Science.gov

Sample records for 2-year follow-up randomized

  1. Group and Individual Treatment of Obsessive-Compulsive Disorder Using Cognitive Therapy and Exposure Plus Response Prevention: A 2-Year Follow-Up of Two Randomized Trials

    ERIC Educational Resources Information Center

    Whittal, Maureen L.; Robichaud, Melisa; Thordarson, Dana S.; McLean, Peter D.

    2008-01-01

    Relatively little is known about the long-term durability of group treatments for obsessive-compulsive disorder (OCD) and contemporary cognitive treatments. The current study investigated the 2-year follow-up results for participants who completed randomized trials of group or individual treatment and received either cognitive therapy (CT) or…

  2. Posterolateral instrumented fusion with and without transforaminal lumbar interbody fusion for the treatment of adult isthmic spondylolisthesis: A randomized clinical trial with 2-year follow-up

    PubMed Central

    Etemadifar, Mohammad Reza; Hadi, Abdollah; Masouleh, Mehran Feizi

    2016-01-01

    Background: Spondylolisthesis is a common cause of surgery in patients with lower back pain. Although posterolateral fusion and pedicle screw fixation are a relatively common treatment method for the treatment of spondylolisthesis, controversy exists about the necessity of adding interbody fusion to posterolateral fusion. The aim of our study was to assess the functional disability, pain, and complications in patients with spondylolisthesis treated by posterolateral instrumented fusion (PLF) with and without transforaminal lumbar interbody fusion (TLIF) in a randomized clinical trial. Materials and Methods: From February 2007 to February 2011, 50 adult patients with spondylolisthesis were randomly assigned to be treated with PLF or PLF+TLIF techniques (25 patients in each group) by a single surgeon. Back pain, leg pain, and disability were assessed before treatment and until 2 years after surgical treatment using visual analog scale (VAS) and oswestry disability index (ODI). Patients were also evaluated for postoperative complications such as infection, neurological complications, and instrument failure. Results: All patients completed the 24 months of follow-up. Twenty patients were females and 30 were males. Average age of the patients was 53 ± 11 years for the PLF group and 51 ± 13 for the PLF + TLIF group. Back pain, leg pain, and disability score were significantly improved postoperatively compared to preoperative scores (P < 0.001). At 3 months of follow-up, there was no statistically significant difference in VAS score for back pain and leg pain in both groups; however, after 6 months and 1 year and 2 years follow-up, the reported scores for back pain and leg pain were significantly lower in the PLF+TLIF group (P < 0.05). The ODI score was also significantly lower in the PLF+TLIF group at 1 year and 2 years of follow-up (P < 0.05). One screw breakage and one superficial infection occurred in the PLF+TLIF group, which had no statistical significance (P = 0

  3. Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial

    PubMed Central

    Manchikanti, Laxmaiah; Singh, Vijay; Cash, Kimberly A; Pampati, Vidyasagar

    2012-01-01

    Background The literature is replete with evaluations of failed surgery, illustrating a 9.5%–25% reoperation rate. Speculated causes of post lumbar surgery syndrome include epidural fibrosis, acquired stenosis, recurrent disc herniation, sacroiliac joint pain, and facet joint pain among other causes. Methods Patients (n = 120) were randomly assigned to two groups with a 2-year follow-up. Group I (control group, n = 60) received caudal epidural injections with catheterization up to S3 with local anesthetic (lidocaine 2%, 5 mL), nonparticulate betamethasone (6 mg, 1 mL), and 6 mL of 0.9% sodium chloride solution. Group II (intervention group, n = 60) received percutaneous adhesiolysis of the targeted area, with targeted delivery of lidocaine 2% (5 mL), 10% hypertonic sodium chloride solution (6 mL), and nonparticulate betamethasone (6 mg). The multiple outcome measures included the Numeric Rating Scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as 50% improvement in pain and Oswestry Disability Index scores. Results Significant improvement with at least 50% relief with pain and improvement in functional status was illustrated in 82% of patients at the 2-year follow-up in the intervention group compared to 5% in the control group receiving caudal epidural injections. The average number of procedures over a period of 2 years in Group II was 6.4 ± 2.35 with overall total relief of approximately 78 weeks out of 104 weeks. Conclusion The results of this study show significant improvement in 82% of patients over a period of 2 years with an average of six to seven procedures of 1-day percutaneous adhesiolysis in patients with failed back surgery syndrome. PMID:23293536

  4. Evaluation of Lumbar Facet Joint Nerve Blocks in Managing Chronic Low Back Pain: A Randomized, Double-Blind, Controlled Trial with a 2-Year Follow-Up

    PubMed Central

    Manchikanti, Laxmaiah; Singh, Vijay; Falco, Frank J.E.; Cash, Kimberly A.; Pampati, Vidyasagar

    2010-01-01

    Study Design: A randomized, double-blind, controlled trial. Objective: To determine the clinical effectiveness of therapeutic lumbar facet joint nerve blocks with or without steroids in managing chronic low back pain of facet joint origin. Summary of Background Data: Lumbar facet joints have been shown as the source of chronic pain in 21% to 41% of low back patients with an average prevalence of 31% utilizing controlled comparative local anesthetic blocks. Intraarticular injections, medial branch blocks, and radiofrequency neurotomy of lumbar facet joint nerves have been described in the alleviation of chronic low back pain of facet joint origin. Methods: The study included 120 patients with 60 patients in each group with local anesthetic alone or local anesthetic and steroids. The inclusion criteria was based upon a positive response to diagnostic controlled, comparative local anesthetic lumbar facet joint blocks. Outcome measures included the numeric rating scale (NRS), Oswestry Disability Index (ODI), opioid intake, and work status, at baseline, 3, 6, 12, 18, and 24 months. Results: Significant improvement with significant pain relief of ≥ 50% and functional improvement of ≥ 40% were observed in 85% in Group 1, and 90% in Group II, at 2-year follow-up. The patients in the study experienced significant pain relief for 82 to 84 weeks of 104 weeks, requiring approximately 5 to 6 treatments with an average relief of 19 weeks per episode of treatment. Conclusions: Therapeutic lumbar facet joint nerve blocks, with or without steroids, may provide a management option for chronic function-limiting low back pain of facet joint origin. PMID:20567613

  5. Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up.

    PubMed

    Fritzell, Peter; Berg, Svante; Borgström, Fredrik; Tullberg, Tycho; Tropp, Hans

    2011-07-01

    This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (-45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the "non-difference" in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (-73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time. PMID:21053028

  6. A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC®) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers

    PubMed Central

    Anders, Sven; Volz, Martin; Frick, Hubert; Gellissen, Jörg

    2013-01-01

    Microfracture (MFx) is currently the recommended option for the treatment of small cartilage defects but is not regarded as suitable for the treatment of defects larger than 2.5 cm2. To extent its applicability to medium-sized defects MFx has been combined with a collagen type I/III matrix (Chondro-Gide®). This technique is called Autologous Matrix-Induced Chondrogenesis (AMIC®) and meanwhile a clinically established treatment option for localized full-thickness small- to medium-sized cartilage defects. Despite its more spreading clinical use, clinical data published so far are limited to mainly case report series. In this study, we report the first results of a randomized, controlled trial assessing the efficacy and safety of AMIC® versus MFx. Patients enrolled in 2 centers were included in this analysis. 38 patients (aged 21-50 years, mean defect size 3.4 cm2) were randomized and treated either with MFx, with sutured AMIC® or glued AMIC®. Clinical outcomes (modified Cincinnati and ICRS score) could be assessed in 30 patients at 1-year and 27 patients at 2-years post-operation. Improvements in both scores were seen at 1-and 2-years post-operation, irrespective of the technique used. MRI assessment revealed a satisfactory and homogenous defect filling in the majority of patients. No treatment-related adverse events were reported. This interim analysis confirms the mid-term results for AMIC® reported in literature. It demonstrates clearly that clinical outcomes at 1-year post-operation are maintained at 2-years. Therefore we consider enhancing MFx with Chondro-Gide® is a valid and safe cartilage repair option for small- to medium-sized cartilage defects of the knee. PMID:23730377

  7. Randomized comparison between the cemented Scientific Hip Prosthesis and Omnifit: 2-year DEXA and minimum 10-year clinical follow-up.

    PubMed

    Broeke, René H M Ten; Harings, Steffie E J M; Emans, Pieter J; Jutten, Liesbeth M C; Kessels, Alfons G H; Geesink, Rudolph G T

    2013-09-01

    Radiostereometry (RSA) of the cemented Scientific Hip Prosthesis (SHP) reported excessive migration and predicted high failure rates. In a prospective randomized clinical trial we compared minimum 10 years results of the SHP (n=38) with the Omnifit-stem (n=37). Two-year bone remodelling, compared with dual energy x-ray absorptiometry and assessed in regions of interest A-D based on the 7 Gruen zones, showed better periprosthetic bone preservation around the SHP in all but one regions (P<.05). At 10 years Harris Hip Score was better for the SHP (P=.0001) but Oxford Hip Score was the same (P=.79). There were no revisions in either group, but radiographic loosening was definite in 1 SHP and 1 Omnifit. Based on earlier RSA studies, the rough surface finish of the SHP was expected to cause cement abrasion, osteolysis and inferior survival. However our clinical and remodelling results could not confirm these expectations, suggesting that the link of early migration and mid-term clinical results is not sufficiently clear for the SHP. PMID:23453292

  8. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION).

    PubMed

    Kantarjian, Hagop M; Shah, Neil P; Cortes, Jorge E; Baccarani, Michele; Agarwal, Mohan B; Undurraga, María Soledad; Wang, Jianxiang; Ipiña, Juan Julio Kassack; Kim, Dong-Wook; Ogura, Michinori; Pavlovsky, Carolina; Junghanss, Christian; Milone, Jorge H; Nicolini, Franck E; Robak, Tadeusz; Van Droogenbroeck, Jan; Vellenga, Edo; Bradley-Garelik, M Brigid; Zhu, Chao; Hochhaus, Andreas

    2012-02-01

    Dasatinib is a highly potent BCR-ABL inhibitor with established efficacy and safety in imatinib-resistant/-intolerant patients with chronic myeloid leukemia (CML). In the phase 3 DASISION trial, patients with newly diagnosed chronic-phase (CP) CML were randomized to receive dasatinib 100 mg (n = 259) or imatinib 400 mg (n = 260) once daily. Primary data showed superior efficacy for dasatinib compared with imatinib after 12 months, including significantly higher rates of complete cytogenetic response (CCyR), confirmed CCyR (primary end point), and major molecular response (MMR). Here, 24-month data are presented. Cumulative response rates by 24 months in dasatinib and imatinib arms were: CCyR in 86% versus 82%, MMR in 64% versus 46%, and BCR-ABL reduction to ≤ 0.0032% (4.5-log reduction) in 17% versus 8%. Transformation to accelerated-/ blast-phase CML on study occurred in 2.3% with dasatinib versus 5.0% with imatinib. BCR-ABL mutations, assessed after discontinuation, were detected in 10 patients in each arm. In safety analyses, fluid retention, superficial edema, myalgia, vomiting, and rash were less frequent with dasatinib compared with imatinib, whereas pleural effusion and grade 3/4 thrombocytopenia were more frequent with dasatinib. Overall, dasatinib continues to show faster and deeper responses compared with imatinib, supporting first-line use of dasatinib in patients with newly diagnosed CML-CP. This study was registered at ClinicalTrials.gov: NCT00481247. PMID:22160483

  9. Polyadenylic-polyuridylic acid as an adjuvant in resectable colorectal carcinoma: a 6 1/2 year follow-up analysis of a multicentric double blind randomized trial.

    PubMed

    Lacour, J; Laplanche, A; Malafosse, M; Gallot, D; Julien, M; Rotman, N; Guivarc'h, M; Roullet-Audy, J C; Lasser, P; Hautefeuille, P

    1992-12-01

    In a double blind study, patients with operable carcinoma of the colon and the upper rectum, who have undergone a macroscopically complete resection of their tumor, were randomized to receive either (i) polyadenylic-polyuridylic acid (AU), one i.v. injection of 60 mg (in 50 ml of solution) once a week for 6 weeks, or (ii) a placebo (P) one i.v. injection of 50 ml of a saline solution with the same schedule. From January 1983 to December 1986, 288 patients were enrolled: 145 in AU group and 143 in P group. The main clinical and pathological characteristics were equally distributed throughout the two groups. There was a significant difference (P < 0.02) in the overall survival (OS) between the two groups, in favor of the P group. The 5-year OS rate was 68% (SD = 4%) in the AU group versus 81% (SD = 3%) in the P group. Thus, AU as a single adjuvant, appears to be ineffective and therefore has no indication in the treatment of colorectal carcinoma. PMID:1478293

  10. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION)

    PubMed Central

    Shah, Neil P.; Cortes, Jorge E.; Baccarani, Michele; Agarwal, Mohan B.; Undurraga, María Soledad; Wang, Jianxiang; Kassack Ipiña, Juan Julio; Kim, Dong-Wook; Ogura, Michinori; Pavlovsky, Carolina; Junghanss, Christian; Milone, Jorge H.; Nicolini, Franck E.; Robak, Tadeusz; Van Droogenbroeck, Jan; Vellenga, Edo; Bradley-Garelik, M. Brigid; Zhu, Chao; Hochhaus, Andreas

    2012-01-01

    Dasatinib is a highly potent BCR-ABL inhibitor with established efficacy and safety in imatinib-resistant/-intolerant patients with chronic myeloid leukemia (CML). In the phase 3 DASISION trial, patients with newly diagnosed chronic-phase (CP) CML were randomized to receive dasatinib 100 mg (n = 259) or imatinib 400 mg (n = 260) once daily. Primary data showed superior efficacy for dasatinib compared with imatinib after 12 months, including significantly higher rates of complete cytogenetic response (CCyR), confirmed CCyR (primary end point), and major molecular response (MMR). Here, 24-month data are presented. Cumulative response rates by 24 months in dasatinib and imatinib arms were: CCyR in 86% versus 82%, MMR in 64% versus 46%, and BCR-ABL reduction to ≤ 0.0032% (4.5-log reduction) in 17% versus 8%. Transformation to accelerated-/ blast-phase CML on study occurred in 2.3% with dasatinib versus 5.0% with imatinib. BCR-ABL mutations, assessed after discontinuation, were detected in 10 patients in each arm. In safety analyses, fluid retention, superficial edema, myalgia, vomiting, and rash were less frequent with dasatinib compared with imatinib, whereas pleural effusion and grade 3/4 thrombocytopenia were more frequent with dasatinib. Overall, dasatinib continues to show faster and deeper responses compared with imatinib, supporting first-line use of dasatinib in patients with newly diagnosed CML-CP. This study was registered at ClinicalTrials.gov: NCT00481247. PMID:22160483

  11. Emotionally Focused Interventions for Couples with Chronically Ill Children: A 2-Year Follow-Up

    ERIC Educational Resources Information Center

    Cloutier, Paula F.; Manion, Ian G.; Walker, Jan Gordon; Johnson, Susan M.

    2002-01-01

    Couples with chronically ill children are particularly at risk for experiencing marital distress. The study presented here is a 2-year follow-up of a randomized control trial that assessed the efficacy of Emotionally Focused Therapy (EFT) in decreasing marital distress in a sample of couples with a chronically ill child. Thirteen couples with…

  12. Influence of intravenous amifostine on xerostomia, tumor control, and survival after radiotherapy for head-and- neck cancer: 2-year follow-up of a prospective, randomized, phase III trial

    SciTech Connect

    Wasserman, Todd H. . E-mail: twasserman@bellsouth.net; Brizel, David M.; Henke, Michael; Monnier, Alain; Eschwege, Francois; Sauer, Rolf; Strnad, Vratislav

    2005-11-15

    Purpose: To evaluate chronic xerostomia and tumor control 18 and 24 months after initial treatment with amifostine in a randomized controlled trial of patients with head-and-neck cancer; at 12 months after radiotherapy (RT), amifostine had been shown to reduce xerostomia without changing tumor control. Methods and Materials: Adults with head-and-neck cancer who underwent once-daily RT for 5-7 weeks (total dose, 50-70 Gy) received either open-label amifostine (200 mg/m{sup 2} i.v.) 15-30 min before each fraction of radiation (n = 150) or RT alone (control; n = 153). Results: Amifostine administration was associated with a reduced incidence of Grade {>=}2 xerostomia over 2 years of follow-up (p = 0.002), an increase in the proportion of patients with meaningful (>0.1 g) unstimulated saliva production at 24 months (p = 0.011), and reduced mouth dryness scores on a patient benefit questionnaire at 24 months (p < 0.001). Locoregional control rate, progression-free survival, and overall survival were not significantly different between the amifostine group and the control group. Conclusions: Amifostine administration during head-and-neck RT reduces the severity and duration of xerostomia 2 years after treatment and does not seem to compromise locoregional control rates, progression-free survival, or overall survival.

  13. Cost-utility analysis modeling at 2-year follow-up for cervical disc arthroplasty versus anterior cervical discectomy and fusion: A single-center contribution to the randomized controlled trial

    PubMed Central

    Warren, Daniel; Andres, Tate; Hoelscher, Christian; Ricart-Hoffiz, Pedro; Bendo, John; Goldstein, Jeffrey

    2013-01-01

    Background Patients with cervical disc herniations resulting in radiculopathy or myelopathy from single level disease have traditionally been treated with Anterior Cervical Discectomy and Fusion (ACDF), yet Cervical Disc Arthroplasty (CDA) is a new alternative. Expert suggestion of reduced adjacent segment degeneration is a promising future result of CDA. A cost-utility analysis of these procedures with long-term follow-up has not been previously reported. Methods We reviewed single institution prospective data from a randomized trial comparing single-level ACDF and CDA in cervical disc disease. Both Medicare reimbursement schedules and actual hospital cost data for peri-operative care were separately reviewed and analyzed to estimate the cost of treatment of each patient. QALYs were calculated at 1 and 2 years based on NDI and SF-36 outcome scores, and incremental cost effectiveness ratio (ICER) analysis was performed to determine relative cost-effectiveness. Results Patients of both groups showed improvement in NDI and SF-36 outcome scores. Medicare reimbursement rates to the hospital were $11,747 and $10,015 for ACDF and CDA, respectively; these figures rose to $16,162 and $13,171 when including physician and anesthesiologist reimbursement. The estimated actual cost to the hospital of ACDF averaged $16,108, while CDA averaged $16,004 (p = 0.97); when including estimated physicians fees, total hospital costs came to $19,811 and $18,440, respectively. The cost/QALY analyses therefore varied widely with these discrepancies in cost values. The ICERs of ACDF vs CDA with Medicare reimbursements were $18,593 (NDI) and $19,940 (SF-36), while ICERs based on actual total hospital cost were $13,710 (NDI) and $9,140 (SF-36). Conclusions We confirm the efficacy of ACDF and CDA in the treatment of cervical disc disease, as our results suggest similar clinical outcomes at one and two year follow-up. The ICER suggests that the non-significant added benefit via ACDF comes at a

  14. Infantile Amnesia across the Years: A 2-Year Follow-Up of Children's Earliest Memories

    ERIC Educational Resources Information Center

    Peterson, Carole; Warren, Kelly L.; Short, Megan M.

    2011-01-01

    Although infantile amnesia has been investigated for many years in adults, only recently has it been investigated in children. This study was a 2-year follow-up and extension of an earlier study. Children (4-13 years old) were asked initially and 2 years later for their earliest 3 memories. At follow-up, their age at the time of these memories…

  15. Comparative Efficacy and Durability of Continuation Phase Cognitive Therapy for Preventing Recurrent Depression: Design of a Double-Blinded, Fluoxetine- and Pill-Placebo–Controlled, Randomized Trial with 2-Year Follow-up

    PubMed Central

    Thase, Michael E.

    2010-01-01

    Background Major depressive disorder (MDD) is highly prevalent and associated with disability and chronicity. Although cognitive therapy (CT) is an effective short-term treatment for MDD, a significant proportion of responders subsequently suffer relapses or recurrences. Purpose This design prospectively evaluates: 1) a method to discriminate CT-treated responders at lower versus higher risk for relapse; and 2) the subsequent durability of 8-month continuation phase therapies in randomized higher risk responders followed for an additional 24-months. The primary prediction is: after protocol treatments are stopped, higher risk patients randomly assigned to continuation phase CT (C-CT) will have a lower risk of relapse/recurrence than those randomized to fluoxetine (FLX). Methods Outpatients, aged 18 to 70 years, with recurrent MDD received 12–14 weeks of CT provided by 15 experienced therapists from two sites. Responders (i.e., no MDD and 17-item Hamilton Rating Scale for Depression ≤ 12) were stratified into higher and lower risk groups based on stability of remission during the last 6 weeks of CT. The lower risk group entered follow-up for 32 months; the higher risk group was randomized to 8 months of continuation phase therapy with either C-CT or clinical management plus either double-blinded FLX or pill placebo. Following the continuation phase, higher risk patients were followed by blinded evaluators for 24 months. Results The trial began in 2000. Enrollment is complete (N=523). The follow-up continues. Conclusions The trial evaluates the preventive effects and durability of acute and continuation phase treatments in the largest known sample of CT responders collected worldwide. PMID:20451668

  16. Effects of cognitive rehabilitation training on schizophrenia: 2 years of follow-up

    PubMed Central

    Tao, Jianqing; Zeng, Qiang; Liang, Jia; Zhou, Aihua; Yin, Xuebing; Xu, Ai

    2015-01-01

    Objective: Schizophrenia is a mental disorder and characterized by abnormal social behavior and failure to recognize what is real. The current study was to explore the long-term effects of cognitive rehabilitation training on schizophrenia. Methods: Eighty six cases of hospitalized patients with schizophrenia were randomly divided into study group and control group. The relapse and employment (attending school) rates were used as indicators to assess the treatment effect. All patients were followed up by 2 years. Kaplan-Meier survival analysis was conducted with relapse and employment (attending school) rates. Results: The rates of relapse in the study group and the control group were 18% and 41%, and relapse free survival time was 22.22 months and 18.55 months; the rates of employment (attending school) were 64% and 43%, and not employment (attending school) time were 10.68 months and 15.74 months, respectively. There was significant difference between the two groups (P<0.05). Conclusions: We found that the cognitive rehabilitation training could significantly reduce schizophrenic relapse rate, prolong the time of patients without relapse, improve the employment (attending school) rate, and shorten the discharged time, which is a powerful treatment method to improve social competence in schizophrenia patients. PMID:26629117

  17. 2-year follow-up report on micromotion of a short tibia stem

    PubMed Central

    Toksvig-Larsen, Sören

    2015-01-01

    Background and purpose A shortened tibial stem could influence the early prosthetic fixation. We therefore compared the short stem to the standard-length stem using radiostereometric analysis (RSA) as primary outcome measure. Patients and methods 60 patients were randomized to receive a cemented Triathlon total knee arthroplasty (TKA) with a tibial tray of either standard or short stem length. The patients were blinded regarding treatment allocation. The micromotion of the tibial component was measured by RSA postoperatively, at 3 months, and after 1 and 2 years; clinical outcome was measured with the American Knee Society score (AKSS) and the knee osteoarthritis and injury outcome score (KOOS). Results The maximum total point motion (MTPM) for the standard stem was 0.36 (SD 0.16) mm at 3 months, 0.51 (SD 0.27) mm at 1 year, and 0.54 (SD 0.28) mm at 2 years. For the short stem, it was 0.42 (0.24) mm, 0.59 (0.43) mm, and 0.61 (0.39) mm. 4 short-stemmed components and 2 standard-stemmed components had more than 0.2 mm of migration between the first- and second-year follow-up, and were classified as continuously migrating. Interpretation The short-stemmed cemented tibial prosthesis showed an early prosthetic migratory pattern similar to that of the standard-stemmed cemented Triathlon knee prosthesis. The number of continuously migrating tibial plates in each group is predictive of a lower revision rate than 5% at 10 years. PMID:25809183

  18. Cytokines as a predictor of clinical response following hip arthroscopy: minimum 2-year follow-up.

    PubMed

    Shapiro, Lauren M; Safran, Marc R; Maloney, William J; Goodman, Stuart B; Huddleston, James I; Bellino, Michael J; Scuderi, Gaetano J; Abrams, Geoffrey D

    2016-08-01

    Hip arthroscopy in patients with osteoarthritis has been shown to have suboptimal outcomes. Elevated cytokine concentrations in hip synovial fluid have previously been shown to be associated with cartilage pathology. The purpose of this study was to determine whether a relationship exists between hip synovial fluid cytokine concentration and clinical outcomes at a minimum of 2 years following hip arthroscopy. Seventeen patients without radiographic evidence of osteoarthritis had synovial fluid aspirated at time of portal establishment during hip arthroscopy. Analytes included fibronectin-aggrecan complex as well as a multiplex cytokine array. Patients completed the modified Harris Hip Score, Western Ontario and McMaster Universities Arthritis Index and the International Hip Outcomes Tool pre-operatively and at a minimum of 2 years following surgery. Pre and post-operative scores were compared with a paired t-test, and the association between cytokine values and clinical outcome scores was performed with Pearson's correlation coefficient with an alpha value of 0.05 set as significant. Sixteen of seventeen patients completed 2-year follow-up questionnaires (94%). There was a significant increase in pre-operative to post-operative score for each clinical outcome measure. No statistically significant correlation was seen between any of the intra-operative cytokine values and either the 2-year follow-up scores or the change from pre-operative to final follow-up outcome values. No statistically significant associations were seen between hip synovial fluid cytokine concentrations and 2-year follow-up clinical outcome assessment scores for those undergoing hip arthroscopy. PMID:27583163

  19. Cytokines as a predictor of clinical response following hip arthroscopy: minimum 2-year follow-up

    PubMed Central

    Shapiro, Lauren M.; Safran, Marc R.; Maloney, William J.; Goodman, Stuart B.; Huddleston, James I.; Bellino, Michael J.; Scuderi, Gaetano J.; Abrams, Geoffrey D.

    2016-01-01

    Hip arthroscopy in patients with osteoarthritis has been shown to have suboptimal outcomes. Elevated cytokine concentrations in hip synovial fluid have previously been shown to be associated with cartilage pathology. The purpose of this study was to determine whether a relationship exists between hip synovial fluid cytokine concentration and clinical outcomes at a minimum of 2 years following hip arthroscopy. Seventeen patients without radiographic evidence of osteoarthritis had synovial fluid aspirated at time of portal establishment during hip arthroscopy. Analytes included fibronectin–aggrecan complex as well as a multiplex cytokine array. Patients completed the modified Harris Hip Score, Western Ontario and McMaster Universities Arthritis Index and the International Hip Outcomes Tool pre-operatively and at a minimum of 2 years following surgery. Pre and post-operative scores were compared with a paired t-test, and the association between cytokine values and clinical outcome scores was performed with Pearson’s correlation coefficient with an alpha value of 0.05 set as significant. Sixteen of seventeen patients completed 2-year follow-up questionnaires (94%). There was a significant increase in pre-operative to post-operative score for each clinical outcome measure. No statistically significant correlation was seen between any of the intra-operative cytokine values and either the 2-year follow-up scores or the change from pre-operative to final follow-up outcome values. No statistically significant associations were seen between hip synovial fluid cytokine concentrations and 2-year follow-up clinical outcome assessment scores for those undergoing hip arthroscopy. PMID:27583163

  20. Early intervention and prevention of anxiety disorders in children: results at 2-year follow-up.

    PubMed

    Dadds, M R; Holland, D E; Laurens, K R; Mullins, M; Barrett, P M; Spence, S H

    1999-02-01

    The Queensland Early Intervention and Prevention of Anxiety Project evaluated a child- and family-focused group intervention for preventing anxiety problems in children. This article reports on 12- and 24-month follow-up data to previously reported outcomes at posttreatment and at 6-month follow-up. A total of 1,786 7- to 14-year-olds were screened for anxiety problems using teacher nominations and children's self-report. After diagnostic interviews, 128 children were selected and assigned to either a 10-week school-based child- and parent-focused psychosocial intervention or a monitoring group. Both groups showed improvements immediately at postintervention and at 6-month follow-up; the improvement was maintained in the intervention group only reducing the rate of existing anxiety disorder and preventing the onset of new anxiety disorders. At 12 months, the groups converged, but the superiority of the intervention group was evident again at 2-year follow-up. Severity of pretreatment diagnoses, gender, and parental anxiety predicted poor initial response to intervention, whereas pretreatment severity was the only predictor of chronicity at 24 months. Overall, follow-up results show that a brief school-based intervention for children can produce durable reductions in anxiety problems. PMID:10028219

  1. Patient factors predict functional outcomes after cruciate retaining TKA: a 2-year follow-up analysis.

    PubMed

    Roth, Justin S; Buehler, Knute C; Shen, Jianhua; Naughton, Marybeth

    2013-09-01

    We analyzed preoperative patient characteristics and postoperative functional outcomes to identify the most predictive preoperative characteristics of postoperative functional outcome for Cruciate Retaining (CR) TKA. In a prospective, multicenter study, 307 knees with minimum 2-year follow-up were first divided into groups based on 2-year functional performance. Logistic regression then determined SF-36 General Health Score (GHS) to be the most predictive preoperative patient characteristic. Subsequently, a second analysis was performed using preoperative SF-36 GHS to stratify patients into groups. Statistical significance was achieved in both analyses by gender, BMI and hypertension. Statistical significance was achieved in a single analysis by age, preoperative narcotic use, preoperative metabolic medication usage, preoperative pulmonary disease and preoperative use of medication for anxiety or depression. PMID:23523205

  2. Learning, Memory, and Executive Function in New MDMA Users: A 2-Year Follow-Up Study

    PubMed Central

    Wagner, Daniel; Tkotz, Simon; Koester, Philip; Becker, Benjamin; Gouzoulis-Mayfrank, Euphrosyne; Daumann, Joerg

    2015-01-01

    3,4-Methylenedioxymethamphetamine (MDMA) is associated with changes in neurocognitive performance. Recent studies in laboratory animals have provided additional support for the neurodegeneration hypothesis. However, results from animal research need to be applied to humans with caution. Moreover, several of the studies that examine MDMA users suffer from methodological shortcomings. Therefore, a prospective cohort study was designed in order to overcome these previous methodological shortcomings and to assess the relationship between the continuing use of MDMA and cognitive performance in incipient MDMA users. It was hypothesized that, depending on the amount of MDMA taken, the continued use of MDMA over a 2-year period would lead to further decreases in cognitive performance, especially in visual paired association learning tasks. Ninety-six subjects were assessed, at the second follow-up assessment: 31 of these were non-users, 55 moderate-users, and 10 heavy-users. Separate repeated measures analyses of variance were conducted for each cognitive domain, including attention and information processing speed, episodic memory, and executive functioning. Furthermore, possible confounders including age, general intelligence, cannabis use, alcohol use, use of other concomitant substances, recent medical treatment, participation in sports, level of nutrition, sleep patterns, and subjective well-being were assessed. The Repeated measures analysis of variance (rANOVA) revealed that a marginally significant change in immediate and delayed recall test performances of visual paired associates learning had taken place within the follow-up period of 2 years. No further deterioration in continuing MDMA-users was observed in the second follow-up period. No significant differences with the other neuropsychological tests were noted. It seems that MDMA use can impair visual paired associates learning in new users. However, the groups differed in their use of concomitant use of

  3. Study of 2 years follow-up of referral patients with abnormal Pap smear

    PubMed Central

    Behnamfar, Fariba; Zafarbakhsh, Azam; Allameh, Taj-Alsadat

    2015-01-01

    Background: Abnormal Pap smear consists of premalignant or malignant cervical lesions. Many of premalignant cervical lesions will never progress to invasive malignancy, or even may regress over the time. Thus, there is always a risk of overtreatment of patients with an abnormal Pap smear. A long-term follow-up of these patients can reveal final events associated with each subtype of abnormal Pap smear, and, therefore, help us to prevent unnecessary interventions. The aim of our study was to present 2 years follow-up of referral patients with abnormal Pap smear. Materials and Methods: A total of 334 consecutive women aged more than 16 who were referred with an abnormal Pap smear were entered into the study. Patients were followed with biannual Pap smear and annual colposcopy and biopsy for 2 years. Results: At baseline, the majority of patients with abnormal Pap smear were normal on colposcopy and biopsy (68% and 86%, respectively). Six months after first abnormal Pap smear majority of patients in each group showed a significant regress to normal or less invasive lesion (P < 0.001). Twelve patients (4%) had no change in Pap smear, whereas 313 (94%) had at least one stage improvement. Only nine (3%) patients had deteriorated Pap smear after 6 months. All 308 patients who underwent colposcopy and biopsy had normal Pap smear 24 months after the first abnormal Pap smear. Conclusion: Pap smear is associated with a high rate of false-positive results. In addition, the majority of low-grade cervical lesions can spontaneously regress. A long-term follow-up of a patient with abnormal Pap smear can help us to avoid needless interventions. PMID:26958048

  4. Learning, Memory, and Executive Function in New MDMA Users: A 2-Year Follow-Up Study.

    PubMed

    Wagner, Daniel; Tkotz, Simon; Koester, Philip; Becker, Benjamin; Gouzoulis-Mayfrank, Euphrosyne; Daumann, Joerg

