To Treat or not to Treat? The Fate of Patients with Intermittent Claudication Following Different Therapeutic Options.

Background: Peripheral artery disease (PAD) is recognized as a significant contributor to the public health burden in the cardiovascular field and has a significant rate of morbidity and mortality. In the intermediate stages, exercise therapy is recommended by the guidelines, although supervised programs are scarcely available. This single-center observational study aimed to evaluate the long-term outcomes of patients with PAD and claudication receiving optimal medical care and follow-up or revascularization procedures or structured home-based exercise. Methods: The records of 1590 PAD patients with claudication were assessed at the Vascular Surgery Unit between 2008 and 2017. Based on the findings of the recruitment visit, patients were assigned to one of the three following groups according to the available guidelines: Revascularization (Rev), structured exercise therapy (Ex), or control (Co). The exercise program was prescribed at the hospital and executed at home with two daily 10-minute interval walking sessions at a pain-free speed. The number and date of deaths, all-cause hospitalizations, and peripheral revascularizations for 5 years were collected from the Emilia-Romagna regional database. Results: At entry, 137 patients underwent revascularization; 1087 patients were included in the Ex group, and 366 were included in the Co group. At baseline, patients in the Rev group were significantly younger and had fewer comorbidities (p < 0.001). A propensity score matching analysis was performed, and three balanced subgroups of 119 patients were each created. The mortality rate was significantly (p < 0.001) greater in the Co (45%) group than in the Rev (11%) and Ex (11%) groups, as was the incidence of all-cause hospitalizations (Co: 95%; Rev 56%; Ex 60%; p < 0.001). There were no differences in peripheral revascularizations (Co: 19%; Rev: 17%; Ex 11%). Conclusions: In PAD patients with claudication, both revascularization procedures and structured home-based exercise sessions are associated with better long-term clinical outcomes than walking advice and follow-up only.

CHRONOFALLS: A multicentre nurse-led intervention in the chronoprevention of in-hospital falls in adults.

BACKGROUND: Falls are among the most common and serious adverse events for hospitalised patients. In-hospital falls pose a major medical and economic challenge for public health worldwide. Nevertheless, the issue is often addressed without regard to certain relevant variables such as the time of the fall. The aim of this study was to determine the effect of the implementation of a nurse-led intervention based on the temporal patterns of falls and their aetiology on the occurrence of falls. METHODS: A mixed-method research design was carried out in three phases: a) a longitudinal prospective study (audits, chronobiological analyses and implementation of a multicentre nurse-led intervention based on temporal patterns of falls); b) a retrospective study of fall records; and c) a qualitative study based on focus groups. The protocol was published in 2021. RESULTS: A difference was observed in the number of fall records before and after the chronopreventive intervention (retrospective: 64.4% vs. 35.6%; p < 0,001). According to the interrupted series analysis, considering the influence of the COVID-19 pandemic, a reduction in falls of 2.96% (95% CI 1.70%-4.17%) was observed. The concepts of falls, the COVID-19 pandemic and the causes of non-registration have emerged as categories for qualitative analysis. CONCLUSIONS: A multicentric nurse-led program based on tailored organisational, educational and behavioural chronopreventive measures seems to lead to a reduction in the number of in-hospital falls. The findings of the present study, highlighting the implementation of chronopreventive measures, can serve as a basis for future health policies. TRIAL REGISTRATION: The project was registered on the Clinical Trials Registry NCT04367298 (29/04/2020).

Chronoprevention in hospital falls of older people: protocol for a mixed-method study.

