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1.
Rheumatol Ther ; 2019 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-31385264

RESUMO

INTRODUCTION: Many rheumatoid arthritis (RA) patients do not achieve their treatment goals and experience symptoms that affect psychosocial outcomes and daily activities. This study aimed to identify and quantify the unmet needs perceived by US patients with RA currently taking a disease-modifying antirheumatic drug (DMARD). METHODS: A cross-sectional, web-based survey was conducted with RA patients recruited through CreakyJoints, an online patient support community, and ArthritisPower®, an online patient research registry, from December 2017 to January 2018. Participant patients were aged ≥ 21 years, failed ≥ 1 DMARDs, and were receiving their current DMARD(s) for ≥ 6 months; they answered 50 questions about treatment history, RA symptoms, and flares and completed the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire and the Treatment Satisfaction Questionnaire for Medication (TSQM). Treatment satisfaction was defined by a TSQM global satisfaction score ≥ 80. RESULTS: Of 415 patients screened, 258 (62%) were eligible and completed the survey; 87% were women, and 87% white, with mean (SD) age of 54.5 (11.4) years. A total of 232 patients (90%) had current or past biologic DMARD (bDMARD) use, with 67% currently on a bDMARD, 65% on ≥ 1 conventional synthetic DMARD, and 40% on methotrexate. Forty-three percent of patients reported daily/almost daily use of prescription pain medications, and 44% reported a current flare. Mean (SD) TSQM scores were 59 [20] for effectiveness, 59 [26] for side effects, 72 [18] for convenience, and 65 [21] for global satisfaction. The mean (SD) RAID overall score was 5.1 (2.0) on a 0-10 scale. Only 26% (67 patients) were satisfied with their RA treatment. Patients not satisfied with treatment reported higher RAID scores overall and by domain, and approximately half reported a current flare. CONCLUSIONS: Results from this real-world survey suggest that three-fourths of RA patients are not satisfied with treatments, which include bDMARDs. Patients continued to experience bothersome symptoms that impacted their daily activities and life. There remains a need for improved disease management among currently treated RA patients. FUNDING: Eli Lilly and Company (Indianapolis, IN, USA).

2.
Artigo em Inglês | MEDLINE | ID: mdl-31421018

RESUMO

OBJECTIVE: To determine the performance of administrative-based algorithms for classifying interstitial lung disease (ILD) complicating rheumatoid arthritis (RA). METHODS: Participants in a large, multicenter RA registry were screened for ILD using International Classification of Diseases (ICD) codes. Medical record review confirmed ILD among participants screening positive and a random sample of those screening negative. ICD and procedure codes, provider specialty, and dates were extracted from Veterans Affairs administrative data to construct ILD algorithms. Performance of these algorithms against medical record review was assessed by sensitivity, specificity, positive predictive value (PPV), negative predictive value, and Kappa using inverse probability weighting to account for sampling methods. RESULTS: Medical records of 536 RA patients were reviewed, confirming 182 (stringent definition) and 203 (relaxed definition) ILD cases. Initially, we identified ≥2 ICD codes from inpatient or outpatient encounters as optimal discriminating factors (specificity 96.0%, PPV 65.5%, Kappa 0.70). Subsequently, we constructed a set of ICD-9/10 codes that improved algorithm specificity (specificity 96.8%, PPV 69.5%, Kappa 0.72). Algorithms that included a pulmonologist diagnosis or chest CT plus pulmonary function testing or lung biopsy had improved performance (specificity 98.0%, PPV 77.4%, Kappa 0.75). PPV increased with exclusion of other ILD causes (78.5%), in comparisons with the relaxed ILD definition (82.4%), and in sensitivity analyses (83.4-86.3%). Gains in specificity and PPV with greater algorithm requirements were accompanied by declines in sensitivity. CONCLUSION: Administrative algorithms with optimal combinations of ICD codes, provider specialty, diagnostic testing, and exclusion of other ILD causes accurately classify ILD in RA.

