Pediatric antiphospholipid syndrome: clinical features and therapeutic interventions in a single center retrospective case series.

BACKGROUND/PURPOSE: Pediatric antiphospholipid syndrome (APS) is a thromboinflammatory disease characterized by the presence of circulating antiphospholipid antibodies and either thrombotic events or pregnancy morbidity. The objective of this study was to review a large institution's experience to better understand the characteristics of children with APS. METHODS: We conducted a retrospective review of pediatric APS at a tertiary referral center. The electronic medical record system was queried from 2000 through 2019, and 21 cases were included based on meeting the revised Sapporo Classification criteria by age 18 or younger. Comparisons between primary and secondary APS patients were made with two-tailed t-tests. RESULTS: Twenty-one patients were included with a median age at diagnosis of 16 years and median follow-up of 5.8 years. Secondary APS was slightly more common than primary APS (11 vs. 10 cases) and was primarily diagnosed in the context of systemic lupus erythematosus. Two thirds of patients (67%) also had "non-criteria" manifestations of APS including thrombocytopenia, autoimmune hemolytic anemia, and livedo reticularis/racemosa. Almost half of patients (43%) had recurrent thrombosis, typically when patients were subtherapeutic or non-adherent with anticoagulation. Damage Index in Patients with Thrombotic APS (DIAPS) scores indicated a chronic burden of disease in both primary and secondary APS patients. CONCLUSION: This case series of pediatric APS provides important context regarding disease phenotypes displayed by children with APS. High prevalence of non-criteria clinical manifestations highlights the need to consider these characteristics when developing pediatric-specific classification criteria and when considering this relatively rare diagnosis in pediatric practice.

Exploring the clinical meaningfulness of the Scale for the Assessment and Rating of Ataxia: A comparison of patient and physician perspectives at the item level.

BACKGROUND: The Scale for the Assessment and Rating of Ataxia (SARA) is commonly used as the primary outcome measure in therapeutic trials. Driven by spontaneous comments from ataxia patients participating in a trial, we aimed to examine the clinical meaningfulness of the SARA from their perspective. METHODS: Twenty mildly to moderately affected individuals with spinocerebellar ataxia type 3 (SARA score 11.3 ± 4.1) completed a custom-designed survey. SARA item scores were compared with self-reported complaints in everyday life. Discrepancies between SARA ratings and patients' daily life experiences were reported as "overestimation" (i.e., a SARA item score more than 0, but no corresponding complaints) or "underestimation" (i.e., a SARA item score of 0, yet accompanying complaints). RESULTS: Patient-physician discrepancies were present in essentially all SARA items except for gait. The mean number of overestimated SARA points per patient was 3.1 ± 2.1. Underestimation occurred less frequently, but was relatively common in stance and fast alternating hand movements. Three quarters of patients marked gait as the most valuable SARA item, while the remaining 25% selected stance. CONCLUSION: On average, a quarter of total SARA score does not reflect meaningful impairments from a patient's perspective. Our data suggest that it is doubtful whether potential improvements at some of the items will be perceived as comparably important by mildly to moderately affected ataxia patients. These observations question the utility of delta SARA score as the most appropriate primary endpoint in clinical trials and call for the addition of outcome measures, such as the Patient Global Impression of Change scale and validated ataxia-specific patient-reported outcome measures.

Impact of Confinement in Patients under Long-Term Noninvasive Ventilation during the First Wave of the SARS-CoV-2 Pandemic: A Remarkable Resilience.

BACKGROUND: During the first wave of the SARS-CoV-2 pandemic in Switzerland, confinement was imposed to limit transmission and protect vulnerable persons. These measures may have had a negative impact on perceived quality of care and symptoms in patients with chronic disorders. OBJECTIVES: To determine whether patients under long-term home noninvasive ventilation (LTHNIV) for chronic respiratory failure (CRF) were negatively affected by the 56-day confinement (March-April 2020). METHODS: A questionnaire-based survey exploring mood disturbances (HAD), symptom scores related to NIV (S3-NIV), and perception of health-care providers during confinement was sent to all patients under LTHNIV followed up by our center. Symptom scores and data obtained by ventilator software were compared between confinement and the 56 days prior to confinement. RESULTS: Of a total of 100 eligible patients, 66 were included (median age: 66 years [IQR: 53-74]): 35 (53%) with restrictive lung disorders, 20 (30%) with OHS or SRBD, and 11 (17%) with COPD or overlap syndrome. Prevalence of anxiety (n = 7; 11%) and depressive (n = 2; 3%) disorders was remarkably low. Symptom scores were slightly higher during confinement although this difference was not clinically relevant. Technical data regarding ventilation, including compliance, did not change. Patients complained of isolation and lack of social contact. They felt supported by their relatives and caregivers but complained of the lack of regular contact and information by health-care professionals. CONCLUSIONS: Patients under LTHNIV for CRF showed a remarkable resilience during the SARS-CoV-2 confinement period. Comments provided may be helpful for managing similar future health-care crises.