    2015-01-01

    3,4-Methylenedioxymethamphetamine (MDMA) is associated with changes in neurocognitive performance. Recent studies in laboratory animals have provided additional support for the neurodegeneration hypothesis. However, results from animal research need to be applied to humans with caution. Moreover, several of the studies that examine MDMA users suffer from methodological shortcomings. Therefore, a prospective cohort study was designed in order to overcome these previous methodological shortcomings and to assess the relationship between the continuing use of MDMA and cognitive performance in incipient MDMA users. It was hypothesized that, depending on the amount of MDMA taken, the continued use of MDMA over a 2-year period would lead to further decreases in cognitive performance, especially in visual paired association learning tasks. Ninety-six subjects were assessed, at the second follow-up assessment: 31 of these were non-users, 55 moderate-users, and 10 heavy-users. Separate repeated measures analyses of variance were conducted for each cognitive domain, including attention and information processing speed, episodic memory, and executive functioning. Furthermore, possible confounders including age, general intelligence, cannabis use, alcohol use, use of other concomitant substances, recent medical treatment, participation in sports, level of nutrition, sleep patterns, and subjective well-being were assessed. The Repeated measures analysis of variance (rANOVA) revealed that a marginally significant change in immediate and delayed recall test performances of visual paired associates learning had taken place within the follow-up period of 2 years. No further deterioration in continuing MDMA-users was observed in the second follow-up period. No significant differences with the other neuropsychological tests were noted. It seems that MDMA use can impair visual paired associates learning in new users. However, the groups differed in their use of concomitant use of

  5. Evolution of nonspecific duodenal lymphocytosis over 2 years of follow-up

    PubMed Central

    Losurdo, Giuseppe; Piscitelli, Domenico; Giangaspero, Antonio; Principi, Mariabeatrice; Buffelli, Francesca; Giorgio, Floriana; Montenegro, Lucia; Sorrentino, Claudia; Amoruso, Annacinzia; Ierardi, Enzo; Di Leo, Alfredo

    2015-01-01

    AIM: To assess the evolution of duodenal lymphocytosis (DL), a condition characterized by increased intraepithelial lymphocytes (IELs), over 2 years of follow-up. METHODS: Consecutive patients undergoing upper endoscopy/histology for abdominal pain, diarrhea, weight loss, weakness or other extraintestinal features compatible with celiac disease (CD) were included. Evaluation of IELs infiltrate in duodenal biopsy samples was carried out by CD3-immunohistochemistry and expressed as number of positive cells/100 enterocytes. Diagnostic agreement on the IELs count was tested by calculating the weighted k coefficient. All patients underwent serological detection of autoantibodies associated with CD: IgG and IgA anti-tissue transglutaminase and endomysium. Each patient underwent further investigations to clarify the origin of DL at baseline and/or in the course of 2 years of follow-up every six months. Autoimmune thyroiditis, intestinal infections, parasitic diseases, bacterial intestinal overgrowth, hypolactasia and wheat allergy were detected. Colonoscopy and enteric magnetic resonance imaging were performed when necessary. Risk factors affecting the final diagnosis were detected by multinomial logistic regression and expressed as OR. RESULTS: Eighty-five patients (16 males, 69 females, aged 34.1 ± 12.5 years) were followed up for a mean period of 21.7 ± 11.7 mo. At baseline, endoscopy/duodenal biopsy, CD3 immunohistochemistry revealed: > 25 IELs/100 enterocytes in 22 subjects, 15-25 IELs in 37 and < 15 IELs in 26. They all had negative serum anti-transglutaminase and anti-endomysium, whilst 5 showed IgG anti-gliadin positivity. In the course of follow-up, 23 developed CD seropositivity and gluten sensitivity (GS) was identified in 19. Other diagnoses were: 5 Helicobacter pylori infections, 4 jejunal Crohn’s disease, 1 lymphocytic colitis and 1 systemic sclerosis. The disease in the remaining 32 patients was classified as irritable bowel syndrome because of the lack

  6. Functional outcomes of proximal row carpectomy: 2-year follow-up

    PubMed Central

    Mandarano-Filho, Luiz Garcia; Campioto, Débora Schalge; Bezuti, Márcio Takey; Mazzer, Nilton; Barbieri, Cláudio Henrique

    2015-01-01

    ABSTRACT OBJECTIVE : To evaluate functional outcomes of patients submit-ted to proximal row carpectomy for the treatment of wrist arthri-tis METHODS : This is a retrospective study using wrist motion and grip strenght of patients diagnosed with Kienböck disease and scaphoid non-union surgically treated by this technique RESULTS : Eleven patients with 2-year follow-up were evaluated. Wrist motion (flexion, extension and ulnar deviation) and grip strength were significantly better from preoperative values. Ho-wever, no difference in radial deviation was observed in these patients CONCLUSION : Proximal row carpectomy provides an alternative option for treatment of wrist arthritis, resulting in better active range of motion and grip strength in the long run. Level of Evidence IV, Case Series. PMID:27057144

  7. Effects of a Prototype Internet Dissonance-Based Eating Disorder Prevention Program at 1- and 2-Year Follow-up

    PubMed Central

    Stice, Eric; Durant, Shelley; Rohde, Paul; Shaw, Heather

    2014-01-01

    Objective A group-based eating disorder prevention program wherein young women explore the costs of pursuing the thin ideal reduces eating disorder risk factors and symptoms. However, it can be challenging to identify school clinicians to effectively deliver the intervention. The present study compares the effects of a new Internet-based version of this prevention program, which could facilitate dissemination, to the group-based program and to educational video and educational brochure control conditions at 1- and 2-year follow-up. Method Female college students with body dissatisfaction (N = 107; M age = 21.6 SD = 6.6) were randomized to these four conditions. Results Internet participants showed reductions in eating disorder risk factors and symptoms relative to the two control conditions at 1- and 2-year follow-up (M d = .34 and .17 respectively), but the effects were smaller than parallel comparisons for the group participants (M d = .48 and .43 respectively). Yet the Internet intervention produced large weight gain prevention effects relative to the two control conditions at 1- and 2-year follow-up (M d = .80 and .73 respectively), which were larger than the parallel effects for the group intervention (M d = .19 and .47 respectively). Conclusions Although the effects for the Internet versus group intervention were similar at posttest, results suggest that the effects faded more quickly for the Internet intervention. However, the Internet intervention produced large weight gain prevention effects, implying that it might be useful for simultaneously preventing eating disordered behavior and unhealthy weight gain. PMID:25020152

  8. Effectiveness of a tinnitus management programme: a 2-year follow-up study

    PubMed Central

    Gudex, Claire; Skellgaard, Preben H; West, Torben; Sørensen, Jan

    2009-01-01

    Background Tinnitus impairs the possibility of leading a normal life in 0.5–1% of the population. While neither medical nor surgical treatment appears effective, counselling may offer some relief. An intervention combining counselling and hearing devices is offered to clients referred to the Centre for Help Aids and Communication (CHC) in southern Denmark. The aims of this exploratory study were to examine i) the characteristics of CHC's clients and their tinnitus, ii) the effectiveness of the treatment, and iii) whether particular client groups benefit more than others. Methods One hundred new clients presenting with tinnitus completed the Tinnitus Handicap Inventory (THI) three times – before their first consultation, after one month and after 1–2 years. The scores were tested for significant differences over time using tests for paired data. Logistic regression was used to examine factors associated with a clinically important difference (i.e. THI score improvement of at least 20 points). Results At final follow-up, total THI score was significantly lower than baseline, i.e. 29.8 (CI 25.5–34.2) vs. 37.2 (CI 33.1–37.2), p < 0.01. The programme achieved a clinically important difference for 27% and 24% of the clients one month and 1–2 years after the first consultation, respectively. It appeared that greater improvement in THI score was related to higher baseline THI score and possibly also to treatment by a particular CHC therapist. The absolute reduction in mean THI score after 1–2 years for clients with moderate and severe handicap was 14 and 20 points, respectively, i.e. similar to that previously reported for TRT (14–28 points). The cost of the current programme was approximately 200 EUR per client. Conclusion The tinnitus management programme appeared to provide significant benefit to many clients at a relatively low cost. It would be useful to conduct a randomised controlled study comparing the current programme with alternative forms of

  9. Efficacy Trial of a Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents: Effects at 1- and 2-Year Follow-Up

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Gau, Jeff M.; Wade, Emily

    2010-01-01

    Objective: To evaluate the effects of a brief group cognitive-behavioral (CB) depression prevention program for high-risk adolescents with elevated depressive symptoms at 1- and 2-year follow-up. Method: In this indicated prevention trial, 341 at-risk youths were randomized to a group CB intervention, group supportive expressive intervention, CB…

  10. Efficacy Trial of a Selective Prevention Program Targeting Both Eating Disorders and Obesity among Female College Students: 1- and 2-Year Follow-Up Effects

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Shaw, Heather; Marti, C. Nathan

    2013-01-01

    Objective: Evaluate the effects of a prevention program targeting both eating disorders and obesity at 1- and 2-year follow-ups. Method: Female college students at risk for these outcomes because of body image concerns (N = 398) were randomized to the "Healthy Weight 2" group-based 4-hr prevention program, which promotes lasting healthy…

  11. Percutaneous laser disc decompression (PLDD): 352 cases with an 8 1/2-year follow-up.

    PubMed

    Choy, D S

    1995-02-01

    Percutaneous laser disc decompression (PLDD) was pioneered by Dr. Peter Ascher and myself in 1986. This report describes patient selection, operative technique, laser dosimetry, and results in 352 cases with an 8 1/2-year follow-up. The conclusion is that PLDD is relatively non-invasive, safe, simple and effective. PMID:10150569

  12. Involvement in bullying and suicidal ideation in middle adolescence: a 2-year follow-up study.

    PubMed

    Heikkilä, Hanna-Kaisa; Väänänen, Juha; Helminen, Mika; Fröjd, Sari; Marttunen, Mauri; Kaltiala-Heino, Riittakerttu

    2013-02-01

    The objective of the study was to ascertain whether involvement in bullying increases the risk for subsequent suicidal ideation. A total of 2,070 Finnish girls and boys aged 15 were surveyed in the ninth grade (age 15) in schools, and followed up 2 years later in the Adolescent Mental Health Cohort Study. Involvement in bullying was elicited at age 15 by two questions focusing on being a bully and being a victim of bullying. Suicidal ideation was elicited by one item of the short Beck Depression Inventory at age 17. Baseline depressive symptoms and externalizing symptoms, age and sex were controlled for. Statistical analyses were carried out using cross-tabulations with Chi-square/Fisher's exact test and logistic regression. Suicidal ideation at age 17 was 3-4 times more prevalent among those who had been involved in bullying at age 15 than among those not involved. Suicidal ideation at age 17 was most prevalent among former victims of bullying. Being a victim of bullying at age 15 continued to predict subsequent suicidal ideation when depressive and externalizing symptoms were controlled for. Being a bully at age 15 also persisted as borderline significantly predictive of suicidal ideation when baseline symptoms were controlled for. Findings indicate adolescent victims and perpetrators of bullying alike are at long-term risk for suicidal ideation. PMID:23053774

  13. Interdental papilla regeneration around implants: A novel window technique (2 years follow-up)

    PubMed Central

    Lambodharan, R.; Balaji, V. R.

    2015-01-01

    Reconstructing predictable and esthetic papilla is the most complex and challenging aspect of implant dentistry. To obtain an esthetic and predictable gingival architecture and implant restoration, interdental papilla plays an important role. The main objective of the surgeon during the second stage of implant treatment should be the creation of interdental papilla prior to prosthetic restoration. The aim of this case report was to demonstrate a novel window technique for developing predictable and esthetic papilla around dental implants, which was followed for 2 years with excellent esthetic results. PMID:26538979

  14. Full mouth rehabilitation with zygomatic implants in patients with generalized aggressive periodontitis: 2 year follow-up of two cases

    PubMed Central

    Rajan, Gunaseelan; Natarajarathinam, Gowri; Kumar, Saravana; Parthasarathy, Harinath

    2014-01-01

    Rehabilitation of severely atrophied maxillae is often a challenge and patients with generalized aggressive periodontitis (GAP) make it even more complicated. This clinical report describes rehabilitation of GAP patients with zygomatic implants and followed-up for 2 years. Two patients of age 33 and 44 reported to a private dental practice and were diagnosed with GAP. Various treatment options were considered after which it was decided to do a full mouth implant supported fixed rehabilitation, with a combination of conventional and zygomatic implants. Two zygomatic and four conventional implants were placed and immediately loaded with a provisional prosthesis. After 6 months, definitive prosthesis was delivered. Implants and prostheses were followed-up for 2 years. No implant failures occurred, but a few biological complications were observed. The most common clinical observation in these patients during recall visits was peri-implant soft-tissue inflammation, which is a biological complication. This was with no trouble, controlled by using proper oral hygiene aids and maintenance. Within the limitations of this study, we can state that it can definitely be considered as a viable treatment option treating patients with GAP. However, studies with more follow-up time and controlled clinical trials should be performed in order to document the longevity of this treatment modality. PMID:24744558

  15. Lumbar total disc replacement using ProDisc II: a prospective study with a 2-year minimum follow-up.

    PubMed

    Chung, Sung Soo; Lee, Chong Suh; Kang, Chang Seok

    2006-08-01

    A lumbar total disc replacement (TDR) is believed to be a promising substitute in the surgical treatment for lumbar degenerative disc disease. The purpose of this study is to report the clinical and radiographic outcomes of 36 consecutive patients who underwent lumbar TDR using ProDisc II, and the factors associated with a better clinical outcome after a 2-year minimum follow-up. At the time of the latest follow-up, the success rate was 94% of 36 patients according to the criteria of the US Food and Drug Administration. Of the 10 patients unable to work preoperatively, 7 patients returned to work. Moreover, mean score on the visual analog scale for low back and leg pain improved significantly from 7.5 and 4.7 to 3.0 and 1.2, respectively (P<0.001). In addition, mean Oswestry disability index scores improved significantly from 69.2 to 21.0 (P<0.001). Mean disc height at the operative level increased significantly from 9.0 to 17.6 mm, and mean range of motion increased significantly from 9.7 to 12.7 degrees (P<0.01). Statistical analysis showed that the factors associated with a better clinical outcome were single level, and a higher postoperative segmental ROM at the operative level. At a minimum follow-up of 2 years, the lumbar TDR using ProDisc II showed excellent clinical and radiographic outcomes without any significant complication. However, future efforts need to be directed toward the evaluation of a larger number of patients with longer follow-up. PMID:16891976

  16. [Arthroplasty of the cervical disks using artificial prodisc C(tm) in 54 patients with 2-year follow-up].

    PubMed

    Sukhomel, P; Byval'tsev, V A

    2008-01-01

    Aim of the study was to analyze results of arthroplasty using artificial discs Prodisc C(tm) ("Synthes, Inc., Paoli, PA) during a 2-year period. 54 patients with degenerative cervical disk disease were included in the study. 65 artificial disks Prodisc C(tm) were implanted. Results were assessed by neurological examination, neuroradiological techniques and Neck Disability Index (NDI). Significance of differences in parameters was evaluated using Student and Fischer tests (p < 0.05). Results of treatment were the following parameters: timing of surgery--82 minutes, blood loss--81 ml, hospital stay--4 days. Significant decrease of frequency and intensity of pain in cervical spine and upper extremities was observed after surgery (according to Visual Analog Scale (VAS) data). VAS assessment revealed discovered reduction of cervical pain severity from 4.5 to 2.8 points and its frequency from 6.1 to 3.2 points, and intensity of pain in arms decreased from 5.6 to 2.5 points while frequency changed from 7.0 to 2.7 points. 2-year of postoperative follow-up discovered decrease of NDI from 32 to 22. Full preservation of movement range in operated segments after 2 years was observed in 76.9% patients, stage 0, I and II limitation of movements--in 15.4%, absence of movements (stage IV)--in 7.7% (p < 0.05). Spontaneous heterotopy of bone tissue after implantation of artificial disks was encountered in 61.5% cases (stages I-IV) (p < 0.05). 2 intraoperative complications (splitting of vertebral body during insertion of implant) occurred. Arthroplasty using artificial disks Prodisc C(tm) is a perspective innovation of modem spinal surgery. Analysis of results of treatment during 2-year follow-up demonstrates necessity of further investigations in this area of neurosurgery. PMID:19062591

  17. Patients with Fabry Disease after Enzyme Replacement Therapy Dose Reduction and Switch-2-Year Follow-Up.

    PubMed

    Lenders, Malte; Canaan-Kühl, Sima; Krämer, Johannes; Duning, Thomas; Reiermann, Stefanie; Sommer, Claudia; Stypmann, Jörg; Blaschke, Daniela; Üçeyler, Nurcan; Hense, Hans-Werner; Brand, Stefan-Martin; Wanner, Christoph; Weidemann, Frank; Brand, Eva

    2016-03-01

    Because of the shortage of agalsidase-β supply between 2009 and 2012, patients with Fabry disease either were treated with reduced doses or were switched to agalsidase-α. In this observational study, we assessed end organ damage and clinical symptoms with special focus on renal outcome after 2 years of dose-reduction and/or switch to agalsidase-α. A total of 89 adult patients with Fabry disease who had received agalsidase-β (1.0 mg/kg body wt) for >1 year were nonrandomly assigned to continue this treatment regimen (regular-dose group, n=24), to receive a reduced dose of 0.3-0.5 mg/kg and a subsequent switch to 0.2 mg/kg agalsidase-α (dose-reduction-switch group, n=28), or to directly switch to 0.2 mg/kg agalsidase-α (switch group, n=37) and were followed-up for 2 years. We assessed clinical events (death, myocardial infarction, severe arrhythmia, stroke, progression to ESRD), changes in cardiac and renal function, Fabry-related symptoms (pain, hypohidrosis, diarrhea), and disease severity scores. Determination of renal function by creatinine and cystatin C-based eGFR revealed decreasing eGFRs in the dose-reduction-switch group and the switch group. The Mainz Severity Score Index increased significantly in these two groups (P=0.02 and P<0.001, respectively), and higher frequencies of gastrointestinal pain occurred during follow-up. In conclusion, after 2 years of observation, all groups showed a stable clinical disease course with respect to serious clinical events. However, patients under agalsidase-β dose-reduction and switch or a direct switch to agalsidase-α showed a decline of renal function independent of the eGFR formula used. PMID:26185201

  18. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups

    PubMed Central

    Jafar, Tazeen H.; Jehan, Imtiaz; Liang, Feng; Barbier, Sylvaine; Islam, Muhammad; Bux, Rasool; Khan, Aamir Hameed; Nadkarni, Nivedita; Poulter, Neil; Chaturvedi, Nish; Ebrahim, Shah

    2015-01-01

    Background Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP) is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA) Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE) and trained general practitioner (GP) intervention delivered over 2 years was more effective than no intervention (usual care) in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up. Methods A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment) were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense) in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE) were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes. Findings After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1–0.1] mm Hg) compared to those randomised to usual care, (P = 0.04). Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl. Conclusions The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still

  19. Results of a unicentric series of 15 wrist prosthesis implantations at a 5.2 year follow-up.

    PubMed

    Chevrollier, Jérémie; Strugarek-Lecoanet, Clotilde; Dap, François; Dautel, Gilles

    2016-03-01

    Our retrospective study aimed to evaluate functional and radiological results of a unicentric series of 17 total wrist prostheses implanted between 2001 and 2011. Nine women and seven men, mean age 59, underwent wrist joint arthroplasty, bilateral in one case. Universal Total Wrist and Remotion prostheses were used and followed-up at a mean of 5.2 years (1.1-10). Fifteen patients were reviewed. Four patients had postoperative complications, three of whom required arthrodesis. The rest obtained satisfactory pain relief. Grip strength nevertheless decreased compared to the contralateral side and mobility was reduced: flexion/extension=33°, ulnar/radial deviation=20°. The Quick DASH score was 29% and PRWE, 26%. Radiological assessment revealed carpal implant loosening in eight patients. Our series confirms the discordance generally observed between patients' subjective satisfaction and mediocre clinical and radiological results over the medium term. PMID:26984652

  20. Femoro Patella Vialla patellofemoral arthroplasty: An independent assessment of outcomes at minimum 2-year follow-up

    PubMed Central

    Halai, Mansur; Ker, Andrew; Anthony, Iain; Holt, Graeme; Jones, Bryn; Blyth, Mark

    2016-01-01

    AIM To determine outcomes using the Femoro-Patella Vialla (FPV) arthroplasty and if there is an ideal patient for this implant. METHODS A total of 41 FPV patellofemoral joint replacements were performed in 31 patients (22 females, 9 males, mean age 65 years). Mean follow-up was 3.2 years (minimum 2 years). Radiographs were reviewed preoperatively and postoperatively. We assessed whether gender, age, previous surgery, patella atla or trochlear dysplasia influenced patient satisfaction or patient functional outcome. RESULTS The median Oxford Knee Score was 40 and the median Melbourne Patellofemoral Score was 21 postoperatively. Seventy-six percent of patients were satisfied, 10% unsure and 14% dissatisfied postoperatively. There was no radiological progression of tibiofemoral joint arthritis, using the Ahlback grading, in any patient. One patient, who was diagnosed with rheumatoid arthritis postoperatively, underwent revision to total knee replacement. There were no intraoperative lateral releases and no implant failures. Gender, age, the presence of trochlear dysplasia, patella alta or bilateral surgery did not influence patient outcome. Previous surgery did not correlate with outcome. CONCLUSION In contrast to the current literature, the FPV shows promising early results. However, we cannot identify a subgroup of patients with superior outcomes.

  1. Use of Ergonomic Measures Related to Musculoskeletal Complaints among Construction Workers: A 2-year Follow-up Study

    PubMed Central

    Boschman, Julitta S.; Frings-Dresen, Monique H.W.; van der Molen, Henk F.

    2015-01-01

    Background The physical work demands of construction work can be reduced using ergonomic measures. The aim of this study was to evaluate the use of ergonomic measures related to musculoskeletal disorders (MSDs) among construction workers. Methods A questionnaire was sent at baseline and 2 years later to 1,130 construction workers. We established (1) the proportion of workers reporting an increase in their use of ergonomic measures, (2) the proportion of workers reporting a decrease in MSDs, (3) the relative risk for an increase in the use of ergonomic measures and a decrease in MSDs, and (4) workers' knowledge and opinions about the use of ergonomic measures. Results At follow-up, response rate was 63% (713/1,130). The proportion of workers using ergonomic measures for vertical transport increased (34%, 144/419, p < 0.01); for measures regarding horizontal transport and the positioning of materials, no change was reported. The proportion of workers reporting shoulder complaints decreased (28%, 176/638, p = 0.02). A relationship between the use of ergonomic measures and MSDs was not found; 83% (581/704) of the workers indicated having sufficient knowledge about ergonomic measures. Lightening the physical load was reported to be the main reason for using them. Conclusion Only the use of ergonomic measures for vertical transport increased over a 2-year period. No relationship between the use of ergonomic measures and MSDs was found. Strategies aimed at improving the availability of ergonomic equipment complemented with individualized advice and training in using them might be the required next steps to increase the use of ergonomic measures. PMID:26106507

  2. Effectiveness Trial of an Indicated Cognitive-Behavioral Group Adolescent Depression Prevention Program versus Bibliotherapy and Brochure Control at 1- and 2-Year Follow-Up

    PubMed Central

    Rohde, Paul; Stice, Eric; Shaw, Heather; Gau, Jeff M.

    2015-01-01

    Objective Evaluate the longterm effects of a brief group cognitive-behavioral (CB) adolescent depression indicated prevention program through 2-year follow-up, relative to CB bibliotherapy and brochure control, when high school personnel recruited students and delivered the program. Method 378 adolescents (M age = 15.5, SD = 1.2; 68% female, 72% White) with elevated self-assessed depressive symptoms who were randomized to CB group, CB bibliotherapy, or educational brochure control were assessed at pre, post, 6-, 12-, 18-, and 24-month follow-up. Results By 2 years post-intervention, CB group participants showed significantly lower major depressive disorder (MDD) onset versus CB bibliotherapy (10% vs. 25%, respectively; HR = 2.48, p = .006), but the incidence difference relative to brochure controls (17%) was nonsignificant; MDD incidence for bibliotherapy and brochure controls did not differ. Although CB group participants showed lower depressive symptoms at post versus brochure controls, there were no effects for this outcome or for social adjustment or substance use over 2-year follow-up. Moderator analyses suggested that participants with higher baseline depressive symptoms showed greater longterm symptom reductions in the CB group intervention versus bibliotherapy. Conclusions The evidence that a brief CB group intervention delivered by real-world providers significantly reduced MDD onset versus CB bibliotherapy is potentially encouraging. However, the lack of MDD prevention effects relative to brochure control and lack of longterm symptom effects (though consistent with results from other depression prevention trials), suggest that the delivery of CB group should be refined to strengthen its effectiveness. PMID:25894666

  3. Intermediate clinical and radiological results of cervical TDR (Mobi-C®) with up to 2 years of follow-up

    PubMed Central

    Beaurain, J.; Bernard, P.; Dufour, T.; Fuentes, J. M.; Hovorka, I.; Huppert, J.; Steib, J. P.; Vital, J. M.; Aubourg, L.

    2009-01-01

    The interest in cervical total disc replacement (TDR) as an alternative to the so-far gold standard in the surgical treatment of degenerative disc disease (DDD), e.g anterior cervical discectomy and fusion (ACDF), is growing very rapidly. Many authors have established the fact that ACDF may result in progressive degeneration in adjacent segments. On the contrary, but still theoretically, preservation of motion with TDR at the surgically treated level may potentially reduce the occurrence of adjacent-level degeneration (ALD). The authors report the intermediate results of an undergoing multicentre prospective study of TDR with Mobi-C® prosthesis. The aim of the study was to assess the safety and efficacy of the device in the treatment of DDD and secondary to evaluate the radiological status of adjacent levels and the occurrence of ossifications, at 2-year follow-up (FU). 76 patients have performed their 2-year FU visit and have been analyzed clinically and radiologically. Clinical outcomes (NDI, VAS, SF-36) and ROM measurements were analyzed pre-operatively and at the different post-operative time-points. Complications and re-operations were also assessed. Occurrences of heterotopic ossifications (HOs) and of adjacent disc degeneration radiographic changes have been analyzed from 2-year FU X-rays. The mean NDI and VAS scores for arm and neck are reduced significantly at each post-operative time-point compared to pre-operative condition. Motion is preserved over the time at index levels (mean ROM = 9° at 2 years) and 85.5% of the segments are mobile at 2 years. HOs are responsible for the fusion of 6/76 levels at 2 years. However, presence of HO does not alter the clinical outcomes. The occurrence rate of radiological signs of ALD is very low at 2 years (9.1%). There has been no subsidence, no expulsion and no sub-luxation of the implant. Finally, after 2 years, 91% of the patients assume that they would undergo the procedure again. These intermediate

  4. Two Years Follow up of Domain Specific Cognitive Training in Relapsing Remitting Multiple Sclerosis: A Randomized Clinical Trial

    PubMed Central

    Mattioli, Flavia; Bellomi, Fabio; Stampatori, Chiara; Provinciali, Leandro; Compagnucci, Laura; Uccelli, Antonio; Pardini, Matteo; Santuccio, Giuseppe; Fregonese, Giuditta; Pattini, Marianna; Allegri, Beatrice; Clerici, Raffaella; Lattuada, Annalisa; Montomoli, Cristina; Corso, Barbara; Gallo, Paolo; Riccardi, Alice; Ghezzi, Angelo; Roscio, Marco; Tola, Maria Rosaria; Calanca, Chiara; Baldini, Daria; Trafficante, Debora; Capra, Ruggero

    2016-01-01

    Cognitive rehabilitation in multiple sclerosis (MS) has been reported to induce neuropsychological improvements, but the persistence of these effects has been scarcely investigated over long follow ups. Here, the results of a multicenter randomized clinical trial are reported, in which the efficacy of 15 week domain specific cognitive training was evaluated at 2 years follow up in 41 patients. Included patients were randomly assigned either to domain specific cognitive rehabilitation, or to aspecific psychological intervention. Patients who still resulted to be cognitively impaired at 1 year follow up were resubmitted to the same treatment, whereas the recovered ones were not. Neuropsychological tests and functional scales were administered at 2 years follow up to all the patients. Results revealed that both at 1 and at 2 years follow up more patients in the aspecific group (18/19, 94% and 13/17, 76% respectively) than in the specific group (11/22, 50% and 5/15, 33% respectively) resulted to be cognitively impaired. Furthermore patients belonging to the specific group showed significantly less impaired tests compared with the aspecific group ones (p = 0.02) and a significant amelioration in the majority of the tests. On the contrary patients in the aspecific group did not change. The specific group subjects also perceived a subjective improvement in their cognitive performance, while the aspecific group patients did not. These results showed that short time domain specific cognitive rehabilitation is a useful treatment for patients with MS, shows very long lasting effects, compared to aspecific psychological interventions. Also subjective cognitive amelioration was found in patients submitted to domain specific treatment after 2 years. PMID:26941630

  5. Two Years Follow up of Domain Specific Cognitive Training in Relapsing Remitting Multiple Sclerosis: A Randomized Clinical Trial.

    PubMed

    Mattioli, Flavia; Bellomi, Fabio; Stampatori, Chiara; Provinciali, Leandro; Compagnucci, Laura; Uccelli, Antonio; Pardini, Matteo; Santuccio, Giuseppe; Fregonese, Giuditta; Pattini, Marianna; Allegri, Beatrice; Clerici, Raffaella; Lattuada, Annalisa; Montomoli, Cristina; Corso, Barbara; Gallo, Paolo; Riccardi, Alice; Ghezzi, Angelo; Roscio, Marco; Tola, Maria Rosaria; Calanca, Chiara; Baldini, Daria; Trafficante, Debora; Capra, Ruggero

    2016-01-01

    Cognitive rehabilitation in multiple sclerosis (MS) has been reported to induce neuropsychological improvements, but the persistence of these effects has been scarcely investigated over long follow ups. Here, the results of a multicenter randomized clinical trial are reported, in which the efficacy of 15 week domain specific cognitive training was evaluated at 2 years follow up in 41 patients. Included patients were randomly assigned either to domain specific cognitive rehabilitation, or to aspecific psychological intervention. Patients who still resulted to be cognitively impaired at 1 year follow up were resubmitted to the same treatment, whereas the recovered ones were not. Neuropsychological tests and functional scales were administered at 2 years follow up to all the patients. Results revealed that both at 1 and at 2 years follow up more patients in the aspecific group (18/19, 94% and 13/17, 76% respectively) than in the specific group (11/22, 50% and 5/15, 33% respectively) resulted to be cognitively impaired. Furthermore patients belonging to the specific group showed significantly less impaired tests compared with the aspecific group ones (p = 0.02) and a significant amelioration in the majority of the tests. On the contrary patients in the aspecific group did not change. The specific group subjects also perceived a subjective improvement in their cognitive performance, while the aspecific group patients did not. These results showed that short time domain specific cognitive rehabilitation is a useful treatment for patients with MS, shows very long lasting effects, compared to aspecific psychological interventions. Also subjective cognitive amelioration was found in patients submitted to domain specific treatment after 2 years. PMID:26941630

  6. Two-Year Follow-up of a Randomized Effectiveness Trial Evaluating MST for Juveniles Who Sexually Offend

    PubMed Central

    Letourneau, Elizabeth J.; Henggeler, Scott W.; McCart, Michael R.; Borduin, Charles M.; Schewe, Paul A.; Armstrong, Kevin S.

    2015-01-01

    Objective Building on prior efficacy trials (i.e., university based, graduate students as therapists), the primary purpose of this study was to determine whether favorable 12-month outcomes obtained in a randomized effectiveness trial (i.e., implemented by practitioners in a community mental health center) of multisystemic therapy (MST) with juveniles who had sexually offended (JSO) were sustained through a second year of follow-up. Method JSO (n = 124 male youth) and their families were randomly assigned to MST, which was family based and delivered by community-based practitioners, or to treatment as usual (TAU), which was primarily group-based cognitive-behavioral interventions delivered by professionals within the juvenile justice system. Youth averaged 14.7 (SD = 1.7) years of age at referral, were primarily African American (54%), and 30% were Hispanic. All youth had been diverted or adjudicated for a sexual offense. Analyses examined whether MST effects reported previously at 1-year follow-up for problem sexual behaviors, delinquency, substance use, and out-of-home placement were sustained through a second year of follow-up. In addition, arrest records were examined from baseline through 2-year follow-up. Results During the second year of follow-up, MST treatment effects were sustained for three of four measures of youth problem sexual behavior, self-reported delinquency, and out-of-home placements. The base rate for sexual offense rearrests was too low to conduct statistical analyses, and a between-groups difference did not emerge for other criminal arrests. Conclusions For the most part, the 2-year follow-up findings from this effectiveness study are consistent with favorable MST long-term results with JSO in efficacy research. In contrast with many MST trials, however, decreases in rearrests were not observed. PMID:24188082

  7. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial

    PubMed Central

    Bitan, Fabien; Lockstadt, Harry; Kovalsky, Don; Cher, Daniel; Hillen, Travis

    2016-01-01

    Background Sacroiliac joint (SIJ) dysfunction is an underdiagnosed condition. Several published cohorts have reported favorable mid-term outcomes after SIJ fusion using titanium implants placed across the SIJ. Herein we report long-term (24-month) results from a prospective multicenter clinical trial. Methods One hundred and seventy-two subjects at 26 US sites with SI joint dysfunction were enrolled and underwent minimally invasive SI joint fusion with triangular titanium implants. Subjects underwent structured assessments preoperatively and at 1, 3, 6, 12, 18 and 24 months postoperatively, including SIJ pain ratings (0-100 visual analog scale), Oswestry Disability Index (ODI), Short Form-36 (SF-36), EuroQOL-5D (EQ-5D), and patient satisfaction. Adverse events were collected throughout follow-up. All participating patients underwent a high-resolution pelvic CT scan at 1 year. Results Mean subject age was 50.9 years and 69.8% were women. SIJ pain was present for an average of 5.1 years prior to surgical treatment. SIJ pain decreased from 79.8 at baseline to 30.4 at 12 months and remained low at 26.0 at 24 months (p<.0001 for change from baseline). ODI decreased from 55.2 at baseline to 31.5 at 12 months and remained low at 30.9 at 24 months (p<.0001 for change from baseline). Quality of life (SF-36 and EQ-5D) improvements seen at 12 months were sustained at 24 months. The proportion of subjects taking opioids for SIJ or low back pain decreased from 76.2% at baseline to 55.0% at 24 months (p <.0001). To date, 8 subjects (4.7%) have undergone one or more revision SIJ surgeries. 7 device-related adverse events occurred. CT scan at one year showed a high rate (97%) of bone adherence to at least 2 implants on both the iliac and sacral sides with modest rates of bone growth across the SIJ. Conclusions In this study of patients with SIJ dysfunction, minimally invasive SI joint fusion using triangular titanium implants showed marked improvements in pain, disability and

  8. A Randomized Effectiveness Trial of Brief Parent Training: Six-Month Follow-Up

    ERIC Educational Resources Information Center

    Kjøbli, John; Bjørnebekk, Gunnar

    2013-01-01

    Objective: To examine the follow-up effectiveness of brief parent training (BPT) for children with emerging or existing conduct problems. Method: With the use of a randomized controlled trial and parent and teacher reports, this study examined the effectiveness of BPT compared to regular services 6 months after the end of the intervention.…

  9. Thirty-Month Follow-Up of Drinking Moderation Training for Women: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Walitzer, Kimberly S.; Connors, Gerard J.

