Evaluation of Bleeding Rate and Time in Therapeutic Range in Patients Using Warfarin Before and During the COVID-19 Pandemic-Warfarin Treatment in COVID-19.

The treatment process of patients using warfarin is expected to be hindered during the COVID-19 pandemic. Therefore we investigated whether the time in therapeutic range (TTR) and bleeding complications were affected during the COVID-19 pandemic. 355 patients using warfarin were included between March 2019 to March 2021. Demographic parameters, INR (international normalized ratio), and bleeding rates were recorded retrospectively. The TTR value was calculated using Rosendaal's method. The mean age of the patients was 61 ± 12 years and 55% of them were female. The mean TTR value during the COVID-19 pandemic was lower than the pre-COVID-19 period (56 ± 21 vs 68 ± 21, P < 0.001). Among the patients, 41% had a lack of outpatient INR control. During the COVID-19 pandemic, 71 (20%) patients using VKA suffered bleeding. Among patients with bleeding, approximately 60% did not seek medical help and 6% of patients performed self-reduction of the VKA dose. During the COVID-19 pandemic, TTR values have decreased with the lack of monitoring. Furthermore, the majority of patients did not seek medical help even in case of bleeding.

Patients' experience of haemorrhagic cystitis after Haematopoietic Stem Cell Transplantation: Findings from a phenomenological study.

PURPOSE: Haemorrhagic cystitis (HC) is a severe complication of haematopoietic stem cell transplantation (HSCT), which significantly affects patients' quality of life. However, no qualitative studies have described to date the experience of patients who have developed this complication. Therefore, the aim of this interpretative phenomenological study performed on 2019 was to explore the experience of patients who developed HC after HSCT. METHOD: A purposeful sample of nine patients who had experienced at least one episode of HC after the HSCT were approached. The audio-recorded interviews were transcribed verbatim and then analysed according to Giorgi's method. Member checking of the findings was also performed. RESULTS: The experience of the participants with HC after HSCT has been summarised around three main themes: "Being alerted", "It has arrived" and "It has been overcome." Patients reported to have been informed regarding the HC; after the first devastating symptoms, they reported fear and in searching for causes and strategies to alleviate the problem, which seemed to be never resolved. Patients' experience with HC is complex and experienced dramatically due to the pain and the discomforting consequences of the treatments received; they develop a sense of exhaustion that can further increase both their physical and emotional burden. The process of recovery from the huge impact, required time over the end of the HC symptoms. CONCLUSIONS: Patients' experience of HC is complex, and varies according to the various phases of the complication. HC creates an increased physical and psychological stresses that demand additional coping strategies: therefore, the emotional support of patients is crucial. Moreover, strategies used autonomously by patients to alleviate symptoms are at merit of consideration in future studies.

Physicians' perceptions regarding acute bleeding management: an international mixed qualitative quantitative study.

BACKGROUND: Acute bleeding is an omnipresent challenge for all physicians. Uncontrolled hemorrhage is the most common preventable cause of death after trauma worldwide. In different surgical disciplines, hemorrhage represents an independent risk factor for increased postoperative morbimortality, directly affecting patients' outcomes. This study asked anesthesiologists about their personal perceived challenges when treating bleeding patients. METHODS: This investigator-initiated, prospective, international, dual-center, mixed qualitative and quantitative study interrogated anesthesiologists about what they found easy and what difficult in treating acutely bleeding patients. Following the template approach for qualitative research, we identified major and minor topics through free inductive coding and word count. In a second step, we derived ten statements from the participants' answers. Using a field survey, we then asked the participants to rate their level of agreement with the derived statements. We analyzed the answers using one sample Wilcoxon test and the Mann-Whitney test. RESULTS: We included a total of 84 physicians in the qualitative interrogations and a different group of 42 anesthesiologists in the quantitative part. We identified 11 major topics and 19 associated subtopics. The main topics and the degree of agreement (here as agree or strongly agree) were as follows: "Complexity of the topic" (52.4% agreed to find the topic complex), "Cognitive aids" (92.9% agreed to find them helpful), "Time management" (64.3% agreed to feeling time pressure), "Human factors" (95.2% agreed that human factors are essential), "Resources" (95.2% agreed that resources are essential), "Experience" and "Low frequency of cases" (57.1% agreed to lack practice), "Diagnostic methods" (31.0% agreed that the interpretation of test results is difficult), "Anticoagulation" (85.7% agreed to it being difficult), "Treatment" (81.0% agreed to knowing the first therapeutic steps), and "Nothing". CONCLUSIONS: Anesthesiologists in two large tertiary care facilities in different parts of the world found coagulation management, especially in anticoagulated patients, complex. We identified the delayed diagnostic test results and their interpretation as challenges. Resources, treatment protocols and human factors such as team communication were perceived to facilitate management. Future studies should explore the challenges in smaller hospitals and other parts of the world and test new technologies addressing the identified difficulties.

