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1.
Artigo em Inglês | MEDLINE | ID: mdl-33931327

RESUMO

BACKGROUND: The Australian Breast Device Registry (ABDR) is a clinical quality registry designed to monitor the performance of breast devices; and the quality and safety of breast device surgery. OBJECTIVE: To report on breast device surgery characteristics across Australia. METHODS: Participants were registered patients in the ABDR from 2012 to 2018. Results are described using percentages, mean and median. Revision rates were calculated using survival analysis methods. RESULTS: A total of 37,603 patients were registered and had undergone reconstruction (post-cancer 15.1%, risk-reducing mastectomy 3.4% and developmental deformity 2.4%) or cosmetic augmentation (74.7%) procedures. The majority of breast implant devices were silicone filled with textured surface (reconstruction 74.0% and augmentation 64.0%). Sub-pectoral plane was the most common for both reconstruction (60.1%) and augmentation (76.6%) procedures. For reconstruction surgery, the most common surgical incision was previous mastectomy scar (44.0%) and inframammary (31.8%), and for augmentation, it was inframammary (83.4%). Intraoperative/postoperative antibiotic usage for reconstruction was 85.8% and augmentation was 89.4%. Revision incidence due to complication at 12 months post-cancer reconstruction was 5.1%, risk-reducing reconstruction 5.7% and developmental deformity implants 4.5%. Revision incidence due to complication at 12 months after augmentation procedure was 1.1%. Patient-reported outcome measures (PROMs) indicate high levels of satisfaction at 1 year for augmentation and reconstruction procedures. CONCLUSION: We report on early data from the ABDR and reflect on the uptake of the registry by surgeons and patients. The registry also benefits from international collaborative approaches to addressing challenges and is committed to facilitate international post-market surveillance.

2.
Artigo em Inglês | MEDLINE | ID: mdl-33525316

RESUMO

Many Australians are intermittently exposed to landscape fire smoke from wildfires or planned (prescribed) burns. This study aimed to investigate effects of outdoor smoke from planned burns, wildfires and a coal mine fire by assessing biomarkers of inflammation in an exposed and predominantly older population. Participants were recruited from three communities in south-eastern Australia. Concentrations of fine particulate matter (PM2.5) were continuously measured within these communities, with participants performing a range of health measures during and without a smoke event. Changes in biomarkers were examined in response to PM2.5 concentrations from outdoor smoke. Increased levels of FeNO (fractional exhaled nitric oxide) (ß = 0.500 [95%CI 0.192 to 0.808] p < 0.001) at a 4 h lag were associated with a 10 µg/m3 increase in PM2.5 levels from outdoor smoke, with effects also shown for wildfire smoke at 4, 12, 24 and 48-h lag periods and coal mine fire smoke at a 4 h lag. Total white cell (ß = -0.088 [-0.171 to -0.006] p = 0.036) and neutrophil counts (ß = -0.077 [-0.144 to -0.010] p = 0.024) declined in response to a 10 µg/m3 increase in PM2.5. However, exposure to outdoor smoke resulting from wildfires, planned burns and a coal mine fire was not found to affect other blood biomarkers.


Assuntos
Poluentes Atmosféricos , Fogo , Poluentes Atmosféricos/análise , Austrália , Exposição Ambiental/efeitos adversos , Exposição Ambiental/análise , Material Particulado/análise , Material Particulado/toxicidade , Fumaça/efeitos adversos , Fumaça/análise , Austrália do Sul
3.
Aesthet Surg J ; 2020 Dec 08.
Artigo em Inglês | MEDLINE | ID: mdl-33289030

