Drug Saf. 2021 Dec;44(12):1247-1269. doi: 10.1007/s40264-021-01131-6. Epub 2021 Nov 5.

ABSTRACT

To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit-risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories.

PMID:34739716 | PMC:PMC8569292 | DOI:10.1007/s40264-021-01131-6

Rheumatology (Oxford). 2022 Apr 11;61(4):1518-1528. doi: 10.1093/rheumatology/keab572.

ABSTRACT

OBJECTIVES: Limited data about use of biosimilars (BIOs) are available in children with JIA. This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars (BIOs), in children with JIA, in a real-world setting.

METHODS: This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar.

RESULTS: A total of 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA) and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced adverse event (AE).

CONCLUSION: Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs, also in paediatric patients with JIA.

PMID:34273158 | DOI:10.1093/rheumatology/keab572

Clin Toxicol (Phila). 2022 Feb;60(2):175-183. doi: 10.1080/15563650.2021.1919693. Epub 2021 May 28.

ABSTRACT

INTRODUCTION: Exposure of the embryo or fetus to ionizing radiations is a potential danger since it may induce clinically relevant fetal and/or neonatal damages. The aim of the present study was to examine fetal and neonatal outcomes after maternal exposure to radio-diagnostic procedures during first trimester of pregnancy, and to evaluate whether these effects might be related to the fetal absorbed dose of ionizing radiations.

METHODS: A 10-year prospective cohort study was performed on 1979 pregnant women who underwent a radio-diagnostic procedure within the first trimester of pregnancy. Women were divided into two groups: those exposed to abdominal or lumbar radio-diagnostic procedure (Cohort A, n = 130), and those exposed to radio-diagnostic procedures in any other body regions (Cohort B, n = 415). Health physicists performed tailored fetal radiation dose calculation. Multivariate logistic regression model was used to estimate the risk of adverse pregnancy outcomes.

RESULTS: The tailored fetal radiation dose was calculated for a total of 97 women (range 0.05-92 mSv). Major congenital malformations were detected in four infants in Cohort A, six infants in Cohort B, and 24 infants in controls (p = 0.445). Multivariate analysis confirmed the negative association between age and adverse pregnancy outcomes (OR 1.08 [1.06-1.11]), and the protective role of folic acid. A higher rate of small for gestational age seems to be present in women who underwent radio-diagnostic procedures that involve maternal thyroid.

CONCLUSION: Despite several limitations, our study confirms that exposure to radio-diagnostic procedures that may involve uterus at doses below 100 mSv does not increase the risk of embryo-fetal toxicity. The relationship between maternal thyroid irradiation and small for gestational age needs to be further investigated.

PMID:34047628 | DOI:10.1080/15563650.2021.1919693

Front Psychol. 2021 Mar 18;12:615699. doi: 10.3389/fpsyg.2021.615699. eCollection 2021.

ABSTRACT

Background: When infertility is diagnosed, physicians have the difficult task to break bad news. Their communication skills play a central role in improving patients' coping abilities and adherence to infertility treatments. However, specific guidelines and training courses on this topic are still lacking. The aim of the present study is to provide some practical advice for improving breaking bad news in infertility diagnosis through a systematic literature review of qualitative and quantitative studies. Methods: Electronic searches were performed in the MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Psychology and Behavioral Sciences Collection databases. All articles focusing on the communication of the diagnosis of infertility were included. The main findings of each included article were then summarized. Results: Literature search identified 11,838 references that were screened for eligibility. Full texts of 81 articles were retrieved, and their analysis led to the inclusion of 4 articles, which treated the theme of communication of infertility only partially. The main addressed aspects concerning the communication of the infertility diagnosis were the following: (i) the value that patients give to healthcare professionals' communication skills; (ii) the importance of giving clear information on diagnostic procedures and treatments in order to decrease patients' anxiety; and (iii) the importance of involving both partners. Conclusions: This review pointed out that the communication of the infertility diagnosis is still underinvestigated. Specific guidelines are currently not available, but other protocols could be used. Taking into account the principal aspects of communication highlighted with this review, in this study, we suggested an adaptation of the original SPIKES protocol that could be used by healthcare professionals for the communication of the infertility status.

PMID:33815202 | PMC:PMC8015870 | DOI:10.3389/fpsyg.2021.615699

Birth. 2021 Sep;48(3):366-374. doi: 10.1111/birt.12546. Epub 2021 Mar 18.

ABSTRACT

BACKGROUND: Stillbirth, the death of a baby before birth, is associated with significant psychological and social consequences that can be mitigated by respectful and supportive bereavement care. The absence of high-level evidence to support the broad scope of perinatal bereavement practices means that offering a range of options identified as valued by parents has become an important indicator of care quality. This study aimed to describe bereavement care practices offered to parents across different high-income and middle-income countries.

METHODS: An online survey of parents of stillborn babies was conducted between December 2014 and February 2015. Frequencies of nine practices were compared between high-income and middle-income countries. Differences in proportions of reported practices and their associated odds ratios were calculated to compare high-income and middle-income countries.

RESULTS: Over three thousand parents (3041) with a self-reported stillbirth in the preceding five years from 40 countries responded. Fifteen countries had atleast 40 responses. Significant differences in the prevalence of offering nine bereavement care practices were reported by women in high-income countries (HICs) compared with women in middle-income countries (MICs). All nine practices were reported to occur significantly more frequently by women in HICs, including opportunity to see and hold their baby (OR = 4.8, 95% CI 4.0-5.9). The widespread occurrence of all nine practices was reported only for The Netherlands.

CONCLUSIONS: Bereavement care after stillbirth varies between countries. Future research should look at why these differences occur, their impact on parents, and whether differences should be addressed, particularly how to support effective communication, decision-making, and follow-up care.

PMID:33738843 | DOI:10.1111/birt.12546

Women Birth. 2022 Feb;35(1):48-58. doi: 10.1016/j.wombi.2021.01.003. Epub 2021 Jan 26.

ABSTRACT

BACKGROUND: Respectful care of bereaved parents after stillbirth plays a pivotal role in enabling the grieving process and reducing the traumatic impact of this life-changing event. Unfortunately, professionals and midwives, in particular, are often emotionally unprepared and frequently left alone when dealing with these stressful events.

AIM: The BLOSSoM (Burnout after perinatal LOSS in Midwifery) study aims to address the levels of professional burnout in Italian midwives and evaluate the psychological impact of bereavement care on professionals.

METHODS: Web-based cross-sectional study, including socio-demographic questionnaire, survey on the knowledge of guidelines for stillbirth management and two psychometric tests: Maslach Burnout Inventory (MBI) and Impact of Event Scale - Revised (IES-R).

FINDINGS: Of 445 female midwives, mean age 35.1 (SD 9.9), working years 11.2 (SD 10.2), 149 (33.4%) reported specific training on stillbirth and 420 (94.6%) highlighted the need for further training and support. Medium to high levels of burnout (Emotional Exhaustion) were present in 65 midwives (15.9%) with a high prevalence of Reduced Personal Accomplishment (292, 64.2%). 'Communicating the diagnosis of death' was considered the hardest task, followed by 'assisting the meeting with the baby'; 109 midwives (24.5%) reported high IES-R scores (>30), suggesting symptoms of PTSD related to stillbirth events; a good level of knowledge of guidelines favoured Personal Accomplishment (OR 0.3 [0.1 - 0.6]). The number of stillbirths assisted by midwives was not associated with burnout levels.

CONCLUSION: Midwives are particularly at risk of developing professional burnout, as early as after five years of work, with a significant association with the psychological impact exerted by stressful events (stillbirth).

PMID:33509735 | DOI:10.1016/j.wombi.2021.01.003

Intern Emerg Med. 2021 Aug;16(5):1357-1367. doi: 10.1007/s11739-020-02609-4. Epub 2021 Jan 21.

