Clinical Question:
Is holmium laser enucleation of the prostate (HoLEP) effective compare to transurethral resection of the prostate (TURP) for treatment of men with bladder outflow obstruction (BOO) secondary to benign prostatic hyperplasia?

Bottom Line:
HoLEP has less perioperative morbidity and produces superior urodynamic outcomes than TURP, when treating prostates >40 g. At 24 months of follow-up, HoLEP is equivalent to TURP.

Reference:
A randomised trial comparing holmium laser enucleation versus transurethral resection in the treatment of prostates larger than 40 grams: results at 2 years.Wilson LC, Gilling PJ, Williams A, Kennett KM, Frampton CM, Westenberg AM, Fraundorfer MR. Eur Urol. 2006 Sep;50(3):569-73. Epub 2006 May 2

Study Design:
Randomized Controlled Trial

Synopsis:
The authors compared holmium laser enucleation of the prostate (HoLEP) with transurethral resection of the prostate (TURP) for treatment of men with bladder outflow obstruction (BOO) secondary to benign prostatic hyperplasia with a minimum of 24-month follow-up. Sixty-one patients were randomised to either HoLEP or TURP. All patients had BOO proven on urodynamic studies pre-operatively (prostate size 40-200 g). One patient died before treatment, which left 30 patients in each group. Perioperative data, as well as symptom scores, Quality of Life (QoL) scores, and maximum urinary flow rates (Qmax) were obtained at one, three, six,12, and 24 months. Post-void residual volumes, transrectal ultrasound (TRUS) volumes, and pressure flow studies were obtained six months post-operatively. Continence and potency data were also recorded. There were no significant differences between the two surgical groups pre-operatively. Mean pre-operative TRUS volume was 77.8+/-5.6 g (42-152) in the HoLEP group and 70.0+/-5.0 g (46-156) in the TURP group. Patients in the HoLEP group had shorter catheter times and hospital stays. More prostate tissue was retrieved in the HoLEP group. At six months, HoLEP was urodynamically superior to TURP in relieving BOO. At 24 months, there was no significant difference between the two surgical groups with respect to American Urology Association scores, QoL scores, or Qmax values; however, two patients in the TURP group required re-operation.

Clinical Question:
Can an elective cesarean delivery avoid maternal pelvic trauma and preserve anal continence?

Bottom Line:
The best evidence to assess the efficacy of cesarean section in the prevention of anal incontinence would be in randomized trials of average-risk pregnancies with few crossovers. In the absence of such trials and based on this review, cesarean section does not prevent anal incontinence. This implies that incontinence associated with delivery may be more likely incontinence caused by pregnancy.

Reference:
Nelson RL, Westercamp M, Furner SE. A systematic review of the efficacy of cesarean section in the preservation of anal continence. Dis Colon Rectum 2006;49:1587-1595.

Study Design:
Systematic review

Synopsis:
Elective primary cesarean section is performed largely to avoid maternal pelvic trauma that may result in anal incontinence, although its efficacy in this regard has not been thoroughly assessed. The authors performed a systematic review of published reports that compare anal incontinence risk by mode of delivery. PubMed was searched from 1966 through August 2005. Authors were contacted for missing data or analyses. Both randomized and nonrandomized reports were included. Eligible studies included females having vaginal delivery or cesarean section, fecal and/or flatal incontinence was reported as an outcome, and risk was calculable from the reported data. Crude data were extracted from the reports, as well as reported odds ratios and confidence intervals. In the nonrandomized studies, adjusted odds ratios also were extracted and additional data obtained from authors to adjust risks for age and parity if not originally done. Sensitivity analyses were performed using quality indicators: age and parity adjustment, time to continence assessment, and mode of previous delivery. Fifteen studies were found eligible, encompassing 3,010 cesarean sections and 11,440 vaginal deliveries. The summary relative risk for fecal incontinence was 0.91 (95 percent confidence interval, 0.74-1.14). For flatus the relative risk was 0.98 (range, 0.86-1.13). The number needed to treat by cesarean section was 167 to prevent a single case of fecal incontinence. Five studies were judged to be of high quality. In these studies, the summary relative risk was 0.94 (range, 0.72-1.22) and number needed to treat was 198.

Clinical Question:
Do clinical factors reliably predict which patients with transient ischemic attacks will experience a stroke in the next 30 days?