RESUMO

BACKGROUND: Patient Reported Outcome Measures (PROM) are increasingly used in healthcare to assess outcomes. The BREAST-Q Implant Surveillance (BREAST-Q IS) is a 5-question Patient Reported Outcome Measure (PROM) used by the Australian Breast Device Registry (ABDR) to monitor the performance of breast devices. Validation of this tool is needed to assess its utility in this setting. OBJECTIVES: The objective of our study was to assess the test-retest reliability of the BREAST-Q IS among breast implant recipients within a registry setting. METHODS: A test-retest reliability study was undertaken. Patients who had breast augmentation or breast reconstruction and registered with the ABDR were eligible to participate. Two hundred and fifty surveys were distributed. The BREAST-Q IS was administered to the same group of participants on two separate occasions with a 2-week test interval. Participants were divided into two groups, breast augmentation and breast reconstruction. A weighted kappa coefficient was calculated to assess the degree of test-retest reliability of the BREAST-Q IS. RESULTS: Two hundred and seven participants completed both tests. Response rate was 82% (n=113) for the breast augmentation group and 94% (n=94) for the breast reconstruction group. All 5 questions on the BREAST-Q IS obtained weighted kappa scores above 0.74 among both groups. CONCLUSIONS: The BREAST-Q IS has good-to-excellent test-retest reliability for use among breast implant recipients in a registry setting. Further validation of the BREAST-Q IS will be required to establish the BREAST-Q IS as a valid and reliable PROM tool for breast implant recipients following breast device surgery.

5.
JMIR Mhealth Uhealth ; 8(12): e18496, 2020 12 22.
Artigo em Inglês | MEDLINE | ID: mdl-33350962

RESUMO

BACKGROUND: Heart failure decompensation is a major driver of hospitalizations and represents a significant burden to the health care system. Identifying those at greatest risk of admission can allow for targeted interventions to reduce this risk. OBJECTIVE: This paper aims to compare the predictive value of objective and subjective heart failure respiratory symptoms on imminent heart failure decompensation and subsequent hospitalization within a 30-day period. METHODS: A prospective observational pilot study was conducted. People living at home with heart failure were recruited from a single-center heart failure outpatient clinic. Objective (blood pressure, heart rate, weight, B-type natriuretic peptide) and subjective (4 heart failure respiratory symptoms scored for severity on a 5-point Likert scale) data were collected twice weekly for a 30-day period. RESULTS: A total of 29 participants (median age 79 years; 18/29, 62% men) completed the study. During the study period, 10 of the 29 participants (34%) were hospitalized as a result of heart failure. For objective data, only heart rate exhibited a between-group difference. However, it was nonsignificant for variability (P=.71). Subjective symptom scores provided better prediction. Specifically, the highest precision of heart failure hospitalization was observed when patients with heart failure experienced severe dyspnea, orthopnea, and bendopnea on any given day (area under the curve of 0.77; sensitivity of 83%; specificity of 73%). CONCLUSIONS: The use of subjective respiratory symptom reporting on a 5-point Likert scale may facilitate a simple and low-cost method of predicting heart failure decompensation and imminent hospitalization. Serial collection of symptom data could be augmented using ecological momentary assessment of self-reported symptoms within a mobile health monitoring strategy for patients at high risk for heart failure decompensation.


Assuntos
Insuficiência Cardíaca , Telemedicina , Idoso , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Frequência Cardíaca , Hospitalização , Humanos , Masculino , Estudos Prospectivos
7.
Ann Intern Med ; 173(11): 861-869, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-32926799

