Industry and evidence-based medicine: Believable or conflicted? A systematic review of the surgical literature

Background

Over the last few decades medical research and development has come to depend more heavily on the financial support of industry. However, there is concern that financial relations between the medical community and medical industry could unduly influence medical research and therefore patient care. Our objective was to determine whether conflict of interest owing to authors’/investigators’ financial affiliation with industry associated with their academic research has been identified in the surgical literature. In particular, we sought to answer the following questions: What is the extent of such conflict of interest? Does conflict of interest bias the results of academic surgical research in favour of industry? What are the potential causes of this proindustry bias?

Methods

We conducted a systematic review of the literature in May 2008 using the OVID SP search engine of MEDLINE, EMBASE, CINAHL, the Cochrane Database of Systematic Reviews, DARE and Health Technology Assessment. Quantitative studies that included a methods section and reported on conflict of interest as a result of industry funding in surgery-related research specifically were included in our analysis.

Results

The search identified 190 studies that met our criteria. Author/investigator conflict of interest owing to financial affiliation with industry associated with their academic research is well documented in the surgical literature. Six studies demonstrated that authors with such conflicts of interest were significantly more likely to report a positive outcome than authors without industry funding, which demonstrates a proindustry bias. Two studies found that the proindustry bias could not be explained by variations in study quality or sample size.

Conclusion

The conflict of interest that exists when surgical research is sponsored by industry is a genuine concern.     

Pediatric clean surgical wounds: is dressing necessary?

Background/Purpose

The covering of the sutured surgical wound with a sterile dressing is usually considered a routine conclusion to an aseptic operation. The wound is usually left dressed for a minimum of 3 to 5 days. The main purpose of dressing is protection of the wound against bacterial contamination that remains a significant source of postoperative morbidity. The aim of this study was to compare the infectious local risk when the clean pediatric surgical wounds were dressed or left exposed without dressing after the completion of wound closure.

Methods

Four hundred fifty-one patients with clean surgical wounds were randomized prospectively to receive dressing (n = 216) or have their wounds left exposed without any dressing (n = 235) after the completion of wound closure.

Results

In the group that received wound dressing, wound infection developed in 3 patients (1.4%), whereas in the group that had wounds exposed without any dressing, 4 patients (1.7%) developed wound infection.

Conclusions

In children, there was no significant difference in terms of wound infection after applying dressing or leaving the clean surgical wounds exposed without any dressing after completion of wound closure. Dressing clean surgical wounds may be unnecessary.     

Pelvic packing or angiography: Competitive or complementary?

Pelvic angiography is an established technique that has evolved into a highly effective means of controlling arterial pelvic haemorrhage. The current dominant paradigm for haemodynamically unstable patients with pelvic fractures is angiographic management combined with mechanical stabilisation of the pelvis. However, an effective rapid screening tool for arterial bleeding in pelvic fracture patients has yet to be identified. There is also no precise way to determine the major source of bleeding responsible for haemodynamic instability. In many pelvic fracture patients, bleeding is from venous lacerations which are not effectively treated with angiography to fractured bony surfaces. Modern pelvic packing consists of time-saving and minimally invasive techniques which appear to result in effective control of the haemorrhage via tamponade. This review article focuses on the recent body of knowledge on angiography and pelvic packing. We propose the optimal role for each modality in trauma centres.     

Optimal closure of surgical wounds in forefoot surgery: are adhesive strips beneficial?

A subcuticular suture is an ideal closure method of surgical wounds where the aim is healing by primary intention. The addition of adhesive strips over the subcuticular suture appears to be based on anecdotal, rather than experimental evidence. We performed a prospective study to compare the postoperative wound complications of combination closure with subcuticular closure alone. The wounds of 60 consecutive patients undergoing foot surgery were assessed clinically for wound complications at one week postoperatively. Patients who had a combined closure were more likely to develop wound complications. They were also twice as likely to return to clinic for a further wound check. The addition of adhesive strips to such a closure appears to offer no clinical benefit, and can be detrimental to wound healing. We recommend meticulous closure of surgical wounds with continuous, absorbable, subcuticular suture without adhesive strips, for an optimal outcome.     

Has endovascular surgery reduced the number of open vascular operations performed by an established surgical practice?

OBJECTIVE: Driven by new technology and the trend toward minimally invasive techniques, vascular surgeons have eagerly begun performing catheter-based arterial interventional procedures, a subspecialty termed endovascular surgery. How incorporation of endovascular surgery by vascular surgeons has influenced the number of standard open peripheral vascular operations is unknown. The purpose of this observational study was to examine the effect of endovascular surgery performed by the vascular surgeons of an established vascular surgery service on the volume of open peripheral vascular operations performed. METHODS: With our prospective vascular registry, we compared the number of index vascular procedures from 1996 to 1998 (immediately before the start of an endovascular program) with the numbers from 1999 to 2000 (immediately after the start of an endovascular program). Differences in proportions (endovascular versus open/standard) between the two time periods were compared with the chi(2) test for homogeneity. RESULTS: From 1996 to 1998, 122 procedures were referred to radiology for arterial intervention versus none from 1999 to 2000, reflecting the initiation of the endovascular program. During the entire study period, annual volume (endovascular + open/standard) of vascular procedures, excluding the procedures referred to radiology, increased by 70% (1996, n = 402; to 2000, n = 685). Although open procedures from 1996 to 1999 increased 49% (n = 356 to n = 531), the number decreased by 5% from 1999 to 2000 (n = 531 to n = 507). In contrast, the endovascular volume from 1996 to 2000 increased 324% (n = 42 to n = 178). A statistically significant reduction was seen over time in the proportion of open/standard cases to endovascular cases in comparison of 1996 to 1998 with 1999 to 2000 for total cases (n = 1539, 88% open; versus n = 1341, 77% open) and for all index procedures (aortoiliac, 70% versus 55%; abdominal aortic aneurysm, 100% versus 63%; brachiocephalic, 73% versus 47%; renal, 60% versus 24%) except carotid procedures (100% versus 99%) and femoral-popliteal/tibial procedures (87% versus 87%). CONCLUSION: The integration of endovascular procedures by vascular surgeons of an established vascular practice significantly reduced the proportion of all open vascular procedures except for carotid and femoral-popliteal/tibial intervention. These data may have important implications for the future training of general and vascular surgeons.     

