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Background: Fatigue is an important symptom for most patients with axial spondyloarthritis (axSpA). The FACIT-Fatigue is a 13-item patient-reported outcome (PRO) instrument that has been used in axSpA clinical trials to measure fatigue severity and impact on daily activities. However, the psychometric properties of the FACIT-Fatigue are not fully evaluated across the entire spectrum of axSpA including non-radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA). This study determined: (1) the psychometric properties of the FACIT-Fatigue in nr-axSpA, r-axSpA, and the broad axSpA population and (2) FACIT-Fatigue scores representing meaningful within-patient change (MWPC), meaningful between-group differences, and cross-sectional severity bands. Methods: Data from two Phase 3 trials in adults with nr-axSpA (BE MOBILE 1; N = 254) and r-axSpA (BE MOBILE 2; N = 332) were analyzed pooled and separately to assess the psychometric properties of the FACIT-Fatigue. MWPC and meaningful between-group difference estimates were derived using anchor-based and distribution-based methods. Cross-sectional fatigue severity bands were estimated using logistic regression analysis. Results: The FACIT-Fatigue presented good internal consistency, adequate convergent and known-groups validity, and was sensitive to change over time across the full axSpA spectrum. A 5–11-point increase in FACIT-Fatigue score was estimated to represent a MWPC, with an 8-point increase selected as the responder definition. A 2.14–5.34-point difference in FACIT-Fatigue score change over a 16-week period was estimated to represent a small-to-medium meaningful between-group difference. FACIT-Fatigue score severity bands were defined as: none or minimal (>40), mild (>30 to ≤40), moderate (>21 to ≤30), and severe (≤21). Conclusions: These findings support the use of the FACIT-Fatigue as a fit-for-purpose measure to assess fatigue-related treatment benefit in axSpA clinical trials. The proposed score estimates and thresholds can guide FACIT-Fatigue score interpretation across the full axSpA spectrum. Trial registration: ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019—Retrospectively registered, https://classic.clinicaltrials.gov/ct2/show/NCT03928704. ClinicalTrials.Gov, NCT03928743. Registered 26 April 2019—Retrospectively registered, https://classic.clinicaltrials.gov/ct2/show/NCT03928743. Plain English summary: Fatigue is common in patients with axial spondyloarthritis (axSpA)—a painful, chronic disease that mainly affects the joints of the spine. Measuring fatigue in clinical trials is important to see if new treatments for axSpA help reduce this symptom. This study investigated whether a patient-completed measure of fatigue, the 'FACIT-Fatigue', is suitable for use by patients with either of the two main types of axSpA—radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA). This study was needed because we did not know if the FACIT-Fatigue is valid and reliable in both axSpA subtypes and because we are lacking information to interpret the FACIT-Fatigue score in axSpA. Psychometric analysis of clinical trial data showed that the FACIT-Fatigue accurately measures fatigue severity in both types of axSpA. The study additionally pinpointed what change in FACIT-Fatigue score can be used to define whether a treatment has reduced fatigue in a patient, or what constitutes a meaningful between-group difference. It also identified severity score bands that can be used to classify patients into those with no, mild, moderate, or severe fatigue. These findings support using the FACIT-Fatigue in axSpA clinical trials to measure how well treatments reduce fatigue. [ABSTRACT FROM AUTHOR]

Within a small geographic area, Marion County contains a stark spectrum of health outcomes and socioeconomic statuses. The Indiana University Student Outreach Clinic (IUSOC) serves as a safety net provider, offering free health and social services in the Near Eastside neighborhood of Indianapolis. The aim of this study was to characterize the demographics and geographic distribution of the IUSOC's patient population. From January to September 2023, 612 patients visited the IUSOC, and 460 self-identified as Marion County residents. 63.9% of patients were between 45 and 64 years old. 66.8% were Non-Hispanic (NH) Black, and 23.3% were Hispanic. 18.9% spoke Spanish and had limited English proficiency. Based on the Distressed Communities Index (DCI), 58.7% lived in "Distressed" zip codes, indicating economic vulnerability and disparities. The zip code with the greatest number of IUSOC patients had the highest rate of uninsured adults in Marion County. IUSOC patients are primarily middle-aged minorities who live in zip codes with low socioeconomic rankings by DCI. This information can be used to improve community resource referral pathways in the clinic. [ABSTRACT FROM AUTHOR]

Objectives: Periodontitis is one of the most common chronic inflammatory diseases. It causes changes in the biting abilities of individuals. However, periodontal treatment has positive effects on masticatory function. The aim of this study is to determine the effect of periodontitis and periodontal treatment on masticatory abilities by measuring masseter and temporal muscle thicknesses with ultrasonography before and after periodontal treatment in chronic periodontitis patients. Methods: The patients included in the study were determined by clinical and radiological examination. The thickness of the masseter and temporal muscles of the patients were measured by ultrasonography. Periodontal measurements and treatments of the patients were completed by a single physician. IBM SPSS 20.0 (IBM Corp., Armonk, NY) statistical program was used for statistical analysis. Results: A statistically significant difference was found between the values of periodontal measurements before and after treatment (p<0.05). In the ultrasonography measurements of the thickness of masseter and anterior temporal muscles, a statistically significant increase was observed in both rest and contraction values at all time intervals (p<0.05). Muscle thicknesses of male patients were higher than female patients. Conclusions: Periodontitis negatively affects the masticatory performance of individuals. Chronic periodontitis patients should be referred for periodontal treatment without wasting time. [ABSTRACT FROM AUTHOR]

Background: Chronic migraine (CM) is a debilitating neurofunctional disorder primarily affecting females, characterized by central sensitization. Central sensitization refers to the enhanced response to sensory stimulation, which involves changes in neuronal excitability, synaptic plasticity, and neurotransmitter release. Environmental enrichment (EE) can increase the movement, exploration, socialization and other behaviors of mice. EE has shown promising effects in various neurological disorders, but its impact on CM and the underlying mechanism remains poorly understood. Therefore, the purpose of this study was to determine whether EE has the potential to serve as a cost-effective intervention strategy for CM. Methods: A mouse CM model was successfully established by repeated administration of nitroglycerin (NTG). We selected adult female mice around 8 weeks old, exposed them to EE for 2 months, and then induced the CM model. Nociceptive threshold tests were measured using Von Frey filaments and a hot plate. The expression of c-Fos, calcitonin gene-related peptide (CGRP) and inflammatory response were measured using WB and immunofluorescence to evaluate central sensitization. RNA sequencing was used to find differentially expressed genes and signaling pathways. Finally, the expression of the target differential gene was investigated. Results: Repeated administration of NTG can induce hyperalgesia in female mice and increase the expression of c-Fos and CGRP in the trigeminal nucleus caudalis (TNC). Early exposure of mice to EE reduced NTG-induced hyperalgesia in CM mice. WB and immunofluorescence revealed that EE inhibited the overexpression of c-Fos and CGRP in the TNC of CM mice and alleviated the inflammatory response of microglia activation. RNA sequencing analysis identified that several central sensitization-related signaling pathways were altered by EE. VGluT1, a key gene involved in behavior, internal stimulus response, and ion channel activity, was found to be downregulated in mice exposed to EE. Conclusion: EE can significantly ameliorate hyperalgesia in the NTG-induced CM model. The mechanisms may be to modulate central sensitization by reducing the expression of CGRP, attenuating the inflammatory response, and downregulating the expression of VGluT1, etc., suggesting that EE can serve as an effective preventive strategy for CM. [ABSTRACT FROM AUTHOR]

Aim: To further develop the Person-Centred Care instrument for outpatient care (PCCoc), evaluate its user-friendliness and content validity, and to explore its basic psychometric properties in various outpatient settings for adults with long-term conditions. Background: Person-centred care (PCC) has been identified as a key factor to provide high-quality care. However, there is still a lack of instruments that are based on a clearly defined framework for PCC for persons with long-term conditions in an outpatient context. The PCCoc is a patient-reported experience measure under development aiming to fill this gap. Methods: First, the 35-item PCCoc was reviewed and further developed in collaboration with a user-council. Second, the revised 36-item PCCoc was tested among persons receiving outpatient care for various long-term conditions. A total of 179 persons with long-term conditions from four different specialties participated in the study. User-friendliness and content validity were assessed through structured interviews and relevance ratings of each item. Content validity index (CVI) for individual items (I-CVI) and for the overall scale (S-CVI) were calculated, and basic psychometric properties of the PCCoc using classical test theory were explored. Results: It took a median of 8 min for participants to complete the PCCoc. The majority found items easy to understand, response categories distinct and that no important areas were missing. Results from the CVI analyses suggested that participants found the content of the PCCoc relevant (I-CVI range 0.82-1, S-CVI = 0.95). All psychometric properties examined were satisfactory (e.g., item-total correlations, 0.45–0.75; Cronbach's alpha, 0.96; test-retest stability, 0.83). Conclusion: The PCCoc was considered user-friendly and relevant by the intended users, and its psychometric properties were satisfactory. This implies that the PCCoc can be a valuable instrument for evaluating and developing PCC in outpatient care for persons with long-term conditions. However, further studies of the PCCoc are needed to establish its measurement properties in various outpatient settings. Key points for decision makers: The Person-Centred Care instrument for outpatient care (PCCoc) is a generic questionnaire intended to measure patient-perceived levels of PCC in outpatient care for persons with long-term conditions. The PCCoc was considered user-friendly and relevant (overall content validity index, 0.95) by persons receiving outpatient care for various long-term conditions, and exhibited good psychometric properties. The PCCoc can be a valuable tool for evaluating and developing PCC in outpatient care for persons with long-term conditions. [ABSTRACT FROM AUTHOR]

