Increasing system-wide implementation of opioid prescribing guidelines in primary care: findings from a non-randomized stepped-wedge quality improvement project.

BACKGROUND: Clinician utilization of practice guidelines can reduce inappropriate opioid prescribing and harm in chronic non-cancer pain; yet, implementation of "opioid guidelines" is subpar. We hypothesized that a multi-component quality improvement (QI) augmentation of "routine" system-level implementation efforts would increase clinician adherence to the opioid guideline-driven policy recommendations. METHODS: Opioid policy was implemented system-wide in 26 primary care clinics. A convenience sample of 9 clinics received the QI augmentation (one-hour academic detailing; 2 online educational modules; 4-6 monthly one-hour practice facilitation sessions) in this non-randomized stepped-wedge QI project. The QI participants were volunteer clinic staff. The target patient population was adults with chronic non-cancer pain treated with long-term opioids. The outcomes included the clinic-level percentage of target patients with a current treatment agreement (primary outcome), rates of opioid-benzodiazepine co-prescribing, urine drug testing, depression and opioid misuse risk screening, and prescription drug monitoring database check; additional measures included daily morphine-equivalent dose (MED), and the percentages of all target patients and patients prescribed ≥90 mg/day MED. T-test, mixed-regression and stepped-wedge-based analyses evaluated the QI impact, with significance and effect size assessed with two-tailed p < 0.05, 95% confidence intervals and/or Cohen's d. RESULTS: Two-hundred-fifteen QI participants, a subset of clinical staff, received at least one QI component; 1255 patients in the QI and 1632 patients in the 17 comparison clinics were prescribed long-term opioids. At baseline, more QI than comparison clinic patients were screened for depression (8.1% vs 1.1%, p = 0.019) and prescribed ≥90 mg/day MED (23.0% vs 15.5%, p = 0.038). The stepped-wedge analysis did not show statistically significant changes in outcomes in the QI clinics, when accounting for the comparison clinics' trends. The Cohen's d values favored the QI clinics in all outcomes except opioid-benzodiazepine co-prescribing. Subgroup analysis showed that patients prescribed ≥90 mg/day MED in the QI compared to comparison clinics improved urine drug screening rates (38.8% vs 19.1%, p = 0.02), but not other outcomes (p ≥ 0.05). CONCLUSIONS: Augmenting routine policy implementation with targeted QI intervention, delivered to volunteer clinic staff, did not additionally improve clinic-level, opioid guideline-concordant care metrics. However, the observed effect sizes suggested this approach may be effective, especially in higher-risk patients, if broadly implemented. TRIAL REGISTRATION: Not applicable.

Enhancing system-wide implementation of opioid prescribing guidelines in primary care: protocol for a stepped-wedge quality improvement project.

BACKGROUND: Systematic implementation of guidelines for opioid therapy management in chronic non-cancer pain can reduce opioid-related harms. However, implementation of guideline-recommended practices in routine care is subpar. The goal of this quality improvement (QI) project is to assess whether a clinic-tailored QI intervention improves the implementation of a health system-wide, guideline-driven policy on opioid prescribing in primary care. This manuscript describes the protocol for this QI project. METHODS: A health system with 28 primary care clinics caring for approximately 294,000 primary care patients developed and implemented a guideline-driven policy on long-term opioid therapy in adults with opioid-treated chronic non-cancer pain (estimated N = 3980). The policy provided multiple recommendations, including the universal use of treatment agreements, urine drug testing, depression and opioid misuse risk screening, and standardized documentation of the chronic pain diagnosis and treatment plan. The project team drew upon existing guidelines, feedback from end-users, experts and health system leadership to develop a robust QI intervention, targeting clinic-level implementation of policy-directed practices. The resulting multi-pronged QI intervention included clinic-wide and individual clinician-level educational interventions. The QI intervention will augment the health system's "routine rollout" method, consisting of a single educational presentation to clinicians in group settings and a separate presentation for staff. A stepped-wedge design will enable 9 primary care clinics to receive the intervention and assessment of within-clinic and between-clinic changes in adherence to the policy items measured by clinic-level electronic health record-based measures and process measures of the experience with the intervention. DISCUSSION: Developing methods for a health system-tailored QI intervention required a multi-step process to incorporate end-user feedback and account for the needs of targeted clinic team members. Delivery of such tailored QI interventions has the potential to enhance uptake of opioid therapy management policies in primary care. Results from this study are anticipated to elucidate the relative value of such QI activities.

Typical Time to Treatment of Patients With Lung Cancer in a Multisite, US-Based Study.

INTRODUCTION: The importance of high-quality, timely lung cancer care and the need to have indicators to measure timeliness are increasingly discussed in the United States. This study explored when and why delays occur in lung cancer care and compared timeliness between two states with divergent disease incidence. METHODS: Patients with small-cell or non-small-cell lung cancer were recruited through cancer centers, outpatient clinics, and community approaches, and interviewed over the phone. Statistical analysis of patient-reported dates included descriptive statistics and comparing time intervals between states and across the sites with Mann-Whitney U tests. Additionally, data from patients with longer timelines were qualitatively analyzed to identify possible reasons for delays. RESULTS: On the basis of the dates reported by 275 patients, the median time from first presentation to a clinician to treatment was 52 days; 29% of patients experienced a wait of 90 days or more. Median times for key intervals were 36.5 days from abnormal radiograph to treatment, 9.5 days from initial presentation to specialist referral, 15 days from patient informed of diagnosis to first therapy, and 16 days from referral to treatment to first therapy. More than one quarter of patients perceived delays in care. No significant differences in length of time intervals were identified between states. Monitoring of small nodules, missed diagnosis, and other reasons for longer timelines were documented. CONCLUSION: Results defined typical time to treatment of patients with lung cancer across a variety of health systems and should facilitate establishing metrics for determining timeliness of lung cancer care.