ABSTRACT

Women with criteria and non-criteria obstetric antiphospholipid syndrome (APS) carry an increased risk of pregnancy complications, including fetal growth restriction (FGR). The management of obstetric APS traditionally involves clinicians, obstetricians and gynaecologists; however, the most appropriate prophylactic treatment strategy for FGR prevention in APS is still debated. We performed a systematic review and network meta-analysis (NetMA) to summarize current evidence on pharmacological treatments for the prevention of FGR in APS. We searched PubMed and Embase from inception until July 2020, for randomized controlled trials and prospective studies on pregnant women with criteria or non-criteria obstetric APS. NetMA using a frequentist framework were conducted for the primary outcome (FGR) and for secondary outcomes (fetal or neonatal death and preterm birth). Adverse events were narratively summarised. Out of 1124 citations, we included eight studies on 395 pregnant patients with obstetric APS treated with low-dose aspirin (LDA) + unfractionated heparin (UFH) (n = 132 patients), LDA (n = 115), LDA + low molecular weight heparin (n = 100), LDA + corticosteroids (n = 29), LDA + UFH + intravenous immunoglobulin (n = 7), or untreated (n = 12). No difference among treatments emerged in terms of FGR prevention, but estimates were largely imprecise, and most studies were at high/unclear risk of bias. An increased risk of fetal or neonatal death was found for LDA monotherapy as compared to LDA + heparin, and for no treatment as compared to LDA + corticosteroids. The risk of preterm birth was higher for LDA + UFH + IVIg as compared to LDA or LDA + heparin, and for LDA + corticosteroids as compared to LDA or LDA + LMWH. No treatment was associated with an increased risk of bleeding, thrombocytopenia or osteopenia.

PMID:33475972 | PMC:PMC8310508 | DOI:10.1007/s11739-020-02609-4

Clin Pharmacol Ther. 2021 Jul;110(1):189-199. doi: 10.1002/cpt.2164. Epub 2021 Feb 26.

ABSTRACT

The prevention of fetal growth restriction (FGR) is challenging in clinical practice. To date, no meta-analysis summarized evidence on the relative benefits and harms of pharmacological interventions for FGR prevention. We performed a systematic review and network meta-analysis (NetMA), searching PubMed, Embase, Cochrane Library, and ClinicalTrials.gov from inception until November 2019. We included clinical trials and observational studies on singleton gestating women evaluating antiplatelet, anticoagulant, or other treatments, compared between each other or with controls (placebo or no treatment), and considering the pregnancy outcome FGR (primary outcome of the NetMA). Secondary efficacy outcomes included preterm birth, placental abruption, and fetal or neonatal death. Safety outcomes included bleeding and thrombocytopenia. Network meta-analyses using a frequentist framework were conducted to derive odds ratios (ORs) and 95% confidence intervals (CIs). Of 18,780 citations, we included 30 studies on 4,326 patients. Low molecular weight heparin (LMWH), alone or associated with low-dose aspirin (LDA), appeared more efficacious than controls in preventing FGR (OR 2.00, 95% CI 1.27-3.16 and OR 2.67, 95% CI 1.21-5.89 for controls vs. LMWH and LDA + LMWH, respectively). No difference between active treatments emerged in terms of FGR prevention, but estimates for treatments other than LMWH +/- LDA were imprecise. Only the confidence in the evidence regarding LMWH vs. controls was judged as moderate, according to the Confidence in Network Meta-Analysis framework. No treatment was associated with an increased risk of bleeding, although estimates were precise enough only for LMWH. These results should inform clinicians on the benefits of active pharmacological prophylaxis for FGR prevention.

PMID:33423282 | DOI:10.1002/cpt.2164

Lancet Glob Health. 2021 Jan;9(1):e17. doi: 10.1016/S2214-109X(20)30462-9.

NO ABSTRACT

PMID:33338452 | DOI:10.1016/S2214-109X(20)30462-9

Arch Womens Ment Health. 2020 Dec;23(6):783-786. doi: 10.1007/s00737-020-01086-0. Epub 2020 Nov 20.

ABSTRACT

Italy was the first COVID-19 pandemic epicenter among European countries and established a period of full "lockdown", consisting of travel bans, mandatory staying at home, and temporary closure of nonessential businesses. Similar measures are known risk factors for psychological disturbances in the general population; still, little is known about their impact on pregnant women's mental health during COVID-19 pandemic. The cross-sectional, web-based, national survey "COVID-19 related Anxiety and StreSs in prEgnancy, poSt-partum and breaStfeeding" (COVID-ASSESS) was conducted during the first month of full "lockdown" in Italy. Participants were recruited via social networks with a snowball technique. The questionnaire was specifically developed to examine COVID-19 concerns and included the psychometric tests National Stressful Events Survey (NSESSS) for posttraumatic stress disorder (PTSD) and State-Trait Anxiety Inventory. A multivariable logistic regression model was fitted to explore the association of the concern, anxiety and PTSD symptoms with age, gestational weeks, parity, days of "lockdown", assisted reproductive technology use, psychopathological history, and previous perinatal losses. Out of 1015 pregnant women reached, 737 (72.6%) fully answered the questionnaire; no woman reported a COVID-19 infection. Median age was 34.4 years [quartiles 31.7, 37.2], median days in "lockdown" were 13.1 [11.0, 17.0], median gestational weeks were 27.8 [19.8, 34.0]. Clinically significant PTSD symptoms were present in 75 women (10.2%, NSESSS cutoff 24) and clinically significant anxiety symptoms were present in 160 women (21.7%, STAI-Y1 cutoff 50). Women were particularly worried about the health of their baby and of their elderly relatives, as well as of the possible impact of pandemic in the future of society. Previous anxiety predicted higher concern and PTSD symptoms; previous depression and anxiety were independently associated with current PTSD symptoms.

PMID:33215247 | PMC:PMC7677012 | DOI:10.1007/s00737-020-01086-0

Data Brief. 2020 Dec;33:106440. doi: 10.1016/j.dib.2020.106440. Epub 2020 Oct 20.

ABSTRACT

The COVID-ASSESS questionnaire (COVID-19 related Anxiety and StreSs in prEgnancy, poSt-partum and breaStfeeding) was developed and distributed by CiaoLapo Foundation, an Italian charity for healthy pregnancy and perinatal loss support. Data were collected during phase 1 and phase 2 of COVID-19 lockdown in Italy (March, April and May 2020). The final dataset consists of 2448 women, of whom 1307 during pregnancy and 1141 women during post-partum or breastfeeding period. Variables collected for each subject are: sociodemographic and clinical information (previous losses, history of psychological disorders), birth expectations before and after COVID-19, concerns regarding pandemic consequences, perception of media and health professionals' information and communication on COVID-19, psychopathological assessment (anxiety, post-traumatic stress and general psychopathology).

PMID:33102644 | PMC:PMC7573634 | DOI:10.1016/j.dib.2020.106440

Women Birth. 2021 Jul;34(4):335-343. doi: 10.1016/j.wombi.2020.07.002. Epub 2020 Jul 13.

ABSTRACT

BACKGROUND: In March 2020, COVID-19 was declared to be a pandemic. While data suggests that COVID-19 is not associated with significant adverse health outcomes for pregnant women and newborns, the psychological impact on pregnant women is likely to be high.

AIM: The aim was to explore the psychological impact of the COVID-19 pandemic on Italian pregnant women, especially regarding concerns and birth expectations.

METHODS: A cross-sectional online survey of pregnant women in Italy was conducted. Responses were analysed for all women and segregated into two groups depending on previous experience of pregnancy loss. Analysis of open text responses examined expectations and concerns before and after the onset of the pandemic.

FINDINGS: Two hundred pregnant women responded to the first wave of the survey. Most (n=157, 78.5%) had other children and 100 (50.0%) had a previous history of perinatal loss. 'Joy' was the most prevalent emotion expressed before COVID-19 (126, 63.0% before vs 34, 17.0% after; p<0.05); fear was the most prevalent after (15, 7.5% before vs 98, 49.0% after; p<0.05). Positive constructs were prevalent before COVID-19, while negative ones were dominant after (p<0.05). Across the country, women were concerned about COVID-19 and a history of psychological disorders was significantly associated with higher concerns (p<0.05). A previous pregnancy loss did not influence women's concerns.

CONCLUSIONS: Women's expectations and concerns regarding childbirth changed significantly as a result of the COVID-19 pandemic in Italy. Women with a history of psychological disorders need particular attention as they seem to experience higher levels of concern.

PMID:32684343 | PMC:PMC7357495 | DOI:10.1016/j.wombi.2020.07.002

Autoimmun Rev. 2020 Sep;19(9):102620. doi: 10.1016/j.autrev.2020.102620. Epub 2020 Jul 16.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of intravenous immunoglobulin (IVIg) in secondary prevention of pregnancy complications for patients with obstetric antiphospholipid syndrome (APS) and history of stillbirth.

