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PubMed2004

Methodology in longitudinal studies on psychological effects of predictive DNA testing: a review.

In the last two decades predictive testing programs have become available for various hereditary diseases, often accompanied by follow-up studies on the psychological effects of test outcomes. The aim of this systematic literature review is to describe and evaluate the statistical methods that were used in these follow-up studies. A literature search revealed 40 longitudinal quantitative studies that met the selection criteria for the review. Fifteen studies (38%) applied adequate statistical methods. The majority, 25 studies, applied less suitable statistical techniques. Nine studies (23%) did not report on dropout rate, and 18 studies provided no characteristics of the dropouts. Thirteen out of 22 studies that should have provided data on missing values, actually reported on the missing values. It is concluded that many studies could have yielded more and better results if more appropriate methodology had been used.

DNA↗
PubMed1989

The efficacy of (+)-4-propyl-9-hydroxynaphthoxazine as adjunctive therapy in Parkinson's disease.

(+)-4-propyl-9-hydroxynaphthoxazine (PHNO) is a novel selective D2 agonist. The efficacy and safety of PHNO was studied in 10 Parkinsonian patients (Hoehn and Yahr Stage II or III) who continued to receive levodopa/carbidopa. At the lowest dose administered (0.25 mg tid), nine of the 10 patients improved with respect to rigidity, bradykinesia and tremor. At this dose there was one dropout because of severe orthostasis. Although there was a trend towards improvement in motor scores with the higher doses (0.5-1.0 mg tid), this was not statistically significant. At higher doses there were a total of four dropouts because of adverse effects such as nausea, vomiting and orthostatic hypotension. It appears that PHNO may prove to be efficacious in the treatment of Parkinson's disease.

Antiparkinson Agents↗
PubMed2006

Liver adenomatosis: classification of MR imaging features and comparison with pathologic findings.

PURPOSE: To retrospectively compare the clinical manifestation and magnetic resonance (MR) imaging features of liver adenomatosis with pathologic findings. MATERIALS AND METHODS: This study had institutional review board approval, and informed consent was waived. Twenty patients were classified on the basis of pathologic findings into three groups: those with a steatotic, those with a peliotic, and those with a mixed (steatotic and peliotic) form of liver adenomatosis. MR images were reviewed in consensus by two abdominal radiologists, and findings were compared with the pathologic classification. Statistical evaluation was performed with the Student t test. RESULTS: All patients were women (mean age, 39 years +/- 10 [standard deviation]). Lesions of the steatotic form (n = 7) showed (a) a mean diameter of 6.3 cm +/- 1.7, (b) slightly hyperintense signal on T2-weighted images, (c) hyper- or isointense signal on T1-weighted images with a signal dropout with fat suppression sequences, and (d) moderate enhancement at the arterial phase with no delayed enhancement. Lesions of the peliotic form (n = 7) showed (a) a somewhat larger size (8.3 cm +/- 3.6), (b) markedly hyperintense signal on T2-weighted images, (c) iso- or hyperintensity on T1-weighted images with no signal dropout with fat suppression sequences, and (d) strong arterial enhancement and persistent enhancement at the portal and delayed phase. Lesions of the mixed form (n = 6) included a combination of imaging features of the steatotic and peliotic forms. Lesions, however, were significantly larger in the mixed form than in the steatotic form (10.3 cm +/- 4, P < .05). CONCLUSION: There are three patterns of MR imaging features of liver adenomatosis that are associated with three pathologic forms (steatotic, peliotic, and mixed).

Adenoma, Liver Cell↗
PubMed1999

Iliofemoral arterial occlusive disease: contrast-enhanced MR angiography for preinterventional evaluation and follow-up after stent placement.

