Meaningful Improvements In Quality Research Articles

Personal Descriptions of Life Before and After Bariatric Surgery From Overweight or Obese Men.

Bariatric surgery is now a common weight loss solution for morbidly obese men where meaningful weight reduction and improvements in quality of life have been identified postsurgery. As the majority of surgical candidates are female, there exists a paucity of literature relating to the experience of males undergoing bariatric surgery. In this study, a qualitative descriptive-exploratory design was used to explore body image descriptions, adaptation of a new lifestyle, new boundaries postsurgery, and any barriers seeking consultation for surgery. Six males who had undergone bariatric surgery were recruited in Australia. Data were collected and analyzed using NVivo between May and October 2014. The themes emerging from the data included living in an obese body, life before surgery, decision making for surgery, and life after surgery. The participants collectively reported that life before surgery was challenging. They described the changes the surgery had made in their lives including positive changes to their health, body image, social lives, and self-esteem. Some participants preferred not to tell others their intentions for surgery due to perceived stigma. The men in this study also described a lack of information available to them depicting male perspectives, a possible barrier for men seeking weight loss surgery options. Implications for practice highlighted in these results relate to a greater need for accessible information specific to men based on real-life experiences.

Commentary on: Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis by Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, et al. NEJM 2016;374 (15):1424-34.

Background:How does an article involving only 66 patients randomized into two spinal surgical groups get into the New England Journal of Medicine? Nevertheless, this one did. The article by Ghogawala et al. entitled Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis, compared the efficacy/outcomes of pedicle/screw/rod instrumented posterolateral lumbar fusions vs. decompressions alone for treating lumbar stenosis with grade I degenerative spondylolisthesis (DS).Methods:They designed a randomized controlled study involving only 66 patients between the ages of 50–80 (average age: 67) with lumbar stenosis and stable DS (3–14 mm). Outcomes were measured utilizing the physical measures from the Short Form 36 (SF-36) up to 4 postoperative years, and the Oswestry Disability Index (ODI) upt to 2 postoperative years. Data were available for 86% of patients at 2, but only for 68% of the patients at 4 postoperative years.Results:At 2 postoperative years, SF-36 scores were higher for the instrumented patients (28 patients) vs. decompressed (29 patients) patients. However, the scores were comparable for both groups using the ODI at 4 years. SF-36 scores, however, remained higher for the 19 remaining instrumented patients. Additionally, reoperation rates were 14% for fusions and a staggering 34% for decompressions alone.Conclusions:The authors concluded; laminectomy with fusion offered a “slightly greater but clinically meaningful improvement in overall physical health-related quality of life vs. laminectomy alone.” Rather, it should have read there were no statistically significant differences between the two groups and an insufficient number of patients were included in the study at all stages.

Tiotropium/Olodaterol: A Review in COPD.

Tiotropium/olodaterol (Stiolto™ Respimat®, Spiolto™ Respimat®) is a fixed-dose combination of the long-acting antimuscarinic agent tiotropium bromide (hereafter referred to as tiotropium) and the long-acting β2-adrenoreceptor agonist olodaterol delivered via the Respimat® Soft Mist™ inhaler. It is indicated for the maintenance treatment of airflow obstruction in adults with COPD. Several randomized, phase III studies of 6-52 weeks' duration evaluated the efficacy of once-daily tiotropium/olodaterol in patients with GOLD stage 2-3 or 2-4 COPD. Tiotropium/olodaterol maintenance therapy improved lung function to a greater extent than the individual components or placebo and provided clinically meaningful improvements in health-related quality of life and dyspnoea in 12- and 52-week studies. Tiotropium/olodaterol consistently improved 24-h lung function in 6-week studies, providing greater benefits than the monotherapies, placebo or twice-daily fixed-dose fluticasone propionate/salmeterol. Inspiratory capacity and exercise endurance were also improved with tiotropium/olodaterol following 6 or 12 weeks' treatment. The tolerability profile of tiotropium/olodaterol in the phase III studies was generally similar to that of the component monotherapies. The most common adverse events and serious adverse events during 52 weeks' therapy were respiratory in nature, with COPD exacerbation, unsurprisingly, reported most frequently with tiotropium/olodaterol and component monotherapies. Although additional data assessing the effect of tiotropium/olodaterol on exacerbations and comparative studies with other recommended therapies are needed to definitively position tiotropium/olodaterol, current evidence indicates that tiotropium/olodaterol is a useful treatment option for patients with COPD.

