Tuesday, January 10, 2012

Considering spinal surgery? According to a study published in The Spine Journal, 87% of spinal surgeries have at least one complication with 37% of them requiring prolonged hospital stay. However, most of those complications were postoperative.

 

Morbidity and mortality of major adult spinal surgery. A prospective cohort analysis of 942 consecutive patients

John T Street, MD, PhD; Brian J. Lenehand, MD; Christian P DiPaola, MD; Michael D Boyd, MD; Brian K Kwon, MD, PhD; Scott J Paquette, MD; Marcel FS Dvorak, MD; Y Raja Rampersaud, MD; Charles G Fisher, MD

Received 25 January 2011; received in revised form 17 November 2011; accepted 1 December 2011. published online 03 January 2012.

Abstract 

Background context

To date, most reports on the incidence of adverse events (AEs) in spine surgery have been retrospective and dependent on data abstraction from hospital-based administrative databases. To our knowledge, there have been no previous rigorously performed prospective analysis of all AEs occurring in the entire population of patients presenting to an academic quaternary referral center.

Purpose

To determine the mortality and true incidence and severity of morbidity (major and minor, medical and surgical) in adults undergoing complex spinal surgery, both trauma and elective, in a quaternary referral center. To examine the influence of the introduction of a dedicated weekly multidisciplinary rounds, and a formal abstraction tool, on the recording of this prospective perioperative morbidity data. To examine the validity and inter- and intraobserver reliability of a dedicated Spine AdVerse Events Severity system, version 2 (SAVES V2) AE abstraction tool.

Study design

Ours is an academic quaternary referral center serving a population of 4.5 million people. Beginning in April 2008, a spine-specific AE-recording instrument, entitled SAVES V2, was introduced at our center for reporting, categorization, and classification of AEs. The use of this system remains an ongoing prospective study.

Patient sample

All adult patients admitted to the spine service of a quaternary referral center for a 12-month period.

Outcome measures

A validity and an inter- and intraobserver reliability examination of the SAVES V2 system, as used at our institution. Morbidity and inhospital deaths, unplanned second surgeries during index admission, wound infections requiring reoperation, and readmissions during the same calendar year. We also examined in detail all intraoperative and nonsurgical postoperative AEs, as well as hospital length of stay (LOS).

Methods

Data on all patients undergoing surgery over a 12-month period were prospectively collected using a perioperative morbidity abstraction tool at weekly dedicated mortality and morbidity rounds. This tool allows identification of each specific AE and grades the severity. Before the introduction of this system, and using the hospital inpatient database, our documented perioperative morbidity rate (major and minor, medical and surgical) was 23%. Diagnosis, operative data, hospital data, major and minor complications both medical and surgical, and deaths were recorded.

Results

One hundred percent of all patients discharged from the unit had complete data available for analysis. Nine hundred forty-two patients with an age range of 16 to 90 years (mean, 54 years; mode, 38 years) were identified. There were 552 males and 390 females. Around 58.5% of patients had undergone elective surgery. Thirty percent of patients were American Spinal Injury Association class D or worse on admission. The average LOS was 13.5 days (range, 1–221 days). Eight hundred twenty-two (87%) patients had at least one documented complication. Thirty-nine percent of these adversely affected hospital LOS. There were 14 mortalities during the study period. The rate of intraoperative surgical complication was 10.5% (4.5% incidental durotomy and 1.9% hardware malposition requiring revision and 2.2% blood loss >2 L). The incidence of postoperative complication was 73.5% (wound complications, 13.5%; delerium, 8%; pneumonia, 7%; neuropathic pain, 5%; dysphagia, 4.5%; and neurological deterioration, 3%).

Conclusions

Major spinal surgery in the adult is associated with a high incidence of intra- and postoperative complications. We identified a very high rate of previously unrecognized postoperative complications, which adversely affect LOS. Without strict adherence to a prospective data collection system, the true complexity of this surgery may be greatly underestimated.

Monday, January 9, 2012

New study claims that if your child has ADHD, the best alternative to drug therapy is a healthy diet. Diets high in fiber, fruits and vegetables, and one free of sugars and processed foods, demonstrate benefits.

Pediatric Study: 'Healthy' Diet Best for ADHD Kids

By John Gever, Senior Editor, MedPage Today
Published: January 09, 2012
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Fast foods, sodas, and ice cream may be American kids' favorite menu items, but they're also probably the worst for those with attention deficit-hyperactivity disorder (ADHD), a new literature review suggests.

