Clinical Health Updates

Asking “Is there something else?” decreases patients’ unmet concerns

Clinical Question:
Can specific wording make a difference in addressing patients’ unmet concerns?

Bottom Line:
After eliciting a patient’s chief concern, asking “Is there something else you want to address in the visit today?” decreases the likelihood of them leaving with unmet concerns. Asking this variation of the more typical, “Is there anything else you want to address in the visit today?” did not increase the average visit duration. The authors did not study whether patient satisfaction was improved.

Reference:
Heritage J, Robinson JD, Elliott MN, Beckett M, Wilkes M. Reducing patients’ unmet concerns in primary care: the difference one word can make. J Gen Intern Med 2007;22(10):1429-1433.

Study Design:
Cross-sectional

Synopsis:
In primary, acute-care visits, patients frequently present with more than 1 concern. Various visit factors prevent additional concerns from being articulated and addressed. The investigators test an intervention to reduce patients’ unmet concerns. They did a cross-sectional comparison of 2 experimental questions, with videotaping of office visits and pre and postvisit surveys. Twenty outpatient offices of community-based physicians equally divided between Los Angeles County and a midsized town in Pennsylvania were included. A volunteer sample of 20 family physicians (participation rate = 80%) and 224 patients approached consecutively within physicians (participation rate = 73%; approximately 11 participating for each enrolled physician) seeking care for an acute condition. After seeing 4 nonintervention patients, physicians were randomly assigned to solicit additional concerns by asking 1 of the following 2 questions after patients presented their chief concern: “Is there anything else you want to address in the visit today?” (ANY condition) and “Is there something else you want to address in the visit today?” (SOME condition). Patients’ unmet concerns: concerns listed on previsit surveys but not addressed during visits, visit time, unanticipated concerns: concerns that were addressed during the visit but not listed on previsit surveys. Relative to nonintervention cases, the implemented SOME intervention eliminated 78% of unmet concerns (odds ratio (OR) = .154, p = .001). The ANY intervention could not be significantly distinguished from the control condition (p = .122). Neither intervention affected visit length, or patients’; expression of unanticipated concerns not listed in previsit surveys.

Warm packs beneficial in labor

Clinical Question:
Do warm packs prevent perineal trauma when applied to the perineum during labor?

Bottom Line:
The application of perineal warm packs in late second stage does not reduce the likelihood of nulliparous women requiring perineal suturing but significantly reduces third- and fourth-degree lacerations, pain during the birth and on days 1 and 2, and urinary incontinence. This simple, inexpensive practice should be incorporated into second stage labor care.

Reference:
Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn R, Brodrick B. Perineal outcomes and maternal comfort related to the application of perineal warm packs in the second stage of labor: A randomized controlled trial. Birth 2007;34(4):282-290.

Study Design:
Randomized controlled trial (nonblinded)

Synopsis:
In this randomized controlled trial of 717 women the use of warm packs from late second-stage labor until crowning was compared with usual care that did not include warm packs. Although masking of women and their birth attendants was not possible, the outcome assessors were masked. Eligible women were nulliparous with singleton term pregnancy in cephalic presentation who anticipated a normal delivery and had not performed perineal massage. Warm packs consisted of perineal pads soaked in boiled tap water at a temperature of approximately 45 degrees centigrade. The trial was conducted in an ethnically diverse population in Australia, where 75% of women are immigrants from other countries. With a study size adequate to detect a 10% difference, there was no difference between groups for the principal outcome of need for perineal suture. However, the number of third- and fourth-degree lacerations was reduced in the wam pack group, (31/357 vs 15/360; number needed to treat [NNT] = 22; 95% CI, 12-109). Women receiving warm packs were less likely to report severe pain during birth than women who were not given warm packs (59% vs 82%, respectively). There were also modest, statistically significant reductions in mean perineal pain scores on days 1 and 2 postpartum using a 10-point visual analog scale, with less than 1-point mean differences. At 3 months postpartum women who had received warm packs were less likely to report urinary incontinence (36/276 vs 46/277; NNT = 28).

LMWH = UFH for thrombocytopenia

Clinical Question:
What is the risk for thrombocytopenia with unfractionated heparin versus low-molecular-weight heparin in patients treated for acute venous thromboembolism?