Association between symptoms, affect and heart rhythm in patients with persistent or paroxysmal atrial fibrillation: an ambulatory pilot study.

Symptoms in atrial fibrillation are generally assumed to correspond to heart rhythm; however, patient affect - the experience of feelings, emotion or mood - is known to frequently modulate how patients report symptoms but this has not been studied in atrial fibrillation. In this study, we investigated the relationship between affect, symptoms and heart rhythm in patients with paroxysmal or persistent atrial fibrillation. We found that presence of negative affect portended reporting of more severe symptoms to the same or greater extent than heart rhythm.

Development of the gait outcomes assessment list for lower-limb differences (GOAL-LD) questionnaire: a child and parent reported outcome measure.

BACKGROUND: To develop a priority-based patient/parent reported outcome measure for children with lower-limb differences (LD) by adapting the Gait Outcomes Assessment List (GOAL) questionnaire. METHODS: Guided by a conceptual framework of patient priorities, the GOAL questionnaire was iteratively modified and its sensibility evaluated by field-testing it on children with LD, and their parents. Cognitive interviews were conducted with a subgroup of these children, and an e-survey administered to a multidisciplinary group of health care professionals with expertise in paediatric LD. Findings were integrated to create the final version of the GOAL-LD. RESULTS: Twenty-five children (9-18 years), 20 parents, and 31 healthcare professionals evaluated the content and sensibility of the GOAL, with an emphasis on the relevance and importance of the items to patients' health related quality of life (HRQL). This resulted in the retention of 26 of the original 50 items, elimination of 12, modification of 12, and addition of seven new items. The new 45-item GOAL-LD questionnaire was shown to be sensible, and its content deemed important. CONCLUSIONS: The GOAL-LD questionnaire has a high level of face and content validity, and sensibility. It comprehensively captures the HRQL goals and outcomes that matter to children with LD and their parents. Following further psychometric evaluation, the GOAL-LD may serve as a much needed patient and parent reported outcome measure for this population.

Validation of an 8-item Recovery Assessment Scale (RAS-8) for people with schizophrenia in China.

BACKGROUND: The 24-item Recovery Assessment Scale (RAS) is the most widely-used and well-validated tool for measuring recovery for people with mental illness. The current study aims to assess the reliability and validity of an 8-item short form of RAS (RAS-8) among a Chinese sample of people living with schizophrenia. METHODS: A sample of 400 people living with schizophrenia were recruited for scale validation. Internal consistency was tested by calculating Cronbach's α. Test-retest reliability was calculated using the intraclass correlation coefficient (ICC) for the total score and weighted kappa for each item. Factor structure was tested with confirmatory factor analysis, and concurrent validity was examined by investigating the correlation of the RAS-8 with patient symptoms, disability, depression, anxiety, patient functioning, quality of life and general health. RESULTS: The RAS-8 full scale and subscales showed good internal consistency with Cronbach's alpha ranging from 0.87 to 0.92. ICC of 0.99 and weighted kappa ranged from 0.62 to 0.88, which generally indicates good test-retest reliability. The findings supported an a priori two-factor structure, χ2/df = 2.93, CFI = 0.98, TLI = 0.98, RMSEA = 0.07, SRMR = 0.035. Concurrent validity of the RAS-8 was further supported by its significant negative correlations with patient symptoms (r = -0.24, p < 0.01), disability (r = -0.30, p < 0.01), depression (r = -0.16, p < 0.05), and anxiety (r = -0.14, p < 0.05), and its significant positive relationships with patient functioning (r = 0.26, p < 0.01), quality of life (r = 0.39, p < 0.01) and general health (r = 0.34, p < 0.01). CONCLUSIONS: This study confirmed the reliability and validity of an 8-item short-form RAS for people living with schizophrenia in Chinese communities. The validation of the RAS-8 allows for its use as an alternative for the full RAS as a rapid assessment tool in clinical and research settings. The findings are discussed for their implications for application and validation with other populations and in other countries.

Characteristics of a COVID-19 confirmed case series in primary care (COVID-19-PC project): a cross-sectional study.