RESUMO

BACKGROUND: Current pharmacologic therapies for patients with osteoarthritis are suboptimal. OBJECTIVE: To determine the efficacy of Curcuma longa extract (CL) for reducing knee symptoms and effusion-synovitis in patients with symptomatic knee osteoarthritis and knee effusion-synovitis. DESIGN: Randomized, double-blind, placebo-controlled trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000080224). SETTING: Single-center study with patients from southern Tasmania, Australia. PARTICIPANTS: 70 participants with symptomatic knee osteoarthritis and ultrasonography-defined effusion-synovitis. INTERVENTION: 2 capsules of CL (n = 36) or matched placebo (n = 34) per day for 12 weeks. MEASUREMENTS: The 2 primary outcomes were changes in knee pain on a visual analogue scale (VAS) and effusion-synovitis volume on magnetic resonance imaging (MRI). The key secondary outcomes were change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and cartilage composition values. Outcomes were assessed over 12 weeks. RESULTS: CL improved VAS pain compared with placebo by -9.1 mm (95% CI, -17.8 to -0.4 mm [P = 0.039]) but did not change effusion-synovitis volume (3.2 mL [CI, -0.3 to 6.8 mL]). CL also improved WOMAC knee pain (-47.2 mm [CI, -81.2 to -13.2 mm]; P = 0.006) but not lateral femoral cartilage T2 relaxation time (-0.4 ms [CI, -1.1 to 0.3 ms]). The incidence of adverse events was similar in the CL (n = 14 [39%]) and placebo (n = 18 [53%]) groups (P = 0.16); 2 events in the CL group and 5 in the placebo group may have been treatment related. LIMITATION: Modest sample size and short duration. CONCLUSION: CL was more effective than placebo for knee pain but did not affect knee effusion-synovitis or cartilage composition. Multicenter trials with larger sample sizes are needed to assess the clinical significance of these findings. PRIMARY FUNDING SOURCE: University of Tasmania and Natural Remedies Private Limited.

8.
Plast Reconstr Surg ; 146(2): 255-267, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32740572

RESUMO

BACKGROUND: The Poly Implant Prothèse incident and breast implant-associated anaplastic large cell lymphoma have pointed to the need for uniform registries for breast implants as key features to monitoring the outcomes of breast implant surgeries internationally. The purpose of this study was to identify and harmonize common data elements collected by breast implant registries across the International Collaboration of Breast Registry Activities (ICOBRA) global consortium. METHODS: The authors convened an international group of surgeons, consumers, nurses, registry experts, and regulators to review the data points. A modified Delphi approach was applied, to rate the importance of each point on a six-point Likert scale. RESULTS: Data points from six national breast implant registries were divided into categories: clinical, implant-related, patient-reported findings; operation details and implanting technique details; patient characteristics; unique device identifiers; unique patient identifiers; and clinical demographics. A total of 52 data points collected by over 33 percent of national registries were identified. After five rounds, 34 data points formed the final set with agreed definitions. The group recognized the critical importance of additional elements that are currently not uniformly collected (e.g., patient-reported outcomes and long-term data) and set out the process for the dynamic global set updates driven by evidence gaps. CONCLUSIONS: The authors defined internationally agreed on common data elements and definitions used in breast implant registries. This collaboration will allow data sets to be combined, enabling an effective global early warning system of implant-related problems and further work on data sets.


Assuntos
Implantes de Mama/efeitos adversos , Neoplasias da Mama/cirurgia , Consenso , Mamoplastia/efeitos adversos , Sistema de Registros , Congressos como Assunto , Feminino , Saúde Global , Humanos , Incidência , Linfoma Anaplásico de Células Grandes/epidemiologia , Linfoma Anaplásico de Células Grandes/etiologia
9.
Heart Lung Circ ; 29(12): 1782-1789, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32646638

RESUMO

BACKGROUND: Multiple co-morbidities complicate initiation of medical therapy in patients with heart failure with reduced ejection fraction (HFrEF). Adherence to guidelines based on individual patient profiles is not well described. This paper examines the effect of individual patient profiles on guideline recommended therapies for HFrEF. METHODS: This was a prospective, observational, non-randomised study of hospitalised HFrEF patients over 30 days, from 2014 to 2017 in 16 hospitals. A previously developed algorithm-based guideline adherence score was used to determine adherence to key performance indicators: prescribing of beta blockers, angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), mineralocorticoid-receptor antagonist (MRAs) for HFrEF patients and early outpatient and heart failure (HF) disease management program review. Patients were classified as low, moderate and excellent adherence to medical therapy. RESULTS: Of the 696 HFrEF patients, 69.1% (n=481) were male with an average age of 73.15 years (SD±14.5 years). At discharge, 64.6% (n=427) were prescribed an ACEI/ARB, 78.7% (n=525) a beta blocker and 45.3% (n=302) prescribed MRA. Based on individual patient profiles, 18.2% (n=107) of eligible patients received an outpatient clinic and HF disease management program review within 30 days and 41.5% (n=71) were prescribed triple therapy. Based on individual profiles, 13% (n=21) of patients received an excellent guideline adherence score. CONCLUSION: Individual patient profiles impact on adherence to guideline recommendations. Review in transitional care and prescribing of triple pharmacotherapy is suboptimal. Translational strategies to facilitate the implementation of guideline recommended therapies is warranted.

