Advance Care Planning in Community-Dwelling Patients With Dementia

Context

Little is known about advance care planning (ACP) among community-dwelling patients with dementia.

A randomized,double-blind, 3-way crossover,analog classroom study of SHP465 mixed amphetamine salts extended-release in adolescents with ADHD

Objectives: To evaluate the duration of efficacy, safety, and tolerability of SHP465 mixed amphetamine salts (MAS) extended-release versus placebo and immediate-release MAS (MAS IR) in adolescents with attention-deficit/hyperactivity disorder (ADHD).

Methods: This phase 2, randomized, 3-period, 3-treatment crossover study compared SHP465 MAS (25/50 mg) with placebo and MAS IR (12.5 mg) in 13–17-year-old adolescents with ADHD having ADHD Rating Scale, Version IV (ADHD-RS-IV) total scores ≥24. A laboratory classroom served as a controlled environment during 16-hour observations, with efficacy assessed on the last day of each 7-day treatment period. The primary efficacy analysis compared SHP465 MAS with placebo on Permanent Product Measure of Performance (PERMP) total score averaged over the 16-hour postdose period using a mixed linear model. Comparisons were also conducted between MAS IR and placebo (for assay sensitivity) and between SHP465 MAS and MAS IR. PERMP problems attempted and answered correctly and ADHD symptoms based on ADHD-RS-IV; participant self-report; Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale; and Revised Conner’s Parent Rating Scale scores were also evaluated. Safety and tolerability assessments included treatment-emergent adverse events and vital signs.

Results: The intent-to-treat population included 84 participants. Least squares mean (95% CI) PERMP total score treatment differences significantly favored SHP465 MAS (combined 25/50 mg) over placebo for the average of all postdose assessment time points (41.26 [32.24, 50.29]; P < 0.0001) and each postdose assessment time point (all P < 0.0001). Similar results were observed for MAS IR versus placebo (all postdose assessment time points averaged: nominal P < 0.0001; each postdose assessment time point: all nominal P < 0.004). The safety and tolerability of SHP465 MAS were consistent with previous reports.

Conclusions: SHP465 MAS significantly improved PERMP total scores versus placebo from 2 to 16 hours postdose in adolescents with ADHD. The safety and tolerability profile of SHP465 MAS was consistent with previous reports of SHP465 MAS in individuals with ADHD.     

The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals

Introduction

Educational brochures are an important tool for communicating risk to health-care professionals. It is important to evaluate the impact of any risk minimization tool to understand the effectiveness of the strategy. The objective of this study was to assess the effectiveness (i.e., respondents’ awareness and understanding of the communication) of a targeted educational brochure distributed to health-care professionals (HCPs) as a risk minimization strategy for the communication of new rare and important adverse events (AEs).

Methods

A prospective, non-interventional, online survey was performed following distribution of a specifically designed brochure highlighting new and important adverse events to a targeted HCP population, consisting of known users of the target medicine, as represented by a commercial database. Predefined multiple-choice survey questions assessed overall HCP awareness of the brochure and understanding and retention of information in those HCPs who reported receiving the brochure.

Results

The educational brochure was sent to a total of 565 HCPs; 121 (21.4%) responded to the survey. The majority of respondents (95.0%) had previously prescribed or dispensed the target medicine. In all, 88 (72.7%) respondents said they had received the educational brochure, of whom 95.5% stated they had at least scanned the main points. More participants who had received the brochure (86.4% to 96.6%) answered the five individual survey questions correctly compared with those who did not (51.5% to 97.0%); this was significant for four out of five questions (P ≤ 0.005). Significantly more HCPs who received the brochure achieved the predefined pass rate (at least four of five questions answered correctly) compared with HCPs who did not receive the brochure (93.2% vs 57.6%, respectively; P = 0.000003).

Conclusions

Distribution of targeted educational brochures may be an effective risk minimization strategy to raise HCP awareness of new rare and important AEs; educational brochures may also be an effective channel for sharing information on how these AEs can be best managed and on the importance and means of reporting AEs.

Funding

Celgene Pty Ltd, Melbourne, Australia.

