General Population Reference Research Articles

Risk of venous thromboembolism in rheumatoid arthritis, and its association with disease activity: a nationwide cohort study from Sweden

ObjectiveTo assess the incidence of venous thromboembolism (VTE) in rheumatoid arthritis (RA) relative to individuals without RA, and to investigate the relationship between aspects of clinical disease activity in RA...

Pain and aetiological risk factors determine quality of life in patients with chronic pancreatitis, but a brick in the puzzle is missing

Background and objectivesChronic pancreatitis (CP) is a debilitating fibro-inflammatory disease with a profound impact on patients’ quality of life (QOL). We investigated determinants of QOL in a large cohort of CP patients. MethodsThis was a multicentre study including 517 patients with CP. All patients fulfilled the EORTC QLQ-C30 questionnaire. Questionnaire responses were compared to results obtained from a general reference population (n = 11,343). Demographic characteristics, risk factors (smoking and alcohol consumption), pain symptoms, disease phenotype (complications) and treatments were recorded. A multivariable regression model was used to identify factors independently associated with QOL scores. ResultsIncluded patients had a mean age of 56.3 ± 12.8 years, 355 (69%) were men and 309 (60%) had alcohol aetiology. Compared to the reference population, patients with CP had lower global health status (50.5 vs. 66.1; p < 0.001) as well as reduced scores for all functional scales (all p < 0.001). Additionally, CP patients reported a higher burden for all symptom items, with pain being the most prominent complaint (all p < 0.001). Constant pain (coefficient −11.3; p = 0.02), opioid based pain treatment (coefficient −19.7; p < 0.001) and alcoholic aetiology (coefficient −5.1; p = 0.03) were independently associated with lowered global health status. The final multivariable model explained 18% of the variance in global health status. ConclusionsPatients with CP have significantly lower QOL compared to a population-based reference population. Factors independently associated with a lowered QOL are constant pain, opioid based pain treatment and alcohol aetiology. However, these factors only explain a fraction of QOL and additional factors need identification.

Changes in the ability to participate in and satisfaction with social roles and activities in patients in outpatient rehabilitation

BackgroundOne of the main aims of rehabilitation is to improve participation. Patient-Reported Outcomes Measurement Information System (PROMIS®) item banks ‘Ability to Participate in Social roles and Activities, (PROMIS-APS) and ‘Satisfaction with Social Roles and Activities’ (PROMIS-SPS) are promising options to measure participation, but the literature on PROMIS measures of (satisfaction with) participation across diagnoses in rehabilitation is limited. Therefore, the objective of this study was to describe levels of and changes in participation, as assessed with the PROMIS-APS and the PROMIS-SPS short forms, of patients in outpatient rehabilitation.MethodsThis study had quantitative, observational design with assessments at admission and discharge. Consecutive patients treated between April and August 2018 receiving outpatient multidisciplinary rehabilitation were the population of this study. The following diagnosis categories were included: brain injury (e.g. stroke), spinal cord and nerve injury, neuromuscular disorder (e.g. lateral sclerosis), amputation, musculoskeletal condition (e.g. osteoarthritis) or heart or lung disease (e.g. myocardial infarction, chronic obstructive pulmonary disease). The main patient-reported outcomes (PRO) of this study were the short form of the PROMIS-APS (8 items, Dutch general population reference score 50.6 [SD 9.5]), and PROMIS-SPS (8 items, Dutch general population reference score 47.5 [SD 8.3].ResultsOf the 1279 patients invited, 777 (61%) completed the online forms at admission. Of those, 329 patients were invited at discharge, with 209 (64%) completing the forms. The mean (SD) T-scores of the PROMIS-APS and PROMIS-SPS were lower at admission (42.7 [SD 7.4]; (41.4 [SD 7.7]) and discharge (43.6 [SD 7.2]; (43.7 [SD 7.8]) than the Dutch general population. The change scores of the PROMIS-APS and PROMIS-SPS were 1.2 (95% CI 0.4–1.9; p = 0.004; effect size 0.16), and 2.4 (95% CI 1.6–3.2; p < 0.0001; effect size 0.31), respectively. In all diagnostic subgroups with > 30 paired measurements statistically significant improvements of PROMIS-APS, PROMIS-SPS or both were seen.ConclusionsPatients undergoing outpatient rehabilitation had, both at admission and discharge, considerably lower PROMIS-APS and PROMIS-SPS T-scores short forms than the general Dutch population, and showed small T-score improvements at discharge.

