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BACKGROUND & AIMS: Vedolizumab and ustekinumab pharmacokinetics in pregnancy and the infant after in utero exposure remain incompletely defined. We aim to define the antenatal stability of ustekinumab and vedolizumab levels and the time at which infant drug levels become undetectable. METHODS: This multicenter prospective observational cohort study recruited pregnant or preconception women with inflammatory bowel disease receiving vedolizumab or ustekinumab. Trough drug levels, clinical data, and biochemical data were documented preconception, during each trimester of pregnancy, and postpartum. Maternal and cord blood drug levels were measured at delivery and in infants until undetectable. Infant outcomes were assessed until 2 years of age. RESULTS: A total of 102 participants (vedolizumab, n = 58) were included. The majority of mothers were, and remained, in clinical and biochemical remission. Maternal vedolizumab levels decreased over the course of pregnancy in association with increasing weight, rather than increasing gestation. Maternal ustekinumab levels remained stable. The median time to drug becoming undetectable in the infant was shorter for vedolizumab (11 wk; range, 5-19 wk; n = 32) than ustekinumab (14 wk; range, 9-36 wk; n = 17) and correlated positively with infant delivery level. Thirty-two of 41 (88%) and 17 of 30 (67%) vedolizumab- and ustekinumab-exposed infants had undetectable drug levels by 15 weeks of age, respectively. Pregnancy and infant outcomes were favorable. Twenty infants with undetectable drug levels received the rotavirus vaccine, with no adverse reactions reported. CONCLUSIONS: Maternal vedolizumab levels decreased, whereas ustekinumab levels remained stable over the course of pregnancy. Most vedolizumab- and approximately half of ustekinumab-exposed infants had undetectable drug levels by 15 weeks of age. No concerning maternal or infant safety signals were identified.
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OBJECTIVES: Cancer has become a chronic disease that requires a considerable amount of informal caregiving, often quite burdensome to family caregivers. However, the influence of spirituality on the caregivers' burden and mental health outcomes has been understudied. This study was to examine how caregiver burden, spirituality, and depression change during cancer treatment and investigate the moderating role of spirituality in the relationship between caregiver burden and depression for a sample of caregivers of persons with cancer. METHODS: This secondary analysis used a longitudinal design employing 3 waves of data collection (at baseline, 3 months, and 6 months). Family caregivers completed the Caregiver Reaction Assessment, Spiritual Perspective Scale, and the PROMIS® depression measure. Linear mixed model analyses were used, controlling for pertinent covariates. RESULTS: Spirituality, total caregiver burden, and depression remained stable over 6 months. More than 30% of the caregivers had mild to severe depressive symptoms at 3 time points. There was evidence of overall burden influencing depression. Of note was a protective effect of caregivers' spirituality on the relationship between depression and caregiver burden over time (b = -1.35, p = .015). The lower the spirituality, the stronger the relationship between depression and burden, especially regarding subscales of schedule burden, financial burden, and lack of family support. SIGNIFICANCE OF RESULTS: Spirituality was a significant resource for coping with caregiving challenges. This study suggests that comprehensive screening and spiritual care for cancer caregivers may improve their cancer caregiving experience and possibly influence the care recipients' health.
