Capsule endoscopy in Italy: An unbalanced review of the literature. Authors' response

The comments by Spada et al. (which are similar in style and content to the ones already made by the authors on the Italian Ministry of Health Web site) are based on misunderstandings and manipulations. The essence of systematic reviews is to sum up available knowledge and minimize bias. The latter is done by a priori stating study inclusion criteria both in the protocol and in the full HTA report (see Fig. 1, p. 299) and assessing methodological quality of included studies using an instrument which was specified in the protocol text and never changed (the Quality Assessment Diagnostic Accuracy Studies checklist or QUADAS). The purpose of inclusion criteria and bias minimization efforts is to ensure that what is included in a review is both relevant and contributes evidence weighted by its reliability to answer the study question (in our case the diagnostic performance of WCE in the small bowel). The high number of excluded studies is thus irrelevant, although it is a common feature of systematic reviews. What matters is what the included studies tell us

The HTA Core Model®-10 Years of Developing an International Framework to Share Multidimensional Value Assessment

BACKGROUND AND OBJECTIVES: The HTA Core Model® as a science-based framework for assessing dimensions of value was developed as a part of the European network for Health Technology Assessment project in the period 2006 to 2008 to facilitate production and sharing of health technology assessment (HTA) information, such as evidence on efficacy and effectiveness and patient aspects, to inform decisions. METHODS: It covers clinical value as well as organizational, economic, and patient aspects of technologies and has been field-tested in two consecutive joint actions in the period 2010 to 2016. A large number of HTA institutions were involved in the work. RESULTS: The model has undergone revisions and improvement after iterations of piloting and can be used in a local, national, or international context to produce structured HTA information that can be taken forward by users into their own frameworks to fit their specific needs when informing decisions on technology. The model has a broad scope and offers a common ground to various stakeholders through offering a standard structure and a transparent set of proposed HTA questions. It consists of three main components: 1) the HTA ontology, 2) methodological guidance, and 3) a common reporting structure. It covers domains such as effectiveness, safety, and economics, and also includes domains covering organizational, patient, social, and legal aspects. There is a full model and a focused rapid relative effectiveness assessment model, and a third joint action is to continue till 2020. CONCLUSION: The HTA Core Model is now available for everyone around the world as a framework for assessing value

The establishment of the gut microbiota in 1-year-aged infants: from birth to family food

none12noAbstract Purpose With the aim of characterizing the gastrointestinal (GI) microbiota and contextually determine how different prenatal, perinatal, and postnatal factors affected its composition in early childhood, infants were enrolled in a longitudinal-prospective study named “A.MA.MI.” (Alimentazione MAmma e bambino nei primi MIlle giorni; NCT04122612, October 2019). Methods Forty-five fecal samples were collected at 12 months of infants’ age, identified as the 3rd follow-up (T3). The evaluated variables were pre-gestational weight and weight gain during pregnancy, delivery mode, feeding, timing of weaning, and presence/absence of older siblings. Fecal alpha and beta-diversities were analyzed. Noteworthy, to determine the impact of the influencing factors, multivariate analyses were conducted. Results At T3, all prenatal and perinatal variables did not result to be significant whereas, among the postnatal variables, type of milk-feeding and weaning showed the greatest contribution in shaping the microbiota. Although aged 1 year, infants exclusively breastfed until 6 months were mainly colonized by Lactobacillaceae and Enterobacteriaceae. Differently, Bacteroidaceae characterized the microbiota of infants that were never breastfed in an exclusive way. Moreover, although an early introduction of solid foods determined higher values of Faith’s PD, high abundances of Ruminococcaceae and Faecalibacterium mainly associated with infants weaned after the 4th month of age. Conclusion The microbial colonization during the first year of life is likely affected by a simultaneous effect of multiple variables playing a significant role at different times. Therefore, these data contribute to add evidence concerning the complex multifactorial interaction between GI microbiota and various stimuli affecting infants during the early stages of life.openMirco Vacca; Benedetta Raspini; Francesco Maria Calabrese; Debora Porri; Rachele De Giuseppe; Marcello Chieppa; Marina Liso; Rosa Maria Cerbo; Elisa Civardi; Francesca Garofoli; Hellas Cena; Maria De AngelisVacca, Mirco; Raspini, Benedetta; Maria Calabrese, Francesco; Porri, Debora; De Giuseppe, Rachele; Chieppa, Marcello; Liso, Marina; Maria Cerbo, Rosa; Civardi, Elisa; Garofoli, Francesca; Cena, Hellas; De Angelis, Mari

Intra-oral orthosis vs amitriptyline in chronic tension-type headache: a clinical and laser evoked potentials study

BACKGROUND: In the present study, we examined clinical and laser-evoked potentials (LEP) features in two groups of chronic tension-type headache (CTTH) patients treated with two different approaches: intra-oral appliance of prosthesis, aiming to reduce muscular tenderness, and 10 mg daily amitriptyline. METHODS: Eighteen patients with diagnosed CTTH participated in this open label, controlled study. A baseline evaluation was performed for clinical features, Total Tenderness Score (TTS) and a topographic analysis of LEPs obtained manually and the pericranial points stimulation in all patients vs. healthy subjects. Thereafter, patients were randomly assigned to a two-month treatment by either amitriptyline or intra-oral appliance. RESULTS AND DISCUSSION: Both the intra-oral appliance and amitriptyline significantly reduced headache frequency. The TTS was significantly reduced in the group treated with the appliance. The amplitude of P2 response elicited by stimulation of pericranial zones showed a reduction after amitriptyline treatment. Both therapies were effective in reducing headache severity, the appliance with a prevalent action on the pericranial muscular tenderness, amitriptyline reducing the activity of the central cortical structures subtending pain elaboration CONCLUSION: The results of this study may suggest that in CTTH both the interventions at the peripheral and central levels improve the outcome of headache