Visual estimates of blood loss by medical laypeople: Effects of blood loss volume, victim gender, and perspective.

A severe hemorrhage can result in death within minutes, before professional first responders have time to arrive. Thus, intervention by bystanders, who may lack medical training, may be necessary to save a victim's life in situations with bleeding injuries. Proper intervention requires that bystanders accurately assess the severity of the injury and respond appropriately. As many bystanders lack tools and training, they are limited in terms of the information they can use in their evaluative process. In hemorrhage situations, visible blood loss may serve as a dominant cue to action. Therefore, understanding how medically untrained bystanders (i.e., laypeople) perceive hemorrhage is important. The purpose of the current study was to investigate the ability of laypeople to visually assess blood loss and to examine factors that may impact accuracy and the classification of injury severity. A total of 125 laypeople watched 78 short videos each of individuals experiencing a hemorrhage. Victim gender, volume of blood lost, and camera perspective were systematically manipulated in the videos. The results revealed that laypeople overestimated small volumes of blood loss (from 50 to 200 ml), and underestimated larger volumes (from 400 to 1900 ml). Larger volumes of blood loss were associated with larger estimation errors. Further, blood loss was underestimated more for female victims than male victims and their hemorrhages were less likely to be classified as life-threatening. These results have implications for training and intervention design.

Influence of hematoma volume and age on cognitive functions and ADL after putaminal hemorrhage.

BACKGROUND AND OBJECTIVE: After cerebral hemorrhage, cognitive functions and activities of daily living (ADL) are affected by various factors, including hematoma volume and patient age. In the present study, we investigated the effect of age and hematoma volume on cognitive functions and on ADL. METHODS: The sample comprised 274 patients (183 men and 91 women; mean age 58.2 ± 12.5 years) with putaminal hemorrhage who were hospitalized in a convalescent rehabilitation ward. Hematoma volume was estimated from computed tomography imaging at stroke onset. Cognitive functions were evaluated using Raven's Colored Progressive Matrices test (RCPM) and the Mini-Mental State Examination (MMSE) at hospital admission, while ADL score was assessed at discharge using the Functional Independence Measure motor subscale (FIM-M). In the present study, we classified the patients into six groups according to whether they were non-elderly or elderly (cutoff age, 60 years) and whether their hematoma was small, medium, or large (cutoff volumes, 20 and 40 mL, respectively). Subsequently, the scores on the RCPM, MMSE, and FIM-M were compared among the groups. RESULTS: In both age groups, patients with a larger hematoma volume had lower RCPM and MMSE scores. Patients <60 years old exhibited different trends in their RCPM and MMSE scores, such that the RCPM score showed a step-wise decrease according to hematoma volume, while a difference in the MMSE score was only observed at the 20 mL boundary. Most of the younger patients (<60 years of age) attained high FIM-M scores at discharge, as long as their hematoma volume was either medium or small (<40 mL). This age group had higher RCPM scores on admission, which may have contributed to their higher FIM-M scores on discharge. CONCLUSIONS: In the present study, we demonstrated that advancing age increases the effect of hematoma volume on RCPM and MMSE scores and identified differences in the effects observed on these two scores. Thus, it may be important to use the RCPM alongside the MMSE for patient assessment.