3.
Gait Posture ; 73: 246-250, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31377580

RESUMO

BACKGROUND: Clinicians often use thirty-second-sit (chair)-to-stand (30CST), timed-up-and-go (TUG), and the five-times-sit-to-stand (5xSTS) since these outcome measures (OMs) are sensitive for strength, balance and mobility. RESEARCH QUESTION: The purpose of this study was to validate a custom smart phone application (App) that can remotely assess the 30CST, TUG, and 5xSTS. METHODS: Thirty-one healthy adults (range: 22-55 y; 54.6-106.8 kg; 160-185 cm; 19 females) participated in this cross-sectional study. Each participant performed the 30CST, TUG, and 5xSTS at a slow and normal speed. They performed each OMs twice while the App collected their performance data using both an iOS and Android phone. The gold standard of each test was the average of the silent count of two investigators for the 30CST and the time recorded by two investigators using stopwatches for the TUG and 5xSTS. Investigators analyzed the data using Intraclass Correlation coefficients (ICC), Pearson R coefficients, Signed Rank Tests, and Wilcoxon Rank-Sum Tests. RESULTS AND SIGNIFICANCE: A significant correlation was observed between the performances recorded by the phones and the direct observation gold standard for all three OMs (r > 0.97). For 30CST, no significant mean count differences were found for the following comparisons: between phones, within phone types, or within phone-by-speed levels. (P-values range 0.06-1.00). While a statistically significant difference was found in all of the time comparisons when performing TUG and 5xSTS (p < 0.0001) except for the between phone comparison with TUG (p = 0.27). For TUG and 5xSTS, the time difference was less than a second when compared to the gold standard and ICCs showed moderate to strong agreement when comparing the phone application to the gold standard (ICCs range 0.60-0.99). These data suggested that the App could validly measure performance of these OMs.

4.
Arthritis Res Ther ; 21(1): 160, 2019 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-31255174

RESUMO

OBJECTIVE: To examine the feasibility, preference, and satisfaction of an interactive voice response (IVR) system versus a customized smartphone application (StudyBuddy) to capture gout flares METHODS: In this 24-week prospective, randomized, crossover, open-label pilot study, 44 gout patients were randomized to IVR vs. StudyBuddy and were crossed over to the other technology after 12 weeks. Flares were reported via weekly (and later daily) scheduled StudyBuddy or IVR queries. Feasibility was ascertained via response rate to scheduled queries. At 12 and 24 weeks, participants completed preference/satisfaction surveys. Preference and satisfaction were assessed using dichotomous or ordinal questions. Sensitivity was assessed by the frequency of flare reporting with each approach. RESULTS: Thirty-eight of 44 participants completed the study. Among completers, feasibility was similar for IVR (81%) and StudyBuddy (80%). Conversely, most (74%) preferred StudyBuddy. Measures of satisfaction (ease of use, preference over in-person clinic visits, and willingness for future use) were similar between the IVR and StudyBuddy; however, more participants deemed the StudyBuddy as convenient (95% vs. 73%, P = 0.01) and less disruptive (97% vs. 82%, P = 0.03). Although the per patient number of weeks in flare was not significantly different (mean 3.4 vs. 2.6 weeks/patient, P = 0.15), the StudyBuddy captured more of the total flare weeks (35%) than IVR (27%, P = 0.02). CONCLUSION: A smartphone application and IVR demonstrated similar feasibility but overall sensitivity to capture gout flares and participant preference were greater for the smartphone application. Participant preference for the smartphone application appeared to relate to perceptions of greater convenience and lower disruption. TRIAL REGISTRATION: NCT, NCT02855437 . Registered 4 August 2016.

5.
Artigo em Inglês | MEDLINE | ID: mdl-31298463

RESUMO

PURPOSE: As more biosimilars become available in the United States, postapproval noninterventional studies describing biosimilar switching and comparing effectiveness and/or safety between switchers and nonswitchers will play a key role in generating real-world evidence to inform clinical practices and policy decisions. Ensuring sound methodology is critical for making valid inferences from these studies. METHODS: The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) convened a workgroup consisting of academic researchers, industry scientists, and practicing clinicians to establish best practice recommendations for the conduct of noninterventional studies of biosimilar and reference biologic switching. The workgroup members participated in eight teleconferences between August 2017 and February 2018 to discuss specific topics and build consensus. RESULTS: This report provides workgroup recommendations covering five main considerations relating to noninterventional studies describing reference biologic to biosimilar switching and comparing reference biologic to biosimilars for safety and effectiveness in the presence of switching at treatment initiation and during follow-up: (a) selecting appropriate data sources from a range of available options including insurance claims, electronic health records, and registries; (b) study designs; (c) outcomes of interest including health care utilization and clinical endpoints; (d) analytic approaches including propensity scores, disease risk scores, and instrumental variables; and (e) special considerations including avoiding designs that ignore history of biologic use, avoiding immortal time bias, exposure misclassification, and accounting for postindex switching. CONCLUSION: Recommendations provided in this report provide a framework that may be helpful in designing and critically evaluating postapproval noninterventional studies involving reference biologic to biosimilar switching.

