The Hard Lessons Learned by the COVID-19 Epidemic in Italy: Rethinking the Role of the National Health Care Service?

The dramatic events precipitated by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus pandemic have highlighted the limitations and contradictions of our country's current health care delivery model plagued by the closure of healthcare delivery structures, staff reductions, privatizations and inadequate funding which have been affecting the Italian National Health System during the past 10 years. The COVID-19 epidemic has a hefty bill: thousands of deaths - mainly elderly, hospitals overwhelmed, residential assistance structures reaching their limits, sick people left alone and uncared in homes, the disruption in life habits and an altered daily way of living never experienced before; all have contributed into making the ongoing tragedy even more painful. Herewith, we present and discuss the information and reflections from our experiences and postulate the rethinking of the established socio-health policies not only in Italy but also in other western countries which have failed to curtail the epidemic via conventional management approaches.

The Early Detection of Osteoporosis in a Cohort of Healthcare Workers: Is There Room for a Screening Program?

Workforce aging is becoming a significant public health problem due to the resulting emergence of age-related diseases, such as osteoporosis. The prevention and early detection of osteoporosis is important to avoid bone fractures and their socio-economic burden. The aim of this study is to evaluate the sustainability of a screening workplace program able to detect workers with osteoporosis. The screening process included a questionnaire-based risk assessment of 1050 healthcare workers followed by measurement of the bone mass density (BMD) with a pulse-echo ultrasound (PEUS) at the proximal tibia in the at-risk subjects. Workers with a BMD value ≤ 0.783 g/cm² were referred to a specialist visit ensuring a diagnosis and the consequent prescriptions. Any possible association between the outcome variable BMD ≤ 0.783 g/cm² and the risk factors was evaluated. The costs were calculated with a full costing method. We identified 60 pathological subjects. We observed increased risks for women, older ages, and menopause (p < 0.01). The yearly cost of our screening program estimated for this study was 8242 euros, and, considering the fragility bone fracture costs, we hypothesize a considerable economic savings, with a possible positive benefits/cost ratio of 2.07. We can say that the margin between the investment and results leads to a preference for this type of screening program. Osteoporosis is an occupational health problem, and a workplace screening program could be a cost-effective intervention.

[Evaluating quality and safety in long term care: results from the experimentation of the Smart Star model]. / La valutazione della qualità e sicurezza assistenziale nelle RSA: risultati della sperimentazione del modello Smart Star.

The Smart Star model is a rating system to evaluate the quality of care in nursing homes for the elderly; it uses a five star rating score. We tested the model in a sample of 16 nursing homes in Italy. The Smart Star model showed to be effective in the multidimensional evaluation of the performance of nursing homes. One of the major strengths of the model consisted in its flexibility of application, that suggested its possible adaptation for different areas of healthcare.

Prevalence and costs of defensive medicine: a national survey of Italian physicians.

Objective To identify the prevalence of the practice of defensive medicine among Italian hospital physicians, its costs and the reasons for practising defensive medicine and possible solutions to reduce the practice of defensive medicine. Methods Cross-sectional web survey. Main outcome measures Number of physicians reporting having engaged in any defensive medicine behaviour in the previous year. Results A total of 1313 physicians completed the survey. Ninety-five per cent believed that defensive medicine would increase in the near future. The practice of defensive medicine accounted for approximately 10% of total annual Italian national health expenditure. Conclusions Defensive medicine is a significant factor in health care costs without adding any benefit to patients. The economic burden of defensive medicine on health care systems should provide a substantial stimulus for a prompt review of this situation in a time of economic crisis. Malpractice reform, together with a systematic use of evidence-based clinical guidelines, is likely to be the most effective way to reduce defensive medicine.

Impact of a care pathway for COPD on adherence to guidelines and hospital readmission: a cluster randomized trial.