BACKGROUND: To estimate the prevalence of symptoms and signs related to a COVID-19 case series confirmed by polymerase chain reaction (PCR) for SARS-CoV-2. Risk factors and the associated use of health services will also be analysed. METHODS: Observational, descriptive, retrospective case series study. The study was performed at two Primary Care Health Centres located in Madrid, Spain. The subjects studied were all PCR SARS-CoV-2 confirmed cases older than 18 years, diagnosed from the beginning of the community transmission (March 13) until April 15, 2020. We collected sociodemographic, clinical, health service utilization and clinical course variables during the following months. All data was gathered by their own attending physician, and electronic medical records were reviewed individually. STATISTICAL ANALYSIS: A descriptive analysis was carried out and a Poisson regression model was adjusted to study associated factors to Health Services use. RESULTS: Out of the 499 patients studied from two health centres, 55.1% were women and mean age was 58.2 (17.3). 25.1% were healthcare professionals. The most frequent symptoms recorded related to COVID-19 were cough (77.9%; CI 95% 46.5-93.4), fever (77.7%; CI95% 46.5-93.4) and dyspnoea (54.1%, CI95% 46.6-61.4). 60.7% were admitted to hospital. 64.5% first established contact with their primary care provider before going to the hospital, with a mean number of 11.4 Healthcare Providers Encounters with primary care during all the follow-up period. The number of visit-encounters with primary care was associated with being male [IRR 1.072 (1.013, 1.134)], disease severity {from mild respiratory infection [IRR 1.404 (1.095, 1.801)], up to bilateral pneumonia [IRR 1.852 (1.437,2.386)]}, and the need of a work leave [IRR 1.326 (1.244, 1.413]. CONCLUSION: Symptoms and risk factors in our case series are similar to those in other studies. There was a high number of patients with atypical unilateral or bilateral pneumonia. Care for COVID has required a high use of healthcare resources such as clinical encounters and work leaves.

SARS-CoV-2 antibody detection in skilled nursing facility residents.

OBJECTIVE: To describe the frequency and timing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody detection in a convenience sample of skilled nursing facility (SNF) residents with and without confirmed SARS-CoV-2 infection. DESIGN: Retrospective analysis of SNF electronic health records. SETTING: Qualitative SARS-CoV-2 antibody test results were available from 81 SNFs in 16 states. PARTICIPANTS: Six hundred and sixty nine SNF residents who underwent both polymerase chain reaction (PCR) and antibody testing for SARS-CoV-2. MEASUREMENTS: Presence of SARS-CoV-2 antibodies following the first positive PCR test for confirmed cases, or first PCR test for non-cases. RESULTS: Among 397 residents with PCR-confirmed infection, antibodies were detected in 4 of 7 (57.1%) tested within 7-14 days of their first positive PCR test; in 44 of 47 (93.6%) tested within 15-30 days; in 182 of 219 (83.1%) tested within 31-60 days; and in 110 of 124 (88.7%) tested after 60 days. Among 272 PCR negative residents, antibodies were detected in 2 of 9 (22.2%) tested within 7-14 days of their first PCR test; in 41 of 81 (50.6%) tested within 15-30 days; in 65 of 148 (43.9%) tested within 31-60 days; and in 9 of 34 (26.5%) tested after 60 days. No significant differences in baseline resident characteristics or symptoms were observed between those with versus without antibodies. CONCLUSIONS: These findings suggest that vulnerable older adults can mount an antibody response to SARS-CoV-2, and that antibodies are most likely to be detected within 15-30 days of diagnosis. That antibodies were detected in a large proportion of residents with no confirmed SARS-CoV-2 infection highlights the complexity of identifying who is infected in real time. Frequent surveillance and diagnostic testing based on low thresholds of clinical suspicion for symptoms and/or exposure will remain critical to inform strategies designed to mitigate outbreaks in SNFs while community SARS-CoV-2 prevalence remains high.

Post-COVID-19 Symptom Burden: What is Long-COVID and How Should We Manage It?

The enduring impact of COVID-19 on patients has been examined in recent studies, leading to the description of Long-COVID. We report the lasting symptom burden of COVID-19 patients from the first wave of the pandemic. All patients with COVID-19 pneumonia discharged from a large teaching hospital trust were offered follow-up. We assessed symptom burden at follow-up using a standardised data collection technique during virtual outpatient clinic appointments. Eighty-six percent of patients reported at least one residual symptom at follow-up. No patients had persistent radiographic abnormalities. The presence of symptoms at follow-up was not associated with the severity of the acute COVID-19 illness. Females were significantly more likely to report residual symptoms including anxiety (p = 0.001), fatigue (p = 0.004), and myalgia (p = 0.022). The presence of long-lasting symptoms is common in COVID-19 patients. We suggest that the phenomenon of Long-COVID may not be directly attributable to the effect of SARS-CoV-2, and believe the biopsychosocial effects of COVID-19 may play a greater role in its aetiology.