Demographics, Baseline Characteristics, and Disease Symptom Burden in RESPONSE-2: A Randomized, Phase 3 Study of Ruxolitinib in Polycythemia Vera Patients (pts) Who Are Resistant to or Intolerant of Hydroxyurea (HU)

BACKGROUND: Polycythemia vera (PV) is characterized by increased red cell mass often associated with elevated leukocyte and platelet counts, splenomegaly and significant symptom burden. In the RESPONSE study, which only enrolled PV patients with splenomegaly, ruxolitinib (Rux) demonstrated superior improvements in hematocrit (HCT) control and reductions in spleen volume compared with best available therapy (BAT) in pts who were resistant to or intolerant of HU. Supportive data included clinically meaningful improvements in PV-related symptom burden and quality of life (QOL) measures. Here, we describe the baseline (BL) characteristics and symptom burden of PV pts resistant to or intolerant of HU enrolled in the RESPONSE-2 study, which unlike RESPONSE, enrolled PV patients with a nonpalpable spleen.METHODS: RESPONSE-2 is an open-label, randomized (1:1), multicenter, phase 3 study evaluating the efficacy and safety of Rux vs BAT in PV pts who are HU-resistant/-intolerant, require phlebotomy (PBT), and have no palpable spleen. Pts' BL symptom burden, BL QOL and BL pt-reported outcomes (PRO) were assessed by using 10-items modified Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS), the Pruritus Symptom Impact Scale (PSIS), European QOL Questionnaire (EQ-5D-5L), and Work Productivity and Activity Impairment: Polycythemia Vera V2.0 (WPAI: PV).RESULTS: A total of 149 pts were enrolled. BL demographic data from both arms combined are summarized in the Table. Forty percent of the patients were resistant whereas 60% were intolerant of HU treatment. Other than HU, prior treatments included interferons (15.4%), alkylating agents (8.1%), alkyl sulfonates (2.7%), pyrimidine analogs (0.7%), and other antineoplastic agents (1.0%). Ninety-seven percent of pts had at least 1 PBT within 16 weeks (wks) prior to screening and 72% had ≥ 2 PBT within 24 wks prior to screening. Past medical histories included hypertension (49%), pruritus (23%) and fatigue (9%). BL demographics of pts in RESPONSE-2 were generally comparable with previous PV studies (Table). Despite using frequent phlebotomy and cytoreductive agents during the screening period prior to randomization, 55% and 52% of pts had WBC counts greater than 10 × 109/L and platelet counts greater than 400 × 109/L, respectively, suggesting inadequately controlled disease even while receiving therapy. Additionally, pts had significant symptom burden at BL as measured by the MPN-SAF with fatigue (3.6) and pruritus (3.4) (Table). As measured by EQ-5D-5L scale, 26% and 19% of pts reported moderate to extreme pain/discomfort and depression, respectively. In WPAI outcomes, 40 of 149 pts reported missing work due to PV accounting for 14.3% of their working time.SUMMARY/CONCLUSION: Demographic and BL data from the RESPONSE-2 study highlight the significant unmet medical need in this inadequately controlled HU-resistant/-intolerant PV population. As expected, pts in RESPONSE-2 reported lower scores for symptoms associated with splenomegaly (early satiety, 1.8 vs 2.0; abdominal discomfort, 1.7 vs 2.0) as compared with RESPONSE population. In comparison to PV pts with splenomegaly in the RESPONSE trial, pts without splenomegaly in the RESPONSE-2 trial have a distinct but comparable disease burden with marked fatigue and pruritus.Table 1Baseline demographics and symptoms (n = 149)Age, median (range), years66.0 (26.0, 87.0)Time since diagnosis of PV, median, months80.7Male, %57.7Female, %42.3ECOG performance status, % 0 172.5 26.8Hematocrit (%), median,(n=149)43.0n (%) < 40 ≥ 40 to ≤ 45 > 452 (1.3) 146 (98.0) 1 (0.7)WBC count (x 109/L), median (n=149)10.6n (%) ≤ 10 > 10 and ≤ 15 > 1567 (45.0) 43 (28.9) 39 (26.2)PLT count (x 109/L), median (n=148)420.0n (%) < 100 ≥ 100 and < 400 ≥ 400 to < 600 ≥ 6002 (1.3) 68 (45.6) 38 (25.5) 40 (26.8)JAK2 mutation, n (%) (n=149) Positive Negative Unknown143 (96.0) 4 (2.7) 2 (1.3)MPN-SAF Symptom (n)Mean (SD)Total score (n=145)2.0 (1.67)Fatigue (n=146)3.6 (2.72)Early satiety (n=145)1.8 (2.47)Abdominal discomfort (n=143)1.7 (2.44)Inactivity (n=142)2.1 (2.77)Concentration problem (n=146)2.3 (2.75)Night sweats (n=145)2.2 (3.07)Pruritus (n=145)3.4 (3.37)Bone pain (n=144)2.1 (2.89)Fever (n=144)0.2 (0.92)Weight loss (n=142)0.7 (1.72) DisclosuresPassamonti:Novartis: Consultancy. Cavo:JANSSEN, CELGENE, AMGEN: Consultancy. Vannucchi:Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Other: Research Funding paid to institution (University of Florence), Research Funding; Shire: Speakers Bureau; Baxalta: Membership on an entity's Board of Directors or advisory committees. Bensasson:Novartis: Employment. Khan:Novartis: Employment. Mounedji:Novartis: Employment.

