One-year Follow-up Results Research Articles

One-year follow-up results of a randomized controlled clinical trial on internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years

Internet-based cognitive behaviour therapy (CBT) is a promising new approach for the treatment of depressive symptoms. The current study had two aims: (1) to determine whether, after 1 year, an internet-based CBT intervention was more effective than a waiting-list control group; and (2) to determine whether the effect of the internet-based CBT differed from the group CBT intervention, 1 year after the start of treatment. A total of 191 women and 110 men (mean age=55 years, s.d.=4.6) with subthreshold depression were randomized into internet-based treatment, group CBT (Lewinsohn's Coping with Depression Course), or a waiting-list control condition. The main outcome measure was treatment response after 1 year, defined as the difference in pretreatment and follow-up scores on the Beck Depression Inventory (BDI). Missing data were imputed using the multiple imputation procedure of data augmentation. Analyses were performed using multiple imputation inference. In the waiting-list control group, we found a pretreatment to follow-up improvement effect size of 0.69, which was 0.62 in the group CBT condition and 1.22 with the internet-based treatment condition. Simple contrasts showed a significant difference between the waiting-list condition and internet-based treatment (p=0.03) and no difference between both treatment conditions (p=0.08). People aged over 50 years with subthreshold depression can still benefit from internet-based CBT 1 year after the start of treatment.

One-year follow-up results of combined use of CO2 laser and cold instrumentation for Reinke’s edema surgery in professional voice users

The purpose of this study was to present our experience with combined use of CO2 laser and cold instrumentation for Reinke's edema surgery and to evaluate 1-year follow-up results of the technique in a series of professional voice users. Fifteen patients with Reinke's edema who underwent microlaryngoscopic surgery were included. Videolaryngostroboscopy, perceptual and acoustic voice analyses were performed before and after surgery. During the 1-year follow-up, no recurrence of Reinke's edema was encountered. Significant postoperative improvement was obtained in the quality of voice, in terms of GRBAS scores, Fo, jitter, shimmer and NHR. No evidence of laryngeal cancer was found on the histological examinations. Combined use of CO2 laser and cold instrumentation provides a reliable and safe method for Reinke's edema surgery, and cessation of smoking, voice rest and control of the laryngopharyngeal reflux contribute to the success of surgery. We consider that the removal of redundant mucosa of the vocal fold reduces the risk of the recurrence of Reinke's edema and provides better quality of voice. However, it does not imply that our method is superior to others', but this procedure constitutes an effective treatment of choice for Reinke's edema patients, including professional voice users.

Adjunctive therapy with low-molecular-weight heparin in patients with chronic heart failure secondary to dilated cardiomyopathy: One-year follow-up results of the randomized trial

Defective endothelial function has been shown in dilated cardiomyopathy. Therefore, improvement in endothelial function after low-molecular-weight heparin (LMWH) therapy may be clinically beneficial. Consequently, the effect of adjunct enoxaparin, a LMWH, on standard treatment of dilated cardiomyopathy was investigated. This was a randomized, standard treatment-controlled, 2-center pilot trial of 102 patients (52 receiving adjunctive therapy with enoxaparin at a dosage of 1.5 mg/kg daily for 3 months and 50 receiving standard therapy with angiotensin-converting enzyme inhibitors, beta-blockers, and diuretics alone) with stable chronic heart failure secondary to dilated cardiomyopathy (New York Heart Association [NYHA] class II and III; left ventricular [LV] ejection fraction, < or = 40%). All patients underwent coronary angiography and endomyocardial biopsy and were clinically stable for at least 6 months before enrollment. The combined primary end point included mortality, urgent heart transplantation, and readmission to hospital due to heart failure progression. The secondary end point was to determine the severity of heart failure (serum level of N-terminal brain natriuretic peptide), cardiac function (LV ejection fraction by radionuclide ventriculography), LV diameters by echocardiography, exercise capacity (changes in NYHA class, changes in peak oxygen consumption), and changes in quality of life (Minnesota Living with Heart Failure questionnaire). The clinical outcome was assessed after 6 and 12 months of therapy. Baseline characteristics were comparable in both groups. Five patients dropped out during 12 months of the study. Twelve patients achieved primary end point (8 in the control group and 4 in the LMWH group). The free survival rate was 94% for the LMWH group and 90% for the controls (not statistically significant). After the 12-month period, in the LMWH group, N-terminal brain natriuretic peptide level and LV diameters decreased significantly (P < .001 and P = .006, respectively), whereas LV systolic function increased (P < .001). Changes in exercise capacity and subjective improvement did not differentiate the groups (nonsignificant). Adverse reactions to the enoxaparin therapy were minor and transient. In patients with chronic heart failure due to dilated cardiomyopathy, adjunct long-term enoxaparin therapy may offer additional clinical benefit without deleterious effects on major cardiac events.