Asymptomatic carriage rates and case fatality of SARS-CoV-2 infection in residents and staff in Irish nursing homes.

BACKGROUND: SARS-CoV-2 has disproportionately affected nursing homes (NH). In Ireland, the first NH case COVID-19 occurred on 16 March 2020. A national point-prevalence testing programme of all NH residents and staff took place (18 April 2020 to 5 May 2020). AIMS: to examine characteristics of NHs across three Irish Community Health Organisations, proportions with COVID-19 outbreaks, staff and resident infection rates symptom profile and resident case fatality. METHODS: in total, 45 NHs surveyed, requesting details on occupancy, size, COVID-19 outbreak, outbreak timing, total symptomatic/asymptomatic cases and outcomes for residents from 29 February 2020 to 22 May 2020. RESULTS: surveys were returned from 62.2% (28/45) of NHs (2,043 residents, 2,303 beds). Three-quarters (21/28) had COVID-19 outbreaks (1,741 residents, 1,972 beds). Median time from first COVID-19 case in Ireland to first case in these NHs was 27.0 days. Resident incidence was 43.9% (764/1,741)-40.8% (710/1,741) laboratory confirmed, with 27.2% (193/710) asymptomatic and 3.1% (54/1,741) clinically suspected. Resident case fatality was 27.6% (211/764) for combined laboratory-confirmed/clinically suspected COVID-19. Similar proportions of residents in NHs with 'early-stage' (<28 days) versus 'later-stage' outbreaks developed COVID-19. Lower proportions of residents in 'early' outbreak NHs had recovered compared with those with 'late' outbreaks (37.4 versus 61.7%; χ2 = 56.9, P < 0.001). Of 395 NH staff across 12 sites with confirmed COVID-19, 24.7% (99/398) were asymptomatic. There was a significant correlation between the proportion of staff with symptomatic COVID-19 and resident numbers with confirmed/suspected COVID-19 (Spearman's rho = 0.81, P < 0.001). CONCLUSION: this study demonstrates the significant impact of COVID-19 on the NH sector. Systematic point-prevalence testing is necessary to reduce risk of transmission from asymptomatic carriers and manage outbreaks in this setting.

Parent-Reported Symptoms and Medications Used Among Children With Severe Neurological Impairment.

Importance: Children with severe neurological impairment (SNI) often take multiple medications to treat problematic symptoms. However, for children who cannot self-report symptoms, no system exists to assess multiple symptoms and their association with medication use. Objectives: To assess the prevalence of 28 distinct symptoms, test whether higher global symptom scores (GSS) were associated with use of more medications, and assess the associations between specific symptoms and medications. Design, Setting, and Participants: This cross-sectional study was conducted between April 1, 2019, and December 31, 2019, using structured parent-reported symptom data paired with clinical and pharmacy data, at a single-center, large, hospital-based special health care needs clinic. Participants included children aged 1 to 18 years with SNI and 5 or more prescribed medications. Data analysis was performed from April to June 2020. Exposure: During routine clinical visits, parent-reported symptoms were collected using the validated 28-symptom Memorial Symptom Assessment Scale (MSAS) and merged with clinical and pharmacy data. Main Outcomes and Measures: Symptom prevalence, counts, and GSS (scored 0-100, with 100 being the worst) were calculated, and the association of GSS with medications was examined. To evaluate associations between symptom-medication pairs, the proportion of patients with a symptom who used a medication class or specific medication was calculated. Results: Of 100 patients, 55.0% were boys, the median (interquartile range [IQR]) age was 9 (5-12) years, 62.0% had 3 or more complex chronic conditions, 76.0% took 10 or more medications, and none were able to complete the MSAS themselves. Parents reported a median (IQR) of 7 (4-10) concurrent active symptoms. The median (IQR) GSS was 12.1 (5.4-20.8) (range, 0.0-41.2) and the GSS was 9.8 points (95% CI, 5.5-14.1 points) higher for those with worse recent health than usual. Irritability (65.0%), insomnia (55.0%), and pain (54.0%) were the most prevalent symptoms. Each 10-point GSS increase was associated with 12% (95% CI, 4%-19%) higher medication counts, adjusted for age and complex chronic condition count. Among the 54.0% of children with reported pain, 61.0% were prescribed an analgesic. Conclusions and Relevance: These findings suggest that children with SNI reportedly experience substantial symptom burdens and that higher symptom scores are associated with increased medication use. Paired symptom-medication data may help clinicians identify targets for personalized symptom management, including underrecognized or undertreated symptoms.