BACKGROUND: Accidental falls in hospitals are serious events concerning the safety of the patients. Recent studies demonstrated that the time of falls is a key factor to be considered in prevention. It has been shown that the time of day, the day of the week and the month of the year impact on the occurrence of falls. The aim of the study is to determine the effect of the application of a programme of preventive measures based on the temporal patterns of the risk factors on the hospital fall occurrence. METHODS: A mixed-method research design. The following three phases will be carried out: 1) Longitudinal prospective study in two parts: (a) audits and seminars of healthcare professionals focused on an effective and efficient hospital falls register. Multi-Component and Single Cosinor analyses will be performed to obtain the temporal patterns of hospital falls and their related variables and (b) implementation of a based-temporal patterns, multidimensional prevention programme. 2) Retrospective study of falls registered in institutional databases. 3) Qualitative study based on focus groups (physicians, nurses and nursing assistants). The study protocol was approved in 2018. DISCUSSION: With regard to the safety of patients, hospital falls are serious events. Recent studies have demonstrated that the time of falls is a key factor to be considered in prevention. It has been shown that the time of day, the day of the week and the month of the year impact on the occurrence of falls. It is imperative to study temporal patterns of hospital falls to effectively and comprehensively define the aetiology of falls and, therefore, design preventive strategies. A reduction of the number of in-hospital falls and related injuries is expected, as well as an improvement in the quality of life of patients. Considering temporal patterns and levels of mood and sleep of healthcare professionals will achieve an improvement in patient safety. TRIAL REGISTRATION: Retrospectively registered in ClinicalTrials.gov ID: NCT04367298.

Assessing Pretest Clinical Risk of Pulmonary Thromboembolism in the Emergency Department: Proposal of a Simple Modification to the Wells' Score.

BACKGROUND: Clinical scores have been proposed to stratify the risk of pulmonary thromboembolism (PTE), although this approach suffers a low specificity and the unavoidable need for computed tomography pulmonary angiography (CTPA) scans. OBJECTIVE: Our study aimed to investigate a simple modification to the already validated Wells' score to improve its diagnostic accuracy in the emergency department (ED). METHODS: We retrospectively reviewed all CTPA scans performed in the ED setting to rule out PTE over a 1-year (2017) period. Clinical variables potentially associated with PTE were assessed to improve diagnostic accuracy of the Wells' score, thus introducing a modified Wells' score (mWells). RESULTS: Four thousand four hundred thirteen CTPAs were identified, of which 504 were for suspected PTE. The prevalence of PTE was 23.9%. Among clinical data, only peripheral capillary oxygen saturation was consistently correlated with PTE at univariate (odds ratio 2.75 [95% confidence interval 1.61-4.73]) and multivariate (odds ratio 3.78 [95% confidence interval 2.13-6.72]) logistic regression analysis. The mWells' score had a higher area under the receiver operating characteristic curve compared with the original Wells' score: 0.71 (95% confidence interval 0.67-0.75) vs. 0.65 (95% confidence interval 0.61-0.69) (p < .01) and improved diagnostic accuracy. CONCLUSIONS: Current clinical stratification tools for PTE are characterized by low specificity, leading to an overuse of CTPA. mWells', rather than Wells', score showed a better predictive performance of PTE detection. Our results suggest that current diagnostic pathway for PTE may be improved by simple adjustments (i.e., mWells') of clinical prediction scores.

Small bowel adenocarcinoma as a complication of celiac disease: clinical and diagnostic features.

BACKGROUND: Small bowel adenocarcinoma (SBA) is a rare neoplasm, which can occur in a sporadic form or can be associated with a number of predisposing conditions such as hereditary syndromes and immune-mediated intestinal disorders, e.g. celiac disease (CD). However, the features of SBA in the context of CD remain only partly understood. This study was aimed to show the main clinical features, diagnostic procedures and management options of SBA cases detected in a large cohort of celiac patients diagnosed in a single tertiary care center. METHODS: We retrospectively reviewed all the SBA cases detected in a cohort of 770 CD patients (599 females; F / M ratio: 3.5:1; median age at diagnosis 36 years, range 18-80 years), diagnosed at the Celiac Disease Referral Center of our University Hospital (Bologna, Italy) from January 1995 to December 2014. RESULTS: Five (0.65%) out of our 770 CD patients developed SBA. All of them were female with a mean age of 53 years (range 38-72 years). SBA, diagnosed at the same time of the CD diagnosis in three cases, was localized in the jejunum in four cases and in the duodenum in one case. The clinical presentation of SBA was characterized by intestinal sub-occlusion in two cases, while the predominant manifestation of the remaining three cases was iron deficiency anaemia, abdominal pain and acute intestinal obstruction, respectively. All the patients were referred to surgery, and three cases with advanced stage neoplasia were also treated with chemotherapy. The overall survival rate at 5 years was 80%. CONCLUSIONS: Although in a limited series, herein presented CD-related SBA cases were characterized by a younger age of onset, a higher prevalence in female gender and a better overall survival compared to sporadic, Crohn- and hereditary syndrome-related SBA.