6.
J Bone Miner Res ; 2019 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-31170317

RESUMO

Our study validated a claims-based algorithm for the identification of incident and recurrent fractures in administrative data. We used Centers for Medicare and Medicaid (CMS) claims from 2005 to 2014 linked to the Reasons for Geographic and Racial Differences in Stroke (REGARDS) database. Case qualifying (CQ) fractures were identified among participants with ≥12 months of fee-for-service coverage before first fracture claim and ≥6 months after. Recurrent fractures were defined as the first CQ fracture that occurred following a clean period of at least 90 days from the last claim associated with the preceding incident fracture. We used medical records (discharge summary, imaging, and surgical report) to adjudicate fractures. We calculated positive predictive values (PPVs) for incident and recurrent fractures. Our study was not designed to assess the algorithm sensitivity or negative predictive value. We identified 2049 potential incident fractures from claims among 1650 participants. Record retrieval was attempted for 728 (35.5%) suspected incident fractures (prioritizing more recent CQ fractures associated with osteoporosis, but without explicitly requiring any osteoporosis ICD-9 diagnosis code). Our final sample included 520 claims-identified fractures with medical records, of which 502 (96.5%) were confirmed. The PPVs (95% CI) of the hip, wrist, humerus, and clinical vertebra-all exceeded 95%. We identified 117 beneficiaries with 292 ≥2 CQ fracture episodes at the same site, and attempted retrieval on 105 (36.0%) episodes. Our analytic sample included 72 (68.5%) CQ episodes from 33 participants. The PPVs for identifying recurrent clinical vertebral, hip/femur, and nonvertebral fractures with a 90-day clean period exceeded 95%. Although we could not ascertain sensitivity, our updated fracture identification algorithms had high PPV for the identification of incident and recurrent fractures of the same site. Although medical record review and clinical adjudication remain a gold standard, our claims-based algorithm provides an alternative approach to fracture ascertainment when high PPV is desired. © 2019 American Society for Bone and Mineral Research.

7.
Ann Intern Med ; 2019 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-31108503

RESUMO

Background: Patients with rheumatoid arthritis (RA) are at increased risk for infection after arthroplasty, yet risks of specific biologic medications are unknown. Objective: To compare risk for postoperative infection among biologics and to evaluate the risk associated with glucocorticoids. Design: Retrospective cohort study. Setting: Medicare and Truven MarketScan administrative data from January 2006 through September 2015. Patients: Adults with RA who were having elective inpatient total knee or hip arthroplasty, either primary or revision, and had a recent infusion of or prescription for abatacept, adalimumab, etanercept, infliximab, rituximab, or tocilizumab before surgery. Measurements: Propensity-adjusted analyses using inverse probability weights evaluated comparative risks for hospitalized infection within 30 days and prosthetic joint infection (PJI) within 1 year after surgery between biologics or with different dosages of glucocorticoids. Secondary analyses evaluated non-urinary tract hospitalized infections and 30-day readmissions. Results: Among 9911 patients treated with biologics, 10 923 surgical procedures were identified. Outcomes were similar in patients who received different biologics. Compared with an 8.16% risk for hospitalized infection with abatacept, predicted risk from propensity-weighted models ranged from 6.87% (95% CI, 5.30% to 8.90%) with adalimumab to 8.90% (CI, 5.70% to 13.52%) with rituximab. Compared with a 2.14% 1-year cumulative incidence of PJI with abatacept, predicted incidence ranged from 0.35% (CI, 0.11% to 1.12%) with rituximab to 3.67% (CI, 1.69% to 7.88%) with tocilizumab. Glucocorticoids were associated with a dose-dependent increase in postoperative risk for all outcomes. Propensity-weighted models showed that use of more than 10 mg of glucocorticoids per day (vs. no glucocorticoid use) resulted in a predicted risk for hospitalized infection of 13.25% (CI, 9.72% to 17.81%) (vs. 6.78%) and a predicted 1-year cumulative incidence of PJI of 3.83% (CI, 2.13% to 6.87%) (vs. 2.09%). Limitation: Residual confounding is possible, and sample sizes for rituximab and tocilizumab were small. Conclusion: Risks for hospitalized infection, PJI, and readmission after arthroplasty were similar across biologics. In contrast, glucocorticoid use, especially with dosages above 10 mg/d, was associated with greater risk for adverse outcomes. Primary Funding Source: Rheumatology Research Foundation, National Institutes of Health, and Bristol-Myers Squibb.

