ResearchPad - pilot-studies https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Associations Between Patients’ Unmet Social Needs and Self-Reported Health Confidence at One Primary Care Clinic]]> https://www.researchpad.co/article/elastic_article_14066 Social determinants of health affect a person’s health at least as much as their interactions with the healthcare system. Increased patient activation and self-efficacy are associated with decreased cost and improved quality. Patient-reported health confidence has been proposed as a more easily measured proxy for self-efficacy. Evaluation of the association between unmet social needs and health confidence is limited. Our objective was to identify and address our patients’ unmet social needs and assess health confidence levels. From November 2017 through July 2018 we screened 2018 patients of an urban academic family medicine residency practice for unmet social needs, measured their health confidence, and made referrals to community resources if desired. Patients reporting the presence of any social need reported lower health confidence scores on average than those with no needs (8.49 vs 9.30, median 9 vs 10, Wilcoxon test P < .001). Low health confidence scores (<7) were strongly associated with number of needs (P < .001) after adjusting for age, gender, race, ethnicity, payer, and visit type (1 vs 0 needs, odds ratio [OR] = 2.566, 95% CI 1.546-4.259; 2 or more vs 0 needs, OR = 6.201, 95% CI 4.022-9.561). Results of this quality improvement project suggest that patients with unmet social needs may have decreased perceived ability to manage health problems. Further study is needed to determine if this finding is generalizable, and if interventions addressing unmet social needs can increase health confidence.

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<![CDATA[Proficiency based progression simulation training significantly reduces utility strikes; A prospective, randomized and blinded study]]> https://www.researchpad.co/article/elastic_article_7871 We evaluated a simulation-based training curriculum with quantitatively defined performance benchmarks for utility workers location and excavation of utility services.BackgroundDamaging buried utilities is associated with considerable safety risks to workers and substantial cost to employers.MethodsIn a prospective, randomized and blinded study we assessed the impact of Proficiency Based Progression (PBP) simulation training on the location and excavation of utility services work.ResultsPBP simulation training reduced performance errors (33%, p = 0.006) in comparison a standard trained group. When implemented across all workers in the same division there was a 35–61% reduction in utility strikes (p = 0.028) and an estimated cost saving of £116,000 –£2,175,000 in the 12 months (47,000 work hours) studied.ConclusionsThe magnitude of the training benefit of PBP simulation training in the utilities sector appears to be the same as it is in surgery, cardiology and procedure-based medicine.ApplicationQuality-assured utility worker simulation training significantly reduces utility damage and associated costs. ]]> <![CDATA[Development and validation of a questionnaire to assess healthcare personnel competence in cardiac arrest and resuscitation in pregnancy]]> https://www.researchpad.co/article/elastic_article_7826 Cardiac arrest is rare in pregnancy, and up-to date competence can be difficult to assess and maintain. The objective of this study was to develop and validate a questionnaire to assess healthcare personnel experiences, self-assessed competence and perception of role and resposibility related to cardiac arrest and cardio-pulmonary resuscitation (CPR) in pregnancyMethodsThe study had a cross-sectional design, developing and validating a questionnaire: the Competence in cardiac arrest and CPR in pregnancy (ComCA-P). Development and validation of the ComCA-P was conducted in three stages: 1) Literature review and expert group panel inputs, 2) a pilot study and 3) a cross-sectional questionnaire study. In stage one, the ComCA-P was developed over several iterations between the researchers, including inputs from an expert group panel consisting of highly competent professionals (n = 11). In stage two, the questionnaire was piloted in a group of healthcare personnel with relevant competence (n = 16). The ComCA-P was then used in a baseline study including healthcare personnel potentially involved in CPR in pregnancy (n = 527) in six hospital wards. Based on these data, internal consistency, intra-class correlations, and confirmatory factor analysis were utilized to validate the questionnaire.ResultsThe expert group and pilot study participants evaluated the appropriateness, relevance and accuracy to be high. Formulation of the items was considered appropriate, with no difficulties identified related to content- or face validity. Cronbach’s alpha was 0.8 on the thematic area self-assessment, and 0.73 on the theoretical knowledge area of the ComCA-P. On both the self-assessed competence items and the teoretical knowledge items, Kaiser-Meyer-Olkin was 0.8. Moreover, the Bertletts’ test of sphericity was greater than the critical value for chi-square, and significant (p < .0001).ConclusionsFindings indicate that the ComCA-P is a valid questionnaire that can be used to assess healthcare personnel competence in cardiac arrest and resuscitation in pregnancy. ]]> <![CDATA[Implementation of HIV Preexposure Prophylaxis in a Homeless Primary Care Setting at the Veterans Affairs]]> https://www.researchpad.co/article/N11233bc7-a9fa-4c21-8ac8-9200383006de