PURPOSE: To evaluate the efficacy of contrast material-enhanced magnetic resonance (MR) angiography for the diagnosis of peripheral arterial occlusion and follow-up after stent placement. MATERIALS AND METHODS: Sixty-seven patients (21 women, 46 men; mean age, 64.6 years) were examined. Digital subtraction angiography and contrast-enhanced MR angiography were performed in 28 patients for preinterventional evaluation of iliofemoral arterial occlusion and in 39 patients for follow-up after stent placement in the iliac or femoral arteries, which had been performed several months before. RESULTS: All 24 occlusions were correctly diagnosed with contrast-enhanced MR angiography. Of the 59 stenoses, 36 were greater than 50% and 23 were 50% or less. Sensitivity and specificity for the detection of stenoses greater than 50% were 100% and 83%, respectively. Patency of the different stents was determined correctly with contrast-enhanced MR angiography. Some stents caused signal intensity dropout, which made MR evaluation of stents difficult. Generally, these signal intensity artifacts were most severe in stainless steel stents and mild in some nitinol stents. CONCLUSION: Contrast-enhanced MR angiography is comparable to digital subtraction angiography for the detection of stenosis greater than 50% and occlusion in the iliofemoral arteries. Stent patency can be determined, but contrast-enhanced MR angiography is not suitable for stent evaluation owing to signal intensity dropout; however, it provides information about the vascular anatomic areas proximal and distal to the stent.

Angiography, Digital Subtraction↗
PubMed2000

History of 7,093 patients with lower urinary tract symptoms related to benign prostatic hyperplasia treated with alfuzosin in general practice up to 3 years.

OBJECTIVES: As we have previously published 4 articles reporting the treatment of 7,093 clinical benign prostatic hyperplasia (BPH) patients treated with alfuzosin in a 3-month open-labelled study which was subsequently extended to 12, 24, and 36 months, the objective of this article is to provide additional data on dropouts, acute urinary retention (AUR), progression to surgery, and safety under the natural conditions of general practice, paying special attention to the predictive factors. METHODS: 7,093 patients were initially enrolled by 1,812 centers for up to 3 months. Subsequently 1,508, 1,325, and 812 general practitioners agreed to extend the study up to 12, 24, and 36 months, respectively, which corresponds to 4 patient populations. RESULTS: The baseline symptom profile of patients who completed the study was identical to that of patients who dropped out (because the center resigned or during treatment). In the 4 patient populations, the percentage of patients per month who dropped out, experienced adverse effects, AUR and surgery were 0. 6-1.6, 0.1-0.5, 0.01-0.03, and 0.1-0.3%, respectively. The classes of symptom severity were not predictive for dropouts: 3.5, 12.6, 20, and 14.3% of the severe patients dropped out during treatment versus 4.2, 13.7, 22.9, and 14.0% of the moderate patients who dropped out up to 3, 12, 24, and 36 months, respectively. Safety was satisfactory regarding the number of adverse events and blood pressure measurement. No retrograde ejaculation was reported. CONCLUSION: Under the natural conditions of general practice the reasons for dropping out were not correlated with symptom severity.

Adrenergic alpha-Antagonists↗
PubMed1985

Prophylaxis of constipation by wheat bran: a randomized study in hospitalized patients.

To evaluate the efficacy of wheat bran in preventing constipation, 200 hospitalized patients were randomly allocated to groups receiving either a dietary supplement of 40 g bran daily or no dietary supplement at all. A quarter of the bran group patients refused to take their bran from the very beginning (refusers), one third stopped bran consumption during the study (dropouts), and only 42% of the patients continued on bran until discharge or death (participants). Independent of a previous history of constipation, neither the hospital incidence of constipation nor the average percentage of days on laxatives was significantly different between the bran group and the control group. Only the dropouts were significantly more constipated than the control patients, whereas no such difference could be demonstrated in the refusers or participants. It is concluded that the administration of bran as a prophylactic laxative confers no benefit in patients hospitalized for a relatively short time.

Aged↗
PubMed1997

Morphologic changes of the macula in a patient with Purtscher's retinopathy.

Purtscher's retinopathy is a rare complication after trauma to the chest or bone fractures. We report about a patient, which we examined 6 months after a serious car accident. Visual acuity was 20/20 in both eyes. Examination with the Amsler grid revealed a paracentral scotoma in the left eye. In the fluorescein angiography of the left eye performed with a scanning laser ophthalmoscope we found capillary dropout, which corresponded well to the scotoma. Measured by digital image analysis, the area of the foveal avascular zone was eccentrically enlarged by a factor of 4. The mean perifoveal intercapillary area was also enlarged in the corresponding quadrant. This reflects that focal capillary dropout may result in scotoma rather than in a decrease in visual acuity as reported in other diseases.

