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Objective Researchers are increasingly using routine clinical data for care evaluations and feedback to patients and clinicians. The quality of these evaluations depends on the quality and completeness of the input data. Study design and Setting We assessed the performance of an electronic health record (EHR)-based data mining algorithm, using the example of the smoking status in a cardiovascular population. As a reference standard we used the questionnaire from the Utrecht Cardiovascular Cohort (UCC). To assess diagnostic accuracy we calculated sensitivity, specificity, negative predictive value, and positive predictive value. Results We analyzed 1,661 patients included in UCC to January 18th 2019. Of those, 14% (n=238) had missing information on smoking status in the UCC questionnaire. Data mining provided information on smoking status in 99% of the 1,661 participants. Diagnostic accuracy for current smoking was: sensitivity 88%, specificity 92%, negative predictive value 98%, and positive predictive value 63%. From false positives, 85% reported they had quit smoking at the time of UCC. Conclusion Data mining showed great potential in retrieving information on smoking (a near complete yield). Its diagnostic performance is good for negative smoking statuses. The implications of misclassification with data mining are dependent on the application of the data.

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) initiative was a collaborative European project that sought to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. Initiated in 2009 and ending in 2015, PROTECT was part of the Innovative Medicines Initiative, a joint undertaking by the European Union and pharmaceutical industry. Thirty-five partners including academics, regulators, small and medium enterprises, and European Federation of Pharmaceuticals Industries and Associations companies contributed to PROTECT. Two work packages within PROTECT implemented research examining the extent to which differences in the study design, methodology, and choice of data source can contribute to producing discrepant results from observational studies on drug safety. To evaluate the effect of these differences, the project applied different designs and analytic methodology for six drug-adverse event pairs across several electronic healthcare databases and registries. This papers introduces the organizational structure and procedures of PROTECT, including how drug-adverse event and data sources were selected, study design and analyses documents were developed, and results managed centrally.

Background. Over the past decade the incidence of pulmonary disease due to drug-resistant strains of Mycobacterium tuberculosis has increased worldwide. We reviewed our local experience to clarify the benefits and risks of pulmonary resection in the management of drug-resistant strains of Mycobacterium tuberculosis . Methods. A retrospective review was performed of 62 patients undergoing pulmonary resection for drugresistant strains of Mycobacterium tuberculosis between January 1990 and November 1995. Results. Fifty-three percent were men and 47% women with an average age of 34 years (range, 16 to 72 years). There was one postoperative death, for a perioperative (30-day) mortality of 1.6%. Sixteen complications occurred in 14 patients for an overall morbidity of 23%. Eighteen of 24 patients (75%) who were persistently sputum positive at the time of operation immediately converted to a negative sputum smear and culture. For all patients who were sputum negative after operation 80% remain relapse-free by actuarial analysis. Conclusions. We believe that operation plays an important ancillary role in the treatment of drug-resistant strains of Mycobacterium tuberculosis . The operation can be performed with acceptable morbidity and mortality and must be combined with appropriate and well-monitored pre- and postoperative antituberculous drug therapy.

De Groot MCH, Van Grootheest AC. Mirena® en uterusperforatie. Huisarts Wet 2005;48(4):165-6. Het Nederlands Bijwerkingen Centrum Lareb ontving een aantal meldingen van uterusperforatie bij gebruik van de Mirena. De meldingen bij Lareb laten zien dat perforaties voorkomen, ook als plaatsing geruime tijd na de bevalling heeft plaatsgevonden. Uterusperforatie treedt ook op bij plaatsing door ervaren artsen. Omdat complicaties van een onopgemerkte perforatie ernstig kunnen zijn en perforaties laat na insertie kunnen optreden of opgemerkt worden, moeten huisartsen bij de differentiele diagnose aan een uterusperforatie denken wanneer patienten met een Mirena-spiraaltje met buikklachten en menstruatiestoornissen op het spreekuur komen.

A metaanalysis of articles concerning the surgical management of acute traumatic rupture of the descending thoracic aorta published in the English-language literature between 1972 and July 1992 was performed. The overall mortality of 1,742 patients who arrived at the hospital alive was 32.0%, one-third died before surgical repair was started. Paraplegia was noted preoperatively in 2.6% of these hospitalized patients, and paraplegia complicated the surgical repair in 9.9% of 1,492 patients who reached the operating room in a relatively stable condition. Patients then were analyzed according to the surgical intervention used. Simple aortic cross-clamping (n = 443) was associated with a hospital mortality of 16.0% and incidence of paraplegia of 19.2%, despite lower average mean cross-clamp times (32 minutes; p < 0.01 versus passive or active methods of providing distal perfusion). In a subset of 290 patients in whom individual data were available, the cumulative risk of paraplegia was shown to increase substantially if the duration of aortic cross-clamping exceeded 30 minutes, but only when distal perfusion was not augmented (p < 0.00001). "Passive" perfusion shunts (n = 424) were associated with a mortality of 12.3%, and the incidence of paraplegia decreased to 11.1% (p < 0.001). However, shunts inserted from the apex of the left ventricle had a contradictory high 26.1% incidence of paraplegia compared with shunts from the ascending aorta (8.2%; p < 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)