Augmentation Mammaplasty with Anatomic Soft, Cohesive Silicone Implant Using the Transaxillary Approach at a Subfascial Level with Endoscopic Assistance

Many augmentation mammaplasty techniques have been developed paying special attention to incision location and pocket plane to achieve more natural-looking breasts. The authors' technique of choice in patients with mammary hypoplasia, empty breasts following a diet program, or more than one lactation episode causing skin flaccidity without ptosis is the placement of an anatomical implant using a transaxillary approach in a subfascial plane with endoscopic assistance. Thus, ideal patients are those presenting mammary hypoplasia, empty breasts following two or more lactation episodes, and breast skin flaccidity without ptosis, with the nipple-areola complex placed above the inframammary fold. The technique and its indications are presented thoroughly. Forty-five patients were operated on using this technique from May of 2001 to October of 2003. One-year follow-up results showed highly rated patient satisfaction. One patient underwent an implant exchange because of implant size dissatisfaction. The authors prefer subfascial plane implants to submuscular ones. Possible rotation of anatomic implants and the subsequent asymmetry when contracting the pectoral muscle are avoided. Pectoral muscle is not detached from its insertions, resulting in less postoperative pain. Likewise, the authors prefer a subfascial to subglandular pocket since the weight of the subglandular pocket and the glandular weight itself are borne by the skin envelope leading to breast ptosis development over time. On the other hand, fascia provides additional support to the subfascial implant, thus eliminating ptosis development and achieving good filling of the upper pole similar to the filling provided by subglandular implants.

Five-Year Follow-Up of the Argentine Randomized Trial of Coronary Angioplasty With Stenting Versus Coronary Bypass Surgery in Patients With Multiple Vessel Disease (ERACI II)

The purpose of the present study is to report the five-year follow-up results of the ERACI II trial. Immediate and one-year follow-up results of the ERACI II study showed a prognosis advantage of percutaneous coronary intervention (PCI) with stents over coronary artery bypass grafting (CABG). A total of 450 patients were randomly assigned to undergo either PCI (n = 225); or CABG (n = 225). Only patients with multi-vessel disease were enrolled. Clinical follow-up during five years was obtained in 92% of the total population after hospital discharge. The primary end point of the study was to compare freedom from major adverse cardiovascular events (MACE) at 30 days, 1 year, 3 years, and 5 years of follow-up. At five years of follow-up, patients initially treated with PCI had similar survival and freedom from non-fatal acute myocardial infarction than those initially treated with CABG (92.8% vs. 88.4% and 97.3% vs. 94% respectively, p = 0.16). Freedom from repeat revascularization procedures (PCI/CABG) was significantly lower with PCI compared with CABG (71.5% vs. 92.4%, p = 0.0002). Freedom from MACE was also significantly lower with PCI compared with CABG (65.3% vs. 76.4%; p = 0.013). At five years similar numbers of patients randomized to each revascularization procedure were asymptomatic or with class I angina. At five years of follow-up, in the ERACI II study, there were no survival benefits from any revascularization procedure; however patients initially treated with CABG had better freedom from repeat revascularization procedures and from MACE.

