Evaluation of hernia surgical meshes sterilised with ethylene oxide for adoption under UK regulations.

BACKGROUND: Low-cost meshes (LCM) have been successfully used in low-income countries (LIC) over the past decades, demonstrating comparable surgical outcomes to commercial meshes at a fraction of the cost. However, LIC sterilisation standards (autoclave sterilisation at 121 °C) do not meet UK regulations for medical devices, which require either ethylene oxide (EO) sterilisation or steam sterilisation at 134 °C. Therefore, the aim of this study was to sterilise UK LCM and characterise their mechanical properties and in vitro biocompatibility to verify whether EO sterilisation causes changes in the mechanical properties and biocompatibility of LCM. METHODS: EO sterilised LCM were used. Uniaxial tensile tests were performed to measure mechanical properties. Biocompatibility was measured through viability and morphology of Human Dermal Fibroblasts (HDFs) cultured in mesh-conditioned media, and by calculating the metabolic activity and proliferation of HDFs attached on the meshes, with alamarBlue assay. RESULTS: Break stress of LCM1 was significantly higher than LCM2 (p < 0.0001), while Young's modulus of LCM1 was significantly lower than LCM2 (p < 0.05) and there was no significant difference in break strain. Viability and morphology showed no significant difference between LCM and control. Attachment and proliferation of HDFs on LCM showed a better proliferation on LCM2 than LCM1, with values similar to the control at the final time point. CONCLUSIONS: We demonstrated that EO sterilisation affects LCM mechanical properties, but they still have values closer to the native tissues than the commercially available ones. We also showed that in vitro biocompatibility of LCM2 is not affected by EO sterilisation, as HDFs attached and proliferated on the mesh, while EO affected attachment on LCM1. A more detailed cost analysis of the potential savings for healthcare systems around the world needs to be performed to strengthen the cost-effectiveness of this frugal innovation.

Intimate Partner Violence Screening Programs in the Veterans Health Administration: Informing Scale-up of Successful Practices.

OBJECTIVES: Screening women for intimate partner violence (IPV) is increasingly expected in primary care, consistent with clinical prevention guidelines (e.g., United States Preventive Services Task Force). Yet, little is known about real-world implementation of clinical practices or contextual factors impacting IPV screening program success. This study identified successful clinical practices, and barriers to and facilitators of IPV screening program implementation in the Veterans Health Administration (VHA). DESIGN: Descriptive, qualitative study of a purposeful sample of 11 Veterans Affairs Medical Centers (VAMCs) categorized as early and late adopters of IPV screening programs within women's health primary care clinics. VAMCs were categorized based on performance measures collected by VHA operations partners. PARTICIPANTS: Thirty-two administrators and clinician key informants (e.g., Women's Health Medical Directors, IPV Coordinators, and physicians) involved in IPV screening program implementation decisions from six early- and five late-adopting sites nationwide. MAIN MEASURES: Participants reported on IPV screening and response practices, and contextual factors impacting implementation, in individual 1-h semi-structured phone interviews. Transcripts were analyzed using rapid content analysis with key practices and issues synthesized in profile summaries. Themes were identified and iteratively revised, utilizing matrices to compare content across early- and late-adopting sites. KEY RESULTS: Five successful clinical practices were identified (use of two specific screening tools for primary IPV screening and secondary risk assessment, multilevel resource provision and community partnerships, co-location of mental health/social work, and patient-centered documentation). Multilevel barriers (time/resource constraints, competing priorities and mounting responsibilities in primary care, lack of policy, inadequate training, and discomfort addressing IPV) and facilitators (engaged IPV champions, internal and external supports, positive feedback regarding IPV screening practices, and current, national attention to violence against women) were identified. CONCLUSIONS: Findings advance national efforts by highlighting successful clinical practices for IPV screening programs and informing strategies useful for enhancing their implementation within and beyond the VHA, ultimately improving services and women's health.

Associations between traumatic brain injury from intimate partner violence and future psychosocial health risks in women.

