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outcome assessment (health care) - Top 30 Publications

Effect of the Apolipoprotein E Genotype on Cognitive Change During a Multidomain Lifestyle Intervention: A Subgroup Analysis of a Randomized Clinical Trial.

The role of the apolipoprotein E (APOE) ε4 allele as an effect modifier in lifestyle interventions to prevent cognitive impairment is still unclear.

Association Between Fluid Balance and Outcomes in Critically Ill Children: A Systematic Review and Meta-analysis.

After initial resuscitation, critically ill children may accumulate fluid and develop fluid overload. Accruing evidence suggests that fluid overload contributes to greater complexity of care and worse outcomes.

E-learning for health professionals.

The use of e-learning, defined as any educational intervention mediated electronically via the Internet, has steadily increased among health professionals worldwide. Several studies have attempted to measure the effects of e-learning in medical practice, which has often been associated with large positive effects when compared to no intervention and with small positive effects when compared with traditional learning (without access to e-learning). However, results are not conclusive.

Antidepressants for depression in adults with HIV infection.

Rates of major depression among people living with HIV (PLWH) are substantially higher than those seen in the general population and this may adversely affect antiretroviral treatment outcomes. Several unique clinical and psychosocial factors may contribute to the development and persistence of depression in PLWH. Given these influences, it is unclear if antidepressant therapy is as effective for PLWH as the general population.

One-year follow-up of a randomized controlled trial of sertraline and cognitive behavior group therapy in depressed primary care patients (MIND study).

The long-term course of symptoms in patients with mild-to-moderate depression is not well understood. A 12-month-follow-up analysis was performed on those participants from a randomized controlled 10-week trial (RCT, MIND-study), who had received either treatment with an antidepressant (sertraline) or a psychotherapeutic intervention (group cognitive-behavioral therapy (CBT)).

Effects of Nutritional Status on 6-Month Outcome of Hip Fractures in Elderly Patients.

To identify the prevalence of malnutrition in elderly hip fracture and to investigate the relationship between hip fracture patients and malnutrition on functional recovery and mortality.

Maternal metabolic response to dietary treatment for impaired glucose tolerance and gestational diabetes mellitus.

Dietary advice is a standard component of treatment for pregnant women with impaired glucose tolerance (IGT) and gestational diabetes (GDM), yet few studies report glycemic profiles in response to dietary therapies and the optimal dietary approach remains uncertain.

The differences in the assessments of side effects at an oncology outpatient clinic.

Background There is a growing interest in the use of targeted and immunotherapies in oncology. However, the assessment of side effects can be different due to interpretation of patients' health status by healthcare professionals in oncology outpatient clinics. Objective To demonstrate the differences in the assessments of side effects conducted independently by a clinical pharmacist and nurses in patients who receive targeted therapies at an oncology outpatient clinic. Setting The study was conducted at the University Oncology Hospital in an outpatient clinic from October 2015 to March 2016. Method Patients receiving ipilimumab, nivolumab, pembrolizumab, bevacizumab, panitumumab or cetuximab during study period were included. The assessment of side effects was conducted by a pharmacist and nurse independently using the NCI-CTCAE version-2. Main outcome measure To compare the severity assessments of side effects between a clinical pharmacist and nurses in an outpatient clinic. Results During the study, 204 visits for 43 patients with a total of 5508 side effect assessments were recorded where 1137 (20.64%) assessments were graded differently. Out of 1137 assessments, 473 of them were graded higher by a clinical pharmacist whereas 664 were graded higher by nurses. Statistically significant differences were detected in the assessment of vomiting, taste changes, sense changes, alopecia, fatigue, mood changes, anxiety, hearing impairment, and allergic reactions. Conclusion An assessment of side effects by healthcare providers in patients with cancer may be challenging due to an increased workload in clinics and undistinguishable symptoms of side effects and cancer itself. Therefore, a new care model which increases an interprofessional communication may improve pharmaceutical care in oncology outpatient clinics.

Effect of Patient Experience on Bypassing a Primary Care Gatekeeper: a Multicenter Prospective Cohort Study in Japan.

To discuss how best to implement the gatekeeping functionality of primary care; identifying the factors that cause patients to bypass their primary care gatekeepers when seeking care should be beneficial.

