Introducing enhanced recovery after surgery in a high-volume orthopaedic hospital: a health technology assessment

Francesco Vanni; Emanuela Foglia; Federico Pennestrì; Lucrezia Ferrario; Giuseppe Banfi

doi:10.1186/s12913-020-05634-3

. 2020 Aug 24;20:773. doi: 10.1186/s12913-020-05634-3

Introducing enhanced recovery after surgery in a high-volume orthopaedic hospital: a health technology assessment

Francesco Vanni ¹, Emanuela Foglia ², Federico Pennestrì ^1,^✉, Lucrezia Ferrario ², Giuseppe Banfi ^1,³

PMCID: PMC7444253 PMID: 32829712

Abstract

Background

The number of patients undergoing joint arthroplasty is increasing worldwide. An Enhanced Recovery After Surgery (ERAS) pathway for hip and knee arthroplasty was introduced in an Italian high-volume research hospital in March 2018.

Methods

The aim of this mixed methods observational study is to perform a health technology assessment (HTA) of the ERAS pathway, considering 938 procedures performed after its implementation, by means of a hospital-based approach derived from the EUnetHTA (European Network for Health Technology Assessment) Core Model. The assessment process is based on dimensions of general relevance, safety, efficacy, effectiveness, economic and financial impact, equity, legal aspects, social and ethical impact, and organizational impact. A narrative review of the literature helped to identify general relevance, safety and efficacy factors, and a set of relevant sub-dimensions submitted to the evaluation of the professionals who use the technology through a 7-item Likert Scale. The economic and financial impact of the ERAS pathway on the hospital budget was supported by quantitative data collected from internal or national registries, employing economic modelling strategies to identify the amount of resources required to implement it.

Results

The relevance of technology under assessment is recognized worldwide. A number of studies show accelerated pathways to dominate conventional approaches on pain reduction, functional recovery, prevention of complications, improvements in tolerability and quality of life, including fragile or vulnerable patients. Qualitative surveys on clinical and functional outcomes confirm most of these benefits. The ERAS pathway is associated with a reduced length of stay in comparison with the Italian hospitalization average for the same procedures, despite the poor spread of the pathway within the country may generate postcode inequalities. The economic analyses show how the resources invested in training activities are largely depreciated by benefits once the technology is permanently introduced, which may generate hospital cost savings of up to 2054,123.44 € per year.

Conclusions

Galeazzi Hospital’s ERAS pathway for hip and knee arthroplasty results preferable to traditional approaches following most of the HTA dimensions, and offers room for further improvement. The more comparable practices are shared, the before this potential improvement can be identified and addressed.

Keywords: Enhanced recovery after surgery, Joint-arthroplasty, Activity-based analysis, Health technology assessment, EUnetHTA, Cost-effectiveness, Value-based healthcare

Background

The spread of chronic musculoskeletal disorders prompted the United Nations, the World Health Organization and 37 countries to proclaim that we are living in the Bone and Joint Decade [1]. The need to provide good quality healthcare at sustainable costs calls for innovative management approaches able to combine effective procedures with efficient allocation of resources.

Improving the value of healthcare became a global priority [2]. At this purpose, the four dimensions of personal, technical, allocative and societal value are being progressively defined by specific indicators of healthcare quality, including clinical, organizational, economic and social implications retrieved from a multidisciplinary and evidence-based health technology assessment (HTA) [3–5].

These efforts are particularly clear in joint arthroplasty (JA), due to high number of procedures delivered worldwide [1]. A number of studies demonstrated how significant improvements in effectiveness and efficiency may not follow from the introduction of a single clinical innovation in the treatment (be it surgical, medical or rehabilitative), but from the way in which the single procedures are related [6–9]. This is the core idea of multidisciplinary accelerated pathways like Fast-Track or Enhanced Recovery After Surgery (ERAS), whose value is maximized by the cooperation between clinical professionals (who offer their expertise on the field) and researchers (who look for best practices and innovations in scientific literature) [10, 11].

