article intends to: 1) describe the laws and practices of countries which allow medically assisted end of life help procedures; 2) clarify the definitions of "assisted suicide", "assistance to suicide" and "euthanasia"; 3) consider available epidemiological data and the roles given to doctors and, more specifically psychiatrists, in these procedures; 4) analyse the rationale behind these demands. These considerations should enable French psychiatrists to clarify their position when facing requests for a medical aid in dying. METHODS: Four European countries (Switzerland, the Netherlands, Belgium, Luxemburg) and Oregon (the first US state to introduce legislation) were considered, since they accumulated and published a large amount of experiences and data about "assisted suicide" and medical help in dying. In total, 127 articles were selected, mainly from PubMed and Cairn databases, published between 1997 and 2020. These articles deal with legal considerations, epidemiological data, ethical and sociological considerations. RESULTS: Laws and practices differ notably according to the state/country. In Belgium, the Netherlands and Luxemburg, as in Oregon, the medical help in dying has been de-criminalized, as long as certain legal criteria are met. In Switzerland, where no specific law exists in the penal code, non-governmental associations have benefited from the legal vacuum and organized the practice of "assisted suicide" for "altruistic motives". In the scientific and legal literature, the terms used to describe and define the medical help in dying upon request differ greatly. In France, the National Advisory Ethics Committee defines euthanasia ("euthanasie"), assisted suicide ("suicide assisté") and suicide assistance ("assistance au suicide"). Available epidemiological data, whatever the country considered, indicate that requests for a medical aid in dying are expressed mainly by patients aged over 60 years and suffering from cancer. Psychiatric diseases account for only 1% to 3%. Most often, systematic assessment by a psychiatrist is neither requested nor made, when the demand does not occur during a primary psychiatric illness. In the case of an existing primary psychiatric pathology, a psychiatrist assesses the case against formal legal predefined criteria. This latter practice was only recently introduced, after some feedback and after legal actions had been brought to Court. When the underlying motivations of the request are considered, it appears that, even in the absence of an evolving psychiatric condition, several psychological or psychopathological reasons prevail such as spirituality, attachment style, social isolation, despair, depression… which should greatly benefit psychiatric exploration, investigation and expertise. CONCLUSION: In some countries, the request for medically assisted help in dying has become a legal and social reality. In France, where the public debate is still open, it should be emphasized that a psychiatric assessment and interview should be systematically provided to any person requesting medical assistance to die or commit suicide. It is the commitment of psychiatrists to understand the implicit demands and unexpressed motives underlying this request which have strong links with the unique life-events and emotional experiences of the person. The psychiatrist has a unique role in the contextualization of such a request.

Spectral CT in clinical routine imaging of neuroendocrine neoplasms.

AIM: To evaluate the potential of new spectral computed tomography (SCT)-based tools in patients with neuroendocrine neoplasms (NEN). MATERIAL AND METHODS: Eighty-eight consecutive patients with NENs were included prospectively. The patients underwent multiphase CT with spectral and standard mode. The signal-to-noise ratio (SNR)/contrast-to-noise-ratio (CNR)tumour-to-liver, iodine concentrations (ICs, total tumour/hotspot) and attenuation slopes in virtual monochromatic images (VMIs) were used to assess NEN-specific SCT values in primary tumours and metastatic lesions and investigate a possible lesion contrast improvement as well as possible correlations of SCT parameters to primary tumour location and tumour grade. Furthermore, the usability of SCT parameters to differentiate between the primary tumour and metastatic lesions, and to predict tumour response after 6-months follow-up was analyzed. The applied dose of spectral and standard mode was compared intra-individually. RESULTS: SNR/CNRtumour-to-liver significantly increased in low-energy VMIs. NENs showed significant differences in ICs between primary and metastatic lesions for both absolute and normalised values (p<0.001) regardless of whether the total tumour or the hotspot was measured. There was also a significant difference in the attenuation slope (p<0.001). No significant correlations were found between SCT and tumour grade. A tumour response prediction by SCT parameters was not possible. The applied dose was comparable between the scan modes. CONCLUSION: SCT was comparable regarding applied dose, improved tumour contrast, and contributed to differentiation between primary NEN and metastasis.

Spectral CT and its specific values in the staging of patients with non-small cell lung cancer: technical possibilities and clinical impact.