METHODS: We described three cases of obstetric APS patients with history of stillbirth treated with IVIg in four pregnancies. In addition, we conducted a systematic literature review on the use of IVIg in obstetric APS with history of stillbirth.

RESULTS: Three patients with obstetric APS and history of stillbirth were treated with prophylactic IVIg, in addition to standard treatment (hydroxychloroquine, low-dose aspirin, low molecular weight heparin, and prednisone), in four pregnancies (three singleton and one twin). All pregnancies resulted in live healthy newborns. Long-term follow-up re-evaluations (24-53 months) did not shown any sign or symptom of active systemic disease, and the children were healthy. The systematic literature review retrieved only three cases of use of IVIg in obstetric APS patients with history of stillbirth. All three cases resulted in live healthy newborns. Only in one case, mild thrombocytopenia occurred during treatment, although this event was unlikely to be related to IVIg.

CONCLUSION: Our experience suggests that IVIg as secondary prevention of APS-related stillbirth is associated with good pregnancy and long-term outcomes, with no relevant safety concerns. However, the literature evidence on this topic is limited to few isolated cases, and further studies are needed to clarify which obstetric APS patients may benefit the most from IVIg.

PMID:32682986 | DOI:10.1016/j.autrev.2020.102620

Women Birth. 2020 Jul;33(4):309-310. doi: 10.1016/j.wombi.2020.04.006. Epub 2020 May 7.

NO ABSTRACT

PMID:32418652 | PMC:PMC7203052 | DOI:10.1016/j.wombi.2020.04.006

Intern Emerg Med. 2020 Oct;15(7):1291-1302. doi: 10.1007/s11739-020-02339-7. Epub 2020 Apr 24.

ABSTRACT

Benzodiazepines (BZD) and z-drugs (ZD) are a widely prescribed group of medicines. They are often used inappropriately, and this is associated with adverse events (AEs), which may cause emergency department (ED) visits. The present study aimed to describe the characteristics of BZD and ZD related AEs leading to emergency department (ED) visit and hospitalisation in Italy, considering their plasma half-life. Ninety-two Italian EDs were monitored between 2007 and 2018. Rates of ED visit and hospitalisation were calculated. Multivariate logistic regression was used to estimate the reporting odds ratios (RORs) of hospitalisation. Univariate linear regression was performed to evaluate the ROR of hospitalisation according the plasma half-life of the suspected agents. A total of 3203 AE reports were collected. Overall, multivariate logistic regression showed that the risk of hospitalisation was higher for prazepam (3.26 [1.31-8.11]), flurazepam (1.62 [1.15-2.27]), and lorazepam (1.36 [1.15-1.61]). In the elderly, this risk was higher for prazepam (3.98 [1.03-15.3]), and lorazepam (1.58 [1.19-2.11]). Parenteral and rectal formulations were associated with a lower risk of hospitalisation compared to oral formulations. Our findings underlined the dangers in the use of BZD and ZD in Italy, particularly in women and older adults. ED clinicians must always take into account that the higher risk in terms of hospitalisation related to the use of BZD and ZD can be observed in patients treated with oral formulations, in those exposed to more than one sedative-hypnotics, and in patients exposed to compounds with intermediate or long plasma half-life.

PMID:32333265 | DOI:10.1007/s11739-020-02339-7

Women Birth. 2021 May;34(3):206-209. doi: 10.1016/j.wombi.2020.03.011. Epub 2020 Apr 8.

ABSTRACT

The COVID-19 pandemic is impacting health systems worldwide. Maternity care providers must continue their core business in caring and supporting women, newborns and their families whilst also adapting to a rapidly changing health system environment. This article provides an overview of important considerations for supporting the emotional, mental and physical health needs of maternity care providers in the context of the unprecedented crisis that COVID-19 presents. Cooperation, planning ahead and adequate availability of PPE is critical. Thinking about the needs of maternity providers to prevent stress and burnout is essential. Emotional and psychological support needs to be available throughout the response. Prioritising food, rest and exercise are important. Healthcare workers are every country's most valuable resource and maternity providers need to be supported to provide the best quality care they can to women and newborns in exceptionally trying circumstances.

PMID:32276778 | PMC:PMC7141547 | DOI:10.1016/j.wombi.2020.03.011

Women Birth. 2020 May;33(3):205-206. doi: 10.1016/j.wombi.2020.03.008. Epub 2020 Mar 30.

NO ABSTRACT

PMID:32241720 | PMC:PMC7270587 | DOI:10.1016/j.wombi.2020.03.008

Scand J Caring Sci. 2020 Sep;34(3):684-689. doi: 10.1111/scs.12772. Epub 2019 Oct 30.

ABSTRACT

AIMS: The short version of the Perinatal Grief Scale (PGS) has 33 items of Likert type whose answers vary from 1 (strongly agree) to 5 (strongly disagree), and is used to assess the grief after perinatal loss and to identify women at major need of specific support. This is the first attempt to validate an Italian version of PGS.

MATERIALS AND METHODS: The English version of PGS by Potvin et al. was translated into Italian by a professional mother tongue English translator. The survey was administered at 3 different times (translated Italian version; original English version after 10 days; and same Italian version after other 10 days) to 16 Italian/English bilingual women who had experienced a perinatal loss. The reproducibility among the three administrations and concordance were assessed using Cronbach's alpha and Cohen's kappa, respectively.

RESULTS: Considering the PGS, median score ranged from 74.5 (58.5-94.5) to 78 (64-95), with no significant difference among the three questionnaire administrations (p = 0.616). No significant difference emerged among the three administered questionnaires for subscales (p = 0.095, 0.410 and 0.410 for 'active grief' AG, 'difficulty in coping' DC and 'despair' D scores, respectively). Concordance varied from good to very good among all questionnaire administrations.

CONCLUSIONS: This Italian version of the PGS can be used by clinicians to assess Italian women's responses to stillbirth and perinatal loss, as well as by researchers for research purposes.

PMID:31667868 | DOI:10.1111/scs.12772

Front Pharmacol. 2019 Aug 30;10:948. doi: 10.3389/fphar.2019.00948. eCollection 2019.

ABSTRACT

Background: The concern for adverse events following immunization (AEFI) and anti-vaccination movements that lacked scientific evidence-based supports may reduce vaccine uptake in the general population. Thus, the aims of the present study were to characterize AEFI in general population (all age groups), in terms of frequency, preventability, and seriousness and to define predictors of their seriousness in children. Methods: A retrospective study was performed on suspected AEFI reports for children and adults who received any form of vaccinations, collected in Tuscany, Italy, between 1 January and 31 December 2017. Patients' characteristics, suspected vaccines, and AEFI description were collected. Causality and preventability were assessed using WHO and Schumock and Thornton algorithms, respectively. Logistic regression was used to estimate the reporting odds ratios of potential predictors of AEFI seriousness in children. Results: A total of 223 suspected AEFI reports were collected, and the majority of them were defined as non-serious (76.7%). Reports were mostly related to one vaccine, and to a median of two to five strains/toxoids. The total number of simultaneously administered strains/toxoids and the presence of allergens did not correlate with AEFI seriousness. Considering vaccines with a high number of administered doses (≥60,000 doses), the rates estimated for serious AEFI reports were always very low, ranging between 0.01 and 0.2/1,000 doses. Twenty-four vaccines (8,993 doses) were not related to any AEFI. Conclusion: Results of present study showed that AEFI were very rare; the vast majority of them was non-serious and, despite the claims of anti-vaccination movements, the simultaneous administration of vaccines was safe and did not influence the risk of reporting a serious AEFI, particularly in children.

PMID:31543816 | PMC:PMC6728926 | DOI:10.3389/fphar.2019.00948

BMJ Open. 2019 Jul 26;9(7):e029467. doi: 10.1136/bmjopen-2019-029467.

ABSTRACT

INTRODUCTION: Fetal growth restriction (FGR) includes different conditions in which a fetus fails to reach the own full growth, and accounts for 28%-45% of non-anomalous stillbirths. The management of FGR is based on the prolongation of pregnancy long enough for fetal organs to mature while preventing starvation. As for pharmacological management, most guidelines recommend treatment with low-dose aspirin and/or with heparin, although this approach is still controversial and innovative promising therapies are under investigation. As no firm evidence exists to guide clinicians towards the most effective therapeutic intervention, this protocol describes methods for a systematic review and network meta-analysis (NetMA) of pharmacological treatments for FGR prevention.