An ERAS pathway for hip and knee arthroplasty was introduced in a high-volume research hospital, IRCCS Orthopedic Institute Galeazzi (Milan, Italy), in March 2018. The aim of this study is to perform a multidimensional evaluation of the pathway 9 months after its implementation, in order to i) compare benefits and disadvantages with conventional JA, ii) identify subsequent challenges and room for improvement, iii) offer a potential comparison with similar practices worldwide.

Methods

An HTA is conducted considering 938 hip and knee JAs performed within the ERAS pathway from March to October 2018. The assessment is based on a hospital version [12] of the EUnetHTA Core Model [13], which includes all the dimensions required by the European framework [13]. The following domains were considered and further divided into appropriate sub-dimensions: i) general relevance of the ERAS pathway (the technology under evaluation); ii) safety; iii) efficacy; iv) economic and financial impact; v) equity; vi) legal aspects; vii) social and ethical impact; viii) organizational impact. Each domain is introduced by the most relevant results selected from a narrative review of the literature, performed by seeking the following keywords on PubMed: “ERAS”, “Enhanced Recovery”, “Fast Track”, “Rapid Recovery”, “Arthroplasty”, “THA”, “TKA”, “orthopaedic”; and including only English language manuscripts.

Qualitative, quantitative, or mixed assessments of the technology are performed according to the type of evidence investigated in the single domain. Qualitative assessments of the ERAS pathway are performed through the administration of a 7-item Likert scale validated questionnaire [14] to the 38 healthcare professionals who employ the technology daily (orthopaedic surgeons, anaesthesiologists, physiotherapists, nurses, and supporting staff), who rated their experience from − 3 to + 3 (the higher the preference, the better the technology). 71% (27) of these professionals answered the questionnaire. According to the EUNetHTA Core Model, the sample is enough to perform a comparable analysis with other providers [13]. Turning subjective preferences into numerical entities, the Likert scale allows to compare the conventional approach with the ERAS pathway, based on the direct evaluation of the healthcare professionals who employ these technologies daily, and calculate the respective average scores assigned on indicators of interest.

Quantitative assessment is performed by gathering comparable data from 1) internal and/or national registries, such as length of hospital stay (LOS) in acute ward or in rehabilitation setting, and 2) economic analysis tools recommended by the literature. Any comment on the results is postponed to the discussion section. The general relevance of the technology is introduced by a narrative literature review and described more in detail by the comparison between conventional treatment and ERAS pathway, as currently performed within the same hospital.

Focusing on statistical analysis, data were analysed considering descriptive statistics, frequencies, and distributions. After having tested the normal distribution of all the variables investigated (− 1 < Skewness< 1 and − 1 < Kurtosis< 1), independent sample t-tests were used to describe the existence of statistically significant differences between the presence or the absence of ERAS pathway, within the qualitative perceptions.

All analyses were conducted with a significance level of 0.05. Results are expressed as average value ± standard error.

Results

General relevance

A healthcare technology is relevant when comparable with another existing procedure to treat a significant epidemiological need. JA is considered the best solution against osteoarthritis and rheumatoid arthritis when conservative treatment is not effective, with increasing worldwide patients undergoing surgery primarily due to aging, overweight and trauma [15, 16].

In Italy, a dedicated National Register (Registro Italiano Artroprotesi, RIAP) was introduced in 2006 in order to collect epidemiological and demographic information associated with patient characteristics from the entire country. According to the last report [17], joint arthroplasties are increasing by 4.1% per year with a major prevalence of hip (56.3%) and knee (38.6%) procedures, following arthrosis as the main diagnosis; the remaining 3.9, 0.3 and 0.9% surgeries are related to shoulder, ankle and other joints. In 2015, respectively 96.1 and 96.6% of hip and knee JAs were financed by the Italian National Health Service (Servizio Sanitario Nazionale, SSN), and the trend is expected to increase. For these reasons, any technology able to ensure quality, and improve sustainability is a relevant innovation which could benefit patients, hospitals and funders.