Growth assessment in children with Williams-Beuren syndrome: a systematic review.

Williams-Beuren syndrome (WBS) is a rare genetic disease caused by a sporadic heterozygous microdeletion in 7q11.23. It is characterized by distinctive facial appearance, cardiopathy, short stature, intellectual disability, and endocrine abnormalities. To evaluate the growth pattern of patients with WBS and to identify the prevalence of malnutrition, overweight, and obesity in this population, a systematic review of studies published in English, between 1987 and 2018, was performed following the PRISMA protocol using the PubMed, Cochrane, and BIREME databases. Original articles and articles that evaluated growth status using weight, or height, or head circumference (HC), or body mass index (BMI) of individuals with WBS were included. Case reports, articles with data from other syndromes, and articles that did not present as a central theme the evaluation of growth were not included. WBS presented specific growth pattern, characterized by intrauterine growth restriction, low weight, length, and HC at birth. This global growth delay persisted during childhood and adolescence. BMI was not different to the reference population, and obesity was not observed in childhood. The mechanisms that determine this typical growth pattern are not totally clear; however, the typical pubertal development of these patients and the intrinsic and secondary lesions caused by microdeletion at 7q11.23 seem to be the major factors involved. Conclusion: Patients with WBS have a growth pattern different from the general reference population. The reference charts for normal population should notbe used for WBS patients because it often underestimate their growth. Specific growth charts for WBS patients are necessary.

Population-based study of patients with primary Sjögren’s syndrome and lymphoma: lymphoma subtypes, clinical characteristics, and gender differences

Objective: To examine lymphoma subtypes, clinical characteristics, and gender differences in patients with primary Sjögren’s syndrome (pSS) and lymphoma in a population-based setting.Method: Patients with Sjögren’s syndrome and lymphoma diagnoses were identified by linkage of the Swedish Patient Register 1964–2007 with the Cancer Register 1990–2007. Clinical data were collected from medical records and lymphoma tissues were re-examined. The lymphoma subtype distribution was compared with the Swedish Lymphoma Register.Results: We identified 105 pSS patients with lymphoma. Diffuse large B-cell lymphoma (DLBCL) (32%) and marginal zone lymphoma [MZL including mucosa-associated lymphoid tissue (MALT) lymphoma] (31%) were the most common lymphoma subtypes. The proportion of DLBCL was not increased compared to the general population reference (32%, p = 1), in contrast to MZL (general population 5%, p < 0.0001). Compared to DLBCL, MALT lymphoma was diagnosed at a younger age (55 vs 67 years, p = 0.0001), and earlier after patient-reported sicca onset (7 vs 18 years, p = 0.0001) and pSS diagnosis (2 vs 9 years, p = 0.0005). Sixteen of the pSS-lymphoma cases were men (15%), twice the proportion in general pSS populations. Compared to women, men had a shorter median time from pSS diagnosis to lymphoma diagnosis (1 vs 8 years, p = 0.0003) and more often had lymphoma in the salivary glands (56% vs 29%, p = 0.04).Conclusion: DLBCL and MZL are common in pSS patients, but only MZL/MALT lymphoma occurs at an increased relative frequency in pSS compared to the general population. The study supports increased awareness of signs of lymphoma in men in the first years after pSS diagnosis.

Biological Monitoring of Occupational Exposure to Metals in Electric Steel Foundry Workers and Its Contribution to 8-Oxo-7,8-Dihydro-2'-Deoxyguanosine Levels.