Management of poor-risk metastatic renal cell carcinoma: current approaches, the role of temsirolimus and future directions.

Targeted therapies have substantially improved outcomes in metastatic renal cell carcinoma (mRCC). As expected, poor-risk patients have the worst outcomes. Temsirolimus is currently the only agent licensed for treatment of poor-risk mRCC patients. It is associated with meaningful improvements in survival and quality of life, highlighting the importance of correctly stratifying risk in mRCC patients so they receive optimal treatment. Currently, data for other targeted therapies in poor-risk patients are relatively sparse. Optimizing outcomes in these patients is the subject of ongoing research, including studies of biomarkers and studies to elucidate the role of nephrectomy and neoadjuvant targeted therapy in poor-risk mRCC patients. The impacts of novel combinations including temsirolimus have also been explored to further improve outcomes.

Pain intensity and interference with functioning and well-being in subgroups of patients with chronic pain treated with once-daily hydrocodone tablets

A previous 52-week trial of patients with chronic noncancer, non-neuropathic pain (CNNP) showed clinically meaningful improvement in pain intensity, pain interference, and physical health-related quality of life (HRQL) following daily treatment with an extended-release, once-daily hydrocodone (Hysingla(®) ER; HYD) bitartrate tablet. To examine treatment response within patient subgroups and to assess between-subgroup differences in effectiveness and side effect profile. Data were from an open-label 52-week trial of treatment with HYD tablets (20-120 mg, once-daily) for patients with moderate-to-severe CNNP. Binary subgroups were defined for the following six factors: age, gender, opioid experience, baseline pain severity, history of depression, and stable HYD dose at completion of a 45-day dose-titration period. Univariable and multivariable models examined changes in average pain intensity (API; 11-point numeric rating scale), pain interference (Brief Pain Inventory-Interference subscale [BPI-I]), physical and mental HRQL (36-item Short Form health survey Physical and Mental Component Summaries [PCS and MCS]), and sleep quality (Medical Outcomes Study Sleep Scale Sleep Problems Index [SPI]) from baseline to maintenance, and subgroup differences in adverse events. All subgroups showed clinically meaningful improvements in API, BPII, and PCS scores; no subgroups showed improvements in MCS or SPI. Between subgroup comparisons found greater improvements for opioid-naïve patients and for patients with severe baseline pain. Incidence of adverse events differed minimally between subgroups. Regardless of subgroup, patients with CNNP treated with HYD showed clinically meaningful improvements in pain intensity, pain interference, and physical HRQL, although not in mental HRQL or sleep quality. Improvements were generally larger for opioid-naïve patients and patients with severe baseline pain.

A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care.

BackgroundPractice facilitation has been associated with meaningful improvements in disease prevention and quality of patient care. Using practice facilitation, the Improved Delivery of Cardiovascular Care (IDOCC) project aimed to improve the delivery of evidence-based cardiovascular care in primary care practices across a large health region. Our goal was to evaluate IDOCC’s impact on adherence to processes of care delivery.MethodsA pragmatic stepped wedge cluster randomized trial recruiting primary care providers in practices located in Eastern Ontario, Canada (ClinicalTrials.gov: NCT00574808). Participants were randomly assigned by region to one of three steps. Practice facilitators were intended to visit practices every 3–4 (year 1—intensive) or 6–12 weeks (year 2—sustainability) to support changes in practice behavior. The primary outcome was mean adherence to indicators of evidence-based care measured at the patient level. Adherence was assessed by chart review of a randomly selected cohort of 66 patients per practice in each pre-intervention year, as well as in year 1 and year 2 post-intervention.ResultsEighty-four practices (182 physicians) participated. On average, facilitators had 6.6 (min: 2, max: 11) face-to-face visits with practices in year 1 and 2.5 (min: 0 max: 10) visits in year 2. We collected chart data from 5292 patients. After adjustment for patient and provider characteristics, there was a 1.9 % (95 % confidence interval (CI): −2.9 to −0.9 %) and 4.2 % (95 % CI: −5.7 to −2.6 %) absolute decrease in mean adherence from baseline to intensive and sustainability years, respectively.ConclusionsIDOCC did not improve adherence to best-practice guidelines. Our results showed a small statistically significant decrease in mean adherence of questionable clinical significance. Potential reasons for this result include implementation challenges, competing priorities in practices, a broad focus on multiple chronic disease indicators, and use of an overall index of adherence. These results contrast with findings from previously reported facilitation trials and highlight the complexities and challenges of translating research findings into clinical practice.Trial registrationClinicalTrials.gov NCT00574808Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-015-0341-y) contains supplementary material, which is available to authorized users.

