CHRONIC HEPATITIS C AND HEPATOLOGY NURSE PRACTITIONERS
Care may be as effective as that provided by physicians.
A recently published study reveals that, compared with a physician, a hepatology nurse practitioner (NP) can provide equally effective care to patients with chronic hepatitis C, including those receiving antiviral combination therapy with ribavirin and interferon alfa-2b (Rebetron).
Seventy-five adult patients with either acute or chronic hepatitis C who were assigned to the care of either an NP or a physician completed the SF-36 Health Survey, which measures the quality of life (QOL) in terms of physical functioning, role limitations imposed by poor physical health, bodily pain, general health, vitality, social functioning, role limitations imposed by emotional problems, mental health, and the patient's perception of change in health status. The patients included those who had never received antiviral combination therapy, those receiving it but without experiencing consequent improvement, and those who had relapsed. To all patients, the NP provided initial education on the medication and the management of its adverse effects and also made follow-up telephone calls. Patients in the NP group were treated by the NP, in conjunction with a hepatologist when necessary, while patients in the physician group were treated by the physician and received follow-up care from a hepatologist. QOL scores in the two groups were compared after one, 12, and 24 weeks of the study.
Patients in the physician group, including those being treated with interferon alfa-2b, had significantly higher physical functioning scores after the first week, compared with those seen by an NP. The other QOL measures, however, were not significantly different in the two groups. After the 12th and 24th weeks, none of the QOL measures differed significantly, statistically, in the two groups, regardless of whether patients were being treated with interferon alfa-2b. In addition, the proportion of patients in the NP group with hepatitis C genotype 1 or genotype 2 or 3 who demonstrated a sustained virologic response was comparable to that in the physician group, 48% (genotype 1) and 59% (genotype 2 or 3), compared with 41% (genotype 1) and 61% (genotype 2 or 3), respectively.
The results of the study suggest that a hepatology NP can provide comprehensive and effective care to patients with chronic hepatitis C, a population that requires much time-consuming attention, support, and follow-up care. -JC
Ahern M, et al. Gastroenterol Nurs 2004; 27(4):149-55.
LOWER BACK PAIN AND PHYSICAL THERAPY
Study reveals such therapy viewed as more effective than professional advice.
The advice of a physical therapist is as effective as routine physical therapy in the treatment of mild-to-moderate lower back pain, according to the results of a recent study conducted in the United Kingdom. Little is known about the effective treatment of this significant public health problem, and international treatment guidelines agree only on advising patients to remain active. The effectiveness of traction, electrotherapy, and laser and ultrasound treatments has not been demonstrated, and the usefulness of other treatments of back pain is uncertain.
The prospective, randomized, blind study compared the effectiveness of physical therapy with the advice of a physical therapist in the long-term relief of lower back pain. Two hundred eighty-six patients who'd had lower back pain for at least six weeks and who'd referred for physiotherapy were randomized into either a therapy group or an advice-only group. In addition to a physical therapy assessment, patients in each group received advisory literature and a consultation based on it during which the physical therapist gave the instruction to remain active and encouraged self-management. The 144 patients in the treatment group received also individualized physical therapy that, according to the therapist's assessment, could include joint mobilization; soft tissue techniques such as stretching, heat, or cold treatment; and exercises to strengthen and stabilize abdominal muscles and mobilize the lumbar spine. The treatment group patients received between one and 12 sessions of physical therapy (median, 5), according to the therapist's assessment of need. Eighty-two percent of all patients complied with treatment, and 70% responded to the questionnaires mailed to them two, six, and 12 months afterward.
After 12 months, there were no statistically significant differences in levels of disability as measured by Oswestry Disability Index scores. Functioning and general health were comparable in the two groups. However, 65% of patients in the therapy group thought that they had benefited, while only 50% of those in the advice-only group thought that they had. Additionally, patients in the therapy group rated the improvement as significantly greater on a 10-point scale.
The validity of the study is limited because of the low response rate among the participants, but routine physical therapy does not seem to be more beneficial in mild-to-moderate lower back pain than a physical therapy assessment performed, and advice and literature provided, by a physical therapist. Nevertheless, the patients who received physical therapy perceived greater benefit. More research is necessary to determine the clinical significance of the difference in perceived benefit. -FM
Frost H, et al. BMJ 2004; 329:708-11.
HEPATITIS B VACCINE SAVES LIVES
But does it also increase the risk of developing MS?
The recombinant hepatitis B vaccine, derived from hepatitis B surface antigen (HBsAg) produced in genetically engineered yeast (Saccharomyces cerevisiae) cells, is 95% effective in preventing chronic hepatitis B infection, which afflicts hundreds of millions of people around the world and leads to death from cirrhosis or liver cancer in approximately 18% of them. However, about 200 cases of demyelinating disorder that developed after the administration of the vaccine were reported in France in 1996, and since then several studies have investigated the possibility of an association between hepatitis B vaccination and the development of multiple sclerosis (MS), with conflicting results.