METHODS AND ANALYSIS: We will search MEDLINE and Embase for clinical trials and observational studies performed on gestating women with clinically diagnosed risk of FGR. Experimental interventions will include heparin and low-molecular-weight heparin, acetylsalicylic acid, antiplatelet agents, phosphodiesterase type 3 and 5 inhibitors, maternal vascular endothelial growth factor gene therapy, nanoparticles, microRNA, statins, nitric oxide donors, hydrogen sulphide, proton pump inhibitors, melatonin, creatine and N-acetylcysteine, and insulin-like growth factors, compared between each other or to placebo or no treatment. Primary efficacy outcome is FGR. Secondary efficacy outcomes will be preterm birth, fetal or neonatal death and neonatal complications. For the safety outcome, all adverse events reported in included studies and experienced by either mothers, fetuses or newborns will be considered. Two review authors will independently screen title, abstract and full paper text, and will independently extract data from included studies. Where possible and appropriate, for primary and secondary efficacy outcomes, a NetMA will be performed using a random-effects model within a frequentist framework. Adverse events will be narratively described.

ETHICS AND DISSEMINATION: Results will be disseminated through a peer-reviewed scientific journal, and by scientific congresses and meetings.

PROSPERO REGISTRATION NUMBER: CRD42019122831.

PMID:31350249 | PMC:PMC6661573 | DOI:10.1136/bmjopen-2019-029467

J Matern Fetal Neonatal Med. 2021 Mar;34(6):952-959. doi: 10.1080/14767058.2019.1622675. Epub 2019 Jun 5.

ABSTRACT

BACKGROUND: Stillbirths affect more than 2.5 million pregnancies worldwide every year and the progress in reducing stillbirth rates is slower than that required by World Health Organization. The aim of the present study was to investigate which factors were associated with stillbirths in a University Hospital in the North of Italy, over a time span of 30 years. The goal was to identify which factors are potentially modifiable to reduce stillbirth rate.

METHODS: Retrospective case-control study (358 stillbirths, 716 livebirths) subdivided into two study periods (1987-2006 and 2007-2017).

RESULTS: The prevalence of conception obtained by assisted reproductive technologies, pregnancy at advanced maternal age, and complications of pregnancy such as preeclampsia, fetal growth restriction (FGR), and other fetal diseases (abnormal fetal conditions including fetal anemia, fetal hydrops, TORCH infections) increased through the years of the study. Despite a rising prevalence, the last 10 years showed a significant reduction in stillbirths associated with preeclampsia and FGR. Similarly, the risk of stillbirth related to abnormal fetal conditions decreased in the second study period and a history of previous stillbirth becomes a nonsignificant risk factor.

CONCLUSIONS: Altogether these results suggest that in pregnancies perceived as "high risk" (i.e. previous stillbirth, preeclampsia, FGR, abnormal fetal conditions) appropriate care and follow-up can indeed lower stillbirth rates. In conclusion, the road to stillbirth prevention passes inevitably through awareness and recognition of risk factors.

PMID:31113267 | DOI:10.1080/14767058.2019.1622675

Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):437-438. doi: 10.1002/pds.4740. Epub 2019 Mar 7.

NO ABSTRACT

PMID:30847998 | DOI:10.1002/pds.4740

Evid Based Complement Alternat Med. 2018 Nov 8;2018:1035875. doi: 10.1155/2018/1035875. eCollection 2018.

ABSTRACT

INTRODUCTION: Complementary and alternative medicines (CAMs) are commonly used among lactating women, despite the poor knowledge of these products and of their safety. Perception of pregnancy- and breastfeeding-related difficulties and consequent use of CAMs may differ in bereaved women, by force of the distress related to previous loss, although no literature evidence is available. This Herbal supplements in Breastfeeding InvesTigation (HaBIT) post hoc analysis explored the impact of previous pregnancy loss on lactating behaviors and on use of CAMs during breastfeeding.

METHODS: A web-based survey was conducted among lactating women with no previous alive child, resident in Tuscany (Italy). Data on lactating behavior and on CAMs use were collected and evaluated among women with previous pregnancy loss as compared to control women.

RESULTS: Out of 476 women answering the questionnaire, 233 lactating women with one child were considered. Of them, 80 had history of pregnancy loss. Cesarean birth was significantly more frequent among women with history of pregnancy loss as compared to controls (41% versus 22%; p=0.004). Proportion, length of exclusive breastfeeding, and occurrence of breastfeeding-related complications were comparable among the two cohorts. More than half of women used CAMs during breastfeeding. Use of CAMs was more frequent among women with previous pregnancy loss (54% versus 68%; p=0.050), specifically considering herbal preparations (16% versus 30%; p=0.018). Major advisors for CAMs use were midwives. 18% and 23% of women without and with history of pregnancy loss declared no clear perception on CAMs efficacy and safety.

CONCLUSION: Overcoming the social taboo of pregnancy loss and training healthcare professionals for an adequate management of the perinatal period are essential for an effective and safe care. Despite the common use and advice on CAMs use during breastfeeding, it is important to acknowledge that limited evidence supports their safety and efficacy during such critical period.

PMID:30532793 | PMC:PMC6250025 | DOI:10.1155/2018/1035875

Minerva Ginecol. 2018 Dec;70(6):663-675. doi: 10.23736/S0026-4784.18.04296-X. Epub 2018 Sep 26.

ABSTRACT

BACKGROUND: The most recent WHO recommendations "Intrapartum care for a positive childbirth experience" highlight the need to identify women-centered interventions and outcomes for intrapartum care, and to include service users' experiences and qualitative research into the assessment of maternity care. Babies Born Better (B3) is a trans-European survey designed to capture service user views and experiences of maternity care provision. Italian service users contributed to the survey.

METHODS: The B3 Survey is an anonymous, mixed-method online survey, translated into 22 languages. We separated out the Italian responses and analyzed them using computer-assisted qualitative software (MAXQDA) and SPSS and STATA for quantitative data analysis. Simple descriptives were used for the numeric data, and content analysis for the qualitative responses. Geomapping was based on the coded qualitative data and postcodes (using Tableau Public).

RESULTS: There were 1000 respondents from every region of Italy, using a range of places of birth (hospital, birth center, home) and experiencing care with both midwives and obstetricians. Most identified positive experiences of care, as well as some practices they would like to change. Both positive and critical comments included provision of care based on the type of providers, clinical procedures, the birth environment, and breastfeeding support. There were clear differences in the geomapped data across Italian regions.

CONCLUSIONS: Mothers highly value respectful, skilled and loving care that gives them a strong sense of personal achievement and confidence, and birth environments that support this. There was distinct variation in the percentage of positive comments made across Italian regions.

PMID:30264953 | DOI:10.23736/S0026-4784.18.04296-X

Midwifery. 2018 Sep;64:53-59. doi: 10.1016/j.midw.2018.05.008. Epub 2018 Jun 7.

ABSTRACT

OBJECTIVE: To assess current practices of health care providers (HCPs) caring for women experiencing a stillbirth and to explore their needs for training to better support bereaved families.

DESIGN: Nationwide cross-sectional survey. The main outcome measures were the evaluation of HCPs cognition, emotions and behaviours with regard to the care of women with a stillbirth care, as well as their compliance with international guidelines.

PARTICIPANTS: 750 HCPs, in 11 Italian hospitals, were administered a multiple-choice questionnaire.

FINDINGS: The response rate was 89.9%; the majority (94.1%) were female, with a mean age of 37.6 (SD = 10.4) years. Midwives were the most represented (72.8%). Half of the respondents recommended immediate birth; only 55% routinely bathed and dressed stillborn babies for their parents to see, while 44.4% of HCPs immediately took the babies away without allowing parents to properly say goodbye to them. More than half felt inadequate and some even reported having failed to provide support to the family when caring for a woman with stillbirth in the past. The need for professional training courses was expressed by 90.2%, and three-quarters had never previously attended a course on perinatal bereavement care. When answers by Italian HCPs are systematically evaluated with reference to international guidelines, the results were very poor with only 27.9% of respondents reported having created memories of the baby and less than 3% complied with all recommendations in the areas of respect for baby and parents, appropriate birth options, and aftercare.

