Patient Safety in Surgery - Latest Comments

Re: Intensivist supervision of resident-placed central venous catheters decreases the incidence of catheter-related blood stream infections

Adamson Sinjani Muula — 2008-05-02T19:26:16Z

The paper by Papadimos et al [1] is timely as it comes at a time when the cost of health care for many patients in the United States is unbearable, and any financial savings are welcome amidst a hurting economy. I commend the authors for using Auto-Regressive Integration Moving Average (ARIMA) analysis to assess if the change in outcome was due to the intervention and not "noise". While the choice of method appears to be appropriate, the reader is left to guess if the assumptions necessary for this method were considered. For instance, it is not known whether the residual variations from the data were or assumed to be normally distributed, to what extent were they independent and whether the authors considered whether there was constant variance [2]. These are important assumptions that, if violated significantly, would make the ARIMA method less appropriate.

While when ARIMA is used, the 'effect' of seasonality is potentially removed, I believe it would have been informative if the authors had considered presenting a graphic distribution of the rate of infections for each month for all the years followed. This would have provided the reader with a pictorial distribution of any patterns in the rate over the years. This could have been easily presented in a single figure.

An interesting observation of Table 1 is that for each year of follow-up after the intervention, in general the rate of infections went down suggesting perhaps that there were cumulative gains or residual effects from the preceding year. And yet the residents were on rotations and new residents were being introduced to the intensive care unit and new patients come to the unit. How is this important? It may suggest that it is the intensivists (the supervisors) who were getting better at the technique! The intensivits were the same over the years, while the residents were new each time a rotation was made. The main conclusion I therefore see in this paper is that: when supervisors are not changed, they get better, and no matter any change in residents, the gains are long lasting and the improvement gains continue. Unless Papadimos et al have other data, I believe my interpretation may be applicable just as Papadimos et al is.

Reference

1.Papadimos TJ, Hensley SJ, Duggan JM, Hofmann JP, Khuder SA, Borst MJ, Fath JJ.Intensivist supervision of resident-placed central venous catheters decreases the incidence of catheter-related blood stream infections.

Patient Saf Surg;2(1):11.

2. Marshall S. Epidemiologic analysis of time to event data: Time series analysis. University of North Carolina at Chapel Hill, 2008.

Adolescent Idiopathic Scoliosis – an indication for surgery?

Hans-Rudolf Weiss — 2007-12-30T14:39:30Z

I´d like to thank Evalina Burger for her input regarding my case report published in Patient Safety in Surgery. Indeed, the Risser sign was missing in the case presentation which was grade IV not promising a significant residual growth in relation to this relatively small curve operated on of 28 degrees with a generally benign prognosis. However menarchial status documented here also shows there was little residual growth left before the operation was performed.

In an unbiased comment I would have expected a statement that in this benign curve obviously no indication for surgery is given. I would have expected that Dr. Burger to be aware of the fact that the paper cited as reference #5 [1], although being published in Pediatric Rehabilitation, is related to Adolescent Idiopathic Scoliosis (AIS) in the first place, and by no means can be attributed as “outdated”.

This paper [1] clearly demonstrates the lack of scientific knowledge about the long-term effects of surgery for AIS. I am personally not aware of any scientific publication which demonstrated that surgery for scoliosis has saved a single life. The above-mentioned reference [1] also shows that signs and symptoms of scoliosis cannot be cured by surgery. But if this is the case, how can someone claim for a medical indication for surgery in patients with AIS?

Recently, a paper [2] was published with a prospective design, showing that the rate of complications is more than 3 times higher in the short-term (>15%) than previously expected (<5%). How big would the long-term re-operation rate be when someone would have a long-term prospective study instead of retrospective ones already showing the re-operation rate might be as high as 40% [1]. Do we know how the instrumented spine behaves in the elderly? How long does the cosmetic effect of an operation last? Is there a prospective controlled study clearly showing that scoliosis surgery really prevents progression in the long term? Does the patient really feel more sick when having 10 degrees more in 20 years?

