The human factor: does the operator performing the embryo transfer significantly impact the cycle outcome?

STUDY QUESTION: Is Ongoing Pregnancy Rate (OPR) operator-dependent, and can experience improve embryo transfer efficiency? SUMMARY ANSWER: OPR is influenced by the operators who perform the embryo transfer (ET), and experience does not assure proficiency for everyone. WHAT IS KNOWN ALREADY: ET remains the critical step in assisted reproduction. Although many other factors such as embryo quality and uterine receptivity impact embryo implantation, the proper ET technique is clearly an operator-dependent variable and as such it should be objectively standardized. STUDY DESIGN, SIZE, DURATION: Retrospective comparative analysis including all fresh ETs performed between January 1996 and December 2016 at the Humanitas Fertility Center after IVF-ICSI cycles. PARTICIPANTS/MATERIALS, SETTING, METHODS: IVF/ICSI fresh ETs performed by 32 operators, 19 824 cycles in all, were analyzed. All transfers consisting of freehand insertion of a preloaded soft catheter into the uterine cavity under transabdominal ultrasound guidance were considered. Two different statistical analyses were performed. First, a logistic regression model with a random intercept for the operator was used to estimate the heterogeneity of the rate of success among operators, accounting for woman age, FSH, number of oocytes retrieved, fertilization rate, year of the procedure, number and stage of transferred embryos and operator's experience. Second, the relationship between experience and pregnancy rate was estimated separately for each operator by logistic regression, and operator-specific results were combined and compared in a random-effects meta-analysis. In both analyses, the operator's experience at time t was measured in terms of number of embryo transfers performed before t. MAIN RESULTS AND THE ROLE OF CHANCE: The heterogeneity among operators was highly significant (P value <0.001) and explained 44.5% of the total variability. The odds ratio of success of the worst operator in respect to the mean was equal to 0.84. For the best operator, the odds ratio of success was equal to 1.13 in respect to the mean. Based on the meta-analysis of the relationship between operator's experience and success rate, it resulted that, on average, the operators' performance did not improve with additional transfers. LIMITATIONS, REASONS FOR CAUTION: At our center, operators become independent for ET's after performing between 30 and 50 transfers under supervision. It is also possible that other relevant factors, such as embryologists on duty for the ET, have not been included in the present analysis and this may represent a potential bias. Among these, it should be mentioned that the embryologists on duty for the ET were not taken into consideration. WIDER IMPLICATIONS OF THE FINDINGS: Continued performance analysis and the use of a digital simulator could help operators to test their expertise over time and either correct poor performance or avoid doing transfers. STUDY FUNDING/COMPETING INTEREST(S): None. TRIAL REGISTRATION NUMBER: NCT03561129.

ISSQoL: a new questionnaire for evaluating the quality of life of people living with HIV in the HAART era.

OBJECTIVE: To design a Health-related Quality of Life (HRQoL) instrument for HIV-infected people in the era of highly active antiretroviral therapy (HAART). METHODS: The self-administered questionnaire was developed by an Italian network including researchers, physicians, people living with HIV, national institutions and community-based organizations (CBO) through several steps: (1) review of existing HRQoL literature and questionnaires for HIV-infected people; (2) selection of relevant domains measuring HRQoL in HIV-infected people, and identification of new domains related to new aspects of HRQoL concerning HAART-treated individuals; (3) conduction of two pre-test analyses in independent groups of Italian HIV-positive people (n approximately =100) distributed throughout the country. The objectives of the first pre-test were to verify the usefulness of the questionnaire, to construct a form easily understandable by everyone, to define the domains and their significance; the second pre-test aimed at evaluating and reshaping the questionnaire based on a statistical analysis of the outcomes of first pre-test; (4) validation analysis. A large cohort of people with HIV infection was recruited for the last step. RESULTS: The internal consistence reliability (Cronbach's alpha) was >or=0.70 for all domains. Most domains had Cronbach's coefficient >0.80. All domains demonstrated convergent and discriminant validity. The final version of ISSQoL includes two sections: HRQoL Core Evaluation Form (9 domains) and Additional Important Areas for HRQoL (6 domains). The ISSQoL was administered together with two additional forms: a Daily Impact of Symptoms Form and a Demographic Information Form. The Additional Important Areas for HRQoL include social support, interaction with medical staff, treatment impact, body changes, life planning, and motherhood/fatherhood. CONCLUSION: The data reported in the present paper provide preliminary evidence of the reliability and validity of the ISSQoL questionnaire for the measurement of HRQoL in HIV-infected people. The direct involvement of HIV-positive people in all the phases of the project was a key aspect of our work.