    2007-01-01

    This study examined the durability of a group-based drinking moderation training for heavily drinking women reporting low physical dependence on alcohol. A 30-month follow-up of participants was conducted based on a previous study of 144 women randomly assigned to treatment conditions (G. J. Connors & K. S. Walitzer, 2001). Thirty-month follow-up…

  10. Changes in the frequency of benign focal spikes accompany changes in central information processing speed: a prospective 2-year follow-up study.

    PubMed

    Ebus, S C M; IJff, D M; den Boer, J T; van Hall, M J H; Klinkenberg, S; van der Does, A; Boon, P J; Arends, J B A M; Aldenkamp, A P

    2015-02-01

    We prospectively examined whether changes in the frequency of benign focal spikes accompany changes in cognition. Twenty-six children with benign focal spikes (19 with Rolandic epilepsy) and learning difficulties were examined with repeated 24-hour EEG recordings, three cognitive tests on central information processing speed (CIPS), and questionnaires on cognition and behavior at baseline, 6months, and 2years. Antiepileptic drug changes were allowed when estimated necessary by the treating physician. At baseline, a lower CIPS was correlated with a higher frequency of diurnal interictal epileptiform discharges (IEDs) and with worse academic achievement. At follow-up, there was a significant correlation between changes in CIPS and EEG changes in wakefulness (in the same direction) when the EEG outcome was dichotomized in IED frequency "increased" or "not increased". Behavioral problems were more often observed in patients with higher frequency of IEDs in sleep at baseline and in those with ongoing IEDs compared with those with EEG remission (without or with sporadic IEDs in the recording) at the end of the study period. No changes were observed in the results of the questionnaires. A lower diurnal IED frequency at baseline, lack of serial IEDs, and occurrence of only unilateral IEDs were correlated with a higher chance of EEG remission at 2-year follow-up. Electroencephalography remission could not be predicted from other epilepsy variables except from seizure freedom in the last six months. Our results confirm the nonbenign character of 'benign' focal spikes. Whether an early and stable EEG remission can be achieved through antiepileptic treatment and whether this is of benefit for cognitive development should be examined in prospective placebo-controlled randomized trials. PMID:25546731

  11. Power Morcellation of Unsuspected High-grade Leiomyosarcoma Within an Inflated Containment Bag: 2-year Follow-up.

    PubMed

    Boruta, David M; Shibley, Tony

    2016-01-01

    The diagnosis of an unsuspected leiomyosarcoma after hysterectomy for the treatment of a presumed benign leiomyoma is a rare but highly clinically significant event. In order to facilitate removal of large uterine specimens using a minimally invasive surgical approach, morcellation with extraction in pieces is often performed. In the event of unsuspected malignancy, this may result in abdominal dispersion of the tumor and contribute to poorer survival. In the present article, we report a case of contained power morcellation of an unsuspected high-grade leiomyosarcoma with 2 years of follow-up. Although further study is necessary, this technique may minimize the risk that women undergoing laparoscopic hysterectomy with morcellation have a worse prognosis when diagnosed with an unexpected malignancy. PMID:27393286

  12. Outcomes of a New Residential Scheme for Adults with Intellectual Disabilities in Taiwan: A 2-Year Follow-Up

    ERIC Educational Resources Information Center

    Chou, Y-C.; Pu, C.; Kroger, T.; Lee, W.; Chang, S.

    2011-01-01

    Background: The Taiwanese government launched a new programme in November 2004 to support adults with intellectual disabilities living in smaller facilities. This paper aims to evaluate the service outcomes of this new residential scheme over 2 years including those residents who moved from an institution and those who moved from their family.…

  13. Continuity, Comorbidity and Longitudinal Associations between Depression and Antisocial Behaviour in Middle Adolescence: A 2-Year Prospective Follow-Up Study

    ERIC Educational Resources Information Center

    Ritakallio, Minna; Koivisto, Anna-Maija; von der Pahlen, Bettina; Pelkonen, Mirjami; Marttunen, Mauri; Kaltiala-Heino, Riittakerttu

    2008-01-01

    The study investigated continuity, comorbidity and longitudinal associations between depression Beck depression inventory (RBDI) and antisocial behaviour Youth self-report (YSR) in middle adolescence. Data were used from a community sample of 2070 adolescents who participated in a 2-year prospective follow-up study. The results indicate that both…

  14. Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

    PubMed Central

    Tullberg, Tycho; Branth, Björn; Olerud, Claes; Tropp, Hans

    2009-01-01

    The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21–55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment (GA), VAS for back and leg pain, Oswestry Disability Index, SF36 and EQ5D at 1 and 2 years. Follow-up rate was 100%, at both 1 and 2 years. All outcome variables improved in both groups between preoperative and follow-up assessment. The primary outcome measure, GA, revealed that 30% in the TDR group and 15% in the fusion group were totally pain-free at 2 years (P = 0.031). TDR patients had reached maximum recovery in virtually all variables at 1 year, with significant differences compared to the fusion group. The fusion patients continued to improve and at 2 years had results similar to TDR patients apart from numbers of pain-free. Complications and reoperations were similar in both groups, but pedicle screw removal as additive surgery, was frequent in the fusion group. One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free. The

  15. Talent identification and early development of elite water-polo players: a 2-year follow-up study.

    PubMed

    Falk, Bareket; Lidor, Ronnie; Lander, Yael; Lang, Benny

    2004-04-01

    The processes of talent detection and early development are critical in any sport programme. However, not much is known about the appropriate strategies to be implemented during these processes, and little scientific inquiry has been conducted in this area. The aim of this study was to identify variables of swimming, ball handling and physical ability, as well as game intelligence, which could assist in the selection process of young water-polo players. Twenty-four players aged 14-15 years underwent a battery of tests three times during a 2-year period, before selection to the junior national team. The tests included: freestyle swim for 50, 100, 200 and 400 m, 100-m breast-stroke, 100-m 'butterfly' (with breast-stroke leg motion), 50-m dribbling, throwing at the goal, throw for distance in the water, vertical 'jump' from the water, and evaluation of game intelligence by two coaches. A comparison of those players eventually selected to the team and those not selected demonstrated that, 2 years before selection, selected players were already superior on most of the swim tasks (with the exception of breast-stroke and 50-m freestyle), as well as dribbling and game intelligence. This superiority was maintained throughout the 2 years. Two-way tabulation revealed that, based on baseline scores, the prediction for 67% of the players was in agreement with the final selection to the junior national team. We recommend that fewer swim events be used in the process of selecting young water-polo players, and that greater emphasis should be placed on evaluation of game intelligence. PMID:15161108

  16. Radical irradiation and misonidazole for T2 grade III and T3 bladder cancer: 2 year follow-up

    SciTech Connect

    Abratt, R.P.; Barnes, D.R.; Hammond, J.A.; Sarembok, L.A.; Tucker, R.D.; Williams, A.M.

    1984-09-01

    Patients with T2 grade III and T3 bladder cancer were treated in a Phase II trial of radical irradiation plus Misonidazole (MISO). Twenty-two patients were treated and the results compared with historical controls. The cystoscopic complete tumor response between 6 and 12 months post therapy were 73 and 43%, respectively. The patient two year survival was 81 and 51%, respectively, and the patient 2 year survival with bladder preservation was 61 and 48%, respectively - 4 patients in the MISO study having undergone salvage cystectomy. Complications that may be radiation related in the MISO study are would sepsis after salvage cystectomy in 2 patients, rectal stenosis requiriing colostomy 16 months after salvage cystecomy in 1 patient and the development of a contracted bladder in 1 patient with a history of prior extensive endoscopic therapy. No misonidazole neurotoxicity seen. These findings are being further evaluated in a prospective radomized trial.

  17. Breast cancer follow-up strategies in randomized phase III adjuvant clinical trials: a systematic review

    PubMed Central

    2013-01-01

    The effectiveness of different breast cancer follow-up procedures to decrease breast cancer mortality are still an object of debate, even if intensive follow-up by imaging modalities is not recommended by international guidelines since 1997. We conducted a systematic review of surveillance procedures utilized, in the last ten years, in phase III randomized trials (RCTs) of adjuvant treatments in early stage breast cancer with disease free survival as primary endpoint of the study, in order to verify if a similar variance exists in the scientific world. Follow-up modalities were reported in 66 RCTs, and among them, minimal and intensive approaches were equally represented, each being followed by 33 (50%) trials. The minimal surveillance regimen is preferred by international and North American RCTs (P = 0.001) and by trials involving more than one country (P = 0.004), with no relationship with the number of participating centers (P = 0.173), with pharmaceutical industry sponsorship (P = 0.80) and with trials enrolling > 1000 patients (P = 0.14). At multivariate regression analysis, only geographic location of the trial was predictive for a distinct follow-up methodology (P = 0.008): Western European (P = 0.004) and East Asian studies (P = 0.010) use intensive follow-up procedures with a significantly higher frequency than international RCTs, while no differences have been detected between North American and international RCTs. Stratifying the studies according to the date of beginning of patients enrollment, before or after 1998, in more recent RCTs the minimal approach is more frequently followed by international and North American RCTs (P = 0.01), by trials involving more than one country (P = 0.01) and with more than 50 participating centers (P = 0.02). It would be highly desirable that in the near future breast cancer follow-up procedures will be homogeneous in RCTs and everyday clinical settings. PMID:24438135

  18. Soft tissue stability in segmental distraction of the anterior mandibular alveolar process. A 2-year follow-up.

    PubMed

    Joss, C U; Triaca, A; Antonini, M; Kiliaridis, S; Kuijpers-Jagtman, A M

    2012-05-01

    This study evaluated soft tissue changes in adult patients treated with distraction osteogenesis (DOG) of the anterior mandibular alveolar process and related it to different parameters. 33 patients (27 females; 6 males) were analysed retrospectively before surgery at T1 (17.0 days), after surgery at T2 (mean 6.5 days), at T3 (mean 24.4 days), and at T4 (mean 2.0 years). Lateral cephalograms were traced by hand, digitized, superimposed, and evaluated. Statistical analysis was carried out using Kolmogorov-Smirnov test, paired t test, Pearson's correlation coefficient, and linear backward regression analysis. 2 years postoperatively (T4), the net effect of the soft tissue at point B' was 100% of the advancement at point B whilst the lower lip (labrale inferior) followed the advancement of incision inferior to 46%. Increased preoperative age was correlated (p<0.05) with more horizontal backward movement (T4-T3) for labrale superior and pogonion'. Higher NL/ML' angles were significantly correlated (p<0.05) with smaller horizontal soft tissue change at point B'. Gender and the amount of skeletal and dental advancement were not correlated with postoperative soft tissue changes (T4-T3). DOG of the anterior mandibular alveolar process is a valuable alternative for mandibular advancement regarding soft tissue change and predictability. PMID:22204924

  19. Randomized trial of partial vs. stepwise caries removal: 3-year follow-up.

    PubMed

    Maltz, M; Garcia, R; Jardim, J J; de Paula, L M; Yamaguti, P M; Moura, M S; Garcia, F; Nascimento, C; Oliveira, A; Mestrinho, H D

    2012-11-01

    This randomized, multicenter clinical trial evaluated the effectiveness of 2 treatments for deep caries lesions - partial caries removal (PCR) and stepwise excavation (SW) - with respect to the primary outcome of pulp vitality for a 3-year follow-up period. Inclusion criteria were as follows: patients with permanent molars presenting deep caries lesions (lesion affecting ≥ 1/2 of the dentin on radiographic examination), positive response to a cold test, absence of spontaneous pain, negative sensitivity to percussion, and absence of periapical lesions (radiographic examination). Teeth randomly assigned to PCR (test) received incomplete caries removal and filling in a single session. Outcome success was evaluated by assessment of pulp vitality, determined by pulp sensitivity to a cold test and the absence of periapical lesions. Data were analyzed by a Weibull regression model with shared frailty term (survival analysis). At baseline, 299 treatments were executed: PCR, 152 and SW, 147. By the end of the 3-year follow-up period, 213 teeth had been evaluated. Adjusted survival rates were 91% for PCR and 69% for SW (p = 0.004). These results suggest that there is no need to re-open a cavity and perform a second excavation for pulp vitality to be preserved (Clinical trials registration NCT00887952). PMID:22983407

  20. Effect of Workplace Noise on Hearing Ability in Tile and Ceramic Industry Workers in Iran: A 2-Year Follow-Up Study

    PubMed Central

    Mirmohammadi, Seyyed Jalil; Mehrparvar, Amir Houshang; Mollasadeghi, Abolfazl

    2013-01-01

    Introduction. Noise as a common physical hazard may lead to noise-induced hearing loss, an irreversible but preventable disorder. Annual audiometric evaluations help detect changes in hearing status before clinically significant hearing loss develops. This study was designed to track hearing threshold changes during 2-year follow-up among tile and ceramic workers. Methods. This follow-up study was conducted on 555 workers (totally 1110 ears). Subjects were divided into four groups according to the level of noise exposure. Hearing threshold in conventional audiometric frequencies was measured and standard threshold shift was calculated for each ear. Results. Hearing threshold was increased during 2 years of follow-up. Increased hearing threshold was most frequently observed at 4000, 6000, and 3000 Hz. Standard threshold shift was observed in 13 (2.34%), 49 (8.83%), 22 (3.96%), and 63 (11.35%) subjects in the first and second years of follow-up in the right and left ears, respectively. Conclusions. This study has documented a high incidence of noise-induced hearing loss in tile and ceramic workers that would put stress on the importance of using hearing protection devices. PMID:24453922

  1. Dasatinib in Imatinib-Resistant or Imatinib-Intolerant Chronic Myeloid Leukemia in Blast Phase After 2 Years of Follow-Up in a Phase 3 Study

    PubMed Central

    Saglio, Giuseppe; Hochhaus, Andreas; Goh, Yeow Tee; Masszi, Tamas; Pasquini, Ricardo; Maloisel, Frederic; Erben, Philipp; Cortes, Jorge; Paquette, Ronald; Bradley-Garelik, M. Brigid; Zhu, Chao; Dombret, Herve

    2016-01-01

    BACKGROUND In a phase 3 study, the authors assessed the effects of dasatinib at doses of 140 mg once daily and 70 mg twice daily in patients who had either chronic myeloid leukemia (CML) in advanced phases or Philadelphia chromosome-positive acute lymphoblastic leukemia and were resistant or intolerant to imatinib. In the current report, the results for patients with CML in blast phase after 2 years of follow-up are reported. METHODS Patients were stratified according to whether they had CML in myeloid blast phase (MBP-CML) or in lymphoid blast phase (LBP-CML) and were randomized (1:1) within each stratum to receive either oral dasatinib 140 mg once daily or 70 mg twice daily. RESULTS In patients with MBP-CML, the major hematologic response rate was 28% for both regimens; and, in patients with LBP-CML, the major hematologic response rate was 42% for once-daily dasatinib and 32% for twice-daily dasatinib. The major cytogenetic response rates were 25% for once-daily dasatinib and 28% for twice-daily dasatinib in patients with MBP-CML, and the respective rates in patients with LBP-CML were 50% and 40%. The overall survival rate at 24 months was 24% for once-daily dasatinib and 28% for twice-daily dasatinib in patients with MBP-CML, and the respective values in patients with LBP-CML were 21% and 16%. Adverse events indicated a trend toward improved tolerability for the once-daily regimen. CONCLUSIONS The current results suggested that dasatinib 140 mg once daily had similar efficacy and improved tolerability relative to the 70-mg twice-daily regimen in patients with imatinib-resistant, blast phase CML. PMID:20564086

  2. Surgical results of dynamic nonfusion stabilization with the Segmental Spinal Correction System for degenerative lumbar spinal diseases with instability: Minimum 2-year follow-up

    PubMed Central

    Ohta, Hideki; Matsumoto, Yoshiyuki; Morishita, Yuichirou; Sakai, Tsubasa; Huang, George; Kida, Hirotaka; Takemitsu, Yoshiharu

    2011-01-01

    Background When spinal fusion is applied to degenerative lumbar spinal disease with instability, adjacent segment disorder will be an issue in the future. However, decompression alone could cause recurrence of spinal canal stenosis because of increased instability on operated segments and lead to revision surgery. Covering the disadvantages of both procedures, we applied nonfusion stabilization with the Segmental Spinal Correction System (Ulrich Medical, Ulm, Germany) and decompression. Methods The surgical results of 52 patients (35 men and 17 women) with a minimum 2-year follow-up were analyzed: 10 patients with lumbar spinal canal stenosis, 15 with lumbar canal stenosis with disc herniation, 20 with degenerative spondylolisthesis, 6 with disc herniation, and 1 with lumbar discopathy. Results The Japanese Orthopaedic Association score was improved, from 14.4 ± 5.3 to 25.5 ± 2.8. The improvement rate was 76%. Range of motion of the operated segments was significantly decreased, from 9.6° ± 4.2° to 2.0° ± 1.8°. Only 1 patient had adjacent segment disease that required revision surgery. There was only 1 screw breakage, but the patient was asymptomatic. Conclusions Over a minimum 2-year follow-up, the results of nonfusion stabilization with the Segmental Spinal Correction System for unstable degenerative lumbar disease were good. It is necessary to follow up the cases with a focus on adjacent segment disorders in the future. PMID:25802671

  3. Revision Total Hip Arthroplasty Using Tantalum Augment in Patients with Paprosky III or IV Acetabular Bone Defects: A Minimum 2-year Follow Up Study

    PubMed Central

    Jeong, Min; Kim, Hyung-Joo; Lim, Seung-Jae; Moon, Young-Wan

    2016-01-01

    Purpose The purpose of this study is to report the short-term outcomes of revision total hip arthroplasty (THA) using tantalum augments in patients with severe acetabular bone defects. Materials and Methods We retrospectively analyzed 15 revision THAs performed in 15 patients using tantalum augments between June 2010 and December 2013. Acetabular bone defects were Paprosky type IIIA in 7 hips, type IIIB in 7, and type IV in 1. The causes of revision surgery were aseptic loosening in 12 hips and deep infection in 3. Revisions were first in 1 hip, second in 3, and third in 11. Six patients were male and 9 female with a mean age of 59 years (range, 48-75 years). Mean follow-up was 29 months (range, 24-48 months). Results Mean Harris hip score was improved from 34 points (range, 12-54 points) preoperatively to 84 points (range, 38-90 points) at final follow-up. On the final follow-up radiographs, there were 12 hips (80.0%) with stable fixation of the acetabular cup, 2 (13.3%) with secondary stability after mild acetabular protrusion, and 1 (6.7%) with radiolucency around the acetabular cup without mechanical symptoms. Complications included one patient with acute hematogenous infection managed by surgical debridement and long-term antibiotic therapy. There were no cases with nerve palsy or dislocation during the follow-up period. Conclusion The present study showed satisfactory clinical and radiographic outcomes of revision THA using tantalum augments due to severe acetabular bone defects of Paprosky type III or IV at a minimum follow-up of 2 years. PMID:27536651

  4. Prognostic value of low and moderately elevated C-reactive protein in acute coronary syndrome: A 2-year follow-up study

    PubMed Central

    Lukin, Ajvor; Novak, Katarina; Polić, Stojan; Puljak, Livia

    2013-01-01

    Background The main goal of this study was to improve diagnostic and predictive value of low and moderately elevated C-reactive protein (CRP) in patients with acute coronary syndrome (ACS), related to noninvasive clinical parameters, in order to improve and prolong patient life with low or no additional costs. Material/Methods A prospective, open clinical study was conducted at the University Hospital Split, Croatia with 112 patients with ACS and low or moderately elevated CRP (<3.0 mg/L). After diagnosing ACS, data on physical activity, alcohol consumption, and functional status were recorded. Anthropometric measurements were made. Blood and urine samples were taken for analyses. Electrocardiographic, ergometric, and echocardiographic testing was performed. A total of 72 parameters were monitored at the time of hospital admission in ACS patients to analyze which ones could predict disease outcome at the end of follow-up in patients with low or moderately elevated CRP. Patients were followed up for 2 years. Results The variables that were predictive of major adverse cardiac events (MACE) within 2 years of ACS hospitalization were hemoglobin, fibrinogen, antithrombin III, cholesterol levels, brain natriuretic peptide, and microalbuminuria. ACS patients with CRP <3.0 mg/L had significantly higher risk of developing MACE within 2 years if ≥50% of the 8 key parameters were outside the reference values. Conclusions Major adverse cardiac events can be predicted in patients with acute coronary syndrome whose CRP values are low or moderately elevated. PMID:24051868

  5. Perceived outcomes and satisfaction of Saudi parents and their children following dental rehabilitation under general anesthesia: A 2-year follow-up

    PubMed Central

    El Batawi, Hisham Yehia; Panigrahi, Priyankar; Awad, Manal A.

    2014-01-01

    Purpose: To investigate the perceived clinical outcome and parents’ satisfaction after dental rehabilitation under general anesthesia over a follow-up period of 2 years. Materials and Methods: A prospective study of questionnaire data obtained from 352 pediatric patients before and after treatment of early childhood caries with full dental rehabilitation under general anesthesia. Questionnaires focused on oral symptoms, functional limitations, and emotional and social well-being before and after dental treatment. Cases were followed up for 2 years postoperatively. Results: A dramatic disappearance of symptoms was reported from parents’ perspective. There was a high satisfaction rate (99.14%) also among parents of the children included in the study. Conclusion: Children with early childhood caries do not necessarily express it verbally as pain. The disease has a lot of other expressions affecting children's behavior and habits, including the ability to sleep, thrive, and socialize. This study contributes to the existing literature that full dental rehabilitation under general anesthesia [dental general anesthesia (DGA)] has an immediate positive impact on the physical and social quality of life of children suffering from early childhood caries as well as on their families. Postoperative preventive care, early diagnosis, and treatment of recurrent caries are key factors to maintain postoperative outcome of DGA. PMID:25625072

  6. Flare, Persistently Active Disease, and Serologically Active Clinically Quiescent Disease in Systemic Lupus Erythematosus: A 2-Year Follow-Up Study

    PubMed Central

    Conti, Fabrizio; Ceccarelli, Fulvia; Perricone, Carlo; Miranda, Francesca; Truglia, Simona; Massaro, Laura; Pacucci, Viviana Antonella; Conti, Virginia; Bartosiewicz, Izabella; Spinelli, Francesca Romana; Alessandri, Cristiano; Valesini, Guido

    2012-01-01

    Objective Several indices have been proposed to assess disease activity in patients with Systemic Lupus Erythematosus (SLE). Recent studies have showed a prevalence of flare between 28–35.3%, persistently active disease (PAD) between 46%–52% and serologically active clinically quiescent (SACQ) disease ranging from 6 to 15%. Our goal was to evaluate the flare, PAD and SACQ rate incidence in a cohort of SLE patients over a 2-year follow-up. Methods We evaluated 394 SLE patients. Flare was defined as an increase in SLEDAI-2K score of ≥4 from the previous visit; PAD was defined as a SLEDAI-2K score of ≥4, on >2 consecutive visits; SACQ was defined as at least a 2-year period without clinical activity and with persistent serologic activity. Results Among the 95 patients eligible for the analysis in 2009, 7 (7.3%) had ≥1 flare episode, whereas 9 (9.4%) had PAD. Similarly, among the 118 patients selected for the analysis in 2010, 6 (5%) had ≥1 flare episode, whereas 16 (13.5%) had PAD. Only 1/45 patient (2.2%) showed SACQ during the follow-up. Conclusion We showed a low incidence of flare, PAD and SACQ in Italian SLE patients compared with previous studies which could be partly explained by ethnic differences. PMID:23029327

  7. Long-term outcome after whiplash injury. A 2-year follow-up considering features of injury mechanism and somatic, radiologic, and psychosocial findings.

    PubMed

    Radanov, B P; Sturzenegger, M; Di Stefano, G

    1995-09-01

    With the increased incidence of whiplash injury following the introduction of compulsory car seat belts, a large number of reports have dealt with the aftermath of this condition. Previous studies, however, focused on somatic symptoms on the one hand or considered only psychological or neuropsychological variables on the other hand, often in loosely defined or selected groups of patients. No study so far has analyzed the long-term outcome in a nonselected group of patients using a clear injury definition considering patient history; somatic, radiologic, and neuropsychological findings; and features of the injury mechanisms assessed soon after trauma and during follow-up. the present investigation was designed to assess these combined factors. According to a strict definition of whiplash injury, we assessed a consecutive nonselected sample of 117 patients with recent injury who had similar sociocultural and educational backgrounds. The patients had been in automobile crashes and were all equally covered by accident insurance according to the country-wide scheme. Initial examination was performed 7.2 +/- 4.2 days after trauma, and follow-up examinations 3, 6, 12, and 24 months later. At baseline, features of injury mechanism, subjective complaints, and different aspects of patient history were documented and cervical spine X rays performed. At all examinations patients underwent neurologic examination and cognitive and psychosocial factor assessment. At 2 years, patients were divided into symptomatic and asymptomatic groups and then compared with regard to the initial findings. In addition, symptomatic patients who were disabled at the 2-year follow-up examination and symptomatic patients not disabled (that is, they were able to work at the pretraumatic level) were compared regarding initial and 2-year findings. At 2 years, 18% of patients still had injury-related symptoms. With regard to baseline findings the following significant differences were found: Symptomatic

  8. Cervical compensatory alignment changes following correction of adult thoracic deformity: a multicenter experience in 57 patients with a 2-year follow-up.

    PubMed

    Oh, Taemin; Scheer, Justin K; Eastlack, Robert; Smith, Justin S; Lafage, Virginie; Protopsaltis, Themistocles S; Klineberg, Eric; Passias, Peter G; Deviren, Vedat; Hostin, Richard; Gupta, Munish; Bess, Shay; Schwab, Frank; Shaffrey, Christopher I; Ames, Christopher P

    2015-06-01

    OBJECT Alignment changes in the cervical spine that occur following surgical correction for thoracic deformity remain poorly understood. The purpose of this study was to evaluate such changes in a cohort of adults with thoracic deformity treated surgically. METHODS The authors conducted a multicenter retrospective analysis of consecutive patients with thoracic deformity. Inclusion criteria for this study were as follows: corrective osteotomy for thoracic deformity, upper-most instrumented vertebra (UIV) between T-1 and T-4, lower-most instrumented vertebra (LIV) at or above L-5 (LIV ≥ L-5) or at the ilium (LIV-ilium), and a minimum radiographic follow-up of 2 years. Sagittal radiographic parameters were assessed preoperatively as well as at 3 months and 2 years postoperatively, including the C-7 sagittal vertical axis (SVA), C2-7 cervical lordosis (CL), C2-7 SVA, T-1 slope (T1S), T1S minus CL (T1S-CL), T2-12 thoracic kyphosis (TK), apical TK, lumbar lordosis (LL), pelvic incidence (PI), PI-LL, pelvic tilt (PT), and sacral slope (SS). RESULTS Fifty-seven patients with a mean age of 49.1 ± 14.6 years met the study inclusion criteria. The preoperative prevalence of increased CL (CL > 15°) was 48.9%. Both 3-month and 2-year apical TK improved from baseline (p < 0.05, statistically significant). At the 2-year follow-up, only the C2-7 SVA increased significantly from baseline (p = 0.01), whereas LL decreased from baseline (p < 0.01). The prevalence of increased CL was 35.3% at 3 months and 47.8% at 2 years, which did not represent a significant change. Postoperative cervical alignment changes were not significantly different from preoperative values regardless of the LIV (LIV ≥ L-5 or LIV-ilium, p > 0.05 for both). In a subset of patients with a maximum TK ≥ 60° (35 patients) and 3-column osteotomy (38 patients), no significant postoperative cervical changes were seen. CONCLUSION Increased CL is common in adult spinal deformity patients with thoracic deformities

  9. Clinical Results and Prognostic Factors of Arthroscopic Surgeries for Discoid Lateral Menisci Tear: Analysis of 179 Cases with Minimum 2 Years Follow-up

    PubMed Central

    Ahn, Ji-Yong; Kim, Tae-Han; Jung, Bong-Sung; Ha, Sang-Ho; Lee, Bum-Sik; Chung, Jong-Won; Kim, Jong-Min

    2012-01-01

    Purpose The purpose of this study was to evaluate the clinical results and prognostic factors of arthroscopic surgeries for tears of the discoid lateral menisci. Materials and Methods From March 1997 to September 2005, 260 patients received arthroscopic surgeries due to discoid lateral menisci tears. Among these patients, 179 knees in 168 patients were followed up for at least 2 years and were enrolled into this study. The following prognostic factors were evaluated: sex, age, symptom duration, and type of meniscal tear. Visual analogue score (VAS), Lysholm score, and Ikeuchi grade were assessed as clinical results of arthroscopic surgeries. Results The mean VAS and Lysholm score improved at the last follow-up. According to the Ikeuchi grade, 104 cases were rated as excellent, 51 cases as good, and 23 cases as fair. Male sex (p<0.033), age younger than 20 years (p=0.0474), and symptom duration less than 12 months (p<0.044) were good prognostic factors. However, there was no correlation between tear types of discoid lateral menisci and clinical results. Conclusions Sex, age, and symptom duration could be significant prognostic factors of arthroscopic surgeries for tears of discoid lateral menisci. PMID:22708112

  10. Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial

    PubMed Central

    Burks, A. Wesley; Wood, Robert A.; Jones, Stacie M.; Sicherer, Scott H.; Fleischer, David M.; Scurlock, Amy M.; Vickery, Brian P.; Liu, Andrew H.; Henning, Alice K.; Lindblad, Robert; Dawson, Peter; Plaut, Marshall; Sampson, Hugh A.

    2015-01-01

    Background We previously reported initial results of the first multi-center randomized, double blind, placebo controlled clinical trial of peanut sublingual immunotherapy (SLIT), observing a favorable safety profile associated with modest clinical and immunologic effects in the first year. Objective To provide long-term (3-year) clinical and immunologic outcomes for our peanut SLIT trial. Key endpoints: (1) percentage of responders at 2 years (could consume 5g of peanut powder or a 10-fold increase from baseline), 2) percentage reaching desensitization at 3 years, (3) percentage attaining sustained unresponsiveness after 3 years, (4) immunologic endpoints and (5) assessment of safety parameters. Methods Response to treatment was evaluated in 40 subjects aged 12-40 years by performing a 10g peanut powder oral food challenge (OFC) following 2 and 3 years of daily peanut SLIT therapy. At 3 years, SLIT was discontinued for 8 weeks followed by another 10g OFC, and an open feeding of peanut butter to assess sustained unresponsiveness. Results Approximately 98% of the 18,165 doses were tolerated without adverse reactions beyond the oropharynx, with no severe symptoms or uses of epinephrine. A high rate (>50%) discontinued therapy. By study end, 4/37 (10.8%) of SLIT treated participants were fully desensitized to 10g of peanut powder, and all 4 achieved sustained unresponsiveness. Responders at 2 years showed a significant decrease in peanut-specific basophil activation and skin prick test titration compared to non-responders. Conclusions Peanut SLIT induced a modest level of desensitization, decreased immunologic activity over 3 years in responders, and had an excellent long-term safety profile. However, most patients discontinued therapy by the end of year 3, and only 10.8% of subjects achieved sustained unresponsiveness. PMID:25656999

  11. Medication persistence over 2 years of follow-up in a cohort of early rheumatoid arthritis patients: associated factors and relationship with disease activity and with disability

    PubMed Central

    Pascual-Ramos, Virginia; Contreras-Yáñez, Irazú; Villa, Antonio R; Cabiedes, Javier; Rull-Gabayet, Marina

    2009-01-01

    Introduction Aggressive treatment with disease-modifying antirheumatic drugs (DMARDs) plays a major role in improving early rheumatoid arthritis (RA) patient outcomes. Persistence and adherence with medication occurs variably (20% to 70%). The objectives of the study were to determine medication persistence (MP) in early RA patients over 13 consecutive visits each 2 months apart, to investigate the relationship between MP and disease activity, disability and structural damage, and to identify baseline prognosticators. Methods Charts from 75 patients of an early RA cohort were reviewed. At each visit, a rheumatologist interviewed patients regarding therapy, scored disease activity with the 28-joint disease activity score (DAS28) and disability with the health assessment questionnaire (HAQ), and recorded comorbidities and treatment. A complete medical history was obtained at baseline. MP was defined as the duration of time from initiation to discontinuation of at least one DMARD and/or corticosteroids for at least 1 week and was reported as a dichotomous variable at consecutive evaluations. Structural damage was defined by detection of new erosions on radiography. Descriptive statistics, Student's t test, the chi-squared test, and logistic regression analyses were used. Results The proportion of MP patients decreased from 98% at 2 months to 34% at 2 years. MP patients (n = 32) had similar DAS28 to non-MP patients (n = 53) at initial visits, lower DAS28 and greater DAS28 improvements at follow-ups (P ≤ 0.05 at visits 4, 6, 7 and 9) and reached sustained remission (≥ 3 consecutive visits with DAS28 < 2.6) more frequently (82.8% versus 46.5%, P = 0.003) and earlier (7.7 ± 4.6 versus 13.6 ± 5.7 months, P = 0.001) than non-MP patients. MP patients had similar baseline HAQ scores, but lower HAQ scores at follow-up (P ≤ 0.05 at visits 3, 5, 6, 7, 9, 10 and 13). More non-MP patients developed erosive disease than MP patients (26.8% versus 17.9%, P = 0.56). Older age

  12. Risk Factors Associated with Adjacent and Remote- Level Pathologic Vertebral Compression Fracture Following Balloon Kyphoplasty: 2-Year Follow-Up Comparison Versus Conservative Treatment.