Factors influencing patient's perception of long-term treatment with low-molecular-weight heparins for cancer-associated thrombosis: an updated analysis of TROPIQUE, a prospective observational study.

PURPOSE: Our objective was to compare patient's expectations to their experience and to identify factors predictive of patient's perception of long-term LMWH for the treatment of cancer-associated thrombosis (CAT). METHODS: Results from the validated Perception Anticoagulant Treatment Questionnaires (PACTQ) completed before inclusion (PACTQ1 for expectations) and at the end (PACTQ2 for convenience and satisfaction) of the 6-month TROPIQUE study were studied with principal component analysis. Possible predictive factors of improved perception of LMWH treatment were analyzed with the Kruskall-Wallis test. RESULTS: Among 409 included patients treated with LMWH, 269 PACT-Q1 and 139 PACT-Q2 were evaluable for treatment perception. Patients had high expectations (A1-A7 score of 26.7 ± 3.5, max = 35). Treatment cost (A7 = 1.90 ± 1.31) and concern about a mistake in anticoagulation (A5 = 1.93 ± 1.12) had little importance while LMWH treatment was considered easy to use (A4 = 4.20 ± 0.93). Six-month treatment with LMWH was associated with a high rate of convenience (B1-B11, C1-C2 = 55.1 ± 8.38, max = 65) and a high satisfaction score (D1-D7 = 25.1 ± 4.32, max = 35). Patients' confidence in treatment and perception of possible LMWH side effects were moderate while perception of autonomy and independence significantly improved at the end of the study compared to inclusion. PACT-Q2 satisfaction score was low in patients who experienced bleeding (PACT-Q2 24.1 ± 3.3 vs. 25.1 ± 4.3). LMWH twice daily tended to be found less convenient compared than once daily (53.3 ± 7.2 vs. 55.0 ± 8.3). CONCLUSION: CAT patients had a good perception of the 6-month LMWH treatment when comparing expectations and experience. Using a quantitative scale validated in the general population for VTE and subcutaneous injection and including a large number of patients, bleeding complications and LMWH twice daily were associated with a nonsignificant trend towards a worsen perception.

Physiotherapy outcome measures of haemophilia acute bleed episodes: What matters to patients?

INTRODUCTION: The research was conducted at a UK teaching hospital and Haemophilia Comprehensive Care Centre (CCC) as part of a research programme investigating physiotherapy for acute bleed management. AIM: The aim of the study was to understand the perspectives of people with haemophilia (PWH) on validated outcome measures (OM) and whether these measures capture changes relevant to them whilst recovering from an acute bleed episode. METHODS: Any person with haemophilia registered to the CCC who reported an acute bleed within the past 2 years was invited to participate. Semi-structured interviews or workshops (activity-focused discussions with small groups) were conducted with PWH who had received physiotherapy treatment in the previous two years. These were used to explore opinions of PWH of commonly used outcome measures. RESULTS: Eight male PWH participated, mean age 61 years, ranging between 39 and 71. Seven participants had severe haemophilia A and 1 had von Willebrands. Participants described numerical rating scales of pain as abstract and expressed a preference for verbal or visual descriptors. In relation to function, the men generally found haemophilia-specific OM to be more relevant. The EuroQol 5-Dimension 5-Level (EQ5D-5L) and Haemophilia and Exercise Project Test Questionnaire (HEP-Test-Q) were considered as good measures due to brevity and ability to capture relevant changes promptly. CONCLUSION: Participants in this study reported a preference for short OMs that allow them to reference their ability during the acute bleed episode in comparison with their normal function.