Primary pulmonary tuberculosis in children remains a leading cause of mortality and morbidity in developing countries. Thirteen children requiring urgent thoracotomy for relief of acute respiratory distress resulting from critical major airway narrowing caused by enlarged tuberculous mediastinal lymph nodes were admitted to two hospitals over a 4-year period. Ages ranged from 2 months to 10 years. The condition of each patient had deteriorated despite appropriate antituberculosis therapy and an oral corticosteroid. At operation, the enlarged tuberculous subcarinal or paratracheal lymph nodes or both were decompressed. Surgical complications included a branchial tear and a pulmonary artery laceration. Additional procedures included a right upper lobectomy, two pneumonectomies, plication of a hemidiaphragm, and mobilization of two muscle flaps. Postoperatively all children showed dramatic improvement. The trachea to main bronchi diameter ratio improved by 49.1% on the left and 44.9% on the right in the immediate postoperative period. In children with respiratory distress produced by compression of the main bronchi between enlarged subcarinal and paratracheal lymph nodes, surgical decompression of the lymph nodes is indicated if there is no marked initial response to appropriate medical therapy. At operation, lymph nodes should be decompressed only by incision and curettage. Attempts at lymph node excision are associated with increased complications.

The development of a postpneumonectomy stump fistula in a ventilated patient is a feared and frequently fatal event. Furthermore, the necessity of a pneumonectomy from sequelae of blunt trauma is rare. We describe the salvage of a young patient with a combination of the above events. The method involves the use of a simple intravenous bag "plombage" in combination with a regional thoracoplasty to buttress a resutured bronchial stump.

Aortoesophageal fistulas due to atherosclerotic thoracic aneurysms are usually fatal, with few reported survivors. We report an aortoesophageal fistula managed successfully in one stage by resection and replacement of the aortic aneurysm with a prosthetic graft and total esophageal resection. Immediate esophageal reconstruction was attained using orthotopic gastric interposition with omentopexy around the prosthetic aortic graft.

Background. Innominate artery stab wounds are rarely encountered, and the optimal management of this injury is different from that of blunt innominate injury in that permanent bypass shunting should not be necessary. Methods. The records of 19 patients with stab wounds of the innominate artery who were treated by our department from January 1982 to June 1995 were reviewed. Results. Eighteen patients (95%) sustained zone 1 neck stabs, with a similar proportion having only a single stab wound. Seventeen (89%) of the 18 patients having chest roentgenograms had mediastinal widening. Thirteen patients (68%) were hemodynamically stable at admission; the remainder were unstable (26%) or moribund (5%). Fourteen patients (74%) underwent angiography, with no false-negative studies for arterial injury. Associated injuries to thoracic viscera occurred in 4 patients (21%). All injuries were repaired with either direct suture (18 of 19) or prosthetic interposition grafting (1 of 19). One patient required cardiopulmonary bypass to repair complex injuries. The overall mortality rate was 5% (1 of 19), and complications occurred in 2 patients (11%). Conclusions. Innominate artery stab wounds can be managed successfully without permanent bypass shunting and with a low mortality rate.

Background. Isolated thoracic duct injuries as a result of penetrating chest trauma without any major vascular or tracheoesophageal injury seldom are seen. Methods. A retrospective 13-year review identified 8 patients with this injury. Results. Seven had supraclavicular or suprascapular knife stabs, and the eighth had a low-velocity gunshot injury entering the mid-lateral right chest wall. All 7 stab victims presented with left-sided chylothoraces, and the site of injury of the thoracic duct was within Poirier's triangle, the borders of which are the arch of aorta, the left subclavian artery, and the vertebral column as seen from a lateral approach. Five patients initially were treated conservatively for 13.4 ± 4.4 days without success. Surgical intervention thus was necessary and was successful in all 8 patients. The thoracic duct injury was controlled successfully through a left posterolateral thoracotomy in 6 patients. A supraclavicular repair was attempted in 1 patient but failed to control the leak and required reexploration via the supraclavicular approach. The right chylothorax from the gunshot injury was explored via a right posterolateral thoracotomy; the leak into the pleura was identified and obliterated. Conclusions. As conservative management was uniformly unsuccessful, we advocate early operative management through a thoracotomy on the side of the chylothorax for this relatively rare injury.

Massive thymic hyperplasia is an extremely rare form of true thymic hyperplasia most often described in infants and children. Hyperplasia of this order is not known to occur in any other organ, and its etiology and prognostic significance remain unknown. As there is no accurate way of preoperatively differentiating massive thymic hyperplasia from other tumors of the thymus and anterior mediastinum, we advise excision in all cases for histological analysis and relief of mediastinal compression. This description of 4 cases updates the 30 previously reported cases, and includes a literature review.

78 patients with limited disease small cell lung carcinoma (SCLC) were entered into a prospective randomised study of two combination regimens (AVE-5 and AVE-1) that differed only in the scheduling of etoposide. Patients in the AVE-5 arm received etoposide intravenously 60 mg/m 2 on day 1 and orally 120 mg/m 2 on days 2–5 of each cycle. Patients in the AVE-1 arm received etoposide 300 mg/m 2 intravenously on day 1. Patients in both arms received doxorubicin and vincristine on day 1 of each cycle. The complete (53% vs. 26%) and the overall (75% vs. 52%) response rates were significantly higher in the AVE-5 arm. Median survival was also increased from 11 to 14 months in this arm. Toxicity was low and similar in both groups. The daily administration of etoposide in low toxicity combination therapy for SCLC is important. This can be conveniently achieved by using etoposide orally.