According to two researchers from Children's Memorial Hospital in Chicago, a relatively simple diet low in fats and high in whole grains, fruits, and vegetables is one of the best alternatives to drug therapy for ADHD. Omega-3 and omega-6 fatty acid supplements have also been shown to help in some controlled studies, they noted.

Writing online in Pediatrics, J. Gordon Millichap, MD, and Michelle M. Yee, CPNP, reviewed nearly 70 publications on diet-based interventions in ADHD, emphasizing recent research and controlled trials.
Activate MedPage Today's CME feature and receive free CME credit on medical stories like this one


They noted that diet is one established contributor to ADHD that parents can modify.

One of the most provocative findings in recent years came from the Australian Raine study, which was a prospective cohort study that followed children from birth to age 14, Millichap and Yee indicated.

It found that development of ADHD was significantly associated with so-called Western diets rich in saturated fats and sugar, compared with a "healthy" diet of proteins derived from low-fat fish and dairy products and with a high proportion of vegetables (including tomatoes), fruits, and whole grains.

However, their review indicated that controlled trials had failed to show significant benefits for such intensive modifications as oligoantigenic, elimination, or additive-free Feingold-type diets except in small subgroups. Such diets also "are complicated, disruptive to the household, and often impractical," they wrote.

The Feingold diet and others are based on the idea that artificial colors and salicylates contribute to ADHD, which became popular in the 1970s. Federally funded trials showed that most ADHD children did not improve significantly on such diets, although some children with genuine sensitivities to additives and preservatives have been identified.

Such children, the researchers suggested, "might benefit from their elimination." More recent research has also indicated that atopic children with ADHD responded to a highly restrictive diet lacking colorings, preservatives, and certain food types.

Millichap and Yee reached similar conclusions for so-called elimination diets that avoid common allergens such as nuts, dairy, and chocolate, as well as citrus fruits. "Studies have provided mixed opinions of efficacy," they noted.

For both types of diet, the researchers pointed out, "a parent wishing to follow [them] needs patience, perseverance, and frequent evaluation by an understanding physician and dietitian."

In another finding likely to raise eyebrows, if not hackles, Millichap and Yee concluded that only weak evidence supports the widespread belief that refined sugar promotes hyperactivity.

Some effects on brain electrical activity have been documented, and reactive hypoglycemia following big jolts of sugary foods may account for behavioral changes seen in some ADHD children.

But studies linking sugar consumption to ADHD have also been compromised by methodological problems. For example, one trial gave children sugar or placebo at breakfast with a high-carbohydrate cereal, which may have contributed to subsequent reactions to the sugar.

Millichap and Yee cited a separate study that demonstrated when children ate a protein meal before or simultaneously with sugar, no hyperactivity reaction occurred.

Still, the researchers conceded, the notion that sugar exacerbates ADHD has become so entrenched it may not matter whether it's true or not.

"No controlled study or physician counsel is likely to change this perception. Parents will continue to restrict the allowance of candy for their hyperactive child at Halloween in the belief that this will curb the level of exuberant activity, an example of the Hawthorne effect. The specific type of therapy or discipline may be less important than the attention provided by the treatment," Millichap and Yee wrote.

They also reviewed studies exploring the potential roles of zinc and iron deficiency in ADHD. The upshot is that there is currently little indication that such deficiencies explain more than a small minority of ADHD cases. Children with confirmed deficiencies should receive supplements or appropriate dietary adjustments regardless of their ADHD status.

They were more impressed with the literature on polyunsaturated fatty acid supplements, especially the 2005 Oxford-Durham study.

In that trial, several ADHD symptoms were significantly improved in children receiving omega-3 and omega-6 fatty acid supplements, "an effect duplicated in other...supplement trials," Millichap and Yee wrote.

They acknowledged that not all studies have confirmed the result, and recent studies have used too many different methodologies to yield firm conclusions. Nevertheless, they indicated that they now recommend it to parents of their patients, though not as the sole treatment approach.

"In almost all cases, for treatment to be managed effectively, medication is also required," they wrote. "The beneficial effects of omega-3 and omega-6 supplements are not clearly demonstrated."

"Supplemental diet therapy is simple, relatively inexpensive, and more acceptable to patient and parent," Millichap and Yee concluded. "Public education regarding a healthy diet pattern and lifestyle to prevent or control ADHD may have greater long-term success."

They suggested that diet-based interventions in ADHD are most appropriate when any of the following apply:
  • Children suffer medication reactions or treatment failure.
  • Parents or children want to try dietary modifications.
  • Mineral deficiencies are evident.
No external funding for the review was reported.
The authors declared they had no relevant financial interests.