A nested case-control study retrospectively reviewed prospectively collected medical records of more than 3 million Britons enrolled in the General Practice Research Database and compared the dates of hepatitis B vaccination with those of the onset of symptoms of MS. One hundred sixty-three patients diagnosed with MS between 1993 and 2000 were identified and compared with 1,565 matched controls who did not have the disorder. In 98% of the subjects, the diagnosis was made by a neurologist, and 85% received a positive magnetic resonance imaging result for the disorder. Significantly more of the MS patients had received the hepatitis B vaccine in the three years before the onset of symptoms (6.7%), compared with the control patients (2.4%). Results were not significantly different according to other variables---age, sex, clinical course of the disease (relapsing-remitting or progressive), or type of initial symptoms (eye symptoms, sensory symptoms, or other). When data pertaining to the three years before the date of diagnosis rather than to the three years before symptom onset (a median of five years later) were analyzed, no risk was found.
Although the study suggests that the hepatitis B vaccine increases the risk of developing MS, only a small absolute number of vaccinated study subjects were found to have the disorder (11), and the great benefit conferred by vaccination against a common, often fatal disease must, of course, be considered. -FM
Hernan MA, et al. Neurology 2004; 63:838-42.
FROM RESTLESS INSOMNIA TO PEACEFUL SLEEP
CBT may be more likely to take you there.
Cognitive-behavioral therapy (CBT) was found to be more effective than either medication or placebo in normalizing sleep patterns in a prospective, randomized study of young and middle-aged adults.
A sleep physician confirmed the diagnosis of chronic sleep-onset insomnia in 54 respondents to newspaper advertisements of the study who did not have other diagnosed medical or psychiatric conditions that could interfere with sleep. Subjects were randomized to receive either CBT, a combination of CBT and pharmacotherapy with zolpidem (Ambien), zolpidem alone, or placebo, over an eight-week treatment period. CBT was administered by either of two sleep psychologists at three individual 30-minute treatment sessions and during one 15-minute telephone session, according to a standardized protocol. Therapy was directed toward changing negative thoughts about sleep, modified sleep restriction therapy (limiting the amount of time in bed spent awake), rising at the same time each morning, modified stimulus control techniques to promote the association of the bed with sleep rather than with the anxious struggle to sleep, and relaxation training. Participants receiving pharmacotherapy had the same degree of contact with the clinician as those in the CBT group did, but for the purposes of education in sleep hygiene and medication only.
As assessed according to a sleep diary, CBT, whether combined with pharmacotherapy or not, was more effective than either medication or placebo in reducing sleep latency (the amount of time elapsed between getting into bed and falling asleep) and improving sleep efficiency (the amount of time asleep divided by the amount of time in bed) after eight weeks of treatment. A "Nightcap" sleep monitor, a device that senses movement of the eyelids and head and records various parameters of sleep, showed a trend toward improvement in sleep latency and efficiency among subjects in the CBT and combination (CBT-pharmacotherapy) groups, but it was not statistically significant. The superiority of CBT with or without medication, compared with medication alone, had been sustained after 12 months of treatment, but because nearly half the participants in the pharmacotherapy and placebo groups chose a different form of treatment after the one-month follow-up period, there was not a sample size large enough for confident interpretation of long-term data. Many of the effects of insomnia were not improved-there were no significant improvements in total time asleep, mood, vigor, fatigue, or daytime functioning.
Because the sample size was very small (only 13 or 14 patients participated in each treatment condition), further research is warranted. However, CBT, which is offered at many sleep centers, may be underused in the treatment of sleep disorders, and patients with chronic sleep-onset insomnia might benefit from referral for such therapy.-FM
Jacobs GD, et al. Arch Intern Med 2004;164:1888-96.
ACUTE INFECTION AND VACCINATION
Are they associated with greater risks of MI and stroke?
Among patients who suffer acute infections such as urinary tract infection, systemic respiratory tract infection, and influenza, there may be a short-term increase in risk of myocardial infarction (MI) or stroke, but this was not the case after influenza, tetanus, or pneumococcal vaccinations have been administered, according to a recent study.
The medical records of patients registered in the expansive United Kingdom General Practice Research Database between 1987 and 2001 with a diagnosis of a first or subsequent MI or stroke and who either had received an influenza, tetanus, or pneumococcal vaccination or had a diagnosis of an acute infection were studied. About 60,000 patients with an MI and 55,000 patients with a stroke were included in the analyses.
