14-day tailored PCR-guided triple therapy versus 14-day non-Bismuth concomitant quadruple therapy for Helicobacter pylori eradication: A multicenter, open-label randomized noninferiority controlled trial.

BACKGROUND: The systematic use of susceptibility testing and tailored first-line treatment for Helicobacter pylori eradication has yet to be established. AIM: To compare 14-day tailored PCR-guided triple therapy to 14-day non-Bismuth concomitant quadruple therapy for first-line Helicobacter pylori eradication. PATIENTS AND METHODS: We performed a multicenter, parallel-group, randomized noninferiority controlled trial. Naive adult patients with Helicobacter pylori infection were treated with 14-day tailored PCR-guided triple therapy (esomeprazole 40 mg and amoxicillin 1000 mg b.d. plus clarithromycin 500 mg or levofloxacin 500 mg b.d. according to clarithromycin susceptibility) or 14-day non-Bismuth concomitant quadruple therapy (esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg b.d.). The primary endpoint was H. pylori eradication. RESULTS: We screened 991 patients for eligibility and randomized 241 patients. The first-line eradication rate was 99.2% in the tailored PCR-guided group and 95.9% in the control group (ITT population; absolute difference of +3.30%, with a lower bound of CI at -0.68%). Both first-line therapies were well tolerated, with a formally significant difference in favor of the tailored PCR-guided group (61.4% vs. 41.2%, p = 0.003). Economic analyses revealed a lower cost of the tailored PCR-guided arm, with a 92% chance of being jointly more effective and less expensive than the control arm in the ITT population. CONCLUSION: In a country with a high level of clarithromycin resistance, the results of our study demonstrated the noninferiority of 14-day tailored PCR-guided triple therapy as a first-line H. pylori eradication therapy compared to 14-day non-Bismuth quadruple therapy (ClinicalTrials.gov NCT02576236).

External Validity of Two Scores for Predicting the Risk of Chemotherapy Toxicity Among Older Patients With Solid Tumors: Results From the ELCAPA Prospective Cohort.

BACKGROUND: Severe chemotherapy-related toxicities are frequent among older patients. The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) and the Cancer and Aging Research Group Study (CARG) score were both developed to predict these events. PATIENTS AND METHODS: The objective of this study was to evaluate the scores' predictive performance in a prospective cohort, which included patients aged 70 years and older referred for a geriatric assessment prior to chemotherapy for a solid tumor. The main endpoints were grades 3/4/5 toxicities for the CARG score and grades 4/5 hematologic toxicities and grades 3/4/5 non-hematologic toxicities for the CRASH score. RESULTS: A total of 248 patients were included, of which 150 (61%) and 126 (51%) experienced at least one severe adverse event as defined respectively in CARG and CRASH studies. The incidence of adverse events was not significantly greater in the intermediate and high-risk CARG groups than in the low-risk group (odds ratio (OR) [95% CI] = 0.3 [0.1-1.4] (P = .1) and 0.4 [0.1-1.7], respectively). The area under curve (AUC) was 0.55. Similarly, the incidence of severe toxicities was no greater in the intermediate-low, intermediate-high, and high-risk CRASH groups than in the low-risk CRASH group (OR [95%CI] = 1 [0.3-3.6], 1 [0.3-3.4], and 1.5 [0.3-8.1], respectively). The AUC was 0.52. The type of cancer, performance status, comorbidities, body mass index, and MAX2 index were independently associated with grades 3/4/5 toxicities. CONCLUSION: In an external cohort of older patients referred for a pretherapeutic GA, the CARG and CRASH scores were poor predictors of the risk of chemotherapy severe toxicities.

More than a third of middle-aged adults (50-65) have understated executive dysfunction.

OBJECTIVES: Understated executive dysfunction (UED) is predictive of cognitive decline and death. We aimed to assess the prevalence of UED, assessed with the clock-drawing test (CDT) and the Frontal Assessment Battery (FAB) in middle-aged adults and to investigate associated characteristics. METHODS: Cross-sectional analysis of data on 516 community-dwellers aged 50-65, lacking cognitive complaints, who were included prospectively (2010-2017) after a multidimensional geriatric assessment at a "healthy ageing" outpatient clinic. Age- and educational-level-adjusted logistic models were used to assess factors associated with UED. RESULTS: The CDT and FAB were impaired in 27.7% and 14.7% of the participants (median age: 59.7 years). The prevalence [95% confidence interval (CI)] of UED was 36.2% [32.2-40.5%]. After adjustment for age and education, participants with UED were more likely to be obese (odds ratio [95%CI] = 1.89 [1.12-3.19], P = 0.02), and to have a metabolic syndrome (1.98 [1.06-3.72], P = 0.03). CONCLUSION: More than one third of middle-aged adults without cognitive complaints have UED, which was linked to obesity and metabolic syndrome. Cognitive screening tests targeting executive functions might be useful for early detection of UED and the initiation of multidomain interventions improving cognitive performance.

