A Cell-Phone Medication Error eHealth App for Managing Safety in Chronically Ill Young Patients at Home: A Prospective Study.

Introduction: Whereas ample information describes medication errors (MEs) in children or in mixed pediatric and adult populations discharged with acute or chronic diseases from hospital to community settings, little is known about MEs in children and adolescents with chronic diseases discharged home, a major concern. To promote home medication safety, we trained parents of children discharged with chronic diseases to record ME with a tailored cell-phone eHealth app. Methods: In a 1-year prospective study, we used the app to monitor ME in patients with chronic diseases discharged home from a tertiary hospital in Rome, Italy. Univariate and multivariate analyses detected the ME incidence rate ratio (IRR). Results: Of the 310 parents enrolled, 194 used the app. The 41 MEs involved all drug management phases. The ME IRR was 0.46 errors per child. Children <1 year had the highest ME risk (1.69 vs. 0.35, p = 0.002). Children discharged from the cardiology unit had a statistically higher ME IRR than others (3.66, 95% confidence interval: 1.01-13.23%). Conclusions: The highest ME risk at home involves children with chronic diseases <1 year old. A significant ME IRR at home concerns children with heart diseases of any age. Parents find a tailored eHealth app for monitoring and reporting ME at home easy to use. At discharge, clinical teams need to identify age-related and disease-residual risks to target additional actions for monitoring ME, thus increasing medication safety at home.

Does letting adolescent and young adult inpatients share decisions in choosing the central-line insertion site reduce central-line-associated bloodstream infections? An empty systematic review.

To study whether allowing adolescents and young adults (AYA) with chronic or oncologic diseases admitted to tertiary or intensive care units to share decisions in choosing the insertion site for central-venous catheters (CVC) implanted for intravenous therapies or parenteral nutrition reduces central-line-associated and catheter-related bloodstream infections (CLABSI and CRBSI). Following the PRISMA guidelines, we systematically reviewed the literature by searching MEDLINE, Embase, CINAHL, CENTRAL, SCOPUS, Cochrane Library, and Web of Science up to December 2019. According to our aims, the review identified no study that could be included. This empty systematic review on healthcare teams allowing AYA with chronic or oncologic diseases admitted in tertiary or intensive care units to share decisions in choosing the site for implanting CVC prompts further research on clinical pathways on this hot-topic. By considering purportedly risk-taking behaviors in youngsters thus reducing CLABSI and CRBSI, healthcare teams should test specific strategies by engaging AYA empathetically in sharing decisions on the site for implanting CVC to improve quality in health care bundles.

In Vitro Newly Isolated Environmental Phage Activity against Biofilms Preformed by Pseudomonas aeruginosa from Patients with Cystic Fibrosis.

As disease worsens in patients with cystic fibrosis (CF), Pseudomonas aeruginosa (PA) colonizes the lungs, causing pulmonary failure and mortality. Progressively, PA forms typical biofilms, and antibiotic treatments determine multidrug-resistant (MDR) PA strains. To advance new therapies against MDR PA, research has reappraised bacteriophages (phages), viruses naturally infecting bacteria. Because few in vitro studies have tested phages on CF PA biofilms, general reliability remains unclear. This study aimed to test in vitro newly isolated environmental phage activity against PA isolates from patients with CF at Bambino Gesù Children's Hospital (OBG), Rome, Italy. After testing in vitro phage activities, we combined phages with amikacin, meropenem, and tobramycin against CF PA pre-formed biofilms. We also investigated new emerging morphotypes and bacterial regrowth. We obtained 22 newly isolated phages from various environments, including OBG. In about 94% of 32 CF PA isolates tested, these phages showed in vitro PA lysis. Despite poor efficacy against chronic CF PA, five selected-lytic-phages (Φ4_ZP1, Φ9_ZP2, Φ14_OBG, Φ17_OBG, and Φ19_OBG) showed wide host activity. The Φ4_ZP1-meropenem and Φ14_OBG-tobramycin combinations significantly reduced CF PA biofilms (p < 0.001). To advance potential combined phage-antibiotic therapy, we envisage further in vitro test combinations with newly isolated phages, including those from hospital environments, against CF PA biofilms from early and chronic infections.

Mindful organizing as a healthcare strategy to decrease catheter-associated infections in neonatal and pediatric intensive care units. A systematic review and grading recommendations (GRADE) system.

