Prior Institutional Experience Research Articles

Being an amateur in politics: a look at the 2022 Italian general election

ABSTRACT The scientific literature on politicians has predominantly focused on political professionalism. Scholars have defined the profile of the professional politician – characterized by a long political career involving roles in local, national and European institutions – and of the successful outsider – who enters politics thanks to external resources. However, there has been little attention to individuals, with contrasting profiles, who stand for election without prior institutional experience. Our research addresses this gap in the literature by examining candidates without electoral experience – referred to as amateurs – in the 2022 Italian general election. Through analysis of the CVs they submitted at the time of their nomination as candidates, the study explores their profiles and proposes a classification based on their previous positions in associations and political parties. The study highlights the different distributions of these two variables and illustrates the different selection strategies pursued by political parties. Moreover, the research confirms the significance of a classification system, demonstrating that different types of amateur candidates, with varying backgrounds, tend to be placed in different positions on party lists and in the district and have different chances of being elected.

My Pathway to Adeno-Associated Virus and Adeno-Associated Virus Gene Therapy: A Personal Perspective.

My Pathway to Adeno-Associated Virus and Adeno-Associated Virus Gene Therapy: A Personal Perspective.

Prospective trial of functional liver image-guided hepatic therapy (FLIGHT) with hepatobiliary iminodiacetic acid (HIDA) scans and update of institutional experience.

373 Background: Functional liver image-guided hepatic therapy (FLIGHT) is a novel stereotactic body radiation therapy (SBRT) planning technique. A functional map, generated from hepatobiliary iminodiacetic acid (HIDA) scans, is used to maximize the functional residual capacity of liver receiving < 15 Gy (FRC15HIDA). We present initial results of a prospective trial evaluating FLIGHT vs standard planning and update our institutional experience. Methods: Eligible patients were ≥ 18 yo with 1o or 2o liver malignancy and Child-Pugh ≤ B7. Liver function was assessed with HIDA and blood chemistry at baseline, mid-treatment, and 3, 6, and 12 months post SBRT. Both standard and FLIGHT (optimized to avoid high functioning liver) plans were generated for each patient. Treating MDs were blinded to planning technique before selecting the treatment plan. The primary endpoint was to show > 5% increase in FRC15HIDA in 3/15 pts. Secondary endpoints included the rate FLIGHT plans were selected and changes in HIDA and other liver function tests. Prior institutional experience included 27 pts with FLIGHT planned retrospectively. Paired t-test was used to compare dosimetric endpoints for FLIGHT vs. standard plans, including: FRC15HIDA, mean liver dose, effective uniform dose (EUD), and functional EUD (FEUD). Results: Fifteen pts were enrolled. The primary endpoint was met, as 4/15 pts had > 5% improvement in FRC15HIDA (mean 5.2%, range -2.3-19.8%). Notably, the FLIGHT plan was selected in 11/15. The mean improvements in FRC15HIDA (5.2 vs 5.0%), mean liver dose (11.9 vs. 13.0%), EUD (5.1 vs 5.2%), and FEUD (6.9 vs 7.1%) were similar between prospective and retrospective cohorts (p > 0.5). In the entire cohort (n = 42), FLIGHT improved FRC15HIDA, mean liver dose, EUD, and FEUD ( p ≤ 0.001). There were > 5% improvements in FRC15HIDA in 15, mean liver dose in 31, EUD in 19, and FEUD in 27. Conclusions: FLIGHT with HIDA led to improvements in all analyzed dosimetric parameters. The extent of benefit was similar in both cohorts, and there was individual variation in the extent of benefit. Longer follow-up is required to determine the effect of FLIGHT on post-SBRT liver function. Clinical trial information: NCT03338062.

Combination of Ipilimumab and Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes for Patients with Metastatic Melanoma.