In this study, the urinary concentrations of selected metals in workers from an electric steel foundry in Tunisia were assessed and compared with existing biological limit values and general population reference values. Moreover, the association between oxidative DNA damage, measured as urinary 8-oxo-7,8-dihydro-2’deoxyguanosine (8-oxodG) and co-exposure to metals and polycyclic aromatic hydrocarbons (PAHs) was evaluated. Urinary levels of 12 metals were determined by inductively coupled plasma-mass spectrometry (ICP-MS) in end-shift spot samples from 89 workers. The urinary levels of phenanthrene (U-PHE), as marker of exposure to PAHs, and 8-oxodG were also available. Median levels ranged from 0.4 µg/L (cobalt, Co, and thallium, Tl) to 895 µg/L (zinc, Zn). Only 1% of samples was above the biological limit values for Co, and up to 13.5% of samples were above limit values for Cd. From 3.4% (Co) to 72% (lead, Pb) of samples were above the reference values for the general population. Multiple linear regression models, showed that manganese (Mn), Zn, arsenic (As), barium (Ba), Tl, and Pb were significant predictors of 8-oxodG (0.012 ≤ p ≤ 0.048); U-PHE was also a significant predictor (0.003 ≤ p ≤ 0.059). The variance explained by models was low (0.11 ≤ R2 ≤ 0.17, p < 0.005), showing that metals and PAHs were minor contributors to 8-oxodG. Overall, the comparison with biological limit values showed that the study subjects were occupationally exposed to metals, with levels exceeding biological limit values only for Cd.

Abstract TP31: Atrial Cardiopathy: Incidence in Endovascular Thrombectomy Patients

Background: Emerging evidence suggests that underlying atrial cardiopathy (AC) may result in thromboembolism formation in the absence of atrial fibrillation (AF). This may explain a proportion of large vessel occlusion (LVO) cryptogenic strokes. The prevalence of AC in endovascular thrombectomy (EVT) patients has not been assessed. Methods: A prospectively maintained database of EVT patients treated at a comprehensive stroke centres between January 2016 and September 2018 was retrospectively screened. Patients undergoing EVT for acute ischemic stroke with admission electrocardiogram (ECG) were selected. Subjects were screened for AF, paroxysmal AF (pAF) and AC with previously validated ECG markers (P-wave terminal force in lead V1 - PTFV1 &gt;4000μV/ms &amp; prolonged P-wave duration - PWD &gt;120 ms. Results: A total of 189 patients were included. Atrial fibrillation was present in 73 (38.6%) patients. Paroxysmal AF was recorded in 31 (16.4%) patients. Atrial cardiopathy markers were present in 88 (46.6%) of the total cohort, compared to 7.7% in a published general population reference (p &lt; 0.001). Atrial cardiopathy was present in 23 (74%) of pAF patients. Conclusion: Atrial cardiopathy occurs frequently in EVT patients, suggesting it may be a LVO stroke risk factor. Atrial cardiopathy may be associated with pAF. Further studies in this patient population are recommended.

OP14 Risk of colorectal cancer diagnosis and colorectal cancer mortality in Crohn’s disease: A Scandinavian population-based cohort study

Abstract Background Crohn’s disease (CD) is a risk factor for colorectal cancer (CRC). Earlier studies reflect older treatment and surveillance strategies, and most have studied incident CRC without addressing potential lead-time and surveillance biases. Such bias can be reduced by examining tumour stage-adjusted CRC incidence and CRC mortality. We aimed to assess risks of CRC mortality and incident CRC among patients with CD compared with the general population. Methods Nationwide register-based cohort study during 1969–2017 of 47,035 patients with CD in Denmark (n = 13,056) and Sweden (n = 33,979), compared with 463,187 general population reference individuals, matched for sex, age, calendar year, and place of residence. We used Cox regression to estimate hazard ratios (HRs) for incident CRC and CRC mortality. In a multistate model, assessing competing events during follow-up (CRC diagnosis, CRC death, other death), we also took a tumour stage into account. Results During 1969–2017, 499 patients with CD developed CRC, corresponding to an adjusted HR of 1.40 [95% confidence interval (CI) 1.27–1.53]. We observed 296 (0.47/1000 person-years) deaths from CRC in patients with CD compared with 1968 (0.31/1000) in reference individuals [HR 1.74 (95% CI 1.54–1.96)]. CD patients diagnosed with CRC were at increased risk of CRC mortality compared with reference individuals also diagnosed with CRC [HR = 1.30 (95% CI 1.06–1.59)] and tumour stage at CRC diagnosis did not differ between groups (p = 0.27). CD patients who had 8 or more years of follow-up or who were diagnosed with primary sclerosing cholangitis (PSC) and hence were potentially eligible for CRC surveillance had an increased overall risk of CRC death [HR 1.41 (95% CI 1.18–1.69)] or CRC diagnosis [HR = 1.12 (95% CI = 0.98–1.28)]. However, in patients potentially eligible for CRC surveillance, we only found significantly increased risks in patients with CD onset &amp;lt;40 years, disease activity in the colon only, or with PSC (Figure 1). Conclusion CD patients are at increased risk of a CRC diagnosis and CRC death. Despite repeated colonoscopies during follow-up, CD patients are not diagnosed earlier (less severe tumour stage) with CRC than reference individuals. Nevertheless, CD patients with CRC have higher mortality than non-CD patients also diagnosed with CRC. CRC surveillance could likely be improved and should be focussed on CD patients &amp;lt;40 years at CD onset, patients with colon inflammation, and patients who have PSC.