Background: Trigger finger is one of the most common causes of pain and dysfunction. The aim of our study was to compare the effectiveness of shock wave therapy versus local corticosteroid injection in the treatment of trigger finger in diabetic patients. Results: The two groups were matched on age, HbA1c, VAS score, and grip force at week zero. There was statistically significant improvement in both groups after treatment. In comparing the two groups after 6 weeks of starting treatment either by shockwave therapy or by local corticosteroid injection, there was a statistically significant improvement in group 1 as regards VAS pain score (p = 0.012), clinical signs (finger extension and locking) (p = 0.018), hand grip dynamometer (p < 0.001), and musculoskeletal ultrasound findings in comparison to group 2. Conclusion: Trigger finger is a common complication of DM. Shockwave therapy was able to reduce pain and improve hand functional level and quality of life. Shockwave is an effective, safe, non-invasive method for conservative management of trigger finger. [ABSTRACT FROM AUTHOR]

Objective: To determine the feasibility of conducting a full-scale randomized controlled trial (RCT) and investigate the basic information and safety of acupuncture for patients with chronic spontaneous urticaria (CSU). Methods: A total of 80 participants with CSU from July 2018 to July 2019 were randomly assigned to receive active acupuncture (n=41) on a fixed prescription of acupoints or sham acupuncture (n=39) with superficial acupuncture on non-acupuncture points through the completely randomized design. Patients in both groups received 5 sessions per week for 2 weeks, and participants were followed for a further 2 weeks. Feasibility was assessed by recruitment and randomization rates, retention of participants, treatment protocol adherence, and the incidence of adverse events (AEs). The clinical primary outcome was the changes from baseline weekly urticaria activity scores (UAS7) after treatment at 2 weeks. Secondary outcomes included the Visual Analogue Scale (VAS) score of itching intensity, Dermatology Life Quality Index (DLQI), Hamilton Depression Scale (HAMD), and Hamilton Anxiety Scale (HAMA). Results: A total of 80 participants were enrolled. The recruitment rate of 24.02%, randomization rate of 100%, a loss rate of 6.25%, and no obvious AEs were observed in either group. The decrease from baseline in the mean UAS7 total score at week 2 in the active acupuncture group was −8.63 (95%CI, −11.78 to −5.49) and −6.21 (95%CI, −9.43 to −2.98) in the sham acupuncture group for a between-group difference of −2.42 (95% CI, −6.93 to 2.07). The change in the DLQI, VAS of itching intensity, HAMA, and HAMD were a slightly better improvement trend in the active acupuncture group than the sham acupuncture group, but the between-group difference was not significant. Conclusions: Active acupuncture had a better improvement trend in alleviating symptoms, improving quality of life and regulating the mood of anxiety and depression in patients with CSU than sham acupuncture. (Registration Nos. AMCTR-ICR-18000190 and ChiCTR2100054776) [ABSTRACT FROM AUTHOR]

Background: Dysfunction of the endothelium is a key precursor of cardiovascular disease. Endothelial function, as assessed via the flow-mediated dilation test, is attenuated with chronic disease (e.g., type 2 diabetes mellitus, hypertension). Exercise training may mitigate this dysfunction and promote better vascular health. Objective: The main objective of this umbrella review was to determine the impact of exercise training on flow-mediated dilation in healthy adults and those with chronic disease. Methods: Studies were included if they conducted a systematic review and/or meta-analysis on flow-mediated dilation responses to exercise interventions in adults. Sources were searched in January 2022 and included Scopus, EMBASE, MEDLINE, CINAHL, and Academic Search Premier. National Institutes of Health quality assessment tools were used. The results were presented narratively. Results: Twenty-seven systematic reviews, including 19 meta-analyses, (total: 5464 unique participants, 2181 reported unique female individuals) met the inclusion criteria. The average overall quality of included reviews was 8.8/11. The quality of studies within each included review varied from low to moderate using a variety of quality assessment scales. Reviews were conducted in healthy adults (n = 9, meta-analyses = 6), as well as those with type 2 diabetes (n = 5, meta-analyses = 4), cardiovascular conditions [i.e., conditions that impact the cardiovascular system, but excluding samples of only type 2 diabetes] (n = 11, meta-analyses = 7), and other chronic conditions (n = 2, meta-analyses = 2). Overall, the included reviews provided evidence that the type of training to optimally improve FMD may vary based on disease condition. Specifically, the evidence suggests that healthy adults benefitted most from higher intensity aerobic training and/or more frequent low-to-moderate resistance training. In addition, adults with type 2 diabetes benefitted most from low-intensity resistance or aerobic exercise training, whereas those with cardiovascular conditions should consider engaging in high-intensity aerobic training to improve endothelial function. Conclusions: This information may help guide the design of specific exercise programs or recommendations for adults with chronic conditions. [ABSTRACT FROM AUTHOR]

Positive adjustment to chronic diseases reduces psychiatric comorbidity and enhances quality of life. Very little is known about the benefit of internet-based and mobile-based Cognitive Behavioral Therapy (IM-CBT) on physical outcomes and its reciprocal interactions with psychiatric outcomes, the active therapeutic elements, and effect moderators among people with major chronic medical conditions. In this systematic review and meta-analysis (PROSPERO: CRD42022265738), CINAHL of Systematic Reviews, MEDLINE, PsycINFO, PubMed, Web of Science are systematically searched up to 1 June 2022, for randomized controlled trials (RCTs) comparing IM-CBT against non-CBT control condition(s) among people with chronic disease(s). Primary outcomes include improvements in psychiatric symptoms (depressive, anxiety, PTSD symptoms, general psychological distress) from baseline to post-intervention and follow-ups. Secondary outcomes include improvements in physical distress (physical symptoms, functional impairment, self-rated ill health, objective physiological dysfunction). Among 44 RCTs (5077 patients with seven different chronic diseases), IM-CBT improves depressive symptoms, anxiety symptoms, and general psychological distress at post-intervention and across follow-ups, and improves physical distress and functional impairment at post-intervention. Preliminary evidence suggests that behavioral modification and problem-solving could be necessary components to reduce psychiatric symptoms in IM-CBT, whereas cognitive restructuring, psychoeducation, and mindfulness elements relate to reduced physical distress. IM-CBT shows stronger benefits in chronic pain, cancer, arthritis, and cardiovascular disease, relative to other conditions. Changes in psychiatric symptoms and physical distress prospectively predict each other over time. IM-CBT is an effective intervention for comprehensive symptom management among people with chronic diseases. [ABSTRACT FROM AUTHOR]

Purpose: In a multicultural diverse society, healthcare professionals (HPs) should adopt a personalized approach with adequate attitudes and behaviors to respond promptly to the needs of patients with different cultural backgrounds who become regular users of the health service. This study aimed to explore the health representations of HPs taking charge of immigrant chronic patients in Italy. Methods: Semi-structured interviews were conducted, recorded, and transcribed on a sample of 54 HPs. Mixed quali-quantitative analysis was applied, including the method of discourse analysis. Results: Results underlined the prevalence of specific recurring topics and words that highlight positive aspects but also weaknesses in chronic care models for immigrant patients, stressing what needs to be done. Keystones are the relational experience between HPs and patients and new specific training opportunities for HPs. Conclusion: To conclude, a new semi-structured interview schedule is proposed, able to obtain in-depth information on the representation of HPs toward immigrant chronic patients. [ABSTRACT FROM AUTHOR]

Background: In Italy, there is scant evidence on the impact of Community Hospitals (CHs) on clinical outcomes. Aims: To assess the effectiveness of CHs versus long-term care hospital or inpatient rehabilitation facilities on mortality, re-admission, institutionalization, and activation of a home care programme in the Emilia-Romagna Region (ERR-Italy) after acute hospitalisation. Methods: We implemented a cohort study drawing upon the ERR Administrative Healthcare Database System and including hospital episodes of ERR residents subject ≥ 65 years, discharged from a public or private hospital with a medical diagnosis to a CH or to usual care between 2017 and 2019. To control for confounding, we applied a propensity score matching. Results: Patients transferred to CHs had a significantly lower risk of dying but an increased risk of being readmitted to community or acute hospital within 30/90 days from discharge. The hazard of institutionalisation within 30/90 days was significantly lower in the whole population of the CH exposed group but not among patients with cardiac or respiratory chronic diseases or diabetes. The activation of a home care program within 90 days was slightly higher for those who were transferred to a CH. Discussion: The findings of our study show mixed effects on outcomes of patients transferred to CHs compared to those who followed the post-acute usual care and should be taken with cautious as could be affected by the so-called 'confounding by indication'. Conclusions: The study contributes to the intermediate care available evidence from a region with a well-established care provision through CHs. [ABSTRACT FROM AUTHOR]

Primary sclerosing cholangitis is a rare chronic inflammatory disease affecting the bile ducts, which can eventually result in bile duct strictures, cholestasis and cirrhosis. Patients are often asymptomatic but may present with clinical features of cholestasis. Imaging plays an important role in the diagnosis and management. This review covers the pathophysiology, clinical features, imaging findings as well as methods of surveillance and post-transplant appearance. [ABSTRACT FROM AUTHOR]