Adoptive cell therapy (ACT) using tumor-infiltrating lymphocytes (TIL) for metastatic melanoma can be highly effective, but attrition due to progression before TIL administration (32% in prior institutional experience) remains a limitation. We hypothesized that combining ACT with cytotoxic T lymphocyte-associated antigen 4 blockade would decrease attrition and allow more patients to receive TIL. Thirteen patients with metastatic melanoma were enrolled. Patients received four doses of ipilimumab (3 mg/kg) beginning 2 weeks prior to tumor resection for TIL generation, then 1 week after resection, and 2 and 5 weeks after preconditioning chemotherapy and TIL infusion followed by interleukin-2. The primary endpoint was safety and feasibility. Secondary endpoints included of clinical response at 12 weeks and at 1 year after TIL transfer, progression free survival (PFS), and overall survival (OS). All patients received at least two doses of ipilimumab, and 12 of the 13 (92%) received TIL. A median of 6.5 × 1010 (2.3 × 1010 to 1.0 × 1011) TIL were infused. At 12 weeks following infusion, there were five patients who experienced objective response (38.5%), four of whom continued in objective response at 1 year and one of which became a complete response at 52 months. Median progression-free survival was 7.3 months (95% CI 6.1-29.9 months). Grade ≥ 3 immune-related adverse events included hypothyroidism (3), hepatitis (2), uveitis (1), and colitis (1). Ipilimumab plus ACT for metastatic melanoma is feasible, well tolerated, and associated with a low rate of attrition due to progression during cell expansion. This combination approach serves as a model for future efforts to improve the efficacy of ACT.

Utilization and outcomes of transcatheter aortic valve replacement in the United States shortly after device approval.

The objective of this study was to assess the national uptake of TAVR, associated in-hospital outcomes, and the effect of procedural experience on outcomes in the first two years following device approval. Transcatheter aortic valve replacement (TAVR) is a newly established therapy for high-risk patients with severe aortic stenosis. Evaluating the manner in which TAVR has disseminated into real-world practice is essential for understanding its impact on population health. We identified patients undergoing TAVR from the National Inpatient Sample from January 2012 through December 2013. During this period, an estimated 21,185 cases were performed in the United States. Mean age was 81.1 years, 50.8% were male, 86.5% were Caucasian, and 89.6% were Medicare patients. The number of TAVRs performed and of hospitals performing the procedure nationally grew linearly throughout the study period. The most frequent complications included bleeding (26.9%), respiratory failure (19.3%), and renal/metabolic issues (17.2%). Median hospital length of stay was 6 days (IQR 4-10). In-hospital mortality was estimated to be 4.9%. A majority of cases were performed in large (80.8%) and in urban teaching (87%) hospitals. In the first year post-market approval, prior institutional experience with TAVR was associated with significantly reduced risk-adjusted, in-hospital mortality (OR 0.82 per 25 additional TAVRs performed, CI 0.70-0.951, P = 0.009). Following device approval, the number of TAVRs and hospitals performing TAVR grew dramatically. Procedural complications were frequent and in-hospital mortality was approximately 4.9%. Finally, increased procedural experience was strongly associated with a reduction in inpatient mortality. © 2017 Wiley Periodicals, Inc.

A standardized protocol to reduce pediatric spine surgery infection: a quality improvement initiative.

Quality improvement methods are being implemented in various areas of medicine. In an effort to reduce the complex (instrumented) spine infection rate in pediatric patients, a standardized protocol was developed and implemented at an institution with a high case volume of instrumented spine fusion procedures in the pediatric age group. Members of the Texas Children's Hospital Spine Study Group developed the protocol incrementally by using the current literature and prior institutional experience until consensus was obtained. The protocol was prospectively applied to all children undergoing complex spine surgery starting August 21, 2012. Acute infections were defined as positive wound cultures within 12 weeks of surgery, defined in alignment with current hospital infection control criteria. Procedures and infections were measured before and after protocol implementation. This protocol received full review and approval of the Baylor College of Medicine institutional review board. Nine spine surgeons performed 267 procedures between August 21, 2012, and September 30, 2013. The minimum follow-up was 12 weeks. The annual institutional infection rate prior to the protocol (2007-2011) ranged from 3.4% to 8.9%, with an average of 5.8%. After introducing the protocol, the infection rate decreased to 2.2% (6 infections of 267 cases) (p = 0.0362; absolute risk reduction 3.6%; relative risk 0.41 [95% CI 0.18-0.94]). Overall compliance with data form completion was 63.7%. In 4 of the 6 cases of infection, noncompliance with completion of the data collection form was documented; moreover, 2 of the 4 spine surgeons whose patients experienced infections had the lowest compliance rates in the study group. The standardized protocol for complex spine surgery significantly reduced surgical site infection at the authors' institution. The overall compliance with entry into the protocol was good. Identification of factors associated with post-spine surgery wound infection will allow further protocol refinement in the future.

