Content and Face Validity of the Evaluation Tool of Health Information for Consumers (ETHIC): Getting Health Information Accessible to Patients and Citizens

Background: Health information concerns both individuals’ engagement and the way services and professionals provide information to facilitate consumers’ health decision making. Citizens’ and patients’ participation in the management of their own health is related to the availability of tools making health information accessible, thus promoting empowerment and making care more inclusive and fairer. A novel instrument was developed (Evaluation Tool of Health Information for Consumers—ETHIC) for assessing the formal quality of health information materials written in Italian language. This study reports ETHIC’s content and face validity. Methods: A convenience sample of 11 experts and 5 potential users was involved. The former were requested to evaluate relevance and exhaustiveness, the latter both readability and understandability of ETHIC. The Content Validity Index (CVI) was calculated for ETHIC’s sections and items; experts and potential users’ feedback were analyzed by the authors. Results: All sections and most items were evaluated as relevant. A new item was introduced. Potential users provided the researchers with comments that partly confirmed ETHIC’s clarity and understandability. Conclusions: Our findings strongly support the relevance of ETHIC’s sections and items. An updated version of the instrument matching exhaustivity, readability, and understandability criteria was obtained, which will be assessed for further steps of the validation process

Making patient centered care a reality: A survey of patient educational programs in Italian Cancer Research and Care Institutes

Background: Educational intervention represents an essential element of care for cancer patients; while several single institutions develop their own patient education (PE) programs on cancer, little information is available on the effective existence of PE programs at the level of research and care institutes. In Italy such institutes - Istituti di Ricovero e Cura a Carattere Scientifico - are appointed by the Ministry of Health, and 11 (Cancer Research & Care Istitute-CRCI) of the 48 are specific for cancer on the basis of specific requirements regarding cancer care, research and education. Therefore, they represent an ideal and homogeneous model through which to investigate PE policies and activities throughout the country. The objective of this study was to assess PE activities in Italian CRCI. Methods: We carried out a survey on PE strategies and services through a questionnaire. Four key points were investigated: a) PE as a cancer care priority, b) activities that are routinely part of PE, c) real involvement of the patients, and d) involvement of healthcare workers in PE activities. Results: Most CRCI (85 %) completed the survey. All reported having ongoing PE activities, and 4 of the 11 considered PE an institutional activity. More than 90 % of CRCI organize classes and prepare PE handouts, while other PE activities (e.g., Cancer Information Services, mutual support groups) are less frequently part of institutional PE programs. Patients are frequently involved in the organization and preparation of educational activities on the basis of their own needs. Various PE activities are carried out for caregivers in 8 (73 %) out of 11 institutes. Finally, health care workers have an active role in the organization of PE programs, although nurses take part in these activities in only half of CRCI and pharmacists are seldom included. Conclusions: The information arising from our research constitutes a necessary framework to identify areas of development and to design new strategies and standards to disseminate the culture of PE. This may ultimately help and stimulate the establishment of institutional integrated PE programs, including policies and interventions that can benefit a significant proportion of cancer patients

Rationality in prophylactic central neck dissection in clinically node-negative (cN0) papillary thyroid carcinoma: Is there anything more to say? A decade experience in a single-center