Objective: Oral preexposure prophylaxis (PrEP) is highly effective in preventing HIV-1 acquisition, yet it is underutilized among at-risk populations. In this pilot quality improvement (QI) initiative, we sought to identify barriers to PrEP implementation and create interventions to improve access to PrEP in a primary care clinic for homeless veterans. Methods: The setting was a large homeless primary care clinic at the Veterans Affairs in an urban area with high HIV prevalence. A root cause analysis was performed to identify barriers to PrEP expansion in the primary care clinic. Targeted interventions to improve provider knowledge and patient access to PrEP were implemented by the QI team. Results: Root cause analysis revealed 3 primary barriers to PrEP expansion in the primary care clinic: institutional limitations for prescribing PrEP, inconsistent screening and recognition of eligible patients by clinic staff, and lack of clinic workflow processes to support PrEP prescription. A multidisciplinary focus group found low levels of PrEP awareness and knowledge, with only 22% of providers reporting comfort discussing PrEP with patients. This improved to 40% of providers following targeted clinic educational interventions. The QI team also developed a pathway for primary care providers to obtain institutional PrEP prescribing privileges and used work groups to develop clinic workflows and protocols for PrEP. At the end of the intervention, at least 50% of primary care providers in the clinic had initiated PrEP in a new patient. Conclusions: We describe a multidisciplinary QI model to implement PrEP within a primary care setting serving Veterans and persons experiencing homelessness. Our program successfully addressed provider knowledge deficits and improved primary care capacity to prescribe PrEP. The primary care clinic can be a viable and important clinical setting to improve access to PrEP for HIV prevention, especially for vulnerable populations.

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<![CDATA[Quantitation of 5-methyltetraydrofolic acid in plasma for determination of folate status and clinical studies by stable isotope dilution assays]]> https://www.researchpad.co/article/5c785012d5eed0c484007c22

Folates play a key role in the prevention of neural tube defects in newborns. Thus, it is important to reliably determine the bioavailability of folates from various foods. Accurate analytical methods are essential for quantifying blood-folates, especially in human studies. Here, we present the development and validation of a sensitive method using stable isotope dilution liquid chromatography coupled with mass spectrometry for determining various folates in plasma. Moreover, this study reports the applicability of the developed method to a human pilot study using strawberries as a test food. Validation of the assay revealed the precision, sensitivity, and accuracy of the method in determining the predominant 5-methyltetrahydrofolate in plasma. This method was also applicable for the screening of individual folate status using finger prick blood and for monitoring the post-absorptive plasma-concentration curve. Moreover, the human study revealed a high recovery of strawberry folates with a calculated relative bioavailability of 96.2%. Thus, the developed method enables prospective bioavailability studies. This work also confirmed, via human studies, that strawberries are a rich and natural source of folates that are available for human metabolism.