Efficacy of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: one-year follow-up results of the assessment of the safety of a new thrombolytic-3 (ASSENT-3) randomized trial in acute myocardial infarction

Background In the ASsessment of the Safety of a New Thrombolytic 3 (ASSENT-3) study, full-dose tenecteplase plus enoxaparin or half-dose tenecteplase plus abciximab reduced the frequency of ischemic complications of acute myocardial infarction, when compared to full-dose tenecteplase plus unfractionated heparin. The aim of the present study was to determine the effect of these fibrinolytic regimens on 1-year mortality. Methods and results Vital status at 1 year was available for 5942 patients (97.5%) of the 6095 initially enrolled in the study. At 1 year, 515 patients (8.7%) had died. Elderly or female patients and patients with low body weight, previous myocardial infarction, anterior wall myocardial infarction, and diabetes were at increased risk for death at 1 year. Mortality at 1 year was 7.9 % (n = 161) in the heparin group, 8.1% (n = 166) in the enoxaparin group, and 9.3% (n = 188) in the abciximab group ( P = .226). Overall, pairwise comparisons did not show a significant difference among treatment regimens: relative risk 1.03 (95% CI 0.82–1.30) for enoxaparin versus heparin ( P = .794) and relative risk 1.18 (95% CI 0.95–1.47) for abciximab versus heparin ( P = .144). However, 1-year outcome tended to be worse with abciximab in diabetic patients. Conclusion Mortality at 1 year after acute myocardial infarction remains high. Despite a reduction in ischemic complications after acute myocardial infarction with the use of full-dose tenecteplase plus enoxaparin or half-dose tenecteplase plus abciximab, mortality at 1 year was similar in these treatment groups.

Psychological adjustment among African American breast cancer patients: One-year follow-up results of a randomized psychoeducational group intervention.

The effectiveness of support group interventions for cancer patients has been established among White patients but has been virtually unstudied among minority patients. The current study represents the 1st randomized support group intervention targeted to African American women with breast cancer. Participants (N = 73) with nonmetastatic breast cancer were randomly assigned to an 8-week group intervention or an assessment-only control condition At 12 months, the intervention resulted in improved mood as well as improved general and cancer-specific psychological functioning among women with greater baseline distress or lower income. Subsequent research is needed to address effective methods of enrolling and following women with fewer psychosocial and financial resources, as they were the most likely to benefit from this particular intervention.

One-Year followup results of a randomized, multi-center clinical study of the NovaSure™ impedance controlled endometrial ablation system

One-Year followup results of a randomized, multi-center clinical study of the NovaSure™ impedance controlled endometrial ablation system

Argentine randomized study: coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple-vessel disease (ERACI II): 30-day and one-year follow-up results

OBJECTIVESThe purpose of this study was to compare percutaneous transluminal coronary revascularization (PTCR) employing stent implantation to conventional coronary artery bypass graft surgery (CABG) in symptomatic patients with multivessel coronary artery disease.BACKGROUNDPrevious randomized studies comparing balloon angioplasty versus CABG have demonstrated equivalent safety results. However, CABG was associated with significantly fewer repeat revascularization procedures.METHODSA total of 2759 patients with coronary artery disease were screened at seven clinical sites, and 450 patients were randomly assigned to undergo either PTCR (225 patients) or CABG (225 patients). Only patients with multivessel disease and indication for revascularization were enrolled.RESULTSBoth groups had similar clinical demographics: unstable angina in 92%; 38% were older than 65 years, and 23% had a history of peripheral vascular disease. During the first 30 days, PTCR patients had lower major adverse events (death, myocardial infarction, repeat revascularization procedures and stroke) compared with CABG patients (3.6% vs. 12.3%, p = 0.002). Death occurred in 0.9% of PTCR patients versus 5.7% in CABG patients, p < 0.013, and Q myocardial infarction (MI) occurred in 0.9% PTCR versus 5.7% of CABG patients, p < 0.013. At follow-up (mean 18.5 ± 6.4 months), survival was 96.9% in PTCR versus 92.5% in CABG, p < 0.017. Freedom from MI was also better in PTCR compared to CABG patients (97.7% vs. 93.4%, p < 0.017). Requirements for new revascularization procedures were higher in PTCR than in CABG patients (16.8% vs. 4.8%, p < 0.002).CONCLUSIONSIn this selected high-risk group of patients with multivessel disease, PTCR with stent implantation showed better survival and freedom from MI than did conventional surgery. Repeat revascularization procedures were higher in the PTCR group.