8.
Curr Opin Rheumatol ; 31(4): 355-361, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31116112

RESUMO

PURPOSE OF REVIEW: This review will describe the available large-scale data sources to study spondyloarthritis (SpA), enumerate approaches to identify SpA and its disease-related manifestations and outcomes, and will outline existing and future methods to collect novel data types [e.g. patient-reported outcomes (PRO), passive data from wearables and biosensors]. RECENT FINDINGS: In addition to traditional clinic visit-based SpA registries, newer data sources, such as health plan claims data, single and multispecialty electronic health record (EHR) based registries, patient registries and linkages between data sources, have catalyzed the breadth and depth of SpA research. Health activity tracker devices and PRO collected via PROMIS instruments have been shown to have good validity when assessed in SpA patients as compared to legacy disease-specific instruments. In certain cases, machine learning outperforms traditional methods to identify SpA and its associated manifestations in EHR and claims data, and may predict disease flare. SUMMARY: Although caution remains in the application of newer data sources and methods including the important need for replication, the availability of new data sources, health tracker devices and analytic methods holds great promise to catalyze SpA research.

9.
J Manag Care Spec Pharm ; 25(6): 697-704, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31134863

RESUMO

BACKGROUND: The treatment for hepatitis C virus (HCV) infection has evolved over time, and direct-acting antivirals (DAA) have revolutionized HCV therapy. OBJECTIVES: To (a) assess early treatment discontinuation and (b) identify predictors of early discontinuation in a cohort of patients receiving second-generation DAAs. METHODS: We identified HCV patients newly prescribed simeprevir/sofosbuvir (SIM/SOF), ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ritonavir + dasabuvir (OPrD), sofosbuvir/velpatasvir (SOF/VEL), elbasvir/grazoprevir (EBR/GZR), and glecaprevir/pibrentasvir (GLE/PIB) between 2014 and 2017. Early discontinuation was defined as duration of therapy less than 8 weeks. Multivariable logistic regression was performed to evaluate the association of drug regimens and potential predictive factors to early discontinuation. RESULTS: We identified 26,098 DAA-treated patients: 67.8% with LDV/SOF, 9.9% with OPrD, 8.5% with SIM/SOF, 7.8% with SOF/VEL, 5.2% with EBR/GZR, and 0.8% with GLE/PIB. With approval of new therapies in 2016 and 2017, use of OPrD, LDV/SOF, and SIM/SOF declined substantially. At baseline, there was some heterogeneity of past HCV drug use and comorbidity across groups; patients on SIM/SOF had the highest frequency of previous interferon, cirrhosis, and decompensated cirrhosis. Most HCV patients received therapy for 8-12 weeks; fewer patients went through 16-week and 24-week therapy courses. Early discontinuation rates (95% CI) were 7.1% (6.0-8.2) for SIM/SOF, 3.2% (2.9-3.5) for LDV/SOF, 9.6% (8.5-10.7) for OPrD, 3.1% (2.3-3.8) for SOF/VEL, 4.2% (3.1-5.3) for EBR/GZR, and 2.5% (0.3-4.7) for GLE/PIB. In multivariable analyses, versus OPrD, patients starting other drug regimens were less likely to discontinue therapy early. Early discontinuation was more common in women, patients with baseline anemia, and Medicare and Medicaid patients. CONCLUSIONS: These real-world data confirm low rates of early discontinuation in users of second-generation DAAs. Future research focusing on socio-economic and sex/gender issues may help further optimize care for patients with HCV. DISCLOSURES: This study was funded by the Canadian Institutes of Health Research. Klein has received grants for investigator-initiated trials from ViiV Healthcare, Janssen, Gilead, and Merck, as well as consulting fees from ViiV Healthcare, Merck, and AbbVie. Feld has received research support and/or scientific consulting fees from AbbVie, Contravir, Enanta, Gilead, Janssen, Merck, and Wako. All other authors have no conflicts of interest to declare. Results from this study were presented as a poster at the 34th International Conference of Phamacoepidemiology and Therapeutic Risk Management; August 22-26, 2018; Prague, Czech Republic.