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Cuidadores , Depresión , Neoplasias , Espiritualidad , Humanos , Masculino , Femenino , Persona de Mediana Edad , Neoplasias/psicología , Neoplasias/complicaciones , Depresión/psicología , Depresión/etiología , Cuidadores/psicología , Anciano , Estudios Longitudinales , Adulto , Encuestas y Cuestionarios , Adaptación Psicológica , Carga del Cuidador/psicología , Costo de EnfermedadRESUMEN
Chronic stress is a well-established risk factor for cardiometabolic disease. Caregiving for individuals with cancer is perceived as a chronic stressor yet research on the risk for cardiometabolic disease in this population, opposed to the elderly and those with Alzheimer's disease, is limited. Additionally, few studies have explored the early physiological changes that occur in family caregivers suggesting an elevated risk for illness. This cross-sectional study was designed to examine levels of cardiometabolic risk biomarkers and their correlates in caregivers of patients with colorectal cancer. Caregivers completed questionnaires that measure exposures to stress and vulnerability factors, psychological distress, and health habits as potential correlates. Traditional lipid and nontraditional lipoprotein particle biomarkers (e.g. concentration and size for all lipoprotein classes) were assayed from blood serum. Caregivers (N = 83, mean age = 49.8, 73% female) displayed levels of cardiometabolic biomarkers that suggest an elevated risk for cardiometabolic disease. Caregivers who were Hispanic, married, highly educated, employed, reported more hours spent caregiving daily, experienced higher caregiver burden associated with the lack of family support and impact on schedule, and psychological distress, demonstrated an elevated risk for cardiometabolic disease; primarily determined by nontraditional lipid biomarkers - large TRL-P, LDL-P, small HDL-P, large HDL-P, TRL-Z, LDL-Z and HDL-Z. These findings suggest that traditional lipid biomarkers may not be robust enough to detect early physiological changes associated with cardiometabolic disease risk in family caregivers. Moreover, findings reiterate the importance of assessing caregiver burden and providing evidence-based interventions to manage caregiving stress with the potential to improve caregivers' cardiometabolic health.
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Enfermedades Cardiovasculares , Neoplasias , Cuidadores/psicología , Costo de Enfermedad , Estudios Transversales , Familia/psicología , Femenino , Humanos , Lípidos , Masculino , Persona de Mediana Edad , Estrés Psicológico/psicología , Encuestas y CuestionariosRESUMEN
BACKGROUND AND AIMS: Strictures are the commonest complication in Crohn's disease. Surgery and endoscopic dilation are the mainstays of treatment, while drug therapy has often been considered contraindicated. The benefit of nonsurgical treatments, particularly drug and endoscopic therapy, need to be defined. METHODS: Ovid MEDLINE, Embase, Emcare, PsycINFO, CINAHL and the Cochrane Library (inception until August 30, 2019) were searched. Studies with ≥ 10 patients with Crohn's disease strictures, reporting on outcomes following medication or endoscopic treatment, were included. RESULTS: Of 3480 records, 85 studies met inclusion criteria and formed the basis of this analysis. Twenty-five studies assessed drug therapy; none were randomized trials. Despite study heterogeneity anti-tumor necrosis factor (TNF) therapy appeared effective, with 50% of patients avoiding surgery after 4 years of follow up. No other drug therapy was of demonstrable benefit. Sixty studies assessed endoscopic therapy including 56 on endoscopic balloon dilation, two assessed needle knife stricturotomy, and two stent insertion. Dilation was equally effective for de novo and anastomotic strictures ≤ 5 cm in length, with most studies reporting a subsequent surgical rate of 30% to 50%. Repeat dilation was required in approximately half of all patients. CONCLUSIONS: Anti-TNF drug therapy and endoscopic balloon dilation are effective strategies for avoiding surgery in patients with stricturing Crohn's disease. Additional endoscopic therapies require further evaluation. Early data suggest that combining these therapies may provide greater benefit than individual therapies. Optimization of current drug and endoscopic therapy, and the incorporation of newer therapies, are needed for stricturing Crohn's disease.
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Anticuerpos Monoclonales/uso terapéutico , Enfermedad de Crohn/terapia , Dilatación/métodos , Endoscopía Gastrointestinal/métodos , Obstrucción Intestinal/terapia , Factor de Necrosis Tumoral alfa/inmunología , Terapia Combinada , Constricción Patológica/etiología , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/patología , Humanos , Obstrucción Intestinal/etiología , Obstrucción Intestinal/patología , Stents , Resultado del TratamientoRESUMEN
BACKGROUND: Patients, providers and health care organisations benefit from an increased understanding and implementation of patient-centred care (PCC) by general practitioners (GPs). This study aimed to evaluate and advance a theoretical model of PCC developed in consultation with practising GPs and patient advocates. METHODS: Qualitative description in a social constructivist/interpretivist paradigm. Participants were purposively sampled from six primary care organisations in south east Queensland/northern New South Wales, Australia. Participants engaged in focus group discussions where they expressed their perceptions, views and feelings of an existing PCC model. Data was analysed thematically using a constant-comparison approach. RESULTS: Three focus groups with 15 patient advocates and three focus groups with 12 GPs were conducted before thematic saturation was obtained. Three themes emerged: i) the model represents the ideal, ii) considering the system and collaborating in care and iii) optimising the general practice environment. The themes related to participants' impression of the model and new components of PCC perceived to be experienced in the 'real world'. The data was synthesised to produce an advanced model of PCC named, "Putting Patients First: A Map for PCC". CONCLUSIONS: Our revised PCC model represents an enhanced understanding of PCC in the 'real world' and can be used to inform patients, providers and health organisations striving for PCC. Qualitative testing advanced and supported the credibility of the model and expanded its application beyond the doctor-patient encounter. Future work could incorporate our map for PCC in tool/tool kits designed to support GPs and general practice with PCC.
