Patient-reported outcome measures for use in clinical trials of SLE: a review.

Inclusion of patient-reported outcomes is important in SLE clinical trials as they allow capture of the benefits of a proposed intervention in areas deemed pertinent by patients. We aimed to compare the measurement properties of health-related quality of life (HRQoL) measures used in adults with SLE and to evaluate their responsiveness to interventions in randomised controlled trials (RCTs). A systematic review was undertaken using full original papers in English identified from three databases: MEDLINE, EMBASE and PubMed. Studies describing the validation of HRQoL measures in English-speaking adult patients with SLE and SLE drug RCTs that used an HRQoL measure were retrieved. Twenty-five validation papers and 26 RCTs were included in the indepth review evaluating the measurement properties of 4 generic (Medical Outcomes Study Short-Form 36 (SF36), Patient Reported Outcomes Measurement Information System (PROMIS) item-bank, EuroQol-5D, and Functional Assessment of Chronic Illness Therapy-Fatigue) and 3 disease-specific (Lupus Quality of Life (LupusQoL), Lupus Patient Reported Outcomes, Lupus Impact Tracker (LIT)) instruments. All measures had good convergent and discriminant validity. PROMIS provided the strongest evidence for known-group validity and reliability among generic instruments; however, data on its responsiveness have not been published. Across measures, standardised response means were generally indicative of poor-moderate sensitivity to longitudinal change. In RCTs, clinically important improvements were reported in SF36 scores from baseline; however, between-arm differences were frequently non-significant and non-important. SF36, PROMIS, LupusQoL and LIT had the strongest evidence for acceptable measurement properties, but few measures aside from the SF36 have been incorporated into clinical trials. This review highlights the importance of incorporating a broader range of SLE-specific HRQoL measures in RCTs and warrants further research that focuses on longitudinal responsiveness of newer instruments

Survival in patients with synchronous liver metastases in central and northern Denmark, 1998 to 2009

Morten Høyer1,2, Rune Erichsen1, Per Gandrup3, Mette Nørgaard1, Jacob Bonde Jacobsen11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Oncology, Aarhus University Hospital, Aarhus, Denmark; 3Department of Gastrointestinal Surgery, Aarhus University Hospital, Aalborg, DenmarkObjective: In Denmark, the strategy for treatment of cancer with metastases to the liver has changed dramatically during the period 1998 to 2009, when multidisciplinary care and a number of new treatments were introduced. We therefore examined the changes in survival in Danish patients with colorectal carcinoma (CRC) or other solid tumors (non-CRC) who had liver metastases at time of diagnosis.Study design and methods: We included patients diagnosed with liver metastases synchronous with a primary cancer (ie, a solid cancer diagnosed at the same date or within 60 days after liver metastasis diagnosis) during the period 1998 to 2009 identified through the Danish National Registry of Patients. We followed those who survived for more than 60 days in a survival analysis (n = 1021). Survival and mortality rate ratio (MRR) at 1, 3, and 5 years stratified by year of diagnosis were estimated using Cox proportional hazards regression analysis.Results: In the total study population of 1021 patients, 541 patients had a primary CRC and 480 patients non-CRC. Overall, the 5-year survival improved from 3% (95% confidence interval [CI]: 1%–6%) in 1998–2000 to 10% (95% CI: 6%–14%) in 2007 to 2009 (predicted value). The 5-year survival for CRC-patients improved from 1% (95% CI: 0%–5%) to 11% (95% CI: 6%–18%) whereas survival for non-CRC patients only increased from 5% (95% CI: 1%–10%) to 8% (95% CI: 4%–14%).Conclusion: We observed improved survival in patients with liver metastases in a time period characterized by introduction of a structured multidisciplinary care and improved treatment options. The survival gain was most prominent for CRC-patients.Keywords: liver metastases, colorectal cancer, noncolorectal cancer, survival improvemen

Patient-reported outcome measures for use in clinical trials of SLE:a review

Inclusion of patient-reported outcomes is important in SLE clinical trials as they allow capture of the benefits of a proposed intervention in areas deemed pertinent by patients. We aimed to compare the measurement properties of health-related quality of life (HRQoL) measures used in adults with SLE and to evaluate their responsiveness to interventions in randomised controlled trials (RCTs). A systematic review was undertaken using full original papers in English identified from three databases: MEDLINE, EMBASE and PubMed. Studies describing the validation of HRQoL measures in English-speaking adult patients with SLE and SLE drug RCTs that used an HRQoL measure were retrieved. Twenty-five validation papers and 26 RCTs were included in the indepth review evaluating the measurement properties of 4 generic (Medical Outcomes Study Short-Form 36 (SF36), Patient Reported Outcomes Measurement Information System (PROMIS) item-bank, EuroQol-5D, and Functional Assessment of Chronic Illness Therapy-Fatigue) and 3 disease-specific (Lupus Quality of Life (LupusQoL), Lupus Patient Reported Outcomes, Lupus Impact Tracker (LIT)) instruments. All measures had good convergent and discriminant validity. PROMIS provided the strongest evidence for known-group validity and reliability among generic instruments; however, data on its responsiveness have not been published. Across measures, standardised response means were generally indicative of poor-moderate sensitivity to longitudinal change. In RCTs, clinically important improvements were reported in SF36 scores from baseline; however, between-arm differences were frequently non-significant and non-important. SF36, PROMIS, LupusQoL and LIT had the strongest evidence for acceptable measurement properties, but few measures aside from the SF36 have been incorporated into clinical trials. This review highlights the importance of incorporating a broader range of SLE-specific HRQoL measures in RCTs and warrants further research that focuses on longitudinal responsiveness of newer instruments