Adult↗
PubMed2004

Trial of preventing hypertension: design and 2-year progress report.

The TRial Of Preventing HYpertension (TROPHY) study is an investigator-initiated trial to examine whether early pharmacological treatment in subjects with "high-normal" blood pressure (BP) might prevent or delay the development of clinical hypertension. This is a 4-year, multicenter, randomized, double-blind study in untreated subjects aged 30 to 65 years with entry BPs of 130 to 139/< or =89 or < or =139/85 to 89. The participants were randomized either to placebo or to a fixed (16 mg once daily) dose of candesartan cilexetil (candesartan). After 2 years, the candesartan group was switched to placebo, and the placebo group continued taking placebo. The main outcome measure was the development of clinical (treatment-requiring) hypertension assessed by an automated (blinded) BP measurement device. We randomized 809 subjects (59% males, average age 49.0+/-SD 8.1 years) in 71 study centers in the United States. The entry BP was 134+/-4.3/84.8+/-3.9 mm Hg. During the first 2 years, 187 subjects (23%) developed clinical hypertension. All have been given antihypertensive treatment, and 170 continue to be followed in study centers. The study dropout rate is 14.8% (120 subjects). The hypertension rates are higher than anticipated, whereas the rates of dropout are within the sample size projections; thus, the study will have sufficient power to evaluate its hypotheses. In this article, we describe baseline characteristics of TROPHY subjects and discuss novel analytical issues and statistical approaches to evaluate the findings in this trial of primary prevention of hypertension.

Adult↗
PubMed2005

Efficacy and safety of nimodipine in subcortical vascular dementia: a randomized placebo-controlled trial.

BACKGROUND AND PURPOSE: Evidence of drug efficacy in vascular dementia (VaD) is scanty. Therapeutic trials should address VaD subtypes. We studied the efficacy and safety of the calcium antagonist nimodipine in subcortical VaD. METHODS: 242 patients defined as affected by subcortical VaD based on clinical (ICD-10) and computed tomography criteria were randomized to oral nimodipine 90 mg/d or placebo. RESULTS: 230 patients (121 nimodipine, mean age 75.2+/-6.1; 109 placebo, 75.4+/-6.0) were valid for the intention-to-treat analysis. At 52 weeks, the Sandoz Clinical Assessment Geriatric scale 5-point variation (primary outcome measure) did not differ significantly between the 2 groups. However, patients on nimodipine performed better than placebo patients in lexical production (P<0.01) and less frequently showed deterioration (3 or more point-drop versus baseline) on a Mini-Mental State Examination (28.1% versus 50.5%; chi2 P<0.01) and Global Deterioration Scale (P<0.05). Dropouts and adverse events were all significantly more common among placebo than nimodipine patients, particularly cardiovascular (30 versus 13; RR, 2.26; 95% CI, 1.11 to 4.60) and cerebrovascular events (28 versus 10; RR, 2.48; 95% CI, 1.23 to 4.98), and behavioral disturbances requiring intervention (22 versus 5; RR, 3.88; 95% CI, 1.49 to 10.12). A worst-rank analysis, performed to correct for the effect of the high dropout rate in the placebo group, showed additional significant differences in favor of nimodipine in Set Test and MMSE total scores. CONCLUSIONS: Nimodipine may be of some benefit in subcortical VaD. Confirming previous results, the safety analysis of this study shows that in this high-risk population, nimodipine might protect against cardiovascular comorbidities.

Aged↗
PubMed2005

Cilostazol prevents the progression of the symptomatic intracranial arterial stenosis: the multicenter double-blind placebo-controlled trial of cilostazol in symptomatic intracranial arterial stenosis.