Assessment of Nicotine and Cannabis Vaping and Respiratory Symptoms in Young Adults.

Importance: Rates of e-cigarette use (ie, nicotine vaping) and cannabis vaping continue to increase among youth and young adults. However, the association of nicotine and cannabis vaping with independent respiratory health outcomes has not been well studied. Objective: To investigate associations of nicotine and cannabis vaping with bronchitic symptoms, wheeze, and shortness of breath. Design, Setting, and Participants: Cross-sectional survey data on self-reported lifetime, 6-month, and 30-day vaping from 2553 young adults recruited from high schools in Southern California were collected from June 2018 to October 2019. Of these participants, 94% provided data for shortness of breath and wheeze, and 86% provided data for chronic bronchitis. Main Outcomes and Measures: Self-reported nicotine and cannabis vaping were measured on a Likert-type scale using the following responses: (1) never used, (2) lifetime but no past 6-month use, (3) past 6-month use but no use in the past 30 days, (4) use on 1 or 2 of the past 30 days, and (5) use on 3 or more of the past 30 days. Three respiratory health outcomes were assessed separately on the basis of self-reported symptoms: bronchitic symptoms in the previous 12 months (ie, daily cough for 3 months in a row, congestion or phlegm other than with a cold, and/or bronchitis), wheeze in the previous 12 months, and shortness of breath when hurrying on level ground or walking up a slight hill. Results: Of 2553 participants in the analytic sample (mean [SD] age, 19.3 [0.79] years; 1477 [57.9%] female individuals), 1095 of 2553 young adults (42.9%) reported vaping nicotine and 939 of 2553 (38.4%) reported vaping cannabis. Compared with those who never vaped cannabis, individuals who vaped cannabis in their lifetime but not in the past 60 months (204 of 2553 [8.4%]; adjusted odds ratio [aOR], 1.83 [95% CI, 1.08-3.10]), in the past 6 months but not in the last 30 days (490 of 2443 [20.1%]; aOR, 1.58 [95% CI, 1.02-2.46]), 1-2 days in the past 30 days (90 of 2443 [3.7%]; aOR, 2.83 [95% CI, 1.46-5.50]), and 3 or more days in the past 30 days (155 of 2443 [6.3%]; aOR, 2.14 [95% CI, 1.16-3.92]) had significantly higher odds of chronic bronchitic symptoms after adjusting for nicotine vaping, cigarette smoking, cannabis smoking, and sociodemographic characteristics. Cannabis vaping 3 or more times in the last 30 days was also associated with increased odds of wheeze (aOR, 2.27 [95% CI, 1.17-4.37]). Associations of cannabis vaping with shortness of breath and nicotine vaping with any respiratory health outcome were not statistically significant in fully adjusted models. Conclusions and Relevance: Findings of this cross-sectional study suggest that cannabis vaping is associated with increased risk of bronchitic symptoms and wheeze in young adults. Further research is needed to understand the temporality of the association and the mechanisms underlying the difference between nicotine and cannabis vaping in the risk of bronchitic symptoms and wheeze.

Association of Receipt of Palliative Care Interventions With Health Care Use, Quality of Life, and Symptom Burden Among Adults With Chronic Noncancer Illness: A Systematic Review and Meta-analysis.