A high variety in patient characteristics, surgeon preferences, logistical arrangements, and regional healthcare financing makes it difficult to compare the approaches adopted by different providers, both in Italy and other European countries [18]. Moreover, more than half of Italian providers are represented by low-volume healthcare institutions, which are generally disadvantaged in implementing effective accelerated pathways [19, 20]. This is why most of the comparisons between conventional treatment and accelerated pathways are performed within the same healthcare supplier or through before-after observational studies [21–23].

The contents of conventional treatment and ERAS pathway as currently provided by Galeazzi Hospital are reported in Table 1.

Table 1.

Galeazzi Hospital - Conventional treatment and ERAS pathway

Conventional (up to February, 2018).

ERAS (from March, 2018).

Preoperative.

Preoperative visit with orthopaedic surgeon and anaesthesiologist (diagnostic exams included).

Informed consent.

Standard preoperative visit.

1-h preoperative group education with a physiotherapist and a nurse, in which details on the pathway are given to the patient in order to facilitate engagement.

The patient is given life-style advice about the risks of smoking, alcohol and bad nutrition in order to maximize postoperative recovery.

The physical therapist describes the muscle strengthening exercises to be performed before surgery and the information which the patient needs to get in advance (crutches, walkers, elastic stockings, etc.). The social conditions of the patients are taken into evaluation in order to verify the presence or not of a caregiver.

In order to reduce preoperative fasting as much as possible, the patient is given a Carbohydrate loading (2 maltodextrins flasks) with relative instructions for consumption (1 at midnight before day of surgery, 1 at 6.00 AM the day of surgery).

Blood management (identification and correction of anaemia).

Informed consent.

Pre-emptive oral analgesia.

Intraoperative.

Surgery according to the surgeon’s choice.

Sub-arachnoid anaesthesia.

Drains and catheterization.

Tranexamic acid is administered before incision in order to reduce perioperative bleeding.

Tissue-sparing surgery according to the surgeon’s choice.

Selective sub-arachnoid anaesthesia in order to maintain vital parameters as stable as possible.

Adductor canal block for total knee arthroplasty (TKA).

Local Infiltration Analgesia (LIA) before surgical suture, if needed, depending on the evaluation of the anaesthesiologist.

Possibly no drains and catheterization.

Postoperative.

Pain management according to the surgeon’s choice.

Mobilization and physiotherapy from 1 day after surgery, once a day, for half an hour.

Pharmacological treatment in case of nausea and vomiting, followed by light dinner or fasting.

Multimodal pain management according to the surgeon’s choice, including if possible opioid-sparing analgesia.

Postoperative nausea and vomiting prophylaxis.

Feeding 3 h after surgery, with tea and rusks.

Mobilization 4–6 h after surgery, assisted by 2 physioterapists, once safety conditions are guaranteed by the anaesthesiologist. Assisted walking with crutches.

Light dinner. Pharmacological treatment of nausea and vomiting if needed.

Gastric protection and intestinal prokinetics treatments in order to prevent paralytic ileus.

Two physiotherapy sessions from 1 day after surgery, half an hour each.

Average Length of Stay (LOS).

Average 5.2 days in the acute ward, then

a) If the patient does not reach a sufficient level of autonomy, or is not supported by family caregiving: transfer to the rehabilitation unit. Average LOS for rehabilitation: 20 days.

b) If the patient reaches a sufficient level of autonomy to face home discharge: direct home discharge.

a) If the patient is affected by clinical and social conditions of fragility resulting from the preoperative assessment; or by risk factors and complications that emerged later: 3 days LOS in acute orthopaedic ward + internal rehabilitation depending on the need.

b) If the recovery proceeds normally: up to 5 days LOS in acute orthopaedic ward + direct home discharge.