Saturday, January 7, 2012

Unless you have a red flag indicating a specific risk, PSA testing for prostate cancer seems of little benefit and some new way of testing for the cancer in healthy populations will need to be devised.

No Mortality Benefit Seen from PSA Screening

By Charles Bankhead, Staff Writer, MedPage Today
Published: January 06, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

Prostate cancer screening with prostate-specific antigen (PSA) afforded no obvious prostate cancer mortality benefit during 13 years of follow-up in a large randomized trial.

In fact, screened patients had a slightly higher prostate cancer mortality: 3.7 per 10,000 person-years, versus 3.4 for unscreened men.

The results emphasize the need to find some means to identify patients who are most likely to benefit from PSA screening, said the first author of a report in the January issue of the Journal of the National Cancer Institute.

"Routine mass screening of the population, purely on the basis of a man's age, is not going to be an effective way of reducing his chance of dying of prostate cancer," Gerald Andriole, MD, of Washington University in St. Louis, told MedPage Today
 
"Having said that, that's not to say that no man should get PSA testing," he continued. "There are subsets of men in the population at large who do seem to stand a good chance of benefiting from PSA testing.

"Those are men who are young, with no comorbidities, and generally very healthy. These are men with the longest life expectancy overall. They are men who, even if they harbor a nonaggressive, slow-growing cancer, are nonetheless expected to live long enough to die of prostate cancer in the absence of it being identified and treated."

Screening also is reasonable for men who have an above-average risk of prostate cancer, such as African Americans and men with a strong family history of the disease, Andriole added.

The data 0ffered nothing to change the conclusions of an earlier analysis of data from the same study, the National Institutes of Health-sponsored Prostate, Lung, Colorectal, and Ovarian (PLCO) screening program. After a median follow-up of seven years (up to as long as 10 years) the screened and unscreened groups had a similar prostate cancer mortality.

The prostate cancer portion of PLCO involved 76,685 men who were ages 55 to 74 and cancer-free at enrollment. Study participants were randomized to annual PSA screening for six years or to usual care, which sometimes included "opportunistic" PSA screening.

The initial report from the study showed a prostate cancer rate of 116 per 10,000 in the screened group compared with 95 per 10,000 in the control group. Prostate cancer mortality was 2 per 10,000 with screening and 1.7 per 10,000 in the control group.

The current report showed that after a median follow-up of 13 years, cancer incidence was 108.4 and 97.1 per 10,000 in the screened and unscreened groups, respectively. The difference represented a statistically significant 12% increase in cancer incidence in the screened group (RR 1.12, 95% CI 1.07 to 1.17).

Mortality was 3.7 and 3.4 per 10,000 with and without screening, respectively, a nonsignificant difference.

"This article updates with more person-years of follow-up our previously reported finding of no reduction in mortality from prostate cancer in the intervention arm compared with the control arm to 10 years, with no indication of a reduction in prostate cancer mortality to 13 years," the authors wrote of their findings.

Responding to the study, Otis W. Brawley, MD, chief medical officer of the American Cancer Society, acknowledged that the results are consistent with other studies that have pointed to a potential harm from overscreening and unnecessary treatment of indolent prostate cancer.

"This trial does suggest that if there is truly an advantage to mass [PSA] screening it is small," Brawley said in a statement.

Even so, the results do not rule out the possibility of a benefit in some high-risk men or the value of PSA screening in men who want the test, he added.

"I truly believe that a man who is concerned about prostate cancer and understands that experts are not certain that screening saves lives, but it definitely causes anxiety and needless treatment, can reasonably choose to be screened," said Brawley.

"A man who is more concerned with unnecessary diagnosis and treatment might reasonably choose not to be screened. It is an area that needs to be left to an informed patient."

The PLCO trial is sponsored by the National Institutes of Health.
Andriole disclosed relationships with Amgen, Augmenix, Bayer, Cambridge Endo, Caris, France Foundation, GenProbe, GlaxoSmithKline, Myriad Genetics, Steba Biotech, Ortho Clinical Diagnostics, and Viking Medical. Co-authors disclosed relationships with GlaxoSmithKline and Human Genome Sciences.

Tuesday, January 3, 2012

Backing up claims often made by doctors of chiropractic, this latest study shows that manipulation and exercise are more effective in treating neck pain than is medication.

 

Spinal Manipulation, Home Exercise May Ease Neck Pain

Medication appeared least effective treatment in small study

By Serena Gordon HealthDay Reporter




MONDAY, Jan. 2 (HealthDay News) -- Spinal manipulation and home exercise are more effective at relieving neck pain in the long term than medications, according to new research.