Evolución de un índice de verdor en hoja para evaluar el status nitrogenado en trigo

El medidor de clorofila (Minolta SPAD 502) es una herramientapromisoria para monitorear el status de nitrógeno (N) del cultivo, a tra-vés del índice de verdor (IV) y del índice de suficiencia de N (ISN) en hoja.Los objetivos fueron describir la evolución del IV y el ISN durante la esta-ción de crecimiento del cultivo de trigo, y establecer la relación entre elIV y el ISN con el rendimiento y el contenido de proteína en grano. Laexperiencia se realizó en 1997/98, en Balcarce (Buenos Aires), en doslotes que tenían 5 y más de 20 años de agricultura. El P disponible no fuelimitante. Los tratamientos fueron dosis de N (0, 30, 60, 90, 120 y 180 kgN ha-1). El diseño experimental fue en bloques completos aleatorizados(DCBA). El IV permitió monitorear el status de N del cultivo de trigo, yaque presentó valores más altos en el sitio de mayor fertilidad nitrogenaday disminuyó a medida que avanzó el ciclo del cultivo, siendo esta disminución más pronunciada para N0 y más atenuada para180. El ISN se com-portó de manera similar al IV, debido a que se empleó la misma variedadde trigo y prácticas de manejo de cultivo similares. Se determinó una bajarelación entre IV e ISN al macollaje con el rendimiento en grano. A partirde encañazón, se alcanzaron aceptables ajustes entre dichas variables (R2=0.68 a 0.84 para IV; R2= 0.70 a 0.84 para ISN), lo que pone de manifiestosu valor predictivo. En grano lechoso temprano, se determinaron buenosajustes entre IV e ISN y el contenido de proteína en grano (R2= 0.82 paraIV; R2= 0.61 para ISN), indicando que ambos son buenos predictores deeste parámetr

Survival of patients with colon and rectal cancer in central and northern Denmark, 1998–2009

Eva B Ostenfeld1, Rune Erichsen1, Lene H Iversen1,2, Per Gandrup3, Mette Nørgaard1, Jacob Jacobsen11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Surgery P, Aarhus University Hospital, Aarhus, Denmark; 3Department of Surgery A, Aarhus University Hospital, Aalborg, DenmarkObjective: The prognosis for colon and rectal cancer has improved in Denmark over the past decades but is still poor compared with that in our neighboring countries. We conducted this population-based study to monitor recent trends in colon and rectal cancer survival in the central and northern regions of Denmark.Material and methods: Using the Danish National Registry of Patients, we identified 9412 patients with an incident diagnosis of colon cancer and 5685 patients diagnosed with rectal cancer between 1998 and 2009. We determined survival, and used Cox proportional hazard regression analysis to compare mortality over time, adjusting for age and gender. Among surgically treated patients, we computed 30-day mortality and corresponding mortality rate ratios (MRRs).Results: The annual numbers of colon and rectal cancer increased from 1998 through 2009. For colon cancer, 1-year survival improved from 65% to 70%, and 5-year survival improved from 37% to 43%. For rectal cancer, 1-year survival improved from 73% to 78%, and 5-year survival improved from 39% to 47%. Men aged 80+ showed most pronounced improvements. The 1- and 5-year adjusted MRRs decreased: for colon cancer 0.83 (95% confidence interval CI: 0.76–0.92) and 0.84 (95% CI: 0.78–0.90) respectively; for rectal cancer 0.79 (95% CI: 0.68–0.91) and 0.81 (95% CI: 0.73–0.89) respectively. The 30-day postoperative mortality after resection also declined over the study period. Compared with 1998–2000 the 30-day MRRs in 2007–2009 were 0.68 (95% CI: 0.53–0.87) for colon cancer and 0.59 (95% CI: 0.37–0.96) for rectal cancer.Conclusion: The survival after colon and rectal cancer has improved in central and northern Denmark during the 1998–2009 period, as well as the 30-day postoperative mortality.Keywords: neoplasms, survival, epidemiology, colorectal cance