Psychometric properties and measurement equivalence of the Multidimensional Fatigue Syndrome Inventory- Short Form (MFSI-SF) amongst breast cancer and lymphoma patients in Singapore.

Currently, several fatigue measurement instruments are available to evaluate and measure cancer-related fatigue. Amongst them, Multidimensional Fatigue Syndrome Inventory-Short Form (MFSI-SF) is a self-reported instrument and a multidimensional scale that aims to capture the global, somatic, affective, cognitive and behavioural symptoms of fatigue. This study examines the psychometric properties and measurement equivalence of the English and Chinese versions of MFSI-SF in breast cancer and lymphoma patients in Singapore.

Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework.

Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. This article presents the development of a simple framework to document, understand and improve the process of trial recruitment.

Frontal assessment battery (FAB) performance following traumatic brain injury hospitalized in an acute care setting.

The Frontal Assessment Battery (FAB) has been shown to be useful in several clinical settings. The aim of the present study was to examine the performance of patients with traumatic brain injury (TBI) on the FAB and to predict their acute outcome. The FAB was administered to 89 patients with mild (27 = uncomplicated and 39 = complicated) and moderate (n = 23) TBI during hospitalization in an acute care setting. The length of stay in days (LOS), Glasgow Outcome Scale-Revised score (GOSE) and Disability Rating Scale (DRS) score were collected. Results showed no significant differences between the three groups on the FAB score, but age and education were significantly associated with the FAB score. Parietal lesions were associated with lower total FAB score, and with the Similarities, Motor series and Conflicting instructions subscales, while frontal lesions were associated with lower performance on the Motor series and Conflicting instructions subscales. Total FAB score was significantly correlated with all outcome measures, and together the FAB total score and the Glasgow Coma Scale (GCS) score explained 30.8% of the variance in the DRS score. The FAB may be useful clinically to acutely assess frontal and parietal lobe functions at bedside in patients with TBI and, in combination with the GCS score to measure TBI severity, can enable clinicians to predict early outcome.

Effects of a population-based, person-centred and integrated care service on health, wellbeing and self-management of community-living older adults: A randomised controlled trial on Embrace.

To evaluate the effects of the population-based, person-centred and integrated care service 'Embrace' at twelve months on three domains comprising health, wellbeing and self-management among community-living older people.

Secondary Alveolar Bone Grafting in Patients Born With Unilateral Cleft Lip and Palate: A 20-Year Follow-up.

To identify factors of oral health important for the final outcome, after secondary alveolar bone grafting in patients born with unilateral cleft lip and palate and compare occlusal radiographs with cone beam computed tomography (CBCT) in assessment of alveolar bone height.

Rating Nasolabial Aesthetics in Unilateral Cleft Lip and Palate Patients: Cropped Versus Full-Face Images.

To determine if cropping facial images affects nasolabial aesthetics assessments in unilateral cleft lip patients and to evaluate the effect of facial attractiveness on nasolabial evaluation.

Uncertain effect of preventative shoulder rehabilitation for patients who underwent total laryngectomy with neck dissection.

Total laryngectomy (TL) with neck dissection (ND) is considered as crucial management for advanced-stage of laryngeal cancer. Shoulder dysfunction has long been recognized as a potential complication resulting from neck dissection. The aim of this study was to evaluate the effect of early prophylactic rehabilitation program in patients who underwent TL with ND.

Clinical Outcomes of Geriatric Care in Cipto Mangunkusumo Hospital, Before and After the Implementation of National Health Insurance Program.

the National Health Insurance (NIH/JKN) has been enacted since January 2014. Various outcomes of geriatric patient care, such as improved functional status and quality of life have not been evaluated. Prolonged hospitalization and re-hospitalization are potentially affecting the efficiency care of this vulnarable group. This study aimed to identify the differences of functional status improvement, quality of life improvement, length of stay, and hospitalization of geriatric patients admitted to CMH between prior to and after NHI implementation.

Near-infrared spectroscopy to predict organ failure and outcome in sepsis: the Assessing Risk in Sepsis using a Tissue Oxygen Saturation (ARISTOS) study.