Radiosurgery for Benign Tumors of the Spine: Clinical Experience and Current Trends

In distinction to the development of the clinical indications for intracranial radiosurgery, spine radiosurgery's initial primary focus was and still remains the treatment of malignant disease. The role of stereotactic radiosurgery for the treatment of intracranial benign tumors has been well established. However, there is much less experience and much more controversy regarding the use of radiosurgery for the treatment of benign tumors of the spine. This study presents the clinical experience and current trends of radiosurgery in the treatment paradigm of benign tumors of the spine as part of a dedicated spine radiosurgery program. Forty consecutive benign spine tumors were treated using cone beam computed tomography (CBCT) image guidance technology for target localization. Lesion location included 13 cervical, 9 thoracic, 11 lumbar, and 7 sacral tumors. Thirty-four cases (85%) were intradural. The most common tumor histologies were schwannoma (15 cases), neurofibroma (7 cases), and meningioma (8 cases). Eighteen cases (45%) had previously undergone open surgical resection, and 4 lesions (10%) had previously been treated with conventional fractionated external beam irradiation techniques. This cohort was compared to a prior institutional experience of 73 consecutive benign spine tumors treated with radiosurgery. No subacute or long term spinal cord or cauda equina toxicity occurred during the follow-up period (median 26 months). Radiosurgery was used as the primary treatment modality in 22 cases (55%) and for recurrence after prior open surgical resection in 18 cases (45%). The mean prescribed dose to the gross tumor volume (GTV) was 14 Gy (range 11 to 17) delivered in a single fraction in 35 cases. In 5 cases in which the tumor was found to be intimately associated with the spinal cord with distortion of the spinal cord itself, the prescribed dose to the GTV was 18 to 21 Gy delivered in 3 fractions. The GTV ranged from 0.37 to 94.5 cm(3) (mean 13.2 cm(3), median 5.1 cm(3)). No evidence of tumor growth was seen on serial imaging in any case. Compared to the prior cohort, there was a trend towards increased patient age, GTV, and use of radiosurgery in the post-surgical setting, as well as a simultaneous decrease in the prescription dose. Radiosurgery is a safe and clinically effective treatment alternative for benign spinal neoplasms. While surgical extirpation is currently felt to be the best initial treatment option for most benign spinal tumors, spine radiosurgery has been demonstrated to have long-term clinical and radiographic benefit for the treatment of such lesions. In a similar manner in which spine radiosurgery has become a primary treatment option for a variety of intracranial benign tumors, radiosurgery may become the most favorable treatment alternative for similar histologies when found in the spine. The application of radiosurgery for non-neoplastic spine disease deserves future investigation.

A standardized protocol to reduce cerebrospinal fluid shunt infection: The Hydrocephalus Clinical Research Network Quality Improvement Initiative

Quality improvement techniques are being implemented in many areas of medicine. In an effort to reduce the ventriculoperitoneal shunt infection rate, a standardized protocol was developed and implemented at 4 centers of the Hydrocephalus Clinical Research Network (HCRN). The protocol was developed sequentially by HCRN members using the current literature and prior institutional experience until consensus was obtained. The protocol was prospectively applied at each HCRN center to all children undergoing a shunt insertion or revision procedure. Infections were defined on the basis of CSF, wound, or pseudocyst cultures; wound breakdown; abdominal pseudocyst; or positive blood cultures in the presence of a ventriculoatrial shunt. Procedures and infections were measured before and after protocol implementation. Twenty-one surgeons at 4 centers performed 1571 procedures between June 1, 2007, and February 28, 2009. The minimum follow-up was 6 months. The Network infection rate decreased from 8.8% prior to the protocol to 5.7% while using the protocol (p = 0.0028, absolute risk reduction 3.15%, relative risk reduction 36%). Three of 4 centers lowered their infection rate. Shunt surgery after external ventricular drainage (with or without prior infection) had the highest infection rate. Overall protocol compliance was 74.5% and improved over the course of the observation period. Based on logistic regression analysis, the use of BioGlide catheters (odds ratio [OR] 1.91, 95% CI 1.19-3.05; p = 0.007) and the use of antiseptic cream by any members of the surgical team (instead of a formal surgical scrub by all members of the surgical team; OR 4.53, 95% CI 1.43-14.41; p = 0.01) were associated with an increased risk of infection. The standardized protocol for shunt surgery significantly reduced shunt infection across the HCRN. Overall protocol compliance was good. The protocol has established a common baseline within the Network, which will facilitate assessment of new treatments. Identification of factors associated with infection will allow further protocol refinement in the future.