     

Abnormal performance of cervical stabilizer muscles in individuals with low back pain

Objectives: To compare the performance of cervical stabilizer muscles using the craniocervical flexion test (CCFT) among individuals with subacute, chronic, and asymptomatic low back pain (LBP) conditions.

Methods: Individuals with subacute (N = 23) and chronic LBP (N = 23) with their age- and gender-matched controls (N = 30) participated in this study. All recruited participants were required to perform the CCFT. The activation score (AS) and the performance index (PI) were recorded by an assessor who was blinded to the group of participants.

Results: Approximately, 74% of subacute LBP participants and 60–65% of chronic LBP participants obtained abnormal AS and PI. AS was significantly lower in participants with subacute (P = 0.0002) and chronic LBP (P = 0.0009) than the control group. Likewise, the PI was significantly lower in participants with subacute (P = 0.0002) and chronic LBP (P = 0.0036) than the control group. Participants in the subacute LBP group showed significantly greater percentages of abnormal responses on the AS (P < 0.0001) and the PI (P = 0.0001) than the control.

Discussion: Abnormal performance of cervical stabilizer muscles using the CCFT was demonstrated in a high proportion of participants with LBP. The findings highlight the plausible association in muscle control between cervical and lumbar stabilizers.

Level of Evidence: 2b.     

Evaluation of left gastric vein in Chinese healthy adults with multi-detector computed tomography

Objectives: To evaluate the classification and diameter of left gastric vein (LGV) in healthy Chinese adults with multi-detector computed tomography (MDCT).

Methods: MDCT angiography was performed in 234 healthy adults for the portal venous system. CT cross-sectional thin-layer reconstruction combined with maximum intensity projection, volume rendering and multiplanar reconstruction were applied. The diameter of LGV was measured at the point within 2 cm from LGV origination.

Results: Of 234 subjects, 11 subjects (4.70%) who did not have clear images were excluded, and 223 subjects (95.30%) with excellent images were included. The LGV was originated from the portal vein in 46.15%, splenic vein in 30.77%, portal splenic angle in 14.53%, and the left branch of the portal vein in 3.85%. The maximal diameter of LGV was 4.74 ± 0.84 mm with a 95% confidence interval of 4.63–4.85 mm, and the LGV diameter was positively correlated with the weight of patients (R = 0.26, P = 0.006). No significant difference existed in the maximal diameter of LGV at different origination sites (P = 0.35). The diameter of LGV was significantly greater in males than in females (4.90 ± 0.85 vs. 4.56 ± 0.80 mm, P = 0.002), and the maximal diameter of LGV was significantly (P = 0.02) greater in the age range of 30–39 and 40–49 years than in the range of >70 years. No statistical significance (P = 0.36) was detected in the other groups.

Conclusion: MDCT can clearly display the detailed anatomy and variation of LGV in healthy adults, providing a normal range of LGV diameter for clinical reference for diagnosing possible portal hypertension and for possible intervention.     

Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies

Objectives: Development of therapies for systemic lupus erythematosus (SLE) has in part been limited by the lack of suitable outcome measures in clinical trials. In the present post-hoc analysis of two clinical trials of belimumab, we investigated two potential outcomes, the Lupus Low Disease Activity State (LLDAS) and clinical SLE disease activity index 2000 (cSLEDAI-2K) zero, in relation to SLE responder index 4 (SRI-4).

Methods: A total of 1684 SLE patients from the BLISS-52 (n = 865) and BLISS-76 (n = 819) trials were surveyed. Physician’s Global Assessment (PGA) scores <0.5 (3-point scale) were used for comparisons. We used the chi-square test for comparisons and the phi coefficient for correlations.

Results: At week 52, LLDAS was achieved by 8.6% of patients, cSLEDAI-2K = 0 by 34.5% and SRI-4 by 45.1%. cSLEDAI-2K = 0 showed the strongest correlation with PGA <0.5 (r_φ = 0.36, P < 0.001). cSLEDAI-2K = 0 unveiled the superiority of belimumab 10 mg/kg over placebo (P = 0.003) with a magnitude which was comparable to that of SRI-4 (P < 0.001). LLDAS displayed a more moderate separation (P = 0.033).