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Médicos Generales , Actitud del Personal de Salud , Australia , Humanos , Nueva Gales del Sur , Defensa del Paciente , Investigación Cualitativa , QueenslandRESUMEN
Nurses are at risk for work-related fatigue, which can impact their health, well-being, and job readiness. The purpose of this study was to examine the levels, types, and factors associated with fatigue in registered nurses (RNs) in direct patient care (DCRNs) and in non-direct patient care (non-DCRNs) roles. A cross-sectional survey was administered to 313 RNs. Measures included: Multidimensional Fatigue Symptom Inventory, Occupational Fatigue Exhaustion Recovery, Brief COPE, PROMIS® Global Sleep Disturbance, and Job Content Questionnaire. Acute fatigue levels in RNs were similar to those in diseased populations, and nearly 50% reported moderate/high levels of chronic fatigue. DCRNs reported higher levels of acute and chronic fatigue than non-DCRNs, but the differences were small and disappeared when accounting for other factors associated with fatigue including sleep disturbance, job strain, workplace support, maladaptive coping, and especially intershift recovery, which accounted for 20%-41% of fatigue variability. This study suggests that it may not be only nurses providing direct patient care who are at risk for acute and chronic fatigue. Intershift recovery may be particularly important in alleviating acute and chronic fatigue in nurses.
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Adaptación Psicológica , Fatiga , Enfermeras y Enfermeros/psicología , Personal de Enfermería en Hospital/psicología , Estrés Laboral/psicología , Adulto , Enfermedad Crónica , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención al Paciente , Seguridad , Sueño , Encuestas y Cuestionarios , Lugar de TrabajoRESUMEN
OBJECTIVE: To describe levels of loneliness in cancer caregivers over a 6 month time period, and to examine factors that influence changes in loneliness in caregivers over time. METHODS: Prospective, repeated measures design was utilized to examine levels of loneliness and factors that influence loneliness in 129 family caregivers of individuals undergoing cancer treatment at three time points over a 6 month period. Measures included: PROMIS global health and sleep disturbance; NIH Toolbox loneliness, self-efficacy and perceived stress; Family Care Inventory mutuality scale; and Caregiver Reaction Assessment. RESULTS: Approximately one third (30.2%, n = 39) of the caregivers had high levels of loneliness, and levels of loneliness did not change over the three time points (P = .985). For any given time point, caregivers who were not married (P = .008), not working (P = .027), with worse mental health (P = .015), more perceived-stress (P < .0001), and more caregiver burden (P = .003) reported higher levels of loneliness. CONCLUSION: This study provides guidance for clinicians attempting to identify at-risk caregivers by confirming the findings of previous research that caregivers with higher burden, stress and in poor mental health are at increased risk for loneliness. This study provides preliminary evidence that continuing to work during the caregiving trajectory may be beneficial to caregivers by reducing levels of loneliness. Future research is needed to confirm these findings and to examine novel interventions to reduce loneliness in cancer caregivers.