People undergoing spinal manipulation therapy for neck pain also reported greater satisfaction than people receiving medication or doing home exercises.

"We found that there are some viable treatment options for neck pain," said Gert Bronfort, vice president of research at the Wolfe-Harris Center for Clinical Studies at Northwestern Health Sciences University in Bloomington, Minn.

"What we don't really know yet is how to individualize these treatments for each particular patient. All are probably still viable treatment options, but what we don't know is what each particular patient will need," Bronfort said, adding that it's possible a combination of treatments might be helpful, too.

Results of the study are published in the Jan. 3 issue of the Annals of Internal Medicine. Funding for the study was provided by the U.S. National Center for Complementary and Alternative Medicine.

Neck pain is an extremely common problem. About three-quarters of adults report having neck pain at some point in their lives, according to background information in the study. Neck pain is responsible for millions of health care visits each year, and it can have a negative impact on quality of life.

Spinal manipulation is one type of treatment that's offered for neck pain, and it can be administered by chiropractors, physical therapists, osteopaths and other health care providers, according to the study.

But, there isn't much evidence for treating neck pain with spinal manipulation. There also isn't a great deal of information on how effective medications or home exercise programs are for treating neck pain, the researchers noted.

Bronfort and colleagues thought that spinal manipulation might prove to be more effective than medications or home exercise therapy. To test their hypothesis, they recruited 272 people between the ages of 18 and 65 who had neck pain. Their neck pain had no known cause, such as a trauma or pinched nerve, and the patients been experiencing the pain for between two and 12 weeks when the study began.

The study volunteers were randomly selected for one of three treatment groups. One group received spinal manipulations over a 12-week period. Each individual was allowed to choose the number of spinal manipulations they felt they needed.

The second group received medications, both over the counter and prescription, depending on their needs. First-line medications included nonsteroidal anti-inflammatory medications or acetaminophen (Tylenol). If people didn't get relief from these drugs, narcotic pain medications and muscle relaxants were offered.

The third group was assigned two one-hour sessions of home exercise. The goal of the home-exercise program was to improve movement in the neck area. Participants were instructed to do the exercises six to eight times per day.

At the 12th week, 82 percent of people receiving spinal manipulation reported at least a 50 percent reduction in pain, compared with 69 percent of those on medication and 77 percent doing home exercises. Also at week 12, of people receiving spinal manipulation, 32 percent reported feeling a 100 percent reduction in pain, compared with 13 percent on medications and 30 percent doing home exercises.

At one year, 27 percent of those receiving spinal manipulation said they felt a 100 percent reduction in pain versus 17 percent of those on medications and 37 percent of those doing home exercises.

"For me, as an ER doctor, this study offers an interesting perspective," said Dr. Robert Glatter, an attending physician in emergency medicine at Lenox Hill Hospital in New York City. "It's a small study, but it found that home exercises and spinal manipulation were effective. So, should we be referring to physical therapists, osteopaths or chiropractors from the ER?"

"This study shows that basically neck pain will get better on its own," said Dr. Victor Khabie, chief of the departments of surgery and sports medicine at Northern Westchester Hospital in Mount Kisco, N.Y. "It would've been good if they had a no-treatment group, too," he added.

"Everyone heals differently. There are different pathways to healing, and whether you feel you're better off with chiropractic, home exercises or medications, this study shows that all three are basically just as effective. Whatever your pathway to healing, in about six to eight weeks, you should start to feel better," said Khabie.

He also noted that it's important for anyone receiving spinal manipulation to know that there are rare, but serious risks that can occur with neck manipulations.

All three experts said anyone experiencing neck pain needs to have it evaluated to make sure there isn't a serious or correctable cause of the pain. This is especially true if you've been in a car accident, or if you have any neurological symptoms, such as repeatedly dropping things, or if you have pain radiating down your arm.

More information
Learn more about neck pain, its causes and treatment from the U.S. National Library of Medicine.
SOURCES: Gert Bronfort, D.C., Ph.D., vice president and professor, research, Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, Minn.; Robert Glatter, M.D., attending physician, emergency medicine, Lenox Hill Hospital, New York City; Victor Khabie, M.D., co-director, Orthopedic and Spine Institute, and chief, surgery, and chief, sports medicine, Northern Westchester Hospital, Mt. Kisco, N.Y.; Jan. 3, 2012, Annals of Internal Medicine
Last Updated: Jan. 03, 2012

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