Conclusions: LLDAS was a stringent measure. cSLEDAI-2K = 0 showed the strongest correlation with the clinician-based evaluation. Being based on the SLEDAI-2K only, cSLEDAI-2K = 0 may be considered a more pragmatic outcome measure in SLE studies compared with composite tools.     

Effects of SHP465 mixed amphetamine salts in adults with ADHD in a simulated adult workplace environment

Objectives: Evaluate the efficacy, duration of effect, and safety of 25 mg SHP465 mixed amphetamine salts (MAS) extended-release versus placebo in adults with attention-deficit/hyperactivity disorder (ADHD).

Methods: Adults (18–55 years) with ADHD and with ADHD Rating Scale-IV (ADHD-RS-IV) scores ≥24 were randomized to treatment in a double-blind, 2-period, 2-treatment crossover study utilizing the Adult Workplace Environment (AWE), as described by Wigal and Wigal (J Atten Disord 2006;10:92–111). On day 7 of each 7-day treatment period, efficacy was assessed during a 16.5-hour postdose period. The primary endpoint, Permanent Product Measure of Performance (PERMP) total score, was analyzed in the intent-to-treat population using a mixed linear model of analysis of variance. Secondary endpoints, for which the study was not powered, included PERMP problems attempted and answered correctly, ADHD clinician ratings based on counselor observations and inputs during the Time Segment Rating System (Co-ADHD-RS TSRS), and the ADHD self-rating scale (ADHD-SRS). Safety and tolerability assessments included treatment-emergent adverse events (TEAEs) and vital signs.

Results: The least squares mean (95% CI) treatment difference (SHP465 MAS–placebo) for PERMP total score significantly favored SHP465 MAS over placebo when averaged across all postdose assessments (19.29 [10.95, 27.63]; P < 0.0001), with significant treatment differences favoring SHP465 MAS over placebo observed at 4–16 hours postdose (all P < 0.01). TEAEs observed with SHP465 MAS (≥5% of participants) included insomnia, decreased appetite, dry mouth, headache, and anorexia. Mean pulse and blood pressure increases with SHP465 MAS exceeded those of placebo.

Conclusions: SHP465 MAS (25 mg) was superior to placebo on PERMP total score, with treatment differences observed from 4 to 16 hours postdose; nominal treatment differences on the ADHD-SRS, but not the Co-ADHD-RS TSRS, were also observed. The safety and tolerability profile of SHP465 MAS was similar to previous reports for SHP465 MAS and other long-acting stimulants.

Clinical trials registry: clinicaltrials.gov (NCT00202605; https://clinicaltrials.gov/ct2/show/NCT00202605)     

超声内镜诊断胰胆管合流异常

目的 观察超声内镜（EUS）诊断胰胆管合流异常（PBM）的价值。方法 纳入45例疑诊PBM患者，其中25例入院后经内镜逆行胰胆管造影（ERCP）（n=4）或手术（n=21）确诊PBM。以ERCP或手术结果为金标准，评价EUS诊断PBM的效能，并与经腹超声、CT及MRI进行比较。结果 45例中，EUS示25例PBM，其中1例经手术排除PBM；EUS结果显示20例阴性，其中1例经手术确认PBM。EUS诊断PBM的敏感度、特异度、阳性预测值、阴性预测值及准确率分别为96.00%（24/25）、95.00%（19/20）、96.00%（24/25）、95.00%（19/20）及95.56%（43/45）。EUS诊断PBM的效能与经腹超声、CT、MRI诊断PBM差异均有统计学意义（P均<0.01）。EUS诊断PBM与ERCP/手术的一致性较好（Kappa=0.910，P<0.001），而与MRI的一致性较差（Kappa=0.393，P<0.05）。结论 EUS诊断PBM的价值较高，可作为疑似PBM的首选影像学检查手段。     

Familial Hemolytic Jaundice Complicated by Acute Purulent Cholecystitis

Objective: Our aim was to explore how differing attitudes, expectations, and experiences among people with obesity (PwO) and healthcare providers (HCPs) might have an impact on effectively implementing current obesity treatment guidelines.