    PubMed

    Faloon, Michael J; Ruoff, Mark; Deshpande, Chetan; Hohman, Donald; Dunn, Conor; Beckloff, Nicholas; Patel, Dipak V

    2015-01-01

    Vertebral compression fractures are a significant source of morbidity and mortality among patients of all age groups. These fractures result in both acute and chronic pain. Patients who sustain such fractures are known to suffer from more comorbidities and have a higher mortality rate compared with healthy people in the same age group. In recent years, balloon kyphoplasty has become a popular method for treating vertebral compression fractures. However, as longer-term follow-up becomes available, the effects of cement augmentation on adjacent spinal segments require investigation. Here, we have performed a retrospective chart review of 258 consecutive patients with pathologic vertebral compression fractures secondary to osteoporosis, treated by either conservative measures or balloon kyphoplasty with polymethylmethacrylate cement augmentation. Multivariate analysis of patient comorbidities was performed to assess the risks associated with subsequent adjacent and remote compression fracture at a minimum of 2 years follow-up. A total of 258 patients had 361 vertebral compression fractures. A total of 121 patients were treated nonoperatively and 137 underwent balloon kyphoplasty with polymethylmethacrylate cement augmentation. The mean follow-up for both cohorts was 2.7 years (range, 2-6 years). The kyphoplasty cohort was significantly older than the nonoperative cohort (mean age, 78.5 versus 74.2 years; p = 0.02), had 24 more patients with diabetes mellitus (37 versus 13; p = 0.05), and had 34 more patients with a history of smoking (50 versus 16; p = 0.05). However, the kyphoplasty cohort had less patients with a history of non-steroidal anti-inflammatory drug (NSAID) use (45 versus 71; p = 0.07). There were no demographic differences between groups in patients with secondary fractures. Nonoperative treatment was identified as a statistically significant independent risk factor for subsequent vertebral compression fracture [odds ratio (OR), 2.28]. Univariate

  13. Safety and Visual Outcome of Visian Toric ICL Implantation after Corneal Collagen Cross-Linking in Keratoconus: Up to 2 Years of Follow-Up

    PubMed Central

    Chelala, Elias; Hamade, Adib; Cherfane, Carole

    2015-01-01

    Purpose. To evaluate the long-term safety and clinical outcome of phakic Visian toric implantable collamer lens (ICL) insertion after corneal collagen cross-linking (CXL) in progressive keratoconus. Methods. This was a retrospective study of 30 eyes (19 patients), with progressive keratoconus, who underwent sequential CXL followed by Visian toric ICL implantation after 6 months. Results. At baseline, 6 eyes had stage I, 14 eyes stage II, and 10 eyes stage III keratoconus graded by Amsler-Krumeich classification. At 6 months after CXL, only K (steep) and K (max) decreased significantly from baseline, with no change in visual acuity or refraction. Flattening in keratometric readings was stable thereafter. There was significant improvement in mean uncorrected distance visual acuity (1.57 ± 0.56 to 0.17 ± 0.06 logMAR, P < 0.001) and mean corrected distance visual acuity (0.17 ± 0.08 to 0.11 ± 0.05 logMAR, P < 0.001) at 12 months after ICL implantation that was maintained at the 2-year follow-up. Mean cylinder power and mean spherical equivalent (SE) also decreased significantly after ICL implantation. A small hyperopic shift in SE (+0.25 D) was observed at 2 years that did not alter visual outcomes. Conclusions. Visian toric ICL implantation following CXL is an effective option for improving visual acuity in patients with keratoconus up to 2 years. PMID:25874116

  14. Imaging of the dopamine transporter predicts pattern of disease progression and response to levodopa in patients with schizophrenia and parkinsonism: a 2-year follow-up multicenter study.

    PubMed

    Tinazzi, Michele; Morgante, Francesca; Matinella, Angela; Bovi, Tommaso; Cannas, Antonino; Solla, Paolo; Marrosu, Francesco; Nicoletti, Alessandra; Zappia, Mario; Luca, Antonina; Di Stefano, Angela; Morgante, Letterio; Pacchetti, Claudio; Minafra, Brigida; Sciarretta, Massimo; Dallocchio, Carlo; Rossi, Simone; Ulivelli, Monica; Ceravolo, Roberto; Frosini, Daniela; Cipriani, Andrea; Barbui, Corrado

    2014-02-01

    Similarly to subjects with degenerative parkinsonism, (123)I-FP-CIT SPECT has been reported either normal or abnormal in patients with drug-induced parkinsonism (DIP), challenging the notion that parkinsonism might be entirely due to post-synaptic D2-receptors blockade by antipsychotic drugs. In a previous multicenter cross-sectional study conducted on a large sample of patients with schizophrenia, we identified 97 patients who developed parkinsonism with a similar bi-modal distribution of DAT-SPECT. In this longitudinal study, we reported clinical and imaging features associated with progression of motor disability over 2-year follow-up in 60 out of those 97 patients with schizophrenia and parkinsonism who underwent (123)I-FP-CIT SPECT at baseline evaluation (normal SPECT=33; abnormal SPECT=27). As second end-point, chronic response to levodopa over a 3-month period was tested in a subgroup of subjects. Motor Unified Parkinson's Disease Rating Scale (UPDRS) at follow-up significantly increased in patients with abnormal SPECT. Specifically, a 6-point worsening was demonstrated in 18.5% of the subjects with abnormal SPECT and in none of the subjects with normal SPECT. Levodopa treatment improved motor UPDRS only in the group with abnormal SPECT. After adjustment for possible confounders, linear regression analysis demonstrated that abnormal SPECT findings at baseline were the only predictor of motor disability progression and of better outcome of levodopa treatment. Our results support the notion that a degenerative disease might underlie parkinsonism in a minority of schizophrenic patients chronically exposed to antipsychotics. Functional imaging of the dopamine transporter can be helpful to select this patient sub-group that might benefit from levodopa therapy. PMID:24369987

  15. Rationale for a 'Male Lumpectomy,' a Prostate Cancer Targeted Approach Using Cryoablation: Results in 21 Patients with at Least 2 Years of Follow-Up

    SciTech Connect

    Onik, Gary

    2008-01-15

    Background. Prostate cancer in men raises many of the same issues that breast cancer does in women. Complications of prostate cancer treatment, including impotence and incontinence, affect the self-image and psyche of a man no less than does the loss of a breast in a woman. We present a pilot study in which 21 patients were treated with a focal cryoablation procedure. Methods. Focal cryoablation was performed using biplane transrectal ultrasound if the tumor was confined to only one prostate lobe. Preoperative PSA values were recorded. Cryoablation was planned to encompass the area of known tumor. PSA values were obtained every 3 months for 2 years and every 6 months thereafter. Potency and continence status was obtained at the same intervals. Routine biopsy was obtained at 1 year. Results. Twenty-one patients had focal cryoablation. Follow-up ranged from 24 to 105 months with a mean of 50 months. Twenty of 21 (95%) patients have stable PSA values with no evidence for cancer, despite 10 patients being at medium to high risk for recurrence. All patients biopsied (n = 19) were negative for tumor. Potency was maintained in 17 of 21 patients (80%). No other complications, including incontinence or fistula formation, were noted. Conclusion. These preliminary results indicate a 'male lumpectomy,' in which the prostate tumor region itself is destroyed, appears to preserve potency in a majority of patients and limits other complications, without compromising cancer control. If these results are confirmed by further studies and long-term follow-up, this treatment approach could have a profound effect on prostate cancer management.

  16. Patient reported outcomes for patients who returned to sport compared with those who did not after hip arthroscopy: minimum 2-year follow-up.

    PubMed

    Domb, Benjamin G; Dunne, Kevin F; Martin, Timothy J; Gui, Chengcheng; Finch, Nathan A; Vemula, S Pavan; Redmond, John M

    2016-07-01

    Previous studies assessed elite athletes' return to sport (RTS) after hip arthroscopy, but few investigated a cohort including athletes from all levels of sport. This study compared athletes who returned to sport to those who did not, based on four patient-reported outcome (PRO) scores, including the Hip Outcome Score-Sports Specific Subscale (HOS-SSS). Between September 2008 and April 2012, hip arthroscopies were performed on 157 patients (168 hips) who reported playing a sport preoperatively and indicated their level of sports activity post-operatively. Two-year follow-up was available for 148 (94%) amateur and professional athletes with a total of 158 hips. Of these 60 cases (65 hips) did not return to sports (NRTS) and were in the NRTS group. The remaining 88 cases (93 hips) constituted the RTS group. The modified Harris Hip Score, Non-Arthric Hip Score, Hip Outcome-Activities of Daily Living (HOS-ADL), and HOS-SSS were used to assess outcomes. The HOS-SSS was used to assess specific sport-related movement. Both groups demonstrated significant improvement at 2 years post-operatively in visual analog score and four PRO scores (P < 0.001). There was no significant preoperative differences in HOS-SSS scores between groups; however, the RTS group had significantly higher HOS-SSS scores at 1 and 2 years post-surgery. Post-operatively, the RTS group had significantly better ability to jump, land from a jump, stop quickly and perform cutting/lateral movements (P < 0.05). In summary, patients who indicated RTSs demonstrated significantly higher PRO scores and abilities to perform several sport-related movements, compared with patients who did not. PMID:27583148

  17. Patient reported outcomes for patients who returned to sport compared with those who did not after hip arthroscopy: minimum 2-year follow-up

    PubMed Central

    Domb, Benjamin G.; Dunne, Kevin F.; Martin, Timothy J.; Gui, Chengcheng; Finch, Nathan A.; Vemula, S. Pavan; Redmond, John M.

    2016-01-01

    Previous studies assessed elite athletes’ return to sport (RTS) after hip arthroscopy, but few investigated a cohort including athletes from all levels of sport. This study compared athletes who returned to sport to those who did not, based on four patient-reported outcome (PRO) scores, including the Hip Outcome Score—Sports Specific Subscale (HOS-SSS). Between September 2008 and April 2012, hip arthroscopies were performed on 157 patients (168 hips) who reported playing a sport preoperatively and indicated their level of sports activity post-operatively. Two-year follow-up was available for 148 (94%) amateur and professional athletes with a total of 158 hips. Of these 60 cases (65 hips) did not return to sports (NRTS) and were in the NRTS group. The remaining 88 cases (93 hips) constituted the RTS group. The modified Harris Hip Score, Non-Arthric Hip Score, Hip Outcome-Activities of Daily Living (HOS-ADL), and HOS-SSS were used to assess outcomes. The HOS-SSS was used to assess specific sport-related movement. Both groups demonstrated significant improvement at 2 years post-operatively in visual analog score and four PRO scores (P < 0.001). There was no significant preoperative differences in HOS-SSS scores between groups; however, the RTS group had significantly higher HOS-SSS scores at 1 and 2 years post-surgery. Post-operatively, the RTS group had significantly better ability to jump, land from a jump, stop quickly and perform cutting/lateral movements (P < 0.05). In summary, patients who indicated RTSs demonstrated significantly higher PRO scores and abilities to perform several sport-related movements, compared with patients who did not. PMID:27583148

  18. High-dose cyclophosphamide for moderate to severe refractory multiple sclerosis: 2-year follow-up (investigational new drug No. 65863).

    PubMed

    Gladstone, Douglas E; Peyster, Robert; Baron, Edward; Friedman-Urevich, Sharon; Sibony, Patrick; Melville, Patricia; Gottesman, Malcolm

    2011-01-01

    High-dose cyclophosphamide (HDC) is a chemotherapy treatment designed to eradicate autoreative B- and T-cells responsible for lymphocyte-mediated autoimmune illness while sparing the pluripotent blood stem cell of any ill effects. Multiple sclerosis (MS) is the most common inflammatory and demyelinating immune-mediated disorder of the central nervous system in young adults. Patients with moderate to severe, refractory MS, defined as an Expanded Disability Status Scale (EDSS) score of 3.5 or higher after two or more Food and Drug Administration-approved disease-modifying agents, received 200 mg/kg of cyclophosphamide over 4 days. For the next 2 years, quarterly EDSS score evaluations and biannual brain magnetic resonance imaging and neuro-ophthalmologic evaluations were obtained. Fifteen patients were evaluated for clinical response. During follow-up, one patient increased their baseline EDSS score by 1.0. EDSS score stability of decrease was realized in five of seven (71%) patients with relapsing-remitting MS and six of eight (75%) patients with secondary progressive MS. Four patients required additional immunomodulatory treatment after treatment. Treatment response was seen regardless of the baseline presence or absence of contrast lesion activity. HDC can effectively decrease symptoms, stop disease progression, and allow for disability regression in relapsing-remitting MS and secondary progressive MS patients. The most appropriate candidates for HDC, its duration of benefit, and the potential need for prophylactic preventative immune manipulation after HDC all require further investigation. PMID:19770795

  19. Influence of Anti-TNF and Disease Modifying Antirheumatic Drugs Therapy on Pulmonary Forced Vital Capacity Associated to Ankylosing Spondylitis: A 2-Year Follow-Up Observational Study

    PubMed Central

    Rocha-Muñoz, Alberto Daniel; Brambila-Tapia, Aniel Jessica Leticia; Zavala-Cerna, María Guadalupe; Vásquez-Jiménez, José Clemente; De la Cerda-Trujillo, Liliana Faviola; Vázquez-Del Mercado, Mónica; Rodriguez-Jimenez, Norma Alejandra; Díaz-Rizo, Valeria; Díaz-González, Viviana; Cardona-Muñoz, Ernesto German; Dávalos-Rodríguez, Ingrid Patricia; Salazar-Paramo, Mario; Gamez-Nava, Jorge Ivan; Nava-Zavala, Arnulfo Hernan; Gonzalez-Lopez, Laura

    2015-01-01

    Objective. To evaluate the effect of anti-TNF agents plus synthetic disease modifying antirheumatic drugs (DMARDs) versus DMARDs alone for ankylosing spondylitis (AS) with reduced pulmonary function vital capacity (FVC%). Methods. In an observational study, we included AS who had FVC% <80% at baseline. Twenty patients were taking DMARDs and 16 received anti-TNF + DMARDs. Outcome measures: changes in FVC%, BASDAI, BASFI, 6-minute walk test (6MWT), Borg scale after 6MWT, and St. George's Respiratory Questionnaire at 24 months. Results. Both DMARDs and anti-TNF + DMARDs groups had similar baseline values in FVC%. Significant improvement was achieved with anti-TNF + DMARDs in FVC%, at 24 months, when compared to DMARDs alone (P = 0.04). Similarly, patients in anti-TNF + DMARDs group had greater improvement in BASDAI, BASFI, Borg scale, and 6MWT when compared to DMARDs alone. After 2 years of follow-up, 14/16 (87.5%) in the anti-TNF + DMARDs group achieved the primary outcome: FVC% ≥80%, compared with 11/20 (55%) in the DMARDs group (P = 0.04). Conclusions. Patients with anti-TNF + DMARDs had a greater improvement in FVC% and cardiopulmonary scales at 24 months compared with DMARDs. This preliminary study supports the fact that anti-TNF agents may offer additional benefits compared to DMARDs in patients with AS who have reduced FVC%. PMID:26078986

  20. Treatment of a large periradicular defect using guided tissue regeneration: A case report of 2 years follow-up and surgical re-entry

    PubMed Central

    Gurav, Abhijit Ningappa; Shete, Abhijeet Rajendra; Naiktari, Ritam

    2015-01-01

    Periradicular (PR) bone defects are common sequelae of chronic endodontic lesions. Sometimes, conventional root canal therapy is not adequate for complete resolution of the lesion. PR surgeries may be warranted in such selected cases. PR surgery provides a ready access for the removal of pathologic tissue from the periapical region, assisting in healing. Recently, the regeneration of the destroyed PR tissues has gained more attention rather than repair. In order to promote regeneration after apical surgery, the principle of guided tissue regeneration (GTR) has proved to be useful. This case presents the management of a large PR lesion in a 42-year-old male subject. The PR lesion associated with 21, 11 and 12 was treated using GTR membrane, fixated with titanium minipins. The case was followed up for 2 years radiographically, and a surgical re-entry confirmed the re-establishment of the lost labial plate. Thus, the principle of GTR may immensely improve the clinical outcome and prognosis of an endodontically involved tooth with a large PR defect. PMID:26941526

  1. A 2-year follow-up survey of 523 cases with peripheral nerve injuries caused by the earthquake in Wenchuan, China

    PubMed Central

    He, Chun-qing; Zhang, Li-hai; Liu, Xian-fei; Tang, Pei-fu

    2015-01-01

    We performed a 2-year follow-up survey of 523 patients with peripheral nerve injuries caused by the earthquake in Wenchuan, Sichuan Province, China. Nerve injuries were classified into three types: type I injuries were nerve transection injuries, type II injuries were nerve compression injuries, and type III injuries displayed no direct neurological dysfunction due to trauma. In this study, 31 patients had type I injuries involving 41 nerves, 419 had type II injuries involving 823 nerves, and 73 had type III injuries involving 150 nerves. Twenty-two patients had open transection nerve injury. The restoration of peripheral nerve function after different treatments was evaluated. Surgical decompression favorably affected nerve recovery. Physiotherapy was effective for type I and type II nerve injuries, but not substantially for type III nerve injury. Pharmacotherapy had little effect on type II or type III nerve injuries. Targeted decompression surgery and physiotherapy contributed to the effective treatment of nerve transection and compression injuries. The Louisiana State University Health Sciences Center score for nerve injury severity declined with increasing duration of being trapped. In the first year after treatment, the Louisiana State University Health Sciences Center score for grades 3 to 5 nerve injury increased by 28.2% to 81.8%. If scores were still poor (0 or 1) after a 1-year period of treatment, further treatment was not effective. PMID:25883624

  2. Violence and Abuse Against Women Who Have Attempted Suicide by Deliberate Self-Poisoning: A 2-Year Follow-Up Study in Iran.

    PubMed

    Hassanian-Moghaddam, Hossein; Zamani, Nasim; Sarjami, Saeedeh

    2016-04-01

    Sources of data about the occurrence of domestic violence are scarce in Iran. The aim of this study was to evaluate the behavioral effects of different types of domestic violence on women who had attempted suicide by deliberate self-poisoning (DSP). A total of 195 women who had attempted suicide by DSP in response to "violence and abuse" were followed up for 2 years. The most common type of violence, as mentioned by the women themselves as the motive of self-poisoning, was physical abuse (92%) followed by verbal abuse (2.1%), multi-abuses (2.1%), emotional abuse (1.6%), and sexual abuse (1.1%). Suicidal ideation and attempt were more common in those who were consulted sometime after they had initially presented to the hospital with DSP or those who had suffered repeated domestic abuse. It was concluded that invention of methods other than the current consultation system is necessary to prevent repeated suicide attempts among abused women in Iran. PMID:25550168

  3. The effects of teachers' homework follow-up practices on students' EFL performance: a randomized-group design.

    PubMed

    Rosário, Pedro; Núñez, José C; Vallejo, Guillermo; Cunha, Jennifer; Nunes, Tânia; Suárez, Natalia; Fuentes, Sonia; Moreira, Tânia

    2015-01-01

    This study analyzed the effects of five types of homework follow-up practices (i.e., checking homework completion; answering questions about homework; checking homework orally; checking homework on the board; and collecting and grading homework) used in class by 26 teachers of English as a Foreign Language (EFL) using a randomized-group design. Once a week, for 6 weeks, the EFL teachers used a particular type of homework follow-up practice they had previously been assigned to. At the end of the 6 weeks students completed an EFL exam as an outcome measure. The results showed that three types of homework follow-up practices (i.e., checking homework orally; checking homework on the board; and collecting and grading homework) had a positive impact on students' performance, thus highlighting the role of EFL teachers in the homework process. The effect of EFL teachers' homework follow-up practices on students' performance was affected by students' prior knowledge, but not by the number of homework follow-up sessions. PMID:26528204

  4. The effects of teachers' homework follow-up practices on students' EFL performance: a randomized-group design

    PubMed Central

    Rosário, Pedro; Núñez, José C.; Vallejo, Guillermo; Cunha, Jennifer; Nunes, Tânia; Suárez, Natalia; Fuentes, Sonia; Moreira, Tânia

    2015-01-01

    This study analyzed the effects of five types of homework follow-up practices (i.e., checking homework completion; answering questions about homework; checking homework orally; checking homework on the board; and collecting and grading homework) used in class by 26 teachers of English as a Foreign Language (EFL) using a randomized-group design. Once a week, for 6 weeks, the EFL teachers used a particular type of homework follow-up practice they had previously been assigned to. At the end of the 6 weeks students completed an EFL exam as an outcome measure. The results showed that three types of homework follow-up practices (i.e., checking homework orally; checking homework on the board; and collecting and grading homework) had a positive impact on students' performance, thus highlighting the role of EFL teachers in the homework process. The effect of EFL teachers' homework follow-up practices on students' performance was affected by students' prior knowledge, but not by the number of homework follow-up sessions. PMID:26528204

  5. Comparison of one-level microendoscopy laminoforaminotomy and cervical arthroplasty in cervical spondylotic radiculopathy: a minimum 2-year follow-up study

    PubMed Central

    2013-01-01

    Background This study aims to compare the perioperative parameters and clinical results between microendoscopy laminoforaminotomy (MELF) and cervical arthroplasty (CA) in the treatment of one-level cervical spondylotic radiculopathy in a retrospective study. Methods From 2003 to 2007, a total of 97 patients with one-level cervical spondylotic radiculopathy were treated. Forty-five patients underwent CA. Fifty-two patients underwent MELF. Patient demographics and operative data were collected with a minimum 2-year follow-up. Perioperative parameters were compared. Clinical assessment in terms of neck disability index (NDI), short form (SF)-36, and visual analogue scale (VAS) of arm pain and neck pain was performed prior to surgery and at 1.5, 3, 6, 12, and 24 months after surgery. Results Fluoroscopy time (CA, 60.3 s; MELF, 12.1 s; P < 0.01) and surgical time (CA, 95.1 min; MELF, 24.0 min; P < 0.01) were significantly longer in the CA cases. Shorter hospitalized days (CA, 1.1 days; MELF, 0.13 days; P < 0.01) and less estimated blood loss (EBL; CA, 75.8 ml; MELF, 31.9 ml; P < 0.01) were observed in the MELF group. Both CA and MELF groups showed significant improvement in NDI, VAS of neck pain and arm pain, and SF-36 (P < 0.05 for each) at 1.5, 3, 6, 12, and 24 months after surgery, but there was no significant difference between them (P > 0.05). Conclusions As alternatives of anterior cervical decompression and fusion (ACDF), both CA and MELF can produce satisfactory clinical outcomes. MELF has the additional benefits of less blood loss, less surgical time, less X-ray time, and shorter hospital stay. PMID:24341633

  6. A rare case of atlantooccipital dissociation in the context of occipitalization of the atlas, with a 2-year follow-up: case report.

    PubMed

    Chaudhary, Navjot; Wang, Bill H; Gurr, Kevin R; Bailey, Stewart I; Bailey, Christopher S

    2013-02-01

    Atlantooccipital dislocation (AOD) is a rare and often fatal injury. In cases of survival, residual deficits are severe and often include cranial nerve palsy, quadriplegia, or respiratory issues. Occipitalization is defined as partial or complete congenital fusion of the occiput to the atlas and is exceptionally rare. The authors present a rare case of AOD superimposed on a congenital occipitalization of the atlas. This 39-year-old man had AOD following a motor vehicle collision. On examination, his overall motor score on the American Spinal Injury Association scale was 5/100, and his rectal tone was absent. Computed tomography demonstrated AOD in an area of occipitalization. Magnetic resonance imaging revealed ligamentous injury leading to C1-2 instability. Intervention included occipital cervical instrumentation fusion from the occiput to C-3. Six months postoperatively, imaging revealed fusion of the graft and consolidation of the fractured occipitalization. At the 2-year follow-up, the patient's strength was 3/5 for wrist extension and handgrip on the right side and full strength in the rest of the myotomes. Bladder and bowel function was also normalized. A high-velocity collision led to disruption of the atlantooccipital ligaments and fracture of the occipitalized lateral masses in this patient. Internal fixation and fusion led to good fusion postoperatively. Occipitalization probably led to abnormal joint mechanics at the C1-occiput junction, which might have altered the amount of force required to fracture the occipitalization and produce AOD. This difference may partially account for the favorable neurological outcome in the featured patient compared with traditional cases of AOD. PMID:23198835

  7. A Follow up Randomized Controlled Trial of "Time to Read": A Volunteer Mentoring Program

    ERIC Educational Resources Information Center

    Miller, Sarah; Connolly, Paul; Maguire, Lisa K.

    2011-01-01

    "Time to Read" is a volunteer mentoring program that recruits volunteers from the local business community to spend one hour of company time each week working on a one-to-one basis with primary school children aged 8 to 9 years with the aim of improving reading skills. The authors first evaluated the program in 2006-8 using a randomized controlled…

  8. Child-Parent Psychotherapy: 6-Month Follow-up of a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lieberman, Alicia F.; Ippen, Chandra Ghosh; Van Horn, Patricia

    2006-01-01

    Objective: To examine the durability of improvement in child and maternal symptoms 6 months after termination of child-parent psychotherapy (CPP). Method: Seventy-five multiethnic preschool-age child-mother dyads from diverse socioeconomic backgrounds were randomly assigned to (1) CPP or (2) case management plus community referral for individual…

  9. Supplemental Reading Strategy Instruction for Adolescents: A Randomized Trial and Follow-up Study

    ERIC Educational Resources Information Center

    Cantrell, Susan Chambers; Almasi, Janice F.; Rintamaa, Margaret; Carter, Janis C.

    2016-01-01

    In this study, the authors examine the impact of a yearlong supplemental reading course involving daily instruction in the learning strategies curriculum on lower achieving adolescent students' reading achievement and motivation. Using a multiple-cohort randomized treatment-control group design over 4 years, they compared achievement and…

  10. Treating Sexually Abused Children: 1 Year Follow-Up of a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Cohen, J.A.; Mannarino, A.P.; Knudsen, K.

    2005-01-01

    Objective:: To measure the durability of improvement in response to two alternative treatments for sexually abused children. Method:: Eighty-two sexually abused children ages 8-15 years old and their primary caretakers were randomly assigned to trauma-focused cognitive-behavioral therapy (TF-CBT) or non-directive supportive therapy (NST) delivered…

  11. An 8-Week Knee Osteoarthritis Treatment Program of Hyaluronic Acid Injection, Deliberate Physical Rehabilitation, and Patient Education is Cost Effective at 2 Years Follow-up: The OsteoArthritis Centers of AmericaSM Experience

    PubMed Central

    Miller, Larry E; Block, Jon E

    2014-01-01

    Numerous nonsurgical interventions have been reported to improve symptoms of knee osteoarthritis (OA) over the short term. However, longer follow-up is required to accurately characterize outcomes such as cost effectiveness and delayed arthroplasty. A total of 553 patients with symptomatic knee OA who previously underwent a single 8-week multimodal treatment program were contacted at 1 year (n = 336) or 2 years (n = 217) follow-up. The percentage of patients who underwent knee arthroplasty was 10% at 1 year and 18% at 2 years following program completion. The treatment program was highly cost effective at $12,800 per quality-adjusted life year at 2 years. Cost effectiveness was maintained under a variety of plausible assumptions and regardless of gender, age, body mass index, disease severity, or knee pain severity. In summary, a single 8-week multimodal knee OA treatment program is cost effective and may lower knee arthroplasty utilization through 2 years follow-up. PMID:25574144

  12. Couple and Individual Adjustment for 2 Years Following a Randomized Clinical Trial Comparing Traditional versus Integrative Behavioral Couple Therapy

    ERIC Educational Resources Information Center

    Christensen, Andrew; Atkins, David C.; Yi, Jean; Baucom, Donald H.; George, William H.

    2006-01-01

    Follow-up data across 2 years were obtained on 130 of 134 couples who were originally part of a randomized clinical trial comparing traditional versus integrative behavioral couple therapy (TBCT vs. IBCT; A. Christensen et al., 2004). Both treatments produced similar levels of clinically significant improvement at 2 years posttreatment (69% of…

  13. Effects of a Prekindergarten Educational Intervention on Adult Health: 37-Year Follow-Up Results of a Randomized Controlled Trial

    PubMed Central

    Schweinhart, Lawrence; Montie, Jeanne; Neidell, Matthew

    2009-01-01

    Objectives. We used 37 years of follow-up data from a randomized controlled trial to explore the linkage between an early educational intervention and adult health. Methods. We analyzed data from the High/Scope Perry Preschool Program (PPP), an early school-based intervention in which 123 children were randomized to a prekindergarten education group or a control group. In addition to exploring the effects of the program on health behavioral risk factors and health outcomes, we examined the extent to which educational attainment, income, family environment, and health insurance access mediated the relationship between randomization to PPP and behavioral and health outcomes. Results. The PPP led to improvements in educational attainment, health insurance, income, and family environment Improvements in these domains, in turn, lead to improvements in an array of behavioral risk factors and health (P = .01). However, despite these reductions in behavioral risk factors, participants did not exhibit any overall improvement in physical health outcomes by the age of 40 years. Conclusions. Early education reduces health behavioral risk factors by enhancing educational attainment, health insurance coverage, income, and family environments. Further follow-up will be needed to determine the long-term health effects of PPP. PMID:19542034

  14. Home-Based Psychiatric Outpatient Care Through Videoconferencing for Depression: A Randomized Controlled Follow-Up Trial

    PubMed Central

    Rössler, Wulf

    2016-01-01

    Background There is a tremendous opportunity for innovative mental health care solutions such as psychiatric care through videoconferencing to increase the number of people who have access to quality care. However, studies are needed to generate empirical evidence on the use of psychiatric outpatient care via videoconferencing, particularly in low- and middle-income countries and clinically unsupervised settings. Objective The objective of this study was to evaluate the effectiveness and feasibility of home-based treatment for mild depression through psychiatric consultations via videoconferencing. Methods A randomized controlled trial with a 6- and 12-month follow-up including adults with mild depression treated in an ambulatory setting was conducted. In total, 107 participants were randomly allocated to the videoconferencing intervention group (n=53) or the face-to-face group (F2F; n=54). The groups did not differ with respect to demographic characteristics at baseline. The F2F group completed monthly follow-up consultations in person. The videoconferencing group received monthly follow-up consultations with a psychiatrist through videoconferencing at home. At baseline and after 6 and 12 months, in-person assessments were conducted with all participants. Clinical outcomes (severity of depression, mental health status, medication course, and relapses), satisfaction with treatment, therapeutic relationship, treatment adherence (appointment compliance and dropouts), and medication adherence were assessed. Results The severity of depression decreased significantly over the 12-month follow-up in both the groups. There was a significant difference between groups regarding treatment outcomes throughout the follow-up period, with better results in the videoconferencing group. There were 4 relapses in the F2F group and only 1 in the videoconferencing group. No significant differences between groups regarding mental health status, satisfaction with treatment, therapeutic

  15. Randomized Trial of Pentoxifylline and Vitamin E vs Standard Follow-up After Breast Irradiation to Prevent Breast Fibrosis, Evaluated by Tissue Compliance Meter

    SciTech Connect

    Jacobson, Geraldine; Bhatia, Sudershan; Smith, Brian J.; Button, Anna M.; Bodeker, Kellie; Buatti, John

    2013-03-01

    Purpose: To conduct a randomized clinical trial to determine whether the combination of pentoxifylline (PTX) and vitamin E given for 6 months after breast/chest wall irradiation effectively prevents radiation-induced fibrosis (RIF). Methods and Materials: Fifty-three breast cancer patients with localized disease were enrolled and randomized to treatment with oral PTX 400 mg 3 times daily and oral vitamin E 400 IU daily for 6 months after radiation (n=26), or standard follow up (n=27). Tissue compliance meter (TCM) measurements were obtained at 18 months to compare tissue compliance in the irradiated and untreated breast/chest wall in treated subjects and controls. Measurements were obtained at 2 mirror image sites on each breast/chest wall, and the average difference in tissue compliance was scored. Differences in TCM measurements were compared using a t test. Subjects were followed a minimum of 2 years for local recurrence, disease-free survival, and overall survival. Results: The mean difference in TCM measurements in the 2 groups was 0.88 mm, median of 1.00 mm (treated) and 2.10 mm, median of 2.4 mm (untreated). The difference between the 2 groups was significant (P=.0478). Overall survival (100% treated, 90.6% controls at 5 years) and disease-free survival (96.2% treated, 86.8% controls at 5 years) were not significantly different in the 2 groups. Conclusions: This study of postirradiation breast cancer patients treated with PTX/vitamin E or standard follow-up indicated a significant difference in radiation-induced fibrosis as measured by TCM. There was no observed impact on local control or survival within the first 2 years of follow-up. The treatment was safe and well tolerated. Pentoxifylline/vitamin E may be clinically useful in preventing fibrosis after radiation in high-risk patients.