Comparison of Two National Databases for General Thoracic Surgery

Improving the quality of surgical care through accurate measurement of outcomes is an important endeavor. The purpose of this study was to compare data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) and The Society of Thoracic Surgeons (STS) general thoracic surgery database to determine if a sampling technique (ACS NSQIP) is as effective and accurate as the comprehensive technique (STS database). A common data abstractor collected and recorded data for the ACS NSQIP and STS database from our institution for the year 2012. The data was completely deidentified and analyzed for demographics, preoperative risk factors, mortality, and morbidity. The STS database recorded 1,595 (100%) operations for the year 2012, whereas the ACS NSQIP by design collects a limited sample and recorded 308 (19.3%) operations. Postoperative events were recorded in 17.2% of ACS NSQIP operations and in 30.1% of operations reported in the STS database. As more specific operations are examined, errors in the NSQIP data increase significantly. For example, the ACS NSQIP underestimated the pneumonia rate for lobectomy (5.9% versus 10.9%) and overestimated the pneumonia rate for an Ivor Lewis esophagogastrectomy (23.8% vs 18.8%). When the ACS NSQIP was used to compare our institution to the ACS NSQIP national norms, our institution was ranked in the lowest eighth decile for 30-day operative mortality; however, we were better than average when using STS database data (1.2% [2 of 162 procedures] vs 1.4% [538 of 37,324 procedures]) for pulmonary resections and 3.0% (3 of 100 procedures) vs 3.6% [138 of 3,865 procedures] for esophagectomy). Databases built on partial sampling that do not capture all patients, such as the ACS NSQIP, may be useful for global analyses, but fall short of providing a foundation for meaningful quality improvement initiatives when analyzing data for specific thoracic surgical operations. These results highlight the utility and importance of complete databases such as the STSDB. National comparisons of clinical outcomes for thoracic surgical procedures should be interpreted with caution when using partial databases.

Tiotropium + olodaterol shows clinically meaningful improvements in quality of life

BackgroundTiotropium + olodaterol improves lung function and symptoms compared to monotherapies in chronic obstructive pulmonary disease (COPD). The OTEMTO 1 and 2 studies investigated the effects of tiotropium + olodaterol on lung function and health-related quality of life compared to placebo in patients with moderate to severe COPD. MethodsIn these two replicate, double-blind, parallel-group, placebo-controlled trials, patients were randomised to receive tiotropium + olodaterol 5/5 μg, 2.5/5 μg, tiotropium 5 μg or placebo for 12 weeks, via the Respimat® inhaler. Primary end points were St George's Respiratory Questionnaire (SGRQ) total score, forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response and trough FEV1 response. ResultsIn OTEMTO 1 and 2, tiotropium + olodaterol 5/5 μg improved SGRQ total score by 4.89 (95% confidence interval [CI] −6.90, −2.88) and 4.56 (95% CI −6.50, −2.63) units versus placebo (both p < 0.0001), and 2.49 (95% CI −4.47, −0.51; p < 0.05) and 1.72 (95% CI −3.63, 0.19) units versus tiotropium 5 μg. Tiotropium + olodaterol 2.5/5 μg significantly improved SGRQ score compared to placebo. Both doses significantly improved FEV1 AUC0–3 response compared to placebo and tiotropium 5 μg. Tiotropium + olodaterol 5/5 and 2.5/5 μg also significantly improved trough FEV1 response compared to placebo (both studies) and separated from tiotropium 5 μg in OTEMTO 2. Adverse-event incidence was similar between treatment groups. ConclusionTiotropium + olodaterol improved lung function and quality of life compared to placebo and tiotropium 5 μg. Trial registrationClinicalTrials.gov: NCT01964352 and NCT02006732.

Improving Healthcare Quality in the United States: A New Approach.