Methods: Online surveys were conducted among 3,008 adult PwO (BMI≥30 by self-reported height and weight) and 606 HCPs.

Results: PwO with weight loss ≥ 10% during the previous three years were more likely to have been diagnosed with obesity and to have discussed a weight loss plan with an HCP. However, only 21% believe HCPs have a responsibility to actively contribute to their obesity treatment. Further, HCPs tend not to effectively communicate the diagnosis of obesity, its nature as a serious and chronic disease, the full range of treatment options, and obesity’s implications for health and quality of life.

Regarding treatment goals, HCPs more often focus on BMI reduction, while PwO’s goals focus on improved functioning, energy, and appearance. HCPs also tend to underestimate their patients’ motivation to address their obesity. Twenty-eight percent of HCPs ‘completely agreed’ that losing weight was a high priority for PwO, whereas more than half of PwO ‘completely agreed’ that losing weight was a high priority for them. When asked how their HCP could better support them, PwO most often expressed a desire for helpful resources, as well as assistance with specific and realistic goal-setting to improve health.

Conclusions: HCPs can more effectively implement obesity treatment guidelines by more clearly and proactively communicating with PwO about their diagnosis, health implications of obesity, desired treatment goals, and the full range of treatment options. HCPs should understand that most PwO believe that managing their disease is solely their own responsibility. HCPs can also encourage more effective conversations by better appreciating their patients’ motivation and treatment goals.     

Preparation and storage characteristics of white cell-reduced high-concentration platelet concentrates collected by anapheresis system for transfusions in utero

BACKGROUND: Important concerns with regard to in utero platelet transfusions are avoidance of volume overload and the immunomodulatory effects of residual white cells (WBCs). This study evaluated a modification of a leukocyte‐reduction system (LRS, Spectra, COBE BCT) for apheresis, which collects high‐concentration WBC‐reduced platelets (HCPs) for in utero transfusion. STUDY DESIGN AND METHODS: The LRS procedure was modified by running the platelet collection pump at specified low flow rates (Q_col) for the first part of the procedure, collecting HCPs by gently purging them from the LRS chamber into a designated collection bag and then restoring the original LRS procedure settings to collect a second standard apheresis platelet concentrate (PC). Two centers carried out 32 procedures. Platelet yield, residual WBCs, and in vitro platelet function studies were evaluated. RESULTS: Platelet concentrations in 60 mL of HCPs were predictable according to Q_col (r² = 0.735). HCP yields varied from 0.9 to 3.2 × 10¹¹, depending on the desired final platelet concentrations in 60 mL, with an overall average of 1.92 × 10¹¹ (n = 32). Apheresis PCs had a mean platelet yield of 2.9 × 10¹¹ (1.3‐4.4 × 10¹¹, n = 20) and 3.9 × 10¹¹ (2.2‐5.8 × 10¹¹, n = 12) at concentrations of 1.3 × 10¹² per L for single‐needle and dual‐ needle procedures, respectively. Median WBC counts were 5.6 × 10³ for HCPs and 2.0 × 10⁴ for apheresis PCs, with >99 percent expected to be less than 1 × 10⁶. HCP in vitro characteristics were equivalent to those of apheresis PCs at 24 hours after collection. In vitro performance declined over storage as a function of HCP yield. HCP pH at 22^oC was maintained at a level of >6.2 for more than 3 days for yields >1.6 × 10¹¹, less than 2 days for yields 1.6 to 2.2 × 10¹¹, and less than 24 hours for yields >2.2 × 10¹¹. HCPs showed good in vitro characteristics and could be stored for 1 to 3 days, depending on the total number of platelets collected. CONCLUSION: A standard apheresis PC and an HCP requiring no secondary processing can be collected with the Spectra LRS. The platelet concentration may be determined by clinical need. HCPs meet the requirements for components that are transfused in utero.     

