Treatment of morbid obesity with the Swedish adjustable gastric band (SAGB): complication rate during a 12-month follow-up period.

BACKGROUND: The Swedish adjustable gastric band (SAGB) is used to treat morbid obesity. However, no quantitative data are available describing the follow-up of these patients with respect to the frequency and the complication rate of inflating and deflating the adjustable system. METHODS: We prospectively investigated 207 morbidly obese patients. All patients completed 12 months of follow-up and were seen in intervals of 1 to 3 months on an outpatient basis. RESULTS: A total of 207 patients had 1692 consultations (8.3 +/- 2.4 consultations per patient per year [mean +/- SD]), 920 port-a-cath punctions (4.6 +/- 2.0), 820 inflations (4.1 +/- 1.6), and 100 deflations (1.4 +/- 0.6). Complications related to the port-a-cath (n = 6, 2.9% of all patients) were 1 leakage of the tube (0.5%), 2 disconnections of the connecting tube (1.0%), and 3 reimplantations of the port-a-cath as a result of discomfort (1.4%). Complications related to the SAGB (n = 10, 4.8%) were 6 leakages of the band (2.9%), 2 penetrations (1.0%), 1 intraoperative perforation of the esophagus (0.5%), and 1 dystopically implanted SAGB (0.5%). Additionally, 9 minor early postoperative wound infections (4.3%) were recorded. CONCLUSIONS: Follow-up can be safely performed on an outpatient basis after implantation of a SAGB without infectious and other minor complications directly linked to the filling procedure.

Evaluation of chronic insomnia. An American Academy of Sleep Medicine review.

Insomnia is a condition which affects millions of individuals, giving rise to emotional distress, daytime fatigue, and loss of productivity. Despite its prevalence, it has received scant clinical attention. An adequate evaluation of persistent insomnia requires detailed historical information as well as medical, psychological and psychiatric assessment. Use of a classification system for sleep disorders and familiarity with major diagnostic groups will facilitate the clinician's evaluation and treatment. Thorough assessment also requires attention to the unique aspects of presentation and specific set of etiologies which are associated with particular age groups.

Is bariatric surgery worth its costs?

Formal economic evaluations of obesity surgery have not been reported in the medical literature to date. In this article, we briefly review the most important types of health economic evaluations, namely cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. Bariatric surgery has the potential to substantially impact quality of life, morbidity, and mortality costs in patients with morbid obesity. Health economic studies that include these effects are needed.

Swedish adjustable gastric band (SAGB)-distal gastric bypass: a new variant of an old technique in the treatment of superobesity and failed band restriction.

BACKGROUND: Dissatisfied with vertical banded gastroplasty in superobese patients, the authors adopted Salmon's gastroplasty/distal gastric bypass (DGBP) in 1995. When the Swedish adjustable gastric band (SAGB) became available in Switzerland, the authors started using that device instead of the gastroplasty because implanting a SAGB is much easier and gastric restriction with a SAGB is adjustable to the patients' individual demands. METHODS: The authors evaluated 40 consecutive patients with SAGB-DGBP (27 primary and 13 secondary operations) for weight loss and complications, and compared weight loss with that obtained by SAGB alone. The mean initial body weight was 156.6 kg in women and 188.1 kg in men for primary and 108.2 kg/147.0 kg for secondary indications, respectively. The band was placed in a high position without tunneling sutures, and DGBP was done with a 50- to 60-cm common channel and a 60- to 80-cm biliopancreatic limb. RESULTS: Weight loss at 1 year was 33.3% of initial body weight for primary operations. Weight loss was significantly more than with SAGB-alone cases. Complications were as follows: no death, no slipping or pouch dilatation; one marginal ulcer, one splenectomy, four cholecystectomies, one Roux-en-O reconstruction, two band leaks, eight port-related reoperations. Iron or vitamin deficiencies occurred in 75% of patients, with one case of transient protein malnutrition and one of intermittent diarrhea. CONCLUSIONS: The SAGB as gastric restriction in combination with DGBP can be implanted easily. The new-generation SAGB is safe, but longer follow-up is necessary. SAGB-DGBP is more efficient than SAGB alone for weight reduction. It is too early to recommend banded DGBP as a primary procedure. However, in cases of insufficient weight loss after placement of an adjustable band, adding a DGBP without removing the band is an option. Follow-up by a specialized team is mandatory.

Actigraphic assessment of sleep in insomnia: application of the Actigraph Data Analysis Software (ADAS).