Prescription of benzodiazepines and Z-drugs among older patients in primary care: a French, national, cohort study.

BACKGROUND: In France, general practitioners (GPs) prescribe benzodiazepines and Z-drugs (BZD/ZDs) widely, and especially to older adults. Several characteristics of patients and/or GPs linked to BZD/ZD overprescription have been described in the general population but not among older patients in primary care. OBJECTIVES: To estimate the proportion of GP consultations by patients aged 65 and over that resulted in a BZD/ZD prescription, and determine whether any GP-related factors predicted BZD/ZD overprescription in this setting. METHODS: We analyzed sociodemographic and practice-related GP characteristics, and aggregated data on consultations recorded prospectively by 117 GPs in a database between 2000 and 2010. Next, we used logistic regression models to look for factors potentially associated with BZD/ZD overprescription (defined as an above-median prescription rate). RESULTS: The GPs' mean age at inclusion was 47.4 (7.1), and 87.9% were male. During the study period, the median (95% confidence interval) proportion of consultations with patients aged 65 and over resulting in a BZD/ZD prescription was 21.8% (18.1-26.1) (range per GP: 5-34.1%). In a multivariable analysis, a greater number of chronic disease (OR [95% CI] = 2.10 [1.22-3.64]), a greater number of drugs prescribed per consultation (5.29 [2.72-10.28]), and shorter study participation were independently associated with BZD/ZD overprescription. CONCLUSIONS: BZD/ZD overprescription was associated with a greater chronic disease burden and the number of drugs prescribed per consultation but not with any sociodemographic or practice-related GP characteristics. Targeted actions are needed to help GPs limit their prescription of BZD/ZDs to older patients with multiple comorbidities and polypharmacy.

In France, general practitioners (GPs) prescribe benzodiazepines and Z-drugs (BZD/ZDs) widely, and especially to older adults. Even though BZD/ZDs may not have a favorable risk­benefit ratio in older patients, we lack data on GP-related factors that might influence BZD/ZD overprescription in our population. The objectives of the present study were to (i) estimate the proportion of GP consultations by patients aged 65 and over that resulted in a BZD/ZD prescription and (ii) identify GP-related factors that were predictive of overprescription. To achieve this goal, we analyzed consultation notes registered by 117 GPs in a database curated by the French Society of General Practice between 2000 and 2010. About 22% of consultations by patients aged 65 and over resulted in a BZD/ZD prescription. With regard to the GPs, we did not find any sociodemographic or practice-related characteristics associated with overprescription. A greater chronic disease burden and the number of drug prescriptions (other than BZD/ZDs) per consultation was independently associated with overprescription. Targeted actions are therefore needed to help GPs limit their prescription of BZD/ZDs in older patients with multimorbidity and polypharmacy.

Diagnostic Performance of the 4-Item Geriatric Depression Scale for Depression Screening in Older Patients with Cancer: The ELCAPA Cohort Study.

BACKGROUND: In older patients with cancer, depression is difficult to assess because of its heterogeneous clinical expression. The 4-item version of the Geriatric Depression Scale (GDS-4) is quick and easy to administer but has not been validated in this population. The present study was designed to test the diagnostic performance of the GDS-4 in a French cohort of older patients with cancer before treatment. MATERIALS AND METHODS: Our cross-sectional analysis of data from the Elderly Cancer Patient cohort covered all patients with cancer aged ≥70 years and referred for geriatric assessment at two centers in France between 2007 and 2018. The GDS-4's psychometric properties were evaluated against three different measures of depression: the geriatrician's clinical diagnosis (based on a semistructured interview), the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders, and a cluster analysis. The scale's sensitivity, specificity, positive and negative likelihood ratios, and area under the receiver operating characteristic curve (AUROC) were calculated. RESULTS: In a sample of 2,293 patients (median age, 81 years; women, 46%), the GDS-4's sensitivity and specificity for detecting physician-diagnosed depression were, respectively, 90% and 89%. The positive and negative likelihood ratios were 8.2 and 0.11, and the AUROC was 92%. When considering the subset of patients with data on all measures of depression, the sensitivity and specificity values were, respectively, ≥90% and ≥72%, the positive and negative likelihood ratios were, respectively, ≥3.4 and ≤ 0.11, and the AUROC was ≥91%. CONCLUSION: The GDS-4 appears to be a clinically relevant, easy-to-use tool for routine depression screening in older patients with cancer. IMPLICATIONS FOR PRACTICE: Considering the overlap between symptoms of cancer and symptoms of depression, depression is particularly difficult to assess in older geriatric oncology and is associated with poor outcomes; there is a need for a routine psychological screening. Self-report instruments like the 4-item version of the Geriatric Depression Scale appears to be a clinically relevant, easy-to-use tool for routine depression screening in older patients with cancer. Asking four questions might enable physicians to screen older patients with cancer for depression and then guide them toward further clinical evaluation and appropriate care if required.