BACKGROUND AND PURPOSE: Cilostazol, a phosphodiesterase inhibitor, has been reported to reduce restenosis rate after coronary angioplasty and stenting. This study was performed to investigate the effect of cilostazol on the progression of intracranial arterial stenosis (IAS). METHODS: We randomized 135 patients with acute symptomatic stenosis in the M1 segment of middle cerebral artery or the basilar artery to either cilostazol 200 mg per day or placebo for 6 months. Aspirin 100 mg per day was also given to all patients. Patients with potential embolic sources in the heart or extracranial arteries were excluded. IAS was assessed by magnetic resonance angiogram (MRA) and transcranial Doppler (TCD) at the time of recruitment and 6 months later. The primary outcome was the progression of symptomatic IAS on MRA and secondary outcomes were clinical events and progression on TCD. RESULTS: Thirty-eight patients were prematurely terminated. Dropout rates and reasons for dropouts were similar between the cilostazol and placebo groups. There was no stroke recurrence in either cilostazol or placebo group, but there was 1 death and 2 coronary events in each group. In cilostazol group, 3 (6.7%) of 45 symptomatic IAS progressed and 11 (24.4%) regressed. In placebo group, 15 (28.8%) of symptomatic IAS progressed and 8 (15.4%) regressed. Progression of symptomatic IAS in cilostazol group was significantly lower than that in placebo group (P=0.008) CONCLUSIONS: Our study suggests that symptomatic IAS is a dynamic lesion and cilostazol may prevent its progression.

Aged↗
PubMed2006

Paragraph text reading using a pixelized prosthetic vision simulator: parameter dependence and task learning in free-viewing conditions.

PURPOSE: To investigate the feasibility of adequate reading by recipients of future prosthetic visual implants through simulation in sighted observers. METHODS: Four normally sighted subjects used a video headset to view short-story segments at a sixth grade reading level, presented in 6- to 11-word paragraphs through a pixelizing grid defined by five parameters (dot size, grid size, dot spacing, random dropout percentage, and gray-scale resolution). Grid parameters were varied individually, and four character sizes and two contrast levels were used. RESULTS: Reading speeds of 30 to 60 words per minute without errors were recorded for some parameter combinations. In general, reading accuracy and speed were influenced by all parameters. Reading accuracy exceeded 90% if the following conditions were met: At least 3 dots/charwidth were presented, and dropout did not exceed 50%. Reading speed deteriorated below 20 words per minute if accuracy fell below 90% and at low contrast if the grid spanned less than two characters. CONCLUSIONS: It is uncertain whether and to what extent retinal reorganization may limit the perception of multiple phosphenes by blind prosthesis recipients. If distinct phosphenes can be perceived, these results suggest that a 3 x 3-mm2 prosthesis with 16 x 16 electrodes should allow paragraph reading. The effects of stabilizing the dot grid on the retina must be investigated further.

Adult↗
PubMed1976

Lithium prophylaxis of depression in bipolar I, bipolar II, and unipolar patients.

The authors investigated lithium prophylaxis of depression in bipolar I (N=35), bipolar II (N=18), and unipolar I (N=28) outpatients. Depression indices included frequency of depressive episodes, three measures of severity, dropouts due to depression, and time in study. There were significantly fewer episodes and dropouts due to depression in the lithium-treated than in the placebo-treated bipolar I patients. Lithium was superior to placebo on all indices in the bipolar II group (although the sample size did not permit statistical analysis) and on 3 indices in the unipolar group. The authors believe that lithium prophylaxis of depression has been demonstrated in these three subtypes but note the need for further research particularly in the use of tricyclic antidepressants.

Bipolar Disorder↗
PubMed2001

A randomized double-blind study of risperidone and olanzapine in the treatment of schizophrenia or schizoaffective disorder.

OBJECTIVE: The safety and efficacy of risperidone and olanzapine were compared in a double-blind trial that used doses widely accepted in clinical practice. METHOD: Subjects (N=377) who met DSM-IV criteria for schizophrenia or schizoaffective disorder were randomly assigned to receive 2-6 mg/day of risperidone (mean modal dose=4.8 mg/day) or 5-20 mg/day of olanzapine (mean modal dose=12.4 mg/day) for 8 weeks. RESULTS: The two study groups were similar at baseline except that the olanzapine group was slightly younger than the risperidone group. Seventy-five percent of the participants completed the trial, with no between-treatment differences in the proportion of dropouts. Similar proportions of the risperidone and olanzapine groups reported extrapyramidal symptoms (24% and 20%, respectively). Severity of extrapyramidal symptoms was low in both groups, with no between-group differences. Total Positive and Negative Syndrome Scale scores and scores on the five Positive and Negative Syndrome Scale factors were improved in both groups at week 8 (subjects who completed the study) and endpoint (all subjects, including dropouts). There were overall between-treatment differences in efficacy. Comparison of individual factors found no significant differences at endpoint; at week 8, however, improvements on Positive and Negative Syndrome Scale factors for positive symptoms and anxiety/depression were greater with risperidone than olanzapine. An increase in body weight of > or =7% was seen in 27% of olanzapine participants and 12% of risperidone participants. CONCLUSIONS: Both treatments were well tolerated and efficacious. The frequency and severity of extrapyramidal symptoms were similar in the two treatment groups. Greater reductions in severity of positive and affective symptoms were seen with risperidone than with olanzapine treatment among study completers. There was no measure on which olanzapine was superior. Greater weight gain was associated with olanzapine than with risperidone treatment.