10.
Cochrane Database Syst Rev ; 6: CD012572, 2020 06 10.
Artigo em Inglês | MEDLINE | ID: mdl-32519776

RESUMO

BACKGROUND: Hypertension is an important risk factor for subsequent cardiovascular events, including ischaemic and haemorrhagic stroke, myocardial infarction, heart failure, chronic kidney disease, cognitive decline and premature death. Overall, the use of antihypertensive medications has led to reduction in cardiovascular disease, morbidity rates and mortality rates. However, the use of antihypertensive medications is also associated with harms, especially in older people, including the development of adverse drug reactions, drug-drug interactions and can contribute to increasing medication-related burden. As such, discontinuation of antihypertensives may be considered and appropriate in some older people. OBJECTIVES: To investigate whether withdrawal of antihypertensive medications is feasible, and evaluate the effects of withdrawal of antihypertensive medications on mortality, cardiovascular outcomes, hypertension and quality of life in older people. SEARCH METHODS: The Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to April 2019: the Cochrane Hypertension Specialised Register, CENTRAL (2019, Issue 3), Ovid MEDLINE, Ovid Embase, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also conducted reference checking, citation searches and, when appropriate, contacted study authors to identify any additional studies. The searches had no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of withdrawal versus continuation of antihypertensive medications used for hypertension or primary prevention of cardiovascular disease in older adults (defined as 50 years and over). Participants were eligible if they lived in the community, residential aged care facilities, or were based in hospital settings. We sought to include trials looking at the complete withdrawal of the antihypertensive medication, and those focusing on a dose reduction of the antihypertensive medicine. DATA COLLECTION AND ANALYSIS: We compared the intervention of discontinuing or reducing antihypertensive medication to usual treatment using mean differences (MD) and 95% confidence intervals (95% CIs) for continuous variables and we used Peto odds ratios (ORs) and 95% CI for binary variables. Our primary outcomes included: mortality, myocardial infarction, development of adverse drug reactions or adverse drug withdrawal reactions. Secondary outcomes included: blood pressure, hospitalisation, stroke, success of withdrawing from antihypertensives, quality of life, and falls. Two authors independently, and in duplicate, conducted all stages of study selection, data extraction and quality assessment. MAIN RESULTS: Six RCTs met the inclusion criteria and were included in the review (1073 participants). Study duration and follow-up ranged from 4 weeks to 56 weeks. Meta-analysis of studies showed that, in the discontinuation group compared to continuation, the odds for all-cause mortality were 2.08 (95% CI 0.79 to 5.46; low certainty of evidence), for myocardial infarction 1.86 (95% CI 0.19 to 17.98; very low certainty of evidence) and for stroke 1.44 (95% CI 0.25 to 8.35; low certainty of evidence). Blood pressure was higher in the discontinuation group than the continuation group (systolic blood pressure: MD = 9.75 mmHg, 95% CI 7.33 to 12.18; and diastolic blood pressure: MD = 3.5 mmHg, 95% CI 1.82 to 5.18; low certainty of evidence). For the development of adverse events, meta-analysis was not possible; antihypertensive discontinuation did not appear to increase the risk of adverse events and may lead to resolution of adverse drug reactions, although eligible studies had limited reporting of adverse effects of drug withdrawal (very low certainty of evidence). One study reported hospitalisation with an odds ratio of 0.83 for discontinuation compared to continuation (95% CI 0.33 to 2.10; low certainty of evidence). No studies were identified which reported falls. Between 10.5% and 33.3% of participants in the discontinuation group compared to 9% to 15% in the continuation group experienced raised blood pressure or other clinical criteria (as pre-defined by the studies) that would require restarting of therapy/removal from the study. The sources of bias included selective reporting (reporting bias), lack of blinding of outcome assessment (detection bias), incomplete outcome data (attrition bias), and lack of blinding of participants and personnel (performance bias). AUTHORS' CONCLUSIONS: There is no evidence of an effect of discontinuing compared with continuing antihypertensives used for hypertension or primary prevention of cardiovascular disease in older adults on all-cause mortality and myocardial infarction. The evidence was low to very low certainty mainly due to small studies and low event rates. These limitations mean that we cannot make any firm conclusions about the effect of deprescribing antihypertensives on these outcomes. Future research should focus on populations with the greatest uncertainty of the benefit:risk ratio for use of antihypertensive medications, such as those with frailty, older age groups and those taking polypharmacy, and measure clinically important outcomes such as falls, quality of life and adverse drug events.