Children with chronic illness (CI) are at risk for internalizing problems, which reduce their quality of life, hamper treatment, and increase family stress. Accordingly, behavioral interventions are provided at the family level. However, the effects of parental involvement on child outcomes are not consistently beneficial. Therefore, it is relevant to study the working mechanisms. In the present study, we tested child coping and parenting stress as underlying mechanisms of the effect of an intervention for children and an additional group intervention for parents. Data were analyzed from a randomized controlled trial. Families of children with chronic illness (N = 120, child M age = 12.11 years, range 7.98–18.07) participated in a cognitive-behavioral-based group intervention and were randomized in the child-only intervention or parent–child intervention. Primary outcomes were parent- and child-reported internalizing problems, whereas the mediators were the use of child active coping skills and parenting stress. The causal model was tested with multilevel mediation analysis. Active coping skills and parenting stress stood out as significant mediators of the effect of the intervention on parent- and child-reported internalizing behavior (Cohen's d effect size range 0.29–1.57). When parents were involved in the intervention, children increased their use of active coping skills and parents decreased in parenting stress, which in turn improved child internalizing problems. Knowing that coping skills and parenting stress underlie the benefit of involving parents can be used for optimizing interventions for children with CI and addressing the risk of internalizing problems. Highlights: Parental involvement in interventions for children with chronic illness can be beneficial, however explanations are still unclear. In this randomized efficacy trial, child use of active coping skills and parenting stress appeared significant temporal mediators. Parental involvement supported child coping and diminished parenting stress, which in turn decreased child internalizing problems. Interventions for children with internalizing problems might be optimized by focusing on determined active components. [ABSTRACT FROM AUTHOR]

Elite athletes who participate in contact sports are at risk of bleeding injuries, leading to transmission of blood-borne viruses including hepatitis type B, C and D (HBV, HCV and HDV) capable of causing chronic liver disease, liver failure and liver cancer. In view of the significant advances in the viral hepatitis field over the past decade, more structured approaches should be in place to screen for and manage viral hepatitis in elite athletes. HBV status should be assessed in all elite athletes, and those infected should receive nucleos(t)ide analogues for viral suppression, while uninfected individuals should receive HBV vaccination. The all-oral direct acting antivirals for HCV are highly effective and safe, thus the remaining challenge with hepatitis C is case identification and linkage to care. HDV is only found in HBV-infected individuals, which is characterized by rapid disease progression and higher rates of cirrhosis and liver cancer in infected subjects. Pegylated interferon was the mainstay of treatment for HDV infection until bulevirtide, a viral entry inhibitor, was recently approved by the European Union (EMA) and FDA in America, while multiple novel therapies are already in clinical trials as part of the HBV cure program. Overall, awareness of chronic viral hepatitis in athletes should be improved. Prevention remains the cornerstone of the management of viral hepatitis in sport coupled with rigorous disease assessment in infected individuals, and antiviral therapy where indicated. [ABSTRACT FROM AUTHOR]

There is growing interest in offering Internet-delivered cognitive behaviour therapy (ICBT) to individuals with chronic health conditions, with this process often being guided by a single clinician. Due to lack of full time personnel, it is sometimes necessary to have multiple clinicians offer guidance or for no guidance to be offered. In this randomized trial, we compared team-guided ICBT (n = 90) to self-guided ICBT (n = 88). Participants completed measures at pre-, post-, and 3-months post-ICBT. Both groups showed similar rates of treatment completion and large improvements on depression and anxiety at post-treatment and follow-up. Unexpectedly, more participants in the self-guided versus team-guided condition showed clinically significant improvement on depression at post-treatment (76.5% vs 49.2%) and follow-up (70% vs 45.6%). Thus, team-guided ICBT may not provide significant benefits compared to self-guided ICBT. However, it may be an alternative approach to consider among a population of high risk individuals that wants or requires closer monitoring of symptoms. Trail registration TRN: NCT03500237; Date: April 18, 2018. [ABSTRACT FROM AUTHOR]

Background: Chronic pancreatitis (CP) is defined according to the recently proposed mechanistic definition as a pathological fibro-inflammatory syndrome of the pancreas in individuals with genetic, environmental, and/or other risk factors who develop persistent pathological responses to parenchymal injury or stress.Methods: The clinical practice guidelines for CP in Japan were revised in 2021 based on the 2019 Japanese clinical diagnostic criteria for CP, which incorporate the concept of a pathogenic fibro-inflammatory syndrome in the pancreas. In this third edition, clinical questions are reclassified into clinical questions, background questions, and future research questions.Results: Based on analysis of newly accumulated evidence, the strength of evidence and recommendations for each clinical question is described in terms of treatment selection, lifestyle guidance, pain control, treatment of exocrine and endocrine insufficiency, and treatment of complications. A flowchart outlining indications, treatment selection, and policies for cases in which treatment is ineffective is provided. For pain control, pharmacological treatment and the indications and timing for endoscopic and surgical treatment have been updated in the revised edition.Conclusions: These updated guidelines provide clinicians with useful information to assist in the diagnosis and treatment of CP. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study is to provide a synthesis of prior research of estimates of the willingness to pay (WTP) for chronic disease treatment and examines the impact of economic and political institutions, cultures, and other important factors on WTP. Subject and method: The paper applies meta-regression analysis to 1053 estimates of WTP from 188 medical treatment studies from 40 countries. Results: The results suggest that patients assign higher values for medical treatment in more capitalistic and more democratic countries. Cultural traits also appear to matter, with higher WTP in societies characterized by individualism and indulgence. Further, disease types matter. Compared to cancer, WTP is lower for diabetes, obesity, asthma, and heart disease treatment, but higher for amyotrophic lateral sclerosis therapy. GDP per capita is positively associated with WTP. The higher public health expenditure is in a country, the higher citizens value health benefits. If individuals expect to live longer, then they will spend less on their health. The published studies estimate a lower value than unpublished studies. Conclusion: This paper presents a comprehensive synthesis of estimates of chronically ill patients' WTP for medical treatment and identifies the key factors determining WTP through a meta-regression analysis. The main finding is that economic and political institutions, cultural traits, the types of disease, socio-economic characteristics, and valuation methods all influence WTP estimates. [ABSTRACT FROM AUTHOR]

Purpose An increasing number of workers in the US have chronic health conditions that limit their ability to work, and few worksite interventions have been tested to improve worker coping and problem solving at work. The purpose of this study was to evaluate a worksite-based health self-management program designed to improve workplace function among workers with chronic health conditions. Methods We conducted a randomized, controlled trial of a worksite self-management program ("Manage at Work") (clinicaltrials.gov #NCT01978392) for workers with chronic health conditions (N = 119; 82% female, ages 20–69). Most workers were recruited from the health care or light manufacturing industry sectors. Workers attended a 5-session, facilitated psychoeducational program using concepts of health self-management, self-efficacy, ergonomics, and communication. Changes on outcomes of work engagement, work limitation, job satisfaction, work fatigue, work self-efficacy, days absent, and turnover intention at 6-month follow-up were compared to wait-list controls. Results The most prevalent chronic health conditions were musculoskeletal pain, headaches, vision problems, gastrointestinal disorders, respiratory disorders, and mental health disorders. The self-management program showed greater improvement in work engagement and turnover intent at 6-month follow-up, but there was no evidence of a parallel reduction in perceived work limitation. Trends for improved outcomes of work self-efficacy, job satisfaction, and work fatigue in the intervention group did not reach statistical significance in a group x time interaction test. Conclusions Offering a worksite self-management program to workers with chronic health conditions may be a feasible and beneficial strategy to engage and retain skilled workers who are risking disability. Clinical trial registration: Clinicaltrials.gov #NCT01978392. [ABSTRACT FROM AUTHOR]

Ehlers–Danlos-Syndromes (EDS) is a group of hereditary, chronic and potentially disabling conditions. Few studies have tested the effects of psychological interventions to increase well-being in this population. We hypothesized that Positive Psychology Interventions (PPI), first applied to healthy and mentally ill subjects, can also be useful for people with somatic conditions and conducted a study to evaluate the efficacy of a 5-week online PPI designed to improve well-being in EDS patients. A sample of 132 EDS patients were allocated to three groups: assigned PPI, self-selected PPI, and waitlist control-group (WLC). Measures of positive and negative affect, pain disability, fatigue, and life satisfaction were administered before program start, 6 weeks later, and 1 month later. Satisfaction with the program was also evaluated. The results revealed that participants in the self-selected PPI-group, but not in the assigned PPI group, reported significantly lower levels of fatigue and higher levels of positive affect and life satisfaction compared to WLC after 6 weeks. There were no effects on negative affect and pain disability measures. Finally, 77% of the participants were satisfied or very satisfied with the program. These findings confirm and extend previous research by showing the efficacy of PPI for people with chronic illness under the condition that individuals can choose the program content. From a healthcare perspective, online PPIs could complement treatments aimed at symptom reduction and increase well-being in patients with EDS. [ABSTRACT FROM AUTHOR]

