A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy.

BACKGROUND: Improving the quality of information and communication is a priority in organised breast cancer screening and an ethical duty. Programmes must offer the information each woman is looking for, promoting informed decision-making. This study aimed to develop and evaluate a web-based dynamic decision aid (DA). METHODS: A pragmatic randomised trial carried out in six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB). The primary outcome was informed choice measured on knowledge, attitudes, and intentions. Follow-up period: 7-10 days. Secondary outcomes included participation rate, satisfaction, decisional conflict, and acceptability of DA. RESULTS: Two thousand one hundred and nineteen women were randomised and 1001 completed the study. Respectively, 43.9% and 36.9% in the DA and SB reached the informed choice. The DA gave a 13-point higher proportion of women aware about overdiagnosis compared to SB (38.3% versus 25.2%, p < 0.0001). The percentage of women attending screening was the same: 84% versus 83%. Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%). CONCLUSION: DA increases informed choice. Complete information including the pros, cons, controversies, and overdiagnosis-overtreatment issues boost a woman's knowledge without reducing the rate of actual screening participation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT03097653.

Personalised informed choice on evidence and controversy on mammography screening: study protocol for a randomized controlled trial.

BACKGROUND: In Italy women aged 50-69 are invited for a population-based breast cancer (BC) screening. Physicians, policy makers and patients associations agree on the need to inform women about the benefits and harms in order to permit an informed decision. Decision aids (DA) are an effective way to support people in their decisions about health. This trial aims to assess women's informed choices, according to their health literacy and values, on participating or not in BC screening for the first time. Benefits, harms and controversies are presented. METHODS/DESIGN: The impact of the DA will be evaluated in a randomized controlled trial with a two-week follow-up. Women will be randomized via web to DA or a standard brochure. We will invite 8160 women, to obtain a final sample of 816 women. The primary outcome will be informed choice, measured on the basis of knowledge, attitudes and intentions on BC screening. Secondary outcomes are participation rate, satisfaction on information and decisional conflict. DISCUSSION: The web DA will be open-source and implemented on BC screenings and its efficacy for increasing informed choice will be tested. This model could be applied to other healthcare settings, cancer screenings, and public health programs. TRIAL REGISTRATION: The protocol for this trial was registered with the Clinicaltrials.gov registry on March 16, 2017: NCT03097653 .

An Albanian open source telemedicine platform.

INTRODUCTION: The use of open source technologies to create collaboration platforms can produce huge advantages with small investment. MATERIALS AND METHODS: We set up a telemedicine network for a healthcare district with typical centralization issues of developing countries. Our network was built using broadband Internet connection, and the digital divide in rural areas was reduced by means of wireless Internet connection. A software infrastructure was deployed on the network to implement the collaboration platform among different healthcare facilities. RESULTS: We obtained an integrated platform with modest investment in hardware and operating systems and no costs for application software. Messaging, content management, information sharing, and videoconferencing are among the available services of the infrastructure. Furthermore, open source software is managed and continuously updated by active communities, making it possible to obtain systems similar to commercial ones in terms of quality and reliability. CONCLUSIONS: As the use of free software in public administration is being widely promoted across the European Union, our experience may provide an example to implement similar infrastructures in the field of healthcare and welfare.

Could a Behavioral Model Explain Adherence to Second-Level Colonoscopy for Colon Cancer Screening? Results of a Cross-Sectional Study of the Palermo Province Population.

According to Italian Essential Levels of Assistance (ELA), a colonoscopy is strongly recommended after a positive fecal occult blood test (FOBT) due to its effectiveness in early colorectal cancer detection. Despite the evidence, the Palermo province population (Italy), after a positive FOBT, have a lower colonoscopy adherence compared to Italian standards. This cross-sectional study analyzed patients' perceptions of colonoscopy procedures to understand the reasons for non-adherence. Patients with a positive FOBT who did not undergo a colonoscopy within the national organized screening program were administered a telephone interview based on the Health Belief Model (HBM) questionnaire. The number of non-compliant patients with a colonoscopy after a positive FOBT were 182, of which 45 (25.7%) patients had undergone a colonoscopy in another healthcare setting. Among the HBM items, in a multivariate analysis only perceived benefits were significantly associated with colonoscopy adherence (aOR = 6.7, p = 0.03). Health promotion interventions should focus on the importance of the benefits of colorectal screening adherence to prevent colorectal cancer, implementing health communication by healthcare workers that have closer contacts with people, as general practitioners.

[Decision aid and informed decision on breast cancer screening: the "DonnaInformata-Mammografia" project.] / Decision aid e scelta informata sullo screening mammografico: il progetto DonnaInformata-Mammografia.

