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Mobile App-Based Intervention for Pregnant Women With Stress Urinary Incontinence: Protocol for a Hybrid Effectiveness-Implementation Trial

JMIR Res Protoc. 2021 Mar 10;10(3):e22771. doi: 10.2196/22771.

ABSTRACT

BACKGROUND: Stress urinary incontinence (SUI) is a common source of distress among women during and after pregnancy. It has a negative effect on quality of life but with poor care-seeking. Mobile health (mHealth) may be a promising solution with potential advantages. However, there is uncertainty whether a mobile app is effective for SUI symptom improvement during and after pregnancy. The implementation is also unclear. We developed an app named UIW (Urinary Incontinence for Women) aimed at improving perinatal incontinence.

OBJECTIVE: The objective of this study is to evaluate the effectiveness of the UIW app-based intervention in improving SUI symptoms among pregnant women and explore the facilitators and barriers to using the UIW app to help refine and optimize the intervention.

METHODS: This study is a hybrid effectiveness-implementation trial with a randomized controlled trial alongside a mixed-methods process evaluation according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Pregnant women with SUI (n=336) will be recruited from a university-affiliated hospital in China. They will be randomly allocated (1:1) to either the intervention group that receive usual care plus UIW app or control group that receive usual care alone. The intervention period will last 2 months. The 5 dimensions of the RE-AIM framework will be evaluated at recruitment (-T1), baseline (T0), immediately after intervention (T1), 42 days after delivery (T2), 3 months after delivery (T3), and 6 months after delivery (T4) through project documents, online questionnaires and a pelvic floor muscle training diary, surface electromyography, log data in the background management system, and qualitative interviews. Data analysis will follow the intention-to-treat principle. Descriptive statistics, t tests, chi-square tests, and a linear mixed model will be used to analyze the quantitative data. Deductive and inductive content analysis will be used to analyze the qualitative data.

RESULTS: The effectiveness-implementation trial started in June 2020, trial recruitment was completed in October 2020, and the intervention will last for a 2-month period. Completion of the 6-month follow-up will be in July 2021, and we anticipate that the results of this study will be published in December 2021.

CONCLUSIONS: This study will evaluate both effectiveness and implementation of the UIW app-based intervention among pregnant women. The hybrid effectiveness-implementation trial design according to the RE-AIM framework with a mixed-methods approach will give valuable insights into the effects as well as facilitators and barriers to the implementation that will influence the effects of the UIW app-based intervention.

TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/22771.

PMID:33688842 | DOI:10.2196/22771

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Outcome trends in people with heart failure, type 2 diabetes mellitus and chronic kidney disease in the UK over twenty years

EClinicalMedicine. 2021 Feb 4;32:100739. doi: 10.1016/j.eclinm.2021.100739. eCollection 2021 Feb.

ABSTRACT

BACKGROUND: Heart failure (HF) together with type 2 diabetes (T2D) and chronic kidney disease (CKD) are major pandemics of the twenty first century. It is not known in people with new onset HF, what the distinct and combined associations are between T2D and CKD comorbidities and cause-specific hospital admissions and death, over the past 20 years.

METHODS: An observational study using the UK Clinical Practice Research Datalink linked to the Hospital Episode Statistics in England (1998-2017). Participants were people aged ≥30 years with new onset HF. Exposure groups were HF with: (i) no T2D and no CKD (reference group); (ii) CKD-only (estimated glomerular filtration rate (eGFR) <60 ml/min per 1.73 m2); (iii) T2D-only; (iv) T2D and CKD. CKD severity groups were: CKD-3a (eGFR 45-59); CKD-3b (30-44); CKD-4 (15-29); CKD-5 (<15). Outcomes were cardiovascular and non-cardiovascular hospitalisations and all-cause death.