AIM: To investigate how spectral computed tomography (SCT) values impact the staging of non-small cell lung cancer (NSCLC) patients. MATERIALS AND METHODS: One hundred and thirteen patients with confirmed NSCLC were included in a prospective cohort study. All patients underwent single-phase contrast-enhanced SCT (using the fast tube voltage switching technique, 80-140 kV). SCT values (iodine content [IC], spectral slope pitch, and radiodensity increase) of malignant tissue (primary and metastases) and lymph nodes (LNs) were measured. Adrenal masses were evaluated in a virtual non-contrast series (VNS). If pulmonary embolism was present, pulmonary perfusion was analysed as an additional finding. RESULTS: Fifty-two untreated primary NSCLC lesions were evaluable. Lung adenocarcinoma had significantly higher normalised IC (NIC: 19.37) than squamous cell carcinoma (NIC: 12.03; p=0.035). Pulmonary metastases were not significantly different from benign lung nodules. A total of 126 LNs were analysed and histologically proven metastatic LNs (2.08 mg/ml) had significantly lower IC than benign LNs (2.58 mg/ml; p=0.023). Among 34 adrenal masses, VNS identified adenomas with high sensitivity (91%) and specificity (100%). In two patients, a perfusion defect due to pulmonary embolism was detected in the iodine images. CONCLUSION: SCT may contribute to the differentiation of histological NSCLC subtypes and improve the identification of LN metastases. VNS differentiates adrenal adenoma from metastasis. In case of pulmonary embolism, iodine imaging can visualise associated pulmonary perfusion defects.

HLA genetics in bipolar disorder.

OBJECTIVE: Bipolar Disorder (BD) is characterized by deregulated adaptive immune processes. Recent genome-wide association studies (GWAS) implicate the major histocompatibility complex (MHC) region in BD. The present study investigates the potential influence of variations in human leukocyte antigen (HLA) on BD risk and/or clinical presentations. This may have relevance to the dysregulated inflammatory processes commonly found in BD. METHOD: DNAs from 475 BD patients and 195 healthy controls (HC) were genotyped for classical HLA class I and II loci. RESULTS: We found that: (i) the HLA-A*02~B*44~DRB1*07 sub-haplotype is less prevalent in BD, vs. HC (pc = 2.4 × 10-2 ); (ii) the 57.1 and the 8.1-derived ancestral haplotypes i.e. HLA-A*02~B*57~Cw*06~DRB1*07~DQB1*09 and HLA-A*02~B*08~Cw*07 are associated with rapid cycling (pc = 1.9 × 10-3 and 1.05 × 10-2 , respectively); (iii) the 8.1AH-derived HLA class II-DRB*03~HLA-DQB1*02 sub-haplotype is more frequent in BD patients with a history of suicidal behaviors (pc = 2.1 × 10-2 ); and (iv) disease onset by an hypomanic episode or by psychotic symptoms are, respectively, more frequent in BD patients bearing the 7.1 AH-derived A*03~B*07~DRB1*15 sub-haplotype (pc = 8.5 × 10-3 ) and the HLA-A*02~B*07~DRB1*15 sub-haplotype (pc = 4.0 × 10-2 ). CONCLUSION: Corroborating the established link between these HLA haplotypes/sub haplotypes and common immune disorders, our findings suggest possible HLA-mediated proinflammatory processes operating in BD.

Emotional hyper-reactivity and cardiometabolic risk in remitted bipolar patients: a machine learning approach.

OBJECTIVE: Remitted bipolar disorder (BD) patients frequently present with chronic mood instability and emotional hyper-reactivity, associated with poor psychosocial functioning and low-grade inflammation. We investigated emotional hyper-reactivity as a dimension for characterization of remitted BD patients, and clinical and biological factors for identifying those with and without emotional hyper-reactivity. METHOD: A total of 635 adult remitted BD patients, evaluated in the French Network of Bipolar Expert Centers from 2010-2015, were assessed for emotional reactivity using the Multidimensional Assessment of Thymic States. Machine learning algorithms were used on clinical and biological variables to enhance characterization of patients. RESULTS: After adjustment, patients with emotional hyper-reactivity (n = 306) had significantly higher levels of systolic and diastolic blood pressure (P < 1.0 × 10-8 ), high-sensitivity C-reactive protein (P < 1.0 × 10-8 ), fasting glucose (P < 2.23 × 10-6 ), glycated hemoglobin (P = 0.0008) and suicide attempts (P = 1.4 × 10-8 ). Using models of combined clinical and biological factors for distinguishing BD patients with and without emotional hyper-reactivity, the strongest predictors were: systolic and diastolic blood pressure, fasting glucose, C-reactive protein and number of suicide attempts. This predictive model identified patients with emotional hyper-reactivity with 84.9% accuracy. CONCLUSION: The assessment of emotional hyper-reactivity in remitted BD patients is clinically relevant, particularly for identifying those at higher risk of cardiometabolic dysfunction, chronic inflammation, and suicide.