Predictive factors for non-participation or partial participation in breast, cervical and colorectal cancer screening programmes†.

BACKGROUND: No study has investigated factors associated with non-participation or partial participation in the different combination patterns of screening programmes for all three cancers, that is, breast, colorectal and cervical cancer. METHODS: In a retrospective cohort study, we sought to describe combinations of cancer screening participation rates among women in the Val-de-Marne area of France and to identify individual and contextual factors associated with non-participation or partial participation. RESULTS: Women aged between 50 and 65 and who were eligible for all three screening programmes (n = 102 219) were analysed in multilevel logistic models, with the individual as the Level 1 variable and the place of residence as the Level 2 variable. The women who did not participate in any of the screening programmes were 34.4%, whereas 30.1%, 24% and 11.5% participated in one, two or all three screening programmes, respectively. Age below 55, a previous false-positive mammography, prior opportunistic mammography only, no previous mammography, membership of certain health insurance schemes (all P < 0.05) and residence in a deprived area (P < 0.001) were independently associated with non-participation or partial participation. We observed a stronger effect of deprivation on non-participation in all three cancers than in combinations of screening programmes. CONCLUSION: Our findings suggest that the health authorities should focus on improving cancer screenings in general rather than screenings for specific types of cancer, especially among younger women and those living in the most socially deprived areas.

Functional decline in geriatric rehabilitation ward; is it ascribable to hospital acquired infection? A prospective cohort study.

BACKGROUND: In some European countries, including France, older patients with functional decline in acute units are transferred to geriatric rehabilitation units. Some patients may not benefit from their stay in a geriatric rehabilitation unit and paradoxically worsened their functional status. Previous prognostic models of functional decline are based on only baseline parameters. However, some events can occur during rehabilitation and modify the association between baseline parameters and rehabilitation performance such as heart failure episode, falls or hospital-acquired infection (HAI). The incidence of functional decline in these units and factors associated with this decline have not been clearly identified. METHODS: We used a prospective cohort of consecutive patients aged ≥75 years admitted to a geriatric rehabilitation unit in a French university hospital. The main endpoint was functional decline defined by at least an one-point decrease in Activities of Daily Living (ADL) score during the stay. Baseline social and geriatric characteristics were recorded and comorbidities were sought by the Cumulative Illness Rating Scale for Geriatrics (CIRS-G). During follow-up, hospital-acquired infection (HAI) was recorded, as was ADL score at discharge. Multivariate logistic regression and mediation analyses were used to identify factors associated with ADL decrease. RESULTS: Among the 252 eligible patients, 160 (median age 84 years [interquartile range (IQR) 80-88] had available ADL scores at baseline (median score 7 [IQR 4-10]) and at discharge (median 9 [6-12]). Median CIRS-G score was 11 [8-13], 23 (14%) had a pulmonary HAI; 28 (17.5%) showed functional decline. On multivariable analysis, functional decline was associated with comorbidities (global CIRS-G score, P = 0.02, CIRS-G for respiratory disease [CIRS-G-R] ≥2, P = 0.02, or psychiatric disease, P = 0.02) and albumin level < 35 g/l (p = 0.03). Significant associations were found between functional decline and CIRS-G-R (OR 3.07 [95%CI 1.27-7.41], p = 0.01), between functional decline and pulmonary HAI (OR 3.12 [1.17-8.32],p = 0.02), and between CIRS-G-R and pulmonary HAI (OR 12.9[4.4-37.7], p = 0.0001). Theses associations and the reduced effect of CIRS-G-R on functional decline after adjusting for pulmonary HAI (OR 2.26 [0.83-6.16], p = 0.11) suggested partial mediation of pulmonary HAI in the relation between CIRS-G-R and functional decline. CONCLUSION: Baseline comorbidities were independently associated with functional decline in patients hospitalized in a geriatric rehabilitation unit. Pulmonary HAI may have mediated this association. We need to better identify patients at risk of functional decline before transfer to a rehabilitation unit and to test the implementation of modern and individual programs of rehabilitation outside the hospital for these patients.

Mainly Post-Transplant Factors Are Associated with Invasive Aspergillosis after Allogeneic Stem Cell Transplantation: A Study from the Surveillance des Aspergilloses Invasives en France and Société Francophone de Greffe de Moelle et de Thérapie Cellulaire.