10.
J Manag Care Spec Pharm ; 25(5): 518-521, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31039069

RESUMO

In the United States, there is an increased interest to understand the value of health technologies. Cost-effectiveness analysis is arguably the most appropriate framework to quantify value and to inform reimbursement decision making regarding medical interventions; however, a thorough analysis is resource intensive and complex. In many countries, the cost-effectiveness of medical interventions is evaluated by expert agencies at the national level, but in the United States, reimbursement decision making occurs at the local level. This raises the question of how we can provide a means to transparent cost-effectiveness analysis that reflects the local context and patient population and is based on the latest evidence and scientific insights. In other words, how can we maximize the relevance and credibility of cost-effectiveness evaluations in the context of a decentralized decision-making environment? Published cost-effectiveness analyses typically fail on these dimensions. Access to transparent open-source models that can be adapted to reflect the local setting in a relatively straightforward manner is an essential step toward such a goal. However, no model for cost-effectiveness analysis is ever truly "right" or "complete," and it must evolve along with clinical evidence and improvements in scientific methodology to ensure that its credibility remains. We propose a transparent approach of iterative development and collaboration between content and methodology experts to produce up-to-date, open-source consensus-based cost-effectiveness models that account for parameter and structural uncertainty to help local decision makers understand the confidence with which they might make a decision. Our proposed approach provides a way to adapt formal assessments of value-long the province of centralized health care systems-into the decentralized U.S. health care landscape. DISCLOSURES: This research was funded through the Innovation and Value Initiative, a nonprofit multistakeholder research organization. The Innovation and Value Initiative contracted with Precision Medicine Group for research activities related to this article. Jansen and Incerti are salaried employees and shareholders of Precision Medicine Group. Curtis is a paid consultant for the Innovation and Value Initiative. Curtis also reports consulting fees and grants from Amgen, AbbVie, BMS, Corrona, Janssen, Lilly, Myriad, Pfizer, Roche/Genentech, Radius, and UCB, unrelated to this article.


Assuntos
Análise Custo-Benefício/métodos , Assistência à Saúde/organização & administração , Política de Saúde/economia , Modelos Econômicos , Tecnologia Biomédica , Análise Custo-Benefício/normas , Assistência à Saúde/economia , Política de Saúde/legislação & jurisprudência , Invenções/economia , Invenções/legislação & jurisprudência , Formulação de Políticas , Anos de Vida Ajustados por Qualidade de Vida , Mecanismo de Reembolso/economia , Mecanismo de Reembolso/legislação & jurisprudência , Estados Unidos
11.
Rheum Dis Clin North Am ; 45(2): 173-186, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30952391

RESUMO

This article aims to describe key issues, processes, and outcomes related to development of a patient registry for rheumatology research using a digital platform where patients track useful data about their condition for their own use while contributing to research. Digital interventions are effective to build a patient research registry for people with rheumatoid arthritis and other rheumatic and musculoskeletal diseases. ArthritisPower provides evidence of the value of digital interventions to build community support for research and to transform patient engagement and patient-generated data capture.

12.
Rheum Dis Clin North Am ; 45(2): 275-289, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30952398

RESUMO

Real-world evidence requires use of new tools and methods to support efficient evidence generation. Among those tools are pragmatic trials, utilization of central/single institutional review board and electronic consent, and data linkages between diverse types of data sources (eg, a trial or registry to administrative claims or electronic medical record data). This article reviews these topics in the context of describing several exemplar use cases specific to rheumatology and provides perspective regarding both the promise and potential pitfalls in using these tools and approaches.

