What Really Matters for Returning to Work After Breast Cancer? A 6-month Longitudinal Study and a Multidimensional Approach

Purpose. Return to work (RTW) after breast cancer (BC) may easily impact on women recovery and quality of life. Literature on RTW hightlighed several factors associated to RTW after BC, and there is still some concern for exploring the main sociodemographic, clinical, psychological and work-related predictors of RTW after BC treatments especially when considering the first 6 months. The present study aims to explore which baseline factors are associated with RTW at 6-month after BC surgery. Methods. A 6-month follow-up study was performed among patients recruited from a Hospital in Northern Italy after their cancer-related surgery. Partecipants filled in a battery of questionnaires at baseline and at 6-month follow-up. Measurements were on job stress, work engagement, quality of life, anxiety, depression and resilience. Moreover, sociodemographic, clinical and work-related data were collected. Univariate and multivariate analyses were performed. Results. We recruited a sample of 149 patients, whose 73.9% returned to work after surgery. The women who returned to work were more likely to be not in a relationship, nor to have children. Also, they were not treated by chemiotherapy, and had higher scores in expectations of job changes after illness, RTW expectations, perception of physical quality of life and psychological resilience. In the multivariate model, chemiotherapy and women’s RTW expectations resulted as significant predictors of RTW at 6-month after BC surgery. Conclusion Most patients returned to work within first 6 months from breast surgery. Return to work was influenced by chemiotherapy and RTW expectations at baseline. A carefully individual screening of risk factors at baseline can prevent from occupational disability and long sickness absence.

Real-world evidence of sofosbuvir/velpatasvir as an effective and simple hepatitis C virus treatment and elimination tool in homeless populations

Background: People experiencing homelessness are disproportionately affected by hepatitis C virus (HCV) and can face specific barriers to care. Simple treatment algorithms could increase linkage to care in this population. Methods: This retrospective real-world analysis pooling data from 15 clinical cohorts evaluated effectiveness of a once-daily sofosbuvir/velpatasvir (SOF/VEL) regimen in HCV-infected people experiencing homelessness. The primary outcome was sustained virological response (SVR) in the effectiveness population (patients with confirmed SVR status). Secondary outcomes included reasons for not achieving SVR, adherence and time between diagnosis and SOF/VEL treatment start. Results: Of 153 patients treated with SOF/VEL for 12 weeks without ribavirin, SVR was 100% in the effectiveness population (n = 122), irrespective of various baseline factors including active injecting drug use and presence of mental health disorders. Conclusion: HCV-infected people experiencing homelessness can successfully be treated with SOF/VEL. SOF/VEL enables implementation of simple treatment algorithms and can support test-and-treat strategies through rapid treatment starts and minimal monitoring.

High-risk multiple myeloma: how to treat at diagnosis and relapse?

Patients with multiple myeloma have experienced a great improvement in survival over the past century because of the introduction of novel therapeutic strategies. However, a subgroup of patients with poorer outcomes than expected is considered high risk and identified by the presence of patient- and disease-based factors such as frailty, extramedullary disease, cytogenetic abnormalities, or even relapses occurring earlier than expected according to the baseline factors. Although the management of patients with high-risk features is not well established because of the lack of specific trials in this subgroup of patients and because of their underrepresentation in the clinical trials, treatment should be planned on 2 pillars: (1) poor prognosis with the presence of high-risk features can be at least improved or even abrogated by achieving a deep and sustained response over time, and (2) this can most likely be obtained through using the best therapeutic options and in a response-adapted way. Some clinical trials that have been planned or are ongoing include only patients with high-risk features, using the most effective therapies (proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies) as well as chimeric antigen receptor T cells and T-cell engagers that will unravel what the best therapeutic approach will be to overcome the poor prognosis of the presence of high-risk features.

'Real-world' clinical trials in diabetes care: meaningful or meaningless?