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Cuidadores/psicología , Soledad/psicología , Salud Mental , Neoplasias/psicología , Adulto , Anciano , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Neoplasias/enfermería , Estudios Prospectivos , Adulto JovenRESUMEN
BACKGROUND AND AIMS: Strictures are the most common Crohn's disease complication, but their natural history is unknown. This study aimed to characterize inflammation, predict prognosis, and understand the impact of drug therapy using magnetic resonance enterography (MRE). METHODS: Patients with a stricture diagnosed on MRE over a 5-year period were reviewed for MRE disease extent and inflammation, clinical course, C-reactive protein, response to anti-TNF therapy, endoscopic dilatation, hospitalization, and surgery. RESULTS: 136 patients had 235 strictures (77, one and 59, ≥ 2 strictures). TREATMENT: 46% of patients underwent surgery after a median 6 months; median follow-up for those not requiring surgery was 41 months. Predictors of surgery: Hospitalization because of obstruction predicted subsequent surgery (OR 2.50; 95% CI 1.06-5.90) while anti-TNF therapy commenced at stricture diagnosis was associated with a reduced risk (OR 0.23; 95% CI 0.05-0.99). MRE characteristics associated with surgery were proximal bowel dilatation ≥ 30-mm diameter (OR 2.98; 95% CI 1.36-6.55), stricture bowel wall thickness ≥ 10-mm (OR 2.42; 95% CI 1.11-5.27), and stricture length > 5-cm (OR 2.56; 95% CI 1.21-5.43). 81% of patients with these three adverse MRE features required surgery versus 17% if none were present (P < 0.001). Accuracy for these three MRE variables predicting surgery was high (AUC 0.76). CONCLUSION: Magnetic resonance enterography findings in Crohn's disease strictures are highly predictive of the disease course and the need for future surgery. MRE may also identify who would benefit from treatment intensification. Anti-TNF therapy is associated with reduced risk of surgery and appears to alter the natural history of this complication.
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Enfermedad de Crohn/diagnóstico por imagen , Enfermedad de Crohn/terapia , Adulto , Enfermedad de Crohn/complicaciones , Procedimientos Quirúrgicos del Sistema Digestivo , Dilatación/métodos , Endoscopía del Sistema Digestivo/métodos , Femenino , Humanos , Inflamación , Obstrucción Intestinal/diagnóstico por imagen , Obstrucción Intestinal/etiología , Obstrucción Intestinal/terapia , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Pronóstico , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
BACKGROUND: GPs providing patient-centred care (PCC) is embedded in international health care policies due to its positive impact on patients and potential to lower health care costs. However, what is currently known about GP-delivered PCC is unknown. OBJECTIVE: To synthesize literature investigating GP-delivered PCC and address 'what is currently known about GP-delivered PCC?' METHOD: A systematic literature search was conducted between June and July 2018. Eligible articles were empirical, full-text studies published in English between January 2003 and July 2018, related to at least three of the four dimensions of PCC described by Hudon et al. (2011), and related to preventative, acute, and/or chronic care by GPs. Following screening, full-text articles were independently assessed for inclusion by two investigators. Data were extracted and quality assessed by two researchers. Findings on PCC were analysed thematically (meta-synthesis). RESULTS: Thirty medium- to high-quality studies met the inclusions criteria. Included studies utilized varied designs, with the most frequent being quantitative, cross-sectional. A theoretical model of PCC was synthesized from included studies and contained four major components: (i) understanding the whole person, (ii) finding common ground, (iii) experiencing time and (iv) aiming for positive outcomes. Harms of PCC were rarely reported. CONCLUSIONS: Four overarching theoretical components of PCC relate to elements of the consultation and experience of time. These components can be used to inform the development of toolkits to support GPs and general practice organizations in pursuit of PCC as well as tools to measure patient-centredness.
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Médicos Generales , Atención Dirigida al Paciente/métodos , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Derivación y ConsultaRESUMEN
Spirituality is a critical resource for family caregivers of patients with cancer. However, studies on spirituality are hampered because measures of spirituality lack consistency and have not been validated in cancer caregivers. This study examined the validity of the Spiritual Perspective Scale (SPS) among cancer caregivers and explored whether measurement bias may influence differences in spirituality across caregiver and patient characteristics. In this secondary analysis, 124 caregivers of cancer patients were used to evaluate the validity of the 10-item SPS. A multiple indicators multiple causes model was applied to explore differences in the association between a latent spirituality factor and characteristics of caregivers and patients. Overall reliability of the SPS was adequate (Cronbach's α = .95). The SPS scores were predictive of higher meaning and purpose (r = .32, p = .004) and lower depression (r = -.22, p = .046) at 3-month follow-up. Construct validity of the SPS with a single-factor structure was supported in cancer caregivers. Adjusting for a direct effect of race did not alter the pattern of results, and caregivers who were older, female, ethnic minorities, less-educated, affiliated with a religion, and who provided care to another individual in addition to the patient had greater levels of spirituality. This study provides evidence for psychometric validation of the SPS in cancer caregivers. Understanding differences in caregivers' spirituality by using the SPS with psychometrically acceptable properties and minimal measurement bias deserves more attention to optimize spirituality assessment and support in cancer caregiving.