Assuntos
Anti-Hipertensivos/uso terapêutico , Hipertensão/tratamento farmacológico , Suspensão de Tratamento , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/efeitos adversos , Viés , Pressão Sanguínea , Causas de Morte , Intervalos de Confiança , Hospitalização/estatística & dados numéricos , Humanos , Hipertensão/complicações , Hipertensão/mortalidade , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/prevenção & controle , Razão de Chances , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Incerteza
11.
Syst Rev ; 9(1): 104, 2020 05 06.
Artigo em Inglês | MEDLINE | ID: mdl-32375867

RESUMO

BACKGROUND: With technological advances, there has been increasing interest in developing contactless and/or non-invasive wearable technologies that continuously monitor vital signs in the clinical setting, and in particular in the deteriorating patient. These devices as of yet have not been well validated in the clinical setting in the clinical ranges observed in a critically unwell patient. We will perform a systematic review of all novel wearable and contactless devices in the clinical setting with focus on degree of novelty and the range of vital signs captured. METHODS: Ovid MEDLINE including Epub Ahead of Print and In-Process & Other Non-Indexed Citations, Ovid Embase, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL) Health Technology Assessment (HTA) database (Ovid), CINAHL with Full Text, searches of the grey literature, cited references of eligible studies through Web of Science, and reference lists of eligible studies will be searched. Outcomes of interest will include the quality of studies in relation to reporting guidelines, limitations of non-invasive technology, and application in different clinical populations. We will perform a qualitative assessment of the novelty of the device and discuss its validation in deteriorating patients. DISCUSSION: While novel monitoring devices are often proposed as a solution to problems with infection, discomfort, and frequency of monitoring in the clinical setting it has not yet been established which devices have been validated in clinical settings in the pathological ranges of vital signs that reflect patient deterioration. It is equally unclear what additional value these devices might provide. This systematic review will synthesize published data regarding devices that have been tested and validated in patients AND in a clinical setting AND in reference ranges that reflect severe illness. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019130091.

13.
Intern Med J ; 2020 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-32043694

RESUMO

BACKGROUND: We identified variation in delivery of guideline recommended care at our institution, and undertook a project to design a HF model of care. AIM: To maximize time patients with HF spend well in the community by delivering best practice guidelines to reduce variation in care improving overall outcomes. METHOD: This quality improvement project focused on reducing variation in process measures of care. The HF model of care included electronic HF care bundles, a patient education pack with staff training on delivering HF patient education, referral of all HF patients to the Hospital Admissions Risk Program for phone call within 72 h, and a nurse-pharmacist early follow-up clinic. Outcomes were assessed using interrupted time series analyses. RESULTS: The pre-intervention group comprised 1585 patients, and post-intervention 1720 patients with a primary diagnosis of HF admitted under general cardiology and general medicine. Interrupted Time Series analysis indicated 30-day readmissions did not change in overall trend (-0.2% per month, p = 0.479) but with significant step-down of 7.8% (p = 0.018). For 90-day readmissions, a significant trend reduction over the time period was seen (-0.6% per month, p = 0.017) with a significant immediate step-down (-9.4%, p = 0.001). Emergency department re-presentations, in-patient mortality and length of stay did not change significantly. Improvements in process measures were seen at audit. CONCLUSION: This model of care resulted in overall trends of reductions in 30 and 90 day readmissions, without increasing ED representations, mortality and length of stay. This model will be adapted to the electronic medical record at our institution. This article is protected by copyright. All rights reserved.