Today, from the patients perspective, we do have more open questions than answers when we look into the subject of spine surgery in patients with AIS.

Unfortunately outcomes measured with the help of questionnaires [3] do not provide evidence enough to justify a risky procedure:

Studies containing psychological questionnaires may be compromised by the dissonance effect [4-8], which applies to all situations that include important decisions to be made. Cognitive dissonance occurs most often in situations where an individual must choose between two incompatible beliefs or actions and there is a tendency for individuals to seek consistency among their cognitions. Unable to face an inconsistency, such as being dissatisfied with a surgical procedure, a person will often change an attitude or action. Surgery is impossible to reverse, but subjective beliefs and public attitude can be altered more easily. That means a patient not satisfied with a surgical treatment may not necessarily publicly admit this, as Moses et al. have described in their paper [8].

There is also a spine surgery related paper [9] highlighting the problem with such questionnaires: ”Patient satisfaction is subjective. It does not reflect the benefits of surgery with respect to the future preservation of pulmonary function in thoracic curves nor the prevention of osteoarthritis in lumbar curves.”

And another [10] also discussing the problems with such reports: “Radiographic and physical measures of deformity do not correlate well with patients' and parents' perceptions of appearance. Patients and parents do not strongly agree on the cosmetic outcome of AIS surgery.”

From all of the studies based on questionnaires, no evidence can be derived that supports the assumption that patients have experienced benefits from undergoing surgery, as none were able to rule out the cognitive effect of dissonance. Without being able to rule out such effects on the post-operative experience these outcomes do not appear to be valid [8,9,10].

Finally, to come back to the paper which Dr. Burger presents as a “proof” for a beneficial effect of surgery in patients with scoliosis [3]: This is only a two year follow-up which has nothing to do with the long-term negative effects the patients might suffer from and today still are not even revealed. Therefore I´d like to cite an outdated paper at this place, but there is no new evidence that speaks against it:

In view of the high rate of complications, the gains to be derived from spinal fusion should be assessed and clearly explained to patients before the procedure is undertaken [11].

I do agree that patient safety for scoliosis patients merits an unbiased, evidence-based scientific decision making process which should be independent of the subjective preferences by the treating physician. In view of the very many open questions, the lack of medical benefit and the high amount of long-term risks of the surgical procedures applied [1] the only possible way of decision making can be: Let the patient decide after providing all the objective facts available.

Last but not least there is a question which remains to be answered: Is the decision making process in a surgeons office independent of subjective preferences, when the surgeon has an affiliation to industry which benefits from the implants used for surgery [12]?

References

[1] Hawes M: Impact of spine surgery on signs and symptoms of spinal deformity.

Pediatr Rehabil. 2006 Oct-Dec;9(4):318-39.

[2] Carreon LY, Puno RM, Lenke LG, Richards BS, Sucato DJ, Emans JB, Erickson MA:

Non-neurologic complications following surgery for adolescent idiopathic scoliosis.

J Bone Joint Surg Am. 2007 Nov;89(11):2427-32.

[3] Bridwell KH, Berven S, Glassman S, Hamill C, Horton WC 3rd, Lenke LG, Schwab F, Baldus C, Shainline M: Is the SRS-22 instrument responsive to change in adult scoliosis patients having primary spinal deformity surgery?

Spine. 2007 Sep 15;32(20):2220-5.

[4] Crigger NJ, Meek VL: Toward a theory of self-reconciliation following mistakes in nursing practice.

J Nurs Scholarsh. 2007;39(2):177-83.

[5] Kitayama S, Snibbe AC, Markus HR, Suzuki T: Is there any "free" choice? Self and dissonance in two cultures.

Psychol Sci. 2004 Aug;15(8):527-33.

[6] Simmons VN, Webb MS, Brandon TH: College-student smoking: an initial test of an experiential dissonance-enhancing intervention.

Addict Behav. 2004 Aug;29(6):1129-36.

[7] Stone J: Self-consistency for low self-esteem in dissonance processes: the role of self-standards.