OBJECTIVE: The effects of traumatic brain injury (TBI) incurred during military service are widely studied; however, less is known about TBI resulting from intimate partner violence ("IPV-related TBI"). Women Veterans are at high risk for IPV, yet no research has examined future psychosocial health risks associated with IPV-related TBI history in this population. METHODS: We examined psychiatric and physical health outcomes, as well as IPV, in a sample of women Veterans who, at Time 1, reported IPV-related TBI with (n = 13) or without (n = 20) persistent symptoms; that is, symptoms such as memory problems, balance problems or dizziness, sensitivity to bright light, irritability, headaches, and sleep problems that began or got worse immediately following the IPV-related TBI and occurred within the past week. These women completed web-based surveys 18 months later (Time 2), which included validated measures of psychiatric and physical health symptoms as well as past-year IPV. We conducted linear regressions to model whether T1 IPV-related TBI with persistent symptoms predicted worse health outcomes at T2, in comparison to T1 IPV-related without persistent symptoms. RESULTS: Controlling for significant covariates (i.e., military sexual trauma; MST), IPV-related TBI with persistent symptoms at Time 1 was associated with significantly worse outcomes at Time 2 across all health outcome domains (sr2 range: 0.12-0.37). After controlling for MST and probable posttraumatic stress disorder (PTSD) at Time 1, IPV-related TBI with persistent symptoms at Time 1 remained significantly associated with worse Time 2 symptoms of insomnia, depression, and physical health (sr2 range: 0.12-0.25). CONCLUSION: Women who experience IPV-related TBI with persistent symptoms are at higher risk for worse psychosocial health outcomes 18 months later. Findings necessitate screening IPV survivors for TBI with persistent symptoms and tailoring TBI and psychosocial interventions to reduce risk for ongoing health sequelae.

When user-centered design meets implementation science: integrating provider perspectives in the development of an intimate partner violence intervention for women treated in the United States' largest integrated healthcare system.

BACKGROUND: Intimate partner violence (IPV) against women is a global health problem that is a substantial source of human suffering. Within the United States (US), women veterans are at high risk for experiencing IPV. There is an urgent need for feasible, acceptable, and patient-centered IPV counseling interventions for the growing number of women treated in the US's largest integrated healthcare system, the Veterans Health Administration (VHA). Implementation science and user-centered-design (UCD) can play an important role in accelerating the research-to-practice pipeline. Recovering from IPV through Strengths and Empowerment (RISE) is a flexible, patient-centered, modular-based program that holds promise as a brief counseling intervention for women veterans treated in VHA. We utilized a UCD approach to develop and refine RISE (prior to formal effectiveness evaluations) by soliciting early feedback from the providers where the intervention will ultimately be implemented. The current study reports on the feedback from VHA providers that was used to tailor and refine RISE. METHOD: We conducted and analyzed semi-structured, key-informant interviews with VHA providers working in clinics relevant to the delivery of IPV interventions (n = 23) at two large medical centers in the US. Participants' mean age was 42.6 years (SD = 11.6), they were predominately female (91.3%) and from a variety of relevant disciplines (39.1% psychologists, 21.7% social workers, 17.4% physicians, 8.7% registered nurses, 4.3% psychiatrists, 4.3% licensed marriage and family therapists, 4.3% peer specialists). We conducted rapid content analysis using a hybrid inductive-deductive approach. RESULTS: Providers perceived RISE as highly acceptable and feasible, noting strengths including RISE's structure, patient-centered agenda, and facilitation of provider comfort in addressing IPV. Researchers identified themes related to content and context modifications, including requests for additional safety check-ins, structure for goal-setting, and suggestions for how to develop and implement RISE-specific trainings. CONCLUSIONS: These findings have guided refinements to RISE prior to formal effectiveness testing in VHA. We discuss implications for the use of UCD in intervention development and refinement for interventions addressing IPV and other trauma in health care settings globally. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03261700; Date of registration: 8/25/2017, date of enrollment of first participant in trial: 10/22/2018. Unique Protocol ID: IIR 16-062.

MMPI-2: cluster analysis of personality profiles in perinatal depression­preliminary evidence.

