Impact of the introduction of minimally invasive treatments of the thyroid (MITT) for benign thyroid nodules in an Italian hospital: a cost-minimization analysis.

BACKGROUND: Prevalence of thyroid nodules is high in the adult population, approaching 60% in women and older people. Most thyroid nodules are benign and asymptomatic. However, a not negligible part of them causes compressive symptoms and/or cosmetic concerns and need to be treated. In the last two decades, minimally-invasive treatments of the thyroid (MITT) have been proposed in routine clinical practice as a reliable cost-effective alternative to surgery in patients with symptomatic benign thyroid nodules (SBTNs). AIM OF THE STUDY: To perform a cost-minimization analysis comparing direct, indirect and intangible costs of radiofrequency (RFA) and laser thermal ablation (LTA) with traditional surgery in patients with SBTNs. METHODS: Data of patients treated by MITT for SBTNs from October 1st 2019 to September 30th 2022 in a single Italian tertiary Center were analyzed. Costs were compared to those of traditional surgery reported in the 2022 Associazione Medici Endocrinologi Guidelines on the Management of SBTNs. RESULTS: In the study lapse, 157 MITT of SBTNs were performed in 148 patients, 114 females and 34 males (mean age: 59 yrs; median age: 57 yrs). Before MITT, the mean thyroid nodule volume was 19 ml; 1 year after MITT, volume reduction rate >50% and symptom relief were achieved in 89% and 93% of patients, respectively. No major complications occurred. Adding up pre-operative, operative and post-operative costs, total direct costs per single procedure are the following: 1361.43 € for LTA when using one optic fiber; 1761.43 € for LTA when using two optic fibers; 1968.53 € for RFA; 3338.39 € for hemithyroidectomy plus isthmectomy; 4034.99 € for total thyroidectomy. Surgery was impactful on direct-i.e., preoperative, operative and postoperative-costs, due to longer operating room occupation time and hospital stay. Overall, a total saving for the Italian National Health Service of 285,377.15 € has been obtained treating the 148 patients by MITT instead of surgery. Likewise, MITT was advantageous also for indirect costs-i.e., those related to "loss of productivity" caused by time off work due to hospital stay and recovery time-, for both the self-employed workers and the Government, the latter saving 53,838.50 € overall. Finally, intangible costs, related to patients' quality of life-e.g., residual surgical scar, stress related to general anesthesia, convalescence, and life-long intake of L-Thyroxine replacement therapy-were all in favor of MITT. CONCLUSIONS: This real-life cost-minimization analysis demonstrates that LTA and RFA are safe and cost-effective procedures for the treatment of SBTNs. In our 3 years experience, adding the savings of 285,377.15 € for direct costs to those of 53.838,50 € for indirect costs, in total 339,215.65 € were saved. The saving concern patients, the National Health System and the Government.

When helpers need help: A case study on the 2012 earthquakes in Italy.

BACKGROUND: After two strong earthquakes in the Emilia region in Italy, many HCWs had to deal with the psychological consequences of the aftershocks. OBJECTIVE: The aims of this case study were a) to describe the psychosocial condition of the HCWs affected by the earthquake; b) to present an intervention immediately after the earthquake on HCWs in a post-disaster situation using a mixed-method approach. METHODS: A mixed-method study was conducted collecting qualitative data (during Group Counselling sessions) and quantitative data (through questionnaires). RESULTS: The results suggested that the impact of the earthquake was very strong, as more than 80% perceived at least a severe impact event capable of altering their ability to function; most of the thoughts and feelings were related to death and fear. CONCLUSIONS: This study adds knowledge about how to plan interventions aiming to help those workers at both individual and organisational level.

GRADE EVIDENCE TO DECISION (EtD) FRAMEWORK FOR COVERAGE DECISIONS.

OBJECTIVES: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones. METHODS: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework. RESULTS: The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions. CONCLUSIONS: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence.

Contemporary economic and clinical evaluations of endovascular repair for intact descending thoracic aortic aneurysms.

BACKGROUND: The aim of this study was to assess clinical and contemporary costs associated with elective endovascular repair of intact descending thoracic aortic aneurysms (DTAA) into the mid-term follow-up. METHODS: A retrospective review of a prospectively maintained clinical database including 29 consecutive patients from July 2005 to December 2009 treated with elective endovascular repair (TEVAR) or TEVAR and surgical infrarenal repair (hybrid) of intact DTAA was performed. Mean age was 74.5 years old (±7.1). Primary clinical endpoints include mortality and major morbidity. Additionally a comprehensive economic appraisal of individual in-hospital and follow-up costs was executed. Economic endpoints include in-hospital and follow-up costs and patient discharge status. Elective endovascular and open repairs' clinical and economical outcomes in contemporary literature were assessed for comparison according to PRISMA standards. RESULTS: Immediate mortality was 6.9% (1/24 TEVAR and 1/5 hybrid). Three respiratory complications were recorded (11%; 2 TEVAR, 1 hybrid). Renal and cardiac complication rates were 7.4% (1 TEVAR, 1 hybrid) and 3.7% (1 TEVAR) respectively. Routine discharge home was achieved for 85% of patients (95.7% TEVAR, 25% hybrid). Three endoleaks were treated throughout the follow-up (2 TEVAR, 1 hybrid; mean 30.4 mo, ±19.9) rendering an 11% (3/27) reintervention rate. Average immediate cost was €21,976.87 for elective endovascular repair and €33,783.21 for elective endovascular hybrid repair. Additional reintervention and routine follow-up costs augmented immediate costs by 12.4%. CONCLUSIONS: This study supports satisfying immediate clinical outcomes for TEVAR and TEVAR+surgical infrarenal procedures. Although limited by a small population size and difficulties in economic comparisons, this study presents the real world social and economic cost scenario for both elective TEVAR and TEVAR hybrid treatment of DTAA of both the in-hospital and at mid term follow-up periods.

GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence.

OBJECTIVES: In this article, we describe how to include considerations about resource utilization when making recommendations according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. STUDY DESIGN AND SETTINGS: We focus on challenges with rating the confidence in effect estimates (quality of evidence) and incorporating resource use into evidence profiles and Summary of Findings (SoF) tables. RESULTS: GRADE recommends that important differences in resource use between alternative management strategies should be included along with other important outcomes in the evidence profile and SoF table. Key steps in considering resources in making recommendations with GRADE are the identification of items of resource use that may differ between alternative management strategies and that are potentially important to decision makers, finding evidence for the differences in resource use, making judgments regarding confidence in effect estimates using the same criteria used for health outcomes, and valuing the resource use in terms of costs for the specific setting for which recommendations are being made. CONCLUSIONS: With our framework, decision makers will have access to concise summaries of recommendations, including ratings of the quality of economic evidence, and better understand the implications for clinical decision making.

Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for diabetic macular oedema.

BACKGROUND: Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. Although grid or focal laser photocoagulation has been shown to reduce the risk of visual loss in DMO or clinically significant macular oedema (CSMO), vision is rarely improved. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) modalities has recently been proposed for improving vision in people with DMO. OBJECTIVES: To assess the effectiveness, safety and cost-effectiveness of anti-VEGF therapy for preserving or improving vision in people with DMO. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 6), MEDLINE (January 1946 to June 2012), EMBASE (January 1980 to June 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 13 June 2012. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing any antiangiogenic drugs with an anti-VEGF mechanism of action versus another treatment, sham treatment, or no treatment in patients with DMO. We also included economic evaluations to assess cost-effectiveness. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data. The risk ratio (RR) of visual loss and visual gain of three or more lines was estimated at least six months after treatment. Each economic analysis was described narratively using a structured format. MAIN RESULTS: Eleven studies provided data on three comparisons of interest in this review. We based our conclusions on the RR of gain or loss of three or more lines of vision at about one year, which was more consistently reported as follow-up.Compared with sham treatment, there was evidence of moderate quality in three studies (497 participants, follow-up 8 to 12 months) that antiangiogenic therapy (pegaptanib: two studies, 246 participants; ranibizumab: one study, 151 participants) doubled and, respectively, halved, the chance of gaining or losing three or more lines of vision (RR: 2.19, 95% confidence interval (CI) 1.36 to 3.53; RR: 0.28, 95% CI: 0.13 to 0.59). In meta-analyses, the benefit was larger for ranibizumab compared to pegaptanib, but no significant subgroup difference could be demonstrated regarding our primary outcome.Compared with grid laser photocoagulation, there was evidence of moderate quality that antiangiogenic therapy (bevacizumab: two studies, 167 participants; ranibizumab: two studies, 300 participants; aflibercept: one study, 221 participants, 89 used for data extraction) more than doubled and, respectively, reduced by at least two thirds, the chance of gaining or losing three or more lines of vision (RR: 3.20, 95% CI 2.07 to 4.95 and RR: 0.13, 95% CI: 0.05 to 0.34, respectively). In meta-analyses, no significant subgroup difference could be demonstrated between bevacizumab, ranibizumab and aflibercept regarding our primary outcome, but, again, there was little power to detect a difference.Compared with grid laser photocoagulation alone, there was high quality evidence that ranibizumab plus photocoagulation (three studies, 783 participants) doubled and, respectively, at least halved, the chance of gaining or losing three or more lines of vision (RR: 2.11, 95% CI 1.67 to 2.67; RR: 0.29, 95% CI: 0.15 to 0.55).Systemic and ocular adverse events were rare in the included studies. Meta-analyses conducted for all antiangiogenic drugs compared with either sham or photocoagulation (nine studies, 104 events in 2159 participants) did not show a significant difference regarding arterial thromboembolic events (RR: 0.85 (0.56 to 1.28). Similarly, no difference was suggested regarding overall mortality (53 events, RR: 0.95 (0.52 to 1.74), but clinically significant differences could not be ruled out. AUTHORS' CONCLUSIONS: There is moderate quality evidence that antiangiogenic drugs provide a definite, but small, benefit compared to current therapeutic options for DMO, i.e. grid laser photocoagulation, or no treatment when laser is not an option. The quality and quantity of the evidence was larger for ranibizumab, but there was little power to investigate drug differences. Most data were obtained at one year, and a long-term confirmation is needed, since DMO is a chronic condition. Safety of both drug and the intravitreal injection procedure were good in the trials, but further long-term data are needed to exclude small, but clinically important differences regarding systemic adverse events.

