This prospective cohort study aimed to characterise the impact of oxaliplatin-based chemotherapy and its neurotoxic side effects (i.e., chemotherapy-induced neuropathy) on functional fall-risk and falls. Twenty chemotherapy-naïve participants (mean age, 59 years; 16 males) were consecutively included. A multimodal fall risk assessment was performed at four time points within 6 months. Polyneuropathy was assessed using the Neurologic Disability Scale; the fall risk was assessed by functional tests (Tinetti Test, Chair-Rising Test, and Timed up and Go Test). Patient-reported outcomes comprised the Hospitality Anxiety and Depression Scale (HADS), the Falls Efficacy Scale - International (FES-I) to assess the fear of falling, and the Physical Activity for the Elderly (PASE) questionnaire. Three falls occurred during the study. All fallen participants had a high fall risk-index (≥4 more risk factors) compared to only 30% of the non-fallen participants (p = 0.03) and suffered more frequently from pre-existing mild polyneuropathy (p = 0.049). Study discontinuation (n = 12) was associated with a higher rate of polypharmacy (p = 0.045), anxiety (HADS-A, p = 0.03), and specific fear of falling (FES-I, p = 0.025). In contrast, study completers (n = 8) reported an improvement in physical activity (PASE) (p = 0.018). In summary, pre-existing fall-risk factors impacted more falls than chemotherapy. A fall risk index offers a time-efficient screening option in an outpatient oncological setting.

OBJECTIVE: The use of selective reporting of antibiotic susceptibility testing (AST) results is a recommended antimicrobial stewardship strategy to improve the appropriateness of antibiotic prescriptions. We conducted a large, pragmatic, prospective, multicentre, controlled (selective reporting versus complete reporting) before-after intervention study to assess the impact of selective reporting of AST results for Escherichia coli-positive urine cultures on the prescription of broad-spectrum antibiotics carrying a higher risk of selection of resistance (i.e. amoxicillin-clavulanate, third-generation cephalosporins, and quinolones) in the outpatient setting. We also looked for possible unintended clinical consequences of the intervention leading to consultations and/or hospitalizations.
METHODS: We compared two groups of laboratories located in a French region. We collected data from the health insurance databases before (2017) and after the implementation of the intervention (2019). The primary outcome was the prescription proportion of broad-spectrum antibiotics.
RESULTS: We included 42,956 Escherichia coli-positive urine cultures with AST. The decrease in the proportion of broad-spectrum antibiotic prescriptions between 2017 and 2019 was significantly higher for selective reporting of AST, attributable to a decrease in the prescription proportion of third-generation cephalosporins (-8.5% for selective reporting versus -0.1% for complete reporting, p < 0.001). This impact was more marked for targeted therapy and female patients. Requests from clinicians for the complete reporting of AST results were infrequent (1.2% of all the selective AST results reported in 2019). No unintended consequences were observed.
CONCLUSIONS: The results showed a positive impact of the selective reporting of AST results, but room for improvement is still important.