Bottom Line:
There was no difference in risk of thrombocytopenia between unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in patients with acute deep venous thrombosis (DVT) or pulmonary embolism (PE).

Reference:
Morris TA, Castrejon S, Devendra G, Gamst AC. No difference in risk for thrombocytopenia during treatment of pulmonary embolism and deep venous thrombosis with either low-molecular-weight heparin or unfractionated heparin: a metaanalysis. Chest 2007:132(4):1131-1139.

Study Design:
Meta-analysis (randomized controlled trials)

Synopsis:
A thorough search of English language literature was done to identify randomized controlled trials comparing the incidence of thrombocytopenia with UFH versus LMWH in patients with objectively diagnosed DVT or PE. Two independent reviewers evaluated studies for inclusion and quality. Studies were rated on the basis of 9 criteria; a score of 8 was needed to be considered high enough quality for inclusion. Thrombocytopenia was defined as platelet counts between 80,000 mm3 to 120,000 mm3 or a decrease in platelets by at least 50%. A secondary analysis included all definitions of thrombocytopenia specified in the respective articles. The diagnosis of heparin-induced thrombocytopenia (HIT) required an objective test, such as a heparin-induced serotonin release assay, heparin-induced platelet aggregation, or heparin-platelet factor 4 (PF4) enzyme-linked immunosorbent assay. Heparin-induced thrombocytopenia thrombosis (HITT) was defined as thrombocytopenia with new arterial or venous thrombosis.

Thirteen studies including 5275 patients were included for analysis of the primary outcome, 4 for the outcome of HIT, and 5 for HITT. The incidence of thrombocytopenia was 1.2% for enoxaparin-treated patients and 1.5% for those receiving UFH. Only a total of 5 patients had serologically confirmed HIT (2 receiving LMWH, 3 receiving UFH), and only 1 patient in the UFH group had HITT. These results may be limited by the lack of routine serologic testing for HIT among patients with thrombocytopenia.

Less bleeding with fondaparinux vs enoxaparin for ACS with PCI

Clinical Question:
In patients with acute coronary syndromes who are managed with percutaneous coronary intervention, is fondaparinux as safe and effective as enoxaparin?

Bottom Line:
For patients with acute coronary syndromes (ACS) who undergo percutaneous coronary intervention (PCI), fondaparinux is equally as effective as enoxaparin and results in less major bleeding.

Reference:
Mehta SR, Granger CB, Eikelboom JW, et al. Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary intervention. J Amer Coll Cardiol 2007;50(18):1742-1751.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
This study was a preplanned analysis of patients from the OASIS-5 trial (Fifth Organization to Assess Strategies in Ischemic Syndromes), which evaluated the efficacy and safety of subcutaneous fondaparinux (2.5 mg daily) versus enoxaparin (1 mg/kg twice daily) in patients with unstable angina or non-ST-segment elevation myocardial infarction. Primary end points were rates of major bleeding and the composite of death, myocardial infarction, or stroke at days 9, 30, and 180. Results were analyzed by intention to treat. Patients were matched for baseline characteristics. PCI was done in 6238 patients of the 12,715 enrolled in the main trial who underwent cardiac catheterization during the period of study drug administration. Fondaparinux and enoxaparin were given for a mean of 2.4 days and 2.6 days, respectively, before PCI. More than 90% of patients received a thienopyridine, and approximately 40% were treated with glycoprotein (GP) IIb/IIIa inhibitors. At 30 days and 6 months, there was no difference in the rate of the composite primary end point or in the rates of the individual events. Major bleeding at day 9 was significantly lower among patients receiving fondaparinux [2.4% vs 5.1%; number needed to treat = 40; 95% CI, 25 – 86]. This difference persisted at 180 days. The reduction in bleeding with fondaparinux was seen both in patients who did and did not receive treatment with a GP IIb/IIIa inhibitor.

HPV DNA screening detects CIN3 and cancer earlier

Clinical Question:
Is screening for cervical cancer with human papillomavirus DNA testing in addition to cytology more effective than cytology alone?