Adult↗
PubMed1980

Utilization patterns of a CMHC in an urban ghetto area.

Economically disadvantaged and minority patients often are viewed as being reluctant to use outpatient mental health services, especially psychoanalytically oriented ones. They are also believed to have high rates of dropout from treatment. A community mental health center in New York City's Spanish Harlem studied its clientele over a year and found that center usage and client outcome were unrelated to social, ethnic, or cultural factors, but depended on clinical considerations. A small percentage of the patients consumed more than half of the center's services over the study period. A very low initial dropout rate also was noted. The authors found no significant evidence of the so-called "machismo" effect among Hispanic males that would reduce their participation in mental health services.

Adult↗
PubMed1997

Psychoeducational workshops for elderly patients with recurrent major depression and their families.

OBJECTIVE: This report details an extension of the use of psychoeducational workshops with psychiatric patients and their families to families of elderly patients with recurrent unipolar late-life depression. METHODS: Subjects were 132 participants in a study of maintenance therapies for late-life depression and their 182 family members and significant others who accepted invitations to single-session family workshops. Participants provided feedback on their satisfaction with the content and quality of the workshops. Associations between workshop attendance, preworkshop demographic and clinical characteristics, treatment adherence, and outcome were explored through comparisons between 108 patients who attended workshops and 24 patients who declined the workshop invitation. RESULTS: Favorable feedback from participants suggested that the extension of the workshops to families of elderly patients with depression was successful. Workshop attendance was associated with a lower rate of dropout during continuation treatment. CONCLUSIONS: Results associating workshop refusal and treatment dropout, as well as the overall treatment compliance and retention rates in this randomized clinical trial involving geriatric patients, support the need for further study of factors relating to elderly patients' willingness to engage in family-centered interventions.

Aged↗
PubMedDate not supplied

Prevention of edema, flight microangiopathy and venous thrombosis in long flights with elastic stockings. A randomized trial: The LONFLIT 4 Concorde Edema-SSL Study.