The usefulness of the actigraph methodology has been demonstrated in normal individuals. However, the validity of actigraphy has been questioned in insomnia patients because of the considerable measurement error that has been reported between actigraphy (ACT) and polysomnography (PSG). Two independent investigations have reported errors of 48 and 49 min in total sleep time between ACT and PSG. With a new scoring method called the Actigraph Data Analysis Software, a reanalysis of one of these studies was conducted. Based on this reanalysis, we have obtained a measurement error of only 25 min between the two methods. This finding may be an indication of the advantage of this new scoring method. A strong correlation coefficient (r = 0.82, p < 0.0001) was noted between ACT and PSG for total sleep time, thus suggesting a high degree of accuracy of the actigraph methodology in assessing the sleep/wake profile of insomniacs.

Evaluation of a sleep switch device.

STUDY OBJECTIVE: To evaluate the performance of a sleep switch device (held between finger and thumb) in normal sleepers and in insomniacs by comparing its performance to PSG data, wrist actigraphy, and subjective estimates. DESIGN: 19 insomniacs and 6 normal sleepers each spent one night in the sleep laboratory. Sleep latency and total sleep time were evaluated by the sleep switch device, polysomnography, wrist actigraphy, and subjective estimates. SETTING: NA. PATIENTS OR PARTICIPANTS: NA. INTERVENTIONS: NA. RESULTS: The sleep switch device correlated .98 with PSG sleep latency (to the onset of the first 10 minutes of solid sleep, stage 1 or deeper). Mean and standard deviations were almost identical between the two measures. The sleep switch was somewhat less accurate than the wrist actigraph in assessing total sleep time. CONCLUSIONS: The sleep switch device is a very accurate and inexpensive tool when trying to assess sleep latency in insomniacs and in normals.

Nonpharmacologic treatment of chronic insomnia. An American Academy of Sleep Medicine review.

This paper reviews the evidence regarding the efficacy of nonpharmacological treatments for primary chronic insomnia. It is based on a review of 48 clinical trials and two meta-analyses conducted by a task force appointed by the American Academy of Sleep Medicine to develop practice parameters on non-drug therapies for the clinical management of insomnia. The findings indicate that nonpharmacological therapies produce reliable and durable changes in several sleep parameters of chronic insomnia sufferers. The data indicate that between 70% and 80% of patients treated with nonpharmacological interventions benefit from treatment. For the typical patient with persistent primary insomnia, treatment is likely to reduce the main target symptoms of sleep onset latency and/or wake time after sleep onset below or near the 30-min criterion initially used to define insomnia severity. Sleep duration is also increased by a modest 30 minutes and sleep quality and patient's satisfaction with sleep patterns are significantly enhanced. Sleep improvements achieved with these behavioral interventions are sustained for at least 6 months after treatment completion. However, there is no clear evidence that improved sleep leads to meaningful changes in daytime well-being or performance. Three treatments meet the American Psychological Association (APA) criteria for empirically-supported psychological treatments for insomnia: Stimulus control, progressive muscle relaxation, and paradoxical intention; and three additional treatments meet APA criteria for probably efficacious treatments: Sleep restriction, biofeedback, and multifaceted cognitive-behavior therapy. Additional outcome research is needed to examine the effectiveness of treatment when it is implemented in clinical settings (primary care, family practice), by non-sleep specialists, and with insomnia patients presenting medical or psychiatric comorbidity.

Insomnia.

This article reviews issues involved in the diagnosis of insomnia and discusses treatment options, including pharmacologic treatment, which is indicated mainly in acute insomnia. Sleep hygiene is then discussed. Finally, the various behavioral treatments are reviewed, including light therapy, relaxation training, cognitive therapy, sleep curtailment, and stimulus control therapy.

Clinical factors contributing to the differential diagnosis of primary insomnia and insomnia related to mental disorders.