14.
J Clin Monit Comput ; 34(6): 1275-1284, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31792761

RESUMO

Respiratory rate (RR) is one of the most sensitive markers of a deteriorating patient. Despite this, there is significant inter-observer discrepancy when measured by clinical staff, and modalities used in clinical practice such as ECG bioimpedance are prone to error. This study utilized infrared thermography (IRT) to measure RR in a critically ill population in the Intensive Care Unit. This study was carried out in a Single Hospital Centre. Respiratory rate in 27 extubated ICU patients was counted by two observers and compared to ECG Bioimpedance and IRT-derived RR at distances of 0.4-0.6 m and > 1 m respectively. IRT-derived RR using two separate computer vision algorithms outperformed ECG derived RR at distances of 0.4-0.6 m. Using an Autocorrelation estimator, mean bias was - 0.667 breaths/min. Using a Fast Fourier Transform estimator, mean bias was - 1.000 breaths/min. At distances greater than 1 m no statistically significant signal could be obtained. Over all frequencies, there was a significant relationship between the RR estimated using IRT and via manual counting, with Pearson correlation coefficients between 0.796 and 0.943 (p < 0.001). Correlation between counting and ECG-derived RR demonstrated significance only at > 19 bpm (r = 0.562, p = 0.029). Overall agreement between IRT-derived RR at distances of 0.4-0.6 m and gold standard counting was satisfactory, and outperformed ECG derived bioimpedance. Contactless IRT derived RR may be feasible as a routine monitoring modality in wards and subacute inpatient settings.

15.
J Card Fail ; 26(2): 166-179, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31704198

RESUMO

BACKGROUND: Nutraceuticals are pharmacologically active substances extracted from vegetable or animal food and administered to produce health benefits. We recently reviewed the current evidence for nutraceuticals in patients diagnosed with heart failure as part of the writing of the Australian Guidelines for the prevention, diagnosis, and management of heart failure. METHODS: A systematic search for studies that compared nutraceuticals to standard care in adult patients with heart failure was performed. Studies were included if >50 patients were enrolled, with ≥6 months follow-up. If no studies met criteria then studies <50 patients and <6 months follow-up were included. The primary outcomes included mortality/survival, hospitalization, quality of life, and/or exercise tolerance. Iron was not included in this review as its role in heart failure is already well established. RESULTS: Forty studies met the inclusion criteria. The strongest evidence came from studies of polyunsaturated fatty acids, which modestly decreased mortality and cardiovascular hospitalizations in patients with mostly New York Heart Association class II and III heart failure across a range of left ventricular ejection fraction. Coenzyme Q10 may decrease mortality and hospitalization, but definite conclusions cannot be drawn. Studies that examined nitrate-rich beetroot juice, micronutrient supplementation, hawthorn extract, magnesium, thiamine, vitamin E, vitamin D, L-arginine, L-carnosine, and L-carnitine were too small or underpowered to properly appraise clinical outcomes. CONCLUSION: Only one nutraceutical, omega-3 polyunsaturated fatty acid, received a positive recommendation in the Australian heart failure guidelines. Although occasionally showing some promise, all other nutraceuticals are inadequately studied to allow any conclusion on efficacy. Clinicians should favor other treatments that have been clearly shown to decrease mortality.