UNLABELLED: The LONFLIT1/2 studies have established that in high-risk subjects after long (> 10 hours) flights the incidence of deep venous thrombosis (DVT) is between 4% and 6%. The LONFLIT4 study has been planned to evaluate the control of edema and DVT in low-medium-risk subjects. The aim of this study was to evaluate edema and its control with specific flight stockings, in long-haul flights. In the first part of the study 400 subjects at low-medium risk for DVT were contacted; 28 were excluded for several nonmedical problems; 372 were randomized into 2 groups to evaluate prophylaxis with stockings in 7-8-hour flights; the control group had no prophylaxis. Below-knee, Scholl, Flight Socks, producing 14-17 mm Hg of pressure at the ankle, were used in the treatment group. The occurrence of DVT was evaluated with high-resolution ultrasound scanning (femoral, popliteal, and tibial veins). Edema was assessed with a composite score based on parametric and nonparametric measurements. Part II: In this part of the study 285 subjects at low-medium risk for DVT were included and randomized into 2 groups to evaluate edema prophylaxis in 11-12-hour flights; the controls had no prophylaxis while the prevention group had below-knee, Scholl, Flight Socks (comparable to part I). RESULTS: Part 1: DVT evaluation. Of the 184 included subjects in the stockings group and 188 in the control group, 358 (96.2%) completed the study. Dropouts were due to compliance or connection problems. Age/sex distributions were comparable in the groups. Stockings Group: of 179 subjects (mean age 49; SD 7; M:F = 101:78), none had DVT or superficial thromboses. CONTROL GROUP: of 179 subjects (mean age 48.4; SD 7.3; M:F = 98:81), 4 (2.2%) had a DVT. There were also 2 superficial thromboses. In total, 3.35% (6) subjects had a thrombotic event. The difference (p<0.002) is significant. Intention-to-treat analysis detects 15 failures in the control group (9 lost + 6 thromboses) out of 188 subjects (7.9%) versus 5 subjects (2.7%) in the stockings group (p <0.05). All thrombotic events were observed in passengers sitting in nonaisle seats. The tolerability of the stockings was very good and there were no complaints or side effects. Thrombotic events were asymptomatic. No difference was observed in the distribution of events between men and women. The 3 women who had a thrombotic event were taking low-dose, oral contraceptives. Edema evaluation: The level of edema at inclusion was comparable in the 2 groups. After the flight there was a score of 6.7 (3.1) in controls; in the stockings group the score was 2.9 times lower (p<0.05). The control of edema with stockings was clear considering both parametric (circumference, volume) and nonparametric (analogue scale lines) data. Part II: DVT evaluation. Of the 285 included subjects, 271 (95%) completed the study. Dropouts were due to low compliance or connection problems. Age/sex distributions were comparable in the groups. Stockings Group: of 142 subjects (mean age 48; SD 8; M:F = 89:53), none had DVT or superficial thromboses. CONTROL GROUP: of 143 subjects (mean age 47; SD 8; M:F = 87:56), 3 had a popliteal DVT and 3 a superficial thrombosis. In total, 4.2% (6) subjects had a thrombotic event. The difference (p<0.02) between groups is significant. Intention-to-treat analysis detects 14 failures in the control group (8 lost + 6 thromboses = 9.7%) versus 6 (all lost = 4.2% in the stockings group) (p<0.05). Four of 6 events (3 DVT + 1 SVT) were observed in non-aisle seats. The tolerability of the stockings was very good. No difference was observed in the distribution of events between men and women. Edema evaluation: The level of edema at inclusion was comparable in the 2 groups. After the flight there was a score of 8.08 (2.9) in controls while in the stockings group the score was 2.56 (1.5) (p < 0.005). In conclusion. Scholl Flight Socks are very effective in controlling edema. Also this type of compression is effective in significantly reducing the incidence of DVT and thrombotic events in low-medium-risk subjects, in long-haul flights. CONCLUSIONS: Considering these observations, Flight Socks are effective in controlling edema and in reducing the incidence of DVT in low-medium-risk subjects, in long-haul flights (7-11 hours).

Aerospace Medicine↗
PubMed2003

The LONFLIT4-Concorde--Sigvaris Traveno Stockings in Long Flights (EcoTraS) Study: a randomized trial.

UNLABELLED: The LONFLIT1/2 studies have established that in high-risk subjects after long ( > 10 hours) flights the incidence of deep venous thrombosis (DVT) may be between 4% and 6%. The LONFLIT4 study was aimed at evaluating the control of edema and DVT prevention in low-medium-risk subjects. In this study prophylaxis of edema with specific travel stockings was evaluated in 2 separate studies involving flights lasting 7 hours and 10-12 hours. Part I. Subjects at low-medium risk for DVT were contacted; 55 subjects were excluded for several nonmedical, travel-related problems or inconvenient evaluation time; the remaining 211 were randomized into 2 groups to evaluate prophylaxis with elastic stockings in 7-8-hour, long-haul flights. The control group had no prophylaxis; the treatment group used below-knee, Sigvaris Traveno elastic stockings (Ganzoni, Switzerland, producing 12-18 mm Hg of pressure at the ankle). Color duplex scanning was used to evaluate the possible presence of DVT; edema/swelling were evaluated with a composite score including the presence of edema (with an edema tester), variations in ankle circumference and leg volumetry, subjective swelling, and discomfort (scale ranging from 0 to 10). RESULTS: Of the 103 included subjects in the stockings group and 108 in the control group (total 211), 195 subjects completed the study. Dropouts (16) were due to low compliance or traveling and connection problems. Age, sex distribution, and risk factors distributions were comparable in the 2 groups. Stockings Group: Of 97 subjects none had DVT or superficial thromboses. CONTROL GROUP: Of 98 subjects none had thrombosis. The level of edema at inclusion was comparable in the 2 groups of subjects. After flights there was an average score of 6.4 (1.3) in the control group, while in the stockings group the score was on average 2.4 (SD 1), 2.6 times lower than in the control group (p < 0.05). In the control group 83% of the subjects had an evident increase in ankle circumference and volume that was visible at inspection and associated with discomfort. The control of edema with stockings was clear, considering both parametric data (circumference and volume) and nonparametric (analogue scale lines) measurements. Part II. In this part of the study 200 subjects at low-medium risk for DVT were contacted; 35 subjects were excluded for several nonmedical, travel-related problems or inconvenient evaluation time; the remaining 165 were randomized into 2 groups to evaluate prevention in flights lasting between 11 and 12 hours. The control group had no prophylaxis; the treatment group used Traveno stockings. Of the 83 included subjects in the stockings group and 82 in the control group (total 165), 146 subjects completed the study. Dropouts were due to low compliance or connection problems. Age/sex distribution were comparable. Of 75 subjects completing the study in the stockings group and 71 in the control group, none had thrombosis. The average level of edema at inclusion was comparable in the 2 groups (1.1). After the flight there was a score of 8.9 (2) in controls; in the stockings group the score was 2.56 (1.3) (p < 0.05). The control of edema and swelling with stockings even after 11 hours of flight was clear, considering both parametric (circumference, volume) and nonparametric (analogue scale lines) measurements. The tolerability of the stockings was very good and there were no complaints or side effects. In conclusion Sigvaris Traveno stockings are very effective in controlling edema in long-haul flights.

