Table 1 Methods used for the assessment of each dimension

General relevance

An in-depth literature review [14] was carried out, adapting the results obtained for the practices observed within the specific hospital involved in the study. The quality of scientific evidence and the agreement with the hospital policies were examined. This dimension required a description of the technology and the pathology under assessment and, in addition, the definition of the real and potential catchment area of reference for the procedures.

In this view, evidence was retrieved using both Pubmed and Cochrane Databases, including the following keywords: “HTA assessment”, “surgical disposable devices”, “surgical instrument kit”. In particular, the literature review considered the following PICO: P (patients undergoing spinal surgical procedure), I (surgical disposable instrument kit), C (surgical reusable instrument kit), O (outcome related to the development of adverse events, economic data and clinical effectiveness).

Safety

The safety of patients (in terms of evaluation of adverse events, mortality or morbidity related to the technologies under assessment) and of healthcare professionals, as well as the environmental impact related to the use of the different technologies, was investigated using a 5-level Likert scale, ranging from a minimum of 1 (worst impact) to a maximum of 5 (best impact).

Efficacy and effectiveness

Since no comparative parameters of efficacy were found in the literature review, a qualitative indicator was collected from the real world evidence by means of a survey, directed at the experienced surgeons of the Clinical Institute performing these surgical procedures. This methodological approach was consistent with the literature of reference in the case of an absence of specific metrics and indicators [15]. The perceived effectiveness declared by the surgeons, using a 5-level scale ranging from a minimum of 1 (least performant), to a maximum of 5 (most performant), was retrieved, considering the ease of kit opening, the traceability, the comfort in use and the ease of identification of the product.

Economic and financial impact (assuming the hospital perspective)

• Activity Based Costing (ABC) analysis [16, 17]: an analysis that led to the identification, quantification, and consequent evaluation of resources required for a single clinical process, with the evaluation of all the direct costs (considering human resources, laboratory services, consumer products, and drugs, as well as sterilisation processes) related to each technology. In this view, the duration of each procedure and the level of the instrumentation, as well as the number of x-rays performed, were calculated in order to have a preliminary idea of the impact of the surgical procedure. Data regarding the pre-operative processes (order preparation time, supply time, storage area occupied, time, and cost of sterilisation) and intra-operative data (kit unpacking time, instrument preparation, and surgeons’ perceptions) were acquired. Here, it should be noted that all the information used for the proper economic assessment was directly retrieved from the hospital involved in the analysis. These aspects of expenditure were evaluated considering the 2014 Lombardy Region’s outpatients and hospital admission reimbursement tariff and drug costs, derived from the official NHS price list.

• Cost-effectiveness analysis (CEA): an analysis correlated the above mentioned process costs (derived from the ABC) with the effectiveness data.

• Budget Impact Analysis (BIA) [13]: a baseline scenario (historical) consisting only of patients undergoing the standard procedure (i.e. the reusable device) compared with an innovative scenario composed of the introduction and the implementation of the innovative technology.

Equity aspects

The health professionals involved in the study rated their perceptions, using a 7-item Likert scale, with regard to the accessibility, rapidity, usability, and invasiveness of the alternative technologies, as well as the access to care for persons of a legally protected status.

Legal impact

Both the indications of use for all the surgical procedures, categories of patients, and presence of authorization of use at national, European and International levels were evaluated using a 7-item Likert scale.

Ethical and social dimension

Usinging a 7-item Likert scale, the professionals involved evaluated the acceptability of the technologies under investigation, the impact of the technologies on the patient’s life style, the productivity losses impact, and the environmental impact and the impact of the procedure on the care giver’s life and perceptions.

Organisational impact

The organisational impact was evaluated using both a qualitative and a quantitative approach. From a quantitative perspective, all the additional investments required for the proper implementation of the technologies, as well as the impact of the innovative technology on the hospital processes, were investigated. From a qualitative point of view, the following items were assessed, considering the professionals’ perceptions: additional staff, training course, meetings and communication, learning curve, and equipment/furniture purchase or update.