The diagnosis of acute respiratory infection was found to be associated with significant increases in the rate of first MI or stroke, particularly during the first three days of infection, of nearly five times and more than three times, respectively. The diagnosis of acute urinary infection also was found to be associated with higher rates of vascular events. Subsequent MI or stroke rates followed comparable, but less dramatic, patterns. The rates of vascular events were not found to be affected after vaccination with the influenza, tetanus, or pneumococcal vaccines, however, suggesting to the researchers that the greater systemic inflammation induced by naturally occurring infection is responsible for the greater risk of MI or stroke.-JC
Smeeth L, et al. N Engl J Med 2004; 351(25):2611-8.
FECAL DNA TESTING FOR COLORECTAL CANCERS
It's more effective than fecal occult blood testing, but less so than colonoscopy.
In a recent comparison, a fecal DNA panel detected 52% (16) of 31 invasive adenocarcinomas, and fecal occult blood testing detected only 13% (4). A study of the two screening tests was conducted at 81 sites in a population of 4,404 patients 50 years of age or older who were at average risk for colorectal cancer.
The Exact Sciences fecal DNA panel was used, and the Hemoccult II fecal occult blood test was chosen because it is the only one that has been proven to reduce the risk of death from colorectal cancer. Study participants submitted one stool sample for DNA analysis of shed epithelial cells and three for occult blood testing, then underwent colonoscopy. Clinicians and laboratory personnel performing each test were blind to the results of the other two.
The fecal DNA panel detected 13 invasive adenocarcinomas that fecal occult blood testing did not, and the latter detected one that the former did not, a statistically significant difference.
Cells develop DNA mutations as they become malignant, including mutations in genes necessary for tumor suppression, DNA repair, and apoptosis. The sensitivity of the fecal DNA panel was lesser in earlier stages of disease, when only 15% of advanced adenomas were detected. Because cancer cells develop more mutations as the disease progresses, there may be too few of them for the detection of the disease in its early stages, and noninvasive cancers may not cause epithelial cells to be shed into the bowel. Its inability to detect clinically significant cancerous lesions early limits the value of fecal DNA testing as a onetime test.
The study, despite the inclusion of 4,404 participants, did not involve enough cases of invasive cancer to determine the precise sensitivity of either test. Larger studies of the sensitivity of fecal DNA testing in an asymptomatic population at average risk are necessary. Although colorectal cancer is the second leading cause of death from cancer in the United States, its incidence in the asymptomatic population in the 50-to-59-year-old age group is only 240 cases per 100,000 people (0.0024%) per year. The relative cost of the two screening tests per life saved was not calculated in the study. In the long term, inexpensive and noninvasive tests performed frequently, even though they are less sensitive in the detection of colorectal cancer, may be more effective in preventing deaths from the disease. A more sensitive noninvasive test to screen for colorectal cancer could lead to early treatment, preventing death from the disease. -FM
Imperiale TF, et al. N Engl J Med 2004;351(26):2704-14; Woolf, SH. N Engl J Med 2004;351(26):2755-8.
POSTNATAL HOME NURSING VISITS
Diminishing the necessity of hospital care.
A recent study conducted by the Pennsylvania State University College of Medicine, Hershey, Pennsylvania, reports that home nursing visits made to newborns within four days of delivery led to a decrease in hospital visits for jaundice or dehydration after discharge.
The study included all newborns discharged from the new-born nursery at the Hershey Medical Center, from January 2000 to December 2002. All infants were born full term or near term without risk factors or anomalies that necessitated more intensive care, observation, or extended hospital stay. Data were collected on newborns brought back to the ED for jaundice or dehydration during the first 10 days of life.
The results were enlightening. Of the 2,641 newborns who did not receive a home visit, 73 (2.8%) were readmitted in the first 10 days of life for jaundice or dehydration or both, compared with two (0.6%) of the 326 newborns who did receive a visit. Additionally, 92 (3.5%) of the 2,641 newborns who did not receive a home visit were seen and treated in the ED for jaundice or dehydration or both within the first 10 days of life, compared with none of the 326 who did.
The comparative cost of treatment in the two groups differed overall; among infants who did not receive home nursing visits, the average cost was $118.70 per child, compared with a $109.80 average cost per child among those who did. The estimated cost savings of a routine home visit strategy, compared with a no-visit strategy, was found to be $181.82.
Many insurance companies either will cover or are required to cover a newborn home nursing visit, and health care providers and social workers should inform the patient that the service is available. Further, not all home nursing visits are necessitated by the concern with jaundice or dehydration--nurses can help with questions about breastfeeding, with parental anxiety, and with general concerns. "This study indicates that physicians should strongly consider home nurse visits," the lead researcher, Ian Paul, said in a press release. -PWF
Paul IM, et al. Pediatrics 2004;114(4):1015-22; Penn State College of Medicine. Postpartum home nurse visits improve infant health, reduce costs. 2004. http://www.hmc.psu.edu/news/pr/2004/oct/IPaul_nursevisits.doc.