Long-term employment outcomes after epilepsy surgery in childhood.

ObjectiveTo analyze long-term employment outcomes in a population-based cohort of adults who underwent epilepsy surgery in childhood or adolescence and to compare the results to general population reference data.MethodsProspective data on epilepsy surgery procedures performed on patients <19 years of age between 1995 and 2012 were extracted from the Swedish National Epilepsy Surgery Register. Five-, 10-, 15- and 20-year follow-up data were analyzed. Patients aged ≥19 years at follow-up were eligible for inclusion. Educational attainment and employment status were analyzed in relation to seizure outcome. Education and employment outcomes of seizure-free patients with a preoperative IQ of ≥70 were compared to general population reference data.ResultsA total of 203 patients were included. The mean age at surgery was 13.6 years and 66% had IQ ≥70. Of these, a majority had attained at least high school education 5 years after surgery. Employment rates were 44%, 69%, 71%, and 77% at the 5-, 10-, 15-, and 20-year follow-ups, respectively. Seizure-free patients were significantly more likely to work full-time. Educational attainment and rates of full-time employment of seizure-free patients were similar to the general population. A majority of patients with IQ <70 had attended special education and were reliant on social benefits.ConclusionLong-term overall employment rates were higher compared to most previous studies on surgery in adults. Seizure-free patients with a preoperative IQ ≥70 showed rates of full-time employment similar to the general population. Further research is needed to determine whether this also applies for occupational complexity and wages.

Association Between Renal Function and Troponin T Over Time in Stable Chronic Kidney Disease Patients.

BackgroundPeople with reduced glomerular filtration rate (GFR) often have elevated cardiac troponin T (cTnT) levels. It remains unclear how cTnT levels develop over time in those with chronic kidney disease (CKD). The aim of this study was to prospectively study the association between cTnT and GFR over time in older advanced‐stage CKD patients not on dialysis.Methods and ResultsThe EQUAL (European Quality Study) study is an observational prospective cohort study in stage 4 to 5 CKD patients aged ≥65 years not on dialysis (incident estimated GFR, <20 mL/min/1.73 m²). The EQUAL cohort used for the purpose of this study includes 171 patients followed in Sweden between April 2012 and December 2018. We used linear mixed models, adjusted for important groups of confounders, to investigate the effect of both measured GFR and estimated GFR on high‐sensitivity cTnT (hs‐cTnT) trajectory over 4 years. Almost all patients had at least 1 hs‐cTnT measurement elevated above the 99th percentile of the general reference population (≤14 ng/L). On average, hs‐cTnT increased by 16%/year (95% CI, 13–19; P<0.0001). Each 15 mL/min/1.73 m2 lower mean estimated GFR was associated with a 23% (95% CI, 14–31; P<0.0001) higher baseline hs‐cTnT and 9% (95% CI, 5–13%; P<0.0001) steeper increase in hs‐cTnT. The effect of estimated GFR on hs‐cTnT trajectory was somewhat lower than a previous myocardial infarction (15%), but higher than presence of diabetes mellitus (4%) and male sex (5%).ConclusionsIn CKD patients, hs‐cTnT increases over time as renal function decreases. Lower CKD stage (each 15 mL/min/1.73 m2 lower) is independently associated with a steeper hs‐cTnT increase over time in the same range as other established cardiovascular risk factors.