14.
Eur Respir J ; 54(1)2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31000676

RESUMO

INTRODUCTION: Non-cystic fibrosis (CF) bronchiectasis ("bronchiectasis") is a chronic airway disease for which little data exist to inform treatment decisions. We sought to compare the risks of respiratory infections in chronic users of inhaled corticosteroids (ICSs) versus macrolide monotherapy. METHODS: We identified a cohort of US Medicare enrollees with a bronchiectasis diagnosis (International Classification of Diseases, Ninth Revision, Clinical Modification code 494.0 or 494.1) between 2006 and 2014, excluding CF. We defined chronic new use as the first ≥28-day prescription of ICS therapy or macrolide monotherapy. We compared the characteristics of the exposure cohorts using standardised mean differences (SMDs) and computed a propensity score (PS) to account for treatment differences. The risks of acute exacerbation, hospitalised respiratory infection, all-cause hospitalisation and mortality were compared using PS decile-adjusted Cox regression models. RESULTS: We identified 83 589 new users of ICSs and 6500 new users of macrolides from 285 043 included Medicare enrollees with bronchiectasis. The crude incidence of hospitalised respiratory infection was 12.6 (ICS therapy) and 10.3 (macrolide monotherapy) per 100 patient-years. The PS-adjusted HRs comparing ICS with macrolide new users were 1.39 (95% CI 1.23-1.57) for hospitalised respiratory infection, 1.56 (95% 1.49-1.64) for acute exacerbation and 1.09 (95% 0.95-1.25) for mortality. INTERPRETATION: Among patients with bronchiectasis, the use of ICSs was associated with an increased risk of hospitalised respiratory infections compared with macrolide monotherapy.

15.
Arthritis Res Ther ; 21(1): 89, 2019 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-30953540

RESUMO

BACKGROUND: Final data are presented for the ORAL Sequel long-term extension (LTE) study evaluating the safety and efficacy of tofacitinib 5 mg and 10 mg twice daily (BID) for up to 9.5 years in patients with rheumatoid arthritis (RA). METHODS: Eligible patients had previously completed a phase 1, 2, or 3 qualifying index study of tofacitinib and received open-label tofacitinib 5 mg or 10 mg BID. Stable background therapy, including csDMARDs, was continued; adjustments to tofacitinib or background therapy were permitted at investigators' discretion. Assignment to dose groups (5 mg or 10 mg BID) was based on patients' average total daily dose. The primary objective was to determine the long-term safety and tolerability of tofacitinib 5 mg and 10 mg BID; the key secondary objective was to evaluate the long-term persistence of efficacy. RESULTS: Between February 5, 2007, and November 30, 2016, 4481 patients were enrolled. Total tofacitinib exposure was 16,291 patient-years. Safety data are reported up to month 114 for all tofacitinib; efficacy data are reported up to month 96 for tofacitinib 5 mg BID and month 72 for 10 mg BID (with low patient numbers limiting interpretation beyond these time points). Overall, 52% of patients discontinued (24% due to adverse events [AEs] and 4% due to insufficient clinical response); the safety profile remained consistent with that observed in prior phase 1, 2, 3, or LTE studies. The incidence rate (IR; number of patients with events per 100 patient-years) for AEs leading to discontinuation was 6.8. For all-cause AEs of special interest, IRs were 3.4 for herpes zoster, 2.4 for serious infections, 0.8 for malignancies excluding non-melanoma skin cancer, 0.4 for major adverse cardiovascular events, and 0.3 for all-cause mortality. Clinically meaningful improvements in the signs and symptoms of RA and physical functioning, which were observed in the index studies, were maintained. CONCLUSIONS: Tofacitinib 5 mg and 10 mg BID demonstrated a consistent safety profile (as monotherapy or combination therapy) and sustained efficacy in this open-label LTE study of patients with RA. Safety data are reported up to 9.5 years, and efficacy data up to 8 years, based on adequate patient numbers to support conclusions. TRIAL REGISTRATION: NCT00413699 , funded by Pfizer Inc (date of trial registration: December 20, 2006).