Importance: The evidence for palliative care exists predominantly for patients with cancer. The effect of palliative care on important end-of-life outcomes in patients with noncancer illness is unclear. Objective: To measure the association between palliative care and acute health care use, quality of life (QOL), and symptom burden in adults with chronic noncancer illnesses. Data Sources: MEDLINE, Embase, CINAHL, PsycINFO, and PubMed from inception to April 18, 2020. Study Selection: Randomized clinical trials of palliative care interventions in adults with chronic noncancer illness. Studies involving at least 50% of patients with cancer were excluded. Data Extraction and Synthesis: Two reviewers independently screened, selected, and extracted data from studies. Narrative synthesis was conducted for all trials. All outcomes were analyzed using random-effects meta-analysis. Main Outcomes and Measures: Acute health care use (hospitalizations and emergency department use), disease-generic and disease-specific quality of life (QOL), and symptoms, with estimates of QOL translated to units of the Functional Assessment of Chronic Illness Therapy-Palliative Care scale (range, 0 [worst] to 184 [best]; minimal clinically important difference, 9 points) and symptoms translated to units of the Edmonton Symptom Assessment Scale global distress score (range, 0 [best] to 90 [worst]; minimal clinically important difference, 5.7 points). Results: Twenty-eight trials provided data on 13 664 patients (mean age, 74 years; 46% were women). Ten trials were of heart failure (n = 4068 patients), 11 of mixed disease (n = 8119), 4 of dementia (n = 1036), and 3 of chronic obstructive pulmonary disease (n = 441). Palliative care, compared with usual care, was statistically significantly associated with less emergency department use (9 trials [n = 2712]; 20% vs 24%; odds ratio, 0.82 [95% CI, 0.68-1.00]; I2 = 3%), less hospitalization (14 trials [n = 3706]; 38% vs 42%; odds ratio, 0.80 [95% CI, 0.65-0.99]; I2 = 41%), and modestly lower symptom burden (11 trials [n = 2598]; pooled standardized mean difference (SMD), -0.12; [95% CI, -0.20 to -0.03]; I2 = 0%; Edmonton Symptom Assessment Scale score mean difference, -1.6 [95% CI, -2.6 to -0.4]). Palliative care was not significantly associated with disease-generic QOL (6 trials [n = 1334]; SMD, 0.18 [95% CI, -0.24 to 0.61]; I2 = 87%; Functional Assessment of Chronic Illness Therapy-Palliative Care score mean difference, 4.7 [95% CI, -6.3 to 15.9]) or disease-specific measures of QOL (11 trials [n = 2204]; SMD, 0.07 [95% CI, -0.09 to 0.23]; I2 = 68%). Conclusions and Relevance: In this systematic review and meta-analysis of randomized clinical trials of patients with primarily noncancer illness, palliative care, compared with usual care, was statistically significantly associated with less acute health care use and modestly lower symptom burden, but there was no significant difference in quality of life. Analyses for some outcomes were based predominantly on studies of patients with heart failure, which may limit generalizability to other chronic illnesses.

The effectiveness and cost-effectiveness of hospital-based specialist palliative care for adults with advanced illness and their caregivers.