Functional exams are performed depending on the surgeon’s choice.

Perioperative.

No audit between the professionals involved in the treatment.

Dedicated nurses.

Non-dedicated physical therapists (turnover between different wards and procedures).

Internal audit (ward data analysis and problem solving) every 4 months.

Dedicated acute ward, physiotherapists and nurses.

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Safety

Faster recovery must not preclude safe recovery. Up to 52% of reduced hospital LOS was obtained without a significant increase in readmissions [24–27], except for old, frail, or psychiatric patients affected by clinical comorbidities could not bear the efforts of enhanced recovery. This occurence will be discussed the domain of equity. Reduced readmissions, complications, transfusions and mortality have been found by comparative studies, reviews and meta-analyses from 1 week to 10 years after surgery [5–35]. An increased risk of urinary tract infections was resolved by gradually abandoning the use of bladder catheters [36]. The incidence of postoperative delirium and cognitive dysfunction was reduced by the introduction of opioid-sparing analgesia [37, 38].

The 938 procedures under assessment included hip and knee, primary and revision, unilateral and bilateral, total and unicompartmental, simultaneous and staged JAs, offering an exhaustive sample of surgical procedures. Eight different surgical teams accepted to adopt the ERAS pathway for all the patients undergoing hip or knee arthroplasty in their unit, without selecting for patient characteristics or type of surgery. Follow-up visits are generally performed after 6 weeks, 3 months, 6 months and 1 year, depending on the surgeon’s decision, the evolution of recovery and patient characteristics. Since all the procedures were performed between March and October 2018, at the moment of writing it is impossible to collect data on long-run complications, readmissions, and patient experiences of pain.

The lack of comparative data required preliminary estimations of safety to be carried out by means of a qualitative questionnaire, completed by the 27 healthcare professionals currently employed in the ERAS pathway. According to the EUnetHTA Core Model, they evaluated 9 safety indicators which were largely retrieved from the before-mentioned literature review (Fig. 1).

ERAS pathway dominates conventional treatment on patient safety, reporting a slight improvement in the mean rate (0.29 ± 0.011 vs 0.07 ± 0.006). General security, tolerability, pain, and risk of readmission are the items in which the technology dominates with a difference of more than 0.50 units, calculated by the mean preferences expressed by the professionals through the 7-item Likert Scale. On the contrary, the technology seems not to be equally safe in terms of errors within the procedure, which may trigger risks to the healthcare providers and caregivers which do not comply with a certain innovation introduced within the pathway. However, the mean difference perceived in comparison with the conventional procedure is under 0.50 units.

Efficacy

Efficacy is different from effectiveness. Efficacy is retrieved from the literature as a parameter of how a certain treatment performs in different settings and/or different patients. Effectiveness is a real-world indicator of how the same treatment performs in a specific setting on specific patients. Then, the efficacy of a certain intervention (“can it work?”) is a preliminary condition to test the effectiveness of the same intervention under usual clinical circumstances (“does it work in practice”?) [12, 39].

A number of studies support the efficacy of accelerated pathways. A retrospective comparative study between conventional and accelerated total knee revisions (TKRs) resulted in faster postoperative recovery for those patients who underwent the latter [6]. According to a randomized controlled trial, accelerated TKA resulted in significantly lower knee pain scores and improved functional outcomes 7 days after surgery [32]. An evidence-based review on blood management in Total Joint Arthroplasty (TJA) underlined how accelerated pathways provide useful room for perioperative planning and prediction, generating additional value in comparison to a conventional protocol [9]. A prospective cohort study reported improved function, quality of life, reduced pain, and better Patient-Related Outcome Measurements (PROMs) after accelerated total hip arthroplasty (THA) [40]. Unicompartmental Knee Arthroplasty (UKA) performed under an accelerated pathway including minimally invasive surgery, discharge the same day of surgery, and no inpatient physiotherapy reported earlier improvements in knee motion in comparison to a conventional, more invasive approach, equal safety provided [41]. Similar findings were reported by a retrospective observational study on TJAs in a Veteran setting, which concludes how these protocols are essential to support the “transition into an era of value-based arthroplasty” [42].