CT follow-up in patients with neuroendocrine tumors (NETs): combined radiation and contrast dose reduction.

Background Frequent computed tomography (CT) follow-ups involve significant radiation related risks for patients with low-grade neuroendocrine tumors (NETs). Contrast agent (CA) application is essential for diagnostic evidence and has additional risks especially in patients with limited renal function. Purpose To investigate if a combination of dose and contrast agent (CA) reduction affects image quality and diagnostic evidence in neuroendocrine tumor (NET) patients. Material and Methods A total of 51 NET patients were enrolled in the study and 153 CT scans were analyzed. Patients underwent a baseline CT scan (A = 120 kVp, filtered back projection [FBP]) and two follow-up CTs (B = 120 kVp, adaptive statistical iterative reconstruction [ASIR] 40%; C1 = 100 kVp, ASIR 40%; C2 = 100 kVp, ASIR 60%; the latter two protocols were applied with a 30% reduction in CA volume). We evaluated image quality and applied dose. Results In C1/2, the combination of low kV (100 kVp) with ASIR 40%/60% reduced the mean applied dose significantly by 28% compared to B and by 57% compared to A. Signal-to-noise ratio (SNR) and contrast-to-noise ratios (CNR) of tumor to liver/muscle were significantly increased by using C1/2 compared to B and A. With respect to subjective image quality, a slight loss of diagnostic confidence in C1 could be counterbalanced by the higher ASIR blending in C2. Conclusion Combined dose reduction techniques can be used to reduce radiation dose and CA volume without sacrificing image quality and diagnostic confidence in staging CT of NET patients.

Considering Tangible Benefit for Interdependent Donors: Extending a Risk-Benefit Framework in Donor Selection.

From its infancy, live donor transplantation has operated within a framework of acceptable risk to donors. Such a framework presumes that risks of living donation are experienced by the donor while all benefits are realized by the recipient, creating an inequitable distribution that demands minimization of donor risk. We suggest that this risk-tolerance framework ignores tangible benefits to the donor. A previously proposed framework more fully considers potential benefits to the donor and argues that risks and benefits must be balanced. We expand on this approach, and posit that donors sharing a household with and/or caring for a potential transplant patient may realize tangible benefits that are absent in a more distantly related donation (e.g. cousin, nondirected). We term these donors, whose well-being is closely tied to their recipient, "interdependent donors." A flexible risk-benefit model that combines risk assessment with benefits to interdependent donors will contribute to donor evaluation and selection that more accurately reflects what is at stake for donors. In so doing, a risk-benefit framework may allow some donors to accept greater risk in donation decisions.

Affective lability mediates the association between childhood trauma and suicide attempts, mixed episodes and co-morbid anxiety disorders in bipolar disorders.

BACKGROUND: Many studies have shown associations between a history of childhood trauma and more severe or complex clinical features of bipolar disorders (BD), including suicide attempts and earlier illness onset. However, the psychopathological mechanisms underlying these associations are still unknown. Here, we investigated whether affective lability mediates the relationship between childhood trauma and the severe clinical features of BD. METHOD: A total of 342 participants with BD were recruited from France and Norway. Diagnosis and clinical characteristics were assessed using the Diagnostic Interview for Genetic Studies (DIGS) or the Structured Clinical Interview for DSM-IV Axis I disorders (SCID-I). Affective lability was measured using the short form of the Affective Lability Scale (ALS-SF). A history of childhood trauma was assessed using the Childhood Trauma Questionnaire (CTQ). Mediation analyses were performed using the SPSS process macro. RESULTS: Using the mediation model and covariation for the lifetime number of major mood episodes, affective lability was found to statistically mediate the relationship between childhood trauma experiences and several clinical variables, including suicide attempts, mixed episodes and anxiety disorders. No significant mediation effects were found for rapid cycling or age at onset. CONCLUSIONS: Our data suggest that affective lability may represent a psychological dimension that mediates the association between childhood traumatic experiences and the risk of a more severe or complex clinical expression of BD.