Ｂｒａｎｔｉｇａｎ Ｉ／Ｆ Ｃａｇｅ使用によるＰＬＩＦの手術成績

This study reviewed an over one-year follow-up results of 18 cases who underwent posterior lumbar interbody fusion with Brantigan I/F cage. The clinical success was defined according to Hirabayashi's scale. 9 cases were categorized as excellent, 4 cases as good, 2 cases as fair, and the remaining 3 cases as poor. Plane X-ray radiographs revealed bone union in 18 out of 20 levels (union rate 90.0%), and non-union in only one level. The remaining cases could be concluded as neither union nor non-union because of interrueted bone trabeculae. Assessment results of X-ray radiographs were most or less satisfactory and correction loss was not observed.X-rays of some patients treated for degenerative spondylolisthesis showed carbon fiber cages buried deep in the upper vertebral bodies. A reaming device could be slipped onto the edges of the lower vertebral bodies, so pre-shaving them would be important. It is important that the autologous bone graft harvested from the lamina by laminectomy be unrelated with any donor site pain from the ilium. However it should be borne in mind that of MOB patients have poor bone quality after the autologous bone graft, the possibility of non-union is high. We concluded that the Brantigan I/F cage is an useful implant, but certain characteristics should be clarified for clinical and union success.

Comparing Opiate Users in Methadone Treatment with Untreated Opiate Users: Results of a Follow-up Study with a Toronto Opiate User Cohort

Untreated opiate use is correlated with major social harms and costs in Canada. While methadone treatment has existed in Canada since the 1960s, there is little specific Canadian research on its effects. This paper reports on the one-year follow-up results of a Toronto cohort study of opiate users (N = 114) who were not in treatment at baseline. Sixty-nine people were recruited for re-interviewing. A number of these individuals (N = 29) had entered methadone treatment during the year between baseline and follow-up interviews. Comparisons with respect to social functioning, health status and health care utilization, drug use and related risks, and criminal justice system involvement were made between the follow-up subsample who remained untreated, and the subjects who entered methadone treatment. Differences were found with respect to illegal income generation, illicit opiate and other drug use, illicit drug market activities and emergency care and aspects of socio-economic integration, but no major effects on health and criminal justice status could be shown. Research and policy implications are discussed.

Modeling long-term parent outcomes of two universal family-focused preventive interventions: One-year follow-up results.

Modeling long-term parent outcomes of two universal family-focused preventive interventions: One-year follow-up results.

Modeling long-term parent outcomes of two universal family-focused preventive interventions: one-year follow-up results.

The present investigation extended prior work by R. Spoth, C. Redmond, and C. Shin (1998). These researchers reported findings that 2 universal family-focused preventive intervention programs each had direct effects on a proximal parenting outcome (intervention-targeted parenting behaviors) and indirect effects on 2 global and distal outcomes (parent-child affective quality and general child management) at posttesting. A replication of the previously tested parenting outcome model was conducted with 1-year follow-up data and procedures identical to those used in the earlier study. Results of the present study (N = 404 families) indicate that statistically significant effects on parenting outcomes were sustained through a 1-year period following the posttest.

