Understanding the research-care demarcation and why it must be revised

BackgroundA clean-cut separation between research and care was artificially created at the time of the Belmont report more than 40 years ago. The demarcation was initially controversial but eventually was implemented for political reasons. We examine why it must be revised.MethodsWe review historical research scandals as well as the theoretical basis for the Belmont demarcation. We then discuss consequences on medical practice and propose an alternative.DiscussionMost research scandals involved abusing human beings supposedly for the sake of science. Belmont commissioners were aware the research/care problem was double-headed. While research subjects should be protected from abuse in the research context, patients need to be protected from unvalidated medical and surgical interventions in the care context. For political reasons the Commission recommended the regulation of research but to leave medical practice untouched. Thus the Commission had to distinguish research from care. The notion of ‘generalizable knowledge’ was introduced to define and regulate research, but the inadvertent result was that by trying to protect research subjects, the regulation has not only failed to protect all other patients, but also encouraged the widespread practice of unvalidated interventions within the care context. The notion of validated care should be re-introduced into a proper analysis of the care-research demarcation, for care research is an integral ingredient of a good medical practice.ConclusionThe research-care demarcation should be revised to leave room for the validated/unvalidated care distinction. Care research, essential to guide medical practice, should be facilitated at all levels.     

Acute epididymitis: etiology and therapy.

Fifty patients with acute epididymitis were evaluated prospectively by history, examination, and microbiologic studies, including cultures for aerobes, anaerobes, N. gonorrhoeae, Chlamydia trachomatis, and Ureaplasma urealyticum. E. Coli was the predominant pathogen isolated from the urine of men over 35 years old and C. trachomatis and N. gonnorrheae were the predominant pathogens isolated from the urethra of men under 35. The etiologic role of E. Coli and C. trachomatis was confirmed by isolation from epididymal aspirates from a high proportion of men with positive urine of urethral cultures for these agents. C. trachomatis epididymitis accounted for two thirds of "idiopathic epididymitis" in men, and was often associated with oligozoospermia. Of nine female sexual partners of men with C. trachomatis infection, six had antibody to C. trachomatis, of whom two had positive cervical cultures for this organism, and the others had nongonococcal pelvic inflammatory disease. Antibiotic therapy with tetracycline was effective for the treatment of men with C. trachomatis epididymitis, and should be offered to their female sex partner.     

Acute epididymitis: a microbiological and ultrasonographic study

In a prospective study of 24 men (mean age 28.3 years) with acute epididymitis who underwent epididymal aspiration, micro-organisms were detected in 15 (62.5%). Chlamydia trachomatis accounted for 10 (42%) of the cases, being located in both the urethra and epididymis in 5 individuals. Chlamydial serology supported the diagnosis of chlamydial infection, there being a strong correlation between the detection of C. trachomatis and elevated titres of both chlamydial IgG and IgM antibodies. In 4 patients (mean age 55.5 years), Escherichia coli was cultured from both mid-stream urine and epididymal aspirate. Transrectal ultrasound revealed abnormal prostatic scans in 19 patients (79%). These data confirm the aetiological role of C. trachomatis, support the notion that micro-organisms spread intra-canalicularly and suggest that the prostate is also involved in the inflammatory process in acute epididymitis.     

Acute epididymitis in boys: evidence of a post-infectious etiology

PURPOSE: We studied the etiology and management of pediatric epididymitis. MATERIAL AND METHODS: We performed 1-year prospective study in children with epididymitis. All patients underwent an immediate sonographic study of the scrotum. Microbiological studies included throat and urine cultures as well as viral cultures of nasopharyngeal and stool specimens. Serological tests for group A streptococcus and Mycoplasma pneumoniae as well as for enteroviruses, adenoviruses, influenza and parainfluenza viruses in the appropriate seasons were performed in patients and controls. RESULTS: A total of 44 patients 2 to 14 years old (mean age 9.8 +/- 3.2) were studied. Hospital admissions peaked during the summer and winter. The incidence of epididymitis was around 1.2/1,000 boys yearly. One patient had familial Mediterranean fever and another had Henoch-Schonlein purpura. Microbiological studies of the urine, throat, nasopharynx and stool yielded bacterial/viral growth in 9 patients (20.4%). Serological studies revealed significantly elevated titers to certain pathogens in patients with epididymitis compared with controls, including M. pneumoniae (53% vs 20%), enteroviruses (62.5% vs 10%) and adenoviruses (20% vs 0%). Most patients were treated with analgesics and 3 patients received antibiotics intravenously. Systemic and local signs and symptoms resolved gradually in 1 to 7 days. CONCLUSIONS: Our results suggest that epididymitis in boys is not rare and it is mostly an inflammatory phenomenon (presumably post-infectious) with a benign course. The treatment of these patients is basically with analgesics with a little role for antibiotics.     