16.
Hypertension ; 75(1): 23-32, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31786973

RESUMO

Current cardiovascular pharmacotherapy targets maladaptive overactivation of the renin-angiotensin-aldosterone system (RAAS), which occurs throughout the continuum of cardiovascular disease spanning from hypertension to heart failure with reduced ejection fraction. Over the past 16 years, 4 prospective, randomized, placebo-controlled clinical trials using candesartan, perindopril, irbesartan, and spironolactone in patients with heart failure with preserved ejection fraction (HFpEF) failed to demonstrate increased efficacy of RAAS blockade added to guideline-directed medical therapy. We reappraise these trials and their weaknesses, which precluded statistically significant findings. Recently, dual-acting RAAS blockade with sacubitril-valsartan relative to stand-alone valsartan failed to improve outcome in the PARAGON-HF trial (Efficacy and Safety of LCZ696 Compared with Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction). The majority of patients with HFpEF experience hypertension, frequently with subclinical left ventricular dysfunction, contributed to by comorbidities such as coronary disease, diabetes mellitus, overweight, and atrial fibrillation. Contrasting the findings in HFpEF, trials evaluating RAAS blockade on either side of HFpEF on the cardiovascular continuum in patients with high-risk hypertension and heart failure with reduced ejection fraction, respectively, showed positive outcomes. We do not have a biologically plausible explanation for such divergent efficacy of RAAS blockade. Based on considerations of well-established clinical efficacy in hypertension and heart failure with reduced ejection fraction and the shortcomings of aforementioned clinical trials in HFpEF, we argue that RAAS blockers including MRAs (mineralocorticoid receptor antagonists; aldosterone antagonists) should be used in the treatment of patients with HFpEF.


Assuntos
Antagonistas de Receptores de Angiotensina/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Sistema Renina-Angiotensina/efeitos dos fármacos , Volume Sistólico/efeitos dos fármacos , Antagonistas de Receptores de Angiotensina/farmacologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Antagonistas de Receptores de Mineralocorticoides/farmacologia , Volume Sistólico/fisiologia
17.
Plast Reconstr Surg Glob Open ; 7(8): e2348, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31592377

RESUMO

Breast device registries monitor devices encompassing breast implants, tissue expanders and dermal matrices, and the quality of care and patient outcomes for breast device surgery. Defining a standard set of quality indicators and risk adjustment factors will enable consistency and adjustment for case-mix in benchmarking quality of care across breast implant registries. This study aimed to develop a set of quality indicators to enable assessment and reporting of quality of care for breast device surgery which can be applied globally. Methods: A scoping literature review was undertaken, and potential quality indicators were identified. Consensus on the final list of quality indicators was obtained using a modified Delphi approach. This process involved a series of online surveys, and teleconferences over 6 months. The Delphi panel included participants from various countries and representation from surgical specialty groups including breast and general surgeons, plastic and reconstructive surgeons, cosmetic surgeons, a breast-care nurse, a consumer, a devices regulator (Therapeutic Goods Administration), and a biostatistician. A total of 12 candidate indicators were proposed: Intraoperative antibiotic wash, intraoperative antiseptic wash, preoperative antibiotics, nipple shields, surgical plane, volume of implant, funnels, immediate versus delayed reconstruction, time to revision, reoperation due to complications, patient satisfaction, and volume of activity. Results: Three of the 12 proposed indicators were endorsed by the panel: preoperative intravenous antibiotics, reoperation due to complication, and patient reported outcome measures. Conclusion: The 3 endorsed quality indicator measures will enable breast device registries to standardize benchmarking of care internationally for patients undergoing breast device surgery.