The health-related quality of life of nursing workers: A cross-sectional study in medical institutions.

This study aimed to evaluate the health-related quality of life of nursing workers and influential factors. Nursing workers are under great occupational stress. However, few population-level studies of nursing workers' health conditions have been reported from China. This was a cross-sectional study conducted in 12 medical institutions in east China between January and March 2015. Social-demographic information, nursing workers' work-related information and health-related quality of life using the Chinese (mainland) version of the Short Form 36 health survey were collected by a self-administrated questionnaire. Nursing workers reported significantly lower scores of the vitality, mental health dimensions, and mental component summary of the Short Form 36 survey compared with general population reference values. They scored significantly higher for five other dimensions and comparably for the physical role dimension. Pre-job training, families' positive attitudes to their job, and good relationships with clients were positively related with nursing workers' mental well-being. To promote nursing workers' mental health, compulsory work-related training, voluntary psychological counselling, and targeted legislation are needed.

The EORTC Quality of Life Questionnaire for cancer patients (QLQ-C30): Australian general population reference values.

To generate Australian general population reference values for the EORTC Quality of Life Questionnaire for cancer patients (QLQ-C30); to compare Australian values with published EORTC general population reference values, and to explore associations between socio-demographic and health characteristics and QLQ-C30 subscale scores. Analysis of responses to cross-sectional, online survey (QLQ-C30), March 2015 - February 2016, and supplementary health-related and socio-demographic questions. 1979 people quota-sampled from a national online survey panel to be representative of the Australian general population by age and sex. Mean QLQ-C30 subscale scores, adjusted for socio-demographic characteristics and comorbid conditions, by sex and age group. Data for 1821 participants were analysed (92% completion rate); 924 (50.7%) were women. Higher psychological distress was associated with worse outcomes on all QLQ-C30 subscales. Better self-reported general health was associated with better global quality of life and better functioning (except cognitive functioning), and less fatigue, pain, dyspnoea and insomnia. Having arthritis or rheumatism was associated with poorer global quality of life, and poorer physical, role and social functioning, and with more fatigue, pain, insomnia, diarrhoea, and financial difficulties. Although differences between Australian QLQ-C30 subscale scores and EORTC general population values were clinically trivial, the Australian values are more accurate benchmarks for QLQ-C30 results from Australians with cancer. Our Australian QLQ-C30 reference values provide normative benchmarks that facilitate interpretation of data for Australians with cancer in terms of burden of disease and its treatment. In survivorship studies and studies without pre-disease baseline data, comparisons with reference values can indicate the extent to which people have returned to better levels of health.

Mortality in adult-onset and elderly-onset IBD: a nationwide register-based cohort study 1964–2014

ObjectivesTo examine all-cause and cause-specific mortality in adult-onset and elderly-onset IBD and to describe time trends in mortality over the past 50 years.DesignSwedish nationwide register-based cohort study 1964–2014, comparing mortality...

Meaningful Patient-centered Outcomes 1 Year Following Cardiac Surgery.

To evaluate meaningful, patient-centered outcomes including alive-at-home status and patient-reported quality of life 1 year after cardiac surgery. Long-term patient-reported quality of life after cardiac surgery is not well understood. Current operative risk models and quality metrics focus on short-term outcomes. In this combined retrospective/prospective study, cardiac surgery patients at an academic institution (2014-2015) were followed to obtain vital status, living location, and patient-reported outcomes (PROs) at 1 year using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS). We assessed the impact of cardiac surgery, discharge location, and Society of Thoracic Surgeons perioperative predicted risk of morbidity or mortality on 1-year outcomes. A total of 782 patients were enrolled; 84.1% (658/782) were alive-at-home at 1 year. One-year PROMIS scores were global physical health (GPH) = 48.8 ± 10.2, global mental health (GMH) = 51.2 ± 9.6, and physical functioning (PF) = 45.5 ± 10.2 (general population reference = 50 ± 10). All 3 PROMIS domains at 1 year were significantly higher compared with preoperative scores (GPH: 41.7 ± 8.5, GMH: 46.9 ± 7.9, PF: 39.6 ± 9.0; all P < 0.001). Eighty-two percent of patients discharged to a facility were alive-at-home at 1 year. These patients, however, had significantly lower 1-year scores (difference: GPH = -5.1, GMH = -5.1, PF = -7.9; all P < 0.001). Higher Society of Thoracic Surgeons perioperative predicted risk was associated with significantly lower PRO at 1 year (P < 0.001). Cardiac surgery results in improved PROMIS scores at 1 year, whereas discharge to a facility and increasing perioperative risk correlate with worse long-term PRO. One-year alive-at-home status and 1-year PRO are meaningful, patient-centered metrics that help define long-term quality and the benefit of cardiac surgery.