Invasive aspergillosis (IA) occurs in up to 23% of allogeneic hematopoietic stem cell transplantation (HSCT) patients. Although transplant procedures have changed over time, more late cases of IA are being observed. The objective of this study was to identify the pre- and post-transplant factors of IA in a large cohort of HSCT patients mainly transplanted with reduced-intensity conditioning. This multicenter, case-control study was carried out using data collected between 2005 and 2010 by the Surveillance des Aspergilloses Invasives en France program (Institut Pasteur, Paris) and the European Society for Blood and Marrow Transplantation ProMISe registry. Four control subjects without IA were individually matched to each case based on the center, patient age, and year of the transplant. We identified 185 cases of probable and proven IA and 651 control subjects. The median date of IA after the transplant was 133 days, with 35 cases (19%) of early IA (before day 40), 33 cases (18%) of late IA (days 40 to 100), and 117 cases (63%) cases of very late IA (after day 100). In the multivariate analysis early IA was significantly associated with a lack of engraftment, whereas late and very late IA were significantly associated with more than grade II acute graft-versus-host disease (GVHD); very late IA was also significantly associated with relapse and secondary neutropenia. Two-thirds of IA cases occurred more than 100 days after HSCT with different risk factors from those occurring earlier. Prophylactic strategies should consider the specific risk factors for late and very late IA, especially GVHD, relapse after transplant, and secondary neutropenia.

Inclusion of Older Patients with Cancer in Clinical Trials: The SAGE Prospective Multicenter Cohort Survey.

BACKGROUND: The primary objective was to evaluate the rates of older patients with colorectal cancer (CRC) who were eligible for a clinical trial, invited to participate, and, ultimately, included. The secondary objective was to assess the reasons for ineligibility, noninvitation, and noninclusion and factors associated. MATERIALS AND METHODS: The Sujets AGés dans les Essais Cliniques (SAGE; Older Subjects in Clinical Trials) multicenter prospective cohort was established in seven centers (10 departments of medical oncology, digestive oncology, and digestive surgery) between 2012 and 2016. All patients with CRC aged 65 or older were studied. The endpoints were clinical trial availability, patient's eligibility, invitation, and enrollment in a trial. RESULTS: We included 577 older patients (mean age ± SD: 75.6 ± 7 years; males: 56%; metastasis: 41%). Thirty-seven trials were ongoing (one trial for older patients). Of the 474 patients with at least one available trial for their cancer stage and site, 127 (27%) were eligible; 84 of these 127 (66%) were invited to participate, and 70 of these 84 (83%) were included. In a multivariate analysis, noninvitation was found to be associated with older age (p = .016): adjusted relative risk (95% confidence interval), 0.14 (0.02-0.60) for ≥80 vs. 65-69; 0.54 (0.18-1.04) for 75-79 vs. 65-69; 0.47 (0.17-0.93) for 70-74 vs. 65-69. CONCLUSION: Three-quarters of older patients with CRC were ineligible for a clinical trial. One-third of the eligible patients were not invited to participate in a trial, and 17% of invited patients were not included. Few trials are reserved for older patients. Patients aged 80 or older were significantly less likely to be eligible for a trial and invited to participate. Clinical trial identification number: NCT01754636. IMPLICATIONS FOR PRACTICE: The results of this study suggest that barriers to participation of older patients in clinical trials are particularly marked at age 80 years or older. Secondly, the results emphasize the need for trials for older patients. Thirdly, there is also a need for more pragmatic "real-world" trials, rather than solely randomized trials performed in idealized settings with strictly selected patients. Large prospective observational cohorts with a precise follow-up of toxicity, functional decline, and quality of life may constitute one way of generating more data on the risk-benefit ratio for cancer treatments in older patients.

Depressive Symptom Profiles and Survival in Older Patients with Cancer: Latent Class Analysis of the ELCAPA Cohort Study.

BACKGROUND: The expression of depressive symptoms in older people with cancer is heterogeneous because of specific features of age or cancer comorbidity. We aimed to identify depressive symptom profiles in this population and describe the associated features including survival. MATERIALS AND METHODS: Patients ≥70 years who were referred to geriatric oncology clinics were prospectively included in the ELCAPA study. In this subanalysis, depressive symptoms were used as indicators in a latent class analysis. Multinomial multivariable logistic regression and Cox models examined the association of each class with baseline characteristics and mortality. RESULTS: For the 847 complete-case patients included (median age, 79 years; interquartile range, 76-84; women, 47.9%), we identified five depressive symptom classes: "no depression/somatic only" (38.8%), "no depression/pauci-symptomatic" (26.4%), "severe depression" (20%), "mild depression" (11.8%), and "demoralization" (3%). Compared with the no depression/pauci-symptomatic class, the no depression/somatic only and severe depression classes were characterized by more frequent comorbidities with poorer functional status and higher levels of inflammation. "Severe" and "mild" depression classes also featured poorer nutritional status, more medications, and more frequent falls. Severe depression was associated with poor social support, inpatient status, and increased risk of mortality at 1 year (adjusted hazard ratio, 1.62, 95% confidence interval, 1.06-2.48) and 3 years (adjusted hazard ratio, 1.49; 95% confidence interval, 1.06-2.10). CONCLUSION: A data-driven approach based on depressive symptoms identified five different depressive symptom profiles, including demoralization, in older patients with cancer. Severe depression was independently and substantially associated with poor survival. IMPLICATIONS FOR PRACTICE: Older patients with cancer present with distinct profiles of depressive symptomatology, including different severity levels of depression and the demoralization syndrome. Clinicians should use a systematic assessment of depressive symptoms to adequately highlight these distinct profiles. Geriatric and oncological features are differently associated with these profiles. For instance, severe depression was associated with more frequent comorbidities with poorer functional, poor nutritional status, polypharmacy, frequent falls, inpatient status and poor social support. Also, severe depression was independently and substantially associated with poor survival so that the identification and management of depression should be considered a high priority in this population.