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<![CDATA[‘We are the change’ - An innovative community-based response to address self-stigma: A pilot study focusing on people living with HIV in Zimbabwe]]> https://www.researchpad.co/article/5c6dca28d5eed0c48452a859

Introduction

Self-stigma–negative self-judgements resulting in shame, worthlessness and self-blame–may play a crucial role in emotional reactions and cause emotional distress among many people living with HIV and other chronic illnesses. Furthermore, self-stigma negatively impacts on self-agency, quality of life, adherence to treatment, and access to services. High levels of self-stigma have been reported across many countries, however few programmes or interventions exist to specifically tackle this phenomenon. This paper reports the findings of a pilot study carried out in Zimbabwe using a programme incorporating “Inquiry-Based Stress Reduction (IBSR): The Work of Byron Katie”–a guided form of self-inquiry which helps users to overcome negative thoughts and beliefs.

Objectives

The primary objective of this uncontrolled pilot study was to examine the potential role of the IBSR intervention in helping people living with HIV to overcome self-stigma and associated states.

Methods

23 people living with HIV (17 Female, 6 male, average age 41 years) were recruited from a local HIV support network, via open call for volunteers. All participants received the intervention, consisting of a 12-week facilitated programme using techniques derived from IBSR: The Work of Byron Katie. Qualitative and quantitative data were collected and analysed pre- and post-programme.

Results

After taking part in the intervention, participants reported significant improvements in factors including self-stigma (1-month follow-up vs baseline Z = 2.1, p = 0.039; 3-month follow-up vs baseline Z = 3.0, p = 0.003, n = 23, Wilcoxon Matched Pairs Signed Rank Test) and depression (1mo vs baseline Z = 3.7, p = <0.001; 3mo vs baseline Z = 3.3, p = 0.001). Qualitatively, participants reported improvements including lessened fears around disclosure of their HIV status, reduced feelings of life limitations due to HIV, and greater positive mentality. Improvements persisted at three-month follow-up.

Conclusion

With further development and larger comparative studies to confirm effects, the IBSR programme could become a novel tool to enable people living with HIV to support themselves in overcoming self-stigma.

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<![CDATA[Electric stimulation-guided epidural analgesia for vaginal delivery: A randomized prospective study]]> https://www.researchpad.co/article/5c42436ed5eed0c4845e0193

Background

The failure rate of epidural anesthesia using the loss of resistance technique is 13–23%.

Objectives

To investigate the efficacy of epidural electric stimulation-guided epidural analgesia in vaginal delivery.

Study design

An open label randomized prospective study.

Methods

Laboring women were randomized to two groups: epidural catheter insertion using only a loss of resistance technique or a loss of resistance technique with confirmation by electric stimulation. Catheters in both groups were initially tested with 3 ml of 1% lidocaine and those with any evidence of motor blockade were considered intrathecal. Sensory blockade and an 11 point numerical rating score for pain were assessed 30 minutes after administration of an epidural bolus of 10 ml of 0.22% ropivacaine with fentanyl. Successful epidural analgesia was defined as a decrease of 2 or more in the pain score and a bilateral L1-T10 sensory blockade.

Results

Thirty-one patients were randomized to each group. The first 20 patients in each group were enrolled in a pilot study and were also included in the final analysis. One patient in the electric stimulation group was excluded owing to dural puncture by the Tuohy needle. One patient in each group demonstrated motor blockade after test dose and were considered failures. The number (% (95% confidence interval)) of successful cases were 29 out of 30 (97% (85, 100%)) in the electric stimulation group and 24 out of 31 (77% (61, 89%)) in the loss of resistance group (P = 0.053). However, analysis of only patients with absence of motor blockade revealed that 29 out of 29 (100% (92, 100%)) patients in the electric stimulation group and 24 of 29 (80% (63, 91%)) patients in the loss of resistance group had adequate analgesia (P = 0.024).

Conclusions

Although limited by lack of blinding, small study size and inclusion of pilot study data, this study suggests epidural electric stimulation improves the success rate of subsequent labor analgesia.

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<![CDATA[Prevalence of stress and its determinants among residents enrolled in China Standardized Training Program for Resident Doctor (C-STRD) program: A cross-sectional study]]> https://www.researchpad.co/article/5c3d0151d5eed0c48403a372

Background

It has been widely understood that well-trained doctors are crucial for a high-quality public health system and safe patient care. Thus, in 2011, China initiated its first national residency training program, called the China Standardized Training for Resident Doctor (C-STRD), for medical graduates to prepare qualified doctors for the medical care system with increasing demands. So far, no studies have specifically address the prevalence of stress and its determinants among residents enrolled in the C-STRD.