PURPOSE: Current in-hospital management of exacerbations of COPD is suboptimal, and patient outcomes are poor. The primary aim of this study was to evaluate whether implementation of a care pathway (CP) for COPD improves the 6 months readmission rate. Secondary outcomes were the 30 days readmission rate, mortality, length of stay and adherence to guidelines. PATIENTS AND METHODS: An international cluster randomized controlled trial was performed in Belgium, Italy and Portugal. General hospitals were randomly assigned to an intervention group where a CP was implemented or a control group where usual care was provided. The targeted population included patients with COPD exacerbation. RESULTS: Twenty-two hospitals were included, whereof 11 hospitals (n=174 patients) were randomized to the intervention group and 11 hospitals (n=168 patients) to the control group. The CP had no impact on the 6 months readmission rate. However, the 30 days readmission rate was significantly lower in the intervention group (9.7%; 15/155) compared to the control group (15.3%; 22/144) (odds ratio =0.427; 95% confidence interval 0.222-0.822; P=0.040). Performance on process indicators was significantly higher in the intervention group for 2 of 24 main indicators (8.3%). CONCLUSION: The implementation of this in-hospital CP for COPD exacerbation has no impact on the 6 months readmission rate, but it significantly reduces the 30 days readmission rate.

[Second victims in healthcare: the stages of recovery following an adverse event]. / Le seconde vittime in sanità: le fasi di recupero dopo un evento avverso.

A second victim has been defined as "a healthcare worker involved in an unanticipated adverse patient event, medical error and/or a patient related-injury who becomes victimized in the sense that the worker is traumatized by the event". The aim of the present research study was to assess the "second victim" phenomenon in Italy. Fifty interviews were conducted with different health care professionals previously involved in medical errors. All study participants clearly remembered the event. Support obtained by second victims was poor and inefficient. Healthcare workers become second victims every day and, considering that human resources are the most important resource of healthcare organizations, it is fundamental to implement valid programs to support and train these workers about the phenomenon.

[Evaluating the quality of care in nursing homes: comparison of three International models]. / La valutazione della qualità nelle residenze sanitarie assistenziali: tre modelli internazionali a confronto.

The aim of this observational descriptive study was to identify the main international models evaluating the quality of nursing homes for non self-sufficient elderly persons, and to apply them in the Italian health system. Firstly, a bibliographic search of institutional websites and Pubmed-Medline was performed to identify the main international models. Secondly, three variables were chosen to evaluate the level of implementability of the models: (1) frequency of use of quality indicators in the international models; (2) degree of constructability of the models in two Italian nursing homes; (3) perceived relevance of the indicators used by the chosen models, by nursing home workers. Thirdly, the chosen models were evaluated. Three international models were identified, respectively used in USA, Canada and Australia. About 80% of the indicators used by the three models were constructable in the two Italian nursing homes that were evaluated. The two nursing homes were "promoted" according to the Canadian model, "better than sufficient" according to the Australian model, but "failed" when US model indicators were applied. The poorest performances in the two Italian nursing homes, with respect to international quality standards, were related to indicators of incontinence, physical restraints (1,1% for USA and 13% for Canada and Australia, versus 55% in one of the nursing homes and 30% in the second home), diagnosis of depressive symptoms, and antipneumococcical vaccination (0% in the two nursing homes, in comparison with the 93,8% in the USA). A low level of performance in prevention and safety matters was identified, while performance was higher for aspects warranted by law. The survey also revealed thatnursing home workers' perceptions of the utility of specific indicators were often based on habit rather than on the actual relevance of care indicators. The development of a model of quality of care that offers a multidimensional evaluation of the level of performance of Italian nursing homes is needed.

[Defensive Medicine: Defensive Medicine: Overview of the literature]. / Overview della letteratura scientifica sul tema medicina difensiva.

A literature review was performed on the subject of defensive medicine, in order to gather information and evidence for identifying a shared definition of this phenomenon, identify its causes, quantify its frequency and its economic impact.Results show that defensive medicine is primarily the result of medical professionals adapting to the pressure of litigation risks, and whose behaviour is motivated by fear of malpractice claims rather than by the patient's health. Defensive medicine seems to have become a diffuse phenomenon, afflicting all diagnostic-therapeutic areas and some disciplines to a greater degree, and leading to a large waste of human, organizational and economic resources.