Bottom Line:
The findings validate the predictive value of the ABCD score in identifying hospitalized TIA patients with a high risk of early stroke and provide further evidence for its potential applicability in clinical practice.

Reference:
Tsivgoulis G, Spengos K, Manta P, et al. Validation of the ABCD score in identifying individuals at high early risk of stroke after a transient ischemic attack: a hospital-based case series study. Stroke 2006;37:2892-2897.

Study Design:
Decision rule (validation)

Synopsis:
A simple score derived in the Oxfordshire Community Stroke Project (ABCD score) was able to identify individuals at high early risk of stroke after a transient ischemic attack (TIA) both in a population-based and a hospital-referred clinic cohort. The authors aimed to further validate the former score in a cohort of hospitalized TIA patients. They retrospectively reviewed the emergency room and hospital records of consecutive patients hospitalized in our neurological department with a definite TIA according to the World Health Organization (WHO) criteria during a 5-year period. The 6-point ABCD score (age [<60 years="0,"> or =60 years=1]; blood pressure [systolic < or ="140" or ="90" hg="0,">140 mm Hg and/or diastolic >90 mm Hg=1]; clinical features [unilateral weakness=2, speech disturbance without weakness=1, other symptom=0]; duration of symptoms [<10 minutes="0," minutes="1,"> or =60 minutes=2]) was used to stratify the 30-day stroke risk.
ABCD score 7-day stroke risk (95% CI) 30-day stroke risk (95% CI)
2 or less 0 0
3 1.7% (0%-5.1%) 3.5% (0%-8.2%)
4 7.6% (1.2%-14%) 7.6% (1.2%-14%)
5 19.1% (7.8%-30.4%) 21.3% (10.4%-33%)
6 18.8% (0%-37.9%) 31.3% (8.6%-54%)

There is one limitation to this generally well-done study: The ABCD model was developed in an outpatient setting to predict risk for all TIA patients. This study only addresses its application to hospitalized patients.

Clinical Question:
Is cancer screening effective for individuals with Lynch syndrome?

Bottom Line:
The past 10 years have seen major advances in the understanding of Lynch syndrome. Current recommendations regarding cancer screening and prevention require careful consultation between clinicians, clinical cancer genetic services, and well-informed patients.

Reference:
Lindor NM, Petersen GM, Hadley DW, et al. Recommendations for the care of individuals with an inherited predisposition to Lynch syndrome. A systematic review. JAMA 2006;296:1507-17.

Study Design:
Systematic review

Synopsis:
About 2% of all colorectal cancer occurs in the context of the autosomal dominantly inherited Lynch syndrome, which is due to mutations in mismatch repair genes. Potential risk-reducing interventions are recommended for individuals known to have these mutations. The authors review cancer risks and data on screening efficacy in the context of Lynch syndrome (hereditary nonpolyposis colorectal cancer) and to provide recommendations for clinical management for affected families, based on available evidence and expert opinion. A systematic literature search using PubMed and the Cochrane Database of Systematic Reviews, reference list review of retrieved articles, manual searches of relevant articles, and direct communication with other researchers in the field. Search terms included hereditary non-polyposis colon cancer, Lynch syndrome, microsatellite instability, mismatch repair genes, and terms related to the biology of Lynch syndrome. Only peer-reviewed, full-text, English-language articles concerning human subjects published between January 1, 1996, and February 2006 were included. The US Preventive Services Task Force’s 2-tier system was adapted to describe the quality of evidence and to assign strength to the recommendations for each guideline. The evidence supports colonoscopic surveillance for individuals with Lynch syndrome, although the optimal age at initiation and frequency of examinations is unresolved. Colonoscopy is recommended every 1 to 2 years starting at ages 20 to 25 years (age 30 years for those with MSH6 mutations), or 10 years younger than the youngest age of the person diagnosed in the family. While fully acknowledging absence of demonstrated efficacy, the following are also recommended annually: endometrial sampling and transvaginal ultrasound of the uterus and ovaries (ages 30-35 years); urinalysis with cytology (ages 25-35 years); history, examination, review of systems, education and genetic counseling regarding Lynch syndrome (age 21 years). Regular colonoscopy was favored for at-risk persons without colorectal neoplasia. For individuals who will undergo surgical resection of a colon cancer, subtotal colectomy is favored. Evidence supports the efficacy of prophylactic hysterectomy and oophorectomy.

Clinical Question:
Can clinical factors be used to identify children with low risk of serious intracranial pathology after head injury?

