Measuring the Quality of Data Collection in a Large Observational Cohort of HIV and AIDS

The aim of this study was to examine the quality of data collection by studying the validity of collected data. Data were extracted from the clinic charts of two anonymous outpatients by 38 data collectors. A standard for the data to be collected was determined (168 items). The validity was measured by comparing the collected items with the standard; in this way, the percentages of the collected items that were ‘correct’ could be calculated. The percentage ‘correct’ was higher for clinic chart 1 (mean: 83% correct, SD 7%) than for clinic chart 2 (mean: 78% correct, SD 8%). All categories contained incorrectly collected data. These data were divided into missing data, incorrect start-stop dates, and surplus collected data. Almost all start-stop dates would change into ‘correct’ if ‘monthyear’ was considered correct (instead of the standard ‘daymonthyear’). Not all data collectors used specific protocols, and sources other than the written comments were not always checked. This study shows that a high proportion of data was correctly collected. However, the collection of start-stop dates was not optimal, and the collected data included surplus and missing data. Data collectors should be more knowledgeable about HIV disease and trained in the use of difficult protocols, so that they can better recognize what data to collect and how it should be collected. Among physicians, there should be more agreement about what information to record in the charts, to facilitate data extraction for data collectors

A randomized trial of laparoscopic versus open surgery for rectal cancer.

Background Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. Methods In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival. Results A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], −2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, −1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, −1.6 to 7.8). Conclusions Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.

Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial)

<p>Abstract</p> <p>Background</p> <p>Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after breast-conserving surgery, with the volume of the resected breast tissue being the major determinant. There is clear evidence for the efficacy of ultrasonography in the resection of nonpalpable tumours. Surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. These palpation-guided excisions often result in an unnecessarily wide resection of adjacent healthy breast tissue, while the rate of tumour-involved resection margins is still high. It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. The aim of this study is to compare ultrasound-guided surgery for palpable tumours with the standard palpation-guided surgery in terms of the extent of healthy breast tissue resection, the percentage of tumour-free margins, cosmetic outcomes and quality of life.</p> <p>Methods/design</p> <p>In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study design and planned analyses are described.</p> <p>Conclusion</p> <p>The COBALT trial is a prospective, multicentre, randomised controlled study to assess the efficacy of ultrasound-guided breast-conserving surgery in patients with palpable early-stage primary invasive breast cancer in terms of the sparing of breast tissue, oncological margin status, cosmetic outcomes and quality of life.</p> <p>Trial Registration Number</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2579">NTR2579</a></p

Raising awareness of carrier testing for hereditary haemoglobinopathies in high-risk ethnic groups in the Netherlands: a pilot study among the general public and primary care providers

0.05). 191 surveys were collected from general practitioners or midwives. Their attitude towards the education programme for high-risk ethnic groups was positive, yet they did not show strong intention to effectuate carrier testing of their patients on the basis of ethnicity. The main factor which explained their (lack of) intention was social norm, i.e. their perception of negative peer opinion (41% variance explained). The majority of primary health care providers felt that policy change was unnecessary. CONCLUSION: The "infotainment" programme may have a positive effect on people from high-risk groups, but informed general practitioners and midwives were reluctant to facilitate their patients' getting tested. Additional initiatives are needed to motivate primary care providers to facilitate haemoglobinopathy carrier testing for their patients from high-risk background

Cancellations of (helicopter-transported) mobile medical team dispatches in the Netherlands

The trauma centre of the Trauma Center Region North-West Netherlands (TRNWN) has consensus criteria for Mobile Medical Team (MMT) scene dispatch. The MMT can be dispatched by the EMS-dispatch centre or by the on-scene ambulance crew and is transported by helicopter or ground transport. Although much attention has been paid to improve the dispatch criteria, the MMT is often cancelled after being dispatched. The aim of this study was to assess the cancellation rate and the noncompliant dispatches of our MMT and to identify factors associated with this form of primary overtriage. By retrospective analysis of all MMT dispatches in the period from 1 July 2006 till 31 December 2006 using chart review, we conducted a consecutive case review of 605 dispatches. Four hundred and sixty seven of these were included for our study, collecting data related to prehospital triage, patient's condition on-scene and hospital course. Average age was 35.9 years; the majority of the patients were male (65.3%). Four hundred and thirty patients were victims of trauma, sustaining injuries in most cases from blunt trauma (89.3%). After being dispatched, the MMT was cancelled 203 times (43.5%). Statistically significant differences between assists and cancellations were found for overall mortality, mean RTS, GCS and ISS, mean hospitalization, length and amount of ICU admissions (p < 0.001). All dispatches were evaluated by using the MMT-dispatch criteria and mission appropriateness criteria. Almost 26% of all dispatches were neither appropriate, nor met the dispatch criteria. Fourteen missions were appropriate, but did not meet the dispatch criteria. The remaining 318 dispatches had met the dispatch criteria, of which 135 (30.3%) were also appropriate. The calculated additional costs of the cancelled dispatches summed up to a total of a,not sign 34,448, amounting to 2.2% of the total MMT costs during the study period. In our trauma system, the MMT dispatches are involved with high rates of overtriage. After being dispatched, the MMT is cancelled in almost 50% of all cases. We found an undertriage rate of 4%, which we think is acceptable. All cancellations were justified. The additional costs of the cancelled missions were within an acceptable range. According to this study, it seems to be possible to reduce the overtriage rate of the MMT dispatches, without increasing the undertriage rate to non-acceptable level

Long-Term Survival After Complications Following Major Abdominal Surgery

INTRODUCTION: Postoperative complications have been associated with decreased long-term survival in cardiac, orthopedic, and vascular surgery. For major abdominal surgery research, conflicting evidence is reported in smaller studies. The aim of this study was to assess the effect of complications on long-term survival in major abdominal surgery. MATERIAL AND METHODS: An observational cohort study was conducted of 861 consecutive patients that underwent major abdominal surgery between January 2009 and March 2014, with prospective assessment of the survival status. The effect of postoperative complications on survival was assessed. RESULTS: Postoperative complications were associated with decreased survival, even after applying correction for 30-day mortality (p < 0.001). Stratified Cox regression analysis depicted postoperative complications to be an important predictor for survival in upper gastrointestinal and female hepatopancreaticobiliary patients. Correction was applied for age, gender, BMI, ASA classification, radicality, and positive lymph node status. CONCLUSION: These results further indicate the importance of prevention and early diagnosis and treatment of complications. Etiological factors are believed to be both sustained levels of inflammatory markers, as well as attenuated immune response in malignancy with subsequent cancer cell seeding. Future research should aim to prevent and early diagnose postoperative complications to prevent morbidity and mortality not only in the early postoperative phase, but also in the long term