Guidelines from the American Academy of Pediatrics recommend palivizumab immunoprophylaxis for children with CLD in their second year of life if they continue to need treatment within 6 months before the RSV season. The utilization patterns of treatment (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) are not well understood. We examined variations in CLD treatment for ten consecutive 20-day segments preceding RSV season onset. Among infants and children with CLD (n = 19,026), 35.2% received one or more medical treatments for CLD any time within 200 days before entering the second RSV season: 8.6%, 3.2%, and 29.7% received supplemental oxygen, diuretics, and corticosteroids, respectively. Utilization decreased as infants' age increased with corticosteroids surpassing oxygen and diuretics. To avoid the capture of intermittent use of corticosteroids for acute infections, we found requiring a minimum of 45 days cumulative exposure was reasonable to determine chronic use. What is Known: • Guidelines from the American Academy of Pediatrics recommend palivizumab immunoprophylaxis for children with CLD in their second year of life if they continue to need treatment within 6 months before the RSV season. • The utilization patterns of treatment (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) are not well understood. A definition of chronic corticosteroid therapy in this setting is not available. What is New: • Among infants and children with CLD of prematurity, 35.2% received one or more medical treatments for CLD any time within 200 days before entering the second RSV season: 8.6%, 3.2%, and 29.7% received oxygen, diuretics, and corticosteroids, respectively. Utilization decreased as infants' age increased with corticosteroids surpassing oxygen and diuretics. • A minimum of 45 days cumulative corticosteroid use within the past 90 days would accurately capture chronic use to fulfill criteria for immunoprophylaxis while limiting the inclusion of intermittent use of corticosteroids for acute infections. [ABSTRACT FROM AUTHOR]

Objective: To confirm the improvement of cardiac function and quality of life (QOL) in patients with chronic heart failure (CHF) via Chinese medicine (CM) Qishen Taohong Granule (芪参桃红颗粒, QTG). Methods: This study was a single-center, prospective, randomized, controlled clinical trial. Seventy-six patients from 27 to 84 years old diagnosed with CHF New York Heart Association (NYHA) class II or III in stage C were enrolled and randomly assigned at a 1:1 ratio to receive QTG or trimetazidine (TMZ), in addition to their standard medications for the treatment of CHF. The study period was 4 weeks. The primary outcomes included cardiac function evaluated by NYHA classification and left ventricular ejection fraction (LVEF), as well as QOL evaluated by CHF Integrated Chinese and Western Medicine Survival Scale (CHFQLS). The secondary outcomes included 6-min walking test (6MWT), CM syndrome score, symptom and sign scores and N-terminal pro-B-type natriuretic peptide (NT-proBNP). All indices were measured at baseline and the end of the trial. Results: At the 4-week follow-up period, the effective rate according to NYHA classification in the QTG group was better than that in the TMZ group (74.29% vs. 54.29%, P<0.05). But there was no significant difference in post-treatment level of LVEF between the two groups (P>0.05). The CHFQLS scores improved by 13.82±6.04 vs. 7.49±2.28 in the QTG and TMZ groups, respectively (P<0.05). Subgroup analysis of the CHFQLS results showed that physiological function, role limitation and vitality were significantly higher in the QTG group than in the TMZ group (15.76±7.85 vs. 7.40±3.36, P<0.05; 16.00±8.35 vs. 10.53±4.64, P<0.05; 15.31±8.09 vs. 7.89±4.60, P<0.05). Compared with TMZ group, treatment with QTG also demonstrated superior performance with respect to 6MWT, CM syndrome, shortness of breath, fatigue, gasping, general edema and NT-proBNP level. No significant adverse reactions or adverse cardiac events occurred during treatment in either group. Conclusion: In addition to conventional treatments, the use of QTG as an adjuvant therapy significantly improved cardiac function and QOL in patients with CHF class II or III in stage C. [Registration No. ChiCTR1900022036 (retrospectively registered)] [ABSTRACT FROM AUTHOR]

Background: Although circadian, seasonal, and other cycles have been observed for a number of chronic conditions, their impact on patient reported outcomes measurements (PROMs) has not been systematically explored, rendering our understanding of the effect of time of measurement on PROM scores very limited. The aim was to conduct a scoping review to determine what is known about how intra-individual cyclical variation might affect the way individuals with chronic conditions respond to patient-reported outcome measures. Methods: A protocol of a systematic scoping review was registered on PROSPERO (CRD42017058365). We developed a search strategy based on previous relevant reviews and implemented it in: MEDLINE, Embase, PsycINFO, and CINAHL. No restrictions were placed on article types and backward and forward citation searches were conducted. Screening and data extraction were independently completed by up to four reviewers. An adapted version of CASP criteria was used to appraise the quality of included articles. Concepts that were important in understanding the impact of cyclical variation on PROM scores were elicited from the papers and iteratively refined through discussion amongst the authors. Results: 2420 references resulted from the searches, with 33 articles meeting the inclusion criteria. Most study designs included observational research (particularly ecological momentary assessment), 2 were RCTs and 2 were systematic reviews. Studies mainly focused on specific health conditions: mental health, respiratory and musculoskeletal. There was a lack of qualitative research and theoretical framework to explore these concepts more fully. Five overarching concepts emerged: variation in outcomes, variation of scores, psychological status, individual factors, and environmental/situational factors. A conceptual model was developed outlining the relationships between these concepts. Conclusions: There is empirical evidence that supports cyclical variation in PROM scores across different chronic conditions, with potential very significant implications for administration and interpretation of PROMs. The proposed conceptual model can support further research in this area. [ABSTRACT FROM AUTHOR]

Objective: To assess the clinical effectiveness of acupoint application (AP) of Guan Xin Su He Pill (冠心苏合丸, GXSHP) for patients with chronic stable angina pectoris (CSAP). Methods: This study was carried out in 3 local hospitals in Chengdu, China. After baseline evaluation, eligible patients were randomly assigned to the placebo application for acupoints (PAA) group or the herbal application for acupoints (HAA) group. Patients in the HAA group underwent AP with herbal powder, which was mainly GXSHP, and patients in the PAA group underwent AP with sham drugs. For each treatment session, unilateral acupoints including Neiguan (PC 6), Danzhong (RN 17), Xinshu (BL 15) and Jueyinshu (BL 14), were stimulated for both groups. AP was performed 3 times a week with a 2-day interval for 4 weeks. The primary outcome was the frequency of angina pectoris attacks per week, while the secondary outcomes included angina pain intensity measured by the Visual Analogue Scale (VAS), dose of rescue oral drugs (nitroglycerin), scores on the Seattle Angina Questionnaire (SAQ), Self-Rating Anxiety Scale scores (SAS) and Self-Rating Depression Scale scores (SDS). Clinical outcomes were measured at week 0, 4 and 8. The safety of AP of GXSHP treatment for CSAP were assessed. Results: A total of 121 patients were enrolled. Baseline characteristics were comparable across the 2 groups. After treatment, the angina attack numbers in the HAA group were significantly reduced from 11.00 to 4.81 (P<0.05). While, for PAA group, the angina frequency was not significantly improved (baseline 10.55; post-treatment 11.05). The HAA group had significantly fewer angina attacks than the PAA group (P<0.05). Pain intensity measured by VAS in HAA group was significantly reduced from 4.06 to 3.02 (P<0.05). While, for PAA group, the VAS was significantly increased (baseline 3.62; post-treatment 3.96; P<0.05). Clinical outcomes showed better improvement after treatment in the HAA group than in the PAA group in terms of oral administration of rescue drugs, SAS, SDS and SAQ scores (P<0.05). The adverse events were also reported. Conclusion: AP of GXSHP is a safe and effective treatment for CSAP patients (Registration No. NCT02029118). [ABSTRACT FROM AUTHOR]

Background: English versions of the University of Washington Caregiver Stress (UW-CSS) and Benefit (UW-CBS) Scales were developed in the United States (US) to measure impact on caregivers of caring for a child/children. Caregiving stress and benefit are important constructs to study worldwide. The purpose of this study was to translate and validate the UW-CSS and UW-CBS into French, German, Italian, and Spanish languages. Method: UW-CSS and UW-CBS were translated using forward and backward translation with reconciliation. Cognitive interviews (CIs) were completed with caregivers of children < 18 years with severe epilepsy. Translated versions were also administered to at least 100 caregivers in each of the four countries: France, Germany, Italy, and Spain. Differential item functioning (DIF) analyses were used to assess linguistic and cultural bias by country. The US development sample of 722 caregivers was used as a comparison sample for DIF analyses. DIF adjusted scores were calculated to determine impact of DIF on the item response theory (IRT)-based T-score. Benefit and stress scores were also calculated and compared across countries and health condition subgroups. Finally, short forms were modified to minimize the impact of DIF on the UW-CSS and UW-CBS T-scores and to reflect feedback from CIs. Results: Interviews were completed with 47 caregivers (German n = 14; Spanish n = 10; French n = 13; Italian n = 10). UW-CSS and UW-CBS were administered to 456 (German n = 117, Spanish n = 114, French n = 115, Italian n = 110) caregivers of children with and without health conditions. All stress items functioned well in CIs, though results indicated statistically significant DIF for three items in multiple countries and in the overall sample. Four of the 13 benefit items were problematic based on CI feedback, and six items showed DIF in one or more countries or in the combined sample. However, average differences between DIF adjusted and non-adjusted scores were minimal for both scales and all comparisons, indicating the impact of DIF on the total score was negligible. Conclusion: Modified short forms functioned well in all four of the translated versions. All language versions are freely publicly available. [ABSTRACT FROM AUTHOR]