An open-label randomized controlled trial of low-dose corticosteroid plus enteric-coated mycophenolate sodium versus standard corticosteroid treatment for minimal change nephrotic syndrome in adults (MSN Study).

First-line therapy of minimal change nephrotic syndrome (MCNS) in adults is extrapolated largely from pediatric studies and consists of high-dose oral corticosteroids. We assessed whether a low corticosteroid dose combined with mycophenolate sodium was superior to a standard oral corticosteroid regimen. We enrolled 116 adults with MCNS in an open-label randomized controlled trial involving 32 French centers. Participants randomly assigned to the test group (n=58) received low-dose prednisone (0.5 mg/kg/day, maximum 40 mg/day) plus enteric-coated mycophenolate sodium 720 mg twice daily for 24 weeks; those who did not achieve complete remission after week 8 were eligible for a second-line regimen (increase in the prednisone dose to 1 mg/kg/day with or without Cyclosporine). Participants randomly assigned to the control group (n=58) received conventional high-dose prednisone (1 mg/kg/day, maximum 80 mg/day) for 24 weeks. The primary endpoint of complete remission after four weeks of treatment was ascertained in 109 participants, with no significant difference between the test and control groups. Secondary outcomes, including remission after 8 and 24 weeks of treatment, did not differ between the two groups. During 52 weeks of follow-up, MCNS relapsed in 15 participants (23.1%) who had achieved the primary outcome. Median time to relapse was similar in the test and control groups (7.1 and 5.1 months, respectively), as was the incidence of serious adverse events. Five participants died from hemorrhage (n=2) or septic shock (n=3), including 2 participants in the test group and 3 in the control group. Thus, in adult patients, treatment with low-dose prednisone plus enteric-coated mycophenolate sodium was not superior to a standard high-dose prednisone regimen to induce complete remission of MCNS.

Preferences about information and decision-making among older patients with and without cancer.

Background: information of older patients with cancer is crucial to ensure optimal care. Objectives: to compare older patients with and without cancer regarding their preferences about medical information, decision-making and surrogate designation. Design: an intention-to-act questionnaire was completed by patients ≥70 y enroled in the ELderly CAncer PAtients cohort between January and June 2013 and by patients in the same age group enroled in a cross-sectional survey conducted in 2005 in acute geriatric wards. Setting: Henri-Mondor Teaching Hospital in the Paris conurbation, France. Results: the group with cancer had 133 patients [mean age, 79.6 ± 6.5 y; 54.9% women]. The main tumour sites were colorectal [24.1%], breast [23.3%] and prostate [15.8%]; 34.8% had metastases. All these patients wanted full information, 74.2% wanted to participate in decisions about their care, 87.2% would designate a family member to serve as a surrogate in life-threatening situations and 15% had already designated a surrogate. Compared to patients without cancer, those with cancer more often wanted to receive information in a life-threatening situation [93.6% versus 79.2%; P < 0.001]. Factors independently associated with patients wanting their informed consent to be obtained for all interventions were having children [adjusted odds ratio (aOR), 2.13; 95% confidence interval, 1.24; 3.66; P = 0.006], higher Mini Mental State Examination score [aORper point, 1.09; 1.02; 1.17], younger age in the group without cancer [aOR>82 y vs. ≤82 y, 0.50; 0.29-0.88] and being cancer-free [≤82 y, aOR, 0.30; 0.14-0.63; >82 y, aOR, 0.41; 0.17-0.97]. Conclusion: older patients with cancer expressed a strong preference for receiving information and participating in decisions about their care.

Long-term mortality in older patients discharged after acute decompensated heart failure: a prospective cohort study.