PURPOSE: To explore the clinical evidence available on mindful organizing (MO) that will improve teamwork for positioning and managing central venous catheters in patients admitted to neonatal intensive care and other pediatric intensive care units to decrease central-line-associated and catheter-related bloodstream infections (CLABSI and CRBSI). METHODS: We searched several databases (PubMed, Embase, CINAHL, CENTRAL, SCOPUS, and Web of Science) up to June 2018. We included studies investigating the effectiveness of MO teamwork in reducing CLABSI and CRBSI. The systematic review followed the PRISMA guidelines. We used validated appraisal checklists to assess quality. RESULTS: Seven studies were included: only one was a non-randomized case-controlled trial (CCT). All the others had a pre-post intervention design, one a time-series design and one an interrupted time-series design. The methodological heterogeneity precluded a meta-analysis. Despite the low certainty of evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, three studies including thousands of participants provided numerical data for calculating risk ratios (RR) and 95% confidence intervals (CI) comparing MO with no intervention for decreasing the CLABSI rate in neonatal and pediatric ICUs. The one CCT disclosed no significant difference in the CLABSI rate decrease between groups (RR = 0.96; 95%CI 0.47-1.97). Nor did the pre- and post-intervention interrupted time-series design disclose a significant decrease (RR = 0.80; 95%CI 0.36 1.77). In the study using a before-after study design, the GRADE system found that the CLABSI rate decrease differed significantly in favor of post-intervention (RR = 0.13; 95%CI 0.03 0.57; p = 0.007). CONCLUSIONS: Despite the decreased CLABSI rate, the available evidence is low in quality. To reduce the unduly high CLABSI rates in neonatal and pediatric intensive care settings, custom-designed clinical trials should further define the clinical efficacy of MO to include it in care bundles as a new international standard.

A Facebook Page Created Soon After the Amatrice Earthquake for Deaf Adults and Children, Families, and Caregivers Provides an Easy Communication Tool and Social Satisfaction in Maxi-Emergencies.

Although international and Italian conventions have issued numerous communication protocols to assist people with disabilities during earthquakes or other maxi-emergencies, no tailored strategies exist to create and disseminate information online to deaf people. On August 24, 2016, a devastating earthquake destroyed Amatrice in Central Italy. This natural disaster underlined the lack of information on disabled people possibly involved and the lack of tailored, online communication tools. Having various registries listing disabled residents in the earthquake area might have benefitted emergency procedures. To access information easily and expedite risk management, the authors developed an online information tool for deaf persons, their families, and caregivers. Within hours after the earthquake, they published a Facebook page (Facebook, Inc.; Menlo Park, California USA) including a video provided with subtitles, Italian sign language, and service numbers. Those who accessed the Facebook page spread the information to other social media. Although no registry yet specifies figures, the annual incidence of approximately three to five/1,000 new deaf persons diagnosed in Italy implies that around 5.4% of the total 43,507 Italian deaf people live in the earthquake territory, and presumably 1.3% are younger than 18 years of age. The Facebook page obtained unexpectedly numerous accesses and satisfaction from deaf adults and families with deaf children, as well as hearing family relatives and caregivers. A total of 60% deaf and 10% hearing people asked for more information. Despite limitations, the effort to develop a page for deaf people and their families, via a world-wide social media, permits fast access, outlines safety precautions during maxi-emergencies, and disseminates essential information designed for deaf people on civil protection services. The Facebook page provides a replicable example for developing similar, user-friendly, online tools for disabled groups to disseminate important safety information after earthquakes or other maxi-emergencies.Rotondi L, Zuddas M, Marsella P, Rosati P. A Facebook page created soon after the Amatrice Earthquake for deaf adults and children, families, and caregivers provides an easy communication tool and social satisfaction in maxi-emergencies. Prehosp Disaster Med. 2019;34(2):137-141.

Challenges and Promises for Planning Future Clinical Research Into Bacteriophage Therapy Against Pseudomonas aeruginosa in Cystic Fibrosis. An Argumentative Review.