FINDINGS: In 87,709 HF patients (mean age, 78 years; 49% female), 40% had CKD-only, 12% T2D-only, and 16% both. Age-standardised first-year CVD hospitalisation rates were significantly higher in HF patients with CKD-only (46.4; 95% CI 44.9,47.9 per 100 person years) and T2D-only (49.2; 46.7,58.8) than in the reference group (35.1; 34.0,36.1); the highest rate was in patients with T2D-CKD-5: 89.1 (65.8,112.4). Similar patterns were observed for non-CVD hospitalisations and deaths. Group differences remained significant after adjustment for potential confounders. Median survival was highest in the reference (4.4 years) and HF-T2D-only (4.1 years) groups, compared to HF-CKD-only (2.2 years). HF-T2D-CKD group survival ranged from 2.8 (CKD-3a) to 0.7 years (CKD-5). Over time, CVD hospitalisation rates significantly increased for HF-CKD-only (+26%) and reduced (-24%) for HF-T2D-only groups; no reductions were observed in any of the HF-T2D-CKD groups. Trends were similar for non-CVD hospitalisations and death: whilst death rates significantly reduced for HF-T2D-only (-37%), improvement was not observed in any of the T2D-CKD groups.

INTERPRETATION: In a cohort of people with new onset HF, hospitalisations and deaths are high in patients with T2D or CKD, and worst in those with both comorbidities. Whilst outcomes have improved over time for patients with HF and comorbid T2D, similar trends were not seen in those with comorbid CKD. Strategies to prevent and manage CKD in people with HF are urgently needed.

FUNDING: NIHR fellowship [reference: NIHR 30011].

PMID:33688855 | PMC:PMC7910705 | DOI:10.1016/j.eclinm.2021.100739

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Effects of liver transplantation on sexual function and quality of life

Psychol Health Med. 2021 Mar 10:1-12. doi: 10.1080/13548506.2021.1898003. Online ahead of print.

ABSTRACT

This descriptive study aimed to determine patients’ sexual dysfunction and quality of life before and after liver transplantation. The study was conducted with 64 patients who underwent liver transplantation at a university hospital between January 2015 and 2019. The patients were aged 18 or over, able to answer relevant questions and volunteered to participate in the study. The population of the study included patients who underwent liver transplantation on the specified dates and agreed to participate in the study. Descriptive Characteristics Form, Short Form-36 (SF-36), Female Sexual Function Index (FSFI) and International Index of Erectile Function (IIEF) were used for data collection. A significant increase was found in all subscale scores of males on the IIEF scale after transplantation (p = 0.000). The total FSFI score of the females was 24.27 ± 18.60 before transplantation and 29.62 ± 25.19 after transplantation. The results were not statistically significant (p = 0.072). After transplantation, a highly significant increase was observed in the Physical Component Summary and Mental Component Summary subscale scores of the SF-36 both in males and females (p = 0.000). An increase was observed in the sexual functions of males and females after transplantation. A statistically significant increase was found in the mean scores of both males and females on the quality of life after transplantation (p = 0.000). This study concluded that sexual functions of male (p < 0.05) and female (p > 0.05) patients improved after transplantation.

PMID:33688768 | DOI:10.1080/13548506.2021.1898003

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Implication of efflux pumps and ERG11 genes in resistance of clinical Trichosporon asahii isolates to fluconazole

J Med Microbiol. 2021 Mar 10. doi: 10.1099/jmm.0.001236. Online ahead of print.