Sepsis is acute organ dysfunction in the setting of infection. An accurate diagnosis is important to guide treatment and disposition. Tissue oxygen saturation (StO2) can be estimated noninvasively by near-infrared spectroscopy (NIRS), and may be an indicator of microcirculatory dysfunction in early sepsis. We aimed to determine the utility of StO2 for sepsis recognition and outcome prediction among patients presenting to the emergency department (ED) with infection.

Therapy interventions for children with neurodisabilities: a qualitative scoping study.

Therapy interventions emerged four times in the top 10 research priorities in a James Lind Alliance research prioritisation exercise for children with neurodisabilities (Morris C, Simkiss D, Busk M, Morris M, Allard A, Denness J, et al. Setting research priorities to improve the health of children and young people with neurodisability: a British Academy of Childhood Disability-James Lind Alliance Research Priority Setting Partnership. BMJ Open 2015;5:e006233). The National Institute for Health Research (NIHR) commissioned this study as part of an information-gathering exercise in response to this.

Ticagrelor for Secondary Prevention of Atherothrombotic Events After Myocardial Infarction: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

The National Institute for Health and Care Excellence (NICE) invited AstraZeneca, the manufacturer of ticagrelor (Brilique®), to submit evidence on the clinical and cost effectiveness of ticagrelor 60 mg twice daily (BID) in combination with low-dose aspirin [acetylsalicylic acid (ASA)] compared with ASA only for secondary prevention of atherothrombotic events in patients with a history of myocardial infarction (MI) and who are at increased risk of atherothrombotic events. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Maastricht University Medical Centre+, was commissioned as the evidence review group (ERG). This paper summarises the company submission (CS), the ERG report and the NICE guidance produced by the appraisal committee (AC) for the use of ticagrelor in England and Wales. The ERG critically reviewed the clinical- and cost-effectiveness evidence in the CS. The systematic review conducted as part of the CS identified one randomised controlled trial (RCT), PEGASUS-TIMI 54. This trial reported the time to first occurrence of any event from the composite of cardiovascular death, MI and stroke as the primary outcome (hazard ratio 0.84 ticagrelor 60 mg BID vs. placebo, 95% confidence interval 0.74-0.95). The population addressed in the CS was a subgroup of the PEGASUS-TIMI 54 trial population, i.e. the 'base-case' population, which comprised patients who had experienced an MI between 1 and 2 years ago, whereas the full trial population included patients who had experienced an MI between 1 and 3 years ago. While the ERG believed the findings of this RCT to be robust, doubts concerning the applicability of the trial to UK patients were raised. The company submitted an individual patient simulation model to estimate the cost-effectiveness of ticagrelor 60 mg BID + ASA versus ASA only. Parametric time-to-event models were used to estimate the time to first and subsequent (cardiovascular) events, time to treatment discontinuation and time to adverse events. The company's base-case analysis resulted in an incremental cost-effectiveness ratio (ICER) of £20,098 per quality-adjusted life-year (QALY) gained. The main issues surrounding the cost effectiveness of ticagrelor 60 mg BID + ASA were the use of parametric time-to-event models estimated based on the full trial population instead of being fitted to the 'label' population (the 'label' population comprised the 'base-case' population and patients who started ticagrelor 60 mg BID within 1 year of previous adenosine diphosphate inhibitor treatment), the incorrect implementation of the probabilistic sensitivity analysis (PSA) of the individual patient simulation, and simplifications of the model structure that may have biased the health benefits and costs estimations of the intervention and comparator. The ERG believed the use of the full trial population to inform the parametric time-to-event models was not appropriate because the 'label' population was the main focus of the scope and CS. The ERG could not investigate the magnitude of the bias introduced by this assumption. The PSA of the individual patient simulation provided unreliable probabilistic results and underestimated the uncertainty surrounding the results because it was based on a single patient. The ERG used the cohort simulation presented in the cost-effectiveness model to perform its base-case and additional analyses and to obtain probabilistic results. The ERG amended the company cost-effectiveness model, which resulted in an ERG base-case ICER of £24,711 per QALY gained. In its final guidance, the AC recommended treatment with ticagrelor 60 mg BID + low-dose ASA for secondary prevention of atherothrombotic events in adults who have had an MI and are at increased risk of atherothrombotic events.

