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1.  The rheumatoid arthritis treat-to-target trial: a cluster randomized trial within the Corrona rheumatology network 
Background
The treat-to-target (T2T) approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity, frequent follow-up visits for patients with moderate to high disease activity, and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores. The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices. It is designed to identify patient and provider barriers to implementing T2T management. This initial paper focuses on the novel study design and methods created to provide these insights.
Methods/Design
This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T2T or usual care (UC) for qualified patients who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity. Specific medication choices are left to the investigator and patient, rather than being specified in the protocol. Enrollment is expected to be completed by the end of 2013, with 30 practices randomized and enrolling a minimum of 530 patients. During the 12-month follow-up, visits are mandated as frequently as monthly in patients with active disease in the T2T group and every 3 months for the UC group. Safety data are collected at each visit. The coprimary endpoints include a comparison of the proportion of patients achieving low disease activity in the T2T and UC groups and assessment of the feasibility of implementing T2T in rheumatology practices, specifically assessment of the rates of treatment acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity in the 2 groups.
Discussion
This cluster-randomized behavioral intervention study will provide valuable insights on the outcomes and feasibility of employing a T2T treatment approach in clinical practice in the United States.
Trial registration
NCT01407419
doi:10.1186/1471-2474-15-389
PMCID: PMC4258022  PMID: 25416400
Treat to target; Rheumatoid arthritis; Corrona; Usual care
2.  Technetium-99m Bone Scan and Panoramic Radiography in Detection of Bone Invasion by Oral Carcinoma 
Objective: The correct extension of cancer in the bone usually remains undetected on static imaging which may lead to inadequate or over excision. The conventional radiography as well as other anatomical imaging modalities like computed tomography, magnetic resonance imaging often fails to detect functional changes in the bone. However, bone scinitigraphy is highly sensitive in detecting earlier changes in the bone but lack anatomical definition. The purpose of the study was to evaluate the accuracy of combining technetium-99m bone scan and panoramic radiography (Tc scan/PR) over using single diagnostic modality in detection of jaw bone invasion by oral carcinomas. The accuracy of these imaging modalities either alone or in combination were determined by comparing with the histopathological findings.
Materials and Methods: Twenty patients with biopsy-proven oral malignant tumors were randomly selected from Oral Medicine and Radiology department over a period of two years. All patients were investigated preoperatively by Tc scan and PR. Lewis – Jones’s designed diagnostic criterion was applied on Tc scan/PR to evaluate bone involvement by cancer. To test the accuracy of Tc scan, PR and Tc scan/PR, their results were compared with the histopathological findings of resected specimen.
Results: Hybrid Tc scan/PR had higher specificity, accuracy and positive predictive value (83.3%, 94.7%, 92.8%) than Tc scan alone (50%, 84.2%, 81.2%) and higher sensitivity and negative predictive value (100%, 100%) than PR (69.2%, 55.5%).
Conclusion: Combination of Tc scan and PR was more accurate in detecting jaw bone invasion by oral squamous cell carcinoma than Tc scan and PR alone.
doi:10.7860/JCDR/2014/8429.4378
PMCID: PMC4080065  PMID: 24995244
Technetium-99m bone scan; Panoramic radiography; Bone invasion; Oral cancer; Oral squamous cell carcinoma
3.  Factors Associated with Gastrointestinal Perforation in a Cohort of Patients with Rheumatoid Arthritis 
Arthritis care & research  2012;64(12):1819-1828.
Objective
To estimate the incidence and risk factors for gastrointestinal (GI) perforation among patients with rheumatoid arthritis (RA).
Methods
Claims from employer health insurance plans were used to identify RA patients and those hospitalized for upper or lower GI perforation. GI perforation cases were identified using both a sensitive and specific definition. A Cox model using fixed and time-varying covariates was used to evaluate risk of GI perforation.