ABSTRACT

Introduction. Trichosporon asahii has been recognized as an opportunistic agent having a limited sensitivity to antifungal treatment.Hypothesis/Gap Statement. Molecular mechanisms of azole resistance have been rarely reported for Trichosproron asahii. Similar to other fungi, we hypothesized that both ERG11 gene mutation and efflux pumps genes hyper-expression were implicated.Aim. The current work aimed to study the sensitivity of clinical T. asahii isolates to different antifungal agents and to explore their resistance mechanisms by molecular methods including real-time PCR and gene sequencing.Methods. The sensitivity of T. asahii isolates to fluconazole, amphotericin B and voriconazole was estimated by the Etest method. Real-time PCR was used to measure the relative expression of Pdr11, Mdr and ERG11 genes via the ACT1 housekeeping gene. Three pairs of primers were also chosen to sequence the ERG11 gene. This exploration was followed by statistical study including the receiver operating characteristic (ROC) curve analysis to identify a relationship between gene mean expression and the sensitivity of isolates.Results. In 31 clinical isolates, the resistance frequencies were 87, 16.1 and 3.2 %, respectively, for amphotericin B, fluconazole and voriconazole. Quantitative real-time PCR demonstrated that only Mdr over-expression was significantly associated with FCZ resistance confirmed by univariate statistical study and the ROC curve analysis (P <0.05). The ERG11 sequencing revealed two mutations H380G and S381A in TN325U11 (MIC FCZ=8 µg ml-1) and H437R in TN114U09 (MIC FCZ=256 µg ml-1) in highly conserved regions (close to the haem-binding domain) but their involvement in the resistance mechanism has not yet been assigned.Conclusion. T. asahii FCZ resistance mechanisms are proven to be much more complex and gene alteration sequence and/or expression can be involved. Only Mdr gene over-expression was significantly associated with FCZ resistance and no good correlation was observed between FCZ and VCZ MIC values and relative gene expression. ERG11 sequence alteration seems to play a major role in T. asahii FCZ resistance mechanism but their involvement needs further confirmation.

PMID:33688802 | DOI:10.1099/jmm.0.001236

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Mining pre-surgical patterns able to discriminate post-surgical outcomes in the oncological domain

IEEE J Biomed Health Inform. 2021 Mar 9;PP. doi: 10.1109/JBHI.2021.3064786. Online ahead of print.

ABSTRACT

Understanding the individualized risks of undertaking surgical procedures is essential to personalize preparatory, intervention and post-care protocols for minimizing post-surgical complications. This knowledge is key in oncology given the nature of interventions, the fragile profile of patients with comorbidities and cytotoxic drug exposure, and the possible cancer recurrence. Despite its relevance, the discovery of discriminative patterns of post-surgical risk is hampered by major challenges: i) the unique physiological and demographic profile of individuals, as well as their differentiated post-surgical care; ii) the high-dimensionality and heterogeneous nature of available biomedical data, combining non-identically distributed risk factors, clinical and molecular variables; iii) the need to generalize tumors have significant histopathological differences and individuals undertake unique surgical procedures; iv) the need to focus on non-trivial patterns of post-surgical risk, while guaranteeing their statistical significance and discriminative power; and v) the lack of interpretability and actionability of current approaches. Biclustering, the discovery of groups of individuals correlated on subsets of variables, has unique properties of interest, being positioned to satisfy the aforementioned challenges. In this context, this work proposes a structured view on why, when and how to apply biclustering to mine discriminative patterns of post-surgical risk with guarantees of usability, a subject remaining unexplored up to date. These patterns offer a comprehensive view on how the patient profile, cancer histopathology and entailed surgical procedures determine: i) post-surgical complications, ii) survival, and iii) hospitalization needs. The gathered results confirm the role of biclustering in comprehensively finding interpretable, actionable and statistically significant patterns of post-surgical risk. The found patterns are already assisting healthcare professionals at IPO-Porto to establish specialized pre-habilitation protocols and bedside care.

PMID:33687853 | DOI:10.1109/JBHI.2021.3064786

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Effectiveness of nursing case management versus usual care for blood pressure control in adults with hypertension: a systematic review

Invest Educ Enferm. 2021 Feb;39(1). doi: 10.17533/udea.iee.v39n1e04.

ABSTRACT

OBJECTIVES: To synthesize the best available evidence regarding the effectiveness of nursing case management in primary health care, compared to usual care, in improving blood pressure in adults over 18 years with hypertension.

METHODS: Systematic review that includes studies carried out with adult patients diagnosed with hypertension, with or without other concomitant chronic diseases, followed-up by a case manager nurse, who evaluated the effectiveness of case management in the improvement of blood pressure. A critical evaluation of the studies was made and the results of interest were described using the instruments and tools from the Joanna Briggs Institute. Due to the heterogeneity of the included studies, the results of similar measures were not grouped in statistical meta-analysis. A narrative and tabular format was used to synthesize and present them.