BACKGROUND: To assess personality characteristics of women who develop perinatal depression. METHODS: The study started with a screening of a sample of 453 women in their third trimester of pregnancy, to which was administered a survey data form, the Edinburgh Postnatal Depression Scale (EPDS) and the Minnesota Multiphasic Personality Inventory 2 (MMPI-2). A clinical group of subjects with perinatal depression (PND, 55 subjects) was selected; clinical and validity scales of MMPI-2 were used as predictors in hierarchical cluster analysis carried out. RESULTS: The analysis identified three clusters of personality profile: two "clinical" clusters (1 and 3) and an "apparently common" one (cluster 2). The first cluster (39.5%) collects structures of personality with prevalent obsessive or dependent functioning tending to develop a "psychasthenic" depression; the third cluster (13.95%) includes women with prevalent borderline functioning tending to develop "dysphoric" depression; the second cluster (46.5%) shows a normal profile with a "defensive" attitude, probably due to the presence of defense mechanisms or to the fear of stigma. CONCLUSION: Characteristics of personality have a key role in clinical manifestations of perinatal depression; it is important to detect them to identify mothers at risk and to plan targeted therapeutic interventions.

Cosmic kidney disease: an integrated pan-omic, physiological and morphological study into spaceflight-induced renal dysfunction.

Missions into Deep Space are planned this decade. Yet the health consequences of exposure to microgravity and galactic cosmic radiation (GCR) over years-long missions on indispensable visceral organs such as the kidney are largely unexplored. We performed biomolecular (epigenomic, transcriptomic, proteomic, epiproteomic, metabolomic, metagenomic), clinical chemistry (electrolytes, endocrinology, biochemistry) and morphometry (histology, 3D imaging, miRNA-ISH, tissue weights) analyses using samples and datasets available from 11 spaceflight-exposed mouse and 5 human, 1 simulated microgravity rat and 4 simulated GCR-exposed mouse missions. We found that spaceflight induces: 1) renal transporter dephosphorylation which may indicate astronauts' increased risk of nephrolithiasis is in part a primary renal phenomenon rather than solely a secondary consequence of bone loss; 2) remodelling of the nephron that results in expansion of distal convoluted tubule size but loss of overall tubule density; 3) renal damage and dysfunction when exposed to a Mars roundtrip dose-equivalent of simulated GCR.

Relationship of cortisol and alpha amylase to behavioral engagement under three levels of negative evaluative psychosocial stress.

Despite that behavioral engagement is integral to mental health, surprisingly little is known about the relationship of psychosocial stress and behavioral engagement. The current study developed an observer-rated measure of behavioral engagement for lab-based stress inductions, then examined its relationship with stress-responsive biomarkers and affect. Young adults (N = 109, Mage=19.4, SDage=1.59, 57% female) completed one of three Trier Social Stress Test (TSST) conditions-non-stressful Control, Intermediate, or an Explicit Negative Evaluative-and at four timepoints provided self-reports of positive and negative affect and saliva samples for cortisol and salivary alpha-amylase (sAA). Trained study staff (experimenters and TSST judges) completed a programmed questionnaire measure of the novel behavioral engagement measure after the participants completed the TSST. Psychometric review and EFA of the behavioral engagement items resulted in a final 8-item measure with good interrater reliability and well-fitting 2-factor structure, capturing Persistence (4 items; loadings=.41-.89), and Quality of Speech (4 items; loadings=.53-.92). Results indicated that the relationship of positive affect growth and biomarker level to behavioral engagement varied substantially as a function of context: As negative evaluation level strengthened, behavioral engagement became more tightly associated with relative preservation of positive affect. For both cortisol and sAA, the relationship between biomarker levels (but not reactivity) and behavioral engagement varied significantly by condition, such that under milder conditions and elevated levels of biomarkers, engagement was greater, but under Explicit Negative Evaluation, and elevated levels of biomarkers, engagement was less, suggesting behavioral withdrawal. Findings reveal the critical role of context-especially negative evaluation-in the relationship of biomarkers with behavioral engagement.

The Isolation, Culture, and Cryopreservation of Human Rectus Sheath Fibroblasts.