A re-examination of antidepressant treatment-emergent mania in bipolar disorders: evidence of gender differences.

OBJECTIVE: To explore the prevalence and clinical profile of males and females who develop antidepressant treatment-emergent mania (ATEM). METHOD: From an original sample of 754 patients with BD, we identified ATEM+ cases (n = 75) and ATEM- controls (n = 135) that met stringent criteria. We specifically examined the combinations of clinical factors that best classified males and females as ATEM+ cases. RESULTS: Seventy-five individuals were classified as ATEM+; 87% of ATEM events occurred during antidepressant monotherapy. Regression analyses demonstrated that the presence of an alcohol and/or substance use disorder [Odds Ratio (OR) 6.37], a history of one or more suicide attempts (OR 4.19) and higher number of depressive episodes per year of illness (OR 1.71) correctly classified 73% of males. In contrast, 84% of females were correctly classified on the basis of a positive history of thyroid disorder (OR 3.23), a positive family history of BD I (OR 2.68) and depressive onset polarity (OR 2.01). CONCLUSION: Using stringent definitions of ATEM status to reduce the probability of inclusion of false-positive cases and false-negative controls, we identified for the first time that the risk profiles for the development of an ATEM differ significantly according to gender.

Childhood trauma and mixed episodes are associated with poor response to lithium in bipolar disorders.

OBJECTIVES: Reliable predictors of response to lithium are still lacking in bipolar disorders (BDs). However, childhood trauma has been hypothesized to be associated with poor response to lithium. METHODS: We included 148 patients with BD, euthymic when retrospectively and clinically assessed for response to lithium and childhood trauma using reliable scales. RESULTS: According to the 'Alda scale', the sample consisted in 20.3% of excellent responders, 49.3% of partial responders and 30.4% of non-responders to lithium. A higher level of physical abuse significantly correlated with a lower level of response to lithium (P = 0.009). As compared to patients not exposed to any abuse, patients with at least two trauma abuses (emotional, physical or sexual) were more at risk of belonging to the non-responders group (OR = 4.91 95% CI (1.01-27.02)). Among investigated clinical variables, lifetime presence of mixed episodes and alcohol misuse were associated with non-response to lithium. Multivariate analyses demonstrated that physical abuse and mixed episodes were independently associated with poor response to lithium (P = 0.005 and P = 0.013 respectively). CONCLUSIONS: Childhood physical abuse might be involved in a poor future response to lithium prophylaxis, this effect being independent of the association between clinical expression of BD and poor response to lithium.

Affect lability predicts occurrence of suicidal ideation in bipolar patients: a two-year prospective study.

OBJECTIVE: The aim of our study was to investigate, in bipolar patients, whether affect lability was associated with suicidal ideation incidence during 2-year follow-up, and which subtype of affect lability was associated with suicidal ideation. METHOD: A total of 319 euthymic or mildly depressed bipolar outpatients recruited in the French FondaMental Advanced Centres of Expertise for Bipolar Disorder were divided into two subgroups according to the occurrence of suicidal ideation during a 2-year follow-up. Affect lability was assessed by the French version of the Affect Lability Scale. RESULTS: Bipolar patients with high affect lability were more likely to report suicidal ideation during follow-up, even after adjustment for age, study level, rapid cycling, current depression level, anxiety disorder, and lifetime history SA (OR = 2.47; 95% CI [1.15-5.30], P = 0.01). The risk of suicidal ideation increased with the level of affect lability. More specifically, the propensity to switch from neutral to elation affect, from anxious to depressive affect (or inversely), and from neutral to anger affect predicted suicidal ideation. CONCLUSION: Reducing affective lability could become a new therapeutic target of suicidal prevention in bipolar disorder.

Association between childhood dimensions of attention deficit hyperactivity disorder and adulthood clinical severity of bipolar disorders.