Improving the quality of health care has been a focus of health reformers during the last 2 decades, yet meaningful and sustainable quality improvement has remained elusive in many ways. Although a number of individual institutions have made great strides toward more effective and efficient care, progress has not gone far enough on a national scale. Barriers to quality of care lie in fundamental, systemwide factors that impede large-scale change. Notable among these is the third-party financing arrangement that dominates the healthcare system. Long-term goals for healthcare reform should address this barrier to higher quality of care. A new model for healthcare financing that includes patient awareness of the cost of care will encourage better quality and reduced spending by engaging patients in the pursuit of value, aligning incentives for insurers to reduce costs with patients' desire to receive excellent care, and holding providers accountable for the quality and cost of the care they provide. Several new programs implemented under the Patient Protection and Affordable Care Act aim to catalyze improvement in the quality of care, but the law takes the wrong approach, directing incentives at providers only and maintaining a system that excludes patients from the search for high-value care.

Real-life efficacy and safety of omalizumab in Portuguese patients with persistent uncontrolled asthma

IntroductionThe real life effectiveness, safety and the use of omalizumab for Portuguese patients with uncontrolled persistent allergic asthma are not sufficiently well known. The objective of this report was to make an evaluation, in a post-marketing, non-interventional, observational registry, of the Portuguese population included in the eXpeRience study. MethodsThe methods used in this report are the same as the global eXpeRience ones, applied to a Portuguese sub-population. Patients with uncontrolled allergic asthma who had started omalizumab within the previous 15 weeks were enrolled and received omalizumab add-on therapy for 24 months. The physicians’ global evaluation of treatment effectiveness (GETE), asthma symptoms and control (ACT score), quality of life (mini-AQLQ score), exacerbations, and serious adverse events (SAE) were reported. ResultsOf the 943 patients recruited in the eXpeRience registry, 62 patients were from Portugal. 62.1% of them were observed to be responders with good/excellent GETE assessment at Week 16. Clinically meaningful improvements in asthma control (ACT score) and quality of life (mini-AQLQ score) were observed with omalizumab therapy at Months 12 (mean change: +7.7 [n=35]; +2.1 [n=20], respectively) and 24 (mean change: +7.0 [n=26]; +2.7 [n=13], respectively). Asthma symptoms and rescue medication usage were reduced to ≤1 day/week at Month 24 from a baseline of ≥3.5 days/week. The proportion of patients with no clinically significant exacerbations increased from 6.5% during pre-treatment (n=62) to 50% at Month 12 (n=54) and 60% at Month 24 (n=45). ConclusionThe findings from the Portugal subpopulation of eXpeRience registry confirm that omalizumab add-on therapy is efficacious and well tolerated in the management of uncontrolled persistent allergic asthma. Another pertinent issue is the fact that the Portuguese subpopulation response is similar to the international population average of the study.

Indacaterol, a once-daily beta2-agonist, versus twice-daily beta₂-agonists or placebo for chronic obstructive pulmonary disease.