Lymph node clearance: is surgical practice homogenous?

AIM: The aim of our study was to make evident the huge variability in lymph node dissection practice. MATERIAL AND METHODS: Therefore a retrospective study was conducted on 330 patients assessed for cervical, axillary or groin dissections. In each case the authors collected the primary diagnosis and clinical stage indicating lymph node clearance, identity of the surgeon and the pathologist, surgical technique including skin incision and landmarks of tissue removal, size of the clearance, and number of lymph nodes removed. Correlations between diagnosis, surgeon's or pathologist's identity, size of the clearance and number of nodes were analyzed using non-parametric tests. RESULTS: Standardized procedures as axillary dissections occurred few differences between surgeons. In groin or cervical dissections statistical differences were made evident with great technical variability. There was a positive correlation between size of the piece of lymphadenectomy and number of lymph nodes removed. CONCLUSION: Standardized procedures as axillary dissections provide few variations. Cervical and especially groin dissections should be harmonized, published and taught harmoniously in schools of surgery. So the expression "regional lymph node clearance" would mean.     

Treatment of urinary incontinence in men with electrical stimulation: Is practice evidence-based?

Electrical stimulation is frequently recommended for the treatment of urinary incontinence in men. However, few randomized, controlled trials allow practitioners to evaluate the evidence base for this practice. The purpose of this article is to determine, based on a review of the literature, whether adequate evidence exists to support the use of electrical stimulation as a treatment of male urinary incontinence. Urge, stress, and overflow incontinence are evaluated separately. This review led to 3 conclusions: (1) theoretical and urodynamic evidence exists to support the use of electrical stimulation for urge incontinence, (2) conflicting evidence exists in the use of electrical stimulation for stress urinary incontinence, and (3) treatment of overflow incontinence in men has not been evaluated in a systematic way. For both stress urinary or overflow incontinence, practitioners should consider the existing research before recommending electrical stimulation as a first line of treatment. For urge incontinence, electrical stimulation may be an effective first-line treatment strategy.     

Evidence-based practice: friend or foe?

Chiropractic is an increasingly-recognised health profession and systematic reviews of the effectiveness of manipulation for back pain are responsible for much of that recognition. Establishement on this basis, however demands that the profession learns to operate in the new clinical culture of evidence based practice if it is to progress. This calls for changes in emphases in education for self-monitoring through clinical adit. Evidence based practice can remain a positive factor in the future role of chiropractic provided that the profession and its educators invest meaningfully in arrangements which will allow them to respond to the evidence as it emerges.     

Inguinal hernia: laparoscopic or open surgery?

BACKGROUND: Today, mesh repair is the preferred technique in surgery of inguinal hernia. Whether the mesh should be placed laparoscopically or by open techniques is still controversial. METHODS: A comparison of open mesh and laparoscopic techniques was made with the help of meta-analyses and prospective trials. Outcome variables analysed were recurrence, chronic pain, recovery, morbidity and costs. RESULTS: With regard to recurrence rates, both techniques gave comparable results. The laparoscopic technique shows advantages in terms of morbidity, recovery and especially a lower rate of chronic pain. Open mesh repair has the advantage of a lower risk of some rare severe intra-abdominal complications and seems to be more cost-effective. CONCLUSION: Both techniques of inguinal hernia repair are effective and safe. Each technique has its advantages and disadvantages. Therefore, today no single technique can be recommended as a gold standard.     

How will the introduction of surgical care practitioners affect future surgical training and practice?

Surgical care practitioners (SCPs) are defined as non-medical members of the surgical team who perform surgical intervention, pre-operative and postoperative care after completing a Royal College of Surgeons accredited course. Their role across the modern day National Health Service is becoming more significant due to rising waiting times and the European Working Time Directive placing restrictions on the number of hours worked by surgical trainees. The change in consent law after the judgement of Montgomery versus Lanarkshire Health Board means SCPs can play a vital role in enabling a more individualized and effective consent process, whilst evidence suggests their contribution can reduce waiting times and improve continuity of care. However, concern may arise in the future if surgical trainees see their operating exposure significantly cut due to SCPs being granted-consultant supervised elective lists. Clear guidelines are therefore necessary at local and national level to protect surgical trainees' learning opportunities in theatre and to ensure SCPs achieve their ultimate goal of improved patient care.