Bottom Line:
Adding human papillomavirus DNA (HPV DNA) testing to cervical cancer screening programs has the potential to lead to earlier diagnoses of cervical intraepithelial neoplasia grade 3 or cancer (CIN3+). Future research should determine whether this will allow longer screening intervals.

Reference:
Bulkmans NW, Berkhof J, Rozendaal L, et al. Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: a 5-year follow-up of a randomized controlled implementation trial. Lancet 2007;370(9601):1764-1772.

Study Design:
Randomized controlled trial (nonblinded)

Synopsis:
Tests for the DNA of high-risk types of human papillomavirus (HPV) have a higher sensitivity for cervical intraepithelial neoplasia grade 3 or worse (CIN3+) than does cytological testing, but the necessity of such testing in cervical screening has been debated. Our aim was to determine whether the effectiveness of cervical screening improves when HPV DNA testing is implemented. Women aged 29-56 years who were participating in the regular cervical screening programme in the Netherlands were randomly assigned to combined cytological and HPV DNA testing or to conventional cytological testing only. After 5 years, combined cytological and HPV DNA testing were done in both groups. The primary outcome measure was the number of CIN3+ lesions detected. Analyses were done by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN20781131. 8575 women in the intervention group and 8580 in the control group were recruited, followed up for sufficient time (> or =6.5 years), and met eligibility criteria for our analyses. More CIN3+ lesions were detected at baseline in the intervention group than in the control group (68/8575 vs 40/8580, 70% increase, 95% CI 15-151; p=0.007). The number of CIN3+ lesions detected in the subsequent round was lower in the intervention group than in the control group (24/8413 vs 54/8456, 55% decrease, 95% CI 28-72; p=0.001). The number of CIN3+ lesions over the two rounds did not differ between groups.

Hep A vaccine similar to immune globulin for postexposure prophylaxis

Clinical Question:
Is the hepatitis A vaccine an alternative to immune globulin for postexposure prophylaxis?

Bottom Line:
Hepatitis A is a reasonable alternative to immune globulin. Advantages of the vaccine include the likelihood of subsequent immunity, the fact that it is not a blood product, a less painful injection, and its wider availability, while a disadvantage is higher cost (although the authors argue that the cost of immune globulin is nearly as high as that of vaccine now).

Reference:
Victor JC, Monto AS, Surdina TY, et al. Hepatitis A vaccine versus immune globulin for postexposure prophylaxis. N Engl J Med 2007;357(17):1685-1694.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
Hepatitis A vaccine administered to persons after exposure to the hepatitis A virus has not been compared directly with immune globulin, which is known to be highly effective in preventing hepatitis A when given within 2 weeks after exposure to the virus. They randomly assigned household and day-care contacts, 2 to 40 years of age, in Almaty, Kazakhstan, to receive one standard age-appropriate dose of hepatitis A vaccine or immune globulin within 14 days after exposure to patients with hepatitis A. Instances of laboratory-confirmed, symptomatic hepatitis A infection occurring between 15 and 56 days after exposure were then assessed during active follow-up of all susceptible contacts. Of 4524 contacts who underwent randomization, 1414 (31%) were susceptible to hepatitis A virus and 1090 were eligible for the per-protocol analysis. Among these contacts, 568 received hepatitis A vaccine and 522 received immune globulin. Most contacts were children (average age, 12 years), and most received prophylaxis during the second week after exposure (average interval after exposure, 10 days). The baseline characteristics of the contacts were similar in the two groups. Symptomatic infection with hepatitis A virus was confirmed in 25 contacts receiving vaccine (4.4%) and in 17 contacts receiving immune globulin (3.3%) (relative risk, 1.35; 95% confidence interval, 0.70 to 2.67).

Guideline for Medications in Cystic Fibrosis

Clinical Question:
What medications are effective in managing patients with cystic fibrosis?

Bottom Line:
In this evidence-based guideline, patients with cystic fibrosis should be treated with inhaled tobramycin, hypertonic saline, and dornase alfa. Patients with an FEV1 of more than 60% of predicted may benefit from ibuprofen, and those with persistent Pseudomonas aeruginosa may benefit from azithromycin. The guideline identified many areas in which the existing research is not helpful.