Results
Among 143,433 RA patients, and using a maximally sensitive GI perforation definition, 696 hospitalizations with perforation were identified. The rate of perforation was 1.70 per 1000 person years (PYs) [95% CI, 1.58–1.83] and most perforations (83%) occurred in the lower GI tract. The rate of perforation was lower when a more specific GI perforation definition was used (0.87, 95% CI, 0.78–0.96 per 1,000 PYs). Age and diverticulitis were among the strongest risk factors for perforation (diverticulitis hazard ratio=14.5 [95% CI, 11.8–17.7] for more sensitive definition, hazard ratio=3.9 [95% CI, 2.5–5.9] for more specific definition). Among various RA medication groups, and compared to methotrexate, the risk of GI perforation was highest among patients with exposure to concomitant non-biologic disease-modifying antirheumatic drugs and glucocorticoids. Biologics without glucocorticoid exposure was not a risk factor for perforation.
Conclusion
GI perforation is a rare but serious condition that affects patients with RA, most frequently in the lower GI tract. Clinicians should be aware of risk factors for GI perforation when managing RA patients, including age, history of diverticulitis, and use of glucocorticoids or NSAIDs.
doi:10.1002/acr.21764
PMCID: PMC3508293  PMID: 22730417
4.  Bone Scintigraphy and Panoramic Radiography in Deciding the Extent of Bone Resection in Benign Jaw Lesions 
Objective: To find out the value of correlating radiographic and scintigraphic imaging for defining the extent and nature of benign jaw lesions (BJL).
Material and Methods: Twenty patients with histologically proven benign lesions of the jaws were investigated pre-operatively by panoramic radiography (PR) and bone scintigraphy (BS). To test the efficacy of combination of these two imaging modalities, their results were compared with intra-operative and histopathological findings.
Result: Most of the benign lesions presented radiographically as well-defined bone destructions with fine sclerotic rims. Such lesions were found to be silent on scintigraphs and the extent of radionuclide uptake was same as radiographically visible extent of bone involvement. However, aggressive lesions showed ill-defined bone destructions without sclerotic rims on radiographs and their scintigraphic uptake correctly exceeded the radiographic extent of the bone involvement.
Conclusion: The efficacy of combination of both complementary imagings is rewarding in defining the extent of the BJL, especially when radiographic margins are not so well defined. So, that surgical excisions will be complete and the possibility recurrences is reduced.
doi:10.7860/JCDR/2013/5963.3522
PMCID: PMC3843459  PMID: 24298527
Bone scintigraphy; Panoramic radiography; Jaws; Benign lesions
5.  Dyslipidemia and Changes in Lipid Profiles Associated with Rheumatoid Arthritis and Initiation of Anti-TNF Therapy 
Arthritis care & research  2012;64(9):1282-1291.
OBJECTIVE
To investigate the frequency of lipid testing in clinical practice and explore the relationship between rheumatoid arthritis (RA), dyslipidemia, and other cardiovascular (CV) risk factors, with RA treatment.
METHODS
Patients in the retrospective database study were ≥18 years old and had ≥2 physician diagnoses for RA or osteoarthritis (OA) [comparator group] between March 2004-March 2008. Outcomes of interest included the percentage of RA and OA patients receiving lipid tests, lipid profiles (total cholesterol [TC], low-density lipoprotein cholesterol [LDL-C], and high-density lipoprotein cholesterol [HDL-C]) of RA vs. OA patients, and lipid profiles of RA patients before and after initiation with a tumor necrosis factor inhibitor (TNFi). We used multivariable regression to control potential confounders between the cohorts.
RESULTS
Over a median 2+ year follow-up, fewer RA patients than OA patients had at least one lipid test (62% [95% CI, 60-64] vs. 68% [95% CI, 65-71]). Mean TC and LDL-C were each 4 mg/dL lower in the RA cohort (P<0.0001); HDL-C was similar between cohorts. Across the RA cohort, 25.2% of patients had suboptimal LDL-C levels (≥130 mg/dL). Among RA patients not using lipid-lowering therapy who initiated TNFi therapy (n=96), mean TC and LDL-C increased by 5.4 and 4.0 mg/dL, respectively.