The vast majority of pelvic and intra-abdominal surgery is undertaken through at least one incision, through either the linea alba or the rectus sheath. These connective tissue layers are formed from the aponeuroses of the rectus muscles (anterior and posterior rectus sheath) and are vital for the structural integrity of the abdominal wall. Poor healing of these connective tissues after surgery can lead to significant morbidity for patients, who can develop unsightly and painful incisional hernias. Fibroblasts within the rectus sheath are responsible for laying down and remodeling collagen during the healing process after surgery. Despite their importance for this healing process, such cells have not been studied in vitro. In order to carry out such work, researchers must first be able to isolate these cells from human tissue and culture them successfully so they may be used for experimentation. This article provides an extensive and detailed protocol for the isolation, culture, cryopreservation, and thawing of human rectus sheath fibroblasts (RSFs). In our hands, this protocol develops confluent cultures of primary fibroblasts within 2 weeks, and sufficient cultures ready for freezing and storage after a further 2 to 4 weeks. © 2023 The Authors. Current Protocols published by Wiley Periodicals LLC. Basic Protocol: Collagenase digestion of human rectus sheath and isolation of RSFs Alternate Protocol: Collagenase digestion of human rectus sheath and isolation of RSFs, digestion in flask Support Protocol: Cryopreservation and thawing of human RSFs.

Additive serotonergic genetic sensitivity and cortisol reactivity to lab-based social evaluative stress: Influence of severity across two samples.

Prior work demonstrates that an additive serotonergic multilocus genetic profile score (MGPS) predicts amplified risk for depression following significant life stress, and that it interacts with elevations in the cortisol awakening response to predict depression. The serotonin system and HPA-axis have bidirectional influence, but whether this MGPS predicts acute cortisol reactivity, which might then serve as a mechanism for depression, is unknown. Our prior work suggests that depression risk factors predict blunted cortisol reactivity to explicit negative evaluative lab-based stress. Thus, we hypothesized that a 4-variant serotonergic MGPS (three SNPs from the original 5-variant version plus 5HTTLPR) would predict blunted cortisol reactivity to explicit negative evaluative stress versus a control. In Sample 1, growth curve modeling showed that the MGPS predicted heightened cortisol reactivity (p = 0.0001) in an explicitly negative evaluative Trier Social Stress Test variant (TSST) versus a control condition among non-depressed emerging adults (N = 152; 57% female). In Sample 2, 125 males completed the Socially Evaluative Cold Pressor Test (SECPT), an ambiguously negative evaluative manipulation; findings displayed a similar pattern but did not reach statistical significance (ps.075-.091). A participant-level meta-analysis of the two samples demonstrated a significant effect of negative evaluation severity, such that the MGPS effect size on reactivity increased linearly from control to SECPT to an explicitly negative evaluative TSST. Findings indicate that this MGPS contributes to sensitivity to social threat and that cortisol dysregulation in the context of social stress may be one mechanism by which this MGPS contributes to depression.

Strides Toward Recovery From Intimate Partner Violence: Elucidating Patient-Centered Outcomes to Optimize a Brief Counseling Intervention for Women.

Women in the United States continue to experience intimate partner violence (IPV) at unprecedented rates, necessitating the development and implementation of personalized, effective healthcare-based interventions. Methods of developing patient-centered interventions for IPV should elicit the voice of the target population (i.e., women who experience IPV) while assuring that outcomes identified as important are incorporated into the refined intervention. This pilot study is part of a multiphase, larger study aiming to refine an IPV intervention and clinical outcome measurements prior to formal evaluation of the effectiveness of the intervention. Specifically, this study elucidates patient-centered outcomes identified by women who have experienced IPV. Women patients of the Veterans Health Administration (VHA) in New England participated in focus groups to provide feedback and desired outcomes of a new IPV intervention. Patient-centered outcomes were defined by the participants. Focus groups were transcribed and analyzed using conventional content analysis and matrix analysis. A total of 25 women participated in focus groups (n = 5) at two large VHA facilities. Participant feedback revealed five common themes related to desired outcomes. Women opined increased feelings of empowerment as a key outcome of engaging in an IPV intervention. Women desired increased social connectedness and support to be gained during treatment, citing providers and other survivors of IPV as exemplary sources. Self-esteem was viewed as critical to enhancing recovery, as was increased knowledge across domains of IPV (e.g., warning signs, the link between mental and physical health for self and children). Finally, women identified valued action and goal setting, such as achieving more independence, as an optimal outcome. Addressing IPV against women requires patient-centered interventions that specifically target the types of outcomes deemed important by the end users: women who experience IPV. Findings have implications for tailoring treatments for IPV and selecting measures that tap into women's desired outcomes.