Bottom Line:
Clinical factors can accurately predict which children don’t have serious intracranial pathology after head injury. A highly sensitive clinical decision rule is derived for the identification of children who should undergo computed tomography scanning after head injury. This rule has the potential to improve and standardise the care of children presenting with head injuries. Validation of this rule in new cohorts of patients should now be undertaken.

Reference:
Dunning J, Daly JP, Lomas JP, et al, for the Children’s Head injury ALgorithm for the prediction of Important Clinical Events study group. Derivation of the children?s head injury algorithm for the prediction of important clinical events decision rule for head injury in children. Arch Dis Child 2006;91:885-891.

Study Design:
Cohort (prospective)

Synopsis:
This team of researchers identified more than 22,000 children younger than 16 years with any head injury. Specially trained physicians assessed each child with a standardized history and physical, including mechanism of injury and Glasgow Coma Scale. The authors then developed a set of clinical criteria to identify children with “clinically significant intracranial injury,” defined as death as a result of head injury, requirement for neurosurgical intervention, or marked abnormalities on the computed tomography (CT) scan. A total of 744 of the children provided CT scans, but all children completed a clinical follow-up with the authors. The clinical prediction rule (summarized below) was highly sensitive (98%; 95% CI, 96-100) and also had decent specificity (87%; 86-87). The positive likelihood ratio of 7.5 (6.9-7.7) and negative likelihood ratio of 0.02 (0-0.05) suggests this rule is best at ruling out serious intracranial injury. This prediction rule needs to be validated.

The clinical decision rule:
A CT scan is required if any of the following criteria are present:
History:
Witnessed loss of consciousness of greater than 5 minutes duration
History of amnesia (either antegrade or retrograde) of greater than 5 minutes duration
Abnormal drowsiness
More than 3 discrete episodes of vomiting after head injury
Suspicion of nonaccidental injury
Seizure after head injury in a patient who has no history of epilepsy
Examination:
Glasgow Coma Score (GCS) <14, or GCS <15 if younger than 1 year
Suspicion of penetrating or depressed skull injury or tense fontanelle
Signs of a basal skull fracture (blood or cerebrospinal fluid from ear or nose, panda eyes, Battle’s sign, hemotympanum, facial crepitus, or serious facial injury)
Focal neurologic deficit
Presence of bruise, swelling or laceration >5 cm if younger than 1 year
Mechanism:
High-speed road traffic accident either as pedestrian, cyclist, or occupant (defined as accident with speed above 40 miles per hour)
Fall of more than 3 m in height
High-speed injury from a projectile or an object
If none of the above variables are present, the patient is at low risk of intracranial pathology.

Clinical Question:
What is the optimal method for performing a lumbar puncture and for analyzing the results to accurately diagnose bacterial meningitis?

Bottom Line:
Data suggest that small-gauge, atraumatic needles may decrease the risk of headache after diagnostic LP. Reinsertion of the stylet before needle removal should occur and patients do not require bed rest after the procedure. Future research should focus on evaluating interventions to optimize the success of a diagnostic LP and to enhance training in procedural skills.

Reference:
Straus SE, Thorpe KE, Holroyd-Leduc J. How do I perform a lumbar puncture and analyze the results to diagnose bacterial meningitis? JAMA 2006;296:2012-2022.