18.
J Patient Rep Outcomes ; 3(1): 63, 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31641976

RESUMO

BACKGROUND: To examine the acceptability of a Patient Reported Outcome Measure (PROM) that assesses perceptions and experiences of implants for breast reconstruction or augmentation, and the feasibility of implementing it in the Australian Breast Device Registry (ABDR). METHODS: The BREAST-Q Implant Surveillance (BREAST-Q IS) is a 5-question PROM derived from the BREAST-Q questionnaire. It assesses perceptions of breast appearance and sensation, and experiences of pain. Breast implant recipients (recruited via community networks, social media and notices in surgeons' rooms) and surgeons contributing to the ABDR were invited to review the BREAST-Q-IS. Participation was by individual semi-structured interviews by telephone or email, or by completion of a paper questionnaire. Transcripts of audio recordings and emailed text were analysed thematically. RESULTS: Twenty one breast implant recipients (10 after reconstruction and 11 augmentation), 8 surgeons (five plastic, three breast) and 2 medical professionals performing cosmetic surgeries were interviewed. Six themes were identified: Overall impression, Emotional response to the BREAST-Q IS, Method of follow-up, Suggested improvements, Group variation, and Potential Clinical utility. Overall, breast implant recipients and surgeons found the BREAST-Q IS to be acceptable and unlikely to provoke strong emotional reactions. Email was the preferred mode of contact. Most suggested improvements were to add questions. Surgeons expressed concern that subjective responses to the PROM might not accurately reflect experiences and that the PROM would predict need for revision rather than device failure. CONCLUSION: This study supports the acceptability and feasibility of BREAST-Q IS as a PROM for recipients of breast implants. Further validation of the Breast-Q IS is required.

20.
Am J Ther ; 26(6): e671-e678, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31145139

RESUMO

BACKGROUND: Many patients with heart failure (HF) are treated with warfarin or non-vitamin K oral anticoagulants (NOACs). Randomized outcome-driven comparisons of different anticoagulant strategies in HF are lacking. Data from international, government-mandated registries may be useful in understanding the real-life use of various anticoagulants and how they are linked to outcomes. STUDY QUESTION: To assess 2015 annual all-cause mortality, myocardial infarction, and stroke rates co-reported for warfarin and NOACs in subjects with and without HF in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. STUDY DESIGN: We extracted and examined outcome cases in subjects with HF and on warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban and stratified these according to anticoagulants. MEASURES AND OUTCOMES: Annual all-cause mortality, myocardial infarction, and stroke in FAERS. ANALYSIS METHOD: Odds ratio (OR) and χ(Equation is included in full-text article.)for oral anticoagulants from FAERS with and without HF among complete primary reports issued in 2015. RESULTS: FAERS reported 137,026 HF cases, with death co-reported in 42,942 (31.3%). In total, 11,278 (8.2%) HF patients were treated with anticoagulants, with more prescribed warfarin (n = 8260) than all NOACs combined (n = 3018). Very few reports for edoxaban were available. Warfarin consistently displayed a signal for excess adverse events compared to NOACs: OR (95% confidence interval) for the composite of mortality, myocardial infarction, and stroke were 1.91 (1.76-2.07) versus apixaban, 1.92 (1.81-2.03) versus dabigatran, 4.09 (3.38-4.37) versus rivaroxaban, and 2.64 (2.53-2.76) versus all NOACs combined (all P < 0.001). Warfarin, compared to all NOACs combined, demonstrated higher rates of all-cause mortality [OR = 2.69 (95% confidence interval, 2.49-2.90)], myocardial infarction [5.30 (4.17-6.74)], stroke [OR = 8.85 (6.61-11.84)], and ischemic stroke [OR = 12.73 (8.87-18.27); all P < 0.001]. CONCLUSIONS: Annual 2015 FAERS profiles in HF patients reveal that warfarin was numerically dominant. Warfarin was associated with higher risk of death, myocardial infarction, and stroke compared to NOACs. These observational data provide real-world insight into a potential safety benefit of NOACs over warfarin in the setting of HF.


Assuntos
Anticoagulantes/efeitos adversos , Insuficiência Cardíaca/tratamento farmacológico , Varfarina/efeitos adversos , Administração Oral , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Feminino , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Infarto do Miocárdio/complicações , Infarto do Miocárdio/epidemiologia , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/epidemiologia , Resultado do Tratamento , Estados Unidos/epidemiologia , United States Food and Drug Administration , Vitamina K/antagonistas & inibidores , Varfarina/uso terapêutico
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