OBJECTIVE: Primary insomnia and insomnia related to mental disorders are the two most common DSM-IV insomnia diagnoses, but distinguishing between them is difficult in clinical practice. This analysis was performed to identify clinical factors used by sleep specialists to distinguish primary insomnia from insomnia related to mental disorders. METHOD: Clinicians evaluated 216 patients referred for insomnia at five clinical sites, rated a list of clinical factors judged to contribute to each patient's presentation, and assigned diagnoses. Analysis of variance was performed, with contributing factors as the dependent variable and diagnostic group and clinic location as independent variables. RESULTS: Sleep specialists rated a psychiatric disorder as a stronger factor for insomnia related to mental disorders and rated negative conditioning and sleep hygiene as stronger factors for primary insomnia. However, a psychiatric disorder was rated as a contributing factor for 77% of patients who received a first diagnosis of primary insomnia. CONCLUSIONS: While neither sleep hygiene nor negative conditioning is a diagnostic criterion in DSM-IV, these results support the face validity of these clinical factors distinguishing between primary insomnia and insomnia related to mental disorders. The use of a psychiatric disorder as an inclusion criterion for insomnia related to mental disorders and an exclusion criterion for primary insomnia reinforces a categorical distinction between the two diagnoses, but the contribution of psychiatric symptoms in primary insomnia appears to be a clinically relevant one. These findings suggest the need for studies on the validity of negative conditioning and sleep hygiene in the etiology of primary insomnia, as well as on the significance of psychiatric disorders, especially depression, in primary insomnia.

The actigraph data analysis software: I. A novel approach to scoring and interpreting sleep-wake activity.

Decades of empirical observations have established the validity of actigraphy primarily in individuals without sleep disorders. Methodological problems encountered thus far coupled with the widespread use of actigraphy signal the need for concentrated efforts to establish a consensus regarding scoring procedures. Currently available scoring methods show less reliability in clinical populations. To address these issues two validation studies were conducted: one for individuals without sleep disorders and the other for patients diagnosed with insomnia. The results of these two studies using the Actigraph Data Analysis Software as the scoring method have shown that the described system is fairly precise. It can be used for actigraphs with different features and mode of operation and is applicable to individuals with insomnia. These findings corroborate previous research showing that actigraphy is a valid instrument for assessment of sleep and wakefulness.

The actigraph data analysis software: II. A novel approach to scoring and interpreting sleep-wake activity.

The widespread use of actigraphy has led to the recognition that a number of methodological issues have to be addressed to facilitate an increased acceptability of this relatively new method. These methodological issues include actigraph placement, reliability, and sensitivity, and the phenomenon known as the "first night effect." Our findings have demonstrated that actigraphy is a reliable instrument for assessment of sleep and wakefulness. In addition, actigraph placement and reliability do not constitute a significant methodological problem as no differences were found in all of these studies. We have also observed no first-night effects associated with sleep-wake monitoring with actigraphy.

Effects of diagnosis on treatment recommendations in chronic insomnia--a report from the APA/NIMH DSM-IV field trial.

The objective of this study was to determine whether sleep specialists and nonspecialists recommend different treatments for different insomnia diagnoses according to two different diagnostic classifications. Two hundred sixteen patients with chronic insomnia at five sites were each interviewed by two clinicians: one sleep specialist and one nonsleep specialist. All interviewers indicated diagnoses using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV); sleep specialists also indicated diagnoses according to the International Classification for Sleep Disorders (ICSD). Interviewers then indicated how strongly they would recommend each item in a standard list of treatment and diagnostic interventions for each patient. We examined differences in treatment recommendations among the six most common DSM-IV diagnoses assigned by sleep specialists at different sites (n = 192), among the six most common ICSD diagnoses assigned by sleep specialists at different sites (n = 153), and among the six most common DSM-IV diagnoses assigned by nonspecialists at different sites (n = 186). In each analysis, specific treatment and polysomnography recommendations differed significantly for different diagnoses, using either DSM-IV or ICSD criteria. Conversely, different diagnoses were associated with different rank orderings of specific treatment and diagnostic recommendations. Sleep specialist and nonspecialist interviewers each distinguished treatment recommendations among different diagnoses, but in general, nonspecialists more strongly recommended medications and relaxation treatments. Significant site-related differences in treatment recommendations also emerged. Differences in treatment recommendations support the distinction between different DSM-IV and ICSD diagnoses, although they do not provide formal validation. Site-related differences suggest a lack of consensus in how these disorders are conceptualized and treated.

Cognitive deficits in insomnia patients.

This study investigates performance in insomnia patients, comparing it with performance in normals matched not only on age and sex but also on education and occupation. There were 26 pairs of insomniacs and normals; and the computer-driven performance battery, lasting about one hour, was administered three times over the course of a day. In addition, an auditory vigilance test was also administered twice. Insomniacs performed worse than normals on reaction time (they were both slower and more variable), they swayed more on the balance test, and they forgot more numbers on the Digit Span Test. There were no significant differences in Digit Symbol Substitution, Divided Attention, and Auditory Verbal Learning Tests, suggesting that the pattern of deficiencies in insomnia is different than that in sleep-deprived subjects. When insomniacs were administered the performance batteries after spontaneously occurring good or poor nights, little differences in performance were observed.