Study Design:
Systematic review

Synopsis:
Diagnostic lumbar punctures (LPs), commonly used to rule out meningitis, are associated with adverse events. The authors systematically review the evidence about diagnostic LP techniques that may decrease the risk of adverse events and the evidence about test accuracy of cerebrospinal fluid (CSF) analysis in adult patients with suspected bacterial meningitis. They searched the Cochrane Library, MEDLINE (using Ovid and PubMed) from 1966 to January 2006 and EMBASE from 1980 to January 2006 without language restrictions to identify relevant studies and identified others from the bibliographies of retrieved articles. They included randomized trials of patients aged 18 years or older undergoing interventions to facilitate a successful diagnostic LP or to potentially reduce adverse events. Studies assessing the accuracy of biochemical analysis of the CSF for possible bacterial meningitis were also identified. Two investigators independently appraised study quality and extracted relevant data. For studies of the LP technique, data on the intervention and the outcome were extracted. For studies of the laboratory diagnosis of bacterial meningitis, data on the reference standard and test accuracy were extracted. They found 15 randomized trials. A random-effects model was used for quantitative synthesis. Five studies of 587 patients compared atraumatic needles with standard needles and found a nonsignificant decrease in the odds of headache with an atraumatic needle (absolute risk reduction [ARR], 12.3%; 95% confidence interval [CI], -1.72% to 26.2%). Reinsertion of the stylet before needle removal decreased the risk of headache (ARR, 11.3%; 95% CI, 6.50%-16.2%). The combined results from 4 studies of 717 patients showed a nonsignificant decrease in headache in patients who were mobilized after LP (ARR, 2.9%; 95% CI, -3.4 to 9.3%). Four studies on the accuracy of biochemical analysis of CSF in patients with suspected meningitis met inclusion criteria. A CSF-blood glucose ratio of 0.4 or less (likelihood ratio [LR], 18; 95% CI, 12-27]), CSF white blood cell count of 500/muL or higher (LR, 15; 95% CI, 10-22), and CSF lactate level of 31.53 mg/dL or more (> or =3.5 mmol/L; LR, 21; 95% CI, 14-32) accurately diagnosed bacterial meningitis.

Clinical Question:
Following treatment of an initial variceal bleed, is pharmacologic treatment as effective as endoscopic ligation?

Bottom Line:
The combination of the beta-blocker nadolol (Corgard) and 5-isosorbide mononitrate (Imdur) significantly prolongs the time to rebleeding as compared with endoscopic band ligation (EBL) in cirrhotic patients with a previous single episode of variceal bleeding. Other outcomes — death, rebleeding rates, and the likelihood of a severe rebleed — were similar.

Reference:
Romero G, Kravetz D, Argonz J, et al. Comparative study between nadolol and 5-isosorbide mononitrate vs. endoscopic band ligations plus sclerotherapy in the prevention of variceal rebleeding in cirrhotic patients: a randomized controlled trial. Aliment Pharmacol Ther 2006;24:601-611.

Study Design:
Randomized controlled trial (nonblinded)

Synopsis:
After variceal bleeding, cirrhotic patients should receive secondary prophylaxis.
The authors compared nadolol plus 5-isosorbide mononitrate (5-ISMN) with endoscopic band ligation. The end points were rebleeding, treatment failure and death. One hundred and nine cirrhotic patients with a recent variceal bleeding were randomized: nadolol plus 5-ISMN in 57 patients and endoscopic band ligation in 52 patients. The mean follow-up was 17 and 19 months in nadolol plus 5-ISMN and endoscopic band ligation groups, respectively. No differences were observed between groups in upper rebleeding (47% vs. 46%), variceal rebleeding (40% vs. 36%), failure (32% vs. 22%), major complications (7% vs. 13.5%) and death (19% vs. 20%), respectively. The actuarial probability of remaining free of rebleeding, failure and deaths were similar in both groups. Time to rebleeding shows that endoscopic band ligation patients had an early rebleed, with a median of 0.5 month (95% CI: 0.0-4.2) compared with patients from nadolol plus 5-ISMN, 7.6 months (95% CI: 2.9-12.3, P < 0.013). Multivariate analysis indicated that outcome-specific predictive factor(s) for rebleeding was Child A vs. B + C (P < 0.01); for failure was Child A vs. B + C (P < 0.02); and for death ascites (P < 0.01) and rebleeding (P < 0.02).

Clinical Question:
Does distracting children undergoing laceration repair decrease their anxiety and pain?

Bottom Line:
The use of distraction techniques is effective in reducing situational anxiety in older children and lowering parental perception of pain distress in younger children. This technique may have a role in improving the quality of management of procedural pain in a pediatric emergency department (ED) setting.

Reference:
Sinha M, Christopher NC, Fenn R, Reeves L. Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics 2006;117:1162-1168.