  16. Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study

    PubMed Central

    Guédon-Moreau, Laurence; Lacroix, Dominique; Sadoul, Nicolas; Clémenty, Jacques; Kouakam, Claude; Hermida, Jean-Sylvain; Aliot, Etienne; Kacet, Salem

    2014-01-01

    Aims The Effectiveness and Cost of ICD follow-up Schedule with Telecardiology (ECOST) trial evaluated prospectively the economic impact of long-term remote monitoring (RM) of implantable cardioverter defibrillators (ICDs). Methods and results The analysis included 310 patients randomly assigned to RM (active group) vs. ambulatory follow-ups (control group). Patients in the active group were seen once a year unless the system reported an event mandating an ambulatory visit, while patients in the control group were seen in the ambulatory department every 6 months. The costs of each follow-up strategy were compared, using the actual billing documents issued by the French health insurance system, including costs of (i) (a) ICD-related ambulatory visits and transportation, (b) other ambulatory visits, (c) cardiovascular treatments and procedures, and (ii) hospitalizations for the management of cardiovascular events. The ICD and RM system costs were calculated on the basis of the device remaining longevity at the end of the study. The characteristics of the study groups were similar. Over a follow-up of 27 months, the mean non-hospital costs per patient-year were €1695 ± 1131 in the active, vs. €1952 ± 1023 in the control group (P = 0.04), a €257 difference mainly due to device management. The hospitalization costs per patient-year were €2829 ± 6382 and €3549 ± 9714 in the active and control groups, respectively (P = 0.46). Adding the ICD to the non-hospital costs, the savings were €494 (P = 0.005) or, when the monitoring system was included, €315 (P = 0.05) per patient-year. Conclusion From the French health insurance perspective, the remote management of ICD patients is cost saving. Clinical trials registration NCT00989417, www.clinicaltrials.gov PMID:24614572

  17. Effect of radiotherapy on the interpretation of routine follow-up mammography after conservative breast surgery: a randomized study.

    PubMed Central

    Holli, K.; Saaristo, R.; Isola, J.; Hyöty, M.; Hakama, M.

    1998-01-01

    Radiotherapy after conservative surgery causes fat necrosis, fibrosis, skin thickening and other parenchymal distortion of the breast. The interpretation of a mammogram of the irradiated breast may therefore be difficult. We studied the effect of radiotherapy on the interpretation of the routine mammography used in the follow-up of breast cancer patients. A total of 144 low-risk breast cancer patients were randomized to radiotherapy or to no further treatment after conservative surgery. The first routine follow-up mammography was performed 18 months after surgery and every 18 months after that. The number of mammography examinations was estimated per patient and per follow-up year. The number of extra diagnostic tests and the occurrence of positive findings were assessed per mammography session and per follow-up year. Further diagnostic tests prompted by difficulties in interpreting the mammogram were performed to an extent of 0.19 per mammography examination in the radiotherapy group and of 0.15 in the non-radiotherapy group, i.e. 1.3 times more often. Findings that turned out to be negative at confirmation were 2.0 times (P< 0.05) more common in the radiotherapy group. These false-positive findings were more common in the radiotherapy group than in the surgery group and only shortly after treatment. Mammography is more difficult to interpret after radiotherapy than after conservative surgery alone, especially shortly after treatment, and more often involves extra diagnostic tests and findings that will be negative at confirmation. PMID:9716041

  18. Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up

    PubMed Central

    Zigler, Jack E.; Jackson, Robert; Nunley, Pierce D.; Bae, Hyun W.; Kim, Kee D.; Ohnmeiss, Donna D.

    2016-01-01

    Introduction There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up. Methods This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. Results The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p<0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p<0.03) were significantly lower for TDR patients. Conclusions Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and

  19. A Retrospective Review of Outcomes of Dental Treatment Performed for Special Needs Patients under General Anaesthesia: 2-Year Follow-Up

    PubMed Central

    Mallineni, Sreekanth Kumar; Yiu, Cynthia Kar Yung

    2014-01-01

    Objective. The purpose of the study was to evaluate the follow-up pattern of special needs patients (SNP) treated under general anaesthesia (GA) and the failure rates of different treatment procedures and restorative materials. Study Design. The treatment records of the patients who received dental treatment under GA during 2005 to 2009 were reviewed. The duration of follow-up periods, the outcomes of different treatment procedures, and the quality of different restorative materials were recorded and evaluated. Statistics were used for the comparison (SPSS 20.0). Pearson's chi-square test and post hoc analysis were used to evaluate the attendance of postoperative appointments and the associations of failure rates of different treatment procedures and restorative materials. Cohen kappa statistics was used for intraexaminer reliability. Results. A total of 177 patients were included in the study. The attendance of postoperative appointments showed a gradual decrease from 96% to 36% within 24 months (P < 0.05). Restorative procedures had the highest failure rates among all treatment procedures (P < 0.05). Stainless steel crowns showed higher survival rates among different restorative materials (P < 0.05). Pulp treatment in primary molars has higher success rate than primary incisors and canines. Composite restorations placed in primary canines have low survival rates. The intraexaminer reliability was good (k = 0.94). Conclusion. The attendance for postoperative follow-up appointments declined within two years. Restorative treatment was less successful when compared to preventive and pulp treatments. Stainless steel crowns were more reliable restorations with higher survival rates and composite restorations were less durable. PMID:25610913

  20. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up

    PubMed Central

    Bokor, Desmond John; Sonnabend, David; Deady, Luke; Cass, Ben; Young, Allan; Van Kampen, Craig; Arnoczky, Steven

    2016-01-01

    Summary Background partial-thickness rotator cuff tears frequently enlarge due to increased local strain and often progress to full-thickness tears. Studies suggest the addition of new tendinous tissue to injured cuff tendons would significantly decrease peak strain, possibly protecting against tear progression. The aim of this study was to assess the ability of a highly-porous collagen implant to induce new tissue formation and limit tear progression when placed on the bursal surface of partial-thickness cuff tears. Methods following arthroscopic subacromial decompression, the implant was attached to the bursal surface of the supraspinatus tendon in a prospective series of 13 consecutive patients with intermediate – (3–6 mm) to high-grade (>6 mm) partial – thickness cuff tears (5 articular, 3 bursal, 5 intra-substance). Tendon thickness, defect size, and tendon quality were evaluated using magnetic resonance imaging (MRI) preoperatively and at 3, 6, 12, and 24 months postoperatively. Clinical outcomes were assessed using the Constant and American Shoulder and Elbow Society scores at the same preoperative and follow-up times. All 13 patients completed all follow-up exams (mean length of follow-up 27.0 months, range 23.3–32.0); no patients were lost to follow-up. Results the implant induced significant new tissue formation in all patients by 3 months (mean increase in tendon thickness 2.2 ± 0.26 mm). This tissue matured over time and became radiologically indistinguishable from the underlying tendon. The partial-thickness cuff tears showed consistent filling of the defects, with complete healing in 7 patients at 12 months, and a progressive improvement in tendon quality in the remaining patients. No tear progression was observed by MRI in any of the patients at 24 months. All clinical scores improved significantly over time. At 24 months, 12 of 13 patients (92%) had satisfactory or better results. Conclusions the results of this clinical study demonstrated

  1. Effects of oral motor exercises and laser therapy on chronic temporomandibular disorders: a randomized study with follow-up.

    PubMed

    Machado, Barbara Cristina Zanandréa; Mazzetto, Marcelo Oliveira; Da Silva, Marco Antonio M Rodrigues; de Felício, Cláudia Maria

    2016-07-01

    This study investigated the efficacy of combining low-level laser therapy (LLLT) with oral motor exercises (OM-exercises) for rehabilitation of patients with chronic temporomandibular disorders (TMDs). Eighty-two patients with chronic TMD and 20 healthy subjects (control group) participated in the study. Patients were randomly assigned to treatment groups: GI (LLLT + OM exercises), GII (orofacial myofunctional therapy-OMT-which contains pain relief strategies and OM-exercises), and GIII (LLLT placebo + OM-exercises) and GIV (LLLT). LLLT (AsGaAl; 780-nm wavelength; average power of 60 mW, 40 s, and 60 ± 1.0 J/cm²) was used to promote analgesia, while OM-exercises were used to reestablish the orofacial functions. Evaluations at baseline (T1), after treatment immediate (T2), and at follow-up (T3) were muscle and joint tenderness to palpation, TMD severity, and orofacial myofunctional status. There was a significant improvement in outcome measures in all treated groups with stability at follow-up (Friedman test, P < 0.05), but GIV did not show difference in orofacial functions after LLLT (P > 0.05). Intergroup comparisons showed that all treated groups had no difference in tenderness to palpation of temporal muscle compared to GC at follow-up (Kruskal-Wallis test, P < 0.01). Moreover, GI, GII, and GIII showed no difference from GC in orofacial functional condition (T2 and T3) while they differed significantly from GIV (P < 0.01). In conclusion, LLLT combined with OM-exercises was more effective in promoting TMD rehabilitation than LLLT alone was. Similar treatment results were verified with the OMT protocol. PMID:27085322

  2. The European Randomized Study of Screening for Prostate Cancer – Prostate Cancer Mortality at 13 Years of Follow-up

    PubMed Central

    Schröder, Fritz H.; Hugosson, Jonas; Roobol, Monique J.; Tammela, Teuvo L.J.; Zappa, Marco; Nelen, Vera; Kwiatkowski, Maciej; Lujan, Marcos; Määttänen, Lissa; Lilja, Hans; Denis, Louis J.; Recker, Franz; Paez, Alvaro; Bangma, Chris H.; Carlsson, Sigrid; Puliti, Donella; Villers, Arnauld; Rebillard, Xavier; Hakama, Matti; Stenman, Ulf-Hakan; Kujala, Paula; Taari, Kimmo; Aus, Gunnar; Huber, Andreas; van der Kwast, Theo; van Schaik R, Ron H.N.; de Koning, Harry J.; Moss, Sue M.; Auvinen, Anssi

    2015-01-01

    Background The European Randomized study of Screening for Prostate Cancer (ERSPC) is a randomized multi-center trial with a predefined centralized database, analysis plan and core age group (55–69 years) evaluating prostate-specific antigen (PSA) testing in eight European countries. Methods The present results are based on prostate cancer (PCa) incidence and mortality truncated at 9, 11, and 13 years of follow-up in the intervention arm (offered PSA testing) relative to the control arm. A secondary analysis corrected for selection bias due to non-participation was performed. Because of incomplete follow-up, only incidence and no mortality data at 9 years follow-up are reported for the French centers. Findings The rate ratio (RR) of PCa incidence between the intervention and control arms was 1.91 after 9 years (1.64 including France), 1.66 after 11 years and 1.57 after 13 years. The RR of PCa mortality was 0.85, 0.78 and 0.79 at 9, 11 and 13 years respectively (95% confidence interval 13-year 0.69–0.91, p = 0.001). This corresponds to a relative risk reduction of 21% and an absolute risk reduction of death from PCa at 13 years of 0.11 per 1,000 person-years or 1.28 per 1,000 men randomized, which is equivalent to one PCa death averted per 781 men invited for screening or one per 27 additional PCa detected. PCa mortality reduction in screened men after adjustment for non–participation was 27%. Interpretation This update of ERSPC confirms a substantial PCa mortality reduction due to PSA testing, with a substantially increased absolute effect at 13 years compared to findings after 9 and 11 years. Funding All sources of funding per center are indicated in the “Web extra material” section. Trial identification This trial is registered under Current Controlled Trials number: ISRCTN49127736. PMID:25108889

  3. High-Dose Rate Brachytherapy Using Inverse Planning Simulated Annealing for Locoregionally Advanced Cervical Cancer: A Clinical Report With 2-Year Follow-Up

    SciTech Connect

    Kim, Daniel H.; Wang-Chesebro, Alice; Weinberg, Vivian; Pouliot, Jean; Chen, Lee-May; Speight, Joycelyn; Littell, Ramey; Hsu, I.-Chow

    2009-12-01

    Purpose: We present clinical outcomes of image-guided brachytherapy using inverse planning simulated annealing (IPSA) planned high-dose rate (HDR) brachytherapy boost for locoregionally advanced cervical cancer. Methods and Materials: From February 2004 through December 2006, 51 patients were treated at the University of California, San Francisco with HDR brachytherapy boost as part of definitive radiation for International Federation of Gynecology and Obstetrics Stage IB1 to Stage IVA cervical cancer. Of the patients, 46 received concurrent chemotherapy, 43 with cisplatin alone and 3 with cisplatin/5-fluorouracil. All patients had IPSA-planned HDR brachytherapy boost after whole-pelvis external radiation to a total tumor dose of 85 Gy or greater (for alpha/beta = 10). Toxicities are reported according to National Cancer Institute CTCAE v3.0 (Common Terminology Criteria for Adverse Events version 3.0) guidelines. Results: At a median follow-up of 24.3 months, there were no toxicities of Grade 4 or greater and the frequencies of Grade 3 acute and late toxicities were 4% and 2%, respectively. The proportion of patients having Grade 1 or 2 gastrointestinal and genitourinary acute toxicities was 48% and 52%, respectively. Low-grade late toxicities included Grade 1 or 2 vaginal, gastrointestinal, and hormonal toxicities in 31%, 18%, and 4% of patients, respectively. During the follow-up period, local recurrence developed in 2 patients, regional recurrence developed in 2, and new distant metastases developed in 15. The rates of locoregional control of disease and overall survival at 24 months were 91% and 86%, respectively. Conclusions: Definitive radiation by use of inverse planned HDR brachytherapy boost for locoregionally advanced cervical cancer is well tolerated and achieves excellent local control of disease.

  4. Long-term ECG in ambulatory clinical practice. Analysis and 2-year follow-up of 100 patients studied with a portable ECG tape recorder.

    PubMed

    Johansson, B W

    1977-01-01

    A portable tape recorder for long-term ECG monitoring is described. Its light weight (500 g) and small size (138 X 115 X 39 mm) make its usage in routine clinical practice a practical proposition. The most important application has been in the differential diagnosis of Adams--Strokes syndrome. The results from the first 100 patients with a 2-yr follow-up are presented. The importance of GCG recording during the patients' relevant subjective symptoms is stressed. The mean duration of recording was 2.8 days. In the 28 patients with histories which fitted the symptoms of Adams--Stokes syndrome this diagnosis was confirmed by an arrhythmia recorded simultaneously with the symptoms. In 36 other patients with a similar history the diagnosis was excluded becase of a normal ECG during subjective symptoms. Of the 28 patients with Adams--Stokes sydrome, bradyarrhthmia was the causal factor in 20 patients and these had a pacemaker implanted, whereas the remaining 8 patients had a tachyarrhythmia, which wa treated with antiarrhythmic drugs. The 2-yrs follow-up revealed an improvement and a disappearance of the Adams--Stokes attack in all the patients with an implanted pacemaker. In several of the 36 patients in whom Adams--Stokes syndrome could not be confirmed the syncopal attacks disappeared spontaneously. A large number of arrhythmias, including ventricular and supraventricular tachycardia, 2nd degree AV block and sinus bradycardia were observed during symptom-free intervals in these 36 patients. The introduction of long-term ECG recording routinely in patients with dizziness and syncope of unknown reason has resulted in an increase of the number of patients with a confirmed diagnosis of the Adams--Stokes syndrome, and it has contributed to an increase in the incidence of pacemaker implantation in Malmö from 130 per million inhabitants in 1971 to 220 in 1973, and 1974, respectively. PMID:837958

  5. Effectiveness of Cognitive-Behavioral Treatment for Panic Disorder Versus Treatment as Usual in a Managed Care Setting: 2-Year Follow-Up

    ERIC Educational Resources Information Center

    Addis, Michael E.; Hatgis, Christina; Cardemil, Esteban; Jacob, Karen; Krasnow, Aaron D.; Mansfield, Abigail

    2006-01-01

    Eighty clients meeting criteria for panic disorder and receiving either panic control therapy (PCT; M. G. Craske, E. Meadows, & D. H. Barlow, 1994) or treatment as usual (TAU) in a managed care setting were assessed 1 and 2 years following acute treatment. PCT was provided by therapists with little or no previous exposure to cognitive-behavioral…

  6. A randomized double-blind clinical trial of posterior composite restorations with or without bevel: 1-year follow-up

    PubMed Central

    COELHO-DE-SOUZA, Fábio Herrmann; CAMARGO, Junara Cristina; BESKOW, Tiago; BALESTRIN, Matheus Dalmolin; KLEIN-JÚNIOR, Celso Afonso; DEMARCO, Flávio Fernando

    2012-01-01

    Objective This randomized double-blind clinical trial compared the performance of posterior composite restorations with or without bevel, after 1-year follow-up. Material and Methods Thirteen volunteers requiring at least two posterior composite restorations were selected. Twenty-nine cavities were performed, comprising 14 without bevel (butt joint) and 15 with bevel preparation of the enamel cavosurface angle. All cavities were restored with simplified adhesive system (Adper Single Bond) and composite resin (Filtek P60). A halogen light curing unit was used through the study. Restorations were polished immediately. Analysis was carried out at baseline, after 6 months and after 1 year by a calibrated evaluator (Kappa), according to the FDI criteria. Data were statistically analyzed by Mann-Whitney test (p<0.05). Results Beveled and non-beveled cavities performed similarly after 1 year follow-up, regarding to fractures and retention, marginal adaptation, postoperative hypersensitivity, recurrence of caries, surface luster and anatomic form. However, for surface and marginal staining, beveled cavities showed significantly better performance (p<0.05) than butt joint restorations. Conclusions It was concluded that the restorations were acceptable after 1 year, but restorations placed in cavities with marginal beveling showed less marginal staining than those placed in non-beveled cavities. PMID:22666833

  7. Effects of a Randomized Reading Intervention Study Aimed at 9-Year-Olds: A 5-Year Follow-up.

    PubMed

    Wolff, Ulrika

    2016-05-01

    The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27146373

  8. Miniscalpel-Needle versus Steroid Injection for Plantar Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-Up

    PubMed Central

    Li, Shuming; Shen, Tong; Liang, Yongshan; Zhang, Ying; Bai, Bo

    2014-01-01

    Plantar fasciitis is the most common cause of heel pain in adults. A novel alternative medical instrument, the miniscalpel-needle (MSN), which is based on an acupuncture needle, has been recently developed in China. The objective of this study was to evaluate the effectiveness of the MSN release treatment versus that of traditional steroid injection for plantar fasciitis. Patients with plantar fasciitis were randomly assigned to 2 groups and followed up for 12 months, with 29 receiving MSN treatment and 25 receiving steroid injection treatment. The results showed that visual analog scale scores for morning pain, active pain, and overall heel pain all were decreased significantly in the MSN group from 1 to 12 months after treatment. In contrast, treatment with steroid injection showed a significant effect only at the 1-month follow-up but not at 6 or 12 months after treatment. Moreover, the MSN group achieved more rapid and sustained improvements than the steroid group throughout the duration of this study. No severe side effects were observed with MSN treatment. Our data suggest that the MSN release treatment is safe and has a significant benefit for plantar fasciitis compared to steroid injection. PMID:25114704

  9. One-Year Randomized Controlled Trial and Follow-Up of Integrated Neurocognitive Therapy for Schizophrenia Outpatients

    PubMed Central

    Mueller, Daniel R.; Schmidt, Stefanie J.; Roder, Volker

    2015-01-01

    Objective: Cognitive remediation (CR) approaches have demonstrated to be effective in improving cognitive functions in schizophrenia. However, there is a lack of integrated CR approaches that target multiple neuro- and social-cognitive domains with a special focus on the generalization of therapy effects to functional outcome. Method: This 8-site randomized controlled trial evaluated the efficacy of a novel CR group therapy approach called integrated neurocognitive therapy (INT). INT includes well-defined exercises to improve all neuro- and social-cognitive domains as defined by the Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative by compensation and restitution. One hundred and fifty-six outpatients with a diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV-TR or ICD-10 were randomly assigned to receive 15 weeks of INT or treatment as usual (TAU). INT patients received 30 bi-weekly therapy sessions. Each session lasted 90min. Mixed models were applied to assess changes in neurocognition, social cognition, symptoms, and functional outcome at post-treatment and at 9-month follow-up. Results: In comparison to TAU, INT patients showed significant improvements in several neuro- and social-cognitive domains, negative symptoms, and functional outcome after therapy and at 9-month follow-up. Number-needed-to-treat analyses indicate that only 5 INT patients are necessary to produce durable and meaningful improvements in functional outcome. Conclusions: Integrated interventions on neurocognition and social cognition have the potential to improve not only cognitive performance but also functional outcome. These findings are important as treatment guidelines for schizophrenia have criticized CR for its poor generalization effects. PMID:25713462

  10. Preliminary investigation of a biological augmentation of rotator cuff repairs using a collagen implant: a 2-year MRI follow-up

    PubMed Central

    Bokor, Desmond John; Sonnabend, David; Deady, Luke; Cass, Ben; Young, Allan; Van Kampen, Craig; Arnoczky, Steven

    2015-01-01

    Summary Background the inability to restore the normal tendon footprint and limit strains on the repair site are thought to contribute to re-tearing following rotator cuff repair. The purpose of this study was to use a collagen implant to augment rotator cuff repairs through the restoration of the native tendon footprint and the induction of new tissue to decrease overall tendon strain. Methods repairs of full-thickness rotator cuff lesions in 9 adult patients were augmented with a novel collagen implant placed over the bursal surface of the repair. Tendon thickness and footprint anatomy were evaluated using MRI at 3, 6, 12, and 24 months. Clinical results were assessed using standard outcome metrics. Mean follow-up for all patients was 25.8 months. Results the implant induced significant new tissue formation in all patients by 3 months. This tissue matured over time and became indistinguishable from the underlying tendon. At 24 months all repairs remained intact and normal footprint anatomy of the tendon was restored in all patients. All clinical scores improved significantly over time. Conclusion the ability of a collagen implant to induce new host tissue formation and restore the normal footprint anatomy may represent a significant advancement in the biological augmentation and ultimate durability of rotator cuff repairs. PMID:26605186

  11. Comparison of Retrograde Balloon Dilatation and Laparoscopic Pyeloplasty for Treatment of Ureteropelvic Junction Obstruction: Results of a 2-Year Follow-Up

    PubMed Central

    Xue, Xue-Yi; Zheng, Qing-Shui; Wei, Yong; Jiang, Tao; Li, Xiao-Dong; Huang, Jin-Bei; Cai, Hai

    2016-01-01

    Objective To evaluate the efficacy of laparoscopic pyeloplasty relative to retrograde balloon dilatation for the treatment of ureteropelvic junction obstruction (UPJO). Methods This retrospective study enrolled UPJO patients with stricture length < 2 cm who had been treated with laparoscopic pyeloplasty (LP; 44 cases) or balloon dilatation (BD; 38 cases) from Jan 2010 to Jan 2012, according to patients’ preference after consultation. Demographics and clinical parameters were collected. Patients were followed-up at 3, 6, 12, and 24 months. Ultrasonography, intravenous urography, and diuretic renography were applied to evaluate the remission of hydronephrosis. Results Both groups were comparable with respect to age, UPJO location, gender, and other baseline parameters. Compared to the LP group, patients receiving BD experienced significantly shorter operative time, analgesia time, hospital stay, and urethral catheter indwelling time, and less cost (P<0.001). Three and 6 months after their respective procedures, the success rates of the LP (97.7%, both) and BD (94.7% and 86.8%) groups were similar, and at 12 and 24 months the long-term success rate of LP (95.5%, both) was better than that of BD (78.9% and 71.0%). Conclusions LP showed better long-term success rate than did BD in the management of UPJO with length of stricture < 2 cm. Considering that BD is more minimally invasive, simpler and easier to perform, and costs less, we recommend it for some selective UPJO patients as the first-line therapy. PMID:27019289

  12. The Mediterranean diet protects against waist circumference enlargement in 12Ala carriers for the PPARgamma gene: 2 years' follow-up of 774 subjects at high cardiovascular risk.

    PubMed

    Razquin, Cristina; Alfredo Martinez, J; Martinez-Gonzalez, Miguel A; Corella, Dolores; Santos, José Manuel; Marti, Amelia

    2009-09-01

    The PPARgamma gene regulates insulin sensitivity and adipogenesis. The Pro12Ala polymorphism of this gene has been related to fat accumulation. Our aim was to analyse the effects of a 2-year nutritional intervention with Mediterranean-style diets on adiposity in high-cardiovascular risk patients depending on the Pro12Ala polymorphism of the PPARgamma gene. The population consisted of a substudy (774 high-risk subjects aged 55-80 years) of the Prevención con Dieta Mediterránea (PREDIMED) randomised trial aimed at assessing the effect of the Mediterranean diet for CVD prevention. There were three nutritional intervention groups: two of them of a Mediterranean-style diet and the third was a control group advised to follow a conventional low-fat diet. All the participants were genotyped by PCR-restriction fragment length polymorphism (RFLP). The results showed that carriers of the 12Ala allele allocated to the control group had a statistically significant higher change in waist circumference (adjusted difference coefficient = 2.37 cm; P = 0.014) compared with wild-type subjects after 2 years of nutritional intervention. This adverse effect was not observed among 12Ala carriers allocated to both Mediterranean diet groups. In diabetic patients a statistically significant interaction between Mediterranean diet and the 12Ala allele regarding waist circumference change was observed ( - 5.85 cm; P = 0.003). In conclusion, the Mediterranean diet seems to be able to reduce waist circumference in a high-cardiovascular risk population, reversing the negative effect that the 12Ala allele carriers of the PPARgamma gene appeared to have. The beneficial effect of this dietary pattern seems to be higher among type 2 diabetic subjects. PMID:19267951

  13. Evaluation of implant loosening following segmental pedicle screw fixation in adolescent idiopathic scoliosis: a 2 year follow-up with low-dose CT

    PubMed Central

    2014-01-01

    Background The long term radiological status of screw fixation following scoliosis surgery with all pedicle screw construct is not previously studied. Aim To evaluate the incidence of loosening (implant failure) evaluated with low-dose CT two years following scoliosis surgery. Study design Retrospective study. Methods 81 consecutive patients with adolescent idiopathic scoliosis (AIS), aged 18 ± 3 years at 2 years follow-up (83% were female), subjected for scoliosis corrective surgery with all pedicle screw construct (total of 1666 screws) has been examined with plain radiography and with low dose CT 6 weeks and 2 years postoperatively. Results In 26 out of 81 (32%) patients there were signs of loosening of one or more screws, a maximum 3 screws. 47 out of 1666 (2.8%) screws showed evidence of loosening. Preoperative Cobb angle was 56° among patients with loosening compared with 53° among patients with no evidence of loosening (P = 0.288). In males there were signs of loosening in 8 out of 14 (57%) and in females 18 out of 67 (27%), (P = 0.027). Among cases with loosening, 14% had suboptimal screw placement at the first postoperative CT compared with 11% among patients with no evidence of loosening (P = 0.254). One patient with a loosened L4 screw had neurological deficit and subjected for revision of the construct. Out of 26 patients with evidence of loosening, 5 patients reported minor pain or discomfort, 1 patient had a minor proximal junctional kyphosis of about 15° and 3 patients showed evidence of pull-out of 3–5 mm at the upper end of the construct but no clinical complaint. With plain radiography loosening could be observed only in 11 out of 26 cases, 5 were in the lumbar region. Conclusions In a consecutive series of 81 cases with AIS who had underwent scoliosis surgery, one third showed, 2 years after the intervention, minor screw loosening. Males were more prone to develop screw loosening. In CT system that enables low

  14. [The ACL tear from the pre-operative analysis to a 2-year follow-up, influence of the graft choice on the subjective and objective evaluation].

    PubMed

    Dejour, D; Potel, J-F; Gaudot, F; Panisset, J-C; Condouret, J

    2008-12-01

    This study is a synthesis of three series. The first study was prospective on 418 patients with an anterior cruciate ligament (ACL) tear (group I). Two population of ACL ruptures were identified. One population with a postero-lateral bundle preserved in 16%, the mean medial anterior tibial translation side to side was 4.97 mm, the Lachman test was delayed in 40% with no or glide pivot shift in 73%. The second population with a complete ACL tear had a mean medial anterior tibial translation side to side of 7.93 mm, the Lachman test was soft in 98% with gross pivot shift in 80%. The second study was a retrospective study on 258 patients (group II) at 26 months follow-up, it correlated the impact of the type of graft on the clinical objective and subjective results. Twenty-eight percent had anterior knee pain, 33% for the patellar tendon and 25% for the hamstrings, the subjective IKDC was significantly lower for the painful knees, and 68% of the patellar tendon had a hypoesthesia and only 32% for the hamstrings. The ability to walk on the knee was 68% for the hamstrings and 35% for the patellar tendon. The third study was retrospective on 127 patients, 24 months after ACL reconstruction (group III), all were tested on a isokinetic machine for the extensor, the flexor and the internal rotator. In the total population, a 10% extensor and flexor deficit and a 5% rotator deficit was noted. A significant difference between patellar tendon and hamstrings in terms of muscular recovery was found. It pointed out that a more specific rehabilitation should be done on the hamstring group. The muscular recovery was correlated to the highest subjective score. This study allowed the surgeon to be more specific in the ACL tear definition, to adapt the graft choice to the type of sport activity but also to the type of work the patient does and finally to modify the rehabilitation protocol for the hamstring technique. PMID:19046692

  15. Changes in physical activity during a weight loss intervention and follow-up: a randomized controlled trial

    PubMed Central

    Fuller, N R; Williams, K; Shrestha, R; Ahern, A L; Holzapfel, C; Hauner, H; Jebb, S A; Caterson, I D

    2014-01-01

    Summary Physical activity is an important component in weight loss treatment and weight maintenance. We evaluated the physical activity component of two weight loss programmes, either standard care (SC) as defined by national guidelines, or a commercial programme (CP; Weight Watchers) over the period of weight loss and follow-up. 772 adults (mean body mass index: 31.4 ± 2.6 kg m−2) were recruited by primary care practices in Australia, the United Kingdom, and Germany, and randomly assigned to 12 months SC, or the CP. They were then followed up at 24 months. Change in physical activity levels were assessed by the International Physical Activity Questionnaire (IPAQ)-short form, and pedometer recordings. Both groups reported increases in physical activity using the IPAQ from baseline to 12 months and 24 months (within groups P < 0.0001) and in pedometer steps from baseline to 12 months only (within groups P < 0.0001). Differences between groups with both methods of assessment were not significant. There was a significant difference in weight loss between the groups at 12 months favouring the CP group; however, this statistical difference was not maintained at 24 months. In conclusion, despite similar increases in reported activity, there were significant differences in weight loss and regain between groups. Therefore, greater weight loss seen with the CP is unlikely to be due to increases in physical activity. Trends in pedometer steps mirrored changes in weight over time more closely than the IPAQ; however, both assessment tools have limitations. Better activity assessment measures are needed to more accurately gauge changes in physical activity during weight loss interventions. PMID:25826767

  16. Photoselective vaporization of prostate vs. transurethral resection of prostate: A prospective, randomized study with one year follow-up

    PubMed Central

    Mohanty, Nayan K.; Vasudeva, Pawan; Kumar, Anup; Prakash, Sanjay; Jain, Manoj; Arora, Rajender P.

    2012-01-01

    Objectives: To evaluate in a prospective, randomized study, the efficacy and safety profile of photoselective vaporization of prostate (PVP) using a 80W potassium titanyl phosphate (KTP) laser when compared to standard transurethral resection of prostate (TURP) in patients with lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE). Materials and Methods: Between February 2009 and August 2009, 117 patients satisfying the eligibility criteria underwent surgery [60 PVP{Group A}; 57 TURP{Group B}]. The groups were compared for functional outcome (both subjective and objective parameters), perioperative parameters and complications, with a follow up of one year. P value<0.05 was considered statistically significant. Results: The baseline characteristics of the two groups were comparable. Mean age was 66.68 years and 65.74 years, mean IPSS score was 19.98 and 20.88, mean prostate volume was 44.77 cc and 49.02 cc in Group A and B, respectively. Improvements in IPSS, QOL, prostate volume, Q max and PVRU at 12 months were similar in both groups. PVP patients had longer operating time, lesser perioperative blood loss, shorter catheterization time and a higher dysuria rate when compared to TURP patients. The overall complication rate was similar in the two groups. Conclusions: In patients with LUTS due to BPE, KTP-PVP is an equally efficacious alternative to TURP with durable results at one year follow up with additional benefits of lesser perioperative blood loss, lesser transfusion requirements and a shorter catheterization time. Long term comparative data is awaited to clearly define the role of KTP-PVP in such patients. PMID:23204660

  17. Alumina on alumina versus metal on conventional polyethylene: a randomized clinical trial with 9 to 15 years follow-up.