Clinician and Staff Perspectives on Participating in Practice-based Research (PBR): A Report from the Wisconsin Research and Education Network (WREN).

BACKGROUND: The success of practice-based research (PBR) depends on the willingness of clinicians and staff to incorporate meaningful and useful research protocols into already demanding clinic schedules. The impact of participation on those who implement multiple projects and how to address the issues that arise during this complex process remain incompletely described. This article reports a qualitative evaluation of the experiences of primary care clinicians and clinic staff who participated in multiple PBR projects with the Wisconsin Research and Education Network (WREN). Also included are their suggestions to researchers and clinicians for future collaborations. METHODS: For program evaluation purposes, WREN conducted 4 focus groups at its 2014 annual meeting. The main focus group question was, "How has participation in PBR affected you and your clinic?" A total of 27 project members from 13 clinics participated in 4 groups (physicians, nurses, managers, and other clinical staff). The 2-hour sessions were recorded, transcribed, and analyzed to identify recurring themes. RESULTS: Five major focus group themes emerged: receptivity to research, outcomes as a result of participation, barriers to implementation, facilitators of success, and advice to researchers and colleagues. Focus group members find research valuable and enjoy participating in projects that are relevant to their practice, even though many barriers exist. They indicated that research participation produces clinical changes that they believe result in improved patient care. They offered ways to improve the research process, with particular emphasis on collaborative early planning, project development, and communication before, during, and after a project. CONCLUSIONS: Clinics that participate in WREN projects remain willing to risk potential work constraints because of immediate or impending benefits to their clinical practice and/or patient population. Including a broader array of clinic personnel in the communication processes, especially in the development of relevant research ideas and planning for clinic implementation and ongoing participation in research projects, would address many of the barriers identified in implementing PBR. The themes and supporting quotes identified in this evaluation of WREN projects may inform researchers planning to collaborate with primary care clinics and clinicians and staff considering participating in research endeavors.

Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer: final results of the ARIES observational cohort study.

INTRODUCTION: Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor, was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. ARIES (Avastin Regimens: Investigation of Effectiveness and Safety), a prospective observational cohort study, evaluated outcomes in a large, community-based population of patients with first-line NSCLC. METHODS: From 2006 to 2009, ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab, excluding those with predominantly squamous histology. Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment. There were no protocol-defined treatments or assessments. The dosing of bevacizumab and chemotherapy, and the choice of chemotherapy regimen, was at the discretion of the treating physician. RESULTS: ARIES enrolled 1967 patients with first-line NSCLC. At study closure, median follow-up was 12.5 months (range, 0.2-65.5). Median age was 65 years (range, 31-93), and 252 patients (12.8%) identified as never smokers. Median progression-free survival was 6.6 months (95% confidence interval, 6.3-6.9), and median overall survival was 13.0 months (95% confidence interval, 12.2-13.8) with first-line bevacizumab plus chemotherapy. Incidences of bevacizumab-associated adverse events (19.7% overall) were consistent with those in randomized controlled trials of bevacizumab in NSCLC. CONCLUSION: Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC.

2008 Meeting of the National Lung Cancer Partnership: a summary of meeting highlights.

Herein are highlights from National Lung Cancer Partnership's Annual Meeting, held May 30, 2008 in Chicago. Aiming to improve the match between lung cancer patients and their drug treatments, speakers described potential predictive and prognostic biomarkers. Approaches included: (1) in non-small cell lung cancer, testing for predictive links between tumor expression levels of DNA synthesis (RRM1) and repair (ERCC1) enzymes and response to gemcitabine and cisplatin respectively, and looking for a prognostic link with ERCC1 expression; (2) validating a predictive "meta-gene profile" from gene expression microarray studies to distinguish drug-responsive from unresponsive lung cancer tumors; and (3) developing proteomics profiling to distinguish lung cancer patients, including squamous and nonsquamous cell carcinoma patients, who respond to epidermal growth factor receptor tyrosine kinase inhibitors from those who do not. The notion that cancer stem cells are fundamental in the development and progression of solid tumors including lung cancers was also discussed. Potential strategies for using this information to identify useful targets for next-generation therapies were suggested.

2007 Annual Meeting of the National Lung Cancer Partnership: a summary of meeting highlights.

This report presents highlights from The National Lung Cancer Partnership's Annual Meeting, held in June 2007 in Chicago. It discusses recent refinements in the histologic, genetic, and epigenetic subtyping of lung cancers and suggests reasons why certain therapies benefit only a subset of lung cancer patients. It also describes new molecular data about the subtype-specific differences in drug resistance among bronchioloalveolar-associated non-small cell lung cancers and discusses strategies to avoid or tackle specific drug-resistant tumors. Finally, it describes new findings about epigenetic differences-specifically in DNA hypermethylation-among lung tumors, including some male/female differences, which may prove useful as biomarkers for diagnosis, prognosis, and prediction of response to treatments.

Sex, genes and hormones.

The multidisciplinary symposium convened by the Society for Women's Health Research 'Sex Begins in the Womb' was held at the Crowne Plaza Cabana, Palo Alto, CA, USA, on 1 March 2002.