Participants and methods

The research is performed in two stages. In stage I, the authors conducted a pilot study and met 112 C-STRD residents in person. Based on the preliminary data, a revised questionnaire was adopted in stage II, during which the authors conducted a multi-institutional, cross-sectional survey of 340 participants from 11 hospitals in Shanghai in a self-administered manner.

Results

The results showed that C-STRD residents were overall under severe stress as their mean PSS score was 27.5 ± 4.9, which was higher than the threshold of high stress (PSS = 20). Specifically, the PSS score for the residents with Bachelor (MB), Master (MM) and Doctoral of Medicine (MD) educational degree were 26.6 ± 4.1, 27.8 ± 3.5 and 27.1 ± 5.2, respectively (P>0.05). Their stress was mainly associated with their financial income status and workload, as these two factors caused more severe burden than other listed stressors (P<0.05). Specially, the residents indicated that their montly payroll amout were as low as $590.2 ± 127 while no benefit package and allowance were given. Surprisingly, wage arrears up to 5.3 month were reported by 36 (10%) participants. Workload survey showed the residents has high work intensity and inadequate rest. Since no stress management program was provided, the majority of residents tended to cope their stress with unhealthy strategies, such as mesmerizing in TV/computer (88.2%) and overeating (59.7%).

Conclusion

The C-STRD residents are at high risk of perceived stress. Although there was a difference in perception of stress for workload and career future among different educational degree owners, low financial income is the major stressor among all C-STRD residents. Unhealthy stress management strategies were adopted by all residents due to lack of appropriate stress-relieving intervention.

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<![CDATA[Spiroergometric measurements under increased inspiratory oxygen concentration (FIO2)—Putting the Haldane transformation to the test]]> https://www.researchpad.co/article/5c1ab87ad5eed0c484028333

Spiroergometric measurements of persons who require oxygen insufflation due to illness can be performed under conditions of increased inspiratory oxygen concentration (FIO2). This increase in FIO2, however, often leads to errors in the calculation of oxygen consumption (V˙O2). These inconsistencies are due to the application of the Haldane Transformation (HT), an otherwise indispensable correction factor in the calculation of V˙O2 that becomes inaccurate at higher FIO2 concentrations. A possible solution to this problem could be the use of the ‘Eschenbacher transformation’ (ET) as an alternative correction factor. This study examines the concentration of FIO2 at which the HT and the ET are valid, providing plausible data of oxygen consumption corresponding to the wattage achieved during cycle ergometry. Ten healthy volunteers underwent spiroergometric testing under standard conditions (FIO2 = 20.9%), as well as at FIO2 = 40% and 80%. When compared with the predicted values of V˙O2, as calculated according to Wasserman et al. (2012), the data obtained show that both the HT and ET are valid under normal conditions and at an increased FIO2 of 40%. At FIO2 concentrations of 80%, however, the V˙O2 values provided by the HT begin to lose plausibility, whereas the ET continues to provide credible results. We conclude that the use of the ET in place of the HT in spiroergometric measurements with increased FIO2 allows a reliable evaluation of stress tests in patients requiring high doses of supplemental oxygen.

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<![CDATA[Development of MHFA-based 2-h educational program for early intervention in depression among office workers: A single-arm pilot trial]]> https://www.researchpad.co/article/5c141ea5d5eed0c484d27947

Objective

In the workplace depression and suicide are serious mental health problems. A lack of knowledge and mental health skills along with the stigma toward mental health problems often results in delays in seeking professional help. Interventions targeting not only persons with mental health problems but also people around the individual are warranted in order to encourage supporting behavior within entire workplace. In the present study, we investigated the efficacy of our newly developed educational training program in the management with depression and suicidal risk in the workplace as a single-arm pilot trial.