CONCLUSION
RA patients were less likely to be tested for hyperlipidemia and had more favorable lipid profiles than OA patients. TNFi therapy modestly increased all lipid parameters. Additional studies are needed to determine the effect of traditional CV risk factors, inflammation, and the impact of biologics on CV outcomes in RA patients.
doi:10.1002/acr.21693
PMCID: PMC3404153  PMID: 22504829
6.  Validation of ICD-9-CM Codes to Identify Gastrointestinal Perforation Events in Administrative Claims Data among Hospitalized Rheumatoid Arthritis Patients 
Pharmacoepidemiology and drug safety  2011;20(11):1150-1158.
Purpose
To validate, using physician review of abstracted medical chart data as a gold standard, a claims-based algorithm developed to identify gastrointestinal (GI) perforation cases among rheumatoid arthritis (RA) patients.
Methods
Patients with established RA, aged 18 years or older with hospital admissions between January 2004 and September 2009, were selected from a large US hospital-based database. An algorithm with ICD-9-CM diagnosis codes for GI perforation and combinations of GI-related diagnosis codes and CPT-4 procedure codes for relevant GI surgeries was used to identify potential GI perforation cases. Two senior experienced specialist physicians independently reviewed abstracted chart data and classified cases as “confirmed” or “unconfirmed” GI perforations. Positive predictive values (PPVs) to identify “confirmed” GI perforation were calculated and stratified by upper versus lower GI tract.
Results
Overall, 86 of 92 GI perforation cases were confirmed, yielding an overall PPV of 94% (95% CI: 86–98%). PPV was 100% (95% CI: 100–100%) for upper GI perforation (esophagus, stomach) and 91% (95% CI: 90–97%) for lower GI perforation (small intestine, PPV=100%; large intestine, PPV= 94%; unspecified lower GI, PPV=89%).
Conclusions
This algorithm, consisting of a combination of ICD-9-CM diagnosis and CPT-4 codes, could be used in future safety studies to evaluate GI perforation risk factors in RA patients.
doi:10.1002/pds.2215
PMCID: PMC3227025  PMID: 22020901
gastrointestinal perforation; validation; administrative claims; rheumatoid arthritis
7.  Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study 
Rheumatology (Oxford, England)  2012;51(10):1860-1869.
Objective. To investigate the effect of tocilizumab on patient-reported outcomes (PROs) in RA patients with inadequate responses to TNF inhibitors (TNFis).
Methods. In a Phase III randomized controlled trial, 489 patients received 4 or 8 mg/kg tocilizumab or placebo every 4 weeks plus MTX for 24 weeks. Mean changes from baseline over time and proportions of patients reporting improvements greater than or equal to minimum clinically important differences (MCIDs) in PROs were analyzed.
Results. At week 24, 8 mg/kg resulted in significantly greater improvements vs placebo in pain, global assessment of disease activity (P = 0.001), Health Assessment Questionnaire-Disability Index (HAQ-DI; P < 0.0001), Functional Assessment of Chronic Illness Therapy-Fatigue (P = 0.0150) and Medical Outcomes Survey Short Form 36 (SF-36 v2) Physical Component Summary (PCS; P = 0.0003) scores, all greater than MCID; 4 mg/kg resulted in greater improvements in pain (P = 0.0100), HAQ-DI (P = 0.0030) and SF-36 PCS (P = 0.0020) scores. Tocilizumab-associated improvements were evident as early as week 2. At week 24, more tocilizumab-treated than control patients reported improvements greater than or equal to MCID in SF-36 domain scores and related PROs (50.9–84.9% vs 35.0–51.7%) and achieved ACR50 responses and/or Disease Activity Score 28 (DAS28) remission with PRO improvements greater than or equal to MCID (36.2–51.2% vs 10–20.7% and 10.7–37.5% vs 0.0–3.4%, respectively).
Conclusion. Tocilizumab treatment in patients with inadequate responses to TNFis resulted in rapid and sustained improvements in multiple PROs that were statistically significant and clinically meaningful, consistent with previous efficacy reports.
Trial Registration. ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00106522.
doi:10.1093/rheumatology/kes131
PMCID: PMC3448882  PMID: 22753773
rheumatoid arthritis; tocilizumab; health-related quality of life; patient-reported outcomes; randomized controlled trial

Results 1-7 (7)