KEY CONCLUSIONS: There is a substantial gap between the standards of care defined by international guidelines and the practices currently in place in Italy. Italian HCPs feel an urgent need to be offered professional training courses to better meet the needs of grieving families.

IMPLICATION FOR PRACTICE: Perinatal HCPs should be aware of their pivotal role in helping bereaved parents after stillbirth and perinatal loss, and seek appropriate training.

PMID:29929062 | DOI:10.1016/j.midw.2018.05.008

Data Brief. 2018 May 8;19:226-229. doi: 10.1016/j.dib.2018.04.146. eCollection 2018 Aug.

ABSTRACT

Data here reported are sample characteristics of the first nation-wide community based survey on 'obstetric violence' (OV) conducted in a high-income country (Italy). The initiative is the extension of the social media campaign "#Bastatacere: mothers have voice" that in 2016 put under national spotlight the hidden phenomenon of abuse and disrespect in childbirth in hospital facilities, advocating for a respectful maternity care. The questionnaire LOVE-THEM was firstly developed in an open format and then revised according to WHO definition of disrespect and abuse in childbirth, within human rights based approach. The survey was conducted through on line interviews (CAWI method, quota sampling) with 424 respondents representing a significant national sample of mothers with children aged 0-14 years. Here we report summary tables describing the sample distribution according to the socio-demographic characteristics (instruction, employment status, social and economic class), including the number and the age of children. The responding sample is proportionally appropriate and correctly representative of about 5 millions of childbearing women in Italy.

PMID:29892637 | PMC:PMC5992972 | DOI:10.1016/j.dib.2018.04.146

Br J Clin Pharmacol. 2018 Sep;84(9):2040-2047. doi: 10.1111/bcp.13639. Epub 2018 Jul 3.

ABSTRACT

AIMS: The use of complementary and alternative medicines (CAMs) during breastfeeding is increasing, mainly because of their presumed greater safety compared with conventional medications. However, CAMs can cause serious adverse effects, and there is limited high-quality evidence supporting their use during lactation. In Italy, specific investigations on the attitude of lactating women towards CAMs are lacking. The Herbal supplements in Breastfeeding InvesTigation (HaBIT) study aimed to explore attitudes to and knowledge on CAMs among lactating women.

METHODS: A web-based survey was conducted over a 6-year period among lactating women resident in Tuscany, Italy. Data on lactating behaviour, CAMs use during pregnancy or breastfeeding, and women's knowledge about the efficacy and safety of CAMs were collected.

RESULTS: A total of 388 lactating women answered the questionnaire. The majority of them were primiparae, with a high educational level. Of these, 204 women declared themselves to have used CAMs during breastfeeding. Moreover, 61% and 48% of subjects reported also using CAMs before and during pregnancy, respectively. A significant proportion of subjects were unable to identify correctly the types of CAMs they were using. Seventy-three per cent of women were convinced that CAMs were equally safe or safer than conventional medications; nevertheless, 65% of women admitted to have no scientific information about the potential risks of CAMs, and 14 CAMs users reported that they had experienced side effects.

CONCLUSIONS: These results demonstrate the need for healthcare providers to increase the awareness of breastfeeding women about CAMs. Further research is needed to support the evidence base for nonpharmaceutical approaches for symptom control during breastfeeding.

PMID:29768673 | PMC:PMC6089807 | DOI:10.1111/bcp.13639

Eur J Obstet Gynecol Reprod Biol. 2018 May;224:208-209. doi: 10.1016/j.ejogrb.2018.03.055. Epub 2018 Mar 28.

NO ABSTRACT

PMID:29655941 | DOI:10.1016/j.ejogrb.2018.03.055

Clin Infect Dis. 2017 Apr 15;64(8):1142-1143. doi: 10.1093/cid/cix107.

NO ABSTRACT

PMID:28199508 | DOI:10.1093/cid/cix107

BJOG. 2018 Jan;125(2):193-201. doi: 10.1111/1471-0528.14424. Epub 2016 Nov 30.

ABSTRACT

OBJECTIVE: To assess the frequency of additional care, and parents' perceptions of quality, respectful care, in pregnancies subsequent to stillbirth.

DESIGN: Multi-language web-based survey.

SETTING: International.

POPULATION: A total of 2716 parents, from 40 high- and middle-income countries.

METHODS: Data were obtained from a broader survey of parents' experiences following stillbirth. Data were analysed using descriptive statistics and stratified by geographic region. Subgroup analyses explored variation in additional care by gestational age at index stillbirth.

MAIN OUTCOME MEASURES: Frequency of additional care, and perceptions of quality, respectful care.

RESULTS: The majority (66%) of parents conceived their subsequent pregnancy within 1 year of stillbirth. Additional antenatal care visits and ultrasound scans were provided for 67% and 70% of all parents, respectively, although there was wide variation across geographic regions. Care addressing psychosocial needs was less frequently provided, such as additional visits to a bereavement counsellor (10%) and access to named care provider's phone number (27%). Compared with parents whose stillbirth occurred at ≤ 29 weeks of gestation, parents whose stillbirth occurred at ≥ 30 weeks of gestation were more likely to receive various forms of additional care, particularly the option for early delivery after 37 weeks. Around half (47-63%) of all parents felt that elements of quality, respectful care were consistently applied, such as spending enough time with parents and involving parents in decision-making.

CONCLUSIONS: Greater attention is required to providing thoughtful, empathic and collaborative care in all pregnancies following stillbirth. Specific education and training for health professionals is needed.

TWEETABLE ABSTRACT: More support for providing quality care in pregnancies after stillbirth is needed.

PLAIN LANGUAGE SUMMARY: Study rationale and design More than two million babies are stillborn every year. Most parents will conceive again soon after having a stillborn baby. These parents are more likely to have another stillborn baby in the next pregnancy than parents who have not had a stillborn baby before. The next pregnancy after stillbirth is often an extremely anxious time for parents, as they worry about whether their baby will survive. In this study we asked 2716 parents from 40 countries about the care they received during their first pregnancy after stillbirth. Parents were recruited mainly through the International Stillbirth Alliance and completed on online survey that was available in six languages. Findings Parents often had extra antenatal visits and extra ultrasound scans in the next pregnancy, but they rarely had extra emotional support. Also, many parents felt their care providers did not always listen to them and spend enough time with them, involve them in decisions, and take their concerns seriously. Parents were more likely to receive various forms of extra care in the next pregnancy if their baby had died later in pregnancy compared to earlier in pregnancy. Limitations In this study we only have information from parents who were able and willing to complete an online survey. Most of the parents were involved in charity and support groups and most parents lived in developed countries. We do not know how well the findings relate to other parents. Finally, our study does not include parents who may have tried for another pregnancy but were not able to conceive. Potential impact This study can help to improve care through the development of best practice guidelines for pregnancies following stillbirth. The results suggest that parents need better emotional support in these pregnancies, and more opportunities to participate actively in decisions about care. Extra support should be available no matter how far along in pregnancy the previous stillborn baby died.

PMID:27905202 | DOI:10.1111/1471-0528.14424

Lancet. 2016 Feb 13;387(10019):691-702. doi: 10.1016/S0140-6736(15)01020-X. Epub 2016 Jan 19.

ABSTRACT

Variation in stillbirth rates across high-income countries and large equity gaps within high-income countries persist. If all high-income countries achieved stillbirth rates equal to the best performing countries, 19,439 late gestation (28 weeks or more) stillbirths could have been avoided in 2015. The proportion of unexplained stillbirths is high and can be addressed through improvements in data collection, investigation, and classification, and with a better understanding of causal pathways. Substandard care contributes to 20-30% of all stillbirths and the contribution is even higher for late gestation intrapartum stillbirths. National perinatal mortality audit programmes need to be implemented in all high-income countries. The need to reduce stigma and fatalism related to stillbirth and to improve bereavement care are also clear, persisting priorities for action. In high-income countries, a woman living under adverse socioeconomic circumstances has twice the risk of having a stillborn child when compared to her more advantaged counterparts. Programmes at community and country level need to improve health in disadvantaged families to address these inequities.