Methods

The program is a two-hour (2-h) training course for employees based on the Mental Health First Aid (MHFA) program which aims to increase public mental health literacy. We conducted this program at a company workplace among 91 employees, and ultimately 83 participants completed the self-rated questionnaires. Changes in confidence and practical skills in early intervention of depression and suicide-prevention, and stigma toward mental health problems were evaluated using self-rated questionnaires at 3 time-points; pre-program, immediately post-program, and 1 month after the program.

Results

Confidence and practical skills were significantly improved even 1 month after the program, and stigma reduced just after the program.

Conclusions

Our pilot study suggests that the program has a positive impact on encouraging employees to support their co-workers with mental health problems, and is applicable for busy workers due to its short duration. A single-arm design, evaluation using self-rated questionnaire and short-term follow up period are the main limitations of the present study. Hence, future research is required to validate the effects of this program with control groups, and also to assess long-term effectiveness and objective changes such as absenteeism and sick leave.

Trial registration

UMIN Clinical Trials Registry (UMIN-CTR) R000023258

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<![CDATA[The National Institutes of Health measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor analysis and validation]]> https://www.researchpad.co/article/5c1ab827d5eed0c484026e6a

Two hundred patients with severe and/or life-threatening disease were recruited form the NIH Clinical Center and participated in the validation of the NIH-HEALS, which included exploratory factor analysis, principal component analysis, reliability, convergent validity, and divergent validity analyses. Item-reducing principal components analysis and internal consistency and split-half reliability demonstrated excellent internal consistency and split-half reliability (Cronbach’s alpha = 0.89, split-half reliability = 0.95). Exploratory factor analysis revealed a three-factor structure, namely Connection (including religious, spiritual, and interpersonal), Reflection & Introspection, and Trust & Acceptance. Seven items were not retained. Convergent and divergent validity of 35-item NIH-HEALS against other validated measures of healing and spirituality provided strong evidence for its validity. As predicted, the Healed factor of the Self-Integration Scale (SIS), and Meaning, Peace, and Faith factors of the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being-12 Scale (FACIT-SP12) were all positively and significantly correlated with the NIH-HEALS and its three factors. Divergent validity was also confirmed by the significant negative correlation between the NIH-HEALS and the Codependent factor on the SIS. Confirmatory Factor Analyses revealed good model fit by GFI (0.96), adjusted GFI (0.95), SRMR (0.077), and RMSEA (0.065), supporting the use of the NIH-HEALS with 35 items.

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<![CDATA[Cervico-vaginal inflammatory cytokine alterations after intrauterine contraceptive device insertion: A pilot study]]> https://www.researchpad.co/article/5c1028cfd5eed0c48424826a

In a prospective study of twenty sexually transmitted infection (STI)-free women, we examined the impact of an intrauterine contraceptive device (IUCD) insertion on cervico-vaginal cytokine levels. Nine women chose the levonorgestrel-containing IUCD and eight chose a copper IUCD. A cervico-vaginal swab was collected for cytokine analysis pre-insertion and four weeks post-insertion. Significant increases were noted in levels of IL-1α (median 483.4 versus 316.6 pg/mL, p = 0.046), IL-1β (median 605.7 versus 147.3 pg/mL, p = 0.018), IL-6 (median 570.1 versus 157.3 pg/mL, p = 0.046), TNFα (median 1.19 versus 0.6 pg/mL, p = 0.029) and the chemokine MCP-1 (median 340.2 versus 135.2 pg/mL, p = 0.003). No significant changes were noted in the levels of GM-CSF, IL-8, MIG, MIP-3α, RANTES, IL-10, IL-17, IP-10, MIP-1β. Whether this increase in pro-inflammatory cytokine levels decreases epithelial barrier integrity and enhances susceptibility to STIs, including HIV, merits further study.