16.
J Am Med Inform Assoc ; 26(7): 594-602, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-30938759

RESUMO

OBJECTIVE: Patient-powered research networks (PPRNs) are a valuable source of patient-generated information. Diagnosis code-based algorithms developed by PPRNs can be used to query health plans' claims data to identify patients for research opportunities. Our objective was to implement privacy-preserving record linkage processes between PPRN members' and health plan enrollees' data, compare linked and nonlinked members, and measure disease-specific confirmation rates for specific health conditions. MATERIALS AND METHODS: This descriptive study identified overlapping members from 4 PPRN registries and 14 health plans. Our methods for the anonymous linkage of overlapping members used secure Health Insurance Portability and Accountability Act-compliant, 1-way, cryptographic hash functions. Self-reported diagnoses by PPRN members were compared with claims-based computable phenotypes to calculate confirmation rates across varying durations of health plan coverage. RESULTS: Data for 21 616 PPRN members were hashed. Of these, 4487 (21%) members were linked, regardless of any expected overlap with the health plans. Linked members were more likely to be female and younger than nonlinked members were. Irrespective of duration of enrollment, the confirmation rates for the breast or ovarian cancer, rheumatoid or psoriatic arthritis or psoriasis, multiple sclerosis, or vasculitis PPRNs were 72%, 50%, 75%, and 67%, increasing to 91%, 67%, 93%, and 80%, respectively, for members with ≥5 years of continuous health plan enrollment. CONCLUSIONS: This study demonstrated that PPRN membership and health plan data can be successfully linked using privacy-preserving record linkage methodology, and used to confirm self-reported diagnosis. Identifying and confirming self-reported diagnosis of members can expedite patient selection for research opportunities, shorten study recruitment timelines, and optimize costs.

17.
Artigo em Inglês | MEDLINE | ID: mdl-31008566

RESUMO

OBJECTIVE: To identify and prioritize patient- and rheumatologist-perceived barriers to achieving disease control. METHODS: RA patients and rheumatologists from the Consortium of Rheumatology Researchers of North America (Corrona) registry were invited by email to participate in nominal groups (NGs). Two separate lists of barriers were created, one from RA-patient-only NGs and other from rheumatologist-only NGs, and barriers were sorted into themes. Next, using an online survey a random sample of RA patients from Corrona registry were asked to rank their top three barriers to achieving disease control. RESULTS: 4 NGs with 37 RA patients identified patient-barriers to achieving control of RA activity that were classified into 17 themes. 3 NGs with 25 rheumatologists identified barriers that were classified into 11 themes. Financial aspects of RA care ranked 1st for both types of NGs, while medication risk aversion ranked 2nd and 3rd among the physician- and patient-NG-generated barriers, respectively. Among the 450 RA patients surveyed, 77% considered RA a top-health priority, and 51% reported being aware of the treat-to-target (T2T) strategy for RA care; the three most important patient-perceived challenges to achieving disease control were RA prognosis uncertainty, medication risk aversion and the financial/administrative burden associated with RA care. CONCLUSION: There are common, potentially modifiable, patient- and rheumatologist-reported barriers to achieving RA disease control, including perceived medication risk aversion, suboptimal treatment adherence, and suboptimal patient-physician communication regarding the benefits of tight control of disease activity in RA. Addressing these obstacles may improve adherence to goal-directed RA care. This article is protected by copyright. All rights reserved.

18.
Curr Opin Rheumatol ; 31(3): 264-270, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30870218

RESUMO

PURPOSE OF REVIEW: The opioid epidemic remains prominent in both the medical literature and popular media. Rheumatologists are among the physicians at the forefront of the epidemic because of the prominent role of pain in rheumatoid arthritis (RA) and the limited options for treatment of pain. The purpose of this review is to provide an update on the trends of opioid use among patients with RA, to discuss the various mechanisms of RA pain, review the available evidence for opioid efficacy in RA, and to promote a guideline for best practices in opioid prescribing. RECENT FINDINGS: Recent cohort studies have estimated that up to 40% of patients with RA are regular users of opioids, and the effects of disease-modifying antirheumatic drugs are minimal in reducing opioid use. Although the literature supports the efficacy of short-term opioids for the improvement in pain, long-term use is associated with reduced efficacy and increased safety concerns. SUMMARY: Although the data supporting the use of long-term opioid use in patients with RA is poor, rheumatologists can adhere to best practices for determining when and if initiation of opioids is appropriate. Identification of the nature of the pain can help determine the appropriate course of treatment.