PMID:26794070 | DOI:10.1016/S0140-6736(15)01020-X

Eat Weight Disord. 2013 Mar;18(1):11-22. doi: 10.1007/s40519-013-0002-6. Epub 2013 Apr 3.

ABSTRACT

PURPOSE: Eating disorders (EDs) are an important cause of physical morbidity and psychosocial impairment, and eating disordered patients have a worse quality of life than peers. The aim of this study was to develop and validate a new self-report instrument, the Eating Disorders Well Being Questionnaire (EDwell), a measure of eating disorders-related quality of life, which takes into consideration not only the intensity, but also the subjective relevance of physical and psychosocial distress.

METHODS: The questionnaire was administered to 120 eating disordered patients and 60 healthy controls. Patients underwent a psychopathological and clinical evaluation. Test-retest reliability, internal consistency, and psychopathological correlates were evaluated. All patients were also administered the Eating Disorder Examination (EDE12.0D) and the Short Form 36 Health Survey (SF36). A factor analysis was performed to verify the distribution of items into subscales.

RESULTS: EDwell showed good test-retest reliability and internal consistency. EDwell scores significantly correlated with EDE12.0D total and subscale scores. A significant correlation was also found between several EDwell and SF36 scores. Factor analysis identified three factors: Perfectionism/Control, Loneliness/Avoidance, Social Functioning.

CONCLUSIONS: The EDwell questionnaire is a feasible and reliable measure of the specific impact of Eating Disorders psychopathology on quality of life.

PMID:23757246 | DOI:10.1007/s40519-013-0002-6

Psychother Psychosom. 2012;81(1):11-20. doi: 10.1159/000329358. Epub 2011 Nov 22.

ABSTRACT

BACKGROUND: Different studies considered the mechanisms involved in the maintenance of binge eating in bulimia nervosa (BN) and binge eating disorder (BED), suggesting different pathways. The present 3-year follow-up study evaluated the relationships between psychopathological variables, and objective and subjective binge eating episodes in the two syndromes.

METHODS: 85 BN and 133 BED patients were studied. Objective and subjective binge eating, and psychopathological data were collected in a face-to-face interview, and by means of different self-reported questionnaires. The same assessment was repeated at baseline (T0), at the end of an individual cognitive-behavioral treatment (T1), and 3 years after the end of treatment (T2).

RESULTS: At baseline, BN and BED patients showed different emotions associated with binge eating: anger/frustration for BN and depression for BED patients. Objective binge eating frequency reduction across time was associated with lower impulsivity and shape concern in BN patients, and with lower emotional eating and depressive symptoms in BED patients. Lower subjective binge eating frequency at baseline predicted recovery, in both BN and BED patients. Recovery was associated with lower impulsivity and body shape concern at baseline for BN patients, and lower depression and emotional eating for BED patients.

CONCLUSIONS: Eating psychopathology, psychiatric comorbidity, impulsivity and emotional eating have a different pattern of association with objective and subjective binge eating in BN and BED patients, and they act as different moderators of treatment. A different target of intervention for these two syndromes might be taken into account, and subjective binge eating deserves an accurate assessment.

PMID:22116257 | DOI:10.1159/000329358

Compr Psychiatry. 2012 Apr;53(3):245-51. doi: 10.1016/j.comppsych.2011.04.062. Epub 2011 May 26.

ABSTRACT

OBJECTIVES: The relationship between emotional states and eating behaviors is complex, and emotional eating has been identified as a possible factor triggering binge eating in bulimia nervosa (BN) and binge eating disorder. Few studies considered emotional eating in patients with anorexia nervosa.

METHODS: The present study evaluated the clinical correlates of emotional eating in 251 eating-disordered (EDs) subjects (70 AN restricting type, 71 AN binge eating/purging type, 110 BN purging type) and in a group of 89 healthy control subjects. Subjects were assessed by means of a clinical interview (Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) and several self-reported questionnaires, including the Emotional Eating Scale (EES).

RESULTS: No significant differences were found between the 3 EDs groups in terms of EES total score, and all patients with ED showed higher EES scores compared with control subjects. Emotional eating was associated with subjective binge eating in AN binge eating/purging type and with objective binge eating in patients with BN. Among patients with AN restricting type, emotional eating was associated with restraint, but this association was lost when controlling for fear of loss of control over eating, which was the principal determinant of restraint.

CONCLUSION: Emotional eating and fear of loss of control over eating are significantly associated with specific eating attitudes and behaviors, according to the different diagnoses. Emotional eating is a relevant psychopathologic dimension that deserves a careful investigation in both anorectic and bulimic patients.

PMID:21620387 | DOI:10.1016/j.comppsych.2011.04.062

Lancet. 2011 Apr 16;377(9774):1313. doi: 10.1016/S0140-6736(11)60530-8.

NO ABSTRACT

PMID:21497691 | DOI:10.1016/S0140-6736(11)60530-8

Psychosom Med. 2011 Apr;73(3):270-9. doi: 10.1097/PSY.0b013e31820a1838. Epub 2011 Jan 21.

ABSTRACT

OBJECTIVE: To evaluate in a 6-year follow-up study the course of a large clinical sample of patients with eating disorders (EDs) who were treated with individual cognitive behavior therapy. The diagnostic crossover, recovery, and relapses were assessed, applying both Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and the DSM-V proposed criteria. Patients with EDs move in and out of illness states over time, display frequent relapses, show a relevant lifetime psychiatric comorbidity, and migrate between different diagnoses.

METHOD: A total of 793 patients (including anorexia nervosa, bulimia nervosa, binge eating disorder, and EDs not otherwise specified) were evaluated on the first day of admission, at the end of treatment, 3 years after the end of treatment, and 3 years after the first follow-up. Clinical data were collected through a face-to-face interview; diagnosis was performed by means of the Structured Clinical Interview for DSM-IV and the Eating Disorder Examination Questionnaire was applied.

RESULTS: A consistent rate of relapse and crossover between the different diagnoses over time was observed. Mood disorders comorbidity has been found to be an important determinant of diagnostic instability, whereas the severity of shape concern represented a relevant outcome modifier. Using the DSM-V proposed criteria, most patients of EDs not otherwise specified were reclassified, so that the large majority of ED patients seeking treatment would be included in full-blown diagnoses.

CONCLUSIONS: Among EDs, there are different subgroups of patients displaying various courses and outcomes. The diagnostic instability involves the large majority of patients. An integration of categorical and dimensional approaches could improve the psychopathological investigation and the treatment choices.

PMID:21257978 | DOI:10.1097/PSY.0b013e31820a1838

Appetite. 2010 Dec;55(3):656-65. doi: 10.1016/j.appet.2010.09.019. Epub 2010 Sep 24.

ABSTRACT

Few long-term follow-up studies evaluated the response to psychotherapeutic interventions in binge eating disorder (BED). The effectiveness of individual and group cognitive-behavioral therapy, and the possible predictors of outcome were evaluated in a randomized controlled trial. At the beginning, at the end of treatments, and three years after the end of treatments, 144 patients affected by threshold or subthreshold BED were assessed using a clinical interview and self-reported questionnaires evaluating the eating attitudes and behavior, emotional eating, and general psychopathology. The following outcome measures were considered: recovery at 3-year follow-up, weight loss, treatment resistance, relapse, and diagnostic change. Both treatments showed similar response in terms of all outcome measures in the long-term, and determined a significant reduction of binge eating frequency, and a mild reduction of weight. The absence of a history of amphetamine derivatives consumption, lower emotional eating and binge eating severity at baseline were predictors of full recovery in the long-term. A low Emotional eating was found to be the only predictor of weight reduction. Overweight during childhood, full blown BED diagnosis, and high emotional eating were predictors of treatment resistance. Treatments considering the relationships between binge eating and emotional eating could improve the outcome of BED patients.

PMID:20870000 | DOI:10.1016/j.appet.2010.09.019

Clin Pract Epidemiol Ment Health. 2010 Jul 20;6:59-65. doi: 10.2174/1745017901006010059.