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<![CDATA[Long-term impact of a faculty mentoring program in academic medicine]]> https://www.researchpad.co/article/5c2400c7d5eed0c4840990e8

The authors conducted a prospective longitudinal study from 2009 to 2016 to assess the short and long-term impact of a formal mentorship program on junior faculty satisfaction and productivity. Junior faculty mentees enrolled in the program and junior faculty without formal mentorship were administered surveys before and after the program to assess satisfaction with their mentoring experiences. Long-term retention, promotion, and funding data were also collected. Twenty-three junior faculty mentees and 91 junior faculty controls were included in the study. Mentees came from the Departments of Radiation Oncology and Anesthesia, Critical Care, and Pain Management. After participating in the mentorship program, mentees demonstrated an increase in satisfaction from baseline in five of seven domains related to mentoring, while controls experienced no significant change in satisfaction in six of the seven domains. At long-term follow up, mentees were more likely than controls to hold senior faculty positions (percent senior faculty: 47% vs. 13%, p = 0.030) despite no difference in initial administrative rank. When comparing the subset of faculty who were Instructors at baseline, mentees were more likely to be funded and/or promoted than controls (p = 0.030). A majority of mentees reported that the program strengthened their long-term success, and many maintained their original mentoring relationships and formed new ones, highlighting the strong culture of mentorship that was instilled. Several short-term and long-term benefits were fostered from this formal mentorship program. These findings highlight the potential impact of mentorship programs in propagating a culture of mentorship and excellence.

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<![CDATA[Rapid, inexpensive, fingerstick, whole-blood, sensitive, specific, point-of-care test for anti-Toxoplasma antibodies]]> https://www.researchpad.co/article/5b8b29e440307c405292ca53 ]]> <![CDATA[Treatment of Tungiasis with Dimeticone: A Proof-of-Principle Study in Rural Kenya]]> https://www.researchpad.co/article/5989da31ab0ee8fa60b8480f

Tungiasis (sand flea disease) is a neglected tropical disease, prevalent in resource-poor communities in South America and sub-Saharan Africa. It is caused by an inflammatory response against penetrated female sand fleas (Tunga penetrans) embedded in the skin of the host. Although associated with debilitating acute and chronic morbidity, there is no proven effective drug treatment. By consequence patients attempt to remove embedded sand fleas with non-sterile sharp instruments, such as safety pins, a procedure that represents a health threat by itself. In this proof-of-principle study we compared the topical application of a mixture of two dimeticones of low viscosity (NYDA) to the topical application of a 0.05% solution of KMnO4 in 47 school children in an endemic area in rural Kenya. The efficacy of the treatment was assessed during a follow up period of seven days using viability signs of the embedded parasites, alterations in the natural development of lesion morphology and the degree of local inflammation as outcome measures. Seven days after treatment, in the dimeticone group 78% (95% CI 67–86%) of the parasites had lost all signs of viability as compared to 39% (95% CI 28–52%) in the KMnO4 group (p<0.001). In the dimeticone group 90% (95% CI 80–95%) of the penetrated sand fleas showed an abnormal development already after 5 days, compared to 53% (95% CI 40–66%; p<0.001) in the KMnO4 group. Seven days after treatment, signs of local skin inflammation had significantly decreased in the dimeticone group (p<0.001). This study identified the topical application of dimeticones of low viscosity (NYDA) as an effective means to kill embedded sand fleas. In view of the efficacy and safety of the topical treatment with dimeticone, the mechanical extraction of embedded sand fleas using hazardous instruments is no longer warranted.