International Expert Consensus Document on Takotsubo Syndrome (Part II): Diagnostic Workup, Outcome, and Management.

The clinical expert consensus statement on takotsubo syndrome (TTS) part II focuses on the diagnostic workup, outcome, and management. The recommendations are based on interpretation of the limited clinical trial data currently available and experience of international TTS experts. It summarizes the diagnostic approach, which may facilitate correct and timely diagnosis. Furthermore, the document covers areas where controversies still exist in risk stratification and management of TTS. Based on available data the document provides recommendations on optimal care of such patients for practising physicians.

International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology.

Takotsubo syndrome (TTS) is a poorly recognized heart disease that was initially regarded as a benign condition. Recently, it has been shown that TTS may be associated with severe clinical complications including death and that its prevalence is probably underestimated. Since current guidelines on TTS are lacking, it appears timely and important to provide an expert consensus statement on TTS. The clinical expert consensus document part I summarizes the current state of knowledge on clinical presentation and characteristics of TTS and agrees on controversies surrounding TTS such as nomenclature, different TTS types, role of coronary artery disease, and etiology. This consensus also proposes new diagnostic criteria based on current knowledge to improve diagnostic accuracy.

Chronotype, nursing activity, and gender: A systematic review.

AIM: To synthesize evidence about the effect of individual circadian preference (chronotype) and gender in the development of sleep and mood problems in nursing professionals. BACKGROUND: Shift workers are more prone to having unhealthy habits and unfavourable clinical conditions than nonshift workers. These associations are mediated by chronotype and gender differences have also been detected. DESIGN: A quantitative systematic review. DATA SOURCES: Electronic searches were performed in MEDLINE, Scopus, ScienceDirect, and Web of Science from 1 July 2012 - 1 July 2017. REVIEW METHODS: A systematic review was conducted using the Cochrane Collaboration guidelines and two quality assessment tools: the National Heart, Lung and Blood Institute and GRADE. Inclusion criteria were quantitative studies where the sample consists entirely of nurses, analysing circadian rhythms or individual chronotype or gender and sleep/mood disturbances in nursing activity. The review was reported using the PRISMA statement. RESULTS: A total of 23 studies were included in the review (five cohort studies and 18 cross-sectional studies). Data on gender-specific attention were scarce (two studies) and showed a higher incidence of sleep problems. Female nurses with eveningness-oriented personality seem to be more prone to having sleep disorders, insomnia, fatigue, and anxiety than male and morningness ones. CONCLUSIONS: Evidence seems to show that female nurses with an evening-oriented preference suffer more problems of insomnia, sleepiness, fatigue, and anxiety. The impact of our results may affect nurses, patient safety and the quality of clinical practice.

Gender, socioeconomic, medical, and environmental factors related to domestic accidents of the elderly in Spain. Findings of a national survey.

Domestic accidents pose serious threats to the independence of the elderly. We explored associations between domestic accidents and gender, socioeconomic, medical, and environmental factors using data from the European Health Survey 2014 for elderly Spanish female and male nationals. Records of 5960 participants (mean age ± SD: 75.9 ± 7.6 years), 59.8% of whom were women, were examined. Domestic accidents occurred in 460 (7.1%) seniors, predominately in women (78.5%). Age (adjusted odds ratio [aOR]: 1.02 [95% confidence interval [CI]: 1.00-1.03, p = .003], female gender (aOR 2.04 [95% CI 1.60-2.60, p < .001]), difficulty managing 12 stairs (reference: none) (some: aOR 2.03 [95% CI 1.53-2.68, p < .001]; much: aOR 2.88 [95% CI 2.15-3.87, p < .001]; inability: aOR 3.09 [95% CI 2.14-4.45, p < .001]), and depressive symptoms severity (reference: absent) (mild: aOR 1.44 [95% CI 1.10-1.89, p = .008]; moderate: aOR 1.91 [95% CI 1.35-2.71, p < .001];. Very severe: aOR 2.53 [95% CI 1.72-3.71, p < .001]; extremely severe: aOR 2.38 [95% CI 1.45-3.93, p = .001]) were independently associated with domestic accidents. Severity of depressive symptoms was the most prominent feature for women, while inability to manage 12 stairs was the most prominent for men. Our results suggest important gender differences in factors associated with domestic accidents that are relevant to intervention and preventive programs.