Thyroid Function Reference Values in Healthy Iodine-Sufficient Pregnant Women and Influence of Thyroid Nodules on Thyrotropin and Free Thyroxine Values.

Thyroid function assessment in pregnancy requires specific reference intervals stratified by gestational age and according to each laboratory method. Thyroid nodules may influence thyroid function in pregnant women. The aims of this study were to define the reference values of thyrotropin (TSH) and free thyroxine (fT4) in the three pregnancy trimesters in iodine-sufficient pregnant women, and to analyze the influence of thyroid nodules on thyroid function during pregnancy. This was a prospective, longitudinal study comprising 400 pregnant women with no history of thyroid disease and no medication influencing thyroid function. TSH, fT4, antithyroglobulin, and antithyroid peroxidase antibodies were measured each trimester by chemiluminescent immunoassays. Urinary iodine concentration was measured in the first trimester when a thyroid echography was also performed. Women with multiple gestation pregnancies, positive thyroid autoimmunity, TSH values >5 or <0.1 mIU/L with a simultaneous fT4 level above the general population reference value in the first trimester, or clinically significant thyroid nodules (nodules ≥1 cm and/or multiple nodules) were excluded to establish TSH and fT4 reference values. Reference intervals in the first, second, and third trimesters were 0.13-4.16, 0.31-3.73, and 0.58-4.36 mIU/L, respectively, for TSH, and 0.85-1.24, 0.82-1.20, and 0.67-1.06 ng/dL, respectively, for fT4. The total prevalence of thyroid nodules was 28.8% [95% confidence interval (CI) 24.4-33.5%], and 6.0% of the participants showed clinically significant nodules. Pregnant women with thyroid nodules (n = 115) showed consistently lower TSH values during all pregnancy stages (first trimester: median 1.14 mIU/L [interquartile range (IQR) 0.53-1.75 mIU/L] vs. 1.48 mIU/L [IQR 0.94-2.19 mIU/L], p < 0.001; second trimester: 1.22 mIU/L [IQR 0.66-1.77 mIU/L] vs. 1.45 mIU/L [1.04-2.05 mIU/L], p = 0.001; third trimester: 1.74 mIU/L [IQR 1.08-2.36 mIU/L] vs. 1.93 mIU/L [IQR 1.37-2.58 mIU/L], p = 0.041) and higher fT4 values in the first trimester (M ± SD = 1.08 ± 0.14 ng/dL vs. 1.03 ± 0.12, p < 0.001) compared to those without nodules (n = 285). Both pregnant women with clinically significant thyroid nodules and those with nonsignificant ones had lower TSH values than women without nodules. TSH/fT4 reference intervals in pregnant women from the authors' geographical area will thyroid dysfunction in pregnancy to be appropriately diagnosed. The prevalence of thyroid nodules is high in iodine-sufficient pregnant women, and is associated with low TSH values across pregnancy.