A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial.

Written exposure therapy (WET), a 5-session intervention, has been shown to efficaciously treat posttraumatic stress disorder (PTSD). However, this treatment has not yet been directly compared with a first-line PTSD treatment such as cognitive processing therapy (CPT).

Comparison of modified wet suction technique and dry suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for solid lesions: study protocol for a randomized controlled trial.

Several suction techniques have been developed recently to enhance tissue acquisition when sampling solid lesions using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). The aim of this study is to determine whether a new modified wet suction technique (MWST) compared with the conventional dry suction technique (DRST) shall present better outcomes with respect to diagnostic yield and specimen quality of solid lesions in the intra-abdomen and mediastinum.

Effects of two feedback interventions on end-of-life outcomes in nursing home residents with dementia: A cluster-randomized controlled three-armed trial.

Despite increased attention for palliative care in dementia, recent studies found burdensome symptoms and unmet family caregiver needs in the last phase of life. Feedback is being used to improve the quality of palliative care, but we do not know how effective it is.

Assessment of goals and priorities in patients with a chronic condition: a secondary quantitative analysis of determinants across 11 countries.

To assess the impact of patient characteristics, patient-professional engagement, communication and context on the probability that healthcare professionals will discuss goals or priorities with older patients.

Physiology, intervention, and outcome: three critical questions about cerebral tissue oxygen saturation monitoring.

The balance between cerebral tissue oxygen consumption and supply can be continuously assessed by cerebral tissue oxygen saturation (SctO2) monitor. A construct consisting of three sequential questions, targeting the physiology monitored, the intervention implemented, and the outcomes affected, is proposed to critically appraise this monitor. The impact of the SctO2- guided care on patient outcome was examined through a systematic literature search and meta- analysis. We concluded that the physiology monitored by SctO2 is robust and dynamic, fragile (prone to derangement), and adversely consequential when deranged. The inter-individual variability of SctO2 measurement advocates for an intervention threshold based on a relative, not absolute, change. The intra-individual variability has multiple determinants which is the foundation of intervention. A variety of therapeutic options are available; however, none are 100% efficacious in treating cerebral dys-oxygenation. The therapeutic efficacy likely depends on both an appropriate differential diagnosis and the functional status of the regulatory mechanisms of cerebral blood flow. Meta-analysis based on five randomized controlled trials suggested a reduced incidence of early postoperative cognitive decline after major surgeries (RR = 0.53; 95% CI = 0.33-0.87; I2 = 82%; p = 0.01). However, its effects on other neurocognitive outcomes remain unclear. These results need to be interpreted with caution due to the high risks of bias. Quality RCTs based on improved intervention protocols and standardized outcome assessment are warranted in the future.

Cystic Fibrosis Foundation Pulmonary Guidelines: Use of CFTR Modulator Therapy in Patients with Cystic Fibrosis.

CFTR modulators are a new class of medications that target the underlying defect in in cystic fibrosis (CF). Ivacaftor (IVA) and IVA combined with lumacaftor (IVA/LUM) have been approved by the FDA for use in CF patients. However, the FDA label for these medications encompasses patient groups that were not studied as part of the drug approval process. CF clinicians, patients, and their families have recognized a need for recommendations to guide the use of these medications.

Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study.

The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown.

Evaluation Criteria of Noninvasive Telemonitoring for Patients With Heart Failure: Systematic Review.

Telemonitoring can improve heart failure (HF) management, but there is no standardized evaluation framework to comprehensively evaluate its impact.

The effects of functional training, bicycle exercise and exergaming on walking capacity of elderly with Parkinson's disease: a pilot randomized controlled single-blinded trial.

To compare the effects of functional training, bicycle exercise and exergaming on walking capacity of elderly with Parkinson disease (PD).

Preterm Delivery and Future Risk of Maternal Cardiovascular Disease: A Systematic Review and Meta-Analysis.

Preterm delivery (<37 weeks gestational age) affects 11% of all pregnancies, but data are conflicting whether preterm birth is associated with long-term adverse maternal cardiovascular outcomes. We aimed to systematically evaluate and summarize the evidence on the relationship between preterm birth and future maternal risk of cardiovascular diseases.