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Cuidadores/psicología , Familia/psicología , Neoplasias/enfermería , Neoplasias/psicología , Psicometría/métodos , Calidad de Vida/psicología , Espiritualidad , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Estados UnidosRESUMEN
AIMS: To examine the health-promoting behaviours performed by registered nurses (RNs), as well as workplace factors that influence participation in those behaviours. BACKGROUND: Nurses have high levels of overweight/obesity and may not be engaging in health-promoting self-care. METHODS: A cross-sectional Web-based survey collected information from 335 RNs regarding their physical activity, sedentariness and fruit/vegetable consumption. RESULTS: More than half were overweight (34.1%) or obese (23.4%), and 80.1% were "sedentary" (≥3 hr sitting/day), particularly those working outside of direct patient care in management, research and education. Only 47.2% consumed 5+ servings of fruits/vegetables daily. Nurses who enjoyed their jobs (higher levels of compassion satisfaction) reported higher levels of physical activity (p = 0.03) and fruit/vegetable consumption (p = 0.02). CONCLUSION: RNs who work outside of direct patient care might be at increased risk for sedentariness and obesity. RNs who enjoy their jobs may experience less stress and have more energy to exercise and to prepare/consume healthy meals. IMPLICATIONS FOR NURSING MANAGEMENT: Nurse managers should practice self-care by engaging in exercise, proper nutrition and demonstrating work-life balance, both to protect their own health and to serve as role models for RNs in direct patient care.
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Promoción de la Salud/normas , Enfermeras y Enfermeros/psicología , Autocuidado/normas , Adulto , Distribución de Chi-Cuadrado , Estudios Transversales , Ejercicio Físico/psicología , Conducta Alimentaria/psicología , Femenino , Promoción de la Salud/métodos , Humanos , Masculino , Persona de Mediana Edad , Enfermeras y Enfermeros/normas , Obesidad/psicología , Autocuidado/métodos , Autocuidado/psicología , Fumar/psicología , Encuestas y CuestionariosRESUMEN
There is growing evidence linking caregiver stress with an increased risk for morbidity and mortality. While the emotional and practical burden experienced by caregivers is well established, the physiological changes that may affect the caregiver's health are less understood. This study sought to compare self-reported stress, anxiety and depression along with neuroendocrine and immune markers of stress among adult caregivers of allogeneic hematopoietic stem cell transplantation patients during the acute transplant recovery period to matched non-caregivers controls. Biomarkers and self-reported data were collected at three points during the patient's HSCT: (1) before transplant, (2) after initial transplantation discharge (±7 days) and (3) 6 weeks after initial transplantation discharge. Mixed linear modeling was used to examine differences by group and time. Twenty-one caregivers and 20 controls completed all study procedures. The majority of caregivers were female (57% or 57.1%) and married (95.2%), with a mean age of 52 ± 11.4 years. Caregiver perceived stress, anxiety and depression scores were significantly higher than controls (p < 0.001) with effect sizes (ES) ranging from 1.37 to 1.80 and they did not change over time (p > 0.05) for either group. Caregivers had significantly lower serum cortisol levels than controls at both discharge (p = 0.013; ES = 0.81) and 6 weeks after discharge (p = 0.028; ES = 0.72) but exhibited no significant relationship between self-reported stress and serum cortisol. In addition, caregivers showed a significant inverse relationship between stress and epinephrine levels (r(s)=-0.654, p = 0.021). These findings support the evidence of the caregiving experience being stressful. The counter-intuitive relationship between cortisol and epinephrine might suggest dysregulation of the HPA axis and central nervous system but additional research on the physiological impact of caregiving is warranted.
