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The effectiveness of healthcare interventions is a specific characteristic of each intervention and the outcome evaluated. Especially with regard to clinical interventions, the organizational, structural, and process characteristics of healthcare services are potentially strong modifiers of effectiveness measures. Among these characteristics, activity volumes are a measurable process characteristic that can have a significant impact on the effectiveness of interventions. Healthcare systems, by definition, operate in a context of limited resources, especially when companies and governments choose to reduce resources allocated to the healthcare system. In such conditions, streamlining the organization of services can free up resources to improve the effectiveness of interventions. In June 2015, the Ministry of Health issued a decree on “qualitative, structural, technological, and quantitative standards for hospital care,” which identifies minimum thresholds per operational unit for activity volumes and outcomes for certain clinical conditions. The aim is to guarantee equal access to interventions of proven efficacy and safety for the entire Italian population. Continuous updating of available scientific knowledge is necessary to provide useful information for defining additional standards for activity volume or modifying those already established. There is extensive evidence in the literature on the association between activity volume and treatment outcomes. Epidemiology and Prevention published a systematic review of the literature in 2005. This review was updated in 2016. The objective of the review is to identify the topics, clinical conditions, and interventions for which the association between activity volume and treatment outcomes has been studied. In the 80 reviews included, the primary outcome considered is in-hospital or 30-day mortality. The hospital volume-outcome relationship was considered in 47 of the 48 conditions studied; endometrial cancer was only considered in the physician/surgeon volume-outcome relationship. Regarding the outcomes considered: – For 34 conditions, there is evidence of a positive association between hospital activity volumes and the outcomes considered: • 14 conditions relate to the area of ​​oncology surgery: colon, colorectal, esophagus, liver, breast, ovaries, pancreas, lung, prostate, kidney, rectum, stomach, head and neck, bladder; • 11 conditions relate to the cardiocerebrovascular area: ruptured and unruptured abdominal aortic aneurysm, cerebral aneurysm, percutaneous coronary angioplasty (PTCA), coronary artery bypass graft, pediatric cardiac surgery, subarachnoid hemorrhage, carotid endarterectomy, stroke, acute myocardial infarction, and lower limb revascularization; • 2 conditions relate to the orthopedic area: knee arthroplasty and femoral fracture; • Seven conditions relate to other areas: AIDS, bariatric surgery, cholecystectomy, sepsis, neonatal intensive care, intensive care, and trauma; – For three conditions, neither studies nor meta-analyses demonstrate an association: hip arthroplasty, dialysis, and thyroidectomy; – For the remaining 10 conditions studied, the evidence available from the reviews does not allow for definitive conclusions regarding the association between hospital volumes and outcomes: testicular cancer, intracranial tumors, pediatric oncology, aorta-femoral bypass, cardiac catheterization, appendectomy, colectomy, inguinal hernia, respiratory failure, and hysterectomy. The relationship between physician/surgeon volume and outcomes has been the subject of a literature review only; it is not yet possible to analyze this association for Italian hospitals due to the lack of information on the provider on the hospital discharge form (SDO). The literature has highlighted a positive association for 21 conditions: • 9 related to surgical oncology: colon, colorectal, breast, pancreatic, prostate, rectal, gastric, head and neck, and bladder cancers; • 5 related to cardiocerebrovascular disease: ruptured and unruptured abdominal aortic aneurysm, pediatric cardiac surgery, carotid endarterectomy, and lower limb revascularization; • 2 related to orthopedics: hip and knee arthroplasty; • 5 related to other conditions: AIDS, bariatric surgery, hysterectomy, thyroidectomy, and intensive care.

The conditions for which it was possible to analyze the association between treatment volume and outcome using national data were: unruptured abdominal aortic aneurysm, coronary angioplasty, hip arthroplasty, knee arthroplasty, coronary artery bypass grafting, surgery for colon, liver, breast, pancreas, lung, prostate, kidney, and stomach cancer, laparoscopic cholecystectomy, femoral neck fracture, stroke, and acute myocardial infarction. For these conditions, an association between treatment volume and outcome was documented. For laparoscopic cholecystectomy and breast and stomach cancer surgery, the association between discharge unit volume and outcome was also analyzed. Outcomes differ depending on the condition studied. The form of this association varies from one condition to another, with the curves varying in steepness.

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