Reference:
Flume PA, O’Sullivan BP, Robinson KA, et al, and the Cystic Fibrosis Foundation, Pulmonary Therapies Committee. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am J Respir Crit Care Med 2007;176(10):957-969.

Study Design:
Practice guideline

Synopsis:
The Cystic Fibrosis Foundation commissioned a committee to develop evidence-based guidelines for drug therapy in managing patients with cystic fibrosis. Only 4 of the 15 members had potential conflicts of interest. The committee developed a set of questions that were addressed in 1 of 3 ways: a commissioned systematic review, a modified systematic review, or a summary of existing Cochrane reviews. From these questions, the committee made a set of recommendations using the US Preventive Service Task Force rating scheme to grade them. Here is a summary of their main recommendations, all applied to patients aged 6 years or older.

A recommendations
For patients with moderate to severe disease:
Chronic use of inhaled tobramycin reduces exacerbations and improves lung function
Chronic use of dornase alfa reduces exacerbations and improves lung function

B recommendations
For patients with mild disease or who are asymptomatic:
Chronic use of inhaled tobramycin reduces exacerbations and improves lung function
Chronic use of dornase alfa reduces exacerbations and improves lung function
Chronic use of inhaled hypertonic saline reduces exacerbations and improves lung function
Chronic oral ibuprofen slows the loss of lung function in patients whose FEV1 is more than 60% predicted
Chronic azithromycin reduces exacerbations and improves lung function in patients with persistent Pseudomonas aeruginosa

D recommendations
Inhaled corticosteroids provide no benefit in patients with cystic fibrosis and should not be used
Prophylactic oral antistaphylococcal antibiotics should not be used

Fesoterodine effective for treating overactive bladder syndrome

Clinical Question:
Is fesoterodine effective and safe in the treatment of overactive bladder syndrome?

Bottom Line:
Fesoterodine reduces urinary urgency incontinent episodes by an average of one per day compared with placebo. Whether this difference is clinically significant is best made on an individual patient basis. Dry mouth is the most common reason for discontinuing active treatment.

Reference:
Nitti VW, Dmochowski R, Sand PK, et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urology 2007;178(6):2488-2494.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
The authors evaluated the efficacy, tolerability and safety of the new antimuscarinic agent fesoterodine relative to placebo for overactive bladder syndrome. This was a randomized, double-blind, placebo controlled, multicenter trial performed in the United States. Overall 836 subjects with urinary frequency, urinary urgency or urgency urinary incontinence were randomized to placebo (274), 4 mg fesoterodine (283) or 8 mg fesoterodine (279) once daily for 12 weeks. The primary efficacy end point was the change in the number of micturitions per 24 hours. Co-primary end points were the change in the number of urgency urinary incontinence episodes per 24 hours and the treatment response. Secondary efficacy end points were other bladder diary variables, such as the change in mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours. Tolerability and safety were assessed by evaluating adverse events, electrocardiograms, post-void residual urine volume, laboratory parameters and treatment withdrawals. Treatment with 4 or 8 mg fesoterodine resulted in statistically significant and clinically relevant improvements from baseline to end of treatment for the primary and co-primary end points compared with placebo (p <0.05). Results for most secondary end points, including mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours, were also significantly improved vs placebo. The adverse events reported more frequently with fesoterodine than with placebo were dry mouth, constipation and urinary tract infection.

Fenofibrate (Fenoflex) reduces laser photocoagulation (FIELD)

Clinical Question:
Does fenofibrate (Fenoflex) reduce the need for laser photocoagulation in patients with type 2 diabetes?

Bottom Line:
In patients with type 2 diabetes mellitus fenofibrate (Antara, Lofibra, Tricor) modestly reduces the number of laser treatments for retinopathy.