OBJECTIVE: The quality of life of persons with dementia and their relatives crucially depends on whether they succeed in establishing a stable home care situation. In this study, an outreach dyadic support program for persons with dementia and relatives was carried out by dementia nursing experts (DNE) for the first time. The aim of the nurse-led dyadic support program focuses on the lifeworld benefits for dyads and the benefits towards coping with dementia and crisis management in their home environment. Does it turn out to be a suitable offer for dyads in rural areas? Could the program originally developed for therapists be carried out by DNE?
METHODS: Using an interview guideline, 12 episodic interviews were conducted with dyads and additionally two focus groups (n = 5 relatives and n = 2 dementia nursing experts). The interviews were recorded, transcribed verbatim and analyzed using content analysis.
RESULTS: The results of a qualitative evaluation with a multiperspective approach are presented. The participating dyadic benefit depends on several factors, e.g. dyadic relationship, stage of dementia, in different ways. The outreach approach is therefore important. The dyadic setting is mostly seen as helpful, a need for additional one-to-one meetings is desired. The program can be used by DNE, the shift can even be an advantage. It is questionable whether temporary support lasts over the entire course of the disease.
CONCLUSIONS: The results show that home care situations can be improved for dyads through the nurse-led program, they can even benefit by DNE. The possibility of one-to-one meetings and follow-up care should be given. The outreach approach is crucial for rural areas. The results point to the need for more outreach care for persons with dementia in order to reduce stress and strengthen identity and action resources.
UNASSIGNED: HINTERGRUND UND FRAGESTELLUNG: Die Lebensqualität von Personen mit Demenz und ihren Angehörigen wird entscheidend von einer stabilen häuslichen Versorgungssituation beeinflusst. Bislang spielen dyadische Interventionskonzepte keine große Rolle. In dieser Studie wurde ein aufsuchendes dyadisches Unterstützungsprogramm für Personen mit Demenz und Angehörige erstmals durch Pflegeexpert:innen Demenz (PED) durchgeführt. Der lebensweltliche Nutzen eines dyadischen Ansatzes zur Alltags- und zur Krisenbewältigung im häuslichen Umfeld steht dabei im Fokus. Erweist sich das Programm als ein passendes Angebot für Dyaden in ländlichen Regionen? Und kann das ursprünglich für Therapeuten entwickelte Programm von PED durchgeführt werden?
METHODS: Mit 12 Dyaden wurden episodische Interviews geführt, ergänzt durch Fokusgruppen (n = 5 Angehörige, n = 2 Pflegeexpert:innen). Die Interviews wurden aufgezeichnet, regelgeleitet transkribiert und qualitativ-inhaltsanalytisch ausgewertet.
UNASSIGNED: Vorgestellt werden Ergebnisse einer qualitativen Evaluation mit multiperspektivischem Ansatz. Der Benefit der Teilnehmenden ist abhängig von verschiedenen Aspekten (z. B. Dyadenbeziehung, Demenzschweregrad), der aufsuchende Charakter ist dabei zentral. Der dyadische Ansatz wird als hilfreich angesehen, es besteht jedoch zusätzlich ein Bedarf an Einzelgesprächen. Das Programm kann durch PED angewendet werden; der Professionswechsel kann von Vorteil sein. Fraglich ist, ob eine zeitlich limitierte Unterstützung über den gesamten Krankheitsverlauf trägt.
UNASSIGNED: Die Lebenssituationen von Dyaden lassen sich durch das pflegegeleitete Programm verbessern. Die Möglichkeit von Einzelgesprächen sollte integriert und eine Folgebetreuung gegeben sein. Die Ergebnisse zeigen die Notwendigkeit aufsuchende Angebote in der Versorgung von Personen mit Demenz auszubauen, um Stress zu reduzieren und Identitäts- und Handlungsressourcen zu stärken.

Identifying risk factors for progression to severe COVID-19 requiring urgent medical visits and hospitalizations (UMVs) among patients initially diagnosed in the outpatient setting may help inform patient management. The objective of this study was to estimate the incidence of and risk factors for COVID-19-related UMVs after outpatient COVID-19 diagnosis or positive SARS-CoV-2 test.
Data for this retrospective cohort study were from the Optum® de-identified COVID-19 Electronic Health Record database from June 1 to December 9, 2020. Adults with first COVID-19 diagnosis or positive SARS-CoV-2 test in outpatient settings were identified. Cumulative incidence function analysis stratified by risk factors was used to estimate the 30-day incidence of COVID-19-related UMVs. Competing risk regression models were used to derive adjusted hazard ratios (aHR) and 95% confidence intervals (95% CI) for factors associated with UMVs.
Among 206,741 patients [58.8% female, 77.5% non-Hispanic Caucasian, mean (SD) age: 46.7 (17.8) years], the 30-day incidence was 9.4% (95% CI 9.3-9.6) for COVID-19-related emergency room (ER)/urgent care (UC)/hospitalizations and 3.8% (95% CI 3.7-3.9) for COVID-19-related hospitalizations. Likelihood of hospitalization increased with age and body mass index, with age the strongest risk factor (aHR 5.61; 95% CI 4.90-6.32 for patients ≥ 85 years). Increased likelihood of hospitalization was observed for first presentation in the ER/UC vs. non-ER/UC outpatient settings (aHR 2.35; 95% CI 2.22-2.47) and prior all-cause hospitalization (aHR 1.90; 95% CI 1.79-2.00). Clinical risk factors of hospitalizations included pregnancy, uncontrolled diabetes, chronic obstructive pulmonary disease, chronic kidney disease, and autoimmune disease. A study limitation is that data on COVID-19 severity and symptoms were not captured.
Predictors of COVID-19-related UMVs include older age, obesity, and several comorbidities. These findings may inform patient management and resource allocation following outpatient COVID-19 diagnosis.