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Cuidadores/psicología , Trasplante de Células Madre Hematopoyéticas/enfermería , Sistema Hipotálamo-Hipofisario/fisiopatología , Sistema Hipófiso-Suprarrenal/fisiopatología , Estrés Psicológico/fisiopatología , Adulto , Ansiedad/etiología , Ansiedad/fisiopatología , Ansiedad/psicología , Costo de Enfermedad , Depresión/etiología , Depresión/fisiopatología , Depresión/psicología , Emociones/fisiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estrés Psicológico/complicaciones , Estrés Psicológico/psicologíaRESUMEN
Family caregiving is a significant rite of passage experienced by family caregivers of individuals with protracted illness or injury. In an integrative review of 26 studies, we characterized family caregiving from the sociocultural perspective of liminality and explored associated psychosocial implications. Analysis of published evidence on this dynamic and formative transition produced a range of themes. While role ambiguity resolved for most, for others, uncertainty and suffering continued. The process of becoming a caregiver was transformative and can be viewed as a rebirth that is largely socially and culturally driven. The transition to family caregiving model produced by this review provides a holistic perspective on this phenomenon and draws attention to aspects of the experience previously underappreciated. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.
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Adaptación Psicológica , Cuidadores/psicología , Enfermedad Crónica/enfermería , Familia/psicología , Humanos , Estrés Psicológico/psicología , IncertidumbreRESUMEN
All nurses are interested in the effects of diseases and treatments on individuals. Patient-reported outcome (PRO) measures are used to obtain self-reported information about symptoms, function, perceptions, and experiences. However, there are challenges to their use, including multiple measures of the same concept, widely varying quality, excessive length and complexity, and difficulty comparing findings across studies and conditions. To address these challenges, the National Institutes of Health funded the Patient-Reported Outcomes Measurement Information System (PROMIS), a web-based repository of valid and reliable PRO measures of health concepts relevant to clinician and researchers. Through the PROMIS Assessment Center, clinicians and researchers can access PRO measures, administer computerized adaptive tests, collect self-report data, and report instant health assessments. The purpose of this article was to summarize the development and validation of the PROMIS measures and to describe its current functionality as it relates to nursing science.
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Recolección de Datos/métodos , Recolección de Datos/normas , Autoevaluación Diagnóstica , Investigación en Enfermería/métodos , Evaluación del Resultado de la Atención al Paciente , Calidad de Vida , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Programas y Proyectos de Salud , Psicometría/métodos , Psicometría/normas , Estados UnidosRESUMEN
BACKGROUND AND AIMS: The risk of intrahepatic cholestasis of pregnancy [ICP] is increased in thiopurine-exposed pregnancies. Thiopurine 'shunting', with a 6-methylmercaptopurine [MMP] to 6-thioguanine [TGN] ratio ofâ >11, progresses over pregnancy, and may promote ICP development. We aimed to explore the association between thiopurine exposure and ICP, including the hypothesised impact of thiopurine shunting, and identify risk minimisation strategies. METHODS: This prospective multicentre cohort study compared thiopurine and biologic monotherapy-exposed pregnant participants. Disease activity and obstetric outcome data, thiopurine metabolites, bile acids, and transaminases were obtained before conception, in each trimester, at delivery, and postpartum. Thiopurine dose management was at the discretion of the treating physician. RESULTS: Included were 131 thiopurine and 147 biologic monotherapy-exposed pregnancies. MMP/TGN ratio increased from preconception to third trimester [pâ <0.01], with approximately 25% of participants shunting in pregnancy. Second trimester split dosing led to a decrease in the median MMP/TGN ratio from 18 (interquartile range [IQR] 6-57) to 3 [IQR 2-3.5] at delivery [pâ =â 0.04]. The risk of ICP was increased in thiopurine-exposed pregnancies (6.7% [7/105] vs 0% [0/112], pâ <0.001), with all ICP cases occurring in the setting of antenatal thiopurine shunting. Thiopurine dose increases (risk ratio [RR] 8.10, 95% confidence interval [CI] 1.88-34.85, pâ =â 0.005) and shunting in third trimester [6.20, 1.21-30.73, pâ =â 0.028] and at delivery [14.18, 1.62-123.9, pâ =â 0.016] were associated with an increased risk of ICP. CONCLUSIONS: Thiopurine exposure is associated with an increased risk of ICP, particularly following dose increases antenatally and with shunting in late pregnancy. The latter may be effectively managed with split dosing, although further studies are warranted.