10noAim: Papillary thyroid carcinoma (PTC) is the most common thyroid malignancy. Despite its extremely favorable prognosis, cervical lymph node metastases are a common feature of PTC and a known independent risk factor for local recurrence. However, the role of prophylactic central neck dissection (PCND) remains a matter of debate in patients with clinically node-negative (cN0) PTC. To better clarify the current role of PCND in the surgical treatment of PTC, evaluating advantages and disadvantages of PCND and outcome of cN0 PTC patients who have been treated with either total thyroidectomy alone or in combination with PCND. A review of recent literature data is performed. Methods: Between January 2000 and December 2015, 186 consecutive patients with cN0 PTC were identified to be included in the present study. 74 of these underwent total thyroidectomy associated with PCND, while 112 patients underwent total thyroidectomy alone. The epidemiological and clinicalpathological data of all patients included were collected at diagnosis and during follow-up. Results: Overall complication rate was significantly higher in the group of patients undergoing PCND (39.2% vs. 17.8%, p ¼ 0.0006). To be specific, they presented a considerably increased risk of temporary recurrent laryngeal nerve injury (p ¼ 0.009) and of permanent hypothyroidism (p ¼ 0.016). Overall survival and recurrence rates did not differ between those undergoing PCND and those undergoing total thyroidectomy alone (p ¼ 1.000 and p ¼ 0.715, respectively). Conclusions: The results of the present study do not support the routine use of PCND in the treatment of cN0 PTC patients.partially_openopenDobrinja, C; Troian, M.; Cipolat Mis, T.; Rebez, G.; Bernardi, S.; Fabris, B.; Piscopello, L.; Makovac, P.; Di Gregorio, F.; de Manzini, N.Dobrinja, Chiara; Troian, Marina; CIPOLAT MIS, Tommaso; Rebez, Giacomo; Bernardi, Stella; Fabris, Bruno; Piscopello, L.; Makovac, Petra; Di Gregorio, F.; de Manzini, Nicolo

Cross-cultural validation of health literacy measurement tools in Italian oncology patients

Background: The aim of this study was to assess the psychometric characteristics of four Health Literacy (HL) measurement tools, viz. Newest Vital Sign (NVS), Short Test of Functional Health Literacy in Adults (STOFHLA), Single Item Literacy Screener (SILS) and Single question on Self-rated Reading Ability (SrRA) among Italian oncology patients. Methods: The original version of the tools were translated from the English language into Italian using a standard forward-backward procedure and according to internationally recognized good practices. Their internal consistency (reliability) and validity (construct, convergent and discriminative) were tested in a sample of 245 consecutive cancer patients recruited from seven Italian health care centers. Results: The internal consistency of the STOFHLA-I was Chronbach's α=0.96 and that of NVS-I was α=0.74. The STOFHLA-I, NVS-I, SILS-I and SrRA-I scores were in a good relative correlation and in all tools the discriminative known-group validity was confirmed. The reliability and validity values were similar to those obtained from other cultural context studies. Conclusion: The psychometric characteristics of the Italian version of NVS, STHOFLA, SILS and SrRA were found to be good, with satisfactory reliability and validity. This indicates that they could be used as a screening tool in Italian patients. Moreover, the use of the same cross-cultural tools, validated in different languages, is essential for implementing multicenter studies to measure and compare the functional HL levels across countries

Indocyanine green-enhanced fluorangiography (ICGf) in laparoscopic extraperitoneal rectal cancer resection

Anastomotic leak (AL) is one of the worst complications of rectal anterior resection (RAR) and its incidence varies according to the anatomical site, increasing in lower anastomoses. Many etiological factors have been evaluated and most of these are related to bowel perfusion. Indocyanine green-enhanced fluorangiography (ICGf) has been proposed to help surgeons assess colonic perfusion with higher reliability than subjective clinical judgment. The aim of the study was to evaluate the efficacy of this tool in patients subjected to elective laparoscopic RAR for extraperitoneal rectal cancer. All the patients subjected to elective laparoscopic RAR for extraperitoneal rectal cancer between May 2015 and January 2017 were considered. In all of them, ICGf was performed to evaluate bowel perfusion. The control group included an equal number of patients subjected to the same procedure from January 2014 to April 2015, before the start of routine use of this tool at our institution. The endpoint of the study was to compare the incidence of AL between the two groups. A total of 33 patients were included in both groups. Relying on fluorescence intensity in the indocyanine green (ICG) group, we changed the level of resection in 6/33 patients (18.2%). An AL developed in 2/33 patients (6%) in the ICG group versus in 7/33 patients (21.2%) in the control group. The routine use of this technique may help surgeons in selecting the best level of proximal bowel resection during RAR

Coexistence of chronic lymphocytic thyroiditis and papillary thyroid carcinoma. Impact on presentation, management, and outcome