BACKGROUND: Serious illness is often characterised by physical/psychological problems, family support needs, and high healthcare resource use. Hospital-based specialist palliative care (HSPC) has developed to assist in better meeting the needs of patients and their families and potentially reducing hospital care expenditure. There is a need for clarity on the effectiveness and optimal models of HSPC, given that most people still die in hospital and also to allocate scarce resources judiciously. OBJECTIVES: To assess the effectiveness and cost-effectiveness of HSPC compared to usual care for adults with advanced illness (hereafter patients) and their unpaid caregivers/families. SEARCH METHODS: We searched CENTRAL, CDSR, DARE and HTA database via the Cochrane Library; MEDLINE; Embase; CINAHL; PsycINFO; CareSearch; National Health Service Economic Evaluation Database (NHS EED) and two trial registers to August 2019, together with checking of reference lists and relevant systematic reviews, citation searching and contact with experts to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the impact of HSPC on outcomes for patients or their unpaid caregivers/families, or both. HSPC was defined as specialist palliative care delivered by a palliative care team that is based in a hospital providing holistic care, co-ordination by a multidisciplinary team, and collaboration between HSPC providers and generalists. HSPC was provided to patients while they were admitted as inpatients to acute care hospitals, outpatients or patients receiving care from hospital outreach teams at home. The comparator was usual care, defined as inpatient or outpatient hospital care without specialist palliative care input at the point of entry into the study, community care or hospice care provided outside of the hospital setting. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We assessed risk of bias and extracted data. To account for use of different scales across studies, we calculated standardised mean differences (SMDs) with 95% confidence intervals (CIs) for continuous data. We used an inverse variance random-effects model. For binary data, we calculated odds ratio (ORs) with 95% CIs. We assessed the evidence using GRADE and created a 'Summary of findings' table. Our primary outcomes were patient health-related quality of life (HRQoL) and symptom burden (a collection of two or more symptoms). Key secondary outcomes were pain, depression, satisfaction with care, achieving preferred place of death, mortality/survival, unpaid caregiver burden, and cost-effectiveness. Qualitative data was analysed where available. MAIN RESULTS: We identified 42 RCTs involving 7779 participants (6678 patients and 1101 caregivers/family members). Twenty-one studies were with cancer populations, 14 were with non-cancer populations (of which six were with heart failure patients), and seven with mixed cancer and non-cancer populations (mixed diagnoses). HSPC was offered in different ways and included the following models: ward-based, inpatient consult, outpatient, hospital-at-home or hospital outreach, and service provision across multiple settings which included hospital. For our main analyses, we pooled data from studies reporting adjusted endpoint values. Forty studies had a high risk of bias in at least one domain. Compared with usual care, HSPC improved patient HRQoL with a small effect size of 0.26 SMD over usual care (95% CI 0.15 to 0.37; I2 = 3%, 10 studies, 1344 participants, low-quality evidence, higher scores indicate better patient HRQoL). HSPC also improved other person-centred outcomes. It reduced patient symptom burden with a small effect size of -0.26 SMD over usual care (95% CI -0.41 to -0.12; I2 = 0%, 6 studies, 761 participants, very low-quality evidence, lower scores indicate lower symptom burden). HSPC improved patient satisfaction with care with a small effect size of 0.36 SMD over usual care (95% CI 0.41 to 0.57; I2 = 0%, 2 studies, 337 participants, low-quality evidence, higher scores indicate better patient satisfaction with care). Using home death as a proxy measure for achieving patient's preferred place of death, patients were more likely to die at home with HSPC compared to usual care (OR 1.63, 95% CI 1.23 to 2.16; I2 = 0%, 7 studies, 861 participants, low-quality evidence). Data on pain (4 studies, 525 participants) showed no evidence of a difference between HSPC and usual care (SMD -0.16, 95% CI -0.33 to 0.01; I2 = 0%, very low-quality evidence). Eight studies (N = 1252 participants) reported on adverse events and very low-quality evidence did not demonstrate an effect of HSPC on serious harms. Two studies (170 participants) presented data on caregiver burden and both found no evidence of effect of HSPC (very low-quality evidence). We included 13 economic studies (2103 participants). Overall, the evidence on cost-effectiveness of HSPC compared to usual care was inconsistent among the four full economic studies. Other studies that used only partial economic analysis and those that presented more limited resource use and cost information also had inconsistent results (very low-quality evidence). Quality of the evidence The quality of the evidence assessed using GRADE was very low to low, downgraded due to a high risk of bias, inconsistency and imprecision. AUTHORS' CONCLUSIONS: Very low- to low-quality evidence suggests that when compared to usual care, HSPC may offer small benefits for several person-centred outcomes including patient HRQoL, symptom burden and patient satisfaction with care, while also increasing the chances of patients dying in their preferred place (measured by home death). While we found no evidence that HSPC causes serious harms, the evidence was insufficient to draw strong conclusions. Although these are only small effect sizes, they may be clinically relevant at an advanced stage of disease with limited prognosis, and are person-centred outcomes important to many patients and families. More well conducted studies are needed to study populations with non-malignant diseases and mixed diagnoses, ward-based models of HSPC, 24 hours access (out-of-hours care) as part of HSPC, pain, achieving patient preferred place of care, patient satisfaction with care, caregiver outcomes (satisfaction with care, burden, depression, anxiety, grief, quality of life), and cost-effectiveness of HSPC. In addition, research is needed to provide validated person-centred outcomes to be used across studies and populations.

Universal testing for severe acute respiratory syndrome coronavirus 2 in 2 Philadelphia hospitals: carrier prevalence and symptom development over 2 weeks.