In Italy women aged 50-69 are invited for a population-based breast cancer (BC) screening. Physicians, policy makers and patient associations agree on the need to inform women about the benefits and harms in order to permit an informed decision. Decision aids (DA) are an effective way to support people in their decisions about health. This trial aims to assess women's informed choices, according to their health literacy and values, on participating or not in BC screening for the first time. Benefits, harms and controversies are presented. The contents of the DA were developed on the basis of: a) findings of three focus groups and four interviews, organized in the three Italian screening centers; b) analysis of the literature. A web-based platform (www.donnainformata-mammografia) was developed to implement the DA in a multilevel model. The impact of the DA will be evaluated in a randomized controlled trial with a one week follow-up. The women will be randomized to DA or a standard brochure via web. We will invite 8160 women to obtain the final sample size of 816 women. The primary outcome will be informed choice, measured via knowledge, attitudes and intentions on BC screening. SECONDARY OUTCOMES: participation rate and decisional conflict process. If the informed choice will be reached, the web DA will be open source and could be implemented in BC screenings. This model could be applied to other health care settings and cancer screenings.

Accuracy of a Wrist-Worn Heart Rate Sensing Device during Elective Pediatric Surgical Procedures.

The reliability of wearable photoplethysmography (PPG) sensors to measure heart rate (HR) in hospitalized patients has only been demonstrated in adults. We evaluated the accuracy of HR monitoring with a personal fitness tracker (PFT) in children undergoing surgery. HR monitoring was performed using a wrist-worn PFT (Fitbit Charge HR) in 30 children (8.21 ± 3.09 years) undergoing laparoscopy (n = 8) or open surgery (n = 22). HR values were analyzed preoperatively and during surgery. The accuracy of HR recordings was compared with measurements recorded during continuous electrocardiographic (cECG) monitoring; HRs derived from continuous monitoring with pulse oximetry (SpO2R) were used as a positive control. PFT-derived HR values were in agreement with those recorded during cECG (r = 0.99) and SpO2R (r = 0.99) monitoring. PFT performance remained high in children < 8 years (r = 0.99), with a weight < 30 kg (r = 0.99) and when the HR was < 70 beats per minute (bpm) (r = 0.91) or > 140 bpm (r = 0.99). PFT accuracy was similar during laparoscopy and open surgery, as well as preoperatively and during the intervention (r > 0.9). PFT-derived HR showed excellent accuracy compared with HRs measured by cECG and SpO2R during pediatric surgical procedures. Further clinical evaluation is needed to define whether PFTs can be used in different health care settings.

Stress Measured by Allostatic Load in Neurologically Impaired Children: The Importance of Nutritional Status.

BACKGROUND: Allostatic load (AL) is the cumulative physiological wear and tear that results from repeated efforts to adapt to stressors over time. The life stress response is modified by nutritional status. AIM: We estimated AL scores among neurologically impaired (NI) children; the association with malnutrition was also evaluated. METHODS: Forty-one patients with severe disabilities were included. Data based on 15 biomarkers were used to create the AL score. A dichotomous outcome of high AL was defined for those who had ≥6 dysregulated components. Body mass index (BMI)-standard deviation score (SDS) <-2 or SDS ≥2 and biochemical markers (≥4) defined malnutrition. RESULTS: High AL was noted in 17/41 of the whole sample (41.47%). Malnutrition occurred in 36.6% of the subjects. A significant correlation between high AL and malnutrition was observed (p = 0.01; ar ea under the receiver operating characteristic curve, 0.7457). High AL subjects had a significantly higher BMI (p = 0.009) and lower BMI-SDS (p = 0.003) than low AL subjects. AL score correlated with fat mass (p ≤ 0.01) and negatively correlated with fat-free mass (p ≤ 0.02). CONCLUSION: In NI children, high AL was associated with malnutrition. Body composition is a better indicator than BMI of allostatic adjustments. AL estimation should be considered a measure of health risk and be used to promote quality of life in at-risk disabled populations.

Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C.

AIM: To compare the efficacy and safety of recombinant human IFN beta-1a alone or in combination with ribavirin in treatment-naive subjects with chronic hepatitis C. METHODS: Open, randomized trial was performed in 6 Italian tertiary centers: 102 of the 108 patients screened were randomized to receive 6 MIU of recombinant human IFN beta-1a subcutaneously daily for 24 wk, alone (Group 1, n = 51) or in combination with ribavirin 1,000 to 1,200 mg/d (Group 2, n = 51). RESULTS: The end-of-treatment virologic response rate was 29.4% in Group 1 and 41.2% in Group 2 (non-significant). Twenty-four weeks after stopping therapy, sustained virologic response rate was 21.6% in Group 1 and 27.4% in Group 2 (non-significant). All subjects in Group 1 completed treatment, while two subjects in Group 2 stopped therapy due to treatment-related adverse events. CONCLUSION: Recombinant human IFN beta-1a, alone or in combination with ribavirin, has an excellent safety profile and, may represent an alternative for chronic hepatitis C patients who are unable to tolerate pegylated alpha-interferon.