BACKGROUND: Data are available on short- and intermediate-term mortality rates after discharge for acutely decompensated heart failure (ADHF). However, few studies specifically addressed ADHF outcomes in patients aged 75 years or over, who contribute more than half of all ADHF admissions. Our objectives here were to estimate the long-term mortality of patients aged 75 years or over who were discharged after admission for ADHF and to identify factors, especially geriatric findings, independently associated with 2-year mortality. METHODS: This prospective cohort study in five French hospitals included consecutive patients aged 75 years or older and discharged after emergency-department admission for ADHF meeting Framingham criteria (N = 478; median age, 85 years; 68% female). Kaplan-Meier 1-year and 2-year survival curves were plotted. Admission characteristics independently associated with overall 2-year mortality were identified using multivariable Cox proportional-hazards regression. RESULTS: Mortality was 41.7% (95% confidence interval [95% CI], 37.2%-53.5%) after 1 year and 56.0% (95% CI, 51.5%-60.7%) after 2 years. By multivariable analysis, independent predictors of 2-year mortality were male sex (hazard ratio [HR], 1.36; 95% CI, 1.00-1.82), age >85 years (HR, 1.57; 95% CI, 1.19-2.07), higher number of impaired activities of daily living (HR, 1.11 per impaired item; 95% CI, 1.05-1.17), recent weight loss (HR, 1.61; 95% CI, 1.14-2.28), and lower systolic blood pressure (HR, 0.86 per standard deviation increase; 95% CI, 0.74-0.99). Creatinine clearance ≤30 mL/min showed a trend toward an association with 2-year mortality (HR, 1.36; 95% CI, 0.97-2.00). CONCLUSION: Functional impairment before admission is associated with higher long-term mortality in patients ≥75 years admitted for ADHF. This study focused on geriatric markers not traditionally collected in heart-failure patients but did not analyse all cardiologic parameters associated with outcomes in other studies. Nevertheless, our findings may contribute to identify those patients admitted for ADHF who have the worst prognosis.

Optimizing the G8 Screening Tool for Older Patients With Cancer: Diagnostic Performance and Validation of a Six-Item Version.

BACKGROUND: A multidimensional geriatric assessment (GA) is recommended in older cancer patients to inventory health problems and tailor treatment decisions accordingly but requires considerable time and human resources. The G8 is among the most sensitive screening tools for selecting patients warranting a full GA but has limited specificity. We sought to develop and validate an optimized version of the G8. PATIENTS AND METHODS: We used a prospective cohort of cancer patients aged ≥ 70 years referred to geriatricians for GA (2007-2012: n = 729 [training set]; 2012-2014: n = 414 [validation set]). Abnormal GA was defined as at least one impaired domain across seven validated tests. Multiple correspondence analysis, multivariate logistic regression, and bootstrapped internal validation were performed sequentially. RESULTS: The final model included six independent predictors for abnormal GA: weight loss, cognition/mood, performance status, self-rated health status, polypharmacy (≥ 6 medications per day), and history of heart failure/coronary heart disease. For the original G8, sensitivity was 87.2% (95% confidence interval, 84.3-89.7), specificity 57.7% (47.3-67.7), and area under the receiver-operating characteristic curve (AUROC) 86.5% (83.5-89.6). The modified G8 had corresponding values of 89.2% (86.5-91.5), 79.0% (69.4-86.6), and 91.6% (89.3; 93.9), with higher AUROC values for all tumor sites and stable properties on the validation set. CONCLUSION: A modified G8 screening tool exhibited better diagnostic performance with greater uniformity across cancer sites and required only six items. If these features are confirmed in other settings, the modified tool may facilitate selection for a full GA in older patients with cancer. IMPLICATIONS FOR PRACTICE: Several screening tools have been developed to identify older patients with cancer likely to benefit from a complete geriatric assessment, but none combines appropriate sensitivity and specificity. Based on a large prospective cohort study, an optimized G8 tool was developed, combining a systematic statistical approach with expert judgment to ensure optimal discriminative power and clinical relevance. The improved screening tool achieves high sensitivity, high specificity, better homogeneity across cancer types, and greater parsimony with only six items needed, facilitating selection for a full geriatric assessment.

Geriatric assessment findings independently associated with clinical depression in 1092 older patients with cancer: the ELCAPA Cohort Study.

OBJECTIVE: We aim to assess the prevalence and associated factors of clinical depression in older patients with cancer. METHODS: We studied a prospective cohort of cancer patients aged ≥ 70 years and referred to geriatric oncology clinics between 2007 and 2012. A multidimensional geriatric assessment was performed before choosing the cancer-treatment strategy. Clinical depression was diagnosed by senior geriatricians by a semi-structured interview. It encompassed criteria of the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) and of the International Classification of Diseases (10th edition). Multivariate logistic regression was performed. RESULTS: Of 1121 consecutive patients, 1092 had available data (mean age, 80.4 years; women, 48.8%; metastases, 51.3%; cancer location: colorectal 21.1%, breast 16.8%, kidney, bladder or urinary tract 14.0%, and prostate 11.4%). The overall prevalence of clinical depression was 28.4% (95% confidence interval, 25.7-31.2). Factors independently associated with clinical depression by multivariate analysis adjusting for all following factors plus gender, and metastasis were impaired mobility (adjusted odds ratio [aOR], 2.35; 1.59-3.46), impaired functional status defined as Eastern Cooperative Oncology Group Performance Status ≥ 2 (aOR, 2.39; 1.66-3.43) or as activities of daily living < 6 (aOR, 2.43; 1.73-3.41), inpatient status (aOR, 1.68; 1.20-2.37), inadequate social support (aOR, 1.66; 1.16-2.37), cognitive impairment (aOR, 1.76; 1.24-2.49), polypharmacy defined as five or more non-antidepressant drugs (aOR, 1.65; 1.14-2.38), multimorbidity (aOR additional CIRS-G point , 1.08; 1.04-1.12), and cancer-related pain (aOR, 1.76; 1.26-2.46). CONCLUSION: In older patients with as-yet untreated cancer at various sites and stages, clinical depression was highly prevalent. Clinical depression was independently associated with several geriatric assessment findings (impaired mobility and function, inadequate social support, cognitive impairment, polypharmacy, and multimorbidity) independently from gender, tumor site, and metastatic status.

