Patient-Centered Network of Learning Health Systems: Developing a resource for clinical translational research.

INTRODUCTION: The Learning Health System Network clinical data research network includes academic medical centers, health-care systems, public health departments, and health plans, and is designed to facilitate outcomes research, pragmatic trials, comparative effectiveness research, and evaluation of population health interventions. METHODS: The Learning Health System Network is 1 of 13 clinical data research networks assembled to create, in partnership with 20 patient-powered research networks, a National Patient-Centered Clinical Research Network. RESULTS AND CONCLUSIONS: Herein, we describe the Learning Health System Network as an emerging resource for translational research, providing details on the governance and organizational structure of the network, the key milestones of the current funding period, and challenges and opportunities for collaborative science leveraging the network.

Comparative effectiveness and safety of infliximab and adalimumab in patients with ulcerative colitis.

BACKGROUND: Real-world comparative benefits and risks of infliximab (IFX) and adalimumab (ADA) in patients with ulcerative colitis (UC) are unclear. AIM: To evaluate the comparative effectiveness and safety of IFX and ADA in patients with UC who were new users of anti-TNF agents. METHODS: Using an administrative claims database (Optum Labs Data Warehouse), we identified patients who received first anti-TNF (IFX, ADA) prescription after a 12-month period without any anti-TNF treatment (baseline), and with a minimum 6-month follow-up after anti-TNF initiation. Primary outcome measures were: all-cause and UC-related hospitalisation, abdominal surgery, corticosteroid use >60 days after starting anti-TNF, and serious infections. We performed 2:1 propensity-score matched Cox proportional hazard analysis, and inverse probability-of-treatment weight (IPTW) analysis, accounting for healthcare utilisation, comorbidities and use of UC-related medication. RESULTS: We included 1400 new users of anti-TNF agents (age, 43 ± 15 years; 52% males), from 2006 to 2014. On propensity-score matched analysis, there was no significant difference in the risk of UC-related hospitalisation [IFX vs. ADA; adjusted hazard ratio (aHR), 1.04; 95% confidence interval (CI) 0.71-1.51], corticosteroid use (aHR, 0.85; 95% CI, 0.68-1.06) and serious infections (aHR, 0.62; 95% CI, 0.29-1.34) between IFX- and ADA-treated patients; the number of surgical events was very small. On IPTW analysis, risk of corticosteroid use was significantly lower in IFX - as compared to ADA - treated patients (aHR, 0.82; 95% CI, 0.68-0.99). Results were stable on multiple sensitivity analyses. CONCLUSIONS: In a large retrospective cohort of patients with UC who were new users of anti-TNF agents, IFX-treated patients may have lower corticosteroid use than ADA-treated patients, but risk of hospitalisation and serious infections were comparable.

Seasonal variation in detection of oesophageal eosinophilia and eosinophilic oesophagitis.

BACKGROUND: Seasonal variation has been reported in diagnosis of eosinophilic oesophagitis (EoE), but results are not consistent across studies and there are no national-level data in the USA. AIM: To determine if there is seasonal variation in diagnosis of oesophageal eosinophilia and EoE in the USA, while accounting for factors such as climate zone and geographic variation. METHODS: This was a cross-sectional study using a USA national pathology database. Patients with oesophageal eosinophilia (≥15 eosinophils per high-power field) comprised the primary case definition and were compared to those with normal oesophageal biopsies. We calculated the crude and adjusted odds of oesophageal eosinophilia by season, as well as by day of the year. Sensitivity analyses were performed using more restrictive case definitions of EoE, and after stratification by climate zone. RESULTS: Exactly, 14 524 cases with oesophageal eosinophilia and 90 459 normal controls were analysed. The adjusted odds of oesophageal eosinophilia were higher in the late spring and summer months, with the highest odds in July (aOR: 1.13; 95% CI: 1.03-1.24). These findings persisted with increasing levels of oesophageal eosinophilia, as well as across EoE case definitions. Seasonal variation was strongest in temperate and cold climates, and peak diagnosis varied by climate zone. CONCLUSIONS: There is a mild but consistent seasonal variation in the diagnosis of oesophageal eosinophilia and EoE, with cases more frequently diagnosed during summer months. These findings take into account climate and geographic differences, suggesting that aeroallergens may contribute to disease development or flare.