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Colestasis Intrahepática , Enfermedades Inflamatorias del Intestino , Mercaptopurina , Complicaciones del Embarazo , Humanos , Embarazo , Femenino , Complicaciones del Embarazo/tratamiento farmacológico , Adulto , Colestasis Intrahepática/inducido químicamente , Estudios Prospectivos , Mercaptopurina/análogos & derivados , Mercaptopurina/administración & dosificación , Mercaptopurina/efectos adversos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Inmunosupresores/efectos adversos , Inmunosupresores/administración & dosificación , Tioguanina/administración & dosificación , Tioguanina/efectos adversos , Azatioprina/efectos adversos , Azatioprina/administración & dosificación , Factores de RiesgoRESUMEN
Background: Exposure to maternal inflammation is associated with an increased risk of neurocognitive and developmental disorders in offspring. Early diagnosis and intervention improves childhood motor and cognitive functioning. Neonatal cerebral MRI and remote app-based generalised movement assessments (GMAs) are both predictive of adverse neurocognitive outcomes but have only been used in infants at significantly increased risk for these outcomes, rather than following in utero exposure to maternal inflammatory disorders. Methods: Pregnant women with inflammatory bowel disease were assessed clinically and biochemically in each trimester of pregnancy in this single centre prospective study. Neonatal cerebral MRIs were performed at 6-12 weeks post-corrected term. Two GMA videos were filmed using the 'BabyMoves' app from 12 to 16 weeks of age. MRIs and GMAs were assessed by a blinded highly qualified practitioner using validated scoring systems. Results: 40/53 of invited maternal-infant dyads were recruited. C-reactive protein was elevated antenatally in less than 13%. 5/37 neonatal MRIs had incidental or obstetric trauma related gross anatomical abnormalities, with none abnormal on validated gross abnormality scoring. 3/35 GMAs were abnormal, with one GMA abnormality being clinically significant. Of those with abnormal GMAs, 2/3 were in exposed to severely active IBD in-utero. Conclusion: Neonatal cerebral MRI and GMA for neurocognitive screening is feasible in the setting of maternal inflammatory bowel disease, where the risk of cerebral palsy is poorly defined and thus burdensome screening interventions are less appealing to parents. Larger studies are required to stratify adverse neurocognitive outcome risk in infants born to women with maternal inflammatory disorders, but these data are reassuring for women with IBD in remission antenatally.
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BACKGROUND: Despite reassuring clinical safety data, thrombocytosis, anemia, lymphopenia, and liver function derangements have been observed in infants born to women with inflammatory bowel disease (IBD) treated with thiopurines and biologics. We aimed to define the prevalence, course, associations, and clinical impact of hematological and biochemical abnormalities in such infants. METHODS: This multicenter prospective cohort study assessed clinical, hematologic, and biochemical outcomes of infants exposed to thiopurines or biologics in utero for management of maternal IBD. Liver transaminases, full blood examination, and infant thiopurine metabolites (where exposed) were taken at delivery and 6 weeks of age. Abnormal results were repeated until normalization. Infants were followed clinically by a pediatric gastroenterologist up to 2 years of age. RESULTS: A total of 130 infants were included. Thrombocytosis and elevated alanine transaminase (ALT) were seen in over half of infants up to 6 months of age with no significant clinical impact. Elevated ALT was associated with increasing maternal C-reactive protein in second trimester, while thrombocytosis was associated with increasing maternal C-reactive protein and fecal calprotectin in third trimester. Preceding infection and vaccination were associated with an increased risk of elevated alkaline phosphatase at 3 months. In those exposed to thiopurines, increasing maternal 6-methylmercaptopurine at delivery was associated with increased ALT to 6 months. CONCLUSIONS: Infants born to women with IBD commonly developed thrombocytosis, elevated alkaline phosphatase, and elevated ALT. These findings were associated with exposure to maternal inflammation, elevated 6-methylmercaptopurine at delivery, and infant vaccinations and infections, and had minimal clinical consequence.