Inherited thrombophilia and pregnancy loss. Study of an Argentinian cohort

Background and objectivesThrombophilia might increase the risk of suffering from obstetric complications by adversely affecting the normal placental vascular function. Our aim was to study the distributions of five thrombosis-associated genetic variants: factor V Leiden, prothrombin G20210A, −675 4G/5G PAI-1, 10034C/T gamma fibrinogen and 7872C/T factor XI and the frequencies of the deficiencies of protein C, S and antithrombin in Argentinian patients with recurrent pregnancy loss (RPL) and, therefore, to analyse their association with the risk and timing of RPL and the risk of suffering other vascular obstetric pathologies. Patients and methodsWe performed a case–control study that included 247 patients with idiopathic RPL (cases), 107 fertile controls and 224 subjects from general population (reference group). Cases were stratified according to the gestational time of the losses (early RPL, n=89; late losses, n=158; foetal losses, n=107) and according to the type of vascular obstetric pathologies. ResultsNo differences were found in the distribution of the genetic variants among RPL group vs. control/reference group (p>.05). Similarly, no differences were observed in their distributions when analysing RPL patients stratified according to gestational times or vascular obstetric pathologies (p>.05), except for the factor V Leiden carriage in patients with foetal growth retardation vs. controls (11.8%, 4/34 vs. 1.9%, 2/107; p=.04) (OR=7.11 [1.24–40.93], p=.03). ConclusionsFactor V Leiden might have a significant impact on certain obstetric pathologies such as foetal growth retardation. The genetic variants, 10034C/T gamma fibrinogen and 7872C/T factor XI, associated with thromboembolic disease, would not have an impact on PRE.

Health-related quality of life in men with prostate cancer undergoing active surveillance versus radical prostatectomy, external-beam radiotherapy, prostate brachytherapy and reference population: a cross-sectional study

BackgroundThe purpose of this study is to describe Health-Related Quality of Life (HRQoL) of localized prostate cancer patients in an Active Surveillance (AS) program, and to compare them with those undergoing radical prostatectomy (RP), external-beam radiotherapy (XRT) and brachytherapy (BT).MethodsMulti-institutional pooled cross-sectional analysis on patients in an AS protocol: < 75 years old; pathologically confirmed LPC (maximum of three positive cylinders); Gleason score < 3 + 4; clinical stage T1a-T2b; and PSA < 15 ng/ml. Exclusion criteria for this study were: less than 6 months in AS, termination of AS protocol, or incomplete data. Patients in AS were matched with those treated with RP, XRT or BT from the ‘Spanish Multicentric Study of Clinically Localized Prostate Cancer’ cohort according to risk group, time from treatment selection to HRQoL survey, and age. Prostate-specific (EPIC) and generic (SF-36) HRQoL instruments were completed. Analysis was stratified by HRQoL survey moment (>or < 2.5 years from treatment selection), and age (>or < 70 years old).ResultsMedian of time from treatment selection to HRQoL survey in the total 396 patients (99 per treatment group) was 2.4 years (range 0.5–8.3). Patients in AS presented higher (better) urinary incontinence scores than RP ones in both stratus of time from treatment selection to HRQoL survey (92.6 vs 67.0 and 81.4 vs 64.4, p < 0.01). Patients in AS for < 2.5 years presented greater sexual scores than any active treatment (p < 0.01), but only statistically higher than RP for those in AS for longer than 2.5 years. The magnitude of the differences between AS and RP groups in both EPIC domains ranged from moderate (0.7 SD) to large (1.0 SD).Regardless of treatment applied, patients presented similar and slightly increased SF-36 scores than US general population reference norms. Nonetheless, patients in AS for < 2.5 years reported worse outcomes than other treatment groups on physical health domains, especially in bodily pain (0.5–0.6 SD), and vitality (0.6–0.8 SD).ConclusionsConsidering patients’ well-being, AS can be a good therapeutic option due to the low impact caused on urinary continence and sexual function. However, longitudinal studies are required to take into account HRQoL evolution over time.