Reference:
Keech AC, Mitchell P, Summanen PA, et al, for the FIELD study investigators. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. Lancet 2007;370(9600):1687-1697.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
Laser treatment for diabetic retinopathy is often associated with visual field reduction and other ocular side-effects. The investigators assessed whether long-term lipid-lowering therapy with fenofibrate could reduce the progression of retinopathy and the need for laser treatment in patients with type 2 diabetes mellitus. The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was a multinational randomised trial of 9795 patients aged 50-75 years with type 2 diabetes mellitus. Eligible patients were randomly assigned to receive fenofibrate 200 mg/day (n=4895) or matching placebo (n=4900). At each clinic visit, information concerning laser treatment for diabetic retinopathy-a prespecified tertiary endpoint of the main study-was gathered. Adjudication by ophthalmologists masked to treatment allocation defined instances of laser treatment for macular oedema, proliferative retinopathy, or other eye conditions. In a substudy of 1012 patients, standardised retinal photography was done and photographs graded with Early Treatment Diabetic Retinopathy Study (ETDRS) criteria to determine the cumulative incidence of diabetic retinopathy and its component lesions. Analyses were by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN64783481. Laser treatment was needed more frequently in participants with poorer glycaemic or blood pressure control than in those with good control of these factors, and in those with a greater burden of clinical microvascular disease, but the need for such treatment was not affected by plasma lipid concentrations. The requirement for first laser treatment for all retinopathy was significantly lower in the fenofibrate group than in the placebo group (164 [3.4%] patients on fenofibrate vs 238 [4.9%] on placebo; hazard ratio [HR] 0.69, 95% CI 0.56-0.84; p=0.0002; absolute risk reduction 1.5% [0.7-2.3]). In the ophthalmology substudy, the primary endpoint of 2-step progression of retinopathy grade did not differ significantly between the two groups overall (46 [9.6%] patients on fenofibrate vs 57 [12.3%] on placebo; p=0.19) or in the subset of patients without pre-existing retinopathy (43 [11.4%] vs 43 [11.7%]; p=0.87). By contrast, in patients with pre-existing retinopathy, significantly fewer patients on fenofibrate had a 2-step progression than did those on placebo (three [3.1%] patients vs 14 [14.6%]; p=0.004). An exploratory composite endpoint of 2-step progression of retinopathy grade, macular oedema, or laser treatments was significantly lower in the fenofibrate group than in the placebo group (HR 0.66, 95% CI 0.47-0.94; p=0.022).

Esophageal cancer occurs in 7/1000 per year

Clinical Question:
How many patients with Barrett’s esophagus will develop esophageal cancer?

Bottom Line:
Approximately 7 per 1000 (0.7%) patients with Barrett’s esophagus will develop esophageal cancer per year. The low incidence of Barrett’s, followed by this low incidence of esophageal cancer, may make routine evaluation of patients with chronic gastroesophageal reflux less important.

Reference:
Thomas T, Abrams KR, De Caestecker JS, Robinson RJ. Meta analysis: cancer risk in Barrett’s oesophagus. Aliment Pharmacol Ther 2007;26(11-12):1465-1477.

Study Design:
Meta-analysis (other)

Synopsis:
Risk of cancer in Barrett’s oesophagus is reported to vary between studies and also between countries, where the studies were conducted as per several systematic reviews. Cancer incidence has implications on surveillance strategies. The authors performed a meta-analysis to determine the incidence of oesophageal cancer in Barrett’s oesophagus. Articles retrieved by MEDLINE search (English language, 1966-2004). Studies had to necessarily include verified Barrett’s oesophagus surveillance patients, documented follow-up and cancer identified as the outcome measure. A random effects model of meta-analysis was chosen and results were expressed as mean (95% CI). Forty-one articles selected for conventional Barrett’s oesophagus (length >3 cm); eight included short segment Barrett’s oesophagus (one additional article including only short segment Barrett’s oesophagus). Cancer incidence was 7/1000 (6-9) person-years duration of follow-up (pyd), with no detectable geographical variation [UK 7/1000 (4-12) pyd, USA 7/1000 (5-9) pyd and Europe 8/1000 (5-12) pyd]. Cancer incidence in the UK was 10/1000 (7-14), when two large studies were excluded. Cancer incidence in SSBO was 6/1000 (3-12) pyd. When short segment Barrett’s oesophagus compared to conventional Barrett’s oesophagus, there was a trend towards reduced cancer risk [OR 0.55, (95% CI: 0.19-1.6), P = 0.25].