Pers Soc Psychol Bull. 2003 Jul;29(7):846-58.

[8] Moses S, Last U, Mahler D: After aesthetic rhinoplasty: new looks and psychological outlooks on post-surgical satisfaction.

Aesthetic Plast Surg. 1984;8(4):213-7.

[9] Haher TR, Merola A, Zipnick RI, Gorup J, Mannor D, Orchowski J: Meta-analysis of surgical outcome in adolescent idiopathic scoliosis. A 35-year English literature review of 11,000 patients.

Spine 1995 Jul 15;20(14):1575-84.

[10] Smith PL, Donaldson S, Hedden D, Alman B, Howard A, Stephens D, Wright JG: Parents' and patients' perceptions of postoperative appearance in adolescent idiopathic scoliosis.

Spine 2006 Sep 15;31(20):2367-74.

[11]Sponseller PD, Cohen MS, Nachemson AL, Hall JE, Wohl ME: Results of surgical treatment of adults with idiopathic scoliosis.

J Bone Joint Surg Am. 1987 Jun;69(5):667-75.

[12]http://www.nytimes.com/2006/12/30/business/30spine.html?ex=1325134800&en=9c70b96244b5dfc9&ei=5088&partner=rssnyt&emc=rss

Unbiased, evidence-based scientific decision making

Evalina Burger — 2007-12-20T17:44:24Z

I read with high interest the case report by Dr. Weiss on a young patient who deteriorated after surgery for adolescent idiopathic scoliosis (AIS). Despite the lack of detailed reporting on parameters which influence the decision making for surgery, such as the Risser sign, I agree with author that the fusion levels selected in this patient were probably inadequate, leading to a residual imbalance. However, the presentation of the discussion appears almost as imbalanced as the patient described in this paper, due to an obvious, unjustified bias by the author against surgery for scoliosis.

A large percentage of patients with scoliotic curves of more than 45 degrees will deteriorate without surgery. Spontaneous regression is reported in a small number of patients with AIS. The long-term effect of truncal imbalance can lead to debilitating pain. Even though patients with untreated scoliosis seem to function well as adults, it comes at a high price, as patients in modern day society tend to stay more active and may present with debilitating long-term pain.

Outcomes have been scientifically documented through the Scoliosis Research Society (SRS) outcome tools (Berven et al., Spine. 2003;28:2164-9). The most recent literature has clearly demonstrated beneficial outcomes after surgery for scoliosis (Bridwell et al., Spine. 2007;32:2220-5). In contrast to these recent findings, which are not referenced in the present paper, the citations used by the author are predominantly outdated. Furthermore, the author should make a clear distinction in the discussion between the complication rates reported for adults vs. adolescents. These are two very distinct groups with completely different outcomes and complication rates. With regard to the “key” reference used throughout this paper (ref #5), this particular article is based on pediatric (infantile) scoliosis and unrelated to the AIS case presented in the present article.

In summary, the important aspect of patient safety for scoliosis patients merits an unbiased, evidence-based scientific decision making process which should be independent of the subjective preferences by the treating physician.

Testicular atrophy- A rare complication which needs special attention

JOHN GRIFSON — 2007-11-26T18:22:04Z

Testicular atrophy is a rare complication following hernia surgery.Although the incidence of testicular atrophy is 1% following inguinal herniorraphy,the reported incidence in recurrent hernia surgery is around 5%.Atrophy following inguinal hernia surgery is attributed to the pampniform plexus thrombosis which is inadvertently injured during dissection of a large hernial sac from the chord structures.However in laparoscopic hernia surgery ,a large sac is transected and is rarely dissected.Furthermore the pampniform plexus unite to form the testicular vein in the preperitoneal fat.All these factors significantly lowers the chance of testicular atrophy in laparoscopic hernia surgery. Although the medico legal implications following testicular atrophy are obvious,it still remains unclear whether this complication needs to be discussed with every patient undergoing laparoscopic hernia repair.