ABSTRACT

Although the prevalence of fully expressed Eating Disorders is rare in young children, childhood eating disturbances are fairly common. Parents can play a facilitating role for the development of overweight and eating problems among their children. The aim of this study is to detect the possible relationships between children's eating attitudes and behaviour and the parents' beliefs about eating habits and body shape of their offspring.This survey was conducted in the area of Arezzo (Italy), on 900 children, aged 7-12, and on their parents/substitute caregivers. The Kids' Eating Disorder Survey questionnaire, and the CIBUS questionnaire were administered. A fully expressed Eating Disorder was diagnosed in two kids only. KEDS total score and weight/dissatisfaction subscale score positively correlated with parents' answers to the following CIBUS' items (How do you consider the body shape of your son/daughter? How much does your son/daughter eats? Have you ever thought of putting your son/daughter on a diet?). Positive correlations between the children BMI, desired BMI and the aforementioned CIBUS' items were found.The prevalence of formal Eating Disorders in children aged 7-12 is low. Children appear to be more preoccupied with their weight than with their body shape. Parents' beliefs about the offspring's body shape and eating habits have a relevant impact on children's eating attitudes and behaviour.

PMID:20835356 | PMC:PMC2936009 | DOI:10.2174/1745017901006010059

J Endocrinol Invest. 2011 Mar;34(3):e70-7. doi: 10.1007/BF03347079. Epub 2010 Sep 9.

ABSTRACT

BACKGROUND AND AIMS: The degree of motivation before starting the treatment represents a pre-treatment predictor of successful weight management. The aim of this study is to develop and validate a new self-reported questionnaire of motivation and readiness to change before starting a lifestyle modification program (the TREatment MOtivation and REadiness test) (TRE-MORE) for overweight patients.

METHODS AND RESULTS: TRE-MORE was evaluated in a consecutive series of 129 obese patients attending our Outpatient Clinic. Validation of the questionnaire was performed through test-retest reliability, internal consistency, psychopathological correlates, and concurrent validity. Subjects have been evaluated by means of a clinical interview, and different self-reported questionnaires, assessing the eating specific and general psychopathology, and quality of life. TRE-MORE total and subscales scores showed good test-retest reliability and internal consistency. We identified 10 items grouped in 3 areas (obstacles and desire to overcome, taking care of themselves, and sharing the problems, current lifestyle). TREMORE scores were significantly correlated with eating specific psychopathology and quality of life measures. Univariate and Receiver Operating Characteristic curve analysis showed that TRE-MORE total and subscales scores represent a good model for predicting a weight loss >5% of the initial weight after 6 months of treatment.

CONCLUSION: TRE-MORE represents a validated and easy-to-use questionnaire assessing at the meantime the treatment motivation and readiness with good predictive capacity for weight loss.

PMID:20834202 | DOI:10.1007/BF03347079

Prev Med. 2010 Nov;51(5):429-30. doi: 10.1016/j.ypmed.2010.08.009. Epub 2010 Aug 27.

NO ABSTRACT

PMID:20801155 | DOI:10.1016/j.ypmed.2010.08.009

Psychother Psychosom. 2010 Jun;79(4):238-48. doi: 10.1159/000315129. Epub 2010 May 25.

ABSTRACT

BACKGROUND: Few long-term follow-up studies have evaluated the response to psychotherapeutical interventions in anorexia nervosa (AN). The effectiveness of individual cognitive-behavioral therapy (CBT) and the possible predictors of outcome in outpatients suffering from threshold and subthreshold AN (s-AN) were evaluated.

METHODS: At the beginning (T0) and at the end of treatment (T1), and 3 years after the end of treatment (T2), 53 subjects with AN and 50 with s-AN (all DSM-IV criteria except amenorrhea or underweight) were assessed by a face-to-face clinical interview and by self-reported questionnaires for eating attitudes and behavior (Eating Disorder Examination Questionnaire), body uneasiness (Body Uneasiness Test) and general psychopathology (Symptom Checklist, Beck Depression Inventory, State-Trait Anxiety Inventory).

RESULTS: No deaths occurred during the treatment and the follow-up period. At the end of the follow-up 34 subjects (33%) initially enrolled in the study obtained a full recovery. AN and s-AN patients did not show significant differences on most of the clinical measures at baseline and in terms of treatment response (T1, T2). The reduction in weight and shape concerns was associated with weight gain at T1 and T2, and the shape concern level at baseline represented the main risk factor for recovery and treatment resistance. According to survival analysis, patients with high shape concern had a lower probability of remission across time.

CONCLUSIONS: The distinction between threshold and subthreshold AN does not seem to be of clinical relevance in terms of response to CBT. Shape concern rather than demographic or general psychopathological features represents the best predictor of outcome for CBT.

PMID:20502064 | DOI:10.1159/000315129

Appetite. 2009 Dec;53(3):418-21. doi: 10.1016/j.appet.2009.07.008. Epub 2009 Jul 18.

ABSTRACT

The present study compared threshold, subthreshold BED (Binge Eating Disorder), and subjects without BED in a population of overweight/obese individuals seeking weight loss treatment, considering the sociodemografic features, the eating specific and general psychopathology, the organic and psychiatric comorbidity, the quality of life, and the emotional eating as a trigger factor for binge eating. Four hundred thirty eight overweight subjects seeking weight loss treatment have been evaluated by means of a clinical interview (SCID I), and different self-reported questionnaires, assessing the eating specific and general psychopathology. One hundred five subjects (24% of the sample) fulfilled the DSM-IV criteria of BED, 146 (33.3%) fulfilled the criteria of subthreshold BED, and 187 (42.7%) subjects were diagnosed overweight non-BED. The groups did not differ in terms of psychiatric comorbidity, diet attempts, quality of life, and psychopathology, while the presence of binge eating was associated to higher eating, weight, and shape concerns. Emotional eating was positively correlated to the presence/severity of binge eating.

PMID:19619594 | DOI:10.1016/j.appet.2009.07.008

Appetite. 2009 Apr;52(2):405-9. doi: 10.1016/j.appet.2008.11.013. Epub 2008 Dec 3.

ABSTRACT

This study aims to investigate the anamnestic, psychopatological and clinical features of overweight/obese subjects with and without an history of amphetamine derivatives consumption. This survey was conducted on a consecutive series of 451 overweight/obese subjects referring to the Clinics for Obesity of the University of Florence. Subjects with and without previous amphetamines derivatives consumptions were compared in terms of psychopathological and clinical features by means of the Structured Clinical Interview for DSM-IV, the Eating Disorder Examination questionnaire (EDE-Q), the Binge Eating Scale (BES), the Beck Depression Inventory (BDI), and the Spielberg's State-Trait Anxiety Inventory (STAI). Among the 451 participants, 136 patients (30.1%) reported a previous use of amphetamine derivatives drugs. Amphetamine users reported a high rate of childhood overweight, and showed higher BMI, EDE-Q Total score, Weight Concern, Shape Concern subscales and BES scores than amphetamine non-users, whereas the two groups of patients did not differ in terms of BDI and STAI scores. Amphetamine derivatives are widely used by obese patients seeking weight loss treatment. The amphetamine derivatives consumption is associated with higher levels of eating psychopathology and a more severe overweight.

PMID:19103239 | DOI:10.1016/j.appet.2008.11.013

J Matern Fetal Neonatal Med. 2008 Jun;21(6):425-8. doi: 10.1080/14767050802040849.

ABSTRACT

The phenomenon of stillbirth has been poorly addressed in terms of reported statistics and as a clinical issue. A Study Group of the European Association of Perinatal Medicine reviewed the topic and highlighted specific issues. Such proposal was discussed in an open workshop held in Modena, Italy last year and this paper reports the final recommendations. Briefly, at least 22 completed weeks of gestation was endorsed as definition for including SB in statistics and for clinical studies. A minimum diagnostic work-up was suggested together with the emphasis toward a local, multidisciplinary audit process, in order to comprehend causality. Attention for parents emotional support and appropriate counselling was believed as essential part of the clinical process. Finally, the need for funding comprehensive research programs in SB through international, multidisciplinary involvement was believed mandatory for developing effective preventative strategies to avert the devastating occurrence of stillbirth.

PMID:18570122 | DOI:10.1080/14767050802040849

Compr Psychiatry. 2008 Jul-Aug;49(4):359-63. doi: 10.1016/j.comppsych.2008.01.005. Epub 2008 Mar 19.

ABSTRACT

BACKGROUND: Many obese subjects show relevant psychological distress. The aims of this study were to assess the psychopathological and clinical features of a sample of overweight or obese subjects seeking weight loss treatment and to evaluate the possible, significant associations between the levels of overweight and the specific and general eating disorder psychopathology.