Background: Self-management has become the dominant care model for chronic disease management. This study aimed to investigate the effect of changes in self-management strategies on the clinical outcomes of chronic diseases. Methods: Two hundred ninety-seven patients with one or more chronic disease (diabetes, dyslipidemia, or hypertension) were registered and followed in this prospective cohort study. We compared differences in the changes in clinical outcomes from baseline to 6 months according to the improvement of self-management strategies by analysis of covariance. Results: Diabetic patients with improved self-management strategies showed a significantly greater change in HbA1c levels compared to patients without improvement of self-management strategies (group difference in HbA1c = 0.51%). In hypertensive patients, systolic and diastolic blood pressure (BP) showed a significant decline in the patients with improved self-management strategies (group difference in systolic BP = 6.2 mmHg and in diastolic BP = 5.5 mmHg). Clinical outcomes improved significantly when self-management strategies improved in people with a poor self-management strategy at baseline. Conclusions: This study suggests that improvements in self-management strategies are associated with an improvement in clinical outcomes among patients with chronic diseases, especially for those with an initially poor self-management strategy. [ABSTRACT FROM AUTHOR]

Background: Central sensitization is considered a critical pathogenic mechanism of chronic migraine (CM). Activation of microglia in the trigeminal nucleus caudalis (TNC) contributes to this progression. Microglial glucagon-like peptide-1 receptor (GLP-1R) activation can alleviate pain; however, whether it is involved in the mechanism of CM has not been determined. Thus, this study aims to investigate the precise role of GLP-1R in the central sensitization of CM. Methods: Repeated nitroglycerin injection-treated mice were used as a CM animal model in the experiment. To identify the distribution and cell localization of GLP-1R in the TNC, we performed immunofluorescence staining. Changes in the expression of GLP-1R, Iba-1, PI3K and p-Akt in the TNC were examined by western blotting. To confirm the effect of GLP-1R and PI3K/Akt in CM, a GLP-1R selective agonist (liraglutide) and antagonist (exendin(9–39)) and a PI3K selective antagonist (LY294002) were administered. Mechanical hypersensitivity was measured through von Frey filaments. To investigate the role of GLP-1R in central sensitization, calcitonin gene-related peptide (CGRP) and c-fos were determined using western blotting and immunofluorescence. To determine the changes in microglial activation, IL-1β and TNF-α were examined by western blotting, and the number and morphology of microglia were measured by immunofluorescence. We also confirmed the effect of GLP-1R on microglial activation in lipopolysaccharide-treated BV-2 microglia. Results: The protein expression of GLP-1R was increased in the TNC after nitroglycerin injection. GLP-1R was colocalized with microglia and astrocytes in the TNC and was fully expressed in BV-2 microglia. The GLP-1R agonist liraglutide alleviated basal allodynia and suppressed the upregulation of CGRP, c-fos and PI3K/p-Akt in the TNC. Similarly, the PI3K inhibitor LY294002 prevented nitroglycerin-induced hyperalgesia. In addition, activating GLP-1R reduced Iba-1, IL-1β and TNF-α release and inhibited TNC microglial number and morphological changes (process retraction) following nitroglycerin administration. In vitro, the protein levels of IL-1β and TNF-α in lipopolysaccharide-stimulated BV-2 microglia were also decreased by liraglutide. Conclusions: These findings suggest that microglial GLP-1R activation in the TNC may suppress the central sensitization of CM by regulating TNC microglial activation via the PI3K/Akt pathway. [ABSTRACT FROM AUTHOR]

Background: The Rapkin and Schwartz appraisal theory and measure provided a path toward documenting response-shift effects and describing individual differences in ways of thinking about quality of life (QOL) that distinguished people in different circumstances. Recent work developed and validated the QOL Appraisal Profileversion 2 (QOLAPv2), an 85-item measure that taps response-shift-detection domains of Frame of Reference, Standards of Comparison, Sampling of Experience, and Combinatory Algorithm. Recent theoretical work proposed that appraisal measurement constitutes a new class of measurement (idiometric), distinct from psychometric and clinimetric. To validate an idiometric measure, one would document that its items reflect different circumstances and population characteristics, and explain variance in QOL. The present work sought to develop idiometric short-forms of the QOLAPv2 item bank by examining which items were most informative, retaining the appraisal-domain structure. Methods: This secondary analysis (n = 1481) included chronically-ill patients and their caregivers from a longitudinal web-based survey (mean follow-up 16.6 months). Data included the QOLAPv2, the Center for Disease Control Healthy Days Core Module, the PROMIS-10 Global Health, and demographic/medical variables. Appraisal items were measured at baseline (relevant to understanding cognitive appraisal processes); and with change scores (sensitive to response-shift effects). Multivariate analysis of covariance examined what demographic and health-status change variables were reflected by each of 85 appraisal items (in five sets), as dependent variables, and other demographic/medical variables. Multiple linear regression examined how appraisal items explained variance in global physical- and mental-health change, after covariate adjustment. A tally summarized item performance across all five sets of cross-sectional and longitudinal analyses. Results: The vast majority (i.e., 80%) of the QOLAPv2 items performed well across the analyses presented. Using a relatively strict criterion of explaining meaningful variance across 60% of analyses, one would retain 68 items. A more lenient criterion (40%) would retain 71. Conclusions: The present study provides heuristics to support investigators' creating 'discretionary' QOLAPv2 short-forms to fit their study aim and amplifying individual differences in the cognitive processes underlying QOL. This approach enables adapting the measure to the study population, as per the expectation that respondent populations differ in the predominant cognitive processes used. [ABSTRACT FROM AUTHOR]

Chronic diseases have been treated using the phytochemical concepts of ethnomedicinal plant-derived herbal products. Terminalia arjuna, a significant ethnomedicinal plant, was revisited and reconnoitred for antioxidant, free radical scavenging, and DNA nicking inhibiting activity under H2O2 conditions using 21 solvent extracts. Ferric reducing antioxidant power (FRAP), 2,2-diphenyl-1-picrylhydrazyl (DPPH), 2,2′-azino-bis-3-ethylbenzothiazoline-6-sulphonic acid, and nitrous oxide scavenging (%) were found to have a strong positive association and interaction (PCA 1 explains 84.54% variation) with ethanol bark (Etoh-AB) (Meoh-AF). TPC (144.67–1794 µg/mL GAE) and TFC (2.5–34 µM Fe(II)/g were highest in Etoh-AB. In a pattern of combined solvent extracts, Etoh-AB had the highest antioxidant capacity, accompanied by Etoh-AL ≥ Meoh-AB ≥ Dw-AF. With R2 = 0.94, the DNA nicking inhibition behaviour parameters relative front, relative quantity, band (%), and lane (%) formed a positive significant (p < 0.01) connection. For the first time, we show that Etoh-AB nicks supercoiled, circular plasmid DNA in a way that is comparable to normal antioxidants. Normal antioxidants with the ability to prevent DNA nicking include Butylated hydroxy anisole < Butylated hydroxy toluene < ascorbic acid < and Gallic acid. Gallic acid (m/z 170.0208 g/mol) and Ellagic acid (m/z 302.0063 g/mol were present in high concentrations in solvent extracts. 0.48 mg was found to be the effective concentration for inhibiting relative DNA nicking. The current study is the first of its kind to show that steroid concentrations are higher in bark fractions of acetone, ethanol, and methanol. Furthermore, T. arjuna solvent extracts provide a wealth of information on phytochemical profiling, antioxidant ability, and DNA nicking inhibition, which may be useful for exploring the natural way and further research to develop a remedy against geriatric chronic disease. Despite the fact that ethanol is very close to methanol in terms of solvent toxicity, the current study identified it as the preferred solvent. Thus, the current research revisits previous studies and explores the potentiality of non-polar and polar aprotic and polar protic solvent systems, which lend credence to bioactive compounds that may be useful in isolating and formulating safe and cost effective herbal medicament for livestocks and aquaculture, and drugs for deoxygenerative human diseases, and can also be investigated further to instil environmental frugality. [ABSTRACT FROM AUTHOR]

While there has been a rapid growth of digital health apps to support chronic diseases, clear standards on how to best evaluate the quality of these evolving tools are absent. This scoping review aims to synthesize the emerging field of mobile health app quality assessment by reviewing criteria used by previous studies to assess the quality of mobile apps for chronic disease management. A literature review was conducted in September 2017 for published studies that use a set of quality criteria to directly evaluate two or more patient-facing apps supporting promote chronic disease management. This resulted in 8182 citations which were reviewed by research team members, resulting in 65 articles for inclusion. An inductive coding schema to synthesize the quality criteria utilized by included articles was developed, with 40 unique quality criteria identified. Of the 43 (66%) articles that reported resources used to support criteria selection, 19 (29%) used clinical guidelines, and 10 (15%) used behavior change theory. The most commonly used criteria included the presence of user engagement or behavior change functions (97%, n = 63) and technical features of the app such as customizability (20%, n = 13, while Usability was assessed by 24 studies (36.9%). This study highlights the significant variation in quality criteria employed for the assessment of mobile health apps. Future methods for app evaluation will benefit from approaches that leverage the best evidence regarding the clinical impact and behavior change mechanisms while more directly reflecting patient needs when evaluating the quality of apps. [ABSTRACT FROM AUTHOR]