Asthma education programme in Russia: educating patients

To address the recent rise in asthma morbidity and mortality in Russia, an intervention study was conducted to improve asthma diagnosis, treatment and prevention. US recommendations for asthma management were adapted for use in educating Moscow families with children with asthma. Two hundred and fifty-two children with asthma aged 4–14 years receiving health care in eight Moscow public health clinics together with their parents were enrolled in the study to see whether US teaching manuals for asthma management would be acceptable and effective in Russia. Children at four of the clinics with recent asthma attacks were randomly assigned to either the education or control group to test if patient education and guided asthma care would improve outcomes for patients. Modern medications were made available to both groups to see if training in the US guidelines was necessary to get physicians to use the medications. Children with recent asthma attacks at the other four clinics were defined as comparison group 1 to control for the possible effect of medication availability. All children at the eight clinics who had no asthma attacks composed comparison group 2 to see if the outcomes for these children would change over time. One-year follow-up results showed significant improvement in asthma self-management skills of children and parents, in terms of asthma treatment, only among those in the education group. Significant increases were observed in the subgroup of children in the education group using anti-inflammatory drugs for asthma control. Children in the education group had markedly increased peak flow rates and reduced daily peak flow variability as compared to control and comparison groups. There was a significantly greater reduction in doctor visits by the education group of children compared to control. Presumably, changes in parents' and children's behaviour in terms of asthma treatment and prevention skills, proper treatment of the disease and access to medications could be responsible for reducing asthma morbidity in children.

One-year Follow-up Results of Photorefractive Keratectomy for Low, Moderate, and High Primary Astigmatism

Objective: To study the efficacy of excimer laser photorefractive keratectomy (PRK) for high, moderate, and low degrees of primary myopic astigmatism.Patients and Methods: Ninety-two eyes of 54 patients with different degrees of compound myopic astigmatism underwent PRK. The eyes were divided by degree of refractive astigmatism into three groups—high (-2.75 to -5.0 diopters [D]), moderate (-1.25 to -2.50 D), and low (≤1.0 D). Refraction, corneal topography, slit-lamp findings, and visual acuity with and without correction were assessed.Results: At 12 months, the mean reduction from the preoperative refractive cylinder was 80.7% in the high astigmatism group, 68.4% in the moderate astigmatism group, and 47.6% in the low astigmatism group. The post-treatment residual cylinder axis remained stable in 23 (38.3%) of 60 eyes and deviated in 37 (61.7%) of 60 eyes. The maximal deviation of the residual cylinder axis was 15°. Of the 89.2% of eyes with low cylinder, 81.8% had moderate cylinder, and 85% of the eyes with high cylinder achieved a final uncorrected visual acuity between 20/20 and 20/35 at 12 months.Conclusions: A statistically significant reduction in the refractive cylinder was found in the high, moderate, and low astigmatism groups. The difference between the mean reduction of the high and moderate cylinders compared with the mean reduction of the low cylinders also was found to be statistically significant. The laser used in this study is an efficient tool for correcting high and moderate astigmatism. However, regarding low astigmatism, it was found to be less effective.

Multiple coronary thromboemboli complicating valvular heart disease and atrial fibrillation

T, and the Coinvestigators of the National Heart, Lung, and Blood Institute's Percutaneous Transluminal Coronary Angioplasty Registry. One-year follow-up results of the 1985-86 National Heart, Lung, and Blood Institute's Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 1989;80:421-8. 6. Thomas MR, Wainwright RJ. Use of an intracoronary stent to control intrapericardial bleeding during artery rupture complicating coronary angioplasty. Cathet Cardiovasc Diaga 1993;30:169-72.

One-year Follow-up Results of Combined Mitomycin C Trabeculectomy and E~rtracapsular Cataract Extraction

When patients with glaucoma require cataract surgery, combined procedures offer important advantages over cataract surgery alone. Because mitomycin C has improved the success rate of a trabeculectomy in patients at high risk for filtration failure, the authors investigated whether it also would increase the survival rate of functioning filters in combined procedures. Patients with both cataract and glaucoma underwent combined mitomycin C trabeculectomy, extracapsular cataract extraction, and intraocular lens implantation. Mitomycin C (0.5 mg/ml) was applied topically to the trabeculectomy site for 5 minutes before the cataract extraction. Intraocular pressure (IOP), visual acuity, and astigmatism were measured preoperatively and postoperatively. One-year results are available for 74 patients. At 1 year, 54 (73%) of 74 patients had IOPs of 15 mmHg or less without glaucoma medications. Visual acuity was 20/40 or better in 44 (60%) of 74 patients. Ten (15%) patients had a shift of more than 2 diopters of astigmatism against the rule compared with preoperative values. No notable corneal epithelial toxicity was present. Postoperative symptomatic hypotony with the wound construction occurred in 3 (4%) of 74 patients, with 1 patient requiring surgical revision. Other potential complications of mitomycin C include endothelial toxicity (1 patient had decreased vision due to endothelial folds) and wound stability (1 patient had wound rupture after direct ocular trauma). The 1-year survival rate of a functioning trabeculectomy using mitomycin C in combined glaucoma and cataract surgery is encouraging. The longer-term benefits and possible adverse effects of mitomycin C in combined procedures are unknown and continue to be investigated.