Indacaterol is an inhaled long-acting beta2-agonist that is administered once daily and has been investigated as a treatment for chronic obstructive pulmonary disease (COPD). Four different doses have been investigated (75 mcg, 150 mcg, 300 mcg and 600 mcg). The relative effects of different doses of once-daily indacaterol in the management of patients with COPD are uncertain. To compare the efficacy and safety of indacaterol versus placebo and alternative twice-daily long-acting beta2-agonists for the treatment of patients with stable COPD. We identified trials from the Cochrane Airways Group Specialised Register of trials (CAGR), handsearched respiratory journals and meeting abstracts and searched the Novartis trials registry and ClinicalTrials.gov. The date of the most recent search was 8 November 2014. We included all randomised controlled trials comparing indacaterol at any dose versus placebo or alternative long-acting beta2-agonists. Trials were required to be of at least 12 weeks' duration and had to include adults older than 18 years with a confirmed spirometric diagnosis of COPD. Two review authors (JBG, EJD) independently assessed for possible inclusion all citations identified as a result of the search. Disagreements were resolved through discussion or, if required, through resolution by a third review author (RWB). One review author (JBG) extracted data from trials identified by the search and entered these data into Review Manager 5.1 for statistical analysis. Data entry was cross-checked by a second review author (EJD, CJC). A total of 13 trials with 9961 participants were included in the review. Ten trials with a total of 8562 participants involved an indacaterol versus placebo comparison. Five trials with a total of 4133 participants involved an indacaterol versus twice-daily beta2-agonist comparison. The comparator beta2-agonists were salmeterol, formoterol and eformoterol. One of these trials, with a total of 90 participants, provided no data that could be used in this review. Two trials included both indacaterol versus placebo and indacaterol versus twice-daily beta2-agonist comparisons. Trials were between 12 weeks and 52 weeks in duration. Overall the quality of the evidence was strong, and risk of significant bias was minimal in most of the included studies. Enrolled participants had stable COPD across a range of spirometric severities. Forced expiratory volume in 1 second (FEV1) was generally between 30% and 80% predicted, and a mean FEV1 of approximately 50% was predicted in most studies. Patients with concurrent respiratory disease, including asthma, were excluded. Concomitant use of inhaled corticosteroids was permitted.The primary objectives were to compare trough FEV1 at the end of dosing, exacerbation rates and quality of life. Significant adverse events, mortality and dyspnoea were included as secondary outcomes. Compared with placebo, a significant and clinically relevant improvement in trough FEV1 was noted with indacaterol (mean difference (MD) 149.11, 95% confidence interval (CI) 137.09 to 161.12). In addition, compared with placebo, a significant improvement in mean St George Respiratory Questionaire (SGRQ) score (MD -3.60, 95% CI -4.36 to -2.83) was reported, and the proportion of participants experiencing clinically relevant improvement in SGRQ score was significantly greater (odds ratio (OR) 1.63, 95% CI 1.46 to 1.84). Compared with twice-daily beta2-agonists, a small but statistically significant increase in trough FEV1 was seen with indacaterol (MD 61.71 mL, 95% CI 41.24 to 82.17). Differences between indacaterol and twice-daily beta2-agonists in mean SGRQ scores (MD -0.81, 95% CI -2.28 to 0.66) and in the proportions of participants achieving clinically relevant improvements in SGRQ scores (OR 1.07, 95% CI 0.87 to 1.32) were not statistically significant, but the confidence intervals are too wide to permit the conclusion that the treatments were equivalent. Data were insufficient for analysis of differences in exacerbation rates for both placebo and twice-daily beta2-agonist comparisons. For patients with stable COPD, use of indacaterol versus placebo results in statistically significant and clinically meaningful improvements in lung function and quality of life. The clinical benefit for lung function is at least as good as that seen with twice-daily long-acting beta2-agonists. The comparative effect on quality of life remains uncertain, as important differences cannot be excluded.

Hospice utilization and end-of-life care in metastatic breast cancer patients at a comprehensive cancer center.

Metastatic breast cancer patients have many options for therapy and may be at risk for late or absent hospice referrals, which make meaningful improvements in symptoms and quality of life difficult to achieve. We aimed to examine hospice utilization, status of patients on admission, and quality of care of patients treated for metastatic breast cancer from 1999 to 2010 at a National Cancer Institute (NCI)-designated comprehensive cancer center located in Western New York. We conducted a retrospective database review that identified 182 patients with deaths resulting from breast cancer who were eligible for services through a local not-for-profit hospice. Patients with metastatic breast cancer were matched to the hospice database for information on hospice utilization and quality measures. Date of last chemotherapy, medication use, documentation of advance directive and palliative care discussions, and place of death were collected through chart abstraction. One-third (33%) of metastatic breast cancer patients treated at the cancer institute during the study period died without a hospice referral. Only 7% of patients who died without a hospice referral had a documented discussion of palliative care as an option by the oncology team (p < 0.001). Those patients referred to hospice were significantly more likely to have an advance directive and to die at home. Patients with a longer duration of metastatic cancer were at risk for late referral. Efforts to enhance end-of-life (EOL) discussions and earlier referral to palliative care and hospice for patients with metastatic breast cancer are critical to improved patient care.

Receipt of opioid therapy guideline- concordant care among HIV+ and HIV− veterans