The effect of care pathways for hip fractures: a systematic overview of secondary studies.

The aim of this paper was to perform a systematic overview of secondary literature studies on care pathways (CPs) for hip fracture (HF). The online databases MEDLINE-PubMed, Ovid-EMBASE, CINAHL-EBSCO-host, and The Cochrane Library were searched. A total of six papers, corresponding to six secondary studies, were included but only four secondary studies were HF-specific and thus assessed. Secondary studies were evaluated for patients' clinical outcomes. There were wide differences among the studies that assessed the effects of CPs on HF patients, with some contrasting clinical outcomes reported. Secondary studies that were non-specific for CPs and included other multidisciplinary care approaches as well showed, in some cases, a shorter hospital length of stay (LOS) compared to usual care; studies that focused on promoting early mobilization showed better outcomes of mortality, morbidity, function, or service utilization; CPs mainly based on intensive occupational therapy and/or physical therapy exercises improved functional recovery and reduced LOS, with patients also discharged to a more favorable discharge destination; CPs principally focused on early mobilization improved functional recovery. A secondary study specifically designed for CPs showed lower odds of experiencing common complications of hospitalization after HF. In conclusion, although our overview suggests that CPs can reduce significantly LOS and can have a positive impact on different outcomes, data are insufficient for formal recommendations. To properly understand the effects of CPs for HF, a systematic review is needed of primary studies that specifically examined CPs for HF.

Quality indicators for in-hospital management of exacerbation of chronic obstructive pulmonary disease: results of an international Delphi study.

AIM: To report a Delphi study that was conducted to select process and outcome indicators that are relevant to study quality of care and impact of care pathways for patients hospitalized with exacerbation of chronic obstructive pulmonary disease. BACKGROUND: Management of patients hospitalized with exacerbation of chronic obstructive pulmonary disease is suboptimal and outcomes are poor. To evaluate the impact of care pathways properly, relevant indicators need to be selected. DESIGN: Delphi study. METHODS: The study was conducted over 4 months in 2008, with 35 experts out of 15 countries, including 19 medical doctors, 8 nurses and 8 physiotherapists. Participants were asked to rate, for 72 process and 21 outcome indicators, the relevance for follow-up in care pathways for in-hospital management of exacerbation of chronic obstructive pulmonary disease. Consensus (agreement by at least 75% of the participants) that an indicator is relevant for follow-up was sought in two rounds. RESULTS: Consensus was reached for 26 of 72 process indicators (36·1%) and 10 of 21 outcome indicators (47·6%). Highest consensus levels were found for the process indicators regarding oxygen therapy (100%), pulmonary rehabilitation (100%) and patient education (94·5-88·6%) and for the outcome indicators concerning understanding of therapy (91·4-85·7%) and self-management (88·6-88·2%). CONCLUSION: The selected indicators appear to be sensitive for improvement. Therefore, researchers and clinicians that want to study and improve the care for patients hospitalized with exacerbation of chronic obstructive pulmonary disease should primarily focus on these indicators.

The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial.

BACKGROUND: Proximal femur fracture (PFF) is associated with considerable morbidity and mortality. The European Quality of Care Pathway (EQCP) study on PFF (NCT00962910) was designed to determine how care pathways (CP) for hospital treatment of PFF affect consistency of care, adherence to evidence-based key interventions, and clinical outcome. METHODS/DESIGN: An international cluster-randomized controlled trial (cRCT) will be performed in Belgium, Ireland, Italy and Portugal. Based on power analyses, a sample of 44 hospital teams and 437 patients per arm will be included in the study. In the control arm, usual care will be provided. Experimental teams will implement a care pathway which will include three active components: a formative evaluation of quality and organization of the care setting, a set of evidence-based key interventions, and support of the development and implementation of the CP. Main outcome will be the six-month mortality rate. DISCUSSION: The EQCP study constitutes the first international cRCT on care pathways. The EQCP project was designed as both a research and a quality improvement project and will provide a real-world framework for process evaluation to improve our understanding of why and when CP can really work. TRIAL REGISTRATION NUMBER: NCT00962910.