Umbilical cord blood graft engineering: challenges and opportunities.

We are entering a very exciting era in umbilical cord blood transplantation (UCBT), where many of the associated formidable challenges may become treatable by ex vivo graft manipulation and/or adoptive immunotherapy utilizing specific cellular products. We envisage the use of double UCBT rather than single UCBT for most patients; this allows for greater ability to treat larger patients as well as to manipulate the graft. Ex vivo expansion and/or fucosylation of one cord will achieve more rapid engraftment, minimize the period of neutropenia and also give certainty that the other cord will provide long-term engraftment/immune reconstitution. The non-expanded (and future dominant) cord could be chosen for characteristics such as better HLA matching to minimize GvHD, or larger cell counts to enable part of the unit to be utilized for the development of specific cellular therapies such as the production of virus-specific T-cells or chimeric-antigen receptor T-cells which are reviewed in this study.

Perioperative outcomes and hospital reimbursement by type of radical prostatectomy: results from a privately insured patient population.

BACKGROUND: With the increasing use of robotic surgery in the United States, the comparative effectiveness and differences in reimbursement of minimally invasive radical prostatectomy (MIRP) and open prostatectomy (ORP) in privately insured patients are unknown. Therefore, we sought to assess the differences in perioperative outcomes and hospital reimbursement in a privately insured patient population who were surgically treated for prostate cancer. METHODS: Using a large private insurance database, we identified 17,610 prostate cancer patients who underwent either MIRP or ORP from 2003 to 2010. The primary outcomes were length of stay (LOS), perioperative complications, 90-day readmissions rates and hospital reimbursement. Multivariable regression analyses were used to evaluate for differences in primary outcomes across surgical approaches. RESULTS: Overall, 8981 (51.0%) and 8629 (49.0%) surgically treated prostate cancer patients underwent MIRP and ORP, respectively. The proportion of patients undergoing MIRP markedly rose from 11.9% in 2003 to 72.5% in 2010 (P<0.001 for trend). Relative to ORP, MIRP was associated with a shorter median LOS (1.0 day vs 3.0 days; P<0.001) and lower adjusted odds ratio of perioperative complications (OR: 0.82; P<0.001). However, the 90-day readmission rates of MIRP and ORP were similar (OR: 0.99; P=0.76). MIRP provided higher adjusted mean hospital reimbursement compared with ORP (US $19,292 vs. US $17,347; P<0.001). CONCLUSIONS: Among privately insured patients diagnosed with prostate cancer, robotic surgery rapidly disseminated with over 70% of patients undergoing MIRP by 2009-2010. Although MIRP was associated with shorter LOS and modestly better perioperative outcomes, hospitals received higher reimbursement for MIRP compared with ORP.

Specialty bias in treatment recommendations and quality of life among radiation oncologists and urologists for localized prostate cancer.

BACKGROUND: Given the importance of physician attitudes about different treatments and the quality of life (QOL) in prostate cancer, we performed a national survey of specialists to assess treatment recommendations and perceptions of treatment-related survival and QOL. METHODS: We mailed a self-administered survey instrument to a random sample of 1366 specialists in the U.S. Respondents were asked for treatment recommendations and survival that varied by PSA levels and Gleason scores and estimate QOL outcomes. Pearson's chi-square and multivariable regression models were used to test for differences in each outcome. RESULTS: Response rates were similar for radiation oncologists (52.6%) and urologists (52.3%; P=0.92). Across all risk strata, urologists were more likely to recommend surgery than were radiation oncologists, for conditions ranging from PSA>20 and Gleason score 8-10 (35.2 vs. 0.2%; P<0.001) to PSA 4-10 and Gleason score 7 (87.5 vs. 20.9%; P<0.001). Radiation oncologists were also more likely to recommend radiation therapy relative to urologists (all P<0.001). From low- to high-risk prostate cancer, radiation oncologists and urologists perceived their treatment as being better for improving survival (all P<0.001). Each specialty also viewed their treatment as having less urinary incontinence (all P<0.001). CONCLUSIONS: Radiation oncologists and urologists both prefer the treatment modalities they offer, perceive them to be more effective and to lead to a better QOL. Patients may be receiving biased information, and a truly informed consent process with shared decision-making may be possible only if they are evaluated by both specialties before deciding upon a treatment course.