Experiences of patients with haemorrhoidal disease - a qualitative study / Experiências de pacientes com doença hemorroidária - estudo qualitativo

ABSTRACT Purpose: To obtain a better understanding of the patients' experiences with haemorrhoidal disease' impact on their daily life and results of treatment by performing a qualitative study. Method: Individually interviews were conducted among patients with haemorrhoidal disease between 2016 and 2017. Each interview was recorded using an audio recorder and transcribed verbatim. A semi-structured interview guide was used with pre-specified topics, based on a previous conducted literature review. Transcripts were coded and the analysis consisted highlighting passages in the text and assigning each passage a code representing the predefined themes from the interview guide. This resulted in a three-level theme hierarchy: overarching theme, mid-level sub-theme and issues. Results: Fifteen participants underwent individual interviews of whom thirteen were conducted by telephone. The mean age was 60.7 years (35-78); five of them were female (33.3%). Pain and blood loss were the most frequently reported symptoms. Participants indicated that these symptoms were directly associated with emotional burden, daily adjustments and social impact. Before diagnosis with haemorrhoidal disease blood loss resulted in feelings of fear and next in embarrassment during social activities. In daily life participants needed to get up early, used sanitary pads for blood loss and anal ice sticks to reduce pain. Participants were often not completely satisfied with the process and outcome of treatment. Conclusion: This first qualitative study provides detailed insight into the patients' experiences with haemorrhoidal disease, impact on daily life and results of treatment. This information may be used in daily practice to create awareness among clinicians.

RESUMO Objetivo: Este estudo qualitativo teve como objetivo propiciar uma melhor compreensão das experiências dos pacientes com doença hemorroidária, o impacto em sua vida diária e os resultados do tratamento. Métodos: Entre 2016 e 2017, pacientes com doença hemorroidária foram entrevistados individualmente. Cada entrevista foi gravada usando um gravador de áudio e transcrita na íntegra. Utilizou-se guia de entrevista semiestruturado, com tópicos pré-especificados baseados em uma revisão de literatura realizada anteriormente. As transcrições foram codificadas; a análise consistiu em destacar passagens no texto e atribuir a cada passagem um código representando os temas predefinidos no guia de entrevista. Isso resultou em uma hierarquia de temas de três níveis: tema abrangente, subtema de nível médio e problemas. Resultados: Quinze participantes foram submetidos a entrevistas individuais, das quais treze foram conduzidas por telefone. A média de idade foi de 60,7 anos (35-78); cinco deles eram do sexo feminino (33,3%). Dor e hemorragia foram os sintomas mais frequentemente relatados. Os participantes indicaram que esses sintomas estavam diretamente relacionados a sobrecarga emocional, ajustes nas atividades diárias e impacto social. Antes do diagnóstico de doença hemorroidária, a hemorragia levou a sentimentos de medo e de constrangimento durante as atividades sociais. No dia-a-dia, os participantes precisavam acordar cedo, usar absorventes higiênicos para perda de sangue e gelo na região anal para reduzir a dor. Geralmente, os participantes não estavam completamente satisfeitos com o processo e o resultado do tratamento. Conclusão: Este primeiro estudo qualitativo apresenta uma visão detalhada das experiências dos pacientes com doença hemorroidária, o impacto na vida diária e resultados do tratamento. Essas informações podem ser usadas na prática diária para conscientizar os médicos.

Changes in health-related quality of life with long-term eltrombopag treatment in adults with persistent/chronic immune thrombocytopenia: Findings from the EXTEND study.

Patients with persistent/chronic immune thrombocytopenia (cITP) have low platelet counts, increased risk of bleeding and bruising, and often suffer from reduced health-related quality of life (HRQoL). cITP treatments may either improve HRQoL by increasing platelet counts or decrease it because of side effects. The open-label EXTEND study (June 2006 to July 2015) evaluated long-term safety, tolerability, and efficacy of eltrombopag (an oral thrombopoietin-receptor-agonist) in adults with cITP who completed a previous eltrombopag ITP trial. The final results of EXTEND were published and used to assess changes in patient-reported HRQoL over time and association between HRQoL and platelet response. Four validated HRQoL instruments were administered: SF-36v2 including physical component summary (PCS) and Mental Component Summary; Motivation and Energy Inventory Short Form (MEI-SF); Fatigue Subscale of FACIT (FACIT-Fatigue); and FACT-Thrombocytopenia Subscale Six-Item Extract (FACT-Th6). For the 302 patients enrolled, median duration of eltrombopag treatment was 2.37 years. All 4 HRQoL instruments demonstrated positive mean changes from baseline over time adjusted for patient baseline characteristics and rescue therapy use, and had positive association with platelet response (platelet count ≥30 × 109 /L; ≥50 × 109 /L; and ≥50 × 109 /L and >2 times baseline). Improvements from baseline started within 3 months and persisted through 5 years of treatment for FACIT-Fatigue and FACT-Th6 (P <.05 for nearly all time points); through 2.5 years for SF-36v2 PCS and less consistently for the MEI-SF. In conclusion, in addition to eltrombopag increasing platelet counts and reducing bleeding/bruising, it also alleviated fatigue, concerns about bleeding and bruising, and improved physical function in many patients, especially responders.