Cytoprotection by Amifostine during Autologous Stem Cell Transplantation for Advanced Refractory Hematologic Malignancies

This study evaluated whether amifostine protects against mucositis and other toxicities in patients with advanced, refractory, or recurrent hematologic malignancies undergoing high-dose chemotherapy and total body irradiation. Thirty-five patients (20 with non-Hodgkin lymphoma, 12 with Hodgkin disease, and 3 with acute myelogenous leukemia) who underwent autologous stem cell transplantation were conditioned with total body irradiation 2 Gy twice daily on days −8 through −6; cyclophosphamide 6 g/m 2, etoposide 1.8 g/m 2, and carboplatin 1 g/m 2 on days −5 through −3; and amifostine 500 mg/m 2 on days −8 through −2. Prior institutional experience in patients treated without amifostine was used as a historical comparison (no-amifostine group). Severe mucositis occurred in 14 (40%) of 35 patients in the amifostine group, compared with 33 (94%) of 35 in the no-amifostine group ( P < .0001). Total parenteral nutrition was used by 4 (11%) of 35 amifostine-treated patients and 34 (97%) of 35 no-amifostine patients ( P < .0001). The median duration of narcotic use decreased from 15.5 days with no amifostine to 11 days with amifostine ( P = .002). Granulocyte and platelet engraftment times were similar. Prospective trials with innovative designs and clearly defined stopping rules are warranted to confirm whether amifostine reduces the toxicities of a myelosuppressive conditioning regimen before autologous stem cell transplantation without compromising therapeutic response.

Adrenocortical carcinoma: surgical progress or status quo?

Outcome of patients with adrenocortical carcinoma (ACC) has improved with the advent of more widely available and higher quality imaging. Operative management strategies and use of adjuvant therapy have not changed. Retrospective review of patient histories, imaging studies, operative data, adjuvant therapy, and outcomes at a single institution. Follow-up was complete for a mean of 53 months. Data was compared with prior institutional experience. Tertiary care referral center. All patients undergoing operative management for ACC during the period from 1980 to 1996. Determinants of recurrence, survival, and the effect of adjuvant therapy on overall outcome. Fifty-eight patients (30 men, 28 women) with a mean age of 53 years underwent primary operative management for ACC. Functional tumors were identified in 27 patients (47%). Mean tumor size was 12.5 cm. Stage according to the TNM staging system (AJCC Cancer Staging Manual) at presentation was I (n = 0), II (n = 30), III (n = 7), and IV (n = 21). Surgical management included curative resection in 41 (71%), noncurative resection in 14 (24%), and open biopsy in 3 (5%). Perioperative mortality was 5%. Recurrence occurred in 30 patients (73%) with a median time to recurrence of 17 months. Five-year survival by the Kaplan-Meier method was 37%. Prognostic factors (P<.05) included functional status, stage, and chemotherapy in stage III/IV patients. When compared with our prior institutional experience (1960-1980), current patients were more likely to present with stages I to II (52% vs. 34%), have curative resections (71% vs. 50%), and have improved 5-year survival (37% vs. 16%). (1) Surgical resection remains the principal treatment for stage I to III disease. (2) Adjuvant therapy may improve survival in patients with stage III or IV disease. (3) Current patients were more likely to present at an earlier stage, undergo curative resections, and have improved 5-year survival than institutional historical comparisons.

Determinants and impact of local institutions for common resource management

In this article, local institutions for forest conservation and management are analysed. The discussion is based on data from 37 villages and 180 households randomly sampled from a protected area in Rajasthan, India. Local management institutions are described, factors affecting inter-village differences in management institutions and collective action are analysed in a logit model, and the impact of institutions and other variables on common resource dependency and forest outcomes is tested using instrumental variable regression. Village population size has a positive effect and prior institutional experience a negative effect on the probability of collective action. It is concluded that efforts at improving forest management should not be confined to the poorest farmers. Large landowners are heavily involved in degrading use practises, especially when resources have good market potential. Local management institutions play a positive role in the area, but their impact appears insufficient to safeguard forests and commons from continued degradation. Conservation policies should target win–win options through interventions aimed at improving technologies for private and common lands as well as institutional changes.

Source of referral as an indicator of motivational factors and treatment outcome with drug-dependent clients.

Source of referral to substance abuse treatment agencies was investigated as a potential indicator of client motivation and treatment outcome. Clients referred by nine different sources were compared in terms of length of stay in treatment, drug use status at termination, and closing evaluation. There were no differences between the nine referral sources in terms of the frequency with which clients were rated as improved, no improvement, or recovered. However, there were significant differences between referral sources and length of time in treatment. Clients referred by their families or those who had prior institutional experience remained in treatment longer than other groups. Length of stay in treatment was related to drug use status at termination. Clients who had detoxified remained in treatment significantly longer than clients who had not detoxified. It may be that a social support system (family) and experience in a structured setting (prior institutional experience) facilitate positive treatment outcomes.