RESULTS: Six randomized controlled trials were critically evaluated and included in the review. The total sample was 1963 participants. The results showed the outcomes compared at baseline and at the end of follow-up (six or twelve months). Regarding the main outcome, systolic and diastolic blood pressure, there was some reduction in the group followed-up through case management in studies lasting six months; however, the impossibility of comparing the findings poses limitations to answering the questions in this review.

CONCLUSIONS: Despite the heterogeneity of the studies, the narrative and tabular analysis demonstrated that short-term case management in primary care (six-month studies) helped to reduce blood pressure levels, although the level of evidence for these results is low or very low.

PMID:33687808 | DOI:10.17533/udea.iee.v39n1e04

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Caregiver overload and factors associated with care provided to patients under palliative care

Invest Educ Enferm. 2021 Feb;39(1). doi: 10.17533/udea.iee.v39n1e10.

ABSTRACT

OBJECTIVES: To identify overload and associated factors among caregivers of adult patients receiving palliative care.

METHODS: Descriptive, quantitative, and cross-sectional study addressing 40 adults under palliative care and their respective caregivers enrolled in the Home Care System in Ribeirão Preto, Brazil. Data concerning the patients included demographic profile and Mini-Mental State Examination. A form was used to collect the caregivers’ demographic data along with the Zarit Burden Interview Scale, Self-Reporting Questionnaire, Beck Depression Inventory, and Coping Strategies Inventory.

RESULTS: Regarding the patients, 84.2% were women, 52.6% were over 80, 65.8% had no partner, and 76.3% presented cognitive impairment. The caregivers were mostly women (84.5%), aged 56.67 years old on average, were the patients’ children (42.5%); had no partner (55%), and lived with the patient (77.5%). The mean score obtained in the burden scale was 28.78 points, 32.5% had stress, and 42.5% depression. Regarding coping strategies, the ones most frequently used were positive reappraisal (12.8), withdrawal (10.2), and problem solution (9.7). A positive and statistically significant correlation was found between time spent with care (days and hours) and escape/avoidance with overload. Linear regression analysis revealed an association between being a woman (p=0.002), number of days spent with care (p=0.004), and depression (p<0.001) with overload.

CONCLUSIONS: Being a woman, spending more days providing care, and depressive symptoms were associated with caregiver overload.

PMID:33687814 | DOI:10.17533/udea.iee.v39n1e10

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Fear of Falling among Community-dwelling Sedentary and Active Older People

Invest Educ Enferm. 2021 Feb;39(1). doi: 10.17533/udea.iee.v39n1e13.

ABSTRACT

OBJECTIVES: The study sought to compare community-dwelling older people with respect to their level of physical activity and to the fear of falls between a group of sedentary elderly and a group of active elderly.

METHODS: Cross-sectional descriptive study carried out with 113 community-dwelling older people (45 sedentary and 48 active), users of an outpatient care center of the private health system with a geriatric program in Santiago, Chile. The study measured socio-demographic variables, state of health, comprehensive geriatric assessment, exercise, depression with the Yesavage scale, and fear of falling with the Short Falls Efficacy Scale – International (Short FES-I).

RESULTS: Sedentary older people have significantly higher scores in the Yesavage depression scale compared with active older people (4.2 versus 0.8). No statistically significant differences were found when comparing both groups of sedentary and active participants in terms of socio-demographic variables along with health, and functional and cognitive capacity. Regarding the fear of falling, the sedentary had a slightly higher score than the active (12 versus 11), although not significant.

CONCLUSIONS: This study showed that fear of falling was equal in sedentary and active older people who live in the community, although it was found that sedentary individuals had a higher risk of having a positive screening for geriatric depression in those participants who do not perform physical activity.