Home-based exercise for elderly patients with intermittent claudication limited by osteoarticular disorders - feasibility and effectiveness of a low-intensity programme.

BACKGROUND: Peripheral arterial disease (PAD) is a common cardiovascular pathology affecting mobility in elderly. Osteoarticular diseases (ODs), responsible for functional limitations and confounding leg symptoms, may interfere with exercise therapy. This study evaluates the feasibility and effectiveness of a structured home-based exercise programme on rehabilitative outcomes in a cohort of elderly PAD patients with and without coexisting ODs. PATIENTS AND METHODS: Patients were enrolled from 2002 to 2016 in an exercise programme prescribed and controlled at the hospital and based on two daily 10-minute home walking sessions below the self-selected speed. The presence and localization of ODs at baseline were derived from consultation of medical documents. The ankle-brachial index and functional outcomes, defined as speed at the onset of claudication and attainable maximal speed by an incremental treadmill test, were assessed at baseline and discharge. Feasibility was determined according to dropout rate, number of visits, duration of the programme, and adherence. RESULTS: A total of 1,251 PAD patients were enrolled (931 men; 71 ± 9 years; 0.63 ± 0.19 ankle-brachial index). Eight hundred sixty-four patients were free of ODs (ODfreePAD, 69 %), whereas 387 were affected by ODs (ODPAD, 31 %), predominantly located in the spine (72 %). In the logistic regression models, the presence of ODs was associated with female sex, overweight, sedentary and/or driving professions. At discharge, ODPAD and ODfreePAD did not differ in dropout rates (12 % each), programme duration (378 ± 241 vs. 390 ± 260 days), number of visits (7 ± 3 each), and adherence (80 % each). Similar improvements for ODPAD and ODfreePAD were observed for the ankle-brachial index (0.06 ± 0.12 each), the speed at onset of claudication (0.7 ± 0.7 vs. 0.7 ± 0.8 kmh-1; p = 0.70), and maximal speed (0.4 ± 0.6 vs. 0.4 ± 0.6 kmh-1; p = 0.77). CONCLUSIONS: Equally satisfactory rehabilitative outcomes were observed in elderly patients with claudication limited by ODs who completed a well-tolerated, low-impact structured exercise programme.

Sex and Circadian Periodicity of Cardiovascular Diseases: Are Women Sufficiently Represented in Chronobiological Studies?

Women are often excluded/underrepresented in clinical trials; sometimes, the number of men/women participants or separate analysis by sex are not reported. A robust body of evidence demonstrated that several life-threatening acute cardiovascular diseases, for example, acute myocardial infarction, sudden cardiac death, cardiac arrest, rupture or dissection of aortic aneurysms, and stroke, exhibit a circadian periodicity with a morning peak. An analysis of 20 years of chronobiologic studies (44% of them, accounting for 85% of total cases, with separate analysis by sex) confirmed that morning hours are a critical time of onset of acute cardiovascular diseases in men and women.

Temporal Patterns of In-Hospital Falls of Elderly Patients.