Knowledge and attitudes regarding preventative HIV vaccine clinical trials in Italy: results of a national survey.

We carried out a telephone survey to assess willingness to participate in HIV vaccine trials. The survey was conducted by interviewing randomly selected callers to the Italian National AIDS Help line. The questionnaire consisted of four sections: demographic information, knowledge about HIV vaccines and vaccines in general, factors related to participation in HIV vaccine trials, and acceptability of a future HIV vaccine. Over 50% of the sample had adequate knowledge about HIV and vaccines. Among the individuals interviewed, 37% would volunteer for a vaccine trial; those reporting high-risk behaviours were more likely to volunteer. Of the participants, 83% would agree to be vaccinated with a highly effective vaccine, and 92% would pay for the vaccine. Although the limits of telephone surveys should not be neglected, the results of this survey are encouraging.

Quality of life assessment in HIV-positive persons: application and validation of the WHOQOL-HIV, Italian version.

QoL assessment is currently considered essential for clinical trials in HIV infection, as commonly used end-points (CD4 level, viral load, opportunistic diseases) are inadequate to catch the complexity of treatment outcomes. The World Health Organization has recently developed a standardized set of instruments to assess subjective quality of life (QoL) in different medical conditions, including HIV infection. Here we report evidence for the acceptability, reliability and validity of the Italian version of the WHOQOL-HIV. The Italian version of WHOQOL-HIV has been administered in a sample of 151 HIV-positive persons, consecutively attending the largest infectious diseases hospital in southern Italy. Mean time of administration and percentage of missing responses, Cronbach alpha, Pearson coefficient and oneway ANOVA were applied to assess, respectively, acceptability, reliability, convergent and disciminant validity, and sensitivity to change. Mean time of administration was 28 minutes; only 2 questionnaires showed more than 20% of missing responses. Cronbach alpha was above 0.70 in 22 of the 28 sections of the WHOQOL-HIV; it ranged between 0.53 and 0.68 in the remaining 6 sections. Each of the 7 QoL principal domains correlated with overall QoL at a significance level p < 0.001. Moreover, correlation between principal domains were always statistically significant (p < 0.01) with only two exceptions. Finally, mean scores in each QoL domain were in the expected direction (worse in AIDS patients as compared to asymptomatic and symptomatic persons). The Italian version of WHOQOL-HIV is a valid and reliable instrument to assess subjective QoL in HIV-positive persons. It seems potentially useful to assess patients' life satisfaction, and to calibrate standards of care in different stages of the infection.

Capodanno Senza Danno: the effects of an intervention program on fireworks injuries in Naples.

To study the effects of a comprehensive, multifaceted intervention program to reduce fireworks-related injuries during the Italian New Year's holiday season, active surveillance was conducted in the 18 public emergency rooms of Naples, Italy, before and after implementation of the program. Preintervention data collected between December 24, 1992, and January 6, 1993, were compared with data collected during the same period in 1993-1994. The number of injuries decreased by 48% from 353 to 183, with the greatest declines seen among 10- to 12-year-olds. The broad-based intervention implemented during the 1993-1994 holiday season appears to have substantially reduced the number of injuries.

[To what extent is breast feeding practiced in Italy today?]. / Quanto è praticato oggi l'allattamento al seno in Italia.

OBJECTIVES: During a survey regarding infant health in 7 regions, diffusion and length of time of breast-feeding nowadays in Italy were studied. MATERIALS AND METHODS: By OMS Epi methodology, 210 children sampled from each area of study and specialized health workers carried out the interviews at home using a specific questionnaire. The mothers were questioned about the length of time they breast fed their child. RESULTS: 76% of mothers said they breastfed, 32% said they did it for less than 3 months and 44% for more. In each area, the percentage of breastfeeding was 70% or more. This percentage changed only if the birth weight was very low or the mothers' instruction was high, but this is probably because the most cultured mothers answered easier they breast fed longer. DISCUSSION: It seems that mothers are pro-breastfeeding and, in each region, just a quarter of them don't practise it. Besides, about half women breastfed for more than 3 months. This study doesn't permit us to know why some women don't breastfeed or why they wean their children too early. For this reason, we need to curry out further studies.