The effect of care pathways for hip fractures: a systematic review.

We performed a systematic review for primary studies on care pathways (CPs) for hip fracture (HF). The online databases MEDLINE-PubMed, Ovid-EMBASE, CINAHL-EBSCO host, and The Cochrane Library (Cochrane Central Register of Clinical Trials, Health Technology Assessment Database, NHS Economic Evaluation Database) were searched. Two researchers reviewed the literature independently. Primary studies that met predefined inclusion criteria were assessed for their methodological quality. A total of 15 publications were included: 15 primary studies corresponding with 12 main investigations. Primary studies were evaluated for clinical outcomes, process outcomes, and economic outcomes. The studies assessed a wide range of outcome measures. While a number of divergent clinical outcomes were reported, most studies showed positive results of process management and health-services utilization. In terms of mortality, the results provided evidence for a positive impact of CPs on in-hospital mortality. Most studies also showed a significantly reduced risk of complications, including medical complications, wound infections, and pressure sores. Moreover, time-span process measures showed that an improvement in the organization of care was achieved through the use of CPs. Conflicting results were observed with regard to functional recovery and mobility between patients treated with CPs compared to usual care. Although our review suggests that CPs can have positive effects in patients with HF, the available evidence is insufficient for formal recommendations. There is a need for more research on CPs with selected process and outcome indicators, for in-hospital and postdischarge management of HF, with an emphasis on well-designed randomized trials.

[Perceived quality of care in a nursing home in Piedmont (Italy)]. / La qualità dell'assistenza in una casa di cura piemontese: l'opinione dei degenti.

A cross-sectional study was conducted in the years 2003, 2005 and 2006, to assess client satisfaction in a nursing home in Piedmont (Italy). A structured questionnaire was used to evaluate three dimensions of care: interpersonal relationships, clinical care received and room comfort. Six-hundred eighty-four patients participated in the study. Of these, 33.6% were surgical patients, 33.6% were rehabilitation patients and 32.8% were medical patients. Overall, quality of care was reported as being "excellent" by 85% of patients in 2003, 85.3% of patients in 2005 and 66.1% in 2006. The study has made it possible to give a general description of client satisfaction regarding quality of services provided in a nursing home, and to identify the major critical areas. These should be analyzed in more detail, in order to identify which factors are most relevant to the patient and to implement corrective actions.

Indicators for follow-up of multidisciplinary teamwork in care processes: results of an international expert panel.

In order to study the impact of interventions on multidisciplinary teamwork in care processes, relevant indicators need to be defined. In the present study, the authors performed a Delphi survey of a purposively selected expert panel consisting of scientific researchers and hospital managers. Thirty-six experts from 13 countries participated. Each participant rated a list of team indicators on a scale of 1-6. Consensus was sought in two consecutive rounds. The content validity index (CVI) varied from 8% to 92%. A final list of 19 indicators was generated: 5 on team context/structure, 8 on team process, and 6 on team outcomes. Most relevant team indicators were as follows: "team relations," "quality of team leadership," "culture/climate for teamwork," "team perceived coordination of the care process," and "team vision." Scientific researchers and hospital managers that want to study and improve multidisciplinary teamwork in care processes should primarily focus on these team indicators.

The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial.