METHODS: A total of 397 consecutive overweight (body mass index > or =25 kg/m(2)) patients seeking treatment for weight loss at the Outpatient Clinic for Obesity of the University of Florence were studied. The prevalence of binge eating disorder was assessed using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria. All subjects were assessed through the self-report version of the Eating Disorder Examination Questionnaire, the Beck Depression Inventory, and the State-Trait Anxiety Inventory.

RESULTS: The current prevalence of binge eating disorder was 24.2%; 35% of the subjects were overweight during childhood. High prevalence rates of clinical significant depressive (38%) and anxious (71.5%) symptoms were observed. Binge eating disorder, the severity of specific eating disorder psychopathology, and depressive and anxious symptoms were not associated with the severity of overweight.

CONCLUSIONS: The severity of the specific and general eating disorder psychopathology does not predict the levels of overweight. A positive association between severe eating disorder psychopathology and clinical depression was observed.

PMID:18555056 | DOI:10.1016/j.comppsych.2008.01.005

Neuropsychobiology. 2008;57(3):95-115. doi: 10.1159/000138912. Epub 2008 Jun 13.

ABSTRACT

The etiopathogenesis of eating disorders (ED) is complex and poorly understood. Biological, psychological and environmental factors have all been considered to be involved in the onset and the persistence of these syndromes, often with conflicting results. The recent literature focused on the possible role of hormonal pathways, in particular the hypothalamic-pituitary-adrenal (HPA) axis, as a relevant factor capable of influencing the onset and the course of ED. Other studies have suggested that the onset of ED is often preceded by severe life events, and that chronic stress is associated with the persistence of these disorders. As the biological response to stress is the activation of the HPA axis, the available literature considering the relationships between stress, HPA axis functioning and anorexia nervosa, bulimia nervosa and binge eating disorder is reviewed by the present article.

PMID:18552511 | DOI:10.1159/000138912

Eat Weight Disord. 2007 Dec;12(4):147-53. doi: 10.1007/BF03327591.

ABSTRACT

OBJECTIVE: This study is aimed at the comparison between an individual and a group cognitive-behavioral program for the treatment of obesity.

DESIGN: Parallel series, prospective, 3-year study. A group program of 10 weekly sessions focused on lifestyle modification was compared with a similar, individual 10-session program. Fifty-seven patients were assigned to individual treatment, and 84 patients to the group program.

SUBJECTS: One hundred- forty-one obese female outpatients without binge eating disorder, aged 42.0+/-11.6 years (m+/-SD), with Body Mass Index (BMI) 37.3+/-5.2 kg/m(2).

MEASUREMENTS: BMI and waist circumference were measured at 0, 6, 12 and 36 months. Analysis was performed on an intention-to-treat basis.

RESULTS: Mean weight loss was superior with the group program at 6 months (2.0+/-3.9 vs 0.8+/-2.5 kg/m(2); p<0.05), while no difference between the two treatments was observed at 12 and 36 months. Mean waist circumference was significantly different at 6 months (group 97.4+/-2.5 vs individual 102.9+/-2.4, p<0.05), still remaining superior in the patients following individual treatment (100.2+/-5.0 vs 103.7+/-5.9) at 12 months, while no difference between the two treatments was observed at 36 months. The proportion of patients losing more than 5% of initial body weight with the group program (16.6, 15.5, and 38.1% at 6, 12, and 36 months, respectively) was not significantly different from that observed with individual treatment (5.3, 14.0, and 35.0%, respectively).

CONCLUSION: A group cognitive-behavioral program for the treatment of obesity is not inferior to a similar program applied in individual setting, and it may enhance weight loss (especially fat mass, according to the waist measurement) in the short term.

PMID:18227635 | DOI:10.1007/BF03327591

Psychother Psychosom. 2006;75(6):376-83. doi: 10.1159/000095444.

ABSTRACT

BACKGROUND: It is speculated that clinical samples do not fully reflect the characteristics of eating disorders (EDs) as they are in the general population, especially in their lowest range of severity. The present article reports the prevalence of EDs in a community sample aged >14 years, their clinical and psychopathological features, and their course and outcome on naturalistic grounds.

METHODS: The Sesto Fiorentino Study is a three-phase community-based survey where 2,355 out of 2,500 people representative of the population aged >14 years living in Sesto Fiorentino were evaluated by their own general practitioner using the Mini International Neuropsychiatric Interview plus six additional questions. All those who had positive results plus a probability sample of the non-cases were re-interviewed by psychiatrists using the Florence Psychiatric Interview. The subjects who reported ED symptoms were subsequently administered the Eating Disorder Examination (12th edition).

RESULTS: Overall, the lifetime prevalence of EDs was 1.21%. More precisely, 0.42% had anorexia nervosa, 0.32% bulimia nervosa, 0.32% binge eating disorder and 0.32% eating disorder not otherwise specified. All the subjects suffering from an ED fulfilled diagnostic criteria for at least another DSM-IV axis I psychiatric disorder. At the moment of the interview, conducted a few years (average 7 years) after the onset of the disorder, 50% had fully recovered from EDs, 26.9% were currently affected by an ED, 23.1% showed a persistent body image disturbance and/or the presence of compensatory behaviours.

CONCLUSIONS: Community surveys conducted by clinicians may provide useful additional information on the psychopathological features, natural course and outcome of these disorders on naturalistic grounds.

PMID:17053339 | DOI:10.1159/000095444

J Psychosom Res. 2006 Oct;61(4):529-35. doi: 10.1016/j.jpsychores.2006.04.016.

ABSTRACT

OBJECTIVE: Our objective was to evaluate the relationships between gender role, eating behavior, and body image in nonprofessional female ballet dancers.

METHODS: One hundred ten female ballet dancers and 59 controls were administered the Bem Sex Role Inventory, the Eating Disorder Examination (EDE), the Body Uneasiness Test (BUT), and the Beck Depression Inventory.

RESULTS: Ballet dancers scored higher than controls in most of the items evaluating body image and eating behaviors; a high number of ballet dancers with undifferentiated gender role were also observed. In the dancers group, male-typified subjects showed higher median scores of EDE and BUT scales, while in the control group, the highest median scores of EDE and BUT scales were found in undifferentiated subjects.

CONCLUSION: Ballet schools' cultural pressure towards an ideal of leanness could interfere with the process of gender role acquisition. Ballet dancers appear to be overconcerned with performance; this could reinforce the internalization of several constructs that are generally considered as typically male.

PMID:17011362 | DOI:10.1016/j.jpsychores.2006.04.016

Neurosci Lett. 2006 May 22;399(3):230-3. doi: 10.1016/j.neulet.2006.01.060. Epub 2006 Feb 21.

ABSTRACT

Animal studies showed that nitric oxide (NO)/cyclic-GMP (cGMP) pathway is involved in the modulation of eating behavior. To address its role in eating disorders (ED), plasma nitrite and cGMP levels were studied in 50 ED patients (25 with Anorexia Nervosa, AN; 25 with Bulimia Nervosa, BN) and 20 sex- and age-matched controls (C). Nitrites (nmol/mg protein, mean+/-S.E.M.: any ED 1.01+/-0.29; AN 1.15+/-0.47; BN 0.88+/-0.36; C 0.25+/-0.07; p<0.01) and cGMP (nmol/ml plasma, mean+/-S.E.M.: any ED 2.58+/-0.60; AN 2.81+/-1.10; BN 2.41+/-0.70; C 0.11+/-0.05; p<0.01) were significantly higher in ED patients than in C. Nitrite and cGMP levels inversely correlated with BMI in AN patients (nitrites: r=-0.62 p<0.01; cGMP r=-0.45 p<0.05) but not in BN patients (nitrites: r=-0.15 p=0.49; cGMP: r=-0.05 p=0.13) or in control subjects (nitrites: r=0.11 p=0.98; cGMP r=0.37 p=0.32). Significant correlations were also present in bulimic patients between nitrite levels, frequency of binges and several psychopathological dimensions, as assessed through the EDE. This is the first evidence of an alteration of the NO pathway in ED patients. Further studies are needed to ascertain whether an increase in NO levels plays a possible role in the pathogenesis of ED.

PMID:16495002 | DOI:10.1016/j.neulet.2006.01.060