•The Supportive Therapy in Androgen Deprivation Clinic was well attended by patients.•No differences were seen in the outcomes between the intervention arm and control.•Study under accrued, thus how ...to reach a broader population must be explored.
Androgen deprivation therapy (ADT) is associated with numerous toxicities that are potentially modifiable. We sought to evaluate the impact of participation in a multidisciplinary clinic, STAND (Supportive Therapy in Androgen Deprivation) Clinic, designed to provide individualized lifestyle modification and management of ADT-related side effects.
This phase II study recruited men with prostate cancer who had started ADT <6 months prior to enrollment, and in whom ADT was planned for at least 12 months following enrollment. Patients were randomized in a 1:1 ratio to either the STAND Clinic or usual care. Patients randomized to the STAND Clinic were provided monthly multidisciplinary assessment and counseling on exercise, nutrition, and symptom management for 12 months on a rotating schedule. Primary outcome was change from baseline to 12 months in percent body fat. Feasibility outcomes were also assessed by measuring percentage of completed visits. Secondary outcomes included change from baseline to 12 months in 3 domains: (1) metabolic impact and bone health, (2) quality of life (QOL), and (3) physical activity.
A total of 25 men were randomized to STAND clinic, and 23 were randomized to usual care. The study did not meet its accrual target of 32 men in each arm and was closed early due to lack of financial support. Overall, 91% (295 of 325) of STAND clinic visits were completed. Eighteen out of the 25 patients in STAND clinic arm (72%) completed all 12 months of STAND clinic visits, and 80% (20 of 25) completed the first 6 months. For all primary and secondary outcomes, there were no statistically significant differences between treatment arms.
Individualized and comprehensive management of ADT toxicities in a multidisciplinary clinic was well attended by patients. However, we did not find any differences in the outcomes assessed between the intervention arm and control.
Myelodysplastic syndromes (MDS) and myeloproliferative syndromes (MPS) of childhood are a heterogeneous group of clonal disorders of hematopoiesis with overlapping clinical features and inconsistent ...nomenclature. Although a number of genetic conditions have been associated with MDS and MPS, the overall contribution of inherited predispositions is uncertain. We report a retrospective study examining clinical features, genetic associations, and outcomes in 167 children with MDS and MPS. Of these patients, 48 had an associated constitutional disorder. One hundred one patients had adult-type myelodysplastic syndrome (A-MDS), 60 had juvenile myelomonocytic leukemia (JMML), and 6 infants with Down syndrome had a transient myeloproliferative syndrome (TMS). JMML was characterized by young age at onset and prominent hepatosplenomegaly, whereas patients with A-MDS were older and had little or no organomegaly. The most common cytogenetic abnormalities were monosomy 7 or del(7q) (53 cases); this was common both in patients with JMML and those with A-MDS. Leukemic transformation was observed in 32% of patients, usually within 2 years of diagnosis. Survival was 25% at 16 years. Favorable prognostic features at diagnosis included age less than 2 years and a hemoglobin F level of less than 10%. Older patients tended to present with an adult-type MDS that is accommodated within the French-American-British system. In contrast, infants and young children typically developed unique disorders with overlapping features of MDS and MPS. Although the type and intensity of therapy varied markedly in this study, the overall outcome was poor except in patients with TMS.
Staphylococcus aureus (S. aureus) is the leading cause of nosocomial infections and responsible for more than 11 million skin and soft tissue infections annually. Impetigo is a common skin infection ...and the most common bacterial skin infection in children aged two to five years. The emergence of S. aureus isolates resistant to commonly utilized antibacterials for skin infections (beta-lactams, erythromycin, fluoroquinolones and mupirocin) makes successful treatment an ongoing challenge. To treat skin infections such as impetigo, antibacterials with a short dosing schedule and low propensity to develop resistance should be used. In 2007, retapamulin was the first agent for human use approved in the pleuromutilin class of antibacterials in the United States (U.S.), and is the first topical antibacterial indicated to treat impetigo in over 20 years. In vitro, retapamulin is highly potent against S. aureus and has a lower propensity to develop resistance than mupirocin. In clinical studies, the convenient five-day b.i.d. (twice-daily) dosing of retapamulin is highly effective against impetigo due to methicillin- susceptible S. aureus and Streptococcus pyogenes and may play an important role in limiting the development of resistance against systemic agents.