BACKGROUND: Clinical features of attention deficit hyperactivity disorder can be frequently observed in cases with bipolar disorders and associated with greater severity of bipolar disorders. Although designed as a screening tool for attention deficit hyperactivity disorder, the Wender Utah Rating Scale could, given its factorial structure, be useful in investigating the early history of impulsive, inattentive or mood-related symptoms among patients with bipolar disorders. METHODS: We rated the Wender Utah Rating Scale in 276 adult bipolar disorder cases and 228 healthy controls and tested its factorial structure and any associations with bipolar disorder phenomenology. RESULTS: We confirmed a three-factor structure for the Wender Utah Rating Scale (' impulsivity/temper', ' inattentiveness' and ' mood/self-esteem'). Cases and controls differed significantly on Wender Utah Rating Scale total score and sub-scale scores ( p-values < 10-5). About 23% of bipolar disorder cases versus 5% of controls were classified as ' WURS positive' (odds ratio = 5.21 [2.73-9.95]). In bipolar disorders, higher Wender Utah Rating Scale score was associated with earlier age at onset, severity of suicidal behaviors and polysubstance misuse; multivariate analyses, controlling for age and gender, confirmed the associations with age at onset ( p = 0.001) and alcohol and substance misuse ( p = 0.001). CONCLUSION: Adults with bipolar disorders who reported higher levels of childhood symptoms on the Wender Utah Rating Scale presented a more severe expression of bipolar disorders in terms of age at onset and comorbidity. The Wender Utah Rating Scale could be employed to screen for attention deficit hyperactivity disorder but also for ' at-risk behaviors' in adult bipolar disorder cases and possibly for prodromal signs of early onset in high-risk subjects.

Factors associated with different smoking status in European adolescents: results of the SEYLE study.

Early onset and long-term smoking are associated with physical and psychological health problems. The aim of the presented analysis was to investigate risk and influencing factors for different smoking status in a big sample of European adolescents. In the context of the "saving and empowering young lives in Europe" (SEYLE) study we surveyed 12,328 adolescents at the age of 13-17 from 11 countries. The survey took place in a school-based context using a questionnaire. Overall 58% reported the onset of ever-smoking under the age of 14 and 30.9% smoke on a daily basis. Multinomial logistic regression model showed significant positive associations between adolescent smoking and internalizing problems (suicidal behavior, direct self-injurious behavior, anxiety), externalizing problems (conduct problems, hyperactivity, substance consumption) and family problems (parental substance consumption, broken home). Our data show that smoking among adolescents is still a major public health problem and adolescents who smoke are at higher risk for mental problems. Further, adolescent smoking is associated with broken home families and parental behaviors. Therefore, early preventive measures are necessary not only for adolescents, but also for their parents.

Quality of life in systemic lupus erythematosus: description in a cohort of French patients and association with blood hydroxychloroquine levels.

OBJECTIVES: Benefits of hydroxychloroquine (HCQ) use on physician reported outcomes are well documented in systemic lupus erythematosus (SLE). We assess for the first time the association and predictive value of blood HCQ levels towards health-related quality of life (HRQOL) in SLE. METHODS: Data from the PLUS study (a randomized, double-blind, placebo-controlled, multicentre study) were utilized. Blood HCQ levels were quantified by high-performance liquid chromatography along with HRQOL assessments (Medical Outcomes Study-SF-36) at baseline (V1) and month 7 (V2). RESULTS: 166 SLE patients' data were analysed. Mean (SD) age and disease duration were 44.4 (10.7) and 9.3 (6.8) years. Eighty-seven per cent were women. Mean (SD, median, IQR) HCQ concentrations in the blood at V1 were 660 (314, 615, 424) ng/ml and increased to 1020 (632, 906, 781) ng/ml at V2 (mean difference 366 units, 95% confidence interval -472 to -260, p < 0.001). No significant correlations between HCQ concentrations with HRQOL domains at V1 or V2 were noted. There were no differences in HRQOL stratified by HCQ concentrations. HCQ concentrations at V1 or changes in HCQ concentration (V2-V1) were not predictive of HRQOL at V2 or changes in HRQOL (V2-V1). CONCLUSIONS: No association of HCQ concentrations with current or longitudinal HRQOL were found in SLE.