PMID:33687817 | DOI:10.17533/udea.iee.v39n1e13

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Dielectric properties of human active liver, kidney and spleen compared to those of respective inactive tissues, porcine tissues and the data provided by a database in the frequency range of 10Hz to 100MHz

IEEE Trans Biomed Eng. 2021 Mar 9;PP. doi: 10.1109/TBME.2021.3065016. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this work is to study whether the active state and species of biological tissues can influence changes in their dielectric properties.

METHODS: In this paper, the dielectric properties of liver, kidney and spleen tissues from human active, human inactive and animal tissues are measured in the frequency range of 10 Hz to 100 MHz. The four- and two-electrode methods are used to measure dielectric properties at different frequencies. Statistical analysis and the pattern recognition method are used to compare the dielectric properties of human active tissues, human inactive tissues, animal tissues and data provided by the IFAC database.

RESULTS: The results show that the dielectric properties of human active tissues are significantly different from those of human inactive tissues and animal tissues, resulting in a great difference between the dielectric properties provided by the IFAC database and those of human active tissues. The dielectric properties of human active tissues can be identified by the pattern recognition method based on principal component analysis, which further proves that the dielectric properties of human active tissues cannot be replaced.

CONCLUSION: The dielectric properties of biological tissues are closely related to the activity and species of tissues. The dielectric properties of human active tissues cannot be replaced by those of human cadaver tissues or animal tissues.

SIGNIFICANCE: The significance of this study is suggesting that the IFAC database should be updated with the dielectric properties of human active tissues to provide accurate data for bioelectromagnetics research.

PMID:33687834 | DOI:10.1109/TBME.2021.3065016

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Symptom burden and palliative care needs of patients with incurable cancer at diagnosis and during the disease course

Oncologist. 2021 Mar 9. doi: 10.1002/onco.13751. Online ahead of print.

ABSTRACT

BACKGROUND: Although current guidelines advocate early integration of palliative care, symptom burden and palliative care needs of patients at diagnosis of incurable cancer and along the disease trajectory are understudied.

MATERIAL AND METHODS: We assessed distress, symptom burden, quality of life, and supportive care needs in patients with newly diagnosed incurable cancer in a prospective longitudinal observational multicentre study. Patients were evaluated using validated self-report measures (NCCN Distress Thermometer (DT), FACT, SEIQoL-Q, PHQ-4, modified SCNS-SF-34) at baseline (T0), at three (T1), six (T2), and twelve months (T3) follow-up.

RESULTS: From 10/2014 to 10/2016, 500 patients (219 women, 281 men; mean age 64.2 years) were recruited at 20 study sites in Germany following diagnosis of incurable metastatic , locally advanced, or recurrent lung (217), gastrointestinal (156), head and neck (55), gynecological (57) and skin (15) cancer. Patients reported significant distress (DT score ≥5) after diagnosis, which significantly decreased over time (T0: 67.2%, T1: 51.7%, T2: 47.9%, T3: 48.7%). The spectrum of reported symptoms was broad with considerable variety between and within the cancer groups. Anxiety and depressiveness were most prevalent early in the disease course (T0: 30.8%, T1: 20.1%, T2: 14.7%, T3: 16.9%). The number of patients reporting unmet supportive care needs decreased over time (T0: 71.8 %, T1: 61.6%, T2: 58.1%, T3: 55.3%).

CONCLUSION: Our study confirms a variable and mostly high symptom burden at the time of diagnosis of incurable cancer, suggesting early screening by using standardized tools, and underlining the usefulness of early palliative care.

IMPLICATION FOR PRACTICE: A better understanding of symptom burden and palliative care needs of patients with newly diagnosed incurable cancer may guide clinical practice and help to improve the quality of palliative care services. Our study results provide important information for establishing palliative care programs and related guidelines. Distress, symptom burden and the need for support vary, and are often high at the time of diagnosis. These findings underscore the need for implementation of symptom screening as well as early palliative care services, starting at the time of diagnosis of incurable cancer and tailored according to patients’ needs.

PMID:33687742 | DOI:10.1002/onco.13751