Purpose: Fatigue is a prominent symptom in individuals with chronic lymphocytic leukemia (CLL). This work evaluates the content validity and psychometric properties of the Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) in patients with CLL to determine if it is fit for purpose in CLL research. Methods: The FACIT-Fatigue yields a 13-item total score from a five-item symptom subscale and an eight-item impact subscale. To evaluate content validity, cognitive debriefing interviews were conducted with 40 patients with CLL in the first-line or relapsed or refractory setting. Psychometric properties, including structural validity, internal consistency, construct and known-groups validity, were investigated using data from a phase 3 trial in relapsed or refractory CLL (NCT02970318). Results: Interviewed patients considered the FACIT-Fatigue items relevant to their CLL experience, understood the terminology and agreed with response options. Confirmatory factor analysis confirmed the presence of symptom and impact subscales, but also supported unidimensionality of the FACIT-Fatigue. The FACIT-Fatigue total, symptom and impact subscales demonstrated good internal consistency (Cronbach's coefficient α > 0.85 and McDonald's omega ω > 0.90), and strong correlations with relevant EORTC QLQ-C30 scales (all Spearman's r ≥ 0.5). Known-groups validity was shown by significant differences between groups defined by baseline performance status, hemoglobin level and constitutional symptoms (all p <.0001). Cluster analysis supported FACIT-Fatigue score thresholds of 30 and 34 to define a severe fatigue population. Conclusions: Content validity and psychometric evaluation in patients with CLL demonstrated that the FACIT-Fatigue has good psychometric properties and is fit for purpose in CLL. [ABSTRACT FROM AUTHOR]

Background: Most people in a state of illness or reduced self-sufficiency wish to remain in their home environment. Their physiological needs, and their psychological, social, and environmental needs, must be fully met when providing care in their home environment. The aim of this study is to provide an overview of the self-perceived needs of older people living with illness or reduced self-sufficiency and receiving professional home care. Methods: A scoping review of articles published between 2009 and 2018 was conducted by searching six databases and Google Scholar. Inductive thematic analysis was used to analyze data from the articles retrieved. Results: 15 articles were included in the analysis. Inductive thematic analysis identified six themes: coping with illness; autonomy; relationship with professionals; quality, safe and secure care; role in society; environment. Conclusion/discussion: Older home care patients living with chronic illness and reduced self-sufficiency are able to express their needs and wishes. Care must, therefore, be planned in line with recipients' needs and wishes, which requires a holistic approach. [ABSTRACT FROM AUTHOR]

Background: Gains in cancer detection and treatment have meant that more patients are now living with both cancer and other chronic health conditions, which may become burdensome. We used the Patient Experience with Treatment and Self-Management (PETS) framework to study challenges in self-management and its impact on health among survivors of women's cancers who are caring for other chronic health conditions. Methods: Applicability of the PETS domains among survivors of women's cancers with comorbidities was assessed in focus groups to create the study survey. Women surviving primary breast, cervical, ovarian, or endometrial/uterine cancer treated between 6 months and 3 years prior at two large healthcare systems in Virginia were mailed study invitation letters to complete a telephone-based survey. The survey included questions on cancer treatment history, comorbid conditions prior to cancer, treatment and self-management experiences, health literacy, financial security, and items on self-management activities, self-management difficulties and self-management impact (i.e., role/social activity limitations and physical/mental exhaustion). Additionally, general health was assessed with items from the Patient-Reported Outcomes Measurement Information System (PROMIS). Hierarchical regression models and path analysis were used to examine correlates of self-management impact on general physical health (GPH) and mental health (GMH). Results: Of 1448 patients contacted by mail, 274 (26%) returned an interest form providing their consent to be contacted. Of these, 183 completed the survey. Reasons for non-completion included ineligibility (42), unable to be reached (33) and refusal (6). The majority were survivors of breast (58%) or endometrial/uterine cancer (28%), and 45% resided in non-urban locations. After adjusting for age, race, and cancer type, survivors with higher self-management difficulty reported higher self-management impact, which was associated with lower perceived general health. Reports of higher self-management impact was associated with being single or unmarried, white race, fulltime employed, higher financial insecurity, lower health literacy and more comorbidities. In path analysis, self-management impact was a significant mediator in the association of comorbidity and financial insecurity on GPH and GMH. Conclusions: Among survivors of women's cancer, pre-diagnosis comorbidity, health literacy, and financial security are associated with psychosocial impact of self-management and general physical and mental health in the 6 month to 3-year period after cancer treatment has ended. The impact of self-management on psychosocial functioning is an important factor among cancer survivors caring for multiple chronic health conditions. This study provides evidence on the importance of assessing cancer survivors' self-management difficulties such as in future interventions to promote health and wellness. [ABSTRACT FROM AUTHOR]

To perform an integrative review of the literature on the effectiveness of intravascular laser irradiation of blood (ILIB) as an adjunct therapy in the treatment of chronic systemic diseases. This is an integrative literature review that included non-randomized and randomized controlled clinical trials that specifically evaluated the therapeutic effect of ILIB on chronic systemic diseases, without restriction of time, and written in English. The Medical Publications (PubMed)/MEDLINE database was used. MeSH (Medical Subject Headings) was used to select search descriptors with the Boolean operators "AND/OR." After applying the inclusion and exclusion criteria, 13 articles were selected. Coronary diseases were the most prevalent, followed by type 2 diabetes mellitus, with the coronary artery being the most widely used access route for ILIB application. Despite the varied parameters and protocols for using this kind of therapy, all studies have shown satisfactory results in the patients' clinical condition. ILIB proved to be effective in all organic systems, showing some positive result. However, studies on the effect of this therapy on various diseases are still scarce in the literature, and there is a need for more well-designed clinical trials to better understand the role of ILIB in various systemic diseases. [ABSTRACT FROM AUTHOR]

The incidence of depression in individuals with sickle cell disease (SCD) is significantly higher compared to the general population. This systematic literature review was conducted to: (1) describe depressive symptoms in SCD individuals and (2) explore religiosity as a coping mechanism for alleviating depressive symptoms. Emerging themes were physical depressive symptoms and psychosocial depressive implications. Despite uptake of religion and religiosity as a coping strategy in other chronic illnesses, no studies were found that used religiosity to cope with depressive symptoms in SCD. Future research should explore the use of religiosity as an alternative therapy to cope with depression symptoms. [ABSTRACT FROM AUTHOR]

Background: Adaptation of a patient-reported outcomes survey into a new language requires careful translation procedures as well as qualitative and quantitative psychometric testing. This study aimed to evaluate the basic psychometric properties of the new Saudi Arabian SF-36v2 and establish norm data for Saudi Arabia. Methods: Translation and adaptation of the SF-36v2 used standard methodology. Psychometric validation included two stages: 1) A qualitative study (n = 100) explored the components of health and health-related quality of life considered important in Saudi Arabia and evaluated the content validity of the SF-36v2 in Saudi Arabia, and 2) A quantitative study (n = 6166) evaluated the basic psychometric properties of the Saudi SF-36v2 and established norm data for Saudi Arabia. Comparison with US general population data (n = 4040) evaluated differential item function (DIF) and cross-national differences. Results: The qualitative study supported the content validity of the Saudi SF-36v2. Cognitive debriefing identified only few and minor problems. Psychometric analyses supported item convergence within scales and differentiation across scales of the SF-36v2. Scale level exploratory factor analyses did not support the typical distinction between physical health and mental health components. Internal consistency reliability was satisfactory for all scales except the social function scale (alpha = 0.67). Cross-national DIF was identified for 9 items. In the Saudi general population, the average vitality score was lower for women (− 2.71 points) compared to men. For men, older age groups scored lower on the physical function scale (− 3.31) and the physical health component (− 3.06). For women, older age groups scored lower on the role physical (− 3.72), bodily pain (− 3.66), and vitality (− 2.32) scales as well as the physical health component (− 3.52). Compared to the 2009 United States general population, and after adjusting for age, gender, and differential item function, persons in Saudi Arabia had lower average scores for the physical function (− 3.10), role physical (− 4.75), social function (− 4.23), role emotional (− 5.67), and mental health (− 4.82) scales, as well as the mental health component (− 4.57). Conclusion: This Saudi normative study of patient reported outcomes supported the validity and reliability of the new Saudi SF-36v2 and found cross-national differences with the USA. [ABSTRACT FROM AUTHOR]

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a rare and heterogeneous acquired sensory-motor polyneuropathy with autoimmune pathogenesis. Intravenous immunoglobulins (IVIG) are a well-established therapy for CIDP: it is well known that at least two-thirds of these patients need these infusions for several years. More recently, Subcutaneous Immunoglobulins (SCIg) have been proved to be effective: this finding has been confirmed either in isolated cases or in few randomized trials. However, it appeared that the longest SCIg treatment follow up lasted no longer than 48 months. We report herein the results of a long-term SCIg treatment with a follow up period up to 7 years (84 months), considering safety, tolerability and patients' perception of SCIg treatment in a CIDP population. We studied 17 patients (10 M; 7 F) with a diagnosis of CIDP, defined according to the EFNS/PNS criteria, successfully treated with IVIG every 4/6 weeks before being switched to SCIg treatment. Clinical follow-up included, apart from a routinely clinical assessment, the administration of Medical Research Council (MRC) sum-score, the Overall Neuropathy Limitation Scale (ONLS) and the Life Quality Index questionnaire (LQI). The results showed that, in the majority of this pre-selected group of CIDP patients (16/17), SCIg were well tolerated and were preferred over IVIG. Strength and motor functions remained stable or even improved during the long term follow-up (up to 84 months) with benefits on walking capability and resistance, manual activity performances and fatigue reduction. [ABSTRACT FROM AUTHOR]