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<![CDATA[The Cooking and Pneumonia Study (CAPS) in Malawi: A Nested Pilot of Photovoice Participatory Research Methodology]]> https://www.researchpad.co/article/5989d9d6ab0ee8fa60b65db8

The Cooking and Pneumonia Study (CAPS) is a village-level randomised controlled trial of an advanced cookstove intervention to prevent pneumonia in children under the age of 5 in rural Malawi (www.capstudy.org). The trial offers a unique opportunity to gain understanding about the social and cultural factors that may facilitate sustained use of improved cookstoves. In January 2015, the use of Photovoice as a participatory research methodology was piloted at the CAPS Chikhwawa site. Photovoice is a photographic technique that allows communities (including women and marginalised groups) to share knowledge about their perspectives and priorities. Four households were given digital cameras and asked to collect images over 24–48 hours and were then interviewed on film about their selection. This resulted in over 400 images and a one hour long film that revealed community concerns and could be thematically analysed. The collection of interview data through film was useful for capturing discussion and was acceptable to participants. Photovoice is a feasible participatory research methodology that can play a valuable role in qualitative studies of improved cookstove adoption in challenging resource poor settings.

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<![CDATA[Pilot Investigation of PTSD, Autonomic Reactivity, and Cardiovascular Health in Physically Healthy Combat Veterans]]> https://www.researchpad.co/article/5989db01ab0ee8fa60bc6bd4

Posttraumatic stress disorder (PTSD), and combat-related PTSD in particular, has been associated with increased rates of cardiovascular disease, and cardiovascular-related death. However, less research has examined possible factors that may link PTSD to poorer cardiovascular health in combat veteran populations. The current pilot study investigated whether psychological symptomology and autonomic reactivity to emotional scripts would relate to poorer cardiovascular health in combat veterans without a current diagnosis of cardiovascular disease. Male veterans (N = 24), who served in combat since Operation Iraqi Freedom, completed a semi-structured interview and self-report measures to assess psychological symptomology. Autonomic reactivity, measured using heart rate variability (HRV; low to high frequency ratio), was obtained during script-driven imagery of emotional memories. Cardiovascular health was assessed using flow-mediated dilation (FMD) of the brachial artery. Correlational analyses and discriminant analysis were used to assess the relationship between psychological symptoms (PTSD, depression, anger, as measured via self-report), autonomic reactivity to emotional scripts (HRV), and FMD. Overall, veterans in the current study showed poor cardiovascular health despite their relatively young age and lack of behavioral risk factors, with 15/24 exhibiting impaired FMD (FMD < 5%). Psychological symptomology was not associated with FMD; whereas autonomic reactivity to emotional (compared to neutral) scripts was found to relate to FMD. Autonomic reactivity to negative scripts correctly classified 76.5% of veterans as having impaired versus normative FMD. Results from this pilot study highlight the importance of cardiovascular screening with combat veterans despite psychological diagnosis. Results also support the need for longitudinal research assessing the use of autonomic reactivity to emotionally valenced stimuli as a potential risk factor for poorer cardiovascular health.

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<![CDATA[Uncovering precision phenotype-biomarker associations in traumatic brain injury using topological data analysis]]> https://www.researchpad.co/article/5989db50ab0ee8fa60bdbdf6

Background

Traumatic brain injury (TBI) is a complex disorder that is traditionally stratified based on clinical signs and symptoms. Recent imaging and molecular biomarker innovations provide unprecedented opportunities for improved TBI precision medicine, incorporating patho-anatomical and molecular mechanisms. Complete integration of these diverse data for TBI diagnosis and patient stratification remains an unmet challenge.

Methods and findings

The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot multicenter study enrolled 586 acute TBI patients and collected diverse common data elements (TBI-CDEs) across the study population, including imaging, genetics, and clinical outcomes. We then applied topology-based data-driven discovery to identify natural subgroups of patients, based on the TBI-CDEs collected. Our hypothesis was two-fold: 1) A machine learning tool known as topological data analysis (TDA) would reveal data-driven patterns in patient outcomes to identify candidate biomarkers of recovery, and 2) TDA-identified biomarkers would significantly predict patient outcome recovery after TBI using more traditional methods of univariate statistical tests. TDA algorithms organized and mapped the data of TBI patients in multidimensional space, identifying a subset of mild TBI patients with a specific multivariate phenotype associated with unfavorable outcome at 3 and 6 months after injury. Further analyses revealed that this patient subset had high rates of post-traumatic stress disorder (PTSD), and enrichment in several distinct genetic polymorphisms associated with cellular responses to stress and DNA damage (PARP1), and in striatal dopamine processing (ANKK1, COMT, DRD2).

