Methodological issues in online data collection

AIM: This paper is a report of a study to evaluate the use of an online data collection method to survey early survivors of childhood cancer about their physical and psychosocial characteristics and health-related quality of life. BACKGROUND: A major advantage in conducting web-based nursing research is the ability to involve participants who are challenging to study because of their small numbers or inaccessibility because of geographic location. As paediatric oncology patients and early survivors of childhood cancer are often not easily accessible because of their small numbers at single institutions, web-based research methods have been proposed as a potentially effective approach to collect data in studies involving these clinical populations. METHOD: Guided by published literature on using the Internet for data collection, an online protocol was developed; this included construction of a website, development of a homepage and interactive HyperText Markup Language pages and the posting of the study link on various websites. Data collection occurred over a 6-month period between December 2005 and May 2006. FINDINGS: Despite using strategies in conducting online research cited in published literature, the recruitment of subjects was very prolonged and the volume of missing data among many respondents excluded them from the study and created bias within the study's results. CONCLUSION: Web-based, online data collection methods create opportunities to conduct research globally, especially among difficult to access populations. However, web-based research requires careful consideration of how the study will be advertised and how data will be collected to ensure high quality data and validity of the findings.     

The use of methotrexate for treatment of inflammatory bowel disease in clinical practice

BackgroundMethotrexate is considered a treatment for Crohn's disease, whilst few data in ulcerative colitis are available.AimTo evaluate frequency, indications, efficacy and safety of methotrexate in inflammatory bowel disease patients.Methods5420 case histories were reviewed.ResultsMethotrexate was prescribed to 112 patients (2.1%; 89 Crohn's disease, 23 ulcerative colitis). It was the first-line immunosuppressive option in 32 (28.6%), it was an alternative drug due to toxicity or failure of thiopurines in 80 (71.4%). Steroid-dependence represented the main indication both when it was used as first (13/32, 40.6%) and second option (41/80, 51.2%). Efficacy was considered optimal in 39/112 (34.8%), partial in 29/112 (25.9%), absent in 22/112 (19.6%), not assessable in 22/112 (19.6%). Side effects happened in 49 out of 112 patients (43.7%) (39 Crohn's disease, 10 ulcerative colitis), leading to drug discontinuation in 38 (33.9%). The occurrence of side effects was approximately fivefold higher in patients who did not receive folic acid (14/19, 73.7%) than in those who did (35/93, 37.6%): odds ratio 4.64, 95% confidence interval 1.54–14.00; p = 0.005.ConclusionsThe use of methotrexate appears to be negligible in clinical practice. However, our results suggest that, if appropriately used, methotrexate could be more widely administered to inflammatory bowel disease patients with complicated disease.     

Outcomes of Laparoscopic Cholecystectomy in Octogenarians

Background and Objectives:

Extremely elderly patients usually present with complicated gallstone disease and are less likely to undergo definitive treatment. The purpose of this study was to evaluate the results of laparoscopic cholecystectomy in octogenarians, with an interest in patients presenting initially with complicated gallstone disease and pancreatitis who underwent laparoscopic cholecystectomy during the same hospitalization.

Methods:

Data for 42 patients ≥80 years who underwent an elective laparoscopic cholecystectomy between January 2007 and August 2011 were retrospectively reviewed. Indications for the procedure were stratified into 2 groups: Outpatients, who were admitted electively to undergo cholecystectomy, and Inpatients, who came to our Emergency Room due to complicated biliary diseases. Data analysis included age, sex, ASA score, conversion to open surgery, time spent under general anesthesia, and length of hospital stay.

Results:

Mean age was 83.9 years; 19 (45.2%) were men. Thirteen patients (30.9%) were in the outpatient group, and 13 (30.9%) had a preoperative ASA of 3. Fourteen patients (33.3%) needed ICU. Two patients (4.8%) had their surgery converted. There were 7 (16.7%) postoperative complications, all of them classified as Dindo-Clavien I or II. No differences were noted between groups regarding conversion rates or complications. We had no mortalities in this series. There was no difference in hospital length of stay between the groups.

Conclusion:

Laparoscopic cholecystectomy in the extremely elderly is safe, with acceptable morbidity. Patients with complicated gallstone disease seem not to have worse postoperative outcomes once the initial diagnosis is properly treated and would benefit from definitive therapy during the same hospitalization.     

The Philadelphia Episiotomy Intervention Study

OBJECTIVE: To lower the episiotomy rate through physician education and documentation of indication when episiotomy was performed. STUDY DESIGN: The intervention consisted of an evidence-based lecture recommending limited usage of episiotomy and requesting documentation of any episiotomy's indication. Data 3 months prior to the intervention were compared to those of the year following. Adjusted comparisons of episiotomy rates were completed using multivariate logistic regression models. RESULTS: For all vaginal deliveries, there was a 17% decrease in the rate of episiotomy, from 46.9% to 38.8%. For spontaneous vaginal deliveries, there was a 25% decrease in the episiotomy rate, from 40.8% to 30.8%. The most common indications for episiotomy reported were routine/elective, 41.0%; vacuum, 18.6%; forceps, 16.4%; and nonreassuring fetal heart tracing, 10.9%. CONCLUSION: Episiotomy rates may be effectively reduced through physician education and documentation of procedure indication.     

Phase I Trial of Vorinostat Combined With Bortezomib for the Treatment of Relapsing and/or Refractory Multiple Myeloma

BackgroundDevelopment of targeted therapies for MM has improved response rates and increased patient survival, but ultimately the disease becomes refractory and progresses. Vorinostat combined with bortezomib has demonstrated synergistic antiproliferative and proapoptotic activity in preclinical models of MM. The objectives of this study were to determine the maximum tolerated dose for vorinostat with bortezomib in patients with advanced MM and to evaluate the clinical benefit of this new drug combination.Patients and MethodsPatients ≥ 18 years old with relapsed and/or refractory MM were enrolled into escalating dose cohorts of vorinostat and bortezomib combination therapy. Thirty-four patients were enrolled and were evaluable for safety and efficacy analyses.ResultsAll patients reported adverse events, 89% of which were mild to moderate in severity. Thirteen patients experienced 29 serious adverse events, 12 (41%) of which were considered drug-related. The maximum tolerated dose was not reached. Partial responses were observed in 9 (27%) patients. Minimal responses were observed in 2 additional patients (6%), and another 20 patients (59%) experienced disease stabilization.ConclusionVorinostat with bortezomib is generally well-tolerated and has clinical activity in patients with relapsed and/or refractory MM. Response rates were similar in patients previously exposed to bortezomib and patients who were naive to bortezomib therapy.