s / Drug and Alcohol Dependence 146 (2015) e118–e201 e119 VASH may enable needed service use for homeless Veterans, through links to housing and primary care. Financial support: VAGLA CSHIIP. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.241 Receipt of opioid therapy guidelineconcordant care among HIV+ and HIV− veterans J.R. Gaither1, E. Edelman1, W. Becker1,2, S. Crystal4, K. Gordon2, J. Goulet1,2, R. Kerns1,2, M. Skanderson3, D. Weisberg1, K. Bryant5, A. Justice1,2, D. Fiellin1 1 Yale University, New Haven, CT, United States 2 VA CT HCS, New Haven, CT, United States 3 VA Pittsburgh HCS, New Haven, CT, United States 4 Rutgers University, New Brunswick, NJ, United States 5 NIH/NIAAA, Bethesda, MD, United States Aims: To determine whether HIV+ and HIV− patients initiating opioid therapy (OT) are equally likely to receive care concordant with American Pain Society/American Academy of Pain Medicine opioid clinical practice guidelines. Methods: We performed a nested prospective cohort study on 17,961 patients from the Veterans Aging Cohort Study who initiated long-termOT (≥90-days) between 1999 and 2009. Unadjusted and adjusted models were used to evaluate associations between HIV status and outcomes on 12 indicators derived from national OT guidelines. We calculated summary scores (i.e., number of recommended indicators received per patient/number for which they were eligible×100) and examined trends in the receipt of individual indicators over time. Results: Receipt of guideline-concordant care was low for both patient groups. HIV+ patients (n=5,677) were more likely than HIV− patients (n=12,284) to receive a primary care provider (PCP) visit within 1 month (51% vs. 31%; p< .001); PCP follow-up within 6 months (89% vs. 73%; p< .001); urine drug tests (UDTs) within 1 month (8% vs. 6%; p< .001) and 6 months (18% vs. 14%; p< .001); a bowel regimen (31% vs. 25%; p< .001); and concurrent non-opioid pain medications (50% vs. 46%; p< .001). However, HIV+ patients were less likely to receive physical rehabilitation (24% vs. 31%; p< .001) or counseling (30% vs. 33%; p< .01) and more likely to receive sedative co-prescriptions (22% vs. 18%; p< .001). Overall, patients received no more than 35% of recommended care. Over time, we observed an increase in UDTs (10–19%; p for trend <.001) and a decrease in sedative co-prescriptions (22–17%; p for trend <.001). Conclusions: Strategies to increase the provision of OT guideline-concordant care are needed as the majority of HIV+ and HIV− patients receiving incident long-term OT did not receive recommended care and there were few clinically meaningful quality improvements over time. Financial support: F31DA035567, U24AA020794. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.242 Prevalence of illicit drug use among patients of community health centers in East Los Angeles and Tijuana Marianna Garcia1, Melvin Rico1, John Scholtz1, Mani Vahidi1, Guillermina Natera3, Ronald Andersen2, Ietza Bojorquez4, Julia Yacenda1, Miriam Arroyo3, Mario Gonzalez5, Lillian Gelberg1,2 1 Family Medicine, UCLA David Geffen School of Medicine, Los Angeles, CA, United States 2 UCLA School of Public Health, Los Angeles, CA, United States 3 National Institute of Psychiatry Ramon de la Fuente Muniz, Mexico City, Mexico 4 El Colegio de la Frontera Norte Department of Population Studies, Tijuana, Mexico 5 National Commission Against Addictions, Mexico

Innovation and public space: The developmental possibilities of regulation in the global south

AbstractImportant product and process innovations are often developed in “public spaces” that promote collaboration and provide shelter from market competition. Given that most collaborative spaces are costly to establish, the possible implications are bleak for economically strapped developing countries. This paper highlights a less conspicuous – if not unknown – source of collaborative space: the regulatory process. Regulators can induce innovation by promoting collaboration across organizational, sectoral, and disciplinary boundaries in the interest of regulatory compliance. This paper documents the innovative consequences of efforts to regulate the use of lead‐based glazes in the Mexican ceramics industry and reconsiders several recent studies of upgrading in other countries that appear to have been driven, at least in part, by the regulatory process. Drawing on these cases, this paper makes four primary points: (i) that innovation in regulatory spaces is more common than previously acknowledged and is producing meaningful improvements in product quality and working conditions in developing economies; (ii) that promoting innovation in these regulatory spaces is an important developmental tool for countries that are “regulation‐takers” and have many low‐tech sectors; (iii) that this dynamic extends current conceptions of regulatory discretion, as well as development literature on state‐society synergies; and (iv) that establishing collaborative public spaces as a common conceptual framework is a critical step toward understanding the consequences of social regulation on upgrading.

Novel CHF Drug Shows Great Promise

Novel CHF Drug Shows Great Promise

300IR 5-Grass pollen sublingual tablet offers relief from nasal symptoms in patients with allergic rhinitis.

300IR 5-grass pollen sublingual immunotherapy tablets have been approved for the treatment of allergic rhinitis (AR) with or without conjunctivitis in adults and children >5 years with grass pollen allergy. This study was designed to review data on nasal symptoms with 300IR 5-grass pollen sublingual tablets in adults and children. We reviewed data from four double-blind, placebo-controlled, randomized clinical trials. Two groups of patients who received a daily dose of either placebo or 300IR 5-grass pollen sublingual tablets starting 4 months before the expected start of the pollen season and continuing through the season were compared (analysis of covariance) for scores of sneezing, rhinorrhea, nasal pruritus, nasal congestion, total nasal symptom score (TNSS), and adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores. Data for 266 children (one pediatric trial) and 1036 adults (three trials) were analyzed. Compared with the placebo groups, mean TNSS in the 300IR groups was lower by 22% in children and 19-36% in adults. Among the four nasal symptoms, the lowest scores relative to placebo were for nasal congestion in children (31%) and adults (43%). Mean adult RQLQ scores were 21-31% lower in the 300IR group than in the placebo group. Allergen immunotherapy with 300IR 5-grass pollen sublingual tablets was consistently associated with AR symptom relief in adults and children and provided a clinically meaningful improvement in quality of life.