Quality of Life in NSCLC Survivors — A Multicenter Cross-Sectional Study

IntroductionThe objective was to assess quality of life (QoL) in lung cancer survivors, compare it to the general population, and identify factors associated with global QoL, physical functioning, emotional functioning, fatigue, pain, and dyspnea. MethodsData from NSCLC patients who had survived 1 year or longer after diagnosis were collected cross-sectionally in a multicenter study. QoL was assessed with the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and the lung cancer module QLQ-LC13 across different clinical subgroups and compared to age- and sex-standardized general population reference values. Multivariable linear regression analyses were performed to test the associations of patient-, tumor-, and treatment-related factors with the six primary QoL scales. ResultsSix hundred fifty-seven NSCLC patients participated in the study with a median time since diagnosis of 3.7 years (range, 1.0–21.2 years). Compared to the age- and sex-standardized general population, clinically meaningful differences in the QoL detriment were found on almost all domains: lung cancer survivors had clinically relevant poorer global QoL (10 points, p < 0.001). Whereas in 12 months or longer treatment-free patients this detriment was small (8.3), it was higher in patients currently in treatment (16.0). Regarding functioning and symptom scales, respective detriments were largest for dyspnea (41 points), role function (33 points), fatigue (27 points), social function (27 points), physical function (24 points), and insomnia (21 points) observed across all subgroups. The main factor associated with poorer QoL in all primary QoL scales was mental distress (β |19-31|, all p < 0.001). Detriments in QoL across multiple primary QoL scales were also observed with current treatment (β |8-12|, p < 0.01), respiratory comorbidity (β |4-5|, p < 0.01), and living on a disability pension (β |10-11|, p < 0.01). The main factor associated with better QoL in almost all primary QoL scales was higher physical activity (β |10-20|, p < 0.001). Better QoL was also observed in patients with high income (β |10-14|, p < 0.01). ConclusionsLung cancer survivors experience both functional restrictions and symptoms that persist long term after active treatment ends. This substantiates the importance of providing long-term supportive care.

Do the long-term benefits of ALPPS mitigate the perioperative risk?

Objectives: Associating Liver Partition and Portal vein Ligation for Staged hepatectomy (ALPPS) is an innovative two-staged hepatectomy which has elicited controversy within the international hepatobiliary community. ALPPS has been criticized for having high morbidity and mortality and scant oncological and quality of life (QoL) outcome data. Demonstrating reasonable long-term benefits with acceptable short-term risk is necessary to support more widespread endorsement of ALPPS. Methods: Prospectively collected data from two high-volume ALPPS centers were combined and analyzed for disease-free (DFS) and overall survival (OS) from date of surgery. Only patients treated for CRLM with > 6 month post-operative follow-up were included. All patients had bilateral CRLM with initially unresectable tumor load and received pre-operative chemotherapy. The well-validated EORTC QLQ-C30 questionnaire was used to assess patients' QoL. Results: A total of 58 patients underwent ALPPS for CRLM, and 47 patients met inclusion criteria. There were no perioperative mortalities, and the severe complication rate was 21%. The 3-year disease free survival post ALPPS was 28%, while the overall survival was 58%. Most patients experienced first recurrence in the liver (65%). Patient reported QoL following ALPPS was similar to general population reference values. Conclusions: In select patients, ALPPS results in low perioperative risk, reasonable overall survival, and excellent quality of life. Hepatic, not systemic, recurrence is the most common site of relapse after ALPPS.

The French PROMIS-29. Psychometric validation and population reference values.

PROMIS-29 is a new generic standardized questionnaire measuring self-reported health status. It was developed as part of the Patient Reported Outcome Measurement Information System (PROMIS) in the United States. The objective of this study was to carry out the psychometric validation of a French-language version of PROMIS-29 and to establish general population reference values for France. Quota sampling was conducted by an independent polling company (Ipsos) to obtain a general population sample (n=1,501) representative with regards to: gender, age, occupation, region, and population density of the place of residence. Data collected included the results of the questionnaires PROMIS-29 and Short Form Health Survey (SF-36), the presence of selected chronic diseases, and socio-demographic information. The French PROMIS-29 demonstrated excellent factorial validity, confirming the 7-factor model of the original PROMIS-29. The use of modern measurement methods indicated that the PROMIS-29 scales satisfy the important characteristics of unidimensionality and, for five of the seven composite scales, invariance across age, educational level and gender. Gender and age specific (10-year intervals) reference values were generated for PROMIS-29 use in France. The French version of PROMIS-29 is a valid and reliable measure of self-reported health status in the French population. The instrument's sensitivity to change needs to be evaluated before its use in longitudinal studies can be recommended.