Migraine,Tension-Type Headache,and Attention-Deficit/Hyperactivity Disorder in Childhood: A Population-Based Study

Abstract

Objectives: Primary headache syndromes (eg, migraine and tension-type headache [TTH]) and attention-deficit/hyperactivity disorder (ADHD) are prevalent in childhood and may cause impairment in social and academic functioning. We tested if ADHD or its symptoms are associated with specific headache syndromes or with headache frequency. Study design: Cross-sectional epidemiological study with direct interviews to parents and teachers using validated and standardized questionnaires. Setting: Populational study. Participants: Children aged 5 to 11 years (n = 1856). Outcome measures: Prevalence of ADHD as a function of headache status in crude and adjusted analyses. Results: The prevalence of migraine was 3.76%. Infrequent episodic TTH occurred in 2.3% of the sample, and frequent episodic TTH occurred in 1.6%. The prevalence of ADHD was 6.1%. The prevalence of ADHD was not significantly different by headache category. For hyperactivity-impulsivity symptoms, the prevalence was 8.1% in children without headache, 23.7% in children with migraine (relative risk [RR], 2.6; 95% confidence interval [CI], 1.6–4.2), and 18.4% in children with probable migraine (RR, 2.1; 95% CI, 1.4–3.2). For inattention, no significant differences were seen. In multivariate analyses, ADHD or inattention symptoms were not predicted by headache subtypes or headache frequency. Hyperactivity-impulsivity symptoms were significantly associated with any headache (P < 0.01), TTH (P < 0.01), or migraine (P < 0.001). Conclusion: Migraine and TTH are not comorbid to ADHD overall, but are comorbid to hyperactive-impulsive behavior. Providers and educators should be aware of the association.     

实时剪切波弹性成像应用于股总静脉血栓临床分期

目的 探讨实时剪切波弹性成像（SWE）应用于股总静脉血栓（CFVT）临床分期的价值。方法 根据主诉发病时间将92例单侧CFVT患者分为急性期（1~14天,n=41）、亚急性期（15~30天,n=24）及慢性期（>30天,n=27）,比较其二维超声评分及SWE所测杨氏模量值。采用ROC曲线评价二维超声及SWE对急性期、慢性期CFVT的诊断效能。结果 3期患者间二维超声评分及杨氏模量值总体比较（P均<0.001）及两两比较差异均有统计学意义（P均<0.05）。以杨氏模量值=13.50 kPa为截断值,SWE诊断急性期CFVT的AUC为0.916（P<0.05）,敏感度85.37%,特异度82.35%;以二维超声评分=2.00为截断值,二维超声诊断急性期CFVT的AUC为0.800（P<0.05）,敏感度75.61%,特异度66.67%;2种方法AUC差异有统计学意义（P<0.001）。以杨氏模量值=16.40 kPa为截断值,SWE诊断慢性期CFVT的AUC为0.917（P<0.05）,敏感度85.19%,特异度87.69%;以二维超声评分=2.03为截断值,二维超声诊断慢性期CFVT的AUC为0.842（P<0.05）,敏感度87.21%,特异度69.23%;两种方法AUC差异有统计学意义（P=0.010）。结论 SWE可用于判断CFVT临床分期,且效果好于常规超声。     

MRI纹理分析评价注意缺陷多动障碍

目的 观察MRI纹理分析诊断注意缺陷多动障碍(ADHD)及分型的效果.方法 基于纽约大学医学中心公开MRI数据选取88例ADHD患者(ADHD组)及67名健康受试者(对照组),将ADHD组分为注意力缺陷为主型(ADHD-D亚组(n=32)和混合型(ADHD-C)亚组(n=56),提取并比较受试者脑白质和脑灰质的纹理特征...     

Relationship between intra-operative vein graft treatment with DuraGraft® or saline and clinical outcomes after coronary artery bypass grafting

ABSTRACT

Background: Saphenous vein grafts (SVGs) remain the most often used conduits for coronary bypass grafting (CABG). Progressive intimal hyperplasia contributes to vein-graft disease and vein-graft failure (VGF). We compared the impact of intraoperative preservation of SVGs in a storage solution (DuraGraft®) versus heparinized saline on VGF-related outcomes after CABG.