Accelerated perioperative care and rehabilitation after hip and knee arthroplasty demonstrated good results under different settings and circumstances [42], which provides preliminary evidence of efficiency to investigate the specific degree of effectiveness.

Effectiveness

Specific clinical and logistical indicators to assess the effectiveness of accelerated pathways have been identified in maximum 3 days of acute ward LOS, improved patient autonomy and function, positive PROMS, and survivorship after surgery [30, 38].

In the absence of long-term data on patients who underwent surgery in the ERAS pathway, a preliminary estimation of the effectiveness of the technology was performed in three steps.

Comparing the average patient LOS in Galeazzi acute and rehabilitation wards (collecting data from the internal registry) with the average LOS in Italian hospitals (collected from RIAP, year 2017), to perform a hip or knee arthroplasty (Table 2). Since RIAP does not allow to distinguish between acute ward and rehabilitation, the overall LOS was considered for comparison. Demographic characteristics such as age and sex are also reported (Table 3).
Administering a qualitative questionnaire on 5 indicators of effectiveness [13] retrieved from the before-mentioned literature overview. As long as subjective experiences like pain and PROMS are not available at the time of writing, they are replaced by feedback from individual patients as reported by the staff.
Reporting the number of postoperative deaths based on legal complaints.

Table 2.

Overall days of LOS, ERAS Galeazzi vs. Italian standard

Site of surgery.		Italy (RIAP 2017).	ERAS Galeazzi (2018).
Hip.	Primary.	8.1	4.2 ± 0.27
Hip.	Revision.	13.3	4.2 ± 0.56
Knee.	Primary.	7.6	4.4 ± 0.16
Knee.	Revision.	9.7	4.6 ± 0.61

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Table 3.

Mean age and sex prevalence, ERAS Galeazzi vs Italian Standard [F (female), M (male)]

	Italy (RIAP 2017).		ERAS Galeazzi (2018).
	Hip Arthroplasties.	Knee Arthroplasties.	Distinction not available.
Mean age.	F 74.7; M 69.2	F 70.7; M 69.5	F 70.1; M 66.7
Sex prevalence (%).	F 61.2; M 38.8	F 67.9; M 32.1	F 61.9; M 38.1

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The average LOS associated with the ERAS pathway is reduced in comparison to Italian hospitals. Patients undergoing surgery within the pathway are slightly younger and more likely to be males (Fig. 2).

According to the qualitative survey, ERAS dominates the conventional treatment in each of the five indicators, maintaining a difference of more than 0.5 units of preference (1.90 ± 0.076 vs 0.60 ± 0.095). No patients died during hospitalization or after discharge.

Economic and financial impact

Value is given by healthcare outcomes per dollar spent [43]. Accelerated pathways demonstrated to reduce the cost of arthroplasty up to 1 year-postoperatively [44], resulting cost-effective in different settings [42, 45].

The economic and financial impact of the ERAS pathway was evaluated by adopting the following approaches [46–48].

An Activity Based Costing (ABC) [46], in order to compare the cost of the technology under assessment with the previous cost of conventional treatment in the same hospital.
A Cost-Effective Analysis (CEA), by means of an Incremental Cost-Effectiveness Ratio (ICER), in order to define the cost-effectiveness ratios generated by conventional treatment and ERAS technology, based on the hospital internal data [48].
A Budget Impact Analysis (BIA), calculated from the number of patients treated within the ERAS pathway, multiplied by the cost of the average process, assuming the hospital perspective [47], and considering a 12-month time range, as if the new technology entirely replaced the previous treatment.

All costs are expressed in Euros.

Activity based costing analysis (ABC)

The cost of the technology is calculated by the sum of the human and technical resources employed along the process, assuming the hospital perspective (Table 4).