Background: The association between chronic lymphocytic thyroiditis (CLT) and papillary thyroid car- cinoma (PTC) has been investigated for several years from different perspectives. In spite of that, there were only few attempts to design a common frame of references to understand the complex mutual interactions between the various pathways of inflammatory response and of thyroid tumor induction and progression. This study compares two independent groups of patients aiming to determine the frequency and the prognostic significance of CLT in patients with PTC. Material and methods: From January 2005 to September 2013, we conducted a retrospective study on 160 patients with PTC who underwent thyroidectomy. CLT was diagnosed histopathologically. Age, sex, tu- mor features (dimensions, angioinvasion, capsular infiltration, mono/multifocality and lymph node metastases) pathologic findings and outcome were considered. Mean follow-up (metastasis, completeness-of-resection, serum thyroglobulin levels, tumor recurrence) period was 61 months (ranged from 18 to 132 months). A p < 0.05 was considered statistically significant. Results: Patients were divided in 2 groups. In group A there were 90 patients affected by PTC alone, and in group B there were 70 patients affected with PTC associated with CLT. Our data showed that the presence of CLT correlate with a lower grade of PTC (p < 0.05). Considering the sex of the patients there were a statistically significant correlation (p < 0.02) and the presence of CLT associated with PTC was most representative in female patients. Conclusions: The presence of CLT in patients with PTC correlated with a lower grade of PTC, but it does not affect the overall survival of papillary thyroid cancers

Serum carcinoembryonic antigen pre-operative level in colorectal cancer: revisiting risk stratification

Background: Biomarkers may play a role as predictive and prognostic factors in colorectal cancer patients. The aims of the study were to verify the prognostic role of pre-operative serum carcinoembryonic antigen (CEA) level in predicting overall survival and risk of recurrence in a cohort of colorectal cancer patients and to evaluate optimal cut-off values. Methods: A retrospective cohort analysis was performed on colorectal cancer patients undergoing elective curative surgery between 2004 and 2019 at an Italian Academic Hospital. Main outcomes were overall survival, disease-free survival at 3-years and risk of local, loco-regional and distant recurrence during follow-up. A receiver operating characteristic (ROC) curve analysis was plotted using CEA pre-operative values and follow-up data in order to estimate the optimal cut-off values. Results: A total of 559 patients were considered. The mean CEA value was 12.1 \ub1 54.1 ng/mL, and the median 29.3 (0\u20134995) ng/mL. The ROC curve analysis identified 12.5 ng/mL as the best CEA cut-off value to predict the risk of metastatic development after surgery in stage I\u2013III colorectal cancer patients, and 10 ng/mL as the best CEA cut-off value to predict overall survival and disease-free survival in stage III\u2013IV patients. These data suggest a stratification of colorectal cancer patients in three classes of risk: a low risk class (CEA 12.5 ng/mL). Conclusion: In conclusion, pre-operative serum CEA measurements could integrate information to enhance patient risk stratification and tailored therapy

Cryptic amyloidogenic elements in mutant NEFH causing Charcot-Marie-Tooth 2 trigger aggresome formation and neuronal death

Abstract Neurofilament heavy chain (NEFH) gene was recently identified to cause autosomal dominant axonal Charcot-Marie-Tooth disease (CMT2cc). However, the clinical spectrum of this condition and the physio-pathological pathway remain to be delineated. We report 12 patients from two French families with axonal dominantly inherited form of CMT caused by two new mutations in the NEFH gene. A remarkable feature was the early involvement of proximal muscles of the lower limbs associated with pyramidal signs in some patients. Nerve conduction velocity studies indicated a predominantly motor axonal neuropathy. Unique deletions of two nucleotides causing frameshifts near the end of the NEFH coding sequence were identified: in family 1, c.3008_3009del (p.Lys1003Argfs*59), and in family 2 c.3043_3044del (p.Lys1015Glyfs*47). Both frameshifts lead to 40 additional amino acids translation encoding a cryptic amyloidogenic element. Consistently, we show that these mutations cause protein aggregation which are recognised by the autophagic pathway in motoneurons and triggered caspase 3 activation leading to apoptosis in neuroblastoma cells. Using electroporation of chick embryo spinal cord, we confirm that NEFH mutants form aggregates in vivo and trigger apoptosis of spinal cord neurons. Thus, our results provide a physiological explanation for the overlap between CMT and amyotrophic lateral sclerosis (ALS) clinical features in affected patients