Can we mix behavioral therapy with hypnotics when treating insomniacs?

This study asks whether insomniacs undergoing behavioral training need to do so while totally free of hypnotics. Twenty-six insomniacs participated in the study, which included extensive monitoring of sleep both in the laboratory and at home. All subjects received six sessions of training in sleep hygiene and relaxation. About half the subjects were also given a hypnotic for occasional use; the others were asked to abstain from all hypnotics. Follow-up was performed immediately after treatment and again 10 months later. When compared with a waiting list, 6 hours of behavioral therapy improved insomniacs' sleep latency and sleep efficiency immediately after treatment, whether or not hypnotics were given concomitantly. Immediately following the 6 hours of therapy, those who had combined pharmacotherapy and behavior therapy improved about the same as those who had received behavior therapy alone. However, on the 10-month follow-up, those who had learned sleep hygiene and relaxation without the help of occasional hypnotics had more sleep and a better sleep efficiency than those who had been allowed an occasional hypnotic. We conclude that when teaching sleep hygiene and behavioral therapy to insomniacs, it might be advantageous to disallow the concomitant use of hypnotics as needed.

Effects of 24-hr nicotine replacement on sleep and daytime activity during smoking cessation.

BACKGROUND: This study uses wrist actigrapy to assess the effects of 24-hr transdermal nicotine replacement on the sleep and daytime activity of smokers during smoking cessation. METHODS: Seventy-one subjects grouped as light (n = 23), moderate (n = 24), or heavy (n = 24) smokers were randomly assigned to placebo or 11, 22, or 44 mg/day doses of transdermal nicotine for 1 week of intensive inpatient treatment of nicotine dependence. Outpatient patch therapy continued for 7 weeks following the inpatient stay. Those initially on placebo were randomly assigned to 11 or 22 mg/day, and those initially on 44 mg/day were reduced to 22 mg/day at Week 4. RESULTS: There was a significant decrease in daytime wrist activity during patch therapy and the 1st week off patch therapy. These changes in daytime wrist activity were positively correlated with percentage of nicotine and cotinine replacement. No changes from baseline in sleep (sleep efficiency or wrist activity) were detected, nor were there differences in sleep among the four patch doses. CONCLUSIONS: Using wrist actigraphy, this study failed to show any disturbing effects of 24-hr high-dose nicotine replacement on sleep. Lower levels of nicotine replacement were associated with a decrease from baseline in daytime wrist activity.

Seasonal variation in human illumination exposure at two different latitudes.

The authors measured ambient illumination exposure in healthy volunteers in San Diego, California (latitude 32 degrees 43' N, n = 30), and Rochester, Minnesota (latitude 44 degrees 1' N, n = 24), during each of the four quarters of the year, which were centered on the solstices and equinoxes. Subjects wore photosensors on their wrists and lapels (or foreheads while in bed) 24 h per day for an average of 5-6 days per quarter. The maximum of the two illumination readings was stored each minute. Annual average time spent per day in outdoor illumination (> or = 1000 lux) was significantly higher in San Diego than it was in Rochester (p < .04). Daily durations of illumination at or exceeding thresholds of 1, 10, 100, 1000, and 10,000 lux were highly seasonal in the sample as a whole (p < .01 at 1 lux, p < .0001 at other thresholds). Seasonal variation in outdoor illumination was far more pronounced in Rochester than it was in San Diego (interaction p < .001) but remained significant in San Diego (p < or = .03). Seasonal variation in indoor illumination was generally similar in the two cities. The median Rochester subject experienced illumination > or = 1000 lux for 2 h 23 min per day during summer and 23 min per day during winter. The corresponding times in San Diego were 2 h 10 min and 1 h 20 min. Neither age nor gender predicted illumination duration at any level. Both season and geographic location strongly influenced human illumination exposure, and behavior (choice of indoor vs. outdoor environment) was the most important mediating factor.

The role of actigraphy in the evaluation of sleep disorders.