Background: The coronavirus disease 2019 pandemic caused by the severe acute respiratory syndrome coronavirus 2 has challenged obstetrical care providers. Universal testing on labor and delivery units has been implemented by many hospitals to ensure patient and staff safety. Asymptomatic carrier rates are expected to vary based on geographic differences in disease prevalence, although differences within the same city have not been reported previously. In addition, clinical follow-up of women who had a negative result for severe acute respiratory syndrome coronavirus 2 during obstetrical hospitalization has not been included in any previous reports. Objective: This study aimed to describe the prevalence of positive severe acute respiratory syndrome coronavirus 2 test results among asymptomatic pregnant women at 2 Philadelphia obstetrical hospitals, characterize the clinical course of those who had a positive result, and report symptom development among all women tested in the 2 weeks after hospitalization. Study Design: This is an observational study of asymptomatic pregnant women who underwent severe acute respiratory syndrome coronavirus 2 testing at 2 academic health centers (Hospital of the University of Pennsylvania and Pennsylvania Hospital) in Philadelphia, Pennsylvania, between April 13, 2020, and April 26, 2020. All women tested were contacted via telephone for symptom follow-up at 1 and 2 weeks after discharge. Asymptomatic positive test rates are reported for the overall population and by hospital. The hospital and 2-week posthospital course are described for women who had a positive result for severe acute respiratory syndrome coronavirus 2. Posthospital symptom development among women who had a negative result for severe acute respiratory syndrome coronavirus 2 is also described. Results: A total of 318 asymptomatic women underwent severe acute respiratory syndrome coronavirus 2 testing during this 2-week period; 8 women had a positive result. The overall asymptomatic test positive rate was 2.5%. The rate at Hospital of the University of Pennsylvania was 3.8% compared with 1.3% at Pennsylvania Hospital (P=.283). Of note, 3 women (37.5%) who were initially asymptomatic developed mild symptoms in the 2 weeks after a positive test result. Repeat severe acute respiratory syndrome coronavirus 2 testing was performed in 14 of the 310 women (4.5%) who initially had a negative result; 2 women (0.6%) had a positive result on repeat testing. Moreover, 242 (78.1%) and 213 (68.7%) of the 310 women who had a negative result for severe acute respiratory syndrome coronavirus 2 at the time of the initial hospitalization were followed up via telephone at 1 and 2 weeks after admission, respectively. Viral symptoms, including fevers, chills, shortness of breath, or cough, were self-reported in 4.5% and 4.2% of these women at 1 and 2 weeks after discharge, respectively. Conclusion: The asymptomatic positive severe acute respiratory syndrome coronavirus 2 test rate among an obstetrical population in Philadelphia differed between 2 hospitals and was lower than that described in other geographic regions. This supports the importance of institution-specific testing protocols. The development of symptomatic severe acute respiratory syndrome coronavirus 2 infection after hospitalization among women with initial negative test results is uncommon.

Validation of the Dutch version of the Edmonton Symptom Assessment System.

BACKGROUND: The Utrecht Symptom Diary (USD) is a Dutch and adapted version of the Edmonton Symptom Assessment System, a patient-reported outcome measurement (PROM) tool to asses and monitor symptoms in cancer patients. This study analyses the validity and responsiveness of the USD and the cutoff points to determine the clinical significance of a symptom score. METHODS: Observational longitudinal cohort study including adult in- and outpatients treated in an academic hospital in the Netherlands who completed at least one USD as part of routine care (2012-2019). The distress thermometer and problem checklist (DT&PC) was used as a reference PROM. Content, construct and criterion validity, responsiveness, and cutoff points are shown with prevalences, area under receiver operating characteristic (ROC) curve, Chi-squared test, Wilcoxon signed-rank test, and positive and negative predictive values, respectively. RESULTS: A total of 3913 patients completed 22 400 USDs. Content validity was confirmed for all added USD items with prevalences of ≥22%. All USD items also present on the DT&PC demonstrated a good criterion validity (ROC >0.8). Construct validity was confirmed for the USD as a whole and for the items dry mouth, dysphagia and well-being (P < .0001). USD scores differed significantly for patients when improving or deteriorating on the DT&PC which confirmed responsiveness. Optimal cutoff points (3 or 4) differed per symptom. CONCLUSION: The USD is a valid 12-item PROM for the most prevalent symptoms in cancer patients, which has content, criterion, and construct validity, and detects clinically important changes over time, in both curative and palliative phase.

Validity and Reliability of the Antepartum Gastrointestinal Symptom Assessment Instrument.

OBJECTIVE: To examine the psychometric properties of the nine-item Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) instrument. DESIGN: Single-group prospective design. SETTING: Urban prenatal clinic serving a diverse population. PARTICIPANTS: Convenience sample of 45 pregnant women. METHODS: Participants completed the AP-GI-SA before a scheduled prenatal care appointment. We used Bayesian structural equation modeling to evaluate the construct validity of the scale and assessed known-groups validity. We assessed reliability through maximal reliability coefficient estimate and measured internal consistency with Cronbach's alpha coefficient. RESULTS: Participants completed the instrument in 2 minutes or less. Construct validity was supported by confirmatory factor analysis (posterior predictive p value = 0.49, gamma-hat = 0.970, and root mean square error of approximation = 0.065), which indicated that the single-factor model is a plausible data-generative model for GI symptoms. The maximal reliability coefficient of 0.75 and Cronbach's alpha coefficient of 0.67 supported reliability. Average AP-GI-SA scores were the highest for women in the third trimester. Of all nine GI symptoms, heartburn in the third trimester received the highest score. CONCLUSION: Our findings provide preliminary support for the validity and reliability of the AP-GI-SA. The instrument may be used as a measure in intervention studies where GI symptoms of pregnancy are an outcome. The AP-GI-SA could also be useful in clinical settings to quickly evaluate GI symptoms.