Getting Routine Intimate Partner Violence Screening Right: Implementation Strategies Used in Veterans Health Administration (VHA) Primary Care.

BACKGROUND: Evidence supports the clinical effectiveness of intimate partner violence (IPV) screening programs, but less is known about implementing and sustaining them. This qualitative study identified implementation strategies used to integrate IPV screening programs within Veterans Health Administration (VHA) women's health primary care. METHODS: Thirty-two administrators and clinician key informants from 11 VHA facilities participated in semistructured interviews. Implementation strategies were identified using established definitions from implementation science literature, through multistep content analysis, involving site comparisons by implementation status. RESULTS: We identified 8 implementation strategies. Three were present across all sites: (1) conduct ongoing IPV trainings, (2) conduct educational meetings and outreach visits, and (3) develop and distribute educational materials. Five strategies were unique to early adopting sites: (4) identify and prepare champions, (5) change record systems to remind clinicians, (6) create a learning collaborative through advisory boards or workgroups, (7) audit and provide feedback with relay of clinical data to providers, and (8) access new funding. DISCUSSION: Strategies align with and extend literature addressing barriers to screening. Evidence shows that effective IPV screening implementation in primary care requires a bundle of well-defined, carefully selected strategies. CONCLUSIONS: Implementation strategies used collectively can enable integration of IPV screening programs in primary care.

Adoption, penetration, and effectiveness of a secondary risk screener for intimate partner violence: Evidence to inform screening practices in integrated care settings.

OBJECTIVE: Veterans Health Administration (VHA) has implemented screening for past-year intimate partner violence (IPV) in some healthcare facilities along with secondary screening of risk for severe violence among those screening positive in order to facilitate follow-up care for high-risk patients. We evaluated the adoption, penetration, and effectiveness of secondary screening as a tool to facilitate timely follow-up services. METHODS: Retrospective review of medical records (screening and healthcare use) of 774 women screening positive for past-year IPV (IPV+) at 11 facilities nationwide from April 2014-April 2016. Chi-square and t-tests examined factors related to secondary screening. RESULTS: Three of eleven (27.3%) facilities that implemented primary IPV screening adopted secondary screening. At adopting sites, 56.4% eligible (i.e., IPV+) women received secondary screening. Among 185 IPV+ women who completed secondary screening, 33.0% screened positive for severe IPV. Screening positive during secondary screening was associated with higher rate of psychosocial care within 60 days (73.8% vs. 54.0% of IPV+ patients screening negative; p < .05), posttraumatic stress disorder diagnosis (31.1% vs. 15.3%; p < .05), and being physically threatened or harmed (>50% vs. <15%; p < .001). CONCLUSIONS: Secondary risk assessment following IPV screening may expedite access to psychosocial follow-up care in integrated healthcare settings. However, program uptake needs to be enhanced.

[Perinatal depression and affective bonds: experience in close relationship during pregnancy]. / Depressione perinatale e relazioni affettive: l'experience in close relationship in gravidanza.

AIM: This study aims to investigate the influence of the "romantic attachment" style, stressful life events, social factors on the risk of developing a depression during pregnancy and on the severity of depressive symptoms. METHODS: The study started with a screening on a sample of 453 women, during their third trimester of pregnancy, to which has been administered a survey data form, the Edinburgh Postnatal Depression Scale (EPDS) and the Experience in Close Relationship (ECR). Based on the results at EPDS, a clinical group of pre-natal depression (D=89) was selected and compared with a control group (C=89), in regards to psychopathological and social variables, exposure to stressful life events and attachment patterns. Analysis of correlation were performed to evaluate the influence of these factors on depressive symptoms severity. RESULTS: In D group, 52.8% of subjects reported previous psychiatric disorders and 49.4% a familiarity; 29.2% of these women complains of conflicts with their family of origin and 32.6% with partner. The ECR showed a prevalence of "fearful-avoidant" attachment style in clinical group (29.2% vs 1.1%, p=0.000); besides, ECR dimensions ("Avoidance", "Anxiety"), correlate with the severity of depressive symptoms. CONCLUSIONS: Positive family history for psychiatric disorders and an insecure romantic attachment might influence the development and the severity of perinatal depression.