Table 4.

Activity Based Costing Analysis (€)

	Preoperative (per patient).	Intraoperative (per patient).	Surgical ward (per day of hospitalization).	Rehab. (per day of hospitalization).
ERAS Activity Based Costing Analysis.
Human Resources.	42.00	327.80	104.00	153.90
Technologies and equipment.	0	24.21	16.00	16.00
Drugs, consumables, prostheses.	7.00	1410.64	65.52	65.52
Other.	0	85.92	32.62	32.62
Total per each phase.	49.00	1848.52	218.14	268.75
Total per process.	2383.75
Conventional treatment Activity Based Costing Analysis (€).
Human Resources.	24.00	327.80	94.10	153.90
Technologies and equipment.	0	24.21	16.00	16.00
Drugs, consumables, prostheses.	0	1410.64	65.52	65.52
Other.	0	85.92	32.62	32.62
Total per each phase.	24.00	1848.52	208,24	268.75
Total per process.	2349.56

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Assuming the hospital perspective, the ERAS pathway costs € 34,19 more than the conventional pathway, where the human resources employed in the preoperative phase represent the main difference.

Cost-effectiveness analysis (CEA)

Qualitative indicators of effectiveness do not allow rigorous comparisons between similar pathways, and postoperative survivorship is a short-term indicator of effectiveness. Then, an evidence-based comparison between ERAS pathway and conventional treatment can be performed by adopting hospital LOS as a preliminary indicator of the latter (Table 5).

Table 5.

ICER (€ per day)

	Conventional treatment.	ERAS treatment.
Cost (€).	2349.56	2383.75
Average LOS in Orthopaedic Surgery (in days).	5.2	4.6
ICER.	−56.98

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The CEA resulted in −56.98 ICER score, which underlines the greater effectiveness of the ERAS pathway against a moderate economic investment. According to the above, considering an average economic value of a single hospitalization day in Orthopaedic surgery equal to € 218.14, the reduction in LOS will be translated in an economic saving per patient equal to € 130.88 for the hospitalization in Orthopaedic surgery.

Budget impact analysis (BIA)

Guaranteed the effectiveness and safety of each treatment, the ERAS pathway is associated with reduced patient LOS and increased discharge directly at home. Considered the average reimbursement of € 2244.77 per patient rehabilitation charged by the hospital to the SSN, the technology under assessment generates significant savings in terms of public healthcare expenditure.

Table 6 compares the amount of public funds spent by the SSN to cover hip and knee arthroplasties under conventional treatment (year 2017) and ERAS pathway.

Table 6.

Public healthcare expenditure savings following reduced LOS and increased discharge to home (€)

	2017 (conventional).	March–October 2018 (ERAS).
Number of patients.	1271	938
Average LOS in Orthopaedic Surgery.	5.2 days	4.6 days
Patients % discharged directly to home.	12.00% (153)	36.14% (339)
Patients % undergoing inpatient rehabilitation.	88.00% (1118)	63.86% (599)
Average rehabilitation cost per patient.	€ 2244.77	2244.77
Total expenditure.	€ 2,510,730.35	€ 1,821,991.37

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Assuming the public funder perspective, the analysis shows how the introduction of the new technology saved € 688,738.93 to the SSN in less than 1 year, following from reduced LOS and no need for inpatient rehabilitation. However, this evaluation is performed by comparing 12 months of conventional treatment against 9 months of accelerated pathway. In order to uniform the evaluation, consider the scenario in which the ERAS pathway entirely replaced conventional treatment, 1) assuming the same number of patients (1271) from 1 year to the next; 2) including in detail the following items of healthcare expenditure (Table 7):

the cost of admission to orthopaedic surgery (medical costs);
the cost of the surgical activity (major surgical procedures);
the cost of the rehabilitation activities.

Table 7.