OBJECTIVE: To compare three types of biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal women.
METHODS: Postmenopausal women undergoing operative hysteroscopy with endometrial biopsy for abnormal uterine bleeding or endometrial thickness (≥5 mm) were included. Operative hysteroscopy with endometrial biopsy was performed by hysteroscopic forceps. Women were randomized (1:1:1 ratio) in three groups and allocated to undergo endometrial biopsy by hysteroscopy using spoon, alligator, or snake forceps.
RESULTS: Seventy-five women were included in the study, 25 in each group. The duration of the biopsy was comparable between the three groups (P = 0.334) with a median of 180 seconds (range 20-480 seconds). No differences were observed about the number of attempts (P = 0.602), the use of another instrument (P = 0.276), and the biopsy appropriateness (P = 0.592). The spoon forceps group reported higher levels of pain compared to the alligator and snake forceps groups (P < 0.001). The spoon forceps received significantly lower scores by the operator compared to the alligator and snake forceps (P < 0.001). The alligator and snake forceps reported wider biopsy than the spoon forceps (P < 0.001).
CONCLUSIONS: Snake and alligator hysteroscopic forceps may be considered the first choice to perform an endometrial biopsy in postmenopausal women. ClinicalTrials.gov: NCT03427957.

BACKGROUND: Diabetes mellitus type 2 (DM2), one of the four most important chronic diseases worldwide, is generally considered to be preventable. However, it is not yet sufficiently clear whether an aligned collaboration between different health professions could facilitate behavioral changes to be made by patients with DM2 regarding their eating and physical activity habits.
OBJECTIVE: To explore if and how far in current outpatient care for 3 health-care professions it is an objective to collaborate with each other supporting patients with DM2 in changing their eating and physical activity habits.
METHODS: We conducted 18 qualitative problem centered interviews with selected family physicians, nurses, dieticians working in outpatient setting and patients with DM2, transcribed verbatim, and analyzed with qualitative content analysis.
RESULTS: Issues identified ranged from description and reflection of current health-care practice, strategies, and hindrances to cope with changes of eating and physical activity behaviors as well as for health-care practice regarding interprofessional collaboration and patient-centered care up to considerations about collaboration and patient centricity (for health professionals and patients to achieve goals) and changes and ideas of \"ideal care practice\".
CONCLUSIONS: The included professional groups work predominantly for themselves. Collaboration currently only takes place when individually triggered and neither structured nor organized.

The LION-HEART study was a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial evaluating the efficacy and safety of intravenous administration of intermittent doses of levosimendan in outpatients with advanced chronic heart failure.
Sixty-nine patients from 12 centres were randomly assigned at a 2:1 ratio to levosimendan or placebo groups, receiving treatment by a 6-hour intravenous infusion (0.2 μg/kg/min without bolus) every 2 weeks for 12 weeks. The primary endpoint was the effect on serum concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) throughout the treatment period in comparison with placebo. Secondary endpoints included evaluation of safety, clinical events and health-related quality of life (HRQoL). The area under the curve (AUC, pg.day/mL) of the levels of NT-proBNP over time for patients who received levosimendan was significantly lower than for the placebo group (344 × 103 [95% Confidence Interval (CI) 283 × 103 -404 × 103 ] vs. 535 × 103 [443 × 103 -626 × 103 ], p = 0.003). In comparison with the placebo group, the patients on levosimendan experienced a reduction in the rate of heart failure hospitalisation (hazard ratio 0.25; 95% CI 0.11-0.56; P = 0.001). Patients on levosimendan were less likely to experience a clinically significant decline in HRQoL over time (P = 0.022). Adverse event rates were similar in the two treatment groups.
In this small pilot study, intermittent administration of levosimendan to ambulatory patients with advanced systolic heart failure reduced plasma concentrations of NT-proBNP, worsening of HRQoL and hospitalisation for heart failure. The efficacy and safety of this intervention should be confirmed in larger trials.