Study Design:
Randomized controlled trial (nonblinded)

Synopsis:
We know distraction can diminish anxiety and pain during procedures: Think of the Lamaze method used in childbirth. The researchers conducting this study evaluated the effect of age-appropriate distractions on 240 children between the ages of 6 years and 18 years presenting to an emergency department for simple laceration repair. After receiving a topical anesthetic, the children were randomly assigned, using concealed allocation, to either their choice of distraction or waiting without distraction with study personnel. The children in the distraction group were offered a CD player with headphones, video games, or a cartoon video. They could also choose to have a book read to them. Children allocated to the distraction group who weren’t interested in any of the distractions were given help blowing bubbles. Suturing was performed in a standardized manner. Using a 7-point facial pain scale, pain did not differ between the 2 groups. Parental assessment of pain distress, as measured using a 100-mm visual analog scale, was significantly less in distracted children younger than 10 years (P <.01), though preprocedure scores in both groups were very low (2.91 – 3.31 of a possible 10). Children older than 10 years were evaluated using the State Trait Anxiety Inventory for Children, and anxiety scores on this scale were lower in the children receiving distraction, with a change from the start to the end of the procedure of 12.3 (95% CI, 10.5 – 14.2) in the distracted group and 6.1 (4.6 – 7.5) in the control group (P <.001).

Clinical Question:
For women undergoing cesarean delivery without labor, does the number of prior cesareans influence the risk of maternal morbidiity?

Bottom Line:
Because serious maternal morbidity increases progressively with increasing number of cesarean deliveries, the number of intended pregnancies should be considered during counseling regarding elective repeat cesarean operation versus a trial of labor and when debating the merits of elective primary cesarean delivery. LEVEL OF EVIDENCE: II-2.

Reference:
Silver RM, Landon MB, Rouse DJ, et al, for the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean sections. Obstet Gynecol 2006;107:1226-1232.

Study Design:
Cohort (prospective)

Synopsis:
Although repeat cesarean deliveries often are associated with serious morbidity, they account for only a portion of abdominal deliveries and are overlooked when evaluating morbidity. Our objective was to estimate the magnitude of increased maternal morbidity associated with increasing number of cesarean deliveries. The authors did a prospective observational cohort of 30,132 women who had cesarean delivery without labor in 19 academic centers over 4 years (1999-2002). There were 6,201 first (primary), 15,808 second, 6,324 third, 1,452 fourth, 258 fifth, and 89 sixth or more cesarean deliveries. The risks of placenta accreta, cystotomy, bowel injury, ureteral injury, and ileus, the need for postoperative ventilation, intensive care unit admission, hysterectomy, and blood transfusion requiring 4 or more units, and the duration of operative time and hospital stay significantly increased with increasing number of cesarean deliveries. Placenta accreta was present in 15 (0.24%), 49 (0.31%), 36 (0.57%), 31 (2.13%), 6 (2.33%), and 6 (6.74%) women undergoing their first, second, third, fourth, fifth, and sixth or more cesarean deliveries, respectively. Hysterectomy was required in 40 (0.65%) first, 67 (0.42%) second, 57 (0.90%) third, 35 (2.41%) fourth, 9 (3.49%) fifth, and 8 (8.99%) sixth or more cesarean deliveries. In the 723 women with previa, the risk for placenta accreta was 3%, 11%, 40%, 61%, and 67% for first, second, third, fourth, and fifth or more repeat cesarean deliveries, respectively.

Clinical Question:
Is acupuncture more effective than placebo in decreasing symptoms in patients with fibromyalgia?

Bottom Line:
This study paradigm allows for controlled and blinded clinical trials of acupuncture. We found that acupuncture significantly improved symptoms of fibromyalgia. Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety.

Reference:
Martin DP, Sletten CD, Williams BA, Berger IH. Improvement in fibromyalgia symptoms with acupuncture: results of a randomized controlled trial. Mayo Clin Proc 2006;81:749-757.

Study Design:
Randomized controlled trial (single-blinded)

Synopsis:
To test the hypothesis that acupuncture improves symptoms of fibromyalgia. The authors conducted a prospective, partially blinded, controlled, randomized clinical trial of patients receiving true acupuncture compared with a control group of patients who received simulated acupuncture. All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture. We measured symptoms with the Fibromyalgia Impact Questionnaire (FIQ) and the Multidimensional Pain Inventory at baseline, immediately after treatment, and at 1 month and 7 months after treatment. The trial was conducted from May 28, 2002, to August 18, 2003. Fifty patients participated in the study: 25 in the acupuncture group and 25 in the control group. Total fibromyalgia symptoms, as measured by the FIQ, were significantly improved in the acupuncture group compared with the control group during the study period (P = .01). The largest difference in mean FIQ total scores was observed at 1 month (42.2 vs 34.8 in the control and acupuncture groups, respectively; P = .007). Fatigue and anxiety were the most significantly improved symptoms during the follow-up period. However, activity and physical function levels did not change. Acupuncture was well tolerated, with minimal adverse effects.