Conclusions

TDA identified a unique diagnostic subgroup of patients with unfavorable outcome after mild TBI that were significantly predicted by the presence of specific genetic polymorphisms. Machine learning methods such as TDA may provide a robust method for patient stratification and treatment planning targeting identified biomarkers in future clinical trials in TBI patients.

Trial Registration

ClinicalTrials.gov Identifier NCT01565551

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<![CDATA[Complement effectors, C5a and C3a, in cystic fibrosis lung fluid correlate with disease severity]]> https://www.researchpad.co/article/5989db51ab0ee8fa60bdc410

In cystic fibrosis (CF), lung damage is mediated by a cycle of obstruction, infection, inflammation and tissue destruction. The complement system is a major mediator of inflammation for many diseases with the effectors C5a and C3a often playing important roles. We have previously shown in a small pilot study that CF sputum soluble fraction concentrations of C5a and C3a were associated with clinical measures of CF disease. Here we report a much larger study of 34 CF subjects providing 169 testable sputum samples allowing longitudinal evaluation comparing C5a and C3a with clinical markers. Levels of the strongly pro-inflammatory C5a correlated negatively with FEV1% predicted (P < 0.001), whereas the often anti-inflammatory C3a correlated positively with FEV1% predicted (P = 0.01). C5a concentrations correlated negatively with BMI percentile (P = 0.017), positively with worsening of an acute pulmonary exacerbation score (P = 0.007) and positively with P. aeruginosa growth in sputum (P = 0.002). C5a levels also correlated positively with concentrations of other sputum markers associated with worse CF lung disease including neutrophil elastase (P < 0.001), myeloperoxidase activity (P = 0.006) and DNA concentration (P < 0.001). In contrast to C5a, C3a levels correlated negatively with worse acute pulmonary exacerbation score and correlated negatively with sputum concentrations of neutrophil elastase, myeloperoxidase activity and DNA concentration. In summary, these data suggest that in CF sputum, increased C5a is associated with increased inflammation and poorer clinical measures, whereas increased C3a appears to be associated with less inflammation and improved clinical measures.

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<![CDATA[4D-CTA improves diagnostic certainty and accuracy in the detection of proximal intracranial anterior circulation occlusion in acute ischemic stroke]]> https://www.researchpad.co/article/5989db4fab0ee8fa60bdbcaf

Introduction

In acute ischemic stroke, imaging of the cranio-cervical vessels is essential for intra-arterial treatment selection. Fast, reliable and easy accessible imaging is necessary 24 hours a day, 7 days a week. Radiologists in training and non-expert readers often perform initial reviewing. In this pilot study, the potential benefit of adding 4Dimensional-CT Angiography (4D-CTA) to the patient selection protocol for intra-arterial therapy is investigated.

Materials and methods

Twenty-five datasets of prospectively recruited patients, eligible for intra-arterial treatment, were enrolled. Four radiologists-in-training consecutively reviewed CTA, CT-Perfusion and 4D-CTA (post-processed from CTP datasets) and scored: occlusion-presence and diagnostic certainty (scale 1–10). Time-to-diagnosis was registered.

Results

Arterial occlusion was present in 8 patients. Accuracy improved from 88–92% after CTA and CTP assessment to 96–100% after 4D-CTA assessment (P-values >0,05). Mean diagnostic certainty improved from 7,2–8,6 to 8,8–9,3 (P-values all < 0,05). Mean time to diagnosis increased from 3, 5, 5 and 4 minutes after CTA to 9, 14, 12, and 10 minutes after 4D-CTA.

Conclusion

4D-CTA as an additive to regular CTA and CT-Perfusion in patients with acute ischemic stroke eligible for intra-arterial treatment shows a tendency to increase diagnostic accuracy and improves diagnostic certainty, when reviewed by radiologist in training, while only mildly prolonging time to diagnosis.

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