Longitudinal direct medical costs associated with constipation in women.

BACKGROUND: Although direct medical costs for constipation-related medical visits are thought to be high, to date, there have been no studies examining longitudinal resource utilisation in adults with constipation. AIM: To estimate the incremental direct medical costs associated with constipation in women. METHODS: This is a nested case-control study. The study population consisted of all mothers of 5718 children in the population-based birth cohort born during 1976-1982 in a community. The cases presented to the medical facilities with constipation. The controls were randomly selected and matched to cases in a 2:1 ratio. Direct medical costs for constipated women and controls were collected for the years 1987-2002. RESULTS: We identified 168 women with a diagnosis of constipation. The total direct medical costs over the 15-year period for constipated subjects were more than double those of controls [$63 591 (95% CI: 49 786-81 396) vs. $24 529 (95% CI: 20 667-29 260)]. The overall out-patient costs for constipated women were $38 897 (95% CI: 31 381-48 253) compared to $15 110 (95% CI: 12 904-17 781) for controls. The median of annual out-patient visits for constipated women was 0.16 compared to 0.11 for controls. CONCLUSION: Women with constipation have significantly higher medical care utilisation and expenditures compared with women without constipation.

Recurrent limb pain and migraine: case reports and a clinical review.

Recurrent limb pain (RLP) is a well-known entity in childhood. It is considered a precursor of migraine. The temporal relationship of RLP with headache in childhood is lacking in the literature. However, there are many cases with limb pain in a close temporal relationship with migraine headache in adults. We report six female patients with RLP and migraine and delineate the temporal relationship between the two. Three patients had a history of RLP in childhood and developed migraine headache after many years. Conversely, two patients had a long history of migraine headache and later developed RLP. One patient developed RLP and migraine headache at the same age. Isolated limb pain was frequent in all six patients. It was mild to severe, for a few minutes to a few days, and predominantly located in the upper extremities. Only one patient reported allodynia. The patients showed response to preventive measures (all six patients) and abortive therapies (four patients), even in those attacks of RLP that were not associated with headache episodes. We also review the clinical profiles of the patients in whom RLP and migraine were related to each other, and speculate on the possible mechanisms for RLP in the patients with migraine.

Primary chondrosarcoma of the lung with cutaneous and skeletal metastases.

Extraosseous chondrosarcomas are rare tumours. Primary chondrosarcoma of the lung is very rare, and is considered to be a slow-growing, well-circumscribed tumour, with rare incidence of extra-thoracic metastasis. We report a 60-year-old man who had chondrosarcoma of the lung with two local recurrences, namely: recurrent cutaneous metastases and a skeletal metastasis. Cutaneous metastases were treated by excision with adequate margins each time and they did not recur at the same site. Metastasis in the C5 vertebrae was treated by corpectomy and bone grafting. The patient is well six years after diagnosis.

Shift from predominantly white to predominantly black staff: a retrospective study relating to surgical care.

This nine-year study on hysterectomy patients at Southwest Community Hospital in Atlanta, Georgia, indicates that a shift in hospital staff from predominantly white to predominantly black had no detrimental effect on quality of care. The study also shows that the number of consultations increased with the influx of obstetrical/gynecological (ob/gyn) physicians. At the same time, there was an approximately 90 percent positive correlation between clinical and pathological diagnoses with the influx of black ob/gyn physicians to the staff.