BACKGROUND: Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates. The European Quality of Care Pathway (EQCP) study on acute exacerbations of COPD (NTC00962468) is undertaken to determine how care pathways (CP) as complex intervention for hospital treatment of COPD affects care variability, adherence to evidence based key interventions and clinical outcomes. METHODS: An international cluster Randomized Controlled Trial (cRCT) will be performed in Belgium, Italy, Ireland and Portugal. Based on the power analysis, a sample of 40 hospital teams and 398 patients will be included in the study. In the control arm of the study, usual care will be provided. The experimental teams will implement a CP as complex intervention which will include three active components: a formative evaluation of the quality and organization of care, a set of evidence based key interventions, and support on the development and implementation of the CP. The main outcome will be six-month readmission rate. As a secondary endpoint a set of clinical outcome and performance indicators (including care process evaluation and team functioning indicators) will be measured in both groups. DISCUSSION: The EQCP study is the first international cRCT on care pathways. The design of the EQCP project is both a research study and a quality improvement project and will include a realistic evaluation framework including process analysis to further understand why and when CP can really work. TRIAL REGISTRATION NUMBER: NCT00962468.

Inhospital management of COPD exacerbations: a systematic review of the literature with regard to adherence to international guidelines.

Rationale Chronic obstructive pulmonary disease (COPD) exacerbations are a leading cause of hospitalization. Suboptimal inhospital management is expected to lead to more frequent exacerbations and recurrent hospital admission, and is associated with increased mortality. Aims To explore inhospital management of COPD and to compare the results with recommendations from international guidelines. Methods A literature search was carried out for relevant articles published 2000-2009 in the databases Medline, Cochrane Library, Cumulative Index for Nursing and Allied Health Literature and Invert. In addition, the reference lists of the selected articles were examined. Main inclusion criteria were as follows: COPD, exacerbation, hospitalization, description of inpatient management, and clinical trials. Assessment and treatment strategies in different studies were analysed and compared with American Thoracic Society-European Respiratory Society and Global Initiative for Chronic Obstructive Lung Disease guidelines. Outcomes were analysed. Results Seven eligible studies were selected. Non-pharmacological treatment was infrequently explored. When compared with international guidelines, diagnostic assessment and therapy were suboptimal, especially non-pharmacological treatment. Respiratory physicians were more likely to perform recommended interventions than non-respiratory physicians. Conclusions Adherence to international guidelines is low for inhospital management of COPD exacerbations, especially in terms of non-pharmacological treatment. Further investigation is recommended to explore strategies like care pathways that improve performance of recommended interventions.

Ultrasonography for the monitoring of subcutaneous damage in Mycobacterium ulcerans infection (Buruli ulcer).

We used ultrasonography to evaluate the nature and the extent of subcutaneous damage provoked by Mycobacterium ulcerans (M. ulcerans) and to investigate the possible involvement of the tributary lymph nodes during the various stages of progression of Buruli ulcer. Nineteen patients affected by M. ulcerans infection in Benin, West Africa, were studied. Ultrasonography was performed on all subjects, except one, at the site of nonulcerated lesions and/or at perilesional site. The tributary lymph nodes were also studied in six patients. Ultrasound (US) evaluation was carried out using a 10 MHz linear probe and all lesions were compared with the homologous unaffected controlateral site. The ultrasonography showed relevant alterations at the dermo-hypodermic level, in agreement with histological specimens. In the active forms of the disease, these alterations are characterized by significant oedematous imbibition of the adipose tissue and necrosis (adiponecrosis) that leads to varying irregularities in the echogenicity of the hypodermis, which is generally thicker. In agreement with the clinical examination, the lymph nodes in six patients evaluated, despite their possible histological involvement with necrotic phenomena described in literature in M. ulcerans infection, did not display significant alterations visible by ultrasonography. The US scanning we have performed is the first use of this technique for M. ulcerans infection. We have shown that it can reveal the subcutaneous depth and the peripheral extent of the pathological process and it is particularly useful for monitoring the efficacy of or resistance to antibiotic treatment, especially in extensive ulcero-oedomatose forms. Such monitoring offers also a useful guide to the surgeon allowing the reduction or postponement of the removal of the large cutaneous areas that were carried out until recently.