Optimizing large real-world data analysis with parquet files in R: A step-by-step tutorial.

PURPOSE: The use of open-source programming languages can facilitate open science practices in real-world evidence (RWE) studies. Real-world studies often rely on using big data, which makes using such languages complicated. We demonstrate an efficient approach that enables RWE researchers to use R to undertake RWE analysis tasks from cohort building to reporting. METHODS: Using the Merative Marketscan data (2017-2019), we developed an R function to transform the data into parquet format to be used in R. Then, we compared the differences in data size before and after transformation. We compared the performance of the transformed data in R to the original data in terms of numerical consistency and running times required to complete simple exploratory tasks. To show how the transformed databases can be used in practice, we conducted a simplified replication of an active comparator new user study from the literature. All codes are available on GitHub. RESULTS: Our approach exhibited high efficiency in data storage, as evidenced by the converted data size, which ranged from 10% to 43% of that of the original data files. The runtime of the exploratory tasks in R generally outperformed that of the original data with SAS. We showed, through example, how the converted data can be efficiently used to implement an RWE study. CONCLUSION: We demonstrate a free and efficient solution to facilitate the use of open-source programming languages with big real-world databases, which can facilitate the adoption of open science practices.

Pharmacists and Naloxone: Barriers to Dispensing and Effectiveness of an Educational Outreach Program.

BACKGROUND: The Illinois Naloxone Standing Order allows community pharmacists to dispense naloxone; however, this policy initiative may be underutilized. OBJECTIVE: Our study aims to characterize naloxone dispensing barriers, overall and by pharmacy type, make recommendations that can inform future policies to improve naloxone access, and evaluate outreach initiative effectiveness from academic detailers' perspectives. METHODS: We conducted a retrospective analysis of semistructured data collected as part of an educational outreach program targeting Illinois community pharmacists in 2021. Academic detailers conducted educational outreach visits across community pharmacy settings (i.e., primary pharmacy, grocery pharmacy, or independent pharmacy) to promote standing order use and discuss barriers pharmacists face when dispensing naloxone. Following each visit, detailers recorded visit characteristics, pharmacist-identified obstacles impacting naloxone dispensing, and visit effectiveness. RESULTS: Detailers performed in-person visits at 270 (78%) of 348 targeted sites. A lower proportion of independent pharmacies (61%) routinely stock naloxone than primary (95%, P < 0.001) or grocery (98%, P < 0.001) pharmacies. Among pharmacists at independent pharmacies, 43% indicated they were highly or extremely comfortable dispensing naloxone, a significantly lower proportion than pharmacists at grocery (79%, P < 0.001) or primary (68%, P < 0.001) pharmacies. The prevalence of salient barriers to naloxone dispensing was: cost/insurance issues (primary pharmacy = 38% vs. grocery pharmacy = 36% vs. independent pharmacy = 28%, P = 0.46), stigma (36% vs. 49% vs. 16%, P < 0.05), and lack of standing order enrollment (0% vs. 0% vs. 49%, P < 0.05). On average, detailers perceived visits as less useful to pharmacists working at independent pharmacies than those at primary or grocery pharmacies. CONCLUSIONS: Over 80% of pharmacists reported facing greater than one naloxone dispensing barrier. While cost/insurance issues appear ubiquitous, patient stigma-related factors were prevalent in primary and grocery pharmacies. Although many pharmacists are comfortable dispensing naloxone under the standing order, pharmacists at independent pharmacies are less comfortable, potentially secondary to lower standing order enrollment.

Place in Therapy of Cyclin-Dependent Kinase 4/6 Inhibitors in Breast Cancer: A Targeted Literature Review.

Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) are the preferred regimen for patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. However, the optimal treatment sequencing for CDK4/6i with other available therapeutic options is unclear. We conducted a targeted literature review to identify the current evidence on CDK4/6i treatment patterns in patients with breast cancer. The search was initially conducted in October 2021 and subsequently updated in October 2022. Biomedical databases and gray literature were searched, and bibliographies of included reviews were screened for relevant studies. The search identified ten reviews published since 2021 and 87 clinical trials or observational studies published since 2015. The included reviews discussed CDK4/6i usage with or without endocrine therapy (ET) in first-line and second-line treatment for patients with HR+/HER2- advanced or metastatic breast cancer, followed by ET, chemotherapy, or targeted therapy with ET. Clinical studies reported similar treatment sequences consisting of ET, chemotherapy, or targeted therapy with ET prior to CDK4/6i with ET, followed by ET monotherapy, chemotherapy, targeted therapy with ET, or continued CDK4/6i with ET. Current evidence suggests CDK4/6i are effective for HR+/HER2- advanced or metastatic breast cancer in earlier lines of therapy. Efficacy of CDK4/6i as measured by progression-free survival and overall survival was similar within a line of therapy regardless of the type of prior therapy. Survival on different post-CDK4/6i treatments was also similar within the same line of therapy. Additional research is needed to investigate the optimal place in therapy of CDK4/6i and the sequencing of treatments following progression on CDK4/6i.

Real-world Treatment Patterns and Clinical Outcomes Associated With Palbociclib Combination Therapy: A Multinational, Pooled Analysis From the Ibrance Real World Insights Study.

PURPOSE: Palbociclib was the first cyclin-dependent kinase 4/6 inhibitor approved by the US Food and Drug Administration for use in combination with aromatase inhibitors (AIs) as initial endocrine-based therapy or with fulvestrant in postmenopausal women who previously received endocrine therapy based on data from randomized clinical trials. Real-world studies examining the effectiveness of palbociclib in large, diverse patient populations in routine clinical practice were needed. PATIENTS AND METHODS: Ibrance Real World Insights (IRIS) was a retrospective medical record review study of women with confirmed hormone receptor-positive, HER2-negative advanced/metastatic breast cancer treated with palbociclib plus an AI or with palbociclib plus fulvestrant according to approved indications. Participating physicians reviewed medical records of up to 16 sequentially presenting patients, collecting demographic and clinical data. Outcomes included objective response rates, progression-free rates, and survival rates overall and in patients stratified according to age, race and ethnicity, Eastern Cooperative Oncology Group (ECOG) performance status (PS), disease-free interval, visceral disease, liver metastases, bone-only metastases, and previous lines of therapy. FINDINGS: Data were abstracted by 417 physicians for 2954 patients in 13 countries; 1415 patients (47.9%) were ≥65 years of age, 369 patients (12.5%) had an ECOG PS ≥2 at initiation, and 835 patients (28.3%) were races other than White. The 12-month progression-free rate was 88% for palbociclib plus an AI and 79% for palbociclib plus fulvestrant; the 12-month survival rate was 96% in both groups. The objective response rates were 80% for palbociclib plus an AI and 75% for palbociclib plus fulvestrant. Palbociclib was similarly effective in most subgroups examined. IMPLICATIONS: Data from IRIS provide in-depth, real-world evidence for the use of palbociclib in a range of breast cancer populations in multiple countries. These data support the findings of the randomized PALOMA-2 and PALOMA-3 studies.

Academic detailing interventions for opioid-related outcomes: a scoping review.

BACKGROUND: Academic detailing (AD) is a tailored, interactive educational outreach intervention that may improve patient outcomes. Insight into the design of AD interventions and the extent to which they are effective can help inform future AD-based programmes. The objective of this scoping review was to characterize opioid-focused AD interventions and describe their findings. METHODS: A scoping review focused on AD interventions for opioids was conducted in PubMed, EMBASE and CINAHL databases through July 1, 2021. Studies were eligible for inclusion if written in English, included interactive opioid-focused educational interventions, and were conducted either in person, virtually or via telephone. Four independent reviewers reviewed titles and abstracts. Data extraction from full-text publications was completed using a standardized form. RESULTS: Of 6086 articles initially identified, 22 articles met the inclusion criteria and 20 unique interventions were identified. The AD intervention was either delivered one-on-one (n=16) or in a small, interactive group setting (n=4). AD interventions varied in design. Effectiveness was evaluated in terms of opioid and naloxone prescribing rates, provider knowledge gaps, provider adherence to guidelines, and intervention feasibility. Sixteen (80%) interventions resulted in statistically significant improvement in one or more outcomes. CONCLUSION: Generally, opioid-related AD was effective and programmes were primarily conducted one-on-one between pharmacists and primary care providers for 16-30 minutes. A variety of metrics and outcomes were used to assess the success/effectiveness of AD interventions, which is an important consideration in future studies as no single metric captures the effectiveness of an educational outreach-based intervention for pain management.