BACKGROUND: Castor oil is a substance used for labor induction in an inpatient setting. However, its efficacy as an agent for the induction of labor, for post-date pregnancies in an outpatient setup is unknown.
OBJECTIVE: Efficacy of castor oil as an agent for the induction of labor, for post-date pregnancies in outpatient settings.
METHODS: Eighty-one women with a low-risk post-date singleton pregnancy with a Bishop score≤7, without effective uterine contractions were randomized to the intervention, 60ml of castor oil, or the control, 60ml of sun-flower oil. The primary outcome was proportion of women entering the active phase of labor 24, 36, 48h after ingestion. Secondary outcomes included meconium stained amniotic fluid, abnormal fetal heart rate tracing, cesarean section rate, instrumental deliveries, birth weight, 5min Apgar score, chorioamnionitis, hypertensive complications, retained placenta, and post-partum hemorrhage.
RESULTS: Intervention and control groups included 38 and 43 women, respectively. No differences in baseline characteristics, except for age were noted. The observed interaction between castor oil and parity was significant (pinteraction=0.02). Multiparous women in the intervention group exhibited a significant beneficial effect on entering active labor within 24, 36 and 48h after castor oil consumption compared with the placebo (Hazard Ratio=2.93, p=0.048; Hazard Ratio=3.29, p=0.026; Hazard Ratio=2.78, p=0.042 respectively). This effect was not noted among primiparous women. No differences in rate of obstetric complications or adverse neonatal outcomes were noted.
CONCLUSIONS: Castor oil is effective for labor induction, in post-date multiparous women in outpatient settings.

OBJECTIVE: The aim of this phase I study was to adjust the dose of cisplatin as adjuvant combination chemotherapy with S-1 in an outpatient setting for gastric cancer.
METHODS: The first course was initiated with S-1 monotherapy on days 1-28. From the second to the sixth course, S-1 was administered on days 1-28 and cisplatin was added on days 1, 15, and 29. The dose level of cisplatin was escalated as follows: 20 mg/m(2) (level 1); 25 mg/m(2) (level 2); 30 mg/m(2) (level 3). Dose-limiting toxicity was a delay factor of the start of the next course due to incomplete recovery.
RESULTS: The maximum tolerated and recommended doses were confirmed as level 3 and level 2, respectively.
CONCLUSIONS: Although further clinical trials are recommended to evaluate efficacy, this combination of S-1 plus cisplatin regimen is expected to become a standard adjuvant treatment for gastric cancer in the outpatient setting.

OBJECTIVE: The aim of this study was to determine whether intermittent ambulatory treatment with levosimendan would improve functional capacity, quality of life, and event-free survival in patients with advanced heart failure.
RESULTS: This was a prospective, randomized, double-blind, placebo-controlled, multicentre, parallel-group trial of pulsed infusions of levosimendan in 120 outpatients with advanced heart failure (EF ≤35%, NYHA class III or IV). The study was conducted at 11 centres in Austria, Greece, and Germany. Levosimendan (0.2 µg/kg/min) or placebo was administered for 6 h at 2-week intervals over 6 weeks, in addition to standard care therapy. The primary outcome was the proportion of patients with a ≥20% improvement in the 6 min walk test and a ≥15% score increase on the Kansas City Cardiomyopathy Questionnaire at the end of the 24-week study period. Secondary outcomes included event-free survival after 24 weeks. Analyses were performed on an intention-to-treat basis. The primary endpoint was reached in 19% of patients receiving levosimendan and 15.8% of patients receiving placebo (odds ratio 1.25; 95% confidence interval 0.44-3.59; P = 0.810). Cardiac death (four vs. one), heart transplants (two vs. one), and acute heart failure (14 vs. nine) were more frequent with placebo as compared with levosimendan. The incidence of side effects was comparable between groups.
CONCLUSIONS: Intermittent ambulatory treatment with levosimendan in patients with advanced heart failure did not improve significantly functional capacity or quality of life as compared with placebo. An adequately powered, event-driven trial is warranted to enlarge on our findings.
BACKGROUND: NCT01065194.