Effectiveness of a Multidisciplinary Education Protocol in Children with Asthma (0-4 Years) in Primary Health Care

This paper describes the results of an asthma self-management protocol delivered to parents of children aged 0-4 years. The protocol was delivered by general practitioners (GPs), community nurses, asthma nurses, and doctors to child health centers. It consisted of 16 educational modules developed after an initial needs assessment of parents and a task analysis of primary care practitioners. The program was evaluated by means of an experimental design. Parents participating in the program had significantly more knowledge, a more favorable attitude toward asthma, and a higher self-efficacy score with respect to performing asthma self-management behaviors. Also, they reported performing self-management behaviors more frequently than parents in the control group. One-year follow-up results, which were collected for parents in the treatment group only, showed that the described changes were sustained. Further, the treatment group was found to have decreased its emergency and nonemergency use of the physician's office and to have a reduction in (reported) asthma severity. Process evaluation indicated that most modules were provided by the GPs to nearly all parents. After parents had read the modules at home, almost all the information was discussed in the next contact. GPs seldom referred patients to the community nurses, although this was suggested in the protocol.

One-year follow-up results of “culprit” versus multivessel coronary angioplasty trial

Since its introduction 16 years ago, percutaneous transluminal coronary angioplasty (PTCA) has increasingly been applied to patients with multivessel coronary artery disease 1–4 with steadily improving results. The approach to such patients may involve attempted dilation of all significant stenoses in an attempt to achieve complete revascularization. An alternative strategy that might carry lower procedural risk is identifying and dilating only the “culprit” stenosis, i.e., the stenosis judged responsible for the patient's ischemic manifestations. 5–7 Enthusiasm for such an approach has been tempered by studies showing that patients who have undergone incomplete revascularization with PTCA have a higher incidence of recurrent angina and more often require repeated revascularization procedures. 8–13 However, not all studies have shown such results, 14 and a recent study found that when baseline differences from patients with complete and incomplete revascularization are taken into account, the completeness of revascularization does not influence late outcome. 15 We undertook a randomized trial of culprit versus multivessel PTCA in patients with multivessel coronary disease in order to determine whether there were any differences in acute procedural outcome or in clinical status 1 year later.

One-year follow-up results of the 1985-1986 National Heart, Lung, and Blood Institute's Percutaneous Transluminal Coronary Angioplasty Registry.

In 1,801 patients in the 1985-1986 Percutaneous Transluminal Coronary Angioplasty Registry, overall 1-year mortality was 3.2%, the 1-year myocardial infarction rate was 7.2%, and the 1-year coronary artery bypass surgery rate was 13.2%. In the 78% of the cohort with all lesions successfully dilated and without major procedural complications (successful patients), the corresponding rates were 1.9%, 2.6%, and 6.4%. Nearly 20% of all deaths, 40% of all infarctions, and 25% of all bypass operations occurred in the small subset of patients (6.8%) who sustained periprocedural occlusion. Event rates were higher in patients with multivessel disease than in those with one-vessel disease. At 1 year, angina-free status was reported by approximately three fourths of all surviving patients, regardless of initial success. However, compared with successful patients, unsuccessful patients underwent intervening bypass surgery (42% vs. 6%) to achieve asymptomatic status more frequently. Comparison of the 1-year event rates in the 1985-1986 registry with those in the 1977-1981 registry indicated reductions in all major untoward events. These reductions became apparent after controlling for the more extensive disease of the 1985-1986 registry patients. In contrast, use of repeat angioplasty has increased by 50%. We conclude that the improved initial results reported in the 1985-1986 registry cohort were maintained at 1-year follow-up.