Although early aggressive and prolonged treatment with specific antibiotics can extend survival in patients with cystic fibrosis (CF) colonized by opportunistic Pseudomonas aeruginosa (PA), antibiotics fail to eradicate the infecting multidrug-resistant (MDR) PA strains in CF. Century-long research has suggested treating patients with bacteriophages (phages, prokaryotic viruses) naturally hosted by bacteria. Although the only phage types used in therapy, lytic phages, lyse PA aggregated in biofilm matrix by depolymerase degrading enzymes, how they can effectively, safely, and persistently do so in patients with CF is unclear. Even though advanced techniques for formulating phage cocktails, training phages and collecting phage libraries have improved efficacy in vitro, whether personalized or ready-to-use therapeutic approaches or phages and antibiotics combined are effective and safe in vivo, and can reduce PA biofilms, remains debatable. Hence, to advance clinical research on phage therapy in clinical trials, also involving mucoid and non-mucoid multidrug-resistant PA in CF, and overcome problems in Western international regulations, we need reliable and repeatable information from experiments in vitro and in vivo on phage characterization, cocktail selection, personalized approaches, and phages combined with antibiotics. These findings, challenges, and promises prompted us to undertake this argumentative review to seek up-to-date information from papers describing lytic phage activity tested in vitro on PA laboratory strains, and PA strains from chronic infections including CF. We also reviewed in vivo studies on phage activity on pulmonary and non-pulmonary animal host models infected by laboratory or CF PA strains. Our argumentative review provides essential information showing that future phage clinical research in CF should use well-characterized and selected phages isolated against CF PA, tested in vitro under dynamic conditions in cocktails or combined with antibiotics, and in vivo on non-pulmonary and pulmonary host models infected with mucoid and non-mucoid CF MDR PA. Our findings should encourage pharmaceutical industries to conduct clinical trials in vitro and in vivo testing patented genomic engineered phages from phage libraries combined with antibiotics to treat or even prevent multidrug-resistant PA in CF, thus helping international regulatory agencies to plan future clinical research on phage therapy in CF.

Outpatient parents' views on shared-decision-making at an Italian children's hospital.

Information is lacking on what parents in southern European countries know and how they view clinical shared-decision-making (SDM) for their children. This survey assesses general parental views on SDM and patient-physician SDM relationships in an Italian paediatric outpatients' clinic. In a 3-month cross-sectional survey, we enrolled 458 consecutive native and foreign Italian-speaking parents bringing their children to our public hospital for various reasons. Parents completed an anonymous questionnaire exploring their general views on SDM, including what doctor-patient relationship predominates today, and what approach reassures them most. Multivariate logistic regression analysed outcome data from parental questionnaire answers. Results are reported as percentages, odds ratios (OR) and 95% confidence intervals (CI). Multivariate logistic regression showed that 440 parents (96.1%) appreciated SDM, 245 (53.5%) preferred SDM for choosing children's treatment, 126 (27.5%) answered that SDM is the predominant relationship today, and most parents 275 (60.0%) felt reassured by SDM. More native than foreign Italian-speaking parents preferred SDM (97.0 vs 89.7%, OR = 3.8; 95% CI = 1.4-10.8). Highly-educated parents preferred SDM for choosing their child's therapy (57.9 vs 34.1%, OR = 2.7; 95% CI = 1.6-4.4) and this approach reassured them (64.3 vs 41.2%, OR = 2.5; 95% CI = 1.6-4.1). In conclusion, parents bringing children to an Italian outpatient clinic, especially highly-educated parents, wish to be offered SDM and find it reassuring. These findings should encourage paediatricians working in a challenging multicultural environment to change their physician-centred approach and engage parents in tailored SDM strategies.

[Smart-web support: a new tool to help information sharing in managing complex paediatric diseases. Study protocol.] / Smart-web support: un nuovo strumento per la condivisione delle cure in patologie pediatriche complesse. Protocollo di studio.

As devices for learning, smart-web support (SWS) multimedia hypertexts on the web now provide more versatile and interactive reading systems than those traditionally available in static printed texts. Designing similar tools for clinical practice would make complex scientific information easier to comprehend, and present the various therapeutic options to patients as minimally alarming graphical representations. In a pilot project we intend to produce a SWS tool for parents or tutors of children with primary differentiated thyroid cancer (DTC), a heretofore rare disease whose incidence has increased over recent years. The SWS hypertexts, "pre-digested" by the multidisciplinary team caring for these children, will be inserted in a single web page (canvas) including shared sheets explaining the best surgical options (decision aids). To make evidence-based information easier to understand and help information sharing, the decision aids will combine text and graphics. The canvas will store data for the multimedia files in a cloud storage system, opened via a link. To measure parents' and tutors' understanding and appreciation of the information provided on the web, the canvas will include questionnaires to investigate satisfaction, eventual barrier encountered, and type of surgical therapy chosen. The SWS tool should allow users to obtain all the information in a relatively short time and improve parents' and children's satisfaction with the surgical options proposed. The results obtained will be useful for developing similar SWS devices for other complex paediatric diseases.

Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish.

BACKGROUND: Whether information from clinical trial registries (CTRs) and published randomised controlled trial (RCTs) differs remains unknown. Knowing more about discrepancies should alert those who rely on RCTs for medical decision-making to possible dissemination or reporting bias. To provide help in critically appraising research relevant for clinical practice we sought possible discrepancies between what CTRs record and paediatric RCTs actually publish. For this purpose, after identifying six reporting domains including funding, design, and outcomes, we collected data from 20 consecutive RCTs published in a widely read peer-reviewed paediatric journal and cross-checked reported features with those in the corresponding CTRs. METHODS: We collected data for 20 unselected, consecutive paediatric RCTs published in a widely read peer-reviewed journal from July to November 2013. To assess discrepancies, two reviewers identified and scored six reporting domains: funding and conflict of interests; sample size, inclusion and exclusion criteria or crossover; primary and secondary outcomes, early study completion, and main outcome reporting. After applying the Critical Appraisal Skills Programme (CASP) checklist, five reviewer pairs cross-checked CTRs and matching RCTs, then mapped and coded the reporting domains and scored combined discrepancy as low, medium and high. RESULTS: The 20 RCTs were registered in five different CTRs. Even though the 20 RCTs fulfilled the CASP general criteria for assessing internal validity, 19 clinical trials had medium or high combined discrepancy scores for what the 20 RCTs reported and the matched five CTRs stated. All 20 RCTs selectively reported or failed to report main outcomes, 9 had discrepancies in declaring sponsorship, 8 discrepancies in the sample size, 9 failed to respect inclusion or exclusion criteria, 11 downgraded or modified primary outcome or upgraded secondary outcomes, and 13 completed early without justification. The CTRs for seven trials failed to index automatically the URL address or the RCT reference, and for 12 recorded RCT details, but the authors failed to report the results. CONCLUSIONS: Major discrepancies between what CTRs record and paediatric RCTs publish raise concern about what clinical trials conclude. Our findings should make clinicians, who rely on RCT results for medical decision-making, aware of dissemination or reporting bias. Trialists need to bring CTR data and reported protocols into line with published data.

Are parents of children hospitalized with severe community-acquired pneumonia more satisfied with care when physicians allow them to share decisions on the antibiotic route?

CONTEXT AND OBJECTIVE: Despite convincing evidence that oral and injected amoxicillin have equal efficacy in children with severe community-acquired pneumonia (CAP), hospitalized children often receive injected antibiotics. To investigate whether shared decision-making (choosing the antibiotic route) influences parental satisfaction. DESIGN, SETTING AND PARTICIPANTS: In a one-year questionnaire-based study, we enrolled consecutive children hospitalized for CAP. At admission, all children's parents received a leaflet on CAP. Parents arriving during the daytime were assigned to a shared group and could choose the antibiotic route, those admitted at other times were assigned to an unshared group for whom physicians chose the antibiotic route. Shared group parents answered anonymous questionnaire investigating why they chose a specific route. Parents in both groups answered another anonymous questionnaire at discharge assessing perceived satisfaction with care. MAIN OUTCOME MEASURE: Parents' satisfaction with perceived medical information as assessed by data from a questionnaire. RESULTS: Of the 95 children enrolled, more children's parents were assigned to the unshared than the shared group (77 vs. 18). Of the 18 children's parents in the shared group, 14 chose the oral antibiotic route mainly to avoid painful injections. Doctors explanations were considered better in the shared than in the unshared group (P = 0.02). DISCUSSION AND CONCLUSIONS: The larger number of children's parents assigned to the unshared group reflects paediatricians' reluctance to offer shared-decision making. Well-informed parents prefer oral antibiotic therapy for children with severe CAP. Allowing parents choose the antibiotic route respects parents' wishes, reduces children's pain and improves satisfaction.