The development of Chinese medicine and Western medicine andrology is based on different social background and academic systems, either Chinese medicine or Western medicine andrology has their limitations, therefore, integration of Chinese and Western medicine (ICWM) andrology is in a great need. After more than 30 years of development, andrology has made great achievements in the construction of specialized academic association, holding academic conferences and publication of academic monographs, and the research progress on this field is mainly in the combination of disease and syndrome, microdifferentiation of symptoms and signs and basic research development. However, the comprehensive theoretic system of ICWM andrology has not yet established, and the related studies are still on the primary stage. In the future studies, great efforts still need to be made to expand the methods for the investigation of ICWM, and make innovations in the field of andrology. [ABSTRACT FROM AUTHOR]

The objective of this study was to evaluate the clinical attachment level (CAL) gain of Er:YAG, Er,Cr; YSGG, Nd:YAG; and diode laser (DL) as monotherapy or adjunctive to scaling and root planing (SRP) of chronic periodontitis by network meta-analysis (NMA). Randomized controlled clinical trials (RCTs) about lasers applied in SRP of chronic periodontitis were searched from PubMed, Cochrane Library, Web of Science, Ovid, Science Direct, Wan Fang, and China National Knowledge Infrastructure (CNKI) databases up to September 2018 and from references of selected full-texts and related reviews. Standard mean differences and 95% confidence intervals were counted for CAL gain. The random effects NMA were performed in STATA software. There were 25 RCTs about CAL gain at 3 and/or 6 months after lasers were applied in SRP. No inconsistency was detected. Er:YAG as monotherapy gained significantly more CAL at 3 months than did SRP; no significant differences were detected among other comparisons. In terms of CAL gain at 3 months, the ranking result from best to worst was as follows: Er:YAG as monotherapy, DL adjunctive to SRP, Er:YAG adjunctive to SRP, Er,Cr;YSGG as monotherapy, Nd:YAG adjunctive to SRP, and SRP. In terms of CAL gain at 6 months, the ranking result from best to worst was as follows: DL adjunctive to SRP, Nd:YAG adjunctive to SRP, SRP, Er:YAG adjunctive to SRP, and Er:YAG as monotherapy. Laser-assisted periodontal treatment could be superior to SRP alone and could serve as a good adjunctive treatment tool. [ABSTRACT FROM AUTHOR]

Exercise is an efficacious therapy for many chronic diseases. Integrating efficacious evidence-based interventions (EBIs), such as exercise, into daily healthcare practice is a slow and complex pursuit. Implementation science seeks to understand and address this phenomenon by conducting studies about the methods used to promote the routine uptake of EBIs. The purpose of this article is to explore implementation science and a common conceptual framework in the discipline, the Consolidated Framework for Implementation Research (CFIR), as it applies to exercise EBI. We conclude by offering recommendations for future research that leverage implementation science priorities to highlight the potential of this research field for advancing the implementation of exercise EBI. [ABSTRACT FROM AUTHOR]

The use of transition readiness questionnaires is strongly recommended in adolescents with chronic conditions. The aim of our study was to validate "Good2Go," the first French-language transition readiness questionnaire. We analyzed the data from 2 multicentric studies (Canada and France) involving adolescents with chronic conditions (type 1 diabetes, inflammatory bowel disease, cystic fibrosis, epilepsy, juvenile idiopathic arthritis). Content and construct validity were examined using factorial and Rasch analysis (structural validity), Spearman's correlation, and Mann-Whitney test (external validity). Cronbach's α and intra-class correlation coefficients explored reliability. Cognitive interviews assessed wording comprehension and item appropriateness. Good2Go was completed by 321 participants (boys = 51%; mean age = 16.4 years (standard deviation = 1.5; min = 14.0; max = 18.0); Canada = 51.1%). Factor analysis identified 3 domains: "health self-advocacy," "knowledge about chronic conditions," and "self-management skills." The 3-domain structure showed a satisfying Rasch fit, internal consistency, and test-retest reliability. Good2Go domain scores were significantly higher in participants over 17 years of age, indicating satisfactory external validity.Conclusion: Good2Go is a valid 20-item questionnaire to assess transition readiness in adolescents with chronic conditions and may be useful in routine care to propose individually tailored preparation for their transfer to adult healthcare. Further research is now needed to analyze correlation between domain scores and success of transition.What is Known:• In adolescents with chronic conditions, the use of transition readiness questionnaires is recommended to propose individually tailored preparation for their transfer to adult healthcare.• However, no French-language questionnaire has been so far validated.What is New:• Based on a complete validation methodology, this study highlights that the French-language 20-items Good2Go questionnaire has good psychometric properties.• It explores all transition key points though 3 scored domains: "health self-advocacy", "knowledge about chronic disease" and "self-management skills". [ABSTRACT FROM AUTHOR]

Alterations in gut microbiota composition are associated with metabolic syndrome and chronic inflammatory diseases such as inflammatory bowel disease. One feature of inflammation-associated gut microbiotas is enrichment of motile bacteria, which can facilitate microbiota encroachment into the mucosa and activate pro-inflammatory gene expression. Here, we set out to investigate whether elicitation of mucosal anti-flagellin antibodies by direct administration of purified flagellin might serve as a general vaccine against subsequent development of chronic gut inflammation. We show, in mice, that repeated injection of flagellin elicits increases in fecal anti-flagellin IgA and alterations in microbiota composition, reduces fecal flagellin concentration, prevents microbiota encroachment, protects against IL-10 deficiency-induced colitis, and ameliorates diet-induced obesity. Flagellin's impact on the microbiota is B-lymphocyte dependent and, in humans, obese subjects exhibit increased levels of fecal flagellin and reduced levels of fecal flagellin-specific IgA, relative to normal weight subjects. Thus, administration of flagellin, and perhaps other pathobiont antigens, may confer some protection against chronic inflammatory diseases. Gut microbiota alterations, including enrichment of flagellated bacteria, are associated with metabolic syndrome and chronic inflammatory diseases. Here, Tran et al. show, in mice, that elicitation of mucosal anti-flagellin antibodies protects against experimental colitis and ameliorates diet-induced obesity. [ABSTRACT FROM AUTHOR]

Spiritual well-being is a major issue in health care, but instruments for measuring this construct in adolescents are lacking. This study adapted the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12) for use with Brazilian adolescents with chronic diseases and developed a parental observer-rated version, using an expert panel, back-translation, and cognitive interviews with 72 participants. The psychometric properties of both versions were verified with two- and three-factor models by testing with 212 participants. The self- and parental-reported versions showed face validity, content validity, and acceptable levels of internal consistency for the overall scale and the two-factor model. The convergent validity was satisfactory for most items in both two- and three-factor models, but there was a lack of discrimination in the three-factor model using multitrait–multimethod analysis. This study presents the first instrument to assess the spiritual well-being of adolescents from their point of view and to allow their parents to serve as evaluators. However, we recommend further psychometric testing of the self- and parental-report scales to assess spiritual well-being in adolescents with chronic diseases in Brazil. [ABSTRACT FROM AUTHOR]

Background: The teach-back method, also known as the "show-me" method, has been endorsed by many medical and health care societies. However, limited investigation has been conducted regarding its association with patient outcomes.Objectives: To examine the association between patient teach-back experience and the risk of hospitalizations and length of hospital stay among patients with ambulatory care sensitive conditions (ACSCs).Design: A matched cohort study.Setting: Data from the 2011-2015 Longitudinal Medical Expenditure Panel Survey (panels 16-19).Participants: Three thousand nine hundred ninety-four US adults aged ≥ 18 years with any of 5 ACSCs (hypertension, type 2 diabetes, heart disease, asthma, and chronic obstructive pulmonary disease [COPD]).Measurements: Hospital admissions (all-cause or ACSC-related) and the length of stay of the first admission were examined by teach-back during interaction with a health provider.Results: Patients with teach-back experience were less likely to experience hospitalization for an ACSC-related condition (relative risk, 0.85; 95% CI, 0.71 to 0.99) and had a lower risk for a condition-related readmission (hazard ratio, 0.77; 95% CI, 0.60 to 0.99), compared with those without teach-back experience. The median length of hospital stay did not differ between patients with teach-back experience and those without teach-back experience (median 3 days [IQR 1 to 8 days] and median 3 days [IQR 0 to 8 days], respectively; P = 0.84). Subgroup analysis showed that the association of reported teach-back experience on the outcomes was relatively stable among those with hypertension, diabetes, and heart disease, but was not among those with asthma or COPD.Limitation: Teach-back exposure relied on patient self-reported information.Conclusions: Our findings suggest that patient teach-back method is associated with reduced risk of hospitalization for those with ACSCs, especially among patients with cardiovascular diseases and type 2 diabetes. Encouraging providers to utilize the teach-back method at every visit has the potential to further reduce hospitalizations for individuals with ACSCs. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to examine worldwide chronic venous disease (CVD) burden and evaluate effectiveness, adherence and satisfaction with conservative treatment. Materials and methods: The VEIN Act Program (VAP) was an international, prospective, observational study that enrolled adult outpatients with lower-limb pain consulting for any CVD-related clinical presentation. Patients' CVD symptoms, Clinical Etiological Anatomic Pathophysiologic (CEAP) classification, and symptom intensity were recorded. After prescribing conservative treatments, patients returned for a follow-up visit. Result: A total of 567 physicians enrolled 7987 patients, 7397 of whom were included in the analysis. Patients were mainly female (79.3%), mean age was 54.0 ± 15.1 years and mean body mass index was 26.8 ± 4.8 kg/m2. CEAP clinical classifications were C0s (3.6%), C1 (19.4%), C2 (21.8%), C3 (32.0%) and C4–C6 (23.2%). Symptoms were reported by 89.6% of patients and were present across all CEAP classes. Mean intensity (10 cm visual analog scale) was > 5 cm for all symptoms. Only 30.7% of patients had previously consulted for leg problems, and 24.3% had previously received treatment. Conservative treatment alone was prescribed to 78.3% of patients, and in association with operative treatment in 21.6% of patients, and consisted mostly of venoactive drugs (VADs) [99.6%, mostly micronized purified flavonoid fraction] and compression therapy (63.4%) in combination with lifestyle changes such as weight loss. Adherence to prescribed duration was 65.2% for VADs, but only 29.1% wore compression therapy as prescribed. Symptom relief was high with VADs and compression therapy (> 96%), and the majority of patients were satisfied (94.1%). Conclusion: Conservative treatments were beneficial across the spectrum of CVD, highlighting the importance of identifying patients early in the disease course. [ABSTRACT FROM AUTHOR]