So-called 'real-world' studies seem increasingly popular in diabetes care, as are the economic evaluations in secondary literature based upon them. The term is usually used for pharmacoepidemiological uncontrolled observational studies of different designs. Interpretation of the study findings is, however, badly undermined by the very reasons that the randomised controlled blinded study was invented – namely, non-medication study effects and biases in investigator selection and behaviour. In diabetes studies, glucose control seems particularly susceptible to such effects, perhaps through changes in patient motivation and education. Further, insulin studies are heavily influenced by baseline factors such as the site of starting insulin, the health circumstances of the patient at the time and the clinician involved. It is rare to see these issues adequately addressed or attempts made to understand their influence. In this article an attempt is made to discuss some of the issues further.

Effects of Caregiver Interventions for Informal Caregivers of Older Adults With Cognitive Decline

Objectives To identify baseline factors and process factors, which indicate changes that are associated with caregiving confidence improvement attributed to caregiver support. Methods An intervention study using 35 informal caregivers (ICG) of older adults (≥65 years old) with cognitive decline. Recipients of ICGs belonged to the Programs of All Inclusive Care for the Elderly (PACE). Interventions were occupational therapy (OT) support or education about illness and effective caregiving methods, which took place in ICGs’ homes. OT interventions included training to reduce physical strain, and improve time and task organizations, and providing assistive devices). Caregiver confidence was measured using a Visual Analog Scale. Data were divided into two groups: improved confidence and decreased/no-change confidence. Eleven baseline data of care recipients (CRs) and ICGs as well as five process data were analyzed using logistic regression. Results Baseline factors that differentiated the two groups were ICG’s age, caregiving confidence level, and CR’s cognitive status, of which classification accuracy was 94.3%. Only Zarit Buren Interview (ZBI) score was associated with caregiving confidence change, of which classification accuracy was 74.3%. Younger ICGs, lower cognition, and lower caregiving confidence among baseline factors, and improved ZBI among the process factors were associated with improved confidence. Discussion Although our interventions prevented 65.7% of caregivers form declining their caregiving confidence, improving caregiving confidence was difficult while CRs’ cognition continued to decline. However, this positive change was possible even CRs had moderate dementia, on average. Personal interventions may be necessary to improve caregiving confidence and reduce ICG’s burden.

Factors associated with successful dietary changes in an energy-reduced Mediterranean diet intervention: a longitudinal analysis in the PREDIMED-Plus trial

Purpose Long-term nutrition trials may fail to respond to their original hypotheses if participants do not comply with the intended dietary intervention. We aimed to identify baseline factors associated with successful dietary changes towards an energy-reduced Mediterranean diet (MedDiet) in the PREDIMED-Plus randomized trial. Methods Longitudinal analysis of 2985 participants (Spanish overweight/obese older adults with metabolic syndrome) randomized to the active intervention arm of the PREDIMED-Plus trial. Dietary changes were assessed with a 17-item energy-reduced MedDiet questionnaire after 6 and 12 months of follow-up. Successful compliance was defined as dietary changes from baseline of ≥ 5 points for participants with baseline scores < 13 points or any increase if baseline score was ≥ 13 points. We conducted crude and adjusted multivariable logistic regression models to identify baseline factors related to compliance. Results Consistent factors independently associated with successful dietary change at both 6 and 12 months were high baseline perceived self-efficacy in modifying diet (OR6-month: 1.51, 95% CI 1.25–1.83; OR12-month: 1.66, 95% CI 1.37–2.01), higher baseline fiber intake (OR6-month: 1.62, 95% CI 1.07–2.46; OR12-month: 1.62, 95% CI 1.07–2.45), having > 3 chronic conditions (OR6-month: 0.65, 95% CI 0.53–0.79; OR12-month: 0.76, 95% CI 0.62–0.93), and suffering depression (OR6-month: 0.80, 95% CI 0.64–0.99; OR12-month: 0.71, 95% CI 0.57–0.88). Conclusion Our results suggested that recruitment of individuals with high perceived self-efficacy to dietary change, and those who initially follow diets relatively richer in fiber may lead to greater changes in nutritional recommendations. Participants with multiple chronic conditions, specifically depression, should receive specific tailored interventions. Trial registration ISRCTN registry 89898870, 24th July 2014 retrospectively registered http://www.isrctn.com/ISRCTN89898870.