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Background: We evaluated the feasibility and efficacy of a decision support intervention designed to help men with low-risk prostate cancer consider active surveillance and standard ...treatments. The intervention incorporated a decision aid with coaching and question-listing. Our decision aid is the first to include data on long-term survival and side effects from men with prostate cancer undergoing active surveillance, surgery, and radiation. Methods: To develop the intervention, we conducted focus groups using the Nominal Group Technique. We used a survey instrument from the International Patient Decision Aids Standards to measure the stakeholder endorsement of our intervention. To test the intervention, we administered it to newly diagnosed men with low-risk prostate cancer (Gleason sum < = 3+4, stage < = T2N0M0, PSA < = 10 ng/ml) seen at UCSF. Before and after the intervention, we administered a survey with questions from the Decision Quality Instrument for Prostate Cancer. Our primary outcome was change in knowledge as assessed by two multiple-choice items: How many men diagnosed with early stage prostate cancer will eventually die of prostate cancer? How much would waiting 3 months to make a treatment decision affect chances of survival? Correct answers were: “Most will die of something else” and “A little or not at all.” Results: The development phase involved 6 patients, 1 family member, 2 physicians, and 5 other health care providers and four iterations of the intervention until consensus endorsement was reached. In the pilot test, 57 men consented, and 44 received the decision support intervention and completed surveys at both timepoints. Before the intervention, 30/44 (68%) got both questions right, compared to 36/44 (82%) after the intervention. 82% maintained or achieved perfect scores; 16% answered 1 or more incorrectly both before and after the intervention; and 2% answered both items correctly before, but 1 wrong after. Conclusions: This novel decision support intervention was feasible, and appeared to improve knowledge and informed decision-making. Data will guide the development of a larger scale randomized clinical trial to improve decision quality in men with prostate cancer, in the community. Clinical trial information: NCT02451345.
Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical ...features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular artery FMD involvement in isolation (OR=2.31, p<0.0001) or a history of previous intervention for FMD (OR=1.52, p=0.036). A greater number of anti-HTN medications was evident in isolated renal versus isolated cerebrovascular FMD patients. Factors associated with a greater number of anti-HTN medications were older age (OR=1.03 per year, p<0.0001), history of HTN (OR=24.04, p<0.0001), history of CAD (OR=2.71, p=0.0008) and a history of a previous therapeutic procedure (OR=1.72, p=0.001). In conclusion, in FMD, medication use varies based on vascular bed involvement. Isolated renal FMD patients receive more anti-HTN agents and there is greater anti-platelet agent use among patients with cerebrovascular FMD. Further studies correlating medication use in FMD with clinically meaningful patient outcomes are necessary.
The treatment of cutaneous fungal infections has been shown to be directly affected by the extent of patients' adherence to therapy regimens that are often cumbersome and last for several weeks. One ...useful alternative approach is once-daily dosing of topical antifungal agents rather than the traditional twice-daily regimen, an example of what has been called a "forgiving" regimen, designed to promote patient adherence. Sertaconazole, an imidazole antifungal agent, is known to be safe and effective when used twice daily in the treatment of tinea pedis. This report discusses a small (n=32) clinical trial designed to determine whether sertaconazole nitrate 2% cream, used once daily, is as effective as the traditional regimen. Results demonstrated that sertaconazole is as effective when used once daily for four weeks. Patients showed rapid improvement in pruritus as early as week 2, and at six weeks' follow up, all patients were free of erythema while 93.8 percent were free of pruritus; no relapses had occurred. These encouraging findings suggest that sertaconazole nitrate may be useful in a once-daily regimen and also may result in better patient adherence to therapy.