19.
Artigo em Inglês | MEDLINE | ID: mdl-30927515

RESUMO

BACKGROUND/PURPOSE: Health information technology has enabled efficient measurement of patient reported outcomes (PROs). The NIH PROMIS system (The Patient-Reported Outcomes Measurement Information System) is becoming more widely adopted for research and routine care, and some PROMIS instruments might be substituted for lengthier, legacy PRO instruments. METHODS: Four PROMIS computer adaptive testing (CAT) instruments (Pain Interference, Physical Function, Sleep Disturbance, Fatigue) and RAPID3, along with pain intensity and patient global assessment score, were administered to participants in the ArthritisPower registry. The RAPID3 was predicted using different combinations of these variables to create a new score ("CAT-PROMIS RAPID3"). Kappa statistics and Bland-Altman 95% limits of agreement were used to measure agreement between the observed vs. predicted RAPID3. RESULTS: 6,154 eligible patients contributed 11,275 observations. Mean (SD) age was 52.7 (10.5) years, 93% were women. The median assessment times ranged from 29 seconds (PROMIS sleep disturbance) to 116 seconds (RAPID3). As single pairwise comparisons, the PROMIS CATs examined were modestly correlated (r~0.4-0.7) to one other and RAPID3. Together with the pain intensity and patient global, the PROMIS instruments explained a high fraction of total variance (R2 =0.97) of the RAPID3 score. In the model with highest agreement (kappa=0.93) between the observed RAPID3 and the CAT-PROMIS predicted RAPID3, Bland-Altman 95% limits of agreement showed minimal residual differences and no systematic biases. CONCLUSION: There was excellent agreement between the observed RAPID3 and predicted RAPID3 scores estimated using several PROMIS instruments. The MDHAQ and patient global components of RAPID3 may be unnecessary if PROMIS scores are available. This article is protected by copyright. All rights reserved.

20.
Artigo em Inglês | MEDLINE | ID: mdl-30875456

RESUMO

OBJECTIVE: We performed a systematic review and meta-analysis to evaluate the comparative effects of tumor necrosis factor-α inhibitors (TNFi), non-TNFi biologic and conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) on cardiovascular risk in rheumatoid arthritis (RA). METHODS: Through a systematic search through May 8, 2018, we included 14 observational studies in adults with RA treated with TNFi, non-TNFi biologics, tofacitinib or csDMARDs, reporting the risk of major adverse cardiovascular events (MACE) or stroke. Only studies reporting active comparators were included. We performed random effects meta-analysis and estimated odds ratios (OR) and 95% confidence interval (CI). RESULTS: As compared to TNFi, tocilizumab was associated with a decreased risk of MACE (OR, 0.59 [0.34-1.00]), whereas csDMARDs were associated with increased risk of MACE (csDMARDs, including methotrexate: OR, 1.45 [1.09-1.93]; without methotrexate: OR, 2.57 [1.32-5.00]), without heterogeneity (I2 =0%); there was no difference in risk of MACE between abatacept and TNFi (OR, 0.89 [0.71-1.11]), or between tocilizumab and abatacept (OR, 0.81 [0.57-1.16]). Based on 11 cohorts (n=135,053 patients), as compared to TNFi, csDMARDs were associated with increased risk of stroke (OR, 1.17 [1.01-1.36]); there was no difference in risk of stroke between different biologics (tocilizumab vs. TNFi: OR, 0.98 [0.59-1.61]; abatacept vs. TNFi: OR, 1.08 [0.86-1.34]; tocilizumab vs. abatacept: OR, 0.73 [0.39-1.38]), without heterogeneity (I2 =0%). No comparative studies on cardiovascular risk with tofacitinib were identified. CONCLUSION: Based on meta-analysis, as compared to TNFi, tocilizumab may be associated with reduced risk of MACE, whereas csDMARDs may be associated with increased risk of MACE and stroke.

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