Adult↗
PubMedDate not supplied

The LONFLIT4--Concorde Deep Venous Thrombosis and Edema Study: prevention with travel stockings.

BACKGROUND: The LONFLIT1+2 studies have established that in high risk subjects after long flights (> 10 hours) the incidence of deep venous thrombosis (DVT) is between 4% and 6%. The LONFLIT4 study was designed to evaluate the control of edema and DVT in low-medium risk subjects. The aim of this study was to evaluate edema and its control with specific stockings (ankle pressure between 20 and 30 mm Hg) in long-haul flights. The first part of the study included flights lasting 7-8 hours and the second part included flights lasting 11-12 hours. Ultrasound scans were used to assess thrombosis before and after the flights and a composite edema score was used to evaluate edema and swelling. A group of patients with microangiopathy associated to edema (diabetes, venous hypertension, anti-hypertensive treatment) were also included to evaluate the preventive effects of stockings during flight. Part I: DVT evaluation: Of the 74 subjects in the stocking group and 76 in the control group (150), 144 completed the study. Dropouts were due to low compliance or traveling and connection problems. Age and gender distribution were comparable in the 3 groups as was risk factor distribution. In this part of the study there were no DVTs. Edema Evaluation: The level of edema at inclusion was comparable in the two groups of subjects. After the flight there was an average score of 6.9 (1) in the control group. In the stocking group, the score was on average 2.3 (1), three times lower than in the control group (p < 0.05). Part II: DVT evaluation: Of the 66 included subjects in the stocking group and 68 in the control group (134), 132 completed the study. Dropouts were due to low compliance or connection problems. Age and gender distribution were comparable in the two groups. In the stocking group no DVT was observed. In the control group, 2 subjects had a popliteal DVT and 2 subjects had superficial venous thrombosis (SVT); in total 4 subjects (6%) in the control group had a thrombotic event; the incidence of DVT was 3%. The difference (p < 0.02) is significant. EDEMA EVALUATION: The composite edema score at inclusion was comparable in the two groups. After the flight there was a score of 7.94 (2) in the control group, while in the treatment group the score was 3.3 (1.2). MICROANGIOPATHY STUDY: In all these subjects, the level of edema was very high in the control group and significantly lower in the compression stocking group. Stockings are effective in controlling edema during flights even in subjects with microangiopathy and edema. Compression was well tolerated in normal subjects and in patients. CONCLUSION: The Kendall Travel Socks (Tyco Healthcare, Mansfield, MA, USA) which provide 20-30 mm Hg pressure at the ankle, are effective in controlling edema and reducing the incidence of DVT in both low-medium-risk subjects and in patients with microangiopathy and edema in long-haul flights (7-11 hours).

Aerospace Medicine↗