Total public healthcare expenditure and ERAS-generated saving (€)

	2017 (conventional)	1-year ERAS
Number of patients treated annually for hip and knee JA.	1271	1271 (projection of 100% ERAS pathway replacement rate).
Average cost of hospitalization to orthopaedic surgery for 1 patient (total costs per medical procedure: € 218.14, multiplied by average LOS for conventional procedure: 9.7 days; and ERAS pathway: 4.6).	2110.50	1036.24
Total expenditure for 1 year.	2,682,445.50	1,317,061.64
Average cost of surgery for 1 patient (total costs to perform a surgical procedure).	1848.52	1848.52
Total expenditure for 1 year.	2349,468.92	2349,468.92
Average cost or rehabilitation for 1 patient.	2244.77	2244.77
Number of patients rehabilitated.	1118 (88% of patients admitted to the conventional treatment).	813 (64% of patients admitted to the ERAS pathway, calculated out of the projection).
Annual total health care expenditure.	7,542,644.77	5,488,521.33
ERAS pathway-induced savings in case of entire replacement of the conventional treatment.	/	2054, 123.44

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If the ERAS pathway entirely replaced conventional treatment on the same number of patients in 1 year, the technology would generate savings of € 2054,123.44 per year (−27%) in comparison to the baseline scenario. Thus, the ERAS accelerated pathway is more affordable than the conventional treatment.

Equity

The dimension of equity can be distinguished on a macro and a micro level [49, 50].

On the macro level, equity is a matter of allocative justice. Achieving the same outcomes with fewer resources (technical value) allows the public funder to free up financial resources which can be reinvested in treating other morbidities, or a higher number of arthritic patients, with a potential reduction in hospital waiting lists, providing better access to free and quality health care (personal, allocative and societal value). In this sense, the economic and financial assessments support equity of the ERAS pathway on a macro level.

On the micro level, equity is a matter of healthcare accessibility to vulnerable categories of patients. Caution must be kept in case of patients who find it difficult to bear early mobilization and intensive rehabilitation, be them psychiatric, old, frail, or affected by other clinical morbidities (i.e. chronic) or conditions of risk. Despite accelerated pathways show improved accessibility to protected categories of patients [9, 51, 52], their safety remains controversial [53–58].

A qualitative investigation of the equity domain is conducted through 9 indicators retrieved from EUnetHTA Core Model [13] (accessibility of the technology at local level, impact on hospital waiting lists, general inclusivity and ability of the technology to respect the cultural, moral and religious identity of patients) and the before-mentioned literature overview (clinical comorbidity and social frailty) (Fig. 3).

The conventional treatment (average value = 0.49 ± 0.0135) seemed slightly preferable than the ERAS pathway (average value = 0.33 ± 0.0172) when analysed in light of the equity domain.

Legal, social, and ethical impact

The impact of the ERAS pathway from the perspective of society is here declined in terms of i) the human and economic burden removed from the patient and/or his/her family or caregivers, ii) the estimated productivity loss caused by the attendance of the healthcare environment, iii) the need to support the spread and safety of the technology with adequate legal procedures and market regulation.

Points i) and iii) had been evaluated by the administration of a 7-item Likert Scale qualitative questionnaire to the healthcare professionals answering the questionnaire (Figs. 4 and 5); point ii) had been evaluated by calculating the amount of days spent by the patient in the healthcare environment, including hospital admission and rehabilitation process (Table 6).

Human and social burden removed by the technology (Fig. 4)

ERAS pathway dominated the conventional treatment (average value: 1.17 ± 0.139 vs 0.59 ± 0.084) in light of the burden removed by the technology, with the exception of two indicators: economic accessibility to the patient (ability to pay), and social determinants of compliance and technology understanding (i.e. patient language and patient degree of education, health literacy, and consequent ability to comply with the pathway).