Sports participation and physical activity in patients with von Willebrand disease.

INTRODUCTION: Patients with bleeding disorders may experience limitations in sports participation and physical activity. Several studies on sports participation have been performed in haemophilia patients, but studies in patients with von Willebrand disease (VWD) are lacking. AIM: We assessed the sports participation and physical activity of a large cohort of VWD patients. METHODS: Patients were included from the "WiN study." All patients completed a questionnaire on sports participation, physical activity, quality of life and bleeding symptoms (Tosetto bleeding score). RESULTS: From the 798 included patients, 474 had type 1, 301 type 2 and 23 type 3 VWD. The mean age was 39 ± 20 (standard deviation) years. Five hundred and fifty-two patients (69.3%) participated in various types of sports. Type 3 VWD patients more often did not participate in sports due to fear of bleeding and physical impairment, respectively, OR = 13.24 (95% CI: 2.45-71.53) and OR = 5.90 (95% CI: 1.77-19.72). Patients who did not participate in sports due to physical impairment had a higher bleeding score item for joint bleeds 1.0 (±1.6) vs 0.5 (± 1.1) (P = 0.036). Patients with type 3 VWD and patients with a higher bleeding score frequently had severe limitations during daily activities, respectively, OR = 9.84 (95% CI: 2.83-34.24) and OR = 1.08 (95% CI: 1.04-1.12). CONCLUSION: The majority of VWD patients participated in sports. Patients with type 3 VWD, a history of joint bleeds and a more severe bleeding phenotype frequently experienced limitations in sports participation and physical activities during daily life.

Health-related quality of life after adverse bleeding events associated with antithrombotic drug therapy - A systematic review.

Little is known about the health-related quality of life (HRQOL) following adverse bleeding events associated with antithrombotic drug therapy. This systematic review assesses the HRQOL of patients who suffered a bleeding event related to antithrombotic drug use. A literature search was performed using PubMed, EMBASE, and the Cochrane Library from inception through June 16, 2017. Studies measuring HRQOL after a bleeding event related to antithrombotic drug therapy for primary or secondary prevention of a thromboembolic event were included. Four studies with a total of 13,209 patients met the inclusion criteria, and of them, 3,649 patients developed a bleeding event. Patients who were included received antithrombotic drugs because of acute myocardial infarction or atrial fibrillation. EQ-5D, SF-36, and GHP MOS-13 were used to measure HRQOL. The follow-up time ranged from 6 to 29 months. Patients who suffered a bleeding event reported worse HRQOL compared to those who did not (EQ-5D - average increase on all domains of 0.09, p-values ranging from <0.001 to 0.003; SF-36 - average decrease on all domains of 21.4, p < 0.001; and GHP MOS-13 score - decrease of 11.9 points, p < 0.05) and an increased health concern (13.4-point increase; p < 0.05). In conclusion, adverse bleeding events occurring because of the use of antithrombotic agents are associated with a clinically relevant lower HRQOL and hence deserve more attention as part of the shared decision-making process between patients and providers. These data should be valuable for facilitating more substantive care and risk discussions regarding potential changes in outcome and rehabilitation.

Prevalence and correlates of bleeding and emotional harms in a national US sample of patients with venous thromboembolism: A cross-sectional structural equation model.