Acute epididymitis in Schoenlein-Henoch purpura: a case report of emergency exploration

A case of acute scrotal swelling with pain in a 4-year-old boy suffering from Schoenlein-Henoch purpura is reported. Immediate scrotal exploration revealed epididymal ecchymosis and slightly edematous spermatic cord on the right side. Spermatic cord torsion was not recognized. The testis had a normal appearance. Convalescence was uneventful. Scrotal lesion disappeared within a week. Schoenlein-Henoch purpura is systemic vasculitis, which is noticed on any site of the body including male external genitalia. Several reports mainly on the testicular lesion have been made, but the epididymal findings were obscure. This case showed the prominent lesion on the epididymis. The anatomical architecture of the epididymis suggested that the principal inflammatory change of scrotal signs of Schoenlein-Henoch purpura is epididymitis.     

Laparoscopic appendectomy: why it should be done.

OBJECTIVE: Notwithstanding its widely perceived advantages, laparoscopic appendectomy has not yet met with universal acceptance. The aim of the present work is to illustrate retrospectively the results of a case-control experience with laparoscopic versus open appendectomy carried out at our institution. METHODS: Between January 1993 and November 2000, 555 patients (M:F = 210:345; mean age 25.2 +/- 15 years) underwent emergency or urgent appendectomy, or both. Of them, 322 (52%) were operated on laparoscopically, and 233 (48%) were treated via conventional surgery, according to the presence of a well-trained surgical team. RESULTS: The laparoscopic group conversion rate was 3.1% (10/322) and was mainly due to the presence of dense intraabdominal adhesions. Major intraoperative complications ranged as high as 0.3% (1/322) and 0%, respectively, in the laparoscopic and conventional groups (P=ns). Major postoperative complications were 1.6% (5/312) vs 0.8% (2/243), respectively (P=ns). Postoperative mortality was 0.3% (1/312) and 0.4% (1/243) in the laparoscopic and conventional subsets of patients. Reinterventions were 0.9% (3/322) in the laparoscopic patients versus nil in the open group (P=ns). Minor postoperative complications were observed in 0.6% (2/312) and 6.5% (16/243) of patients, respectively, in the laparoscopy and open surgery groups, and consisted mainly of wound infections (P=0.001). Flatus passage and hospitalization were significantly more rapid among the laparoscopic patients. The greater diagnostic accuracy of laparoscopy allowed the diagnosis of concurrent diseases in 12% (30/254) versus 1.5% (3/199) of patients with histology proven appendicitis treated via laparoscopy versus laparotomy (P<0.01). Similarly, among those patients without gross or microscopic evidence of appendicitis, or both gross and microscopic evidence, concurrent diseases were detected in 57.3% (39/68) of laparoscopic patients versus 8.8% (3/34) in the conventional ones (P<0.01). CONCLUSION: Even if limited by its retrospective nature, the present experience shows that laparoscopic appendectomy is as safe and effective as conventional surgery, has a higher diagnostic yield, causes less trauma, and offers a more rapid postoperative recovery. Such features make laparoscopy a challenging alternative to laparotomy in premenopausal women referred for urgent abdominal or pelvic surgery, or both.     

Nasal septal perforations must and can be closed

In this time of increasing occurrence of septal perforations caused by cocaine abuse, the plastic surgeon who deals mainly in rhinoplasty must learn to treat these defects with sophisticated methods. Too many septal perforations, especially large ones, are not treated because the surgical techniques are difficult. This article describes and illustrates two methods that close all kinds of perforations. Local flaps should be considered obsolete. A perforation up to 4 cm in diameter must be repaired in one step. This includes wide dissection of the mucoperichondrium and mucoperiosteum, suture of the hole on both sides, and interposition of parietal fascia or cartilage, sometimes with the help of bilateral small buccal flaps to cover the gap between the columella and the dissected mucoperichondrium containing the closed perforation on both sides. For closure of perforations greater than 4 cm in diameter, a three-step procedure which uses a composite three-layered buccal flap including ear concha cartilage is described. In the second step, the spoon-shaped flap is fed into the nasal cavity to fill the septal defect. The third step divides the pedicle. In many cases a unilateral or bilateral alotomy or the section of the columellar base may facilitate the suture of the flaps.     

Cerebral near infrared spectroscopy: emitter-detector separation must be increased

We have compared the effect of increasing optode separation (range 0.7- 5.5 cm) on the sensitivity of near infrared spectroscopy (NIRS) to discrete reductions in scalp and cerebral oxygenation in 10 healthy men (mean age 32, range 26-39 yr) using multichannel NIRS. During cerebral oligaemia (a mean reduction in middle cerebral artery flow velocity of 47%) induced by a mean reduction in end-tidal PCO2 of 2.4 kPa, the decrease in oxyhaemoglobin detected by NIRS became significantly greater with increasing optode separation (P < 0.0001). In response to scalp hyperaemia induced by inflation and release of a pneumatic scalp tourniquet, increases in oxyhaemoglobin became significantly smaller with increasing optode separation (P < 0.0002). These results are consistent with theoretical models of the behaviour of NIR light in the adult head and support the concept of using multi-detector NIRS to separate intra- and extracranial NIR signal changes. However, the emitter-detector separation used by currently available cerebral oximeters is not large enough to provide optimal spatial resolution.