    PubMed

    Vendittoli, Pascal-André; Rivière, Charles; Lavigne, Martin; Lavoie, Pauline; Alghamdi, Ahmed; Duval, Nicolas

    2013-04-01

    We report the long-term results of a randomized clinical trial that compares, in total hip arthroplasty in a young population, metal-on-conventional polyethylene and alumina-on-alumina ceramic bearings. One hundred and forty hips in 116 patients were randomized. Re-operation, revision rate, clinical scores, and radiological signs of osteolysis and loosening were compared at average follow-up of 123 (9-15) years. At final FU, 107 hips were available for clinical evaluation. Eight (11.6%) revisions were performed in the polyethylene group versus 1 (1.4%) in the ceramic group (p = 0.017). All revisions in the polyethylene group were related to bearing wear: 4 for aseptic loosening with severe osteolysis, 1 for polyethylene induced compressive granulomatous tumor, and 3 for severe liner wear. The only revised case from the ceramic group was secondary to mechanical stem loosening. Mean annual polyethylene wear was 0.19mm/year; wear was not measurable in the ceramic group. Our study confirms, in the long-term, the superiority of ceramic-on-ceramic pairing in comparison to metal-on-conventional polyethylene and supports their use in young, active patients. PMID:23821970

  18. Prediction of Response to Treatment in a Randomized Clinical Trial of Couple Therapy: A 2-Year Follow-Up

    ERIC Educational Resources Information Center

    Baucom, Brian R.; Atkins, David C.; Simpson, Lorelei E.; Christensen, Andrew

    2009-01-01

    Many studies have examined pretreatment predictors of immediate posttreatment outcome, but few studies have examined prediction of long-term treatment response to couple therapies. Four groups of predictors (demographic, intrapersonal, communication, and other interpersonal) and 2 moderators (pretreatment severity and type of therapy) were…

  19. Evaluation of Clinical and Immunological Responses: A 2-Year Follow-Up Study in Children with Allergic Rhinitis due to House Dust Mite

    PubMed Central

    Moed, Heleen; Gerth van Wijk, Roy; Hendriks, Rudi W.; van der Wouden, J. C.

    2013-01-01

    Background. Allergic rhinitis is a disease with polarization towards Th2 and a defect of regulatory T cells. Immunological changes have been reported after immunotherapy treatment. However, there is not much known about the natural course of allergic rhinitis with respect to clinical manifestation and the relation with immunological responses. Objective. To evaluate clinical symptoms of allergic rhinitis, in relation to in vivo allergen-specific skin responses and in vitro allergen-specific effector and regulatory T cells determined at baseline and after two years. Methods. From a large trial, 59 children were randomly selected. The following variables were compared: clinical symptoms, allergen skin tests, specific IgE, T-cell proliferation, IL-5, IL-13, IFN-gamma, IL-10, TGF-beta, CD4+CD25hi cells, and Foxp3 expression. Results. Allergic symptoms had decreased after two years. Whereas skin test reactions correlated between years 0 and 2, there was no change in the size of the reaction. Also, proinflammatory reactions did not change after two years, with a positive correlation between years 0 and 2. No relevant changes were observed with respect to regulatory cells. Conclusion. Whereas, comparable to immunotherapy, allergic complaints decrease, the immunological changes of specific T-cell activity (both effector cells and regulator cells) which are observed after immunotherapy, do not change. PMID:23737646

  20. Two-Year Follow-Up Results of Fluoroscopic Cervical Epidural Injections in Chronic Axial or Discogenic Neck Pain: A Randomized, Double-Blind, Controlled Trial

    PubMed Central

    Manchikanti, Laxmaiah; Cash, Kimberly A.; Pampati, Vidyasagar; Malla, Yogesh

    2014-01-01

    Study Design: A randomized, double-blind, active-controlled trial. Objective: To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain. Summary of Background Data: Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain. Methods: One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone. The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight. Results: Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up

  1. Single and Multiple Level One Stage Posterior Hemivertebrectomy and Short Segment Fixation: Experience with 22 Cases and Comparison of Single vs. Multilevel Procedures with Minimum 2-Year Follow-Up

    PubMed Central

    Basu, Saumyajit; Malik, Farid H.; Ghosh, Jay Deep; Jain, Mantu; Sarangi, Trinanjan

    2016-01-01

    Study Design Data of 22 patients with congenital scoliosis who underwent single stage posterior hemivertebrectomies and short segment fixation with a minimum follow-up of 2 years in our centre were studied retrospectively. Purpose To report the efficacy of posterior hemivertebrectomy in single vs multiple level hemivertebra and compare their results. Overview of Literature Single stage hemivertebrectomy is a standard procedure for single level hemivertebra. Results of multiple level hemivertebrectomies have not been reported. Methods Twenty-two patients (9 male and 13 female) with the mean age of 11.2 years (range, 2 years 4 months to 24 years 10 months) and a mean follow up of 32 months (range, 4 to 73 months) were studied retrospectively and their results were compared. Results Average number of hemivertebrae removed was 1.46 (range, 1 to 3). Mean preoperative and postoperative coronal cob angle was 48.7° (range, 22° to 80°) and 24.2° (range, 7° to 41°), respectively (p<0.001). Mean preoperative and postoperative sagittal cobb angle was 32.1° (range, 7° to 76°) and 13.6° (range, 0° to 23°), respectively (p<0.005). Mean coronal and sagittal cob correction percentage achieved was 50.2% and 51.8% respectively. Mean follow-up was 49 months (range, 30 to 84 months). Mean loss of coronal and sagittal correction at final follow-up was 4% (0% to 13.6%) degrees and 3.5% (0% to 20%), respectively. Conclusions Posterior hemivertebrectomy in congenital scoliosis is a safe treatment option for up to 3-level hemivertebrae. Excision of thoracolumbar hemivertebrae results in better correction than thoracic and lumbar hemivertebrae. PMID:27340519

  2. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up

    PubMed Central

    2014-01-01

    Background Low levels of physical activity, musculoskeletal morbidity and weight gain are commonly reported problems in children with cancer. Intensive medical treatment and a decline in physical activity may also result in reduced motor performance. Therefore, simple and inexpensive ways to promote physical activity and exercise are becoming an increasingly important part of children’s cancer treatment. Methods The aim of this study is to evaluate the effect of active video games in promotion of physical activity in children with cancer. The research is conducted as a parallel randomized clinical trial with follow-up. Patients between 3 and 16 years old, diagnosed with cancer and treated with vincristine in two specialized medical centers are asked to participate. Based on statistical estimates, the target enrollment is 40 patients. The intervention includes playing elective active video games and, in addition, education and consultations for the family. The control group will receive a general recommendation for physical activity for 30 minutes per day. The main outcomes are the amount of physical activity and sedentary behavior. Other outcomes include motor performance, fatigue and metabolic risk factors. The outcomes are examined with questionnaires, diaries, physical examinations and blood tests at baseline and at 2, 6, 12 and 30 months after the baseline. Additionally, the children’s perceptions of the most enjoyable activation methods are explored through an interview at 2 months. Discussion This trial will help to answer the question of whether playing active video games is beneficial for children with cancer. It will also provide further reasoning for physical activity promotion and training of motor skills during treatment. Trial registration ClinicalTrials.gov identifier: NCT01748058 (October 15, 2012). PMID:24708773

  3. Pneumococcal Serotype-Specific Antibodies Persist through Early Childhood after Infant Immunization: Follow-Up from a Randomized Controlled Trial

    PubMed Central

    Trück, Johannes; Snape, Matthew D.; Tatangeli, Florencia; Voysey, Merryn; Yu, Ly-Mee; Faust, Saul N.; Heath, Paul T.; Finn, Adam; Pollard, Andrew J.

    2014-01-01

    Background In a previous UK multi-center randomized study 278 children received three doses of 7-valent (PCV-7) or 13-valent (PCV-13) pneumococcal conjugate vaccine at 2, 4 and 12 months of age. At 13 months of age, most of these children had pneumococcal serotype-specific IgG concentrations ≥0.35 µg/ml and opsonophagocytic assay (OPA) titers ≥8. Methods Children who had participated in the original study were enrolled again at 3.5 years of age. Persistence of immunity following infant immunization with either PCV-7 or PCV-13 and the immune response to a PCV-13 booster at pre-school age were investigated. Results In total, 108 children were followed-up to the age of 3.5 years and received a PCV-13 booster at this age. At least 76% of children who received PCV-7 or PCV-13 in infancy retained serotype-specific IgG concentrations ≥0.35 µg/ml against each of 5/7 shared serotypes. For serotypes 4 and 18C, persistence was lower at 22–42%. At least 71% of PCV-13 group participants had IgG concentrations ≥0.35 µg/ml against each of 4/6 of the additional PCV-13 serotypes; for serotypes 1 and 3 this proportion was 45% and 52%. In the PCV-7 group these percentages were significantly lower for serotypes 1, 5 and 7F. A pre-school PCV-13 booster was highly immunogenic and resulted in low rates of local and systemic adverse effects. Conclusion Despite some decline in antibody from 13 months of age, these data suggest that a majority of pre-school children maintain protective serotype-specific antibody concentrations following conjugate vaccination at 2, 4 and 12 months of age. Trial Registration ClinicalTrials.gov NCT01095471 PMID:24618837

  4. Research Units of Pediatric Psychopharmacology (RUPP) Autism Network Randomized Clinical Trial of Parent Training and Medication: One-Year Follow-Up

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Aman, Michael G.; Li, Xiaobai; Butter, Eric; Humphries, Kristina; Scahill, Lawrence; Lecavalier, Luc; McDougle, Christopher J.; Swiezy, Naomi B.; Handen, Benjamin; Wilson, Krystina; Stigler, Kimberly A.

    2012-01-01

    Objective: To follow up on a three-site, 24-week randomized clinical trial (N = 124) comparing antipsychotic medication alone (MED) with antipsychotic medication plus parent training in the behavior management (COMB) of children with autism spectrum disorders and severe behavior problems. The COMB treatment had shown a significant advantage for…

  5. Metatarsalgia and Morton's Disease: Comparison of Outcomes Between Open Procedure and Neurectomy Versus Percutaneous Metatarsal Osteotomies and Ligament Release With a Minimum of 2 Years of Follow-Up.

    PubMed

    Bauer, Thomas; Gaumetou, Elodie; Klouche, Shahnaz; Hardy, Philippe; Maffulli, Nicola

    2015-01-01

    The present study compared the clinical results of open neurectomy versus a percutaneous procedure for Morton's disease. This was a retrospective study comparing the functional results after 2 surgical procedures: open neurectomy and a percutaneous procedure (with deep transverse metatarsal ligament release and distal metatarsal osteotomies). The present study included 52 patients (26 in each group), and the mean follow-up period was 4 (range 2 to 7) years. The patient evaluation criteria included the presence of painful symptoms of Morton's disease, American Orthopaedic Foot and Ankle Society (AOFAS) functional scale score, patient satisfaction, and delay for recovery. Percutaneous treatment of Morton's disease and open neurectomy produced complete relief of pain in 25 of 26 patients in each group. At the latest follow-up visit, the mean AOFAS score had significantly improved from 36 ± 11 preoperatively to a mean of 89 ± 18 (p < .001). After 2 years, the functional improvement obtained with the percutaneous procedure persisted, with a stable AOFAS score (96 ± 10). Persistent metatarsalgia was reported by patients who had undergone open neurectomy, with a significantly decreased AOFAS score (81 ± 21, p = .009). The percutaneous procedure for Morton's disease provided excellent functional outcomes (AOFAS score >90) significantly more often with a shorter delay than after open neurectomy (p = .03). At the latest follow-up visit, metatarsalgia due to plantar hyperpressure or bursitis and requiring plantar orthotics was present in 11 of 26 patients (44%) after open neurectomy and in 1 of 26 patients (4%) after the percutaneous procedure (p = .002). Percutaneous treatment of Morton's disease is a reliable procedure providing results as good as those after open neurectomy, with significantly better outcomes in the longer term and a lower rate of late metatarsalgia. PMID:25481724

  6. Impact of eLearning course on nurses' professional competence in seclusion and restraint practices: 9-month follow-up results of a randomized controlled study (ISRCTN32869544).

    PubMed

    Kontio, R; Hätönen, H; Joffe, G; Pitkänen, A; Lahti, M; Välimäki, M

    2013-04-01

    eLearning may facilitate continuing vocational education, but data on the long-term effects of an eLearning course are lacking. The aim of this study was to explore the long-term impact of an eLearning course entitled ePsychNurse.Net on psychiatric nurses' professional competence in practicing seclusion and restraint and on their job satisfaction and general self-efficacy at 9-month follow-up. In a randomized controlled study, 12 wards were randomly assigned to the ePsychNurse.Net (intervention) or training as usual (control). Baseline and 9-month follow-up data on nurses' knowledge of coercion-related legislation, physical restraint and seclusion, their attitudes towards physical restraint and seclusion, job satisfaction and general self-efficacy were analysed for 137 completers (those who participated in the 9-month follow-up assessment). No between-group differences were found on any variable, with the exception of a change in attitude to seclusion in favour of the control group. The findings of the long-term effects did not differ from the immediate outcomes (3-month follow-up) and the improved level of knowledge acquired and further consolidation of that knowledge did not take place in the 6-month period after the 3-month ePsychNurse.Net course. The ePsychNurse.Net should be further developed and its future modifications will require additional studies, probably with some new outcome measures. PMID:22672441

  7. Outcomes for intra-substance free coracoid graft in patients with antero-inferior instability and glenoid bone loss in a population of high-risk athletes at a minimum follow-up of 2 years

    PubMed Central

    Arianjam, Afshin; Coghlan, Jennifer; Old, Jason; Sloan, Roger

    2014-01-01

    Background The aim of this retrospective case series study was to assess the outcomes of patients with recurrent anterior shoulder instability with antero-inferior glenoid bone loss treated with a specific open stabilization technique using intra-substance coracoid bone-grafting and Bankart repair. Methods Over a 4-year period, 34 shoulders in all male patients of mean age 21 years were stabilized with this technique. Pre- and postoperative function, motion and stability were assessed as part of Rowe stability scoring, and American Shoulder and Elbow Surgeons (ASES) and Oxford Instability were recorded, with at least 2 years of follow-up in all patients. Union of the graft was determined by post-operative computed tomography (CT) of the affected shoulder. Results For all cases, two redislocations (5.9%) and two subluxations occurred when continuing high-risk sport after 2 years. Post-operative scores [median, mean (SD): Rowe 77.5, 77.2 (19.5); ASES 94.2, 92 (7.7); Oxford 43, 41.2 (6)]. CT scans on 28 shoulders at a mean of 4.5 months after surgery showed non-union in three cases (10%). Conclusions These results demonstrate a high rate of success in cases of glenoid bone loss in the young contact athlete with recurrent instability treated with open stabilization and bone grafting.

  8. Long-Term Effects of Individual Development Accounts on Postsecondary Education: Follow-Up Evidence from a Randomized Experiment

    ERIC Educational Resources Information Center

    Grinstein-Weiss, Michal; Sherraden, Michael; Gale, William G.; Rohe, William M.; Schreiner, Mark; Key, Clinton

    2013-01-01

    This paper presents evidence from a randomized field experiment testing the impact of a 3-year matched savings program on educational outcomes 10 years after the start of the experiment. We examine the effect of an Individual Development Account (IDA) program on (1) educational enrollment, (2) degree completion, and (3) increased education level.…

  9. Extended Follow-Up of a Randomized Controlled Trial of the Lidcombe Program of Early Stuttering Intervention

    ERIC Educational Resources Information Center

    Jones, Mark; Onslow, Mark; Packman, Ann; O'Brian, Sue; Hearne, Anna; Williams, Shelley; Ormond, Tika; Schwarz, Ilsa

    2008-01-01

    Background: In the Lidcombe Program of Early Stuttering Intervention, parents present verbal contingencies for stutter-free and stuttered speech in everyday situations. A previous randomized controlled trial of the programme with preschool-age children from 2005, conducted in two public speech clinics in New Zealand, showed that the odds of…

  10. Long-Term Follow-Up to a Randomized Clinical Trial of Multisystemic Therapy with Serious and Violent Juvenile Offenders

    ERIC Educational Resources Information Center

    Schaeffer, Cindy M.; Borduin, Charles M.

    2005-01-01

    In this study, the authors examined the long-term criminal activity of 176 youths who had participated in either multisystemic therapy (MST) or individual therapy (IT) in a randomized clinical trial (C. M. Borduin et al., 1995). Arrest and incarceration data were obtained on average 13.7 (range = 10.2-15.9) years later when participants were on…

  11. A prospective randomized study of 1- and 2-stage sinus inlay bone grafts: 1-year follow-up.

    PubMed

    Wannfors, K; Johansson, B; Hallman, M; Strandkvist, T

    2000-01-01

    The purpose of the present study was to compare the success of and surgical differences between 1- and 2-stage sinus inlay bone grafts and implants after 1 year in function. The individual risk for implant failure in grafted areas among 1-stage patients was about twice the risk in 2-stage patients (odds ratio 2.3, CI 0.6; 8.5). The risk for implant failure in non-grafted areas was significantly lower (P < .05) than in grafted areas, regardless of the technique used. Forty edentulous patients, selected according to strict inclusion criteria from consecutive referrals, were allocated to one or other of the 2 sinus-inlay procedures. Twenty patients received bone blocks fixed by implants to the residual alveolar crest in a 1-stage procedure (group 1). In another 20 patients, particulated bone was condensed against the antral floor and left to heal for 6 months before implants were placed (group 2). An almost equal number of implants was placed in the patients of each group, 76 in the 1-stage procedure and 74 in the 2-stage procedure. Additionally, 72 and 66 implants were placed in the anterior non-grafted regions of group 1 and group 2 patients, respectively. After 1 year in function, a total of 20 implants failed in 1-stage patients, versus 11 in 2-stage patients. Sixteen and 8 implants, respectively, of these were placed in grafted bone. All but one 1-stage patient received the planned fixed prosthetic restorations, but 1 restoration was redesigned after the first year in function because of a functionally unacceptable prosthetic design. At the 1-year follow-up, one 2-stage patient lost her prosthesis as the result of multiple implant failures. Bruxism and postoperative infections were the only parameters that could be related to implant failure, however, depending on the statistical method used. PMID:11055129

  12. Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial

    PubMed Central

    den Besten, Christine A.; Stalfors, Joacim; Wigren, Stina; Blechert, Johan Ivarsson; Flynn, Mark; Eeg-Olofsson, Måns; Aggarwal, Rohini; Green, Kevin; Nelissen, Rik C.; Mylanus, Emmanuel A. M.; Hol, Myrthe K. S.

    2016-01-01

    Objective: To compare implant stability, survival, and soft tissue reactions for a novel (test) and previous generation (control) percutaneous auditory osseointegrated implant for bone conduction hearing at long-term follow-up of 5 years. Study Design: Single follow-up visit of a previously completed multicenter, randomized, controlled trial. Patients: Fifty-seven of the 77 participants of a completed randomized controlled trial on a new auditory osseointegrated implant underwent a single follow-up visit 5 years after implantation, which comprised implant stability measurements and collection of Holgers scores. Additionally, implant survival was recorded for all 77 patients from the original trial. Results: The test implant showed significantly higher implant stability quotient (ISQ) values compared with the control implant throughout the 5-year follow-up. Mean area under the curve of ISQ high from baseline to 5 years was 71.6 (standard deviation [SD] ±2.0) and 66.7 (SD ±3.4) for the test and control implant, respectively (p < 0.0001). For both implants, the mean ISQ value recorded at 5 years was higher compared with implantation (test group +2.03 [SD ±2.55, within group p < 0.0001] and control group +2.25 [SD ±4.95, within group p = 0.12]). No difference was noticed in increase from baseline between groups (p = 0.64). Furthermore, evaluation of soft tissue reactions continued to show superiority of the test implant. At the 5-year follow-up visit, one patient (2.5%) presented with a Holgers grade 2 in the test group, compared with four patients (23.5%) in the control group (p = 0.048); no patient presented with more severe soft tissue reactions. Excluding explantations, the survival rate was 95.8% for the test group and 95.0% for the control group. The corresponding rates including explantations were 93.9 and 90.0%. Conclusion: The test implant showed superiority in terms of higher mean ISQ values and less adverse soft tissue reactions, both

  13. A Comparison of Anatomic Double- And Single-bundle Techniques for Anterior Cruciate Ligament Reconstruction, A Prospective Randomized Study with A 5-year Follow-up

    PubMed Central

    Karikis, Ioannis; Desai, Neel; Sernert, Ninni; Rostgard-Christensen, Lars; Kartus, Juri T.

    2016-01-01

    Objectives: The purpose of this study was to compare the mid-term outcome after arthroscopic anterior cruciate ligament (ACL) reconstruction with either the anatomic double-bundle (DB) or anatomic single-bundle (SB) technique using hamstring tendon autografts in an unselected group of patients. Methods: 103 patients (33 women, 70 men; median age, 27 years; range, 18-52 years) were randomized and underwent ACL reconstruction (DB group; n=53 and SB group; n=50). All reconstructions were performed anatomically, identifying the ACL footprints, using the anteromedial portal for the femoral tunnel drilling and utilizing interference screw for tibial and femoral fixation. One blinded observer examined the patients both preoperatively and at follow-up (median, 64 months; range, 55-75 months). Radiographic evaluation of OA was performed using the Ahlbäck, Kellgren-Lawrence and Fairbanks grading systems in the early postoperative period and at follow up. Results: Preoperatively, no differences were found between the study groups apart from the pre-injury Tegner activity level, which was lower in the DB group (p=0.02). Eighty-seven patients (83%) were available for examination at 5-year follow-up. There were no significant differences between the groups in terms of the pivot-shift test, KT-1000 arthrometer laxity measurements, manual Lachman test, One-leg-hop test, Square-hop test, range of motion, Lysholm knee scoring scale, Tegner activity scale and Knee Injury and Osteoarthritis Outcome Score (KOOS). Correspondingly, no differences were found between the groups regarding the presence of OA at follow-up. Both DB and SB groups improved significantly at follow-up compared with the preoperative assessment. Conclusion: At mid-term follow-up of an unselected group of patients, anatomic DB reconstruction was not superior to anatomic SB reconstruction in terms of the pivot-shift test or subjective and objective outcome variables, as seen in this prospective randomized study

  14. Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial

    PubMed Central

    Hahn, M.; Brucker, S.; Kraemer, D.; Wallwiener, M.; Taran, F.-A.; Wallwiener, C. W.; Krämer, B.

    2015-01-01

    Aims: Laparoscopic myomectomy (LM) has been the gold standard treatment for uterine fibroids in women desiring uterine conservation. To evaluate a new fibroid treatment modality – radiofrequency volumetric thermal ablation (RFVTA) – we compare 12-month results in women who had symptomatic uterine fibroids and who were randomized to laparoscopic ultrasound-guided RFVTA or LM. Materials and Methods: Our study is a 1 : 1 parallel, randomized, prospective, single-center, longitudinal, comparative analysis of RFVTA to LM for fibroid treatment in women ≥ 18 years of age who desired uterine conservation. Fifty women were randomized intraoperatively to RFVTA (n = 25) or to LM (n = 25) after laparoscopic ultrasound mapping of the uterus. Results: Post surgery, ablation and myomectomy subjects took pain medications for 4 days (range: 1–46) and 7 days (range: 1–83 days) respectively (p = 0.60). Ablation and myomectomy subjects missed 10.0 workdays (range: 2–86 days) and 17.0 workdays (range: 7–30 days) (p = 0.28), resumed normal activities in 20.5 days (range: 5–103 days) versus 28.0 days (range: 10–42 days) (p = 0.86) respectively. Mean symptom severity scores decreased (improved) by − 7.8 for the ablation subjects and by − 17.9 for the myomectomy subjects (p = 0.16). Health-related quality of life improved (increased) by 7.5 and 13.1, respectively, for the two groups (p = 0.46). Two myomectomy subjects had pregnancies that ended in a Cesarean delivery and a vaginal delivery of healthy infants. Two pregnancies in the RFVTA group ended in full-term vaginal deliveries of healthy infants. Conclusions: Early postoperative recovery and twelve-month results attest to similar clinical benefits from RFVTA and LM. PMID:26097247

  15. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    PubMed

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  16. Prevention of Gestational Diabetes: Design of a Cluster-Randomized Controlled Trial and One-Year Follow-Up

    PubMed Central

    2010-01-01

    Background Annual prevalence of gestational diabetes mellitus (GDM) is 12.5% among Finnish pregnant women. The prevalence is expected to rise with the increasing overweight among women before pregnancy. Physical activity and diet are both known to have favourable effects on insulin resistance and possibly on the risk of GDM. We aimed to investigate, whether GDM can be prevented by counseling on diet, physical activity and gestational weight gain during pregnancy. Methods/Design A cluster-randomized controlled trial was conducted in 14 municipalities in the southern part of Finland. Pairwise randomization was performed in order to take into account socioeconomic differences. Recruited women were at 8-12 weeks' gestation and fulfilled at least one of the following criteria: body mass index ≥ 25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (> 4500 g), age ≥ 40 years, first or second degree relative with history of type 1 or 2 diabetes. Main exclusion criterion was pathological oral glucose tolerance test (OGTT) at 8-12 weeks' gestation. The trial included one counseling session on physical activity at 8-12 weeks' gestation and one for diet at 16-18 weeks' gestation, and three to four booster sessions during other routine visits. In the control clinics women received usual care. Information on height, weight gain and other gestational factors was obtained from maternity cards. Physical activity, dietary intake and quality of life were followed by questionnaires during pregnancy and at 1-year postpartum. Blood samples for lipid status, hormones, insulin and OGTT were taken at 8-12 and 26-28 weeks' gestation and 1 year postpartum. Workability and return to work were elicited by a questionnaire at 1- year postpartum. Linkage to the national birth register of years 2007-2009 will provide information on perinatal complications and GDM incidence among the non-participants of the study. Cost-effectiveness evaluation will be based on

  17. Manipulation Therapy Relieved Pain More Rapidly Than Acupuncture among Lateral Epicondylalgia (Tennis Elbow) Patients: A Randomized Controlled Trial with 8-Week Follow-Up.

    PubMed

    Hsu, Chung-Yuan; Lee, Ko-Hung; Huang, Hsin-Chia; Chang, Zi-Yu; Chen, Hsing-Yu; Yang, Tsung-Hsien

    2016-01-01

    Radial bone adjustment manipulation treatment may be effective to reduce pain rapidly in lateral epicondylalgia patients and the pathological tension in the biceps brachii muscle is highly concerned. To prove this hypothesis, we conducted a randomized controlled trial and included 35 patients with lateral epicondylalgia for more than 2 months. Either manipulation treatment (n = 16) or acupuncture (n = 19) was given to these patients for 2 weeks and all patients' symptoms were followed up for 8 weeks after treatment. Both groups demonstrated changes in pain VAS score, grip strength, and DASH questionnaire. Lateral epicondylalgia patients who received manipulation treatment felt pain relief sooner than those who had acupuncture treatments during the first few treatments. However, both acupuncture and manipulation are effective, while the difference has no significance at the 8-week follow-up. The trial was registered with Current Controlled Trials ISRCTN81308551 on 5 February 2016. PMID:27143983

  18. Manipulation Therapy Relieved Pain More Rapidly Than Acupuncture among Lateral Epicondylalgia (Tennis Elbow) Patients: A Randomized Controlled Trial with 8-Week Follow-Up

    PubMed Central

    Lee, Ko-Hung; Chang, Zi-Yu; Chen, Hsing-Yu

    2016-01-01

    Radial bone adjustment manipulation treatment may be effective to reduce pain rapidly in lateral epicondylalgia patients and the pathological tension in the biceps brachii muscle is highly concerned. To prove this hypothesis, we conducted a randomized controlled trial and included 35 patients with lateral epicondylalgia for more than 2 months. Either manipulation treatment (n = 16) or acupuncture (n = 19) was given to these patients for 2 weeks and all patients' symptoms were followed up for 8 weeks after treatment. Both groups demonstrated changes in pain VAS score, grip strength, and DASH questionnaire. Lateral epicondylalgia patients who received manipulation treatment felt pain relief sooner than those who had acupuncture treatments during the first few treatments. However, both acupuncture and manipulation are effective, while the difference has no significance at the 8-week follow-up. The trial was registered with Current Controlled Trials ISRCTN81308551 on 5 February 2016. PMID:27143983

  19. Randomized controlled trial of anterior-chamber intraocular lenses in Nepal: long-term follow-up.

    PubMed Central

    Evans, J. R.; Henning, A.; Pradhan, D.; Foster, A.; Lagnado, R.; Poulson, A.; Johnson, G. J.; Wormald, R. P.

    2000-01-01

    Most of the estimated 20 million people who are blind with cataracts live in rural areas of developing countries, where expert surgical resources are scarce. We have studied the use of multiflex open-loop anterior-chamber intraocular lenses (ACIOL) in high-volume low-cost surgery. Between 1992 and 1995, a total of 2000 people attending Lahan Eye Hospital, Nepal, with bilateral cataracts reducing vision to < or = 6/36 were randomly allocated to receive intracapsular extraction (ICCE) with aphakic spectacles, or ICCE with an ACIOL. We re-examined the cohort (1305/2000, 65%) between November 1996 and April 1997 and report the findings in this article. There were 13 new cases of poor visual outcome (best corrected vision < 6/60) arising after one year: 9 in the ACIOL group and 4 in the control group; odds ratio 2.1 (95% confidence interval, 0.59-9.55). The causes of poor outcome were as follows: ACIOL group--retinal detachment (4 cases), cystoid macular oedema (2), epiretinal membrane (1), age-related macular degeneration (1), and late endophthalmitis (1); control group--retinal detachment (2 cases), late endophthalmitis (1), and primary open-angle glaucoma with age-related macular degeneration (1). In rural areas of developing countries, well-manufactured multiflex open-loop ACIOLs can be implanted safely by experienced ophthalmologists after routine ICCE, avoiding the disadvantages of aphakic spectacle correction. PMID:10812737

  20. Computer-Guided Implant Surgery in Fresh Extraction Sockets and Immediate Loading of a Full Arch Restoration: A 2-Year Follow-Up Study of 14 Consecutively Treated Patients

    PubMed Central

    Daas, M.; Assaf, A.; Dada, K.; Makzoumé, J.

    2015-01-01

    Statement of Problem. Low scientific evidence is identified in the literature for combining implant placement in fresh extraction sockets with immediate function. Moreover, the few studies available on immediate implants in postextraction sites supporting immediate full-arch rehabilitation clearly lack comprehensive protocols. Purpose. The purpose of this study is to report outcomes of a comprehensive protocol using CAD-CAM technology for surgical planning and fabrication of a surgical template and to demonstrate that immediate function can be easily performed with immediate implants in postextraction sites supporting full-arch rehabilitation. Material and Methods. 14 subjects were consecutively rehabilitated (13 maxillae and 1 mandible) with 99 implants supporting full-arch fixed prostheses followed between 6 and 24 months (mean of 16 months). Outcome measures were prosthesis and implant success, biologic and prosthetic complications, pain, oedema evaluation, and radiographic marginal bone levels at surgery and then at 6, 12, 18, and 24 months. Data were analyzed with descriptive statistics. Results. The overall cumulative implant survival rate at mean follow-up time of 16 months was 97.97%. The average marginal bone loss was 0,9 mm. Conclusions. Within the limitations of this study, the results validate this treatment modality for full-arch rehabilitations with predictable outcomes and high survival rate after 2 years. PMID:26064119

  1. Computer-Guided Implant Surgery in Fresh Extraction Sockets and Immediate Loading of a Full Arch Restoration: A 2-Year Follow-Up Study of 14 Consecutively Treated Patients.