INTRODUCTION: Venous thromboembolism (VTE) including deep vein thrombosis (DVT) or pulmonary embolism (PE) is associated with reduced survival, poorer quality of life, and substantial health-care-costs. Limited research, primarily qualitative, suggests that those with VTE may have elevated fear of recurrence, and associated emotional dysfunction and distress. METHODS: A national online survey was administered to 907 patients who had experienced a VTE event in the past two years. The survey assessed for the prevalence of self-reported bleeding harms associated with VTE, the levels of anxiety, depression, cognitive dysfunction and distress experienced by patients, and a range of potential psychosocial correlates that may be associated with these bleeding or emotional harms. RESULTS: The majority (63.0%) of respondents had experienced at least one bleeding related harm following their VTE diagnosis, and 40.6% indicated they experienced fear of another clot often or almost all the time. One-in-four (24.7%) and one-in-ten (11.6%) had abnormal levels of anxiety and depression, respectively. Structural equation modeling was used to define two composite latent bleeding harm and emotional harm factors. Emotional and bleeding harms were associated with younger age, a belief that one's health is due to luck, having multiple comorbidities, having a history of prior VTE events, having multiple barriers to VTE care, and experiencing medical mistakes in diagnosis or treatment. Emotional harms were uniquely predicted by having poorer health literacy, having low self-reported medication adherence, belief others are responsible for one's health, and more recent VTE events. Bleeding harms were uniquely predicted by having a lower frequency of primary care provider contact and having a history of switching between warfarin and direct oral anticoagulants for VTE treatment. CONCLUSIONS: The findings show high levels of self-reported bleeding and emotional harms in a general population of VTE sufferers that are clearly associated with readily identifiable demographic, health status, and psychosocial characteristics. These represent targets for intervention and changes in clinical practice.

What Impact Does Venous Thromboembolism and Bleeding Have on Cancer Patients' Quality of Life?

BACKGROUND: Venous thromboembolism (VTE) is common in cancer patients and its treatment is associated with a high risk of recurrent VTE (rVTE) and bleeding. OBJECTIVES: To analyze data from the Comparison of Acute Treatments in Cancer Hemostasis (CATCH) trial to describe the impact of rVTE and bleeding events on health-related quality of life. METHODS: The three-level EuroQol five-dimensional questionnaire (EQ-5D) data were collected monthly for up to 7 months in patients starting anticoagulation for newly diagnosed VTE. Analyses were designed to describe the impact of rVTE and bleeding on EQ-5D scores while controlling for effects of covariates such as background and clinical variables and longitudinal changes. A repeated-measures model with specification of the variance-covariance matrix to characterize the intrapatient correlation was used to estimate the utility values. The impact of an rVTE or a bleeding event was assumed to be reflected in the utility value when it occurred within 2 weeks from a planned data collection point. RESULTS: Data were available from 883 patients. A total of 76 rVTE and 159 bleeding events occurred during follow-up. rVTE had a significant impact on EQ-5D scores, with a decrement of -0.075 on the basis of our reference case (male, no metastasis, Eastern Cooperative Oncology Group score = 1, Western European), but different patients might have different decrements. Bleeding events had a smaller (nonstatistically significant) impact on EQ-5D scores. CONCLUSIONS: This data set study has quantified the decline in EQ-5D scores associated with experiencing rVTE or bleeding events in cancer patients. These results indicate the net gain in quality of life and impact on cost-effectiveness of secondary VTE prevention.

Physical after-effects of colposcopy and related procedures, and their inter-relationship with psychological distress: a longitudinal survey.