This paper, which has been reviewed and approved by the Board of Directors of the American Sleep Disorders Association, provides the background for the Standards of Practice Committee's parameters for the practice of sleep medicine in North America. The growing use of activity-based monitoring (actigraphy) in sleep medicine and sleep research has enriched and challenged traditional sleep-monitoring techniques. This review summarizes the empirical data on the validity of actigraphy in assessing sleep-wake patterns and assessing clinical and control groups ranging in age from infancy to elderly. An overview of sleep-related actigraphic studies is also included. Actigraphy provides useful measures of sleep-wake schedule and sleep quality. The data also suggest that actigraphy, despite its limitations, may be a useful, cost-effective method for assessing specific sleep disorders, such as insomnia and schedule disorders, and for monitoring their treatment process. Methodological issues such as the proper use of actigraphy and possible artifacts have not been systematically addressed in clinical research and practice.

Diagnostic concordance for DSM-IV sleep disorders: a report from the APA/NIMH DSM-IV field trial.

OBJECTIVE: The frequency and ranking of DSM-IV sleep disorder diagnoses of clinical patients with complaints of insomnia, as well as rates of diagnostic agreement and disagreement between two types of interviewers, were investigated. METHOD: Interviewers at five clinical sites assessed 216 patients referred for insomnia complaints. One sleep specialist and one general clinician interviewed each patient in an unstructured clinical interview, assigned DSM-IV diagnoses, and indicated their reactions to the diagnostic system. RESULTS: Insomnia due to another mental disorder was the most frequent DSM-IV diagnosis across sites, followed by primary insomnia. Interviewers at the five sites differed significantly in the rankings they assigned to different diagnoses. In addition, sleep specialists at most sites diagnosed psychiatric forms of insomnia more frequently than nonspecialists. Kappa values for agreement between the two types of clinicians on multiple DSM-IV sleep diagnoses ranged from 0.26 to 0.80 across sites, indicating moderate agreement overall. Kappa values for individual diagnoses varied across sites and specific diagnoses and ranged from poor to excellent. Interviewers' ratings of their confidence in diagnoses and the fit and ease of use of the DSM-IV categories also showed significant variability related to site and type of interviewer. CONCLUSIONS: The distribution of diagnoses highlights the importance of psychiatric and behavioral factors in the assessment of insomnia. Site-related variability indicates a need for greater standardization in the application of sleep disorder diagnostic criteria. Diagnostic concordance for these diagnoses, while only moderately good, likely reflects actual clinical practice and would be improved through the use of standardized (or structured) interviews and increased training.

Serum nicotine and cotinine levels during nicotine-patch therapy.

We related serum nicotine and cotinine levels while subjects were smoking their usual numbers of cigarettes to levels while wearing a nicotine patch under carefully controlled, smoke-free conditions in a clinical research center. Twenty-four volunteers who needed intensive treatment for severe nicotine dependence were admitted to the clinical research center and were treated with a 22 mg transdermal nicotine patch each day and an intensive smoking-cessation program. Serum nicotine and cotinine levels, withdrawal symptoms, and hours and quality of sleep were noted. The steady-state serum nicotine and cotinine levels produced with the nicotine patch were lower than those observed when the subjects were smoking. Mean nicotine and cotinine levels were inversely related to mean withdrawal scores for the first 6 days. A fixed dose of transdermal nicotine will not be effective for all smokers. Individualization of therapy should be based on objective biologic measures such as serum cotinine and subjective assessment of withdrawal relief.

Consulting about insomnia: a method and some preliminary data.

Sleep specialists are increasingly asked to advise other health care workers and patients about specific cases of insomnia, even when the patients do not plan to seek actual treatment of their insomnia at a sleep center. This paper describes a procedure for such one-time consultations. It also provides some preliminary data on the subjective efficacy of such insomnia consultations by reporting data from follow-up telephone calls placed 1, 3 and 12 months after the interview. The patients' estimates of their sleep seemed significantly improved on all three follow-up contacts, and the telephone calls also provided information on what type of recommendations were actually tried by the insomniacs and which ones seemed beneficial. Acceptance of individual sleep hygiene suggestions ranged between 68 percent and 11 percent, but those who tried a given suggestion generally reported its usefulness to be about 70 percent. Advice to seek relaxation or behavioral therapy and suggestions for various medication changes were accepted by about half of those insomniacs who received such advice, and about two-thirds of those who tried them reported them as being helpful. Advice to seek psychotherapy--although quite carefully given--typically was tried by only one-third of those who received it. Overall, the survey shows good patient acceptance of once-only insomnia consultations.