White Matter Lesions: Prevalence and Clinical Phenotype in Asymptomatic Individuals Aged ≥50 Years.

BACKGROUND: To assess the prevalence of early confluent/confluent white matter lesions (ec/cWMLs) in asymptomatic individuals aged ≥50 years and to identify associated clinical phenotypes. METHODS: Cross-sectional analysis of 141 asymptomatic individuals aged ≥50 years assessed at an outpatient department in France. Brain magnetic resonance imaging was rated using the Fazekas scale. Age-adjusted odds ratios (ORs) and 95% confidence intervals were estimated using logistic models to investigate factors associated with ec/cWMLs; independent risk factors were identified by multivariate analysis. RESULTS: Median age was 63 years; 53.9% were women, 32.6% had hypertension, and 76.6% had ≥1 cardiovascular risk factors. The prevalence of ec/cWMLs was 26.2%. Apart from age, independent risk factors were family history of cardiovascular event (OR = 5.55; 1.13-27.32) and hypertension (2.47; 1.05-5.81). Patients with ec/cWMLs had lower cognitive dual-task walking speed (1.15; 0.98-1.40), MMSE (1.41; 1.06-1.89), and FAB scores (5.21; 1.49-19.84). The Scheltens score was independently associated with the WML severity score. CONCLUSION: ec/cWMLs are common in asymptomatic community-dwelling individuals aged ≥50 years. They are associated with cardiovascular risk factors, impairments in global and executive cognitive function, and Scheltens score elevation.

Functional status and co-morbidities are associated with in-hospital mortality among older patients with acute decompensated heart failure: a multicentre prospective cohort study.

BACKGROUND: Among patients admitted for acute decompensated heart failure (ADHF), half are aged 75 years or over. The high prevalence of co-morbidities and functional impairments in this age group may affect patient outcomes. OBJECTIVE: To assess the association between co-morbidities, functional status and in-hospital mortality in patients with ADHF aged ≥75 years. DESIGN: A prospective, multicentre cohort study. SETTING: Five French hospitals. SUBJECTS: Five hundred and fifty-five patients aged ≥75 years admitted to the emergency department with ADHF. METHODS: Baseline clinical data and co-morbidities were recorded at admission. Functional status and cognition were assessed using the Katz index and Mini-Mental Status Examination score, respectively. The primary outcome was in-hospital mortality. RESULTS: We found high prevalences of co-morbidities and functional impairments including hypertension (74.0%), atrial fibrillation (40.2%), prior acute coronary syndrome (32.3%) and diabetes (18.2%). The average creatinine clearance was 56.3 ml/min/1.73 m(2) (interquartile range, 39.2-77.0). In-hospital mortality was 67/555 (12.1%; 95% confidence interval, 9.4-14.8). In multivariate analysis, in-hospital mortality showed a statistically positive association with prior loss of self-sufficiency (Odds ratio [OR]: 5.85 [2.25-12.19]), hyperglycaemia (OR: 1.80 [1.26-2.54] per 1 SD increase), prior cerebral ischaemic event (OR: 3.56 [1.51-8.44]) and troponin I elevation above upper limit of normal (OR: 2.81 [1.37-5.77]). In addition, systolic blood pressure (OR: 0.98 [0.97-0.99] per 1 mmHg increase) and creatinine clearance (OR: 0.72 [0.51-1.00] per 1 SD increase) were negatively associated with in-hospital mortality. CONCLUSION: Co-morbidities and functional impairments are associated with a worse short-term prognosis in patients aged ≥75 years admitted for ADHF. Assessing these parameters at admission may improve patient management.

Assessment of solid cancer treatment feasibility in older patients: a prospective cohort study.