BACKGROUND: A potentially important factor yet to receive adequate study is the time when hospital falls occur. A prior study conducted before the system-wide introduction of preventive measures revealed a biphasic 24-hour pattern of hospital falls with major peak in the morning. OBJECTIVES: The purpose was to identify the temporal patterning of falls among elderly patients in hospitals with comprehensive fall prevention programs in place. METHODS: A 4-year observational study was conducted by the local health authority in the five nonteaching public hospitals located in the province of Ferrara, Italy. Fall records involving patients of ages ≥65 years hospitalized in the general medical departments were used. Single- and multiple-component cosinor (time series) analyses were used to explore 24-hour, weekly, and annual patterns of falls. RESULTS: A total of 763 falls were experienced by 709 different elderly hospitalized patients. Falls typically took place in the patient's hospital room (72%) and bathroom (23%). Major causes were patient instability (32%) and accident (13%), and most occurred when not wearing footwear (45%) or wearing inappropriate sling-back open-toe shoes (39%). Falls happened while standing (39%), while seated (21%), and while getting into, out of, or laying in bed (32%)-either with the bed rails raised or lowered. Fall outcome usually involved no injury (58%) or slight injury (35%), but some (7%) were disabling. Fall occurrence was higher during the night (46%) compared to either the morning (30%) or afternoon (24%) shift. Patterns across 24 hours were characterized by a single major and one or more minor peaks that seemed to be associated with a variety of scheduled patient, hospital, and nursing activities. Multiple-component cosinor analysis identified significant (p < .05) prominent day-night patterns according to fall location, patient position, cause, injury severity, and type of footwear. Falls were more frequent, but not significantly so, on Fridays, Sundays, and Mondays compared with Tuesdays, and were more frequent in winter and spring (p = .003). DISCUSSION: Documentation by cause and circumstance of these moderate- to high-amplitude temporal patterns in hospital falls of elderly patients advances the knowledge of fall epidemiology by identifying the times of day, week, and year and nursing shifts of elevated risk that is of critical importance to improving hospital patient safety programs.

Renal Transplantation and Outcome.

Emergency surgery represents an independent risk factor for death and postoperative complications. The aim of this study was to investigate the literature data regarding outcome of daytime or nighttime renal transplantation surgery. Relevant papers, focused on renal transplantation surgery, time of the day, and complications, were searched across the PubMed database. We used the following search terms: "renal", "transplantation", "surgery", "daytime", "nighttime", and "outcome". A total of five papers, including 6,991 adult patients were evaluated. All patients received renal transplantation from deceased donor. Daytime or nighttime surgery do not seem to negatively impact on graft survival in renal transplantation. However, two out five studies reported higher odds of complications after nighttime operation. Since it is not possible to predict the availability of a deceased donor, nighttime surgery remains a valid option when necessary, maybe deserving a higher level of caution to reduce or avoid complications.

Chronobiology of Takotsubo Syndrome and Myocardial Infarction: Analogies and Differences.

Several pathophysiologic factors, not harmful if taken alone, are capable of triggering unfavorable events when presenting together within the same temporal window (chronorisk), and the occurrence of many cardiovascular events is not evenly distributed in time. Both acute myocardial infarction and takotsubo syndrome seem to exhibit a temporal preference in their onset, characterized by variations according to time of day, day of the week, and month of the year, although with both analogies and differences.

Renal disease and accidental falls: a review of published evidence.

BACKGROUND: The pathogenesis of falling is complex, and identification of risk factors may be essential for prevention. The relationship between renal disease and falls is unclear, and the goal of this study was to collect the available evidence and investigate the relationship between accidental falls and renal dysfunction. METHODS: Electronic searches were performed in the MEDLINE, Scopus, Ovid SP and Web of Science databases to identify the appropriate literature. The themes used were: falls (combined in the title/abstract fall or falls or falling or faller* or fallen or slip* or trip* or (MeSH) accidental falls) and renal insufficiency (chronic or renal insufficiency or kidney diseases combined in title/abstract renal disease* or kidney disease* or renal insufficiency or kidney insufficiency or kidney failure or renal failure or MeSH renal insufficiency, chronic or renal insufficiency or kidney diseases). The incidence, risk factors, complications, and characteristics of the falls were analyzed. RESULTS: Eight prospective cohorts including five cross-sectional studies, and one case-control study were identified. No randomized controlled studies were found. The incidence of falls in chronic kidney disease patients ranged between 1.18 and 1.60 fall/patient year. These were frequent in frail older adults on hemodialysis treatment. Falling relapses in the same group of patients caused serious consequences. Data on pre-end stage renal disease (ESRD) were scarce. CONCLUSIONS: The risk of falling appears to be common in patients with renal dysfunction especially in older adults undergoing hemodialysis. On the other hand, we could not find any conclusive data on pre-ESRD patients.

Acute oxygenation changes on ischemic foot of a novel intermittent pneumatic compression device and of an existing sequential device in severe peripheral arterial disease.