Economic evidence in decision-making process in laboratory medicine.

Laboratory data play a pivotal role in the clinical decision-making process. Major transformations have occurred in laboratory medicine in recent decades. To face the economic pressures, hospital laboratories are forced to enhance efficiency. Decisions on policy and practice take place at many levels. However, decision-making often does not follow Evidence Based Laboratory Medicine principles. Also, the literature shows limited influence of economic evaluations on health care decisions and diagnostic processes. Several barriers to the use of economic evaluation in decision-making process have been identified, and guidelines tend to focus on issues of effectiveness and have not explicitly considered broader issues, particularly cost. As an example, we analyzed recommendations on the use of brain natriuretic peptide (BNP) or N-terminal fragment of the prohormone BNP (NT-proBNP) in patients with chronic heart failure. All guidelines recommend the use of BNP if available. Nevertheless, none included economic data explicitly, even if economic information exists in the literature. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group, propose using a balance sheet approach, one way of helping decision makers to explicitly consider resource use along with other outcomes when making recommendations. Key aspects of GRADE, such as the explicit presentation of information and the quality evaluation of the economic data can help overcome barriers in the use of economic evaluations in the decision-making in process. This approach can help to give health decision makers, clinical guideline panels and patients, a better appreciation of the overall health benefits, harms and costs of laboratory tests.

Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy.

BACKGROUND: Suboptimal translation of valid and relevant information in clinical practice is a problem for all health systems. Lack of information independent from commercial influences, limited efforts to actively implement evidence-based information and its limited comprehensibility are important determinants of this gap and may influence an excessive variability in physicians' prescriptions. This is quite noticeable in Italy, where the philosophy and methods of Evidence-Based Medicine still enjoy limited diffusion among practitioners. Academic detailing and pharmacist outreach visits are interventions of proven efficacy to make independent and evidence-based information available to physicians; this approach and its feasibility have not yet been tested on a large scale and, moreover, they have never been formally tested in Italy. METHODS/DESIGN: Two RCTs are planned:1) a two-arm cluster RCT, carried out in Emilia-Romagna and Friuli Venezia Giulia, will evaluate the effectiveness of small group meetings, randomising about 150 Primary Care Groups (corresponding to about 2000 GPs) to pharmacist outreach visits on two different topics. Physicians' prescriptions (expressed as DDD per 1000 inhabitants/day), knowledge and attitudes (evaluated through the answers to a specific questionnaire) will be compared for target drugs in the two groups (receiving/not receiving each topic).2) A three-arm RCT, carried out in Sardinia, will evaluate both the effectiveness of one-to-one meetings (one pharmacist visiting one physician per time) and of a 'new' information format (compared to information already available) on changing physicians' prescription of specific drugs. About 900 single GPs will be randomised into three groups: physicians receiving a visit supported by "traditional" information material, those receiving a visit with "new" information material on the same topic and those not receiving any visit/material. DISCUSSION: The two proposed RCTs aim to evaluate the organisational feasibility and barriers to the implementation of independent information programs led by NHS pharmacists. The objective to assess a 10 or 15% decreases in the prescription of the targeted drugs is quite ambitious in such 'natural' settings, which will be minimally altered by the interventions themselves; this in spite of the quite large sample sizes used comparing to other studies of these kind. Complex interventions like these are not easy to evaluate, given the many different variables into play. Anyway, the pragmatic nature of the two RCTs appears to be also one of their major strengths, helping to provide a deeper insight on what is possible to achieve - in terms of independent information - in a National Health System, with special reference to Italy. TRIAL REGISTRATION: ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT).

Characteristics of an Italian diabetic population and long-term changes in glycaemic control at varying body weight categories.

OBJECTIVES: To describe the characteristics of a diabetic population in a primary care setting, and to evaluate changes in glycaemic control at varying body weight categories. METHODS: We collected 4,610 valid baseline and three years follow-up paired data sheets sent from 77% of the general practitioners adhering to our shared-care program (257 GPs out of 521) for people with type 2 diabetes. Three conventional body weight categories were defined: "normal" (BMI, < or = 25 kg/m2), "overweight" (BMI 25.0-29.9), "obesity" (BMI > or = 30). According to weight status we calculated descriptive statistics and follow-up paired changes. RESULTS: A fifth of the diabetic patients had a "normal" BMI, about 45% was "overweight" and 34% was "obese". At follow-up, the glycaemic control significantly improved both in "normal" and "overweight" people, while it significantly worsened in "obese" ones. CONCLUSIONS: Our data confirm the crucial role played by body weight and its changes in diabetic patients.