OBJECTIVE: To estimate prevalence of post-colposcopy physical after-effects and investigate associations between these and subsequent psychological distress. DESIGN: Longitudinal survey. SETTING: Two hospital-based colposcopy clinics. POPULATION: Women with abnormal cytology who underwent colposcopy (±related procedures). METHODS: Questionnaires were mailed to women 4, 8 and 12 months post-colposcopy. Details of physical after-effects (pain, bleeding and discharge) experienced post-colposcopy were collected at 4 months. Colposcopy-specific distress was measured using the Process Outcome-Specific Measure at all time-points. Linear mixed-effects regression was used to identify associations between physical after-effects and distress over 12 months, adjusting for socio-demographic and clinical variables. MAIN OUTCOME MEASURES: Prevalence of post-colposcopy physical after-effects. Associations between the presence of any physical after-effects, awareness of after-effects, and number of after-effects and distress. RESULTS: Five-hundred and eighty-four women were recruited (response rate = 73, 59 and 52% at 4, 8 and 12 months, respectively). Eighty-two percent of women reported one or more physical after-effect(s). Multiple physical after-effects were common (two after-effects = 25%; three after-effects = 25%). Psychological distress scores declined significantly over time. In adjusted analyses, women who experienced all three physical after-effects had on average a 4.58 (95% CI: 1.10-8.05) higher distress scored than those who experienced no after-effects. Women who were unaware of the possibility of experiencing after-effects scored significantly higher for distress during follow-up. CONCLUSIONS: The prevalence of physical after-effects of colposcopy and related procedures is high. The novel findings of inter-relationships between awareness of the possibility of after-effects and experiencing multiple after-effects, and post-colposcopy distress may be relevant to the development of interventions to alleviate post-colposcopy distress. TWEETABLE ABSTRACT: Experiencing multiple physical after-effects of colposcopy is associated with psychological distress.

Impact of mild to severe hemophilia on engagement in recreational activities by US men, women, and children with hemophilia B: The Bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S) study.

The psychosocial impact of hemophilia on activities was recently investigated in the Hemophilia Experiences, Results and Opportunities (HERO) study (675 people with hemophilia and 561 caregivers of children with hemophilia in 10 countries). The impact of hemophilia B may not be accurately reflected in the HERO results, as ~75% of respondents described issues affecting males with hemophilia A. To address the needs of this population, the Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) was developed as a pilot study in the United States in collaboration with the hemophilia community. The analysis reported here assessed engagement in recreational activities and changes to treatment regimens around activities as reported by 299 adults with hemophilia B and 150 caregivers of children with hemophilia B. Nearly all adults with hemophilia B (98%) experienced a negative impact on their participation in recreational activities due to hemophilia-related issues, and most caregivers (90%) reported that hemophilia B had a negative impact on their child's engagement in recreational activities. One of the main reasons identified for discontinuing past activities was the risk of bruising or bleeding (adults/children with hemophilia B, 49%/41%). In particular, adults with hemophilia B reported a history of activity-related bleeding, and most adults decreased their participation in high-risk activities as they aged. Substantial percentages of adults and children with hemophilia B (including mild/moderate severity) altered their treatment regimens to accommodate planned activities. These findings may help inform guidelines for individualizing treatment regimens around participation in recreational activities based on hemophilia severity, baseline factor level, and activity risk and intensity.

Impact of mild to severe hemophilia on education and work by US men, women, and caregivers of children with hemophilia B: The Bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S) study.

The psychosocial impact of hemophilia on work was recently investigated in the Hemophilia Experiences, Results and Opportunities (HERO) study. The findings revealed that hemophilia had an impact for adults with moderate/severe hemophilia and caregivers of children with hemophilia. HERO did not specifically evaluate impact on education in adults/children with mild/moderate hemophilia or the impact on employment of spouses/partners of caregivers of affected children. The Bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S) study evaluated the impact of hemophilia on the lives of adult men/women with mild-severe hemophilia B and caregivers of boys/girls with hemophilia B and their spouses/partners. Many adults with hemophilia B (94%) reported that hemophilia had a negative effect on their ability to complete a formal education, often attributed to the inability to attend or concentrate in school as a result of hemophilia-related bleeding or pain. Most adults with hemophilia B (95%) and caregivers/partners (89%/84%) indicated that hemophilia had a negative impact on employment. Most adults with hemophilia were employed (81%), with construction/manufacturing (35%) as the most frequently reported industry; many worked in jobs requiring manual labor (39%). Of those unemployed, 62% never worked, and those who stopped working reported that they left the workforce due to financial issues (59%), including insurance coverage/co-pays, or hemophilia-related issues (55%). Nearly one-third of caregivers voluntarily left the workforce to care for children with hemophilia. These results suggest a need to focus more effort on career counseling for adults with hemophilia B and caregivers of affected children, especially around mild/moderate hemophilia, as this population may not be as well informed regarding potential impact in school and the workplace.