Productivity loss

The perceived reduction of time spent by the patient in the healthcare environment (Fig. 4) is confirmed by the internal hospital register. Table 8 shows how patients who underwent surgery under the ERAS pathway spent on average 4.39 days less in the healthcare environment (surgery and eventual inpatient rehabilitation), in comparison to patients who underwent surgery under the conventional treatment.

Table 8.

Time spent in the healthcare environment

	2017 (conventional)	2018 March–October (ERAS)
Number of patients.	1271	938
% of which undergoing inpatient rehabilitation.	88	63.86
Average LOS in surgery ward.	5.2 days	4.5 days
Average days for rehabilitation.	12.1	10.9
Total days spent by total patients in the surgical ward.	6609.2	4221
Total days spent by total patients for rehabilitation.	13,533.6	6529.2
Total days spent in the healthcare environment.	20,142.8	10,750.2
Average days spent inside the healthcare environment for each patient (regardless of rehabilitation or not).	15.85	11.46
Variation in the average days spent *inside* the healthcare environment.	4.39

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Multiplying the average days spent outside the healthcare environment by the number of patients who underwent surgery under the ERAS pathway, in 9 months, the technology saved 4115 days of hospital attendance in comparison to the conventional treatment.

Legal procedures and regulation (Fig. 5)

Figure 5 shows how ERAS pathway and conventional treatment reach almost equivalent scores (average value: 0.59 ± 0.079 vs 0.58 ± 0.085) with regards to the legal domain.

Organizational impact

The sustainability of innovation is given not only from a profitable ratio between costs and benefits, but also from the amount of investments required to replace the previous technology. The potential investments required to implement the ERAS pathway are here described in terms of:

The percentage of professionals (right column) agreeing or not to perform a certain investment (left column), including potential specific suggestions (Table 9);
The cost of 30-h specific training to all the professionals who employ the technology (Table 10).

Table 9.

Quantitative analysis of the investments required according to ERAS professionals

Items.	Additional investments required (average).
Additional staff.	78% favourable. On average, 2.8 more nurses, 2.8 more physical therapists, 1.9 more social health operators, 1 case manager, 1 internist, 1 nutritionist, and 1 dedicated physiatrist were requested.
Training.	Specific courses for every professional involved. 1-h training to the patients and their informal caregivers by a nurse and a physical-therapists when in operation (88.9%).
Communications/meetings.	Permanent periodic audit (100%).
Spaces and furnishings.	More space (62.9%), average 43 m². New furniture: a dedicated gym (18.5%), more PCs, desks and chairs (14.8%), electric beds (14.8%), showers (3.7%).
Machinery and equipment.	Additional Continuous Passive Motion machines (18.5%); intraoperative traction beds, ultrasounds, Patient-Controlled Analgesic (PCA) pumps, telemedicine (3.7%).
Management tools and software.	33.3% professionals favourable (inter-operational patient/ward registers, communication between hospital, general practitioner and rehabilitation facilities).

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Table 10.

Cost of 30 h specific training to all the professionals employed by the technology

Professional.	Hourly cost (€).	Hours.	Units needed in ERAS.	Loss of production (€).
Orthopaedic surgeon.	32.12	30	15	14,454.00
Anaesthesiologist.	32.12	30	10	9636.00
Physical therapist.	15.87	30	4	1904.40
Nurse.	16.18	30	15	7281.00
Supporting staff.	13.39	30	3	1205.00
Total cost.				34,480.50

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The benefits of telemedicine [59], permanent audit [7, 22, 34] and management technologies [19] are confirmed in the literature. However, adequate professional training courses must be dedicated to all the professionals involved in their use. To estimate the costs of 30-h training activity in the hospital under consideration, the cost per hour of each professional is multiplied by the number of professionals needed in the ERAS pathway, and by the number of training hours.

Introducing a 30-h training activity would require to the hospital an additional investment of € 34,480.50. Considering the € 2054,123.44 estimated savings generated by the introduction of the ERAS pathway in 1 year, the economic investment in training activities should be largely outweighed by the economic benefits induced by the technology.