Hematological and biochemical abnormalities have been observed in infants born to women with inflammatory bowel disease. This prospective study shows that thrombocytosis and elevated alanine transaminase are common in infants to 6 months of age and are associated with maternal inflammation, rather than with in utero medication exposures.
RESUMEN
A symptom cluster is a group of 2 or more symptoms that occur together and are related to each other. Family caregivers of allogeneic hematopoietic stem cell transplantation (HSCT) recipients experience multiple concurrent symptoms, but the majority of symptom research in this population has focused on assessing and managing individual symptoms. The purpose of this analysis was to determine (1) whether clusters of 5 highly prevalent symptoms (fatigue, sleep disturbance, depression, anxiety, and cognitive impairment) in allogeneic HSCT caregivers could be identified and (2) which caregiver and patient characteristics influence membership in the identified symptom cluster groups. Baseline cross-sectional data were collected from allogeneic HSCT caregivers participating in a randomized controlled trial at the National Institutes of Health Clinical Center. Measures included the Caregiver Reaction Assessment (CRA), Health-Promoting Lifestyle Profile II (HPLP-II), Fatigue Symptom Inventory (MFSI), Pittsburgh Sleep Quality Index (PSQI), and Patient-Reported Outcomes Measurement Information System (PROMIS). Cluster analysis was used to identify symptom clusters, and univariate analyses and multiple logistic regression were performed to identify factors that contribute to symptom clusters. The average age of caregivers (n = 44) was 45.20 ± 15.05 years; primarily white (52.3%) and female (88.6%) and often the spouse/partner of the patient (50.0%). Two symptom cluster groups were identified: low symptom burden (n = 24; 54.5%) and high symptom burden (n = 20; 45.5%). Caregivers with higher levels of loneliness (odds ratio, 1.12; 95% confidence interval, 1.04 to 1.22; P = .004) were more likely to be in the high symptom burden group. This study provides evidence that 5 symptoms commonly found in family caregivers-fatigue, sleep disturbance, depression, anxiety, and cognitive impairment-tend to occur in clusters. Therefore, clinicians should be aware that caregivers with 1 or more of these symptoms may be at higher risk for developing the others, and caregivers reporting high levels of loneliness may be at particular risk. Future research is needed to identify novel interventions that target multiple, co-occurring symptoms. Such interventions also might include components that decrease loneliness. © 2022 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.
Asunto(s)
Cuidadores , Trasplante de Células Madre Hematopoyéticas , Humanos , Femenino , Estados Unidos , Adulto , Persona de Mediana Edad , Cuidadores/psicología , Síndrome , Soledad , Estudios Transversales , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Factores de Riesgo , Fatiga/epidemiología , Fatiga/psicologíaRESUMEN
Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) remains the preferred surgical option for medically refractory ulcerative colitis. Management of individuals with an IPAA prior to and during pregnancy presents challenges that can have serious consequences. Infertility, mechanical obstructive and inflammatory pouch complications are frequently encountered in pregnant women with an IPAA. Mechanical obstructions occur due to a variety of underlying aetiologies, including stricturing disease, adhesions and pouch twists. Conservative management of such obstructions often results in resolution of symptoms without a need for endoscopic or surgical intervention, although endoscopic decompression may be attempted in isolation or as a bridge to definitive surgical intervention. Parenteral nutrition, and early delivery, may also be necessary. Faecal calprotectin and intestinal ultrasound, both of which are accurate in pregnancy, are useful in the setting of suspected inflammatory pouch complications, in some circumstances allowing for avoidance of pouchoscopy. Penicillin-based antimicrobials can be considered first line in pregnancy for the management of pouchitis and pre-pouch ileitis, and biologics can be safely instituted in the setting of refractory disease or suspected Crohn's disease-like inflammation of the pouch or pre-pouch ileum. Pragmatism, clear patient communication and multidisciplinary discussion are essential in approaching pregnant women with complications of an IPAA, particularly given the lack of definitive evidence to guide therapeutic decisions.