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Background: Androgen deprivation therapy (ADT) is associated with numerous metabolic toxicities that are potentially modifiable. We sought to evaluate the impact of participation in ...a multidisciplinary clinic (MDC) designed to provide individualized lifestyle modification and management of ADT-related side effects. Methods: This phase II study recruited men with prostate cancer who had started ADT < 6 months prior to enrollment, and in whom ADT was planned for at least 12 months following enrollment. Patients were randomized in a 1:1 ratio to either the MDC or standard of care (SOC). Patients randomized to the MDC were provided monthly multidisciplinary assessment and counseling on exercise, nutrition, and symptom management for 12 months on a rotating schedule. Endpoints included feasibility endpoints (proportion of visits completed), and efficacy endpoints, including mean change from baseline to 12 months in blood pressure (BP), weight, waist circumference, percent body fat, hemoglobin A1C (HbgA1C), insulin resistance, and fasting lipids. Results: 25 men were randomized to MDC, and 23 were randomized to SOC. Overall 91% (295/325) of MDC visits were completed. 72% (18/25) of patients completed all 12 months of MDC, and 80% (20/25) completed the first 6 months. Compared to SOC, patients in the MDC arm had a trend towards more favorable mean percent change from baseline to 12-month follow up in systolic BP (6.5% vs. 10.3%), diastolic BP (-3.9% vs.10.0%), waist circumference (2.5% vs. 4.0%), HbA1C (-2.4% vs. -1.7%), insulin resistance (0.5% vs. 1.9%), and fasting lipids (total cholesterol: 7.0% vs. 21.8%; LDL: -2.9% vs. 7.6%; triglyceride: 15.5% vs. 37.2%). Conclusions: Individualized and comprehensive management of toxicities of ADT in a multidisciplinary clinic is feasible, and appears to provide some benefit over SOC. Larger randomized studies are warranted to investigate whether this intervention will provide lasting benefit. Clinical trial information: NCT02168062.
Mechanical thrombectomy provides rapid hemodynamic improvements after acute pulmonary embolism (PE), but long-term benefits are uncertain.
FlowTriever All-comer Registry for Patient Safety and ...Hemodynamics is a prospective, single-arm, multicenter registry of patients with acute PE treated with the FlowTriever System (Inari Medical). Six-month outcomes including modified Medical Research Council dyspnea scores (MMRCD), right ventricular (RV) function, 6-minute walk test distances, and PE quality-of-life scores (QoL) were assessed.
In total, 799 patients were enrolled and 75% completed the study with a mean follow-up of 204 ± 46 days. Demographic characteristics included 54.1% men, mean age of 61.2 years, 77.1% intermediate-high-risk PE, and 8.0% high-risk PE. All-cause mortality was 4.6% at study completion. The proportion of patients with normal echocardiographic RV function increased from 15.1% at baseline to 95.1% at 6 months (P < .0001). MMRCD score improved from 3.0 at baseline to 0.0 at 6 months (P < .0001). 6-minute walk test distances increased from 180 m at 48 hours to 398 m at 6 months (P < .001). Median PE QoL total scores were 9.38 at 30 days and 4.85 at 6 months (P < .001). Prevalence of site-reported chronic thromboembolic pulmonary hypertension was 1.0% and chronic thromboembolic disease was 1.9%.
In this large diverse group of PE patients, 6-month all-cause mortality, chronic thromboembolic pulmonary hypertension, and chronic thromboembolic disease were low following thrombectomy with the FlowTriever system. Significant improvements in RV function, patient symptoms, exercise capacity, and QoL were observed at 6 months, suggesting that rapid extraction of thrombus may prevent long-term sequelae in patients with PE.
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•FlowTriever All-comer Registry for Patient Safety and Hemodynamics pulmonary embolism outcomes are reported at 6 months postthrombectomy.•All-cause mortality was 4.6% (29/628) and long-term pulmonary embolism sequelae were infrequent.•At the 6-month visit, multiple clinical and functional improvements were reported.•95.1% had normal right ventricular function on echo and 90.1% had no or only mild dyspnea symptoms.•Median 6-minute walk test distance was 398 m and median total Pulmonary Embolism quality-of-life score was 4.85.•Improvements were predominantly achieved within 30 days and maintained to 6 months.