    PubMed

    Daas, M; Assaf, A; Dada, K; Makzoumé, J

    2015-01-01

    Statement of Problem. Low scientific evidence is identified in the literature for combining implant placement in fresh extraction sockets with immediate function. Moreover, the few studies available on immediate implants in postextraction sites supporting immediate full-arch rehabilitation clearly lack comprehensive protocols. Purpose. The purpose of this study is to report outcomes of a comprehensive protocol using CAD-CAM technology for surgical planning and fabrication of a surgical template and to demonstrate that immediate function can be easily performed with immediate implants in postextraction sites supporting full-arch rehabilitation. Material and Methods. 14 subjects were consecutively rehabilitated (13 maxillae and 1 mandible) with 99 implants supporting full-arch fixed prostheses followed between 6 and 24 months (mean of 16 months). Outcome measures were prosthesis and implant success, biologic and prosthetic complications, pain, oedema evaluation, and radiographic marginal bone levels at surgery and then at 6, 12, 18, and 24 months. Data were analyzed with descriptive statistics. Results. The overall cumulative implant survival rate at mean follow-up time of 16 months was 97.97%. The average marginal bone loss was 0,9 mm. Conclusions. Within the limitations of this study, the results validate this treatment modality for full-arch rehabilitations with predictable outcomes and high survival rate after 2 years. PMID:26064119

  2. Longitudinal 2-Year Follow-up on the Effect of a Non-Randomised School-Based Physical Activity Intervention on Reducing Overweight and Obesity of Czech Children Aged 10–12 Years

    PubMed Central

    Sigmund, Erik; Sigmundová, Dagmar

    2013-01-01

    Background: This study assessed whether the benefits of a 2-year longitudinal non-randomised school-based physical activity (PA) intervention programme to reduce overweight and obesity were still apparent two years after completion of the controlled intervention. Methods: The study involved 84 girls (G) and 92 boys (B) aged 10–12 years who had participated in the PA intervention in 2006–2008 as 6- to 9-year olds and were included in the intervention (I) (43 G and 45 B) and the control (C) groups (41 G and 47 B). Participants’ overweight/obesity was assessed using the percentile graph of Body Mass Index (BMI) from the World Health Organization for girls and boys aged 5–19. Logistic regression (Enter method) determined the overweight/obesity occurrence in a follow-up measurement (2010) two years after completion of the controlled intervention was used. Results: Two years after the controlled PA intervention had finished, the intervention children were less likely to be overweight/obese than the control children (2.3%GI vs. 17.1%GC, 6.7%BI vs. 23.4%BC, odds ratio: 0.25; 95% confidence interval: 0.12; 0.53; p < 0.001). Conclusions: The current study indicates favourable effects of an everyday school-based PA intervention programme on lower overweight/obesity incidence, which was maintained two years after the end of the direct involvement of the researchers. PMID:23959084

  3. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    NASA Astrophysics Data System (ADS)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-06-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls (p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  4. The Nurse-Led Telephone Follow-Up on Medication and Dietary Adherence among Patients after Myocardial Infarction: A Randomized Controlled Clinical Trial

    PubMed Central

    Najafi, Seyed Saeed; Shaabani, Maryam; Momennassab, Marzieh; Aghasadeghi, Kamran

    2016-01-01

    Background: Adherence to dietary and medication regimen plays an important role in successful treatment and reduces the negative complications and severity of the disease. Therefore, the present study aimed to investigate the effect of nurse-led telephone follow-up on the level of adherence to dietary and medication regimen among patients after Myocardial Infarction (MI). Methods: This non-blinded randomized controlled clinical trial was conducted on 100 elderly patients with MI who had referred to the cardiovascular clinics in Shiraz. Participants were selected and randomly assigned to intervention and control groups using balanced block randomization method. The intervention group received a nurse-led telephone follow-up. The data were collected using a demographic questionnaire, Morisky’s 8-item medication adherence questionnaire, and dietary adherence questionnaire before and three months after the intervention. Data analysis was done by the SPSS statistical software (version 21), using paired t-test for intra-group and Chi-square and t-test for between groups comparisons. Significance level was set at<0.05. Results: The results of Chi-square test showed no statistically significant difference between the intervention and control groups with respect to their adherence to dietary and medication regimen before the intervention (P>0.05). However, a statistically significant difference was found between the two groups in this regard after the intervention (P<0.05). The mean differences of dietary and medication adherence scores between pre- and post-tests were significantly different between the two groups. Independent t-test showed these differences (P=0.001). Conclusion: The results of the present study confirmed the positive effects of nurse-led telephone follow-up as a method of tele-nursing on improvement of adherence to dietary and medication regimen in the patients with MI. Trial Registration Number: IRCT201409148505N8 PMID:27382586

  5. Views of family physicians about survivorship care plans to provide breast cancer follow-up care: exploration of results from a randomized controlled trial

    PubMed Central

    O’Brien, M.A.; Grunfeld, E.; Sussman, J.; Porter, G.; Mobilio, M. Hammond

    2015-01-01

    Background The U.S. Institute of Medicine recommends that cancer patients receive survivorship care plans, but evaluations to date have found little evidence of the effectiveness of such plans. We conducted a qualitative follow-on study to a randomized controlled trial (rct) to understand the experiences of family physicians using survivorship care plans to support the follow-up of breast cancer patients. Methods A subset of family physicians whose patients were enrolled in the parent rct in Ontario and Nova Scotia were eligible for this study. In interviews, the physicians discussed survivorship care plans (intervention) or usual discharge letters (control), and their confidence in providing follow-up cancer care. Results Of 123 eligible family physicians, 18 (10 intervention, 8 control) were interviewed. In general, physicians receiving a survivorship care plan found only the 1-page care record to be useful. Physicians who received only a discharge letter had variable views about the letter’s usefulness; several indicated that it lacked information about potential cancer- or treatment-related problems. Most physicians were comfortable providing care 3–5 years after diagnosis, but desired timely and informative communication with oncologists. Conclusions Although family physicians did not find extensive survivorship care plans useful, discharge letters might not be sufficiently comprehensive for follow-up breast cancer care. Effective strategies for two-way communication between family physicians and oncologists are still lacking. PMID:26300663

  6. Single-blind, randomized controlled trial of effectiveness of Naikan therapy as an adjunctive treatment for schizophrenia over a one-year follow-up period

    PubMed Central

    ZHANG, Hong; LI, Chenhu; ZHAO, Liyu; ZHAN, Guilai

    2015-01-01

    Background Current treatments for schizophrenia are often only partially effective. Aims Assess the possible benefit of using adjunctive Naikan therapy, a cognitive approach based on self-reflection that originated in Japan for the treatment of schizophrenia. Methods After resolution of acute psychotic symptoms, 235 psychiatric inpatients with schizophrenia who had a middle school education or higher were randomly assigned to a control group (n=112) that received routine medication and inpatient rehabilitative treatment or an intervention group (n=123) that also received adjunctive Naikan therapy for 2 hours daily, 5 days a week for 4 weeks. The patients were then discharged and followed up for 12 months. The Positive and Negative Syndrome Scale (PANSS), Personal and Social Performance scale (PSP), and Insight and Attitude Questionnaire (ITAQ) were used to assess patients at enrollment, after the 1-month intervention, and after the 12-month follow-up. Evaluators were blind to the group assignment of patients. Results Only 13 (10.6%) of the intervention group participants relapsed over the 12-month follow-up, but 23 (20.5%) control group participants relapsed (X2=4.50, p=0.034). Using a modified intention-to-treat analysis and a repeated measure analysis of variance, the PANSS, PSP, and ITAQ total scores all showed significantly greater improvement over the 12-month follow-up in the Naikan group than in the control group. The drop in mean chlorpromazine-equivalent dosage from enrollment to the end of follow-up was significantly different in the intervention group but not in the control group, though the change in dosage over time between groups was not statistically significant. Conclusions This study provides robust support for the effectiveness of Naikan therapy as an adjunctive treatment during the recovery period of schizophrenia. Compared to treatment as usually, adjunctive Naikan therapy can sustain the improvement in psychotic symptoms achieved during acute

  7. Continued Follow-Up of Phambili Phase 2b Randomized HIV-1 Vaccine Trial Participants Supports Increased HIV-1 Acquisition among Vaccinated Men

    PubMed Central

    Moodie, Zoe; Metch, Barbara; Bekker, Linda-Gail; Churchyard, Gavin; Nchabeleng, Maphoshane; Mlisana, Koleka; Laher, Fatima; Roux, Surita; Mngadi, Kathryn; Innes, Craig; Mathebula, Matsontso; Allen, Mary; Bentley, Carter; Gilbert, Peter B.; Robertson, Michael; Kublin, James; Corey, Lawrence; Gray, Glenda E.

    2015-01-01

    Background The Phase 2b double-blinded, randomized Phambili/HVTN 503 trial evaluated safety and efficacy of the MRK Ad5 gag/pol/nef subtype B HIV-1 preventive vaccine vs placebo in sexually active HIV-1 seronegative participants in South Africa. Enrollment and vaccinations stopped and participants were unblinded but continued follow-up when the Step study evaluating the same vaccine in the Americas, Caribbean, and Australia was unblinded for non-efficacy. Final Phambili analyses found more HIV-1 infections amongst vaccine than placebo recipients, impelling the HVTN 503-S recall study. Methods HVTN 503-S sought to enroll all 695 HIV-1 uninfected Phambili participants, provide HIV testing, risk reduction counseling, physical examination, risk behavior assessment and treatment assignment recall. After adding HVTN 503-S data, HIV-1 infection hazard ratios (HR vaccine vs. placebo) were estimated by Cox models. Results Of the 695 eligible, 465 (67%) enrolled with 230 from the vaccine group and 235 from the placebo group. 38% of the 184 Phambili dropouts were enrolled. Enrollment did not differ by treatment group, gender, or baseline HSV-2. With the additional 1286 person years of 503-S follow-up, the estimated HR over Phambili and HVTN 503-S follow-up was 1.52 (95% CI 1.08–2.15, p = 0.02, 82 vaccine/54 placebo infections). The HR was significant for men (HR = 2.75, 95% CI 1.49, 5.06, p = 0.001) but not for women (HR = 1.12, 95% CI 0.73, 1.72, p = 0.62). Conclusion The additional follow-up from HVTN 503-S supported the Phambili finding of increased HIV-1 acquisition among vaccinated men and strengthened the evidence of lack of vaccine effect among women. Trial Registration clinicaltrials.gov NCT00413725 SA National Health Research Database DOH-27-0207-1539 PMID:26368824

  8. Effectiveness of Mental Health First Aid Training in Sweden. A Randomized Controlled Trial with a Six-Month and Two-Year Follow-Up

    PubMed Central

    Svensson, Bengt; Hansson, Lars

    2014-01-01

    Background According to a recent report from the European Brain Council and the European Colleague of Neuropsychopharmacology the one year prevalence of some kind of mental disorder is around 27% among the adult population in Europe. Research has shown a lack of mental health literacy in the population in general and it is thus important to find ways to improve the public's knowledge and skills to provide first hand support to people with mental disorders. Mental Health First Aid (MHFA) is a training program that has shown positive changes in knowledge and helping behavior. This study investigates if MHFA training in a Swedish context provides a sustained improvement in knowledge about mental disorders, a better ability to be helpful in contacts with people who are ill and if it changes attitudes in a positive direction. Methods and Findings The introduction of the training program was made in accordance with the constructor's instructions. Participants were mainly public sector employees from a county in the west of Sweden. The study was a randomized controlled trial with an experiment group (n = 199) and a control group (n = 207) placed on a waiting list during a 6-month follow-up. A two-year follow-up was conducted for participants (n = 155) from both the intervention and waiting list group who had completed the training and during the follow-up been in contact with persons with mental disorders. The intervention group improved in knowledge as well as in confidence in providing help for someone in need. The two-year follow-up showed that the improvements were to a great extent maintained. Conclusions Mental Health First Aid might raise the level of awareness of mental disorders and have an influence on the number of people who can receive professional treatment for their problems. PMID:24964164

  9. Decrease in self-esteem mediates the association between symptoms of social phobia and depression in middle adolescence in a sex-specific manner: a 2-year follow-up of a prospective population cohort study

    PubMed Central

    2014-01-01

    Background Social phobia and depression are common, highly comorbid disorders in middle adolescence. The mechanism underlying this comorbidity, however, is unclear. Decrease in self-esteem caused by the initial disorder might play a decisive role in the development of the subsequent disorder. The present study aimed to determine whether the association between symptoms of social phobia and depression is mediated by decrease in self-esteem in mid-adolescent girls and boys. Methods As a part of the prospective Adolescent Mental Health Cohort (AMCH), subjects of this study were 9th grade pupils (mean age, 15.5) responding to a survey conducted in 2002–2003 (T1) and to a 2-year follow-up survey in 2004–2005 (T2) (N = 2070, mean age 17.6 years, 54.5% girls). Results Symptoms of social phobia without symptoms of depression at age 15 and symptoms of depression at age 17 were associated only among boys, and this association was mediated by decrease in self-esteem. Symptoms of depression without symptoms of social phobia at age 15 and symptoms of social phobia at age 17 were associated only among girls, and this association was partially mediated by decrease in self-esteem. Conclusions Decrease in self-esteem plays a decisive role in the association between social phobia and depression. Self-esteem should be a key focus in interventions for adolescents suffering from social phobia or depression. Efficient intervention for the first disorder might help to prevent the decline in self-esteem and thus the incidence of the subsequent disorder. These findings are based on a sample of Finnish adolescents and should be confirmed in other jurisdictions or in more ethnically diverse samples. PMID:24641987

  10. Does multicomponent physical exercise with simultaneous cognitive training boost cognitive performance in older adults? A 6-month randomized controlled trial with a 1-year follow-up

    PubMed Central

    Eggenberger, Patrick; Schumacher, Vera; Angst, Marius; Theill, Nathan; de Bruin, Eling D

    2015-01-01

    Background Cognitive impairment is a health problem that concerns almost every second elderly person. Physical and cognitive training have differential positive effects on cognition, but have been rarely applied in combination. This study evaluates synergistic effects of multicomponent physical exercise complemented with novel simultaneous cognitive training on cognition in older adults. We hypothesized that simultaneous cognitive–physical components would add training specific cognitive benefits compared to exclusively physical training. Methods Seniors, older than 70 years, without cognitive impairment, were randomly assigned to either: 1) virtual reality video game dancing (DANCE), 2) treadmill walking with simultaneous verbal memory training (MEMORY), or 3) treadmill walking (PHYS). Each program was complemented with strength and balance exercises. Two 1-hour training sessions per week over 6 months were applied. Cognitive performance was assessed at baseline, after 3 and 6 months, and at 1-year follow-up. Multiple regression analyses with planned comparisons were calculated. Results Eighty-nine participants were randomized to the three groups initially, 71 completed the training, while 47 were available at 1-year follow-up. Advantages of the simultaneous cognitive–physical programs were found in two dimensions of executive function. “Shifting attention” showed a time×intervention interaction in favor of DANCE/MEMORY versus PHYS (F[2, 68] =1.95, trend P=0.075, r=0.17); and “working memory” showed a time×intervention interaction in favor of DANCE versus MEMORY (F[1, 136] =2.71, trend P=0.051, R2=0.006). Performance improvements in executive functions, long-term visual memory (episodic memory), and processing speed were maintained at follow-up in all groups. Conclusion Particular executive functions benefit from simultaneous cognitive–physical training compared to exclusively physical multicomponent training. Cognitive–physical training programs

  11. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study

    PubMed Central

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up. PMID:26380359

  12. A randomized, double blind comparative study of prophylactic parenteral nutritional support with or without glutamine in autologous stem cell transplantation for hematological malignancies -- three years' follow-up.

    PubMed

    Sykorova, A; Horacek, J; Zak, P; Kmonicek, M; Bukac, J; Maly, J

    2005-01-01

    Forty-four adult autologous transplant patients with hematological malignancies were randomized to receive either prophylactic parenteral nutrition PN (P group), or PN given ad hoc (C group). In each group, they were further randomized to receive standard PN (B group), or PN with 0.5 g glutamine/kg as L-Ala-L-Gln (A group). The overall survival (OS), disease-free survival (DFS) and event-free survival (EFS) in groups C vs. P and A vs. B were compared during follow-up with median 38 months. The final outcome rates in C/P/A/B groups, respectively (OS 65/81/63/85%, EFS 45/53/33/65% and DFS 56/50/35/77%), were not significantly different, apart from A < B in DFS rate (p=0.03, Fisher's exact test). Also in survival analysis (logrank test), no significant difference between groups C and P was found but generally worse parameters were observed for A vs. B group: for DFS (p=0.04) and EFS (p=0.01) the difference was significant, and for OS (p=0.09) it was borderline. In the three years' follow-up, no clinically useful benefit of prophylactic PN in autologous transplant patients was proven. Also, glutamine supplementation was not helpful, and was even connected with apparently worse long-term outcome. PMID:16284692

  13. The Effect of Follow up (Telenursing) on Liver Enzymes in Patients with Nonalcoholic Fatty Liver Disease: A Randomized Controlled Clinical Trial

    PubMed Central

    Fard, Sorur Javanmardi; Ghodsbin, Fariba; Kaviani, Mohammad Javad; Jahanbin, Iran; Bagheri, Zahra

    2016-01-01

    Background: Non-alcoholic fatty liver disease (NAFLD) is characterized by macro vesicular steatosis in the absence of alcohol. Patients with (NAFLD)need extensive education and support in their treatment. Our aim was to investigate the effect of telenursing on liver enzymes (ALT and AST) in patients with NAFLD. Methods: Our study is a randomized controlled clinical trial. In this study, 60 patients were enrolled from patients who referred to subspecialty gastrointestinal clinics affiliated to Shiraz University of Medical Sciences. Specialists confirmed their diseases by ultrasound and laboratory test. Simple randomization, based on random number table, was used to randomize the participants into intervention (N=30) and control (N=30) groups. Patients in both groups received dietary advice from a nutritionist and were trained to perform physical activities. Telephone intervention in the intervention group lasted for 12 weeks, in order to see the effect of follow up on the recommended diet and physical activities given by the specialist, while; the control group subjects were only followed up as usual by their physician. Results: The result of an independent t-test showed that the mean difference of liver Enzymes between the two groups was statistically significant (P<0.001). The difference of AST and ALT in the intervention and control groups was 18.03, -1.27 and 40.70, 1.52, respectively. Conclusion: We found out that; telenursing could have a positive effect on reduction of liver enzymes (ALT, AST) in patients with NAFLD. Trial Registration Number: IRCT2015040411691N5 PMID:27382590

  14. Vitamin E and C supplementation and risk of cancer in men: posttrial follow-up in the Physicians’ Health Study II randomized trial1234

    PubMed Central

    Sesso, Howard D; Glynn, Robert J; Christen, William G; Bubes, Vadim; Manson, JoAnn E; Buring, Julie E; Gaziano, J Michael

    2014-01-01

    Background: Recent posttrial analysis of a completed randomized trial found an increased risk of prostate cancer among healthy men taking high-dose vitamin E supplements. Trials that examined the effect of vitamin C supplements on cancer risk are few. Objective: We examined whether vitamin E or vitamin C supplementation affects the risk of cancer events during posttrial follow-up of the Physicians’ Health Study II. Design: Beginning in 1997, a total of 14,641 US male physicians aged ≥50 y were randomly assigned to receive 400 IU of vitamin E every other day, 500 mg of vitamin C daily, or their respective placebos. The vitamin E and vitamin C treatment ended in 2007, and observational follow-up continued through June 2011. Results: This study included an additional 356 cases of incident prostate cancer and 771 total cancers that developed during a mean (maximum) of 2.8 (3.8) y of posttrial observation. During an overall mean of 10.3 (13.8) y, there were a total of 1373 incident prostate cancers and 2669 total cancers documented. In comparison with placebo, vitamin E supplementation had no effect on the incidence of prostate cancer (HR: 0.99; 95% CI: 0.89, 1.10) or total cancers (HR: 1.02; 95% CI: 0.95, 1.10). There was also no effect of vitamin C supplementation on total cancers (HR: 1.02; 95% CI: 0.94, 1.10) or incident prostate cancer (HR: 1.03; 95% CI: 0.93, 1.15). Neither vitamin E nor vitamin C supplementation had effects on other site-specific cancers overall. Stratification by known cancer risk factors, history of cancer, other randomized treatment, and follow-up time showed no significant interactions. Conclusion: In this large-scale randomized trial in men, vitamin E and C supplementation had no immediate or long-term effects on the risk of total cancers, prostate cancer, or other site-specific cancers. This trial was registered at clinicaltrials.gov as NCT00270647. PMID:25008853

  15. Telemedicine Versus Standard Follow-Up Care for Diabetes-Related Foot Ulcers: Protocol for a Cluster Randomized Controlled Noninferiority Trial (DiaFOTo)

    PubMed Central

    Espehaug, Birgitte; Hausken, Marie F; Graue, Marit; Østbye, Truls; Skeie, Svein; Cooper, John G; Tell, Grethe S; Günther, Bodo Erhardt; Dale, Håvard; Smith-Strøm, Hilde; Kolltveit, Beate-Christin H; Kirkevold, Marit; Rokne, Berit

    2016-01-01

    Background This paper presents the protocol for an ongoing study to evaluate a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Diabetes-related foot ulcers represent challenges for patients and the health services. The large increase in the prevalence of diabetes, combined with the aging population, means that the absolute number of patients with diabetes-related foot ulcers is likely to continue to increase. Health care services therefore need to provide close clinical follow-up care for people with diabetes both in primary and specialist care. Information and communication technologies may enable more integrated treatment and care pathways across organizational boundaries. However, we lack knowledge about the effect of telemedicine follow-up and how such services can be optimally organized. Objective To present the design and methods of a study evaluating a telemedicine follow-up intervention for patients with diabetes-related foot ulcers. Methods The study is designed as a cluster randomized controlled trial (noninferiority trial) involving municipalities or municipality districts (clusters) belonging to one clinical site in Western Norway. The study includes patients with type 1 and type 2 diabetes presenting with a new foot ulcer at the initial visit to the clinic. Patients in the intervention group receive telemedicine follow-up care in the community. The key ingredient in the intervention is the close integration between health care levels. The intervention is facilitated by the use of an interactive wound platform consisting of a Web-based ulcer record combined with a mobile phone, enabling counseling and communication between nurses in the community and specialist health care. Patients in the control group receive standard hospital outpatient care. The primary endpoint in the trial is healing time; secondary outcomes include amputation and death, patient-reported outcome measures, and follow-up data on the recurrence of

  16. A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)

    PubMed Central

    Gysin-Maillart, Anja; Schwab, Simon; Soravia, Leila; Megert, Millie; Michel, Konrad

    2016-01-01

    Background Attempted suicide is the main risk factor for suicide and repeated suicide attempts. However, the evidence for follow-up treatments reducing suicidal behavior in these patients is limited. The objective of the present study was to evaluate the efficacy of the Attempted Suicide Short Intervention Program (ASSIP) in reducing suicidal behavior. ASSIP is a novel brief therapy based on a patient-centered model of suicidal behavior, with an emphasis on early therapeutic alliance. Methods and Findings Patients who had recently attempted suicide were randomly allocated to treatment as usual (n = 60) or treatment as usual plus ASSIP (n = 60). ASSIP participants received three therapy sessions followed by regular contact through personalized letters over 24 months. Participants considered to be at high risk of suicide were included, 63% were diagnosed with an affective disorder, and 50% had a history of prior suicide attempts. Clinical exclusion criteria were habitual self-harm, serious cognitive impairment, and psychotic disorder. Study participants completed a set of psychosocial and clinical questionnaires every 6 months over a 24-month follow-up period. The study represents a real-world clinical setting at an outpatient clinic of a university hospital of psychiatry. The primary outcome measure was repeat suicide attempts during the 24-month follow-up period. Secondary outcome measures were suicidal ideation, depression, and health-care utilization. Furthermore, effects of prior suicide attempts, depression at baseline, diagnosis, and therapeutic alliance on outcome were investigated. During the 24-month follow-up period, five repeat suicide attempts were recorded in the ASSIP group and 41 attempts in the control group. The rates of participants reattempting suicide at least once were 8.3% (n = 5) and 26.7% (n = 16). ASSIP was associated with an approximately 80% reduced risk of participants making at least one repeat suicide attempt (Wald χ21 = 13.1, 95% CI

  17. Virtual Reality-Enhanced Cognitive-Behavioral Therapy for Morbid Obesity: A Randomized Controlled Study with 1 Year Follow-Up.

    PubMed

    Manzoni, Gian Mauro; Cesa, Gian Luca; Bacchetta, Monica; Castelnuovo, Gianluca; Conti, Sara; Gaggioli, Andrea; Mantovani, Fabrizia; Molinari, Enrico; Cárdenas-López, Georgina; Riva, Giuseppe

    2016-02-01

    It is well known that obesity has a multifactorial etiology, including biological, environmental, and psychological causes. For this reason, obesity treatment requires a more integrated approach than the standard behavioral treatment based on dietary and physical activity only. To test the long-term efficacy of an enhanced cognitive-behavioral therapy (CBT) of obesity, including a virtual reality (VR) module aimed at both unlocking the negative memory of the body and to modify its behavioral and emotional correlates, 163 female morbidly obese inpatients (body mass index >40) were randomly assigned to three conditions: a standard behavioral inpatient program (SBP), SBP plus standard CBT, and SBP plus VR-enhanced CBT. Patients' weight, eating behavior, and body dissatisfaction were measured at the start and upon completion of the inpatient program. Weight was assessed also at 1 year follow-up. All measures improved significantly at discharge from the inpatient program, and no significant difference was found among the conditions. However, odds ratios showed that patients in the VR condition had a greater probability of maintaining or improving weight loss at 1 year follow-up than SBP patients had (48% vs. 11%, p = 0.004) and, to a lesser extent, than CBT patients had (48% vs. 29%, p = 0.08). Indeed, only the VR-enhanced CBT was effective in further improving weight loss at 1 year follow-up. On the contrary, participants who received only the inpatient program regained back, on average, most of the weight they had lost. Findings support the hypothesis that a VR module addressing the locked negative memory of the body may enhance the long-term efficacy of standard CBT. PMID:26430819

  18. A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up

    PubMed Central

    Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M.; Waterworth, John A.

    2015-01-01

    This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary. PMID:25926790

  19. A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up.

    PubMed

    Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M; Waterworth, John A

    2015-01-01

    This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary. PMID:25926790

  20. Randomized trial on the effectiveness of long- and short-term psychotherapy on psychosocial functioning and quality of life during a 5-year follow-up.

    PubMed

    Knekt, Paul; Heinonen, Erkki; Härkäpää, Kristiina; Järvikoski, Aila; Virtala, Esa; Rissanen, Julius; Lindfors, Olavi; Helsinki Psychotherapy Study Group

    2015-09-30

    Knowledge is incomplete on whether long-term psychotherapy is more effective than short-term therapy in treating mood and anxiety disorder, when measured by improvements in psychosocial functioning and life quality. In the Helsinki Psychotherapy Study, 326 outpatients with mood or anxiety disorder were randomized to solution-focused therapy (SFT), short-term psychodynamic psychotherapy (SPP), or long-term psychodynamic psychotherapy (LPP), and followed up for 5 years from the start of treatment. The outcome measures comprised 4 questionnaires on psychosocial functioning, assessing global social functioning (Social Adjustment Scale (SAS-SR), sense of coherence (Sense of Coherence Scale (SOC)), perceived competence (Self-Performance Survey), dispositional optimism (Life Orientation Test (LOT)), and 1 questionnaire assessing quality of life (Life Situation Survey (LSS)). Short-term therapies improved psychosocial functioning and quality of life more than LPP during the first year. The only exceptions were LOT and perceived competence, which did not differ between SPP and LPP. Later in the follow-up, SOC and perceived competence showed significantly more improvement in LPP than in the short-term therapy groups. No direct differences between SFT and SPP were noted. Short-term therapy has consistently more short-term effects on psychosocial functioning and quality of life than LPP, whereas LPP has some additional long-term benefits on psychosocial functioning. PMID:26162657

  1. An Education- and Telephone-Based Intervention to Improve Follow-up to Vision Care in Patients With Diabetes: A Prospective, Single-Blinded, Randomized Trial.

    PubMed

    Zangalli, Camila S; Murchison, Ann P; Hale, Nicole; Hark, Lisa A; Pizzi, Laura T; Dai, Yang; Leiby, Benjamin E; Haller, Julia A

    2016-01-01

    The aim was to evaluate the effectiveness of a multipronged intervention on diabetic dilated fundus examination (DFE) adherence. In a prospective trial, 521 patients with diabetes who were due for follow-up DFEs were randomized to usual care or the intervention group. Usual care received a form letter reminder to schedule and an automated reminder phone call prior to their appointment. Intervention participants received an educational brochure about diabetic eye disease and a personalized letter reminder to schedule. A research assistant called intervention participants to help schedule the appointment, and they received a reminder letter and an automated phone call prior to the scheduled visit. Patients in the intervention group were significantly more likely to schedule (63% vs 40%; P < .0001) and complete their appointment (48% vs 30%; P < .0001) compared with usual care. A multipronged intervention, including an educational mailing and telephone assistance with scheduling an appointment, significantly improved diabetic DFE adherence. PMID:25270737

  2. A Randomized Controlled Trial of Brief Motivational Interviewing in Impaired Driving Recidivists: A 5-Year Follow-Up of Traffic Offenses and Crashes

    PubMed Central

    Ouimet, Marie Claude; Dongier, Maurice; Di Leo, Ivana; Legault, Lucie; Tremblay, Jacques; Chanut, Florence; Brown, Thomas G

    2013-01-01

    Background In a previously published randomized controlled trial (Brown et al. Alcohol Clin Exp Res 2010; 34, 292–301), our research team showed that a 30-minute brief motivational interviewing (BMI) session was more effective in reducing percentages of risky drinking days in drunk driving recidivists than a control information–advice intervention at 12-month follow-up. In this sequel to the initial study, 2 main hypotheses were tested: (i) exposure to BMI increases the time to further arrests and crashes compared with exposure to the control intervention (CTL) and (ii) characteristics, such as age, moderate the benefit of BMI. Methods A sample of 180 community-recruited recidivists who had drinking problems participated in the study. Participants gave access to their provincial driving records at baseline and were followed up for a mean of 1,684.5 days (SD = 155.7) after randomization to a 30-minute BMI or CTL session. Measured outcomes were driving arrests followed by convictions including driving while impaired (DWI), speeding, or other moving violations as well as crashes. Age, readiness to change alcohol consumption, alcohol misuse severity, and number of previous DWI convictions were included as potential moderators of the effect of the interventions. Results For arrests, Cox proportional hazards modeling revealed no significant differences between the BMI and the CTL group. When analyses were adjusted to age tertile categories, a significant effect of BMI in the youngest age tertile (<43 years old) emerged. For crashes, no between-group differences were detected. Conclusions BMI was better at delaying DWI and other dangerous traffic violations in at-risk younger drivers compared with a CTL similar to that provided in many remedial programs. BMI may be useful as an opportunistic intervention for DWI recidivism prevention in settings such as DWI courts. Treatment effectiveness studies are needed to ascertain how the present findings generalize to the

  3. Predictive significance of the overvaluation of shape/weight in obese patients with binge eating disorder: findings from a randomized controlled trial with 12-month follow-up

    PubMed Central

    Grilo, C. M.; White, M. A.; Gueorguieva, R.; Wilson, G. T.; Masheb, R. M.

    2013-01-01

    Background Undue influence of body shape or weight on self-evaluation – referred to as overvaluation – is considered a core feature across eating disorders, but is not a diagnostic requirement for binge eating disorder (BED). This study examined the concurrent and predictive significance of overvaluation of shape/weight in obese patients with BED participating in a randomized clinical trial testing cognitive behavioral therapy (CBT) and behavioral weight loss (BWL). Method A total of 90 participants were randomly assigned to 6-month group treatments of CBT or BWL. Assessments were performed at baseline, throughout- and post-treatment, and at 6- and 12-month follow-ups after completing treatments with reliably administered semi-structured interviews and established measures. Results Participants categorized with overvaluation (n=52, 58%) versus without overvaluation (n=38, 42%) did not differ significantly in demographic features (age, gender and ethnicity), psychiatric co-morbidity, body mass index or binge eating frequency. The overvaluation group had significantly greater levels of eating disorder psychopathology and poorer psychological functioning (higher depression and lower self-esteem) than the non-overvaluation group. Overvaluation of shape/weight significantly predicted non-remission from binge eating and higher frequency of binge eating at the 12-month follow-up, even after adjusting for group differences in depression and self-esteem levels. Conclusions Our findings suggest that overvaluation does not simply reflect concern commensurate with being obese or more frequent binge eating, but also is strongly associated with heightened eating-related psychopathology and psychological distress, and has negative prognostic significance for longer-term treatment outcomes. Overvaluation of shape/weight warrants consideration as a diagnostic specifier for BED as it provides important information about severity and treatment outcome. PMID:22967857

  4. The effect of a text message and telephone follow-up program on cardiac self-efficacy of patients with coronary artery disease: A randomized controlled trial

    PubMed Central

    Boroumand, Saba; Moeini, Mahin

    2016-01-01

    Background: Cardiac self-efficacy is an essential factor in persistence of healthy behaviors in patients with coronary artery disease (CAD). Today, telenursing methods have numerous applications in health care. Therefore, this study aimed to determine the effect of a text message and telephone follow-up program on cardiac self-efficacy of patients with CAD. Materials and Methods: This was a randomized controlled trial on 70 patients with CAD who were hospitalized in Shahid Chamran Hospital (Isfahan, Iran). The participants were randomly assigned to the experimental and control groups. Collection of data on cardiac self-efficacy was performed before, 3 months after, and 4 months after the beginning of the intervention using Cardiac Self-Efficacy Scale designed by Sullivan et al. During the 3 months of intervention, six messages were sent to the subjects each week and calls were made twice a week in the first month and once a week during the second and third months. The statistical analysis of data was performed using independent t-test, Chi-square, Mann-Whitney U test, and repeated measures analysis of variance (ANOVA). Results: Before the intervention, there was no significant difference between the mean scores of cardiac self-efficacy of the two groups. However, 3 months and 4 months after the beginning of the intervention, the mean score of cardiac self-efficacy in the experimental group was significantly higher than in the control group (P < 0.001). Conclusions: The text message and telephone follow-up program is effective in promoting the cardiac self-efficacy of patients with CAD. PMID:27095991

  5. Virtual Reality for Enhancing the Cognitive Behavioral Treatment of Obesity With Binge Eating Disorder: Randomized Controlled Study With One-Year Follow-up

    PubMed Central

    Cesa, Gian Luca; Bacchetta, Monica; Castelnuovo, Gianluca; Conti, Sara; Gaggioli, Andrea; Mantovani, Fabrizia; Molinari, Enrico; Cárdenas-López, Georgina; Riva, Giuseppe

    2013-01-01

    Background Recent research identifies unhealthful weight-control behaviors (fasting, vomiting, or laxative abuse) induced by a negative experience of the body, as the common antecedents of both obesity and eating disorders. In particular, according to the allocentric lock hypothesis, individuals with obesity may be locked to an allocentric (observer view) negative memory of the body that is no longer updated by contrasting egocentric representations driven by perception. In other words, these patients may be locked to an allocentric negative representation of their body that their sensory inputs are no longer able to update even after a demanding diet and a significant weight loss. Objective To test the brief and long-term clinical efficacy of an enhanced cognitive-behavioral therapy including a virtual reality protocol aimed at unlocking the negative memory of the body (ECT) in morbidly obese patients with binge eating disorders (BED) compared with standard cognitive behavior therapy (CBT) and an inpatient multimodal treatment (IP) on weight loss, weight loss maintenance, BED remission, and body satisfaction improvement, including psychonutritional groups, a low-calorie diet (1200 kcal/day), and physical training. Methods 90 obese (BMI>40) female patients with BED upon referral to an obesity rehabilitation center were randomly assigned to conditions (31 to ECT, 30 to CBT, and 29 to IP). Before treatment completion, 24 patients discharged themselves from hospital (4 in ECT, 10 in CBT, and 10 in IP). The remaining 66 inpatients received either 15 sessions of ECT, 15 sessions of CBT, or no additional treatment over a 5-week usual care inpatient regimen (IP). ECT and CBT treatments were administered by 3 licensed psychotherapists, and patients were blinded to conditions. At start, upon completion of the inpatient treatment, and at 1-year follow-up, patients' weight, number of binge eating episodes during the previous month, and body satisfaction were assessed by self

  6. Intervention Effects on Diurnal Cortisol Rhythms of CPS-Referred Infants Persist into Early Childhood: Preschool Follow-up Results of a Randomized Clinical Trial

    PubMed Central

    Bernard, Kristin; Hostinar, Camelia; Dozier, Mary

    2015-01-01

    Importance A number of interventions for at-risk children have shown benefits immediately after treatment. However, the present study shows persistent long-term effects of a parenting intervention on children's hypothalamic-pituitary-adrenal (HPA) activity, a physiological stress system that is implicated in numerous psychological and physical health problems across the lifespan. Objective To examine whether differences in diurnal cortisol production between children receiving the active parenting intervention and children in the control group persisted at a preschool follow-up (approximately 3 years post-intervention). Design Between-subject comparison of cortisol patterns among 2 groups of children (experimental and control groups). Setting Children involved with Child Protective Services following allegations of neglect. Participants A sample of 115 children (43.5% female) between 46.5 and 69.6 months of age (M = 50.73, SD = 4.98), who had been previously randomly assigned to either the ABC intervention (n = 54) or the control intervention (n = 61). Intervention The Attachment and Biobehavioral Catch-up Intervention (ABC) was the experimental intervention and it focused on three aims: increasing parental nurturance to child distress, increasing synchronous interactions, and decreasing frightening parental behavior. The control intervention provided educational information about child development to parents. Both interventions were manualized and involved 10 sessions implemented by a trained parent coach in the families' homes or other places of residence. Main Outcome Measure Salivary cortisol samples collected at waking and bedtime for children on 3 separate days. Results Analyses revealed significant differences in cortisol production at the preschool follow-up, such that children in the ABC intervention group exhibited a typical pattern with higher morning levels and a steep decline across the day, whereas the control group showed a flatter cortisol rhythm

  7. Randomized Trial of Postoperative Adjuvant Therapy in Stage II and III Rectal Cancer to Define the Optimal Sequence of Chemotherapy and Radiotherapy: 10-Year Follow-Up

    SciTech Connect

    Kim, Tae-Won; Lee, Je-Hwan; Lee, Jung-Hee; Ahn, Jin-Hee; Kang, Yoon-Koo; Lee, Kyoo-Hyung; Yu, Chang-Sik; Kim, Jong-Hoon; Ahn, Seung-Do; Kim, Woo-Kun; Kim, Jin-Cheon; Lee, Jung-Shin

    2011-11-15

    Purpose: To determine the optimal sequence of postoperative adjuvant chemotherapy and radiotherapy in patients with Stage II or III rectal cancer. Methods and Materials: A total of 308 patients were randomized to early (n = 155) or late (n = 153) radiotherapy (RT). Treatment included eight cycles of chemotherapy, consisting of fluorouracil 375 mg/m{sup 2}/day and leucovorin 20 mg/m{sup 2}/day, at 4-week intervals, and pelvic radiotherapy of 45 Gy in 25 fractions. Radiotherapy started on Day 1 of the first chemotherapy cycle in the early RT arm and on Day 1 of the third chemotherapy cycle in the late RT arm. Results: At a median follow-up of 121 months for surviving patients, disease-free survival (DFS) at 10 years was not statistically significantly different between the early and late RT arms (71% vs. 63%; p = 0.162). A total of 36 patients (26.7%) in the early RT arm and 49 (35.3%) in the late RT arm experienced recurrence (p = 0.151). Overall survival did not differ significantly between the two treatment groups. However, in patients who underwent abdominoperineal resection, the DFS rate at 10 years was significantly greater in the early RT arm than in the late RT arm (63% vs. 40%; p = 0.043). Conclusions: After the long-term follow-up duration, this study failed to show a statistically significant DFS advantage for early radiotherapy with concurrent chemotherapy after resection of Stage II and III rectal cancer. Our results, however, suggest that if neoadjuvant chemoradiation is not given before surgery, then early postoperative chemoradiation should be considered for patients requiring an abdominoperineal resection.