BACKGROUND: Intermittent pneumatic compression (IPC) improves haemodynamics in peripheral arterial disease (PAD), but its effects on foot perfusion were scarcely studied. In severe PAD patients we measured the foot oxygenation changes evoked by a novel intermittent IPC device (GP), haemodynamics and compliance to the treatment. Reference values were obtained by a sequential foot-calf device (SFC). METHODS: Twenty ischemic limbs (Ankle-Brachial Index = 0.5 ± 0.2) of 12 PAD patients (7 male, age: 74.5 ± 10.8 y) with an interval of 48 ± 2 hours received a 35 minute treatment in supine position with two IPC devices: i) a Gradient Pump (GP), which slowly inflates a single thigh special sleeve and ii) an SFC (ArtAssist®, ACI Medical, San Marcos, CA, USA), which rapidly inflates two foot-calf sleeves. MAIN OUTCOME MEASURE: changes of oxygenated haemoglobin at foot (HbO2foot) by continuous near-infrared spectroscopy recording and quantified as area-under-curve (AUC) for periods of 5 minutes. Other measures: haemodynamics by echo-colour Doppler (time average velocity (TAV) and blood flow (BF) in the popliteal artery and in the femoral vein), patient compliance by a properly developed form. RESULTS: All patients completed the treatment with GP, 9 with SFC. HbO2foot during the working phase, considered as average value of the 5 minutes periods, increased with GP (AUC 458 ± 600 to 1216 ± 280) and decreased with SFC (AUC 231 ± 946 to -1088 ± 346), significantly for most periods (P < 0.05). The GP treatment was associated to significant haemodynamic changes from baseline to end of the treatment (TAV = 10.2 ± 3.3 to 13.5 ± 5.5 cm/sec, P = 0.004; BF = 452.0 ± 187.2 to 607.9 ± 237.8 ml/sec, P = 0.0001), not observed with SFC (TAV = 11.2 ± 3.4 to 11.8 ± 4.3 cm/sec; BF = 513.8 ± 203.7 to 505.9 ± 166.5 ml/min, P = n.s.). GP obtained a higher score of patient compliance (P < 0.0001). CONCLUSIONS: A novel IPC thigh device, unlike a traditional SFC device, increased foot oxygenation in severe PAD, together with favourable haemodynamic response and high compliance to the treatment under the present experimental conditions.

Chronobiological variation in takotsubo syndrome: an updated systematic review and meta-analysis.

Takotsubo syndrome (TTS) might exhibit particular chronobiological patterns in its onset, characterized by variations according to time of the day, day of the week, and month of the year. The aim of this study was to fully explore the temporal patterns (circadian, weekly and seasonal) in the onset of TTS. A systematic review and meta-analysis of literature were conducted for studies (2006-2024) reporting the temporal patterns (circadian, weekly and/or seasonal) in the onset of TTS. Among the 4257 studies retrieved, 20 (including 64,567 subjects) fulfilled all eligibility criteria. Data were aggregated used random effects model as pooled risk ratio and the attributable risk (AR). The proportion analysis (including 8 studies; n=853) showed a decreasing pattern of the pooled rates of TTS shifting from the morning to the night (pooled TTS rates: 34.0%; 32.1%; 21.7%; 12.7% in the morning, afternoon, evening and night, respectively). The same pattern was observed stratifying by type of preceding stressful factor or event, considering physical stressors (pooled rates in the morning and night: 37.6% and 9.8%, respectively), and also in case no event could be identified. The pooled rates of TTS onset peaked on Monday and Tuesday (17.3% and 18.4% respectively), then declined during the week, reaching the lowest rates on Friday and Saturday (10.6% and 10.8%, respectively), with no sex differences. TTS onset reached the highest values on summer, and the lowest in winter (27.9% versus 21.7% in summer and winter, respectively). The TTS morning peak based analyses (∼33% of all the registered events) account for a RR of 1.46 (95% CI: 1.38-1.54), the week-based for a RR of 1.26 (1.16-1.35), the season-based for a RR of 1.04 (1.04-1.05). TTS onset exhibits specific chronobiological patterns, characterized by a peak during the morning hours, and on Monday and Tuesday. Differing from other cardiovascular emergencies TTS was more frequent during summer. Further studies are needed to fully understand the underlying pathophysiological mechanisms in order to tailor relative management and preventive strategies.