Baseline factors associated with death in a COVID-19 hospital cohort, Sao Paulo, 2020

This study aimed to verify socio-demographic and baseline clinical factors associated with death in a hospital cohort of patients with COVID-19. A retrospective cohort study was conducted between February and December 2020 in a university hospital in the city of São Paulo, using Hospital Epidemiology Center data. RT-PCR-positive patients were selected to compose the sample (n = 1,034). At the end of the study, 362 (32%) patients died. In this cohort, age equal to or greater than sixty years (HR = 1.49) and liver disease (HR = 1.81) were independent risk factors for death from COVID-19 associated with higher in-hospital mortality.

Study on the Baseline Factors and Platelet Indices That Predict Outcome of Acute Ischemic Stroke Patients after Thrombolytic Therapy

<b><i>Background:</i></b> The aim of the study was to investigate the baseline characters that influence 3-month clinical outcomes in patients with acute ischemic stroke (AIS) after thrombolytic therapy. <b><i>Methods:</i></b> We consecutively enrolled 241 AIS patients who are treated with thrombolytic therapy with recombinant tissue plasminogen activator. Baseline characters were measured on admission including the National Institutes of Health Stroke Scale (NIHSS), Trial of Org 10172 in Acute Stroke Treatment (TOAST), risk factors, platelet indices, and lipid parameters. The subjects were divided into good or poor functional outcomes based on modified Rankin Scale at 3 months. The multivariate logistic regression was performed to explore the association between baseline factors and outcomes. Pearson correlation was used to investigate whether linear associations existed between platelet indices in different outcomes. <b><i>Results:</i></b> Multivariate logistic regression analysis showed that the NIHSS, TOAST classification, diabetes, mean platelet volume (MPV) are important factors for predicting clinical outcomes after 3 months in AIS patients. We found a correlation between elevated MPV and worse outcome at 3 months, particularly in large-artery atherosclerosis stroke patients. MPV and platelet count are negative correlated (<i>r</i> = −0.375, <i>p</i> = 0.000). MPV and platelet-to-lymphocyte ratio (PLR) (<i>r</i> = 0.83, <i>p</i> = 0.000), MPV and platelet distribution width (PDW) (<i>r</i> = 0.820, <i>p</i> = 0.000) both have highly positive linear correlations in patients with good outcome. <b><i>Conclusions:</i></b> Overall, lower NIHSS and MPV levels on admission were predictors of good functional outcomes in patients with AIS after undergoing thrombolytic therapy. The correlations between MPV, PDW, and PLR may be helpful to evaluate prognosis in stroke patients and deserve further exploration.

Risk factors for microcystic macular oedema in glaucoma

Background/aimsTo identify clinical characteristics and factors associated with microcystic macular edema (MME) in patients with primary open-angle glaucoma (POAG).MethodsWe included 315 POAG eyes between 2010 and 2019 with good-quality macular volume scans that had reliable visual fields (VF) available within 6 months in this observational retrospective cohort study. Eyes with retinal pathologies except for epiretinal membrane (ERM) were excluded. The inner nuclear layer was qualitatively assessed for the presence of MME. Global mean deviation (MD) and Visual Field Index (VFI) decay rates, superior and inferior MD rates and pointwise total deviation rates of change were estimated with linear regression. Logistic regression was performed to identify baseline factors associated with the presence of MME and to determine whether MME is associated with progressive VF loss.Results25 out of 315 eyes (7.9%) demonstrated MME. The average (±SD) age and MD in eyes with and without MME was 57.2 (±8.7) versus 62.0 (±9.9) years (p=0.02) and −9.8 (±5.7) versus −4.9 (±5.3) dB (p<0.001), respectively. Worse global MD at baseline (p=0.001) and younger age (p=0.02) were associated with presence of MME. ERM was not associated with the presence of MME (p=0.84) in this cohort. MME was not associated with MD and VFI decay rates (p>0.49).ConclusionsMore severe glaucoma and younger age were associated with MME. MME was not associated with faster global VF decay in this cohort. MME may confound monitoring of glaucoma with full macular thickness.