A practical educational tool for teaching child-care hospital professionals attending evidence-based practice courses for continuing medical education to appraise internal validity in systematic reviews.

RATIONALE, AIMS AND OBJECTIVES: Having a quick, practical, educational tool designed for busy child-care professionals to check whether systematic reviews (SRs) contain valid information would help them regularly update their evidence-based knowledge and apply it to their patients. Continuing our annual workshop courses encouraging paediatric hospital professionals to use evidence-based information, in a preliminary study, we compared the commonly used Critical Appraisal Skill Programme (CASP) questionnaire for appraising overall internal validity in SRs with a new, practical tool designed to check internal validity quickly. METHOD: During a course in 2010, two 'teacher-brokers' taught experienced paediatric hospital professionals to use and compare the CASP and the new practical tool to appraise a Cochrane SR on beclomethasone for asthma in children by assessing internal validity only from the two most weighted randomized controlled trials in the forest plot. At 15 days and 6 months, participants then answered questionnaires designed to assess qualitative data including feelings about working together, memorization and possibly provide feedback for Cochrane reviewers. RESULTS: Using the CASP, participants agreed that the Cochrane SR analysed contained overall valid results. Conversely, using the new quick tool, they found poor internal validity. Participants worked well together in a group, took less time to apply the new tool than the CASP (1 vs. 2.5 hours) and provided Cochrane feedback. CONCLUSIONS: Our quick practical tool for teaching critical appraisal encourages busy child-care hospital professionals to work together, carefully check validity in SRs, apply the findings in clinical practice and provide useful feedback for Cochrane reviewers.

'Tell me about your pain': abdominal pain and a history of bullying.

A 7-year-old girl was brought to our outpatient clinic to investigate recurrent abdominal pain. She was unwilling to attend the school. Her mother reported bullying at school and nosebleeds. The girl rated her pain 9 on a visual analogue score card ranging from 1 to 10. Physical examination disclosed painful bruising and haematomas. Emergency laboratory blood tests indicated by the history, physical examination and the pain intensity showed reduced numbers of white blood cells and platelets. A bone marrow smear on admission disclosed 100% blasts and suggested an initial diagnosis of leukaemia but also disclosed the pseudo-rosettes typically seen in neuro-ectodermic tumours. The diagnosis of stage IV primary neuroblastoma was confirmed by trephine biopsies and high urinary catecholamines. The girl died 10 months later. This unusual case underlines the need for outpatient paediatricians to involve children in their initial diagnostic work-up by asking them about their pain thus expediting the diagnosis.

Quality of life and brain function following high-dose recombinant human erythropoietin in low-risk myelodysplastic syndromes: a preliminary report.

OBJECTIVE: In this prospective study we evaluate the effects of high-dose recombinant human erythropoietin (rHuEPO) on quality of life (QOL) and brain function in patients with low-risk myelodysplastic syndromes (MDS) (<10% marrow blasts). Preliminary data are reported. METHODS: Eleven consecutive patients were given rHuEPO (40,000 IU two times a week) for 12 wk. Responsive patients continued with 40,000 IU/wk for further 12 wk. Changes in QOL were assessed by the Functional Assessment of Cancer Therapy-Anemia (FACT-An) self-report. Neurophysiological evaluation at the start of the therapy (t0) included duplex scanning of neck vessels, transcranial Doppler sonography (TCD), a complex neuropsychological evaluation, and quantitative electroencephalography (qEEG). Eight patients completed the neurophysiological evaluation after 24 wk (t1). RESULTS: Six patients (55%) achieved an erythroid response after 12 wk, which was maintained after 24 wk of treatment. FACT-An score showed a relevant improvement between t0 and t1 in these patients. At baseline, TCD showed a mean cerebral blood flow (CBF) velocity in the upper normal range. Abnormalities in brain function were observed in five patients. In the eight patients who were re-evaluated at t1, improvement was observed in three responding patients, two of them with abnormal values at t0. A strict correlation between QOL and neurophysiological improvements was not observed. CONCLUSIONS: A high-dose induction phase with rHuEPO followed by maintenance therapy may be an effective therapeutic schedule for low-risk MDS patients. The erythroid response was associated with positive changes in the QOL. Neurophysiological improvements occurred only in a part (50%) of responding patients, mainly those who showed altered results at baseline.