  8. Is there a role of pulsed electromagnetic fields in management of patellofemoral pain syndrome? Randomized controlled study at one year follow-up.

    PubMed

    Servodio Iammarrone, Clemente; Cadossi, Matteo; Sambri, Andrea; Grosso, Eugenio; Corrado, Bruno; Servodio Iammarrone, Fernanda

    2016-02-01

    Patellofemoral pain syndrome (PFPS) is a common cause of recurrent or chronic knee pain in young adults, generally located in the retropatellar region. Etiology is controversial and includes several factors, such as anatomical defects, muscular imbalance, or joint overuse. Good results have been reported with exercise therapy, including home exercise program (HEP). Joint inflammation with increase of pro-inflammatory cytokines levels in the synovial fluid might be seen especially when chondromalacia becomes evident. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has shown anti-inflammatory effects and anabolic chondrocyte activity. The purpose of this randomized controlled study was to evaluate if the combination of HEP with PEMFs was more effective than HEP alone in PFPS treatment. Thirty-one PFPS patients were enrolled in this study. All patients were instructed to train with HEP. Patients in the PEMFs group associated HEP with PEMFs. Function and pain were assessed with Victorian Institute of Sport Assessment score (VISA), Visual Analog Scale (VAS), and Feller's Patella Score at baseline at 2, 6, and 12 months of follow-up. Drug assumption was also recorded. Increase in VISA score was significantly higher in PEMFs group compared to controls at 6 and 12 months, as well as the increase in the Feller's Patella Score at 12 months. VAS score became significantly lower in the PEMFs group with respect to control group since 6 month follow-up. Pain reduction obtained with PEMFs enhanced practicing therapeutic exercises leading to a better recovery process; this is extremely important in addressing the expectations of young patients, who wish to return to sporting activities. PMID:26756278

  9. THE MOTHERS AND TODDLERS PROGRAM, AN ATTACHMENT-BASED PARENTING INTERVENTION FOR SUBSTANCE-USING WOMEN: RESULTS AT 6-WEEK FOLLOW-UP IN A RANDOMIZED CLINICAL PILOT

    PubMed Central

    SUCHMAN, NANCY E.; DECOSTE, CINDY; MCMAHON, THOMAS J.; ROUNSAVILLE, BRUCE; MAYES, LINDA

    2012-01-01

    Previously, we reported posttreatment findings from a randomized pilot study testing a new attachment-based parenting intervention for mothers enrolled in substance-use treatment and caring for children ages birth to 3 years (N.E. Suchman, C. DeCoste, N. Castiglioni, T. McMahon, B. Rounsaville, & L. Mayes, 2010). The Mothers and Toddlers Program (MTP) is a 12-session, weekly individual parenting therapy that aims to enhance maternal capacity for reflective functioning and soften harsh and distorted mental representations of parenting. In a randomized pilot study, 47 mothers who were enrolled in outpatient substance-abuse treatment and caring for children between birth and 3 years of age were randomized to the MTP versus the Parent Education Program (PE), a comparison intervention that provided individual case management and developmental guidance. At the end of treatment, mothers in the MTP condition demonstrated better reflective functioning, representation quality, and caregiving behavior than did mothers in the PE condition. In this investigation, we examined whether the benefits of MTP at posttreatment were sustained at the 6-week follow-up. Recently, we also identified two components of parental reflective functioning: (a) a self-focused component representing the parent's capacity to mentalize about strong personal emotions (e.g., anger, guilt, or pain) and their impact on the child and (b) a child-focused component representing the parent's capacity to mentalize about the child's emotions and their impact on the mother (N. Suchman, C. DeCoste, D. Leigh, & J. Borelli, 2010). In this study, we reexamined posttreatment outcomes using these two related, but distinct, constructs. PMID:22685361

  10. Long-Term Survival and Dialysis Dependency Following Acute Kidney Injury in Intensive Care: Extended Follow-up of a Randomized Controlled Trial

    PubMed Central

    Gallagher, Martin; Cass, Alan; Bellomo, Rinaldo; Finfer, Simon; Gattas, David; Lee, Joanne; Lo, Serigne; McGuinness, Shay; Myburgh, John; Parke, Rachael; Rajbhandari, Dorrilyn

    2014-01-01

    Background The incidence of acute kidney injury (AKI) is increasing globally and it is much more common than end-stage kidney disease. AKI is associated with high mortality and cost of hospitalisation. Studies of treatments to reduce this high mortality have used differing renal replacement therapy (RRT) modalities and have not shown improvement in the short term. The reported long-term outcomes of AKI are variable and the effect of differing RRT modalities upon them is not clear. We used the prolonged follow-up of a large clinical trial to prospectively examine the long-term outcomes and effect of RRT dosing in patients with AKI. Methods and Findings We extended the follow-up of participants in the Randomised Evaluation of Normal vs. Augmented Levels of RRT (RENAL) study from 90 days to 4 years after randomization. Primary and secondary outcomes were mortality and requirement for maintenance dialysis, respectively, assessed in 1,464 (97%) patients at a median of 43.9 months (interquartile range [IQR] 30.0–48.6 months) post randomization. A total of 468/743 (63%) and 444/721 (62%) patients died in the lower and higher intensity groups, respectively (risk ratio [RR] 1.04, 95% CI 0.96–1.12, p = 0.49). Amongst survivors to day 90, 21 of 411 (5.1%) and 23 of 399 (5.8%) in the respective groups were treated with maintenance dialysis (RR 1.12, 95% CI 0.63–2.00, p = 0.69). The prevalence of albuminuria among survivors was 40% and 44%, respectively (p = 0.48). Quality of life was not different between the two treatment groups. The generalizability of these findings to other populations with AKI requires further exploration. Conclusions Patients with AKI requiring RRT in intensive care have high long-term mortality but few require maintenance dialysis. Long-term survivors have a heavy burden of proteinuria. Increased intensity of RRT does not reduce mortality or subsequent treatment with dialysis. Trial registration www.ClinicalTrials.gov NCT00221013

  11. Evaluation of the efficacy of memantine in the treatment of fibromyalgia: study protocol for a doubled-blind randomized controlled trial with six-month follow-up

    PubMed Central

    2013-01-01

    Background Fibromyalgia is a prevalent chronic rheumatic disease of great clinical importance. Recent studies have found raised levels of glutamate in the insula, hippocampus and posterior cingulate cortex regions of the brains of fibromyalgia (FM) patients. This finding has led researchers to speculate about the usefulness of glutamate-blocking drugs such as memantine in the treatment of fibromyalgia. The hypothesis of this study is that the administration of memantine will reduce the glutamate levels, and futhermore, will decrease the perceived pain. The aim of this study is to evaluate the efficacy of memantine in the treatment of pain (pain perception). A secondary objective is to evaluate the efficacy of memantine in the treatment of other clinical symptoms of FM, and to evaluate the efficacy of memantine in reducing brain levels of glutamate, and its effects on the central nervous system as a whole. Method/Design A double-blind parallel randomized controlled trial. Participants, Seventy patients diagnosed with FM will be recruited from primary health care centers in Zaragoza, Spain. Intervention. The subjects will be randomized in two groups: A) A treatment group (n = 35), which will receive 20 mg of memantine daily; B) A control group (n = 35), to which will be administered a placebo. There will be a six-month follow-up period (including a titration period of one month). Outcomes. The main efficacy variable of this study is pain (pain perception). The secondary efficacy variables are clinical symptoms (pain threshold, cognitive function, health status, anxiety, depression, clinical impression and quality of life) and glutamate levels in different regions of the brain, which will be assessed by magnetic resonance spectroscopy. Randomization and blinding. Randomization has been computer-generated, and the random allocation sequence will be implemented by telephone. Subjects of the study and the research assistants will be blinded to group assignment

  12. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION).

    PubMed

    Jabbour, Elias; Kantarjian, Hagop M; Saglio, Giuseppe; Steegmann, Juan Luis; Shah, Neil P; Boqué, Concepción; Chuah, Charles; Pavlovsky, Carolina; Mayer, Jirí; Cortes, Jorge; Baccarani, Michele; Kim, Dong-Wook; Bradley-Garelik, M Brigid; Mohamed, Hesham; Wildgust, Mark; Hochhaus, Andreas

    2014-01-23

    This analysis explores the impact of early cytogenetic and molecular responses on the outcomes of patients with chronic myeloid leukemia in chronic phase (CML-CP) in the phase 3 DASatinib versus Imatinib Study In treatment-Naive CML patients trial with a minimum follow-up of 3 years. Patients with newly diagnosed CML-CP were randomized to receive 100 mg dasatinib (n = 259) or 400 mg imatinib (n = 260) once daily. The retrospective landmark analysis included patients evaluable at the relevant time point (3, 6, or 12 months). Median time to complete cytogenetic response was 3 vs 6 months with dasatinib vs imatinib. At 3 and 6 months, the proportion of patients with BCR-ABL transcript levels ≤10% was higher in the dasatinib arm. Deeper responses at 3, 6, and 12 months were observed in a higher proportion of patients on dasatinib therapy and were associated with better 3-year progression-free survival and overall survival in both arms. First-line dasatinib resulted in faster and deeper responses compared with imatinib. The achievement of an early molecular response was predictive of improved progression-free survival and overall survival, supporting new milestones for optimal response in patients with early CML-CP treated with tyrosine kinase inhibitors. This study was registered at www.clinicaltrials.gov as NCT00481247. PMID:24311723

  13. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION)

    PubMed Central

    Jabbour, Elias; Saglio, Giuseppe; Steegmann, Juan Luis; Shah, Neil P.; Boqué, Concepción; Chuah, Charles; Pavlovsky, Carolina; Mayer, Jiří; Cortes, Jorge; Baccarani, Michele; Kim, Dong-Wook; Bradley-Garelik, M. Brigid; Mohamed, Hesham; Wildgust, Mark; Hochhaus, Andreas

    2014-01-01

    This analysis explores the impact of early cytogenetic and molecular responses on the outcomes of patients with chronic myeloid leukemia in chronic phase (CML-CP) in the phase 3 DASatinib versus Imatinib Study In treatment-Naive CML patients trial with a minimum follow-up of 3 years. Patients with newly diagnosed CML-CP were randomized to receive 100 mg dasatinib (n = 259) or 400 mg imatinib (n = 260) once daily. The retrospective landmark analysis included patients evaluable at the relevant time point (3, 6, or 12 months). Median time to complete cytogenetic response was 3 vs 6 months with dasatinib vs imatinib. At 3 and 6 months, the proportion of patients with BCR-ABL transcript levels ≤10% was higher in the dasatinib arm. Deeper responses at 3, 6, and 12 months were observed in a higher proportion of patients on dasatinib therapy and were associated with better 3-year progression-free survival and overall survival in both arms. First-line dasatinib resulted in faster and deeper responses compared with imatinib. The achievement of an early molecular response was predictive of improved progression-free survival and overall survival, supporting new milestones for optimal response in patients with early CML-CP treated with tyrosine kinase inhibitors. This study was registered at www.clinicaltrials.gov as NCT00481247. PMID:24311723

  14. A LONG-TERM FOLLOW-UP STUDY OF A RANDOMIZED CONTROLLED TRIAL OF MOTHER-INFANT PSYCHOANALYTIC TREATMENT: OUTCOMES ON MOTHERS AND INTERACTIONS.

    PubMed

    Salomonsson, Majlis Winberg; Sorjonen, Kimmo; Salomonsson, Björn

    2015-01-01

    An earlier randomized controlled trial (RCT) compared 80 mother-infant dyads in a Stockholm sample. One had received mother-infant psychoanalytic treatment [mother-infant psychoanalytic therapies (MIP) group], and the other received Child Health Center care (CHCC group). Effects were found on mother-reported depression and expert-rated mother-infant relationship qualities and maternal sensitivity. When the children were 412 years, the dyads were followed up with assessments of the children's attachment representations, social and emotional development, and global functioning, and the mothers' psychological well-being and representations of the child as well as the mother-child interactions. We gathered data from 66 cases approximately 312 years' posttreatment. All scores involving the mothers had now approached community levels. We found effects on maternal depression in favor of MIP, but no other between-group differences. The MIP treatments seemed to have helped the mothers to recover more quickly on personal well-being, to become more sensitive to their babies' suffering, and to better support and appreciate their children throughout infancy and toddlerhood. If so, this would explain why the MIP children had a better global functioning and were more often "OK" and less often "Troubled" at 412 years. PMID:26551600

  15. Extracorporeal shock wave therapy for non-calcific supraspinatus tendinitis - 10-year follow-up of a randomized placebo-controlled trial.

    PubMed

    Efe, Turgay; Felgentreff, Markus; Heyse, Thomas J; Stein, Thomas; Timmesfeld, Nina; Schmitt, Jan; Roessler, Philip P

    2014-10-01

    Evidence for the efficacy of extracorporeal shock wave therapy (ESWT) in supraspinatus tendinopathy without calcification is sparse, and therefore this treatment option is often controversial. Patients of a randomized placebo-controlled study to analyze the effects of ESWT on function and pain were revisited 10 years after the initial consultation. The former verum group received 6000 impulses (energy flux density, 0.11 mJ/mm²) in three sessions after local anesthesia between 1999 and 2000. The placebo group had 6000 impulses of a sham ESWT after local anesthesia in the same period. Re-evaluation of the patients included a relative Constant score as well as pain measurements (visual analogue scale) during activity and at rest. No significant changes (p>0.05) in relative Constant scores, pain at rest, or pain during activity could be found after a 10-year follow-up between the placebo and verum groups after ESWT. The treatment of non-calcific supraspinatus tendinopathy with ESWT does not seem to have an effect on function or pain improvement in the long run. The results of the present study cannot advise the use of ESWT in cases of non-calcific supraspinatus tendinopathy. PMID:24728846

  16. Twelve-month follow-up of advance provision of emergency contraception among teenage girls in Sweden—a randomized controlled trial

    PubMed Central

    Tydén, Tanja; Darj, Elisabeth; Larsson, Margareta

    2013-01-01

    Objective. The objective of this study was to evaluate the effect of an intervention with advance provision of emergency contraceptive pills (ECP), condoms, and extended information to a targeted group of teenage girls, compared with a control group, 12 months after intervention. Material and methods. A randomized controlled trial among 420 girls, 15–19 years old, requesting emergency contraception at a youth clinic in Sweden was carried out. Data were collected by a questionnaire at the initial visit and structured telephone interviews 12 months after enrolment. Differences between the intervention group and the control group regarding ECP use, time interval from unprotected intercourse to ECP intake, contraceptive use, and sexual risk-taking were analysed. Results. One year after the intervention 62% of the girls could be reached for follow-up. The girls in the intervention group reported a shorter time interval (mean 15.3 hours) from unprotected intercourse to ECP intake compared to the control group (mean 25.8 hours) (p = 0.019), without any evidence of decreased use of contraceptives or increased sexual risk-taking. Conclusion. Even up to 12 months following the intervention, advance provision of ECP at one single occasion, to a specific target group of adolescent girls, shortens the time interval from unprotected intercourse to pill intake, without jeopardizing contraceptive use or increasing sexual risk-taking. Considering the clinical relevance of these results, we suggest that advance provision of ECP could be implemented as a routine preventive measure for this target group. PMID:24102148

  17. Hyperbaric Oxygen Treatment of Chronic Refractory Radiation Proctitis: A Randomized and Controlled Double-Blind Crossover Trial With Long-Term Follow-Up

    SciTech Connect

    Clarke, Richard E. Tenorio, L. M. Catalina; Hussey, James R.; Toklu, Akin S.; Cone, D. Lindsie; Hinojosa, Jose G.; Desai, Samir P.; Dominguez Parra, Luis; Rodrigues, Sylvia D.; Long, Robert J.; Walker, Margaret B.

    2008-09-01

    Purpose: Cancer patients who undergo radiotherapy remain at life-long risk of radiation-induced injury to normal tissues. We conducted a randomized, controlled, double-blind crossover trial with long-term follow-up to evaluate the effectiveness of hyperbaric oxygen for refractory radiation proctitis. Methods and Materials: Patients with refractory radiation proctitis were randomized to hyperbaric oxygen at 2.0 atmospheres absolute (Group 1) or air at 1.1 atmospheres absolute (Group 2). The sham patients were subsequently crossed to Group 1. All patients were re-evaluated by an investigator who was unaware of the treatment allocation at 3 and 6 months and Years 1-5. The primary outcome measures were the late effects normal tissue-subjective, objective, management, analytic (SOMA-LENT) score and standardized clinical assessment. The secondary outcome was the change in quality of life. Results: Of 226 patients assessed, 150 were entered in the study and 120 were evaluable. After the initial allocation, the mean SOMA-LENT score improved in both groups. For Group 1, the mean was lower (p 0.0150) and the amount of improvement nearly twice as great (5.00 vs. 2.61, p = 0.0019). Similarly, Group 1 had a greater portion of responders per clinical assessment than did Group 2 (88.9% vs. 62.5%, respectively; p 0.0009). Significance improved when the data were analyzed from an intention to treat perspective (p = 0.0006). Group 1 had a better result in the quality of life bowel bother subscale. These differences were abolished after the crossover. Conclusion: Hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis, generating an absolute risk reduction of 32% (number needed to treat of 3) between the groups after the initial allocation. Other medical management requirements were discontinued, and advanced interventions were largely avoided. Enhanced bowel-specific quality of life resulted.

  18. Back to the future – feasibility of recruitment and retention to patient education and telephone follow-up after hip fracture: a pilot randomized controlled trial

    PubMed Central

    Langford, Dolores P; Fleig, Lena; Brown, Kristin C; Cho, Nancy J; Frost, Maeve; Ledoyen, Monique; Lehn, Jayne; Panagiotopoulos, Kostas; Sharpe, Nina; Ashe, Maureen C

    2015-01-01

    Objectives Our primary aim of this pilot study was to test feasibility of the planned design, the interventions (education plus telephone coaching), and the outcome measures, and to facilitate a power calculation for a future randomized controlled trial to improve adherence to recovery goals following hip fracture. Design This is a parallel 1:1 randomized controlled feasibility study. Setting The study was conducted in a teaching hospital in Vancouver, BC, Canada. Participants Participants were community-dwelling adults over 60 years of age with a recent hip fracture. They were recruited and assessed in hospital, and then randomized after hospital discharge to the intervention or control group by a web-based randomization service. Treatment allocation was concealed to the investigators, measurement team, and data entry assistants and analysts. Participants and the research physiotherapist were aware of treatment allocation. Intervention Intervention included usual care for hip fracture plus a 1-hour in-hospital educational session using a patient-centered educational manual and four videos, and up to five postdischarge telephone calls from a physiotherapist to provide recovery coaching. The control group received usual care plus a 1-hour in-hospital educational session using the educational manual and videos. Measurement Our primary outcome was feasibility, specifically recruitment and retention of participants. We also collected selected health outcomes, including health-related quality of life (EQ5D-5L), gait speed, and psychosocial factors (ICEpop CAPability measure for Older people and the Hospital Anxiety and Depression Scale). Results Our pilot study results indicate that it is feasible to recruit, retain, and provide follow-up telephone coaching to older adults after hip fracture. We enrolled 30 older adults (mean age 81.5 years; range 61–97 years), representing a 42% recruitment rate. Participants excluded were those who were not community dwelling on

  19. Concomitant Cisplatin and Hyperfractionated Radiotherapy in Locally Advanced Head and Neck Cancer: 10-Year Follow-Up of a Randomized Phase III Trial (SAKK 10/94)

    SciTech Connect

    Ghadjar, Pirus; Simcock, Mathew; Studer, Gabriela; Allal, Abdelkarim S.; Ozsahin, Mahmut; Bernier, Jacques; Toepfer, Michael; Zimmermann, Frank; Betz, Michael; Glanzmann, Christoph; Aebersold, Daniel M.

    2012-02-01

    Purpose: To compare the long-term outcome of treatment with concomitant cisplatin and hyperfractionated radiotherapy versus treatment with hyperfractionated radiotherapy alone in patients with locally advanced head and neck cancer. Methods and Materials: From July 1994 to July 2000, a total of 224 patients with squamous cell carcinoma of the head and neck were randomized to receive either hyperfractionated radiotherapy alone (median total dose, 74.4 Gy; 1.2 Gy twice daily; 5 days per week) or the same radiotherapy combined with two cycles of cisplatin (20 mg/m{sup 2} for 5 consecutive days during weeks 1 and 5). The primary endpoint was the time to any treatment failure; secondary endpoints were locoregional failure, metastatic failure, overall survival, and late toxicity assessed according to Radiation Therapy Oncology Group criteria. Results: Median follow-up was 9.5 years (range, 0.1-15.4 years). Median time to any treatment failure was not significantly different between treatment arms (hazard ratio [HR], 1.2 [95% confidence interval {l_brace}CI{r_brace}, 0.9-1.7; p = 0.17]). Rates of locoregional failure-free survival (HR, 1.5 [95% CI, 1.1-2.1; p = 0.02]), distant metastasis-free survival (HR, 1.6 [95% CI, 1.1-2.5; p = 0.02]), and cancer-specific survival (HR, 1.6 [95% CI, 1.0-2.5; p = 0.03]) were significantly improved in the combined-treatment arm, with no difference in major late toxicity between treatment arms. However, overall survival was not significantly different (HR, 1.3 [95% CI, 0.9-1.8; p = 0.11]). Conclusions: After long-term follow-up, combined-treatment with cisplatin and hyperfractionated radiotherapy maintained improved rates of locoregional control, distant metastasis-free survival, and cancer-specific survival compared to that of hyperfractionated radiotherapy alone, with no difference in major late toxicity.

  20. A phase III randomized trial of postoperative pelvic irradiation in stage IB cervical carcinoma with poor prognostic features: Follow-up of a gynecologic oncology group study

    SciTech Connect

    Rotman, Marvin . E-mail: mrotman@downstate.edu; Sedlis, Alexander; Piedmonte, Marion R.; Bundy, Brian; Lentz, Samuel S.; Muderspach, Laila I.; Zaino, Richard J.

    2006-05-01

    Purpose: To investigate, in a phase III randomized trial, whether postoperative external-beam irradiation to the standard pelvic field improves the recurrence-free interval and overall survival (OS) in women with Stage IB cervical cancers with negative lymph nodes and certain poor prognostic features treated by radical hysterectomy and pelvic lymphadenectomy. Methods and Materials: Eligible patients had Stage IB cervical cancer with negative lymph nodes but with 2 or more of the following features: more than one third (deep) stromal invasion, capillary lymphatic space involvement, and tumor diameter of 4 cm or more. The study group included 277 patients: 137 randomized to pelvic irradiation (RT) and 140 randomized to observation (OBS). The planned pelvic dose was from 46 Gy in 23 fractions to 50.4 Gy in 28 fractions. Results: Of the 67 recurrences, 24 were in the RT arm and 43 were in the OBS arm. The RT arm showed a statistically significant (46%) reduction in risk of recurrence (hazard ratio [HR] = 0.54, 90% confidence interval [CI] = 0.35 to 0.81, p = 0.007) and a statistically significant reduction in risk of progression or death (HR = 0.58, 90% CI = 0.40 to 0.85, p = 0.009). With RT, 8.8% of patients (3 of 34) with adenosquamous or adenocarcinoma tumors recurred vs. 44.0% (11 of 25) in OBS. Fewer recurrences were seen with RT in patients with adenocarcinoma or adenosquamous histologies relative to others (HR for RT by histology interaction = 0.23, 90% CI = 0.07 to 0.74, p = 0.019). After an extensive follow-up period, 67 deaths have occurred: 27 RT patients and 40 OBS patients. The improvement in overall survival (HR = 0.70, 90% CI = 0.45 to 1.05, p = 0.074) with RT did not reach statistical significance. Conclusions: Pelvic radiotherapy after radical surgery significantly reduces the risk of recurrence and prolongs progression-free survival in women with Stage IB cervical cancer. RT appears to be particularly beneficial for patients with adenocarcinoma or

  1. Randomized Controlled Trial of Forward-Planned Intensity Modulated Radiotherapy for Early Breast Cancer: Interim Results at 2 Years

    SciTech Connect

    Barnett, Gillian C.; Wilkinson, Jennifer S.; Moody, Anne M.; Wilson, Charles B.; Twyman, Nicola; Wishart, Gordon C.; Burnet, Neil G.; Coles, Charlotte E.

    2012-02-01

    Purpose: This single-center randomized trial was designed to investigate whether intensity-modulated radiotherapy (IMRT) reduces late toxicity in patients with early-stage breast cancer. Methods and Materials: The standard tangential plans of 1,145 nonselected patients were analyzed. The patients with inhomogeneous plans were randomized to a simple method of forward-planned IMRT or standard radiotherapy (RT). The primary endpoint was serial photographic assessment of breast shrinkage. Results: At 2 years, no significant difference was found in the development of any photographically assessed breast shrinkage between the patients randomized to the interventional or control group (odds ratio, 1.51; 95% confidence interval, 0.83-1.58; p = .41). The patients in the control group were more likely to develop telangiectasia than those in the IMRT group (odds ratio, 1.68; 95% confidence interval 1.13-2.40; p = .009). Poor baseline surgical cosmesis resulted in poor overall cosmesis at 2 years after RT. In patients who had good surgical cosmesis, those randomized to IMRT were less likely to deteriorate to a moderate or poor overall cosmesis than those in the control group (odds ratio, 0.63; 95% confidence interval, 0.39-1.03, p = .061). Conclusions: IMRT can lead to a significant reduction in telangiectasia at comparatively early follow-up of only 2 years after RT completion. An important component of breast induration and shrinkage will actually result from the surgery and not from the RT. Surgical cosmesis is an important determinant of overall cosmesis and could partially mask the longer term benefits of IMRT at this early stage.

  2. Standardized web-based cognitive behavioural therapy of mild to moderate depression: a randomized controlled trial with a long-term follow-up.

    PubMed

    Ruwaard, Jeroen; Schrieken, Bart; Schrijver, Menno; Broeksteeg, Janneke; Dekker, Jack; Vermeulen, Hans; Lange, Alfred

    2009-01-01

    Depression is common but undertreated. Web-based self-help provides a widely accessible treatment alternative for mild to moderate depression. However, the lack of therapist guidance may limit its efficacy. The authors assess the efficacy of therapist-guided web-based cognitive behavioural treatment (web-CBT) of mild to moderate depression. Fifty-four individuals with chronic, moderate depression participated in a randomized wait-list controlled trial, with an 18-month follow-up (immediate treatment: n = 36, wait-list control: n = 18). Primary outcome measures were the Beck Depression Inventory (BDI-IA) and the Depression scale of the Symptom Checklist-90-Revised (SCL-90-R. DEP). Secondary outcome measures were the Depression Anxiety Stress Scales and the Well-Being Questionnaire. Five participants (9%) dropped out. Intention-to-treat analyses of covariance revealed that participants in the treatment condition improved significantly more than those in the wait-list control condition (.011 < p < .015). With regard to the primary measures, between-group effects (d) were 0.7 for the BDI-IA and 1.1 for the SCL-90-R DEP. Posttest SCL-90- R DEP scores indicated recovery of 49% of the participants in the treatment group compared with 6% in the control group (odds ratio = 14.5; p < .004). On average, the effects were stable up to 18 months (n = 39), although medication was a strong predictor of relapse. The results demonstrate the efficacy of web-CBT for mild to moderate depression and the importance of therapist guidance in psychological interventions. PMID:19221919

  3. One-year follow-up of mud-bath therapy in patients with bilateral knee osteoarthritis: a randomized, single-blind controlled trial

    NASA Astrophysics Data System (ADS)

    Fioravanti, A.; Bacaro, G.; Giannitti, C.; Tenti, S.; Cheleschi, S.; Guidelli, G. M.; Pascarelli, N. A.; Galeazzi, M.

    2015-09-01

    The objective of this prospective parallel randomized single-blind study was to assess that a cycle of mud-bath therapy (MBT) provides any benefits over usual treatment in patients with bilateral knee osteoarthritis (OA). Patients with symptomatic primary bilateral knee OA, according to ACR criteria, were included in the study and randomized to one of two groups: one group received a cycle of MBT at spa center of Chianciano Terme (Italy) in addition to the usual treatment, and one group continued their regular care routine alone. Clinical assessments were performed 7 days before enrollment (screening visit), at the time of enrollment (basal time), after 2 weeks, and after 3, 6, 9, and 12 months after the beginning of the study. All assessments were conducted by two researchers blinded to treatment allocation. The primary efficacy outcomes were the global pain score evaluated by Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore for physical function (W-TPFS). Of the 235 patients screened, 103 met the inclusion criteria: 53 patients were included in the MBT group and 50 in the control group. In the group of patients treated with MBT, we observed a statistically significant ( p < 0.001) reduction of VAS and W-TPFS score at the end of the treatment; this improvement was significant ( p < 0.05) also at 3 months of follow-up. The control group did not show significant differences between baseline time and all other times. The differences between one group were significant for both primary parameters already from the 15th day and persisted up to the 9th month. This beneficial effect was confirmed by the significant reduction of symptomatic drug consumption. Tolerability of MBT seemed to be good, with light and transitory side effects. Our results confirm that a cycle of MBT added to usual treatment provides a beneficial effect on the painful symptoms and functional capacities in patients with knee OA that

  4. A Randomized Controlled Trial of Relationship Education in the U.S. Army: 2-Year Outcomes

    PubMed Central

    Stanley, Scott M.; Rhoades, Galena K.; Loew, Benjamin A.; Allen, Elizabeth S.; Carter, Sarah; Osborne, Laura J.; Prentice, Donnella; Markman, Howard J.

    2014-01-01

    This study examined the effectiveness of an evidence-based, community-delivered adaptation of couple relationship education (CRE; specifically, PREP, The Prevention and Relationship Enhancement Program) delivered at two Army installations. The study is a randomized controlled trial with two years of follow-up, examining marital quality and stability. Sample composition was 662 married couples with a spouse in the U.S. Army. Analyses yielded no evidence of overall enduring intervention effects on relationship quality but couples assigned to intervention at the higher risk site were significantly less likely than controls to be divorced at the two-year follow-up (8