Methods: From 1996 to 2004, 2436 patients underwent isolated CABG with ≥ 1 SVG. SVGs were consecutively treated with DuraGraft in 1036 patients (2001?2004) and heparinized saline in 1400 patients (1996?1999). Short- (< 30 days) and long-term (≥ 1000 days) outcomes were assessed using repeat revascularization (primary end point), and major adverse cardiac events (MACE) consisting of the composite of death, nonfatal myocardial infarction, or repeat revascularization.

Results: Mean follow-up in the DuraGraft group was 8.5 ± 4.2 years and 9.9 ± 5.6 years in controls. Short-term event rates were low and generally did not differ between groups. DuraGraft was associated with a 45% lower occurrence of nonfatal myocardial infarction after 1000 days (hazard ratio 0.55, 95% CI 0.41?0.74; P < 0.0001). There was 35% and 19% lower long-term risk for revascularization (HR 0.65, 95% CI 0.44?0.97; P = 0.037) and MACE (HR 0.81, 95% CI 0.70?0.94; P = 0.0051), respectively, after DuraGraft. Mortality was comparable between both groups at 1, 5, and 10 years. There was no statistically significant association between DuraGraft exposure and time to death starting at 30 or 1000 days (HR 0.91, 95% CI 0.76?1.09; P = 0.29).

Conclusion: In this study, intraoperative treatment of SVGs with DuraGraft was associated with a lower risk of long-term adverse events suggesting that efficient intraoperative SVG treatment may reduce VGF-related complications post-CABG. These data warrant randomized clinical trials to validate these findings.     

Health care providers’ use and knowledge of the Edmonton Symptom Assessment System (ESAS): is there a need to improve information and training?

Objectives

The ESAS is a clinical symptom assessment tool developed for patients receiving palliative care for pain and symptom control. Recent studies have indicated that patients have difficulty understanding terminology and correct use of the ESAS, and that they appreciate the presence of a health care provider (HCP) to assist with ESAS completion. As appropriate assessment translates into effective treatment, it is important that HCPs have a good understanding of the tool. The purpose of this study was to assess HCPs’ use, knowledge, and training needs of the ESAS.

Methods

One hundred ninety-three HCPs in palliative care and chronic pain, who used the ESAS, were invited to participate in a survey.

Results

The response rate was 43 % (n?=?83), with 62 % nurses, 26 % physicians, and 12 % other specialties. Most participants were palliative care specialists (79 %). The majority (77 %) had a good understanding of the ESAS terms. Knowledge problems included distinguishing tiredness and drowsiness (25 %), interpreting shortness of breath as a combination of subjective and objective symptoms (19 %), not indicating current symptom level (14 %), and reverse scoring of well-being (13 %) and appetite (9 %). Reported challenges were misinterpretation of some ESAS terms, assessing patients with impaired communication, and lack of time and reliability of caregiver assessments. Participants offered suggestions regarding how their knowledge and use of the ESAS could be improved.

Conclusions

Suggestions for improving ESAS administration and training were to include term definitions and examples of how to ask about terms that might be challenging for patients. Furthermore, initial and ongoing training sessions might help to clarify issues with the tool.     

First-generation versus second-generation drug-eluting stents in patients with chronic kidney disease: a systematic review and meta-analysis

Background: Chronic kidney disease (CKD) patients are associated with very high rate of adverse cardiovascular outcomes after drug-eluting stents (DES) implantation. The clinical outcomes of second-generation DES versus first-generation DES in CKD patients remain controversial.

Objective: The aim of the current study was to perform a systematic review and meta-analysis to assess the safety and efficacy of second-generation DES versus first-generation DES in CKD patients.

Methods: A systematical search of databases of PubMed, EMBASE, and Cochrane Library was conducted for eligible studies comparing the clinical outcomes of first-generation DES versus second-generation DES. Sirolimus-eluting and paclitaxel-eluting stents were classified as first-generation DES, and everolimus-eluting, zotarolimus-eluting, and biolimus-eluting stent (BES) were classified as second-generation DES. A pooled odds ratio (OR) and 95% confidence interval (CI) were used to summary the estimates. Heterogeneity, subgroup analysis, sensitivity analysis and publication bias were also performed.