Chief Complaint–Based Performance Measures: A New Focus for Acute Care Quality Measurement

Performance measures are increasingly important to guide meaningful quality improvement efforts and value-based reimbursement. Populations included in most current hospital performance measures are defined by recorded diagnoses using International Classification of Diseases, Ninth Revision codes in administrative claims data. Although the diagnosis-centric approach allows the assessment of disease-specific quality, it fails to measure one of the primary functions of emergency department (ED) care, which involves diagnosing, risk stratifying, and treating patients' potentially life-threatening conditions according to symptoms (ie, chief complaints). In this article, we propose chief complaint-based quality measures as a means to enhance the evaluation of quality and value in emergency care. We discuss the potential benefits of chief complaint-based measures, describe opportunities to mitigate challenges, propose an example measure set, and present several recommendations to advance this paradigm in ED-based performance measurement.

Diet and physical activity intervention in colorectal cancer survivors: A feasibility study

PurposeEvidence that lifestyle factors are associated with better outcomes in colorectal cancer (CRC) survivors highlights the need for behaviour change interventions. This study examined feasibility and acceptability, and provided an indication of behavioural impact, of a telephone-based, multimodal health behaviour intervention for CRC survivors. MethodParticipants were recruited from five London hospitals. Patients (n = 29) who had recently completed treatment for CRC participated in a 12 week intervention. Behavioural goals were to increase physical activity (PA) and fruit and vegetable (F&V) intake, and reduce consumption of red/processed meat and alcohol. Self-report measures of PA and diet were completed in all patients, supplemented by objective measures in a sub-set. ResultsUptake of the study when patients were approached by a researcher was high (72%), compared with 27% contacted by letter. Methods for identifying eligible patients were not optimal. Study completion rate was high (79%), and completers evaluated the intervention favourably. Significant improvements were observed in objectively-measured activity (+70 min/week; p = .004). Gains were seen in diet: +3 F&V portions a day (p < .001), −147 g of red meat a week (p = .013), −0.83 portions of processed meat a week (p = .002). Changes in serum vitamin levels were not statistically significant, but the small sample size provides limited power. Clinically meaningful improvement in quality of life (p < .001) was observed. ConclusionAn intervention combining print materials and telephone consultations was feasible and acceptable, and associated with improvements in PA, diet and quality of life.

BAX326 (RIXUBIS): a novel recombinant factor IX for the control and prevention of bleeding episodes in adults and children with hemophilia B.

Hemophilia B management has improved considerably since the introduction of high-purity plasma-derived factor IX (pdFIX) products in the early 1990s. Recombinant FIX (rFIX) was introduced more recently and has potential safety advantages over the older blood-based products. Until recently, only one such product, nonacog alfa (BeneFIX(®), Pfizer, Inc.), has been available. However, a new rFIX product, BAX326 (RIXUBIS, Baxter Healthcare Corp.), has now been approved by the US Food and Drug Administration. BAX326 undergoes rigorous virus elimination and purification steps during manufacture, and has low activated FIX activity, which confers low thrombogenic potential in humans. Preclinical studies showed promising pharmacokinetic and safety profiles, and these early findings have since been expanded in a series of prospective, multicenter, clinical studies. Foremost among these is a pivotal phase I/III study of BAX326 and its use in routine prophylaxis or on-demand treatment in patients aged 12-65 years with severe (FIX level <1%) or moderately severe (FIX level ≤2%) hemophilia B. This study confirmed the pharmacokinetic equivalence of BAX326 and nonacog alfa, and showed a significant reduction in annualized bleeding rate with BAX326 prophylaxis compared with on-demand treatment (79% versus historic controls; p < 0.001). The hemostatic efficacy of BAX326 was rated as 'excellent' or 'good' in 96% of bleeds. BAX326 was also associated with statistically significant and clinically meaningful improvements in physical health-related quality of life. Results are similarly encouraging in a pediatric study in children aged up to 12 years and in a study in hemophilia B patients undergoing surgery. A further study showed safe transition, with no inhibitor formation in any patient, from treatment with a pdFIX product to BAX326. Overall, the safety profile of BAX326 in clinical trials has been strong, with no inhibitor or specific antibody formation, thrombosis, or treatment-related serious adverse events or anaphylaxis.