Plants produce and release a vast variety of secondary metabolites with diversified functions, and possess ecological, toxicological and biological effects that mimic the activities of synthetic chemicals. Coumarins extracted from bacteria, fungi and many edible plants are widely used for their antibacterial, antifungal, antiviral, anti-HIV and anticancer activities. This review presents a concise summary based on the latest knowledge of the biological and pharmaceutical uses of coumarin and its derivatives, including an evaluation of future therapeutic potential. The presence of coumarins in various plant organs like fruits, seeds, roots, leaves and latex supplement recent work reported in scientific literature related to these compounds and their development. Due to low production in plants, the upscaling and industrial scale production, commercialization and industry demand of coumarins has faced hurdles. We searched Google Scholar and Web of Science for relevant literature upto 2018 using the keywords pharmaceutical, biological activities and coumarins. This review has thoroughly overviewed the related facts and figures about coumarins and its derivatives, especially in terms of biological and pharmaceutical properties including anti-microbial, anti-viral, anti-diabetic, anticoagulant, estrogenic, dermal photosensitizing, vasodilator, molluscacidal, antithelmintic, sedative and hypnotic, analgesic, hypothermic, anti-cancer activity, anti-oxidant, anti-parasitic, antihelmintic, anti-proliferative, anti-convulsant, anti-inflammatory, and anti-hypertensive activities. The pharmaceutical impact of coumarins on public health is a complex phenomenon, with several questions in relation to safety during medical therapies and consumption through diet. The present review focuses on coumarin clinical studies in the treatment of various chronic diseases such as cancer, diabetes, depression, Alzheimer's, Parkinson's and HIV. However, further research and review are necessary to broaden the therapeutic effectiveness of coumarin in patients suffering from such ailments. [ABSTRACT FROM AUTHOR]

There is increasing emphasis on patient-centred research to support the development, approval and reimbursement of health interventions that best meet patients' needs. However, there is currently little guidance on how meaningful patient engagement may be achieved. An expert working group, representing a wide range of stakeholders and disciplines, was convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the World Health Organization (WHO). Through a structured, collaborative process the group generated practical guidance to facilitate optimal patient engagement in clinical development and regulatory decisions. Patient engagement is a relational process. The principles outlined in this report were based on lessons learned through applied experience and on an extensive dialogue among the expert participants. This practice guidance forms a starting point from which tailoring of the approach to suit different chronic diseases may be undertaken. [ABSTRACT FROM AUTHOR]

Serious and chronic health conditions such as cardiovascular diseases (CVDs) are posing challenges to the health system. Recently clinical trials in these fields have focused on composite endpoints that take into account both disease-related mortality and major disease-related morbidity events. It is the time to the first component of the composite endpoint experienced by a patient that is the traditional study endpoint and treatment aims are to delay the time to the first event and to reduce its frequency. As the name implies, the time-to-first composite event analysis approach focuses only on the first composite event and ignores subsequent events. For a chronic disease, this can lead to a substantial loss of potentially important information. For instance, in chronic heart failure (HF) studies, the traditional composite endpoint of HF-related hospitalizations and CVD death will ignore CVD deaths that are preceded by HF-related hospitalizations. This paper explores the limitations of the traditional time-to-first event approach and discusses the potential value of incorporating all events. The authors argue that endpoints capturing recurrent event information can lead to interpretable measures of treatment effect that better reflect disease burden than traditional time-to-first event endpoints by using the available information beyond the first event. This paper aims to raise awareness of the value and potential pitfalls of alternative treatment effect measures to facilitate meaningful cross-functional conversations among trialists and other stakeholders such as regulators, payers, and treating physicians who all are striving to the same goal—to deliver the most effective treatments to patients. [ABSTRACT FROM AUTHOR]

During the 40 years since the Yale conference on Behavioral Medicine and the founding of the Journal of Behavioral Medicine considerable progress has been made in understanding the role of psychosocial risk and management of physical diseases. We here describe the development of these fundamental concepts from early research on stress through studies of the Type A behavior pattern to more contemporary approaches to the relationship between psychosocial risks and benefits in relation to disease processes. This includes the relationship of psychosocial risk to cancers, cardiovascular diseases (CVD), cardiometabolic disorders, Human Immunodeficiency Virus (HIV)/Acquired Human Immune Deficiency Syndrome. During the past 40 years the effects of prolonged distress responses in the pathogenesis of some cancers and CVD have been well-established and modifiable behavioral, cognitive and social factors have been shown to produce favorable outcome components in the management of such diseases as breast cancer, coronary heart disease and HIV. [ABSTRACT FROM AUTHOR]

Therapeutic antibodies are increasingly used to treat various diseases, including neoplasms and chronic inflammatory diseases. Antibodies exhibit complex pharmacokinetic properties, notably owing to the influence of antigen mass, i.e. the amount of antigenic targets to which the monoclonal antibody binds specifically. This review focuses on the influence of antigen mass on the pharmacokinetics of therapeutic antibodies quantified by pharmacokinetic modelling in humans. Out of 159 pharmacokinetic studies, 85 reported an influence of antigen mass. This influence led to non-linear elimination decay in 50 publications, which was described using target-mediated drug disposition or derived models, as quasi-steady-state, irreversible binding and Michaelis-Menten models. In 35 publications, the pharmacokinetics was apparently linear and the influence of antigen mass was described as a covariate of pharmacokinetic parameters. If some reported covariates, such as the circulating antigen level or tumour size, are likely to be correlated to antigen mass, others, such as disease activity or disease type, may contain little information on the amount of antigenic targets. In some cases, antigen targets exist in different forms, notably in the circulation and expressed at the cell surface. The influence of antigen mass should be soundly described during the early clinical phases of drug development. To maximise therapeutic efficacy, sufficient antibody doses should be administered to ensure the saturation of antigen targets by therapeutic antibodies in all patients. If necessary, antigen mass should be taken into account in routine clinical practice. [ABSTRACT FROM AUTHOR]

Background: Disease management programmes may improve quality of care, improve health outcomes and potentially reduce total healthcare costs. To date, only one very large population-based study has been undertaken and indicated reductions in hospital admissions > 10%.Objective: We sought to confirm the effectiveness of population-based disease management programmes. The objective of this study was to evaluate the relative impact on healthcare utilisation and cost of participants the Costs to Australian Private Insurance - Coaching Health (CAPICHe) trial.Design: Parallel-group randomised controlled trial, intention-to-treat analysis SETTING: Australian population PARTICIPANTS: Forty-four thousand four hundred eighteen individuals (18-90 years of age) with private health insurance and diagnosis of heart failure, chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD), diabetes, or low back pain, with predicted high cost claims for the following 12 months.Intervention: Health coaching for disease management from Bupa Health Dialog, vs Usual Care.Main Outcome Measures: Total cost of claims per member to the private health insurer 1 year post-randomisation for hospital admissions, including same-day, medical and prostheses hospital claims, excluding any maternity costs. Analysis was based on the intent-to-treat population.Results: Estimated total cost 1 year post-randomisation was not significantly different (means: intervention group A$4934; 95% CI A$4823-A$5045 vs control group A$4868; 95% CI A$4680-A$5058; p = 0.524). However, the intervention group had significantly lower same-day admission costs (A$468; 95% CI A$454-A$482 vs A$508; 95% CI A$484-A$533; p = 0.002) and fewer same-day admissions per 1000 person-years (intervention group, 530; 95% CI 508-552 vs control group, 614; 95% CI 571-657; p = 0.002). Subgroup analyses indicated that the intervention group had significantly fewer admissions for patients with COPD and fewer same-day admissions for patients with diabetes.Conclusions: Chronic disease health coaching was not effective to reduce the total cost after 12 months of follow-up for higher risk individuals with a chronic condition. Statistically significant changes were found with fewer same-day admissions; however, these did not translate into cost savings from a private health insurance perspective. [ABSTRACT FROM AUTHOR]