Results: We identified 14 trials involving 9,542 patients with CKD undergoing percutaneous coronary intervention. First-generation DES implantation was associated with higher risk of long-term all-cause mortality (OR, 1.31; 95% CI, 1.02–1.69; P = 0.04; I² = 0%), in stent restenosis (OR, 1.69; 95% CI, 1.14–2.49; P = 0.008; I² = 49%) and stent thrombosis (OR, 1.64; 95% CI, 1.00–2.69; P = 0.05; I² = 49%) compared with second-generation DES implantation. First-generation DES and second-generation DES showed similar efficacy in decreasing risk of repeat revascularization, myocardial infarction (MI), or major adverse cardiac events (MACE) between first-generation and second-generation DES implantation.

Conclusions: In CKD patients, the use of second-generation DES was associated with lower risk of long-term all-cause mortality, in stent restenosis and stent thrombosis as compared with first-generation DES. No differences were found regarding repeat revascularization, MI, and MACE.     

The impact of 'best-practice' patient care in fibromyalgia on practice economics

Objective The office time required for primary care physicians (PCPs) to diagnose, treat and manage fibromyalgia (FM) patients can be extensive. The study objective was to determine if PCPs can positively impact practice economics by requiring fewer patient visits and less office time, while still achieving an acceptable quality of life, as reported by the physician. Study design Survey of PCPs who diagnose, manage and treat FM patients. Methods Surveys were administered to US private practice PCPs, obtaining information on the number of office visits, and time spent with FM patients. PCPs were allotted into two groups: FM‐efficient (FME; n = 40) and FM usual care (FMUC; n = 54), based on their reported ability to achieve an acceptable quality of life for ≥50% of their FM patients in less than four office visits post FM diagnosis. An economic model estimated the monetary value of each PCP cohorts' time spent with a newly diagnosed FM patient over a 2‐year timeframe. Results Significant office time cost differences across 2 years exist between FME PCPs and FMUC PCPs ($840 vs. $1117, P < 0.05). FME PCPs had a significantly lower cost of scheduled time to confirm diagnosis ($243 vs. $339, P < 0.05) and time to find right treatment ($264 vs. $365, P < 0.05) than FMUC PCPs. Both groups incurred costs related to excess visit time, but it was less for FME PCPs ($119, 29 minutes) than FMUC PCPs ($182, 44 minutes, P < 0.01), driven by quicker diagnosis confirmation (P < 0.01) and treatment initiation (P < 0.01). Conclusions Research suggests that efficient FM care delivery during diagnosis and treatment can be associated with improved practice economics.     

Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors

BackgroundYoung breast cancer survivors (YBCS) have unmet needs for managing hot flashes, fertility-related concerns, sexual health, and contraception.PurposeDescribe the design and participant characteristics of a randomized controlled trial testing the efficacy of the survivorship care plan on reproductive health (SCP-R) intervention on improving hot flashes, fertility-related concerns, sexual health, and contraception in YBCS.MethodsSCP-R is a web-based intervention with text message support encompassing evidence- based practices on four reproductive health issues. YBCS with ≥1 reproductive health issue are randomized to intervention (full SCP-R access) or attention control (access to list of online resources) arms with 24-week follow-up. The primary outcome will be improvement of at least one reproductive health issue measured by validated self-report instruments. Each YBCS nominated one healthcare provider (HCP), who can access the same materials as their patient. HCP outcomes are preparedness and confidence in discussing each issue.ResultsAmong 318 YBCS screened, 57.2% underwent randomization. Mean age was 40.0 (SD 5.9), and mean age at cancer diagnosis was 35.6 (SD 5.4). Significant hot flashes, fertility-related concerns, vaginal symptoms, and inadequate contraception were reported by 50.5%, 50%, 46.7%, 62.1% of YBCS, respectively; 70.9% had multiple issues. Among 165 nominated HCPs, 32.7% enrolled. The majority of HCPs reported preparedness (68.5–90.7%) and confidence (50.0–74.1%) in discussing reproductive health issues with YBCS. HCPs were least likely to report preparedness or confidence in discussing fertility-related concerns.ConclusionConducting a trial for improving YBCS reproductive health online is feasible, providing a mechanism to disseminate evidence-based management.