Management of US men, women, and children with hemophilia and methods and demographics of the Bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S) study.

The Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) initiative was launched in an effort to address specific gaps in the understanding of the psychosocial impact of mild-moderate-severe hemophilia B. The original Hemophilia Experiences, Results and Opportunities (HERO) qualitative study evaluated the needs of people with hemophilia A or B in multiple countries; however, a majority of participants had the more common moderate-severe hemophilia A. The B-HERO-S study was designed in collaboration with the hemophilia community to evaluate the needs of adults with hemophilia B and caregivers of children with hemophilia B, including affected women and caregivers of girls with hemophilia. The report presented here describes participant demographics and comorbidities, as well as treatment regimens and access to treatment. Bleeding symptoms were reported by 27% of mothers of children with hemophilia B who participated. Women were more likely than men to self-report arthritis and depression/anxiety as comorbidities associated with hemophilia B. More adults and children with hemophilia B were on routine treatment than on on-demand treatment, and a high percentage of adults with moderate hemophilia B received routine treatment (86%). Many adults with hemophilia B (78%) and caregivers (69%) expressed concern about access to factor in the next 5 years, and of adults with hemophilia B, women more commonly experienced issues with access to factor in the past than did men (72% vs 44%). The findings of the B-HERO-S study reveal potential unmet needs of some patients with mild-moderate hemophilia B, and the results may be leveraged to inform patient outreach by hemophilia treatment centers and education initiatives.

Preference for direct oral anticoagulants in patients treated with vitamin K antagonists for venous thromboembolism.

BACKGROUND: Direct oral anticoagulants (DOACs) are an alternative for vitamin K antagonists (VKA) in the treatment and prevention of venous thromboembolism (VTE). Patient preferences for treatment options have not been extensively explored. METHODS: A random sample of 200 patients was obtained from those treated with VKA for deep vein thrombosis, pulmonary embolism or both at the Thrombosis Service Amsterdam. Preference for DOACs relative to VKA was assessed using a treatment trade-off technique administered as a questionnaire sent to all patients. The trade-off consisted of four consecutive scenarios: 1 (no need for laboratory control), 2 (decreased bleeding risk), 3 (less interactions with food and other drugs), 4 (higher efficacy). RESULTS: The response rate was 68%. In scenario 1, 36% of patients would switch to a DOAC. This proportion rises to 57% (odds ratio [OR] 2.3; 95% confidence interval [CI] 1.6-3.3) for scenario 2. Scenario 3 resulted in 64% of patients preferring a DOAC (OR 3.2; 95%CI 2.2-4.6). The advantage of greater efficacy did not result in a noteworthy change in the preference. Patients who were less satisfied with their current treatment, who were younger and those with higher education were more likely to prefer a DOAC over a VKA. The variables gender, treatment duration, and type of VKA were not significantly associated with DOAC preference. CONCLUSION: Almost two-thirds of patients preferred DOACs over VKA. Patients considered the lack of regular laboratory monitoring, the lower risk of serious bleeding and less interactions with food and other drugs the most important arguments to switch to a DOAC.

Initial and sustained brain responses to threat anticipation in blood-injection-injury phobia.

Blood-injection-injury (BII) phobia differs from other subtypes of specific phobia in that it is associated with elevated disgust-sensitivity as well as specific autonomic and brain responses during processing of phobia-relevant stimuli. To what extent these features play a role already during threat anticipation is unclear. In the current fMRI experiment, 16 female BII phobics and 16 female healthy controls anticipated the presentation of phobia-specific and neutral pictures. On the behavioral level, anxiety dominated the anticipatory period in BII phobics relative to controls, while both anxiety and disgust were elevated during picture presentation. By applying two different models for the analysis of brain responses to anticipation of phobia-specific versus neutral stimuli, we found initial and sustained increases of activation in anterior cingulate cortex (ACC), insula, lateral and medial prefrontal cortex (PFC), thalamus and visual areas, as well as initial activation in the amygdala for BII phobics as compared to healthy controls. These results suggest that BII phobia is characterized by activation of a typical neural defense network during threat anticipation, with anxiety as the predominant emotion.