PURPOSE: To assess solid cancer treatment feasibility in older patients. METHODS: Between 2007 and 2010, 385 consecutive elderly patients (mean age: 78.9 ± 5.4 years; 47.8% males) with solid malignancies referred to two geriatric oncology clinics were included prospectively. We recorded feasibility of first-line chemotherapy (planned number of cycles in patients without metastases and three to six cycles depending on tumor site in patients with metastases), surgery (patient alive 30 days after successfully performed planned surgical procedure), radiotherapy (planned dose delivered), and hormonal therapy (planned drug dose given), and we recorded overall 1-year survival. RESULTS: Main tumor sites were colorectal (28.6%), breast (23.1%), and prostate (10.9%), and 47% of patients had metastases. Planned cancer treatment was feasible in 65.7% of patients with metastases; this proportion was 59.0% for chemotherapy, 82.6% for surgery, 100% for radiotherapy, and 85.2% for hormonal therapy. In the group without metastases, feasibility proportions were 86.8% overall, 72.4% for chemotherapy, 95.7% for surgery, 96.4% for radiotherapy, and 97.9% for hormonal therapy. Factors independently associated with chemotherapy feasibility were good functional status defined as Eastern Cooperative Oncology Group performance status <2 (p < .0001) or activities of daily living >5 (p = .01), normal mobility defined as no difficulty walking (p = .01) or no fall risk (p = .007), and higher creatinine clearance (p = .04). CONCLUSION: Feasibility rates were considerably lower for chemotherapy than for surgery, radiotherapy, and hormonal therapy. Therefore, utilization of limited geriatric oncology resources may be optimized by preferential referral of elderly cancer patients initially considered for chemotherapy to geriatric oncology clinics.

Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR).

BACKGROUND: Survival is poorer in elderly patients with head and neck squamous cell carcinomas [HNSCCs] than in younger patients. Possible explanations include a contribution of co-morbidities to mortality, frequent refusal of standard therapy, and the use of suboptimal treatments due to concern about toxicities. The Comprehensive Geriatric Assessment [CGA] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans. The CGA has been proven effective in several health settings but has not been evaluated in randomised studies of patients with cancer. Our aim here was to assess the impact of the CGA on overall survival, function, and nutritional status of elderly patients with HNSCC. METHODS/DESIGN: EGeSOR is an open-label, multicentre, randomised, controlled, parallel-group trial in patients aged 70 years or older and receiving standard care for HNSCC. The intervention includes four components: the CGA conducted by a geriatrician before cancer treatment, participation of the same geriatrician in cancer treatment selection, a standardised geriatric therapeutic intervention designed by the same geriatrician; and geriatric follow-up for 24 months. The primary endpoint, assessed after 6 months, is a composite criterion including death, functional impairment [Activities of Daily Living score decrease ≥ 2], and weight loss ≥ 10%. Secondary endpoints include progression-free survival, unscheduled admissions, quality of life, treatment toxicities, costs, and completion of the planned cancer treatment. A centralised online system is used to perform 1:1 randomisation with a minimisation algorithm for centre, age, T and N stages, and tumour site [oral, oropharyngeal, hypopharyngeal, or laryngeal]. The estimated sample size is 704 patients, who are being recruited by 14 centres in 9 French cities. DISCUSSION: EGeSOR is the first randomised trial of the CGA in elderly cancer patients. We expect the CGA to have direct clinical benefits on the management of elderly patients with HNSCC. If this expectation is fulfilled, the trial may lead to modifications of the management model for elderly patients with cancer. TRIAL REGISTRATION: Trial registration: NCT02025062.

COVID-19 profiles in general practice: a latent class analysis.

BACKGROUND: General practitioners (GPs) were on the front line of the COVID-19 outbreak. Identifying clinical profiles in COVID-19 might improve patient care and enable closer monitoring of at-risk profiles. OBJECTIVES: To identify COVID-19 profiles in a population of adult primary care patients, and to determine whether the profiles were associated with negative outcomes and persistent symptoms. DESIGN, SETTING AND PARTICIPANTS: In a prospective multicentre study, 44 GPs from multiprofessional primary care practices in the Paris area of France recruited 340 consecutive adult patients (median age: 47 years) with a confirmed diagnosis of COVID-19 during the first two waves of the epidemic. METHOD AND OUTCOME: A latent class (LC) analysis with 11 indicators (clinical signs and symptoms) was performed. The resulting profiles were characterised by a 3-month composite outcome (COVID-19-related hospital admission and/or death) and persistent symptoms three and 6 months after inclusion. RESULTS: We identified six profiles: 'paucisymptomatic' (LC1, 9%), 'anosmia and/or ageusia' (LC2, 12.9%), 'influenza-like syndrome with anosmia and ageusia' (LC3, 15.5%), 'influenza-like syndrome without anosmia or ageusia' (LC4, 24.5%), 'influenza-like syndrome with respiratory impairment' (LC5) and a 'complete form' (LC6, 17.7%). At 3 months, 7.4% of the patients were hospitalised (with higher rates in LC5), and 18% had persistent symptoms (with higher rates in LC5 and LC6). At 6 months, 6.4% of the patients had persistent symptoms, with no differences between LCs. CONCLUSION: Our findings might help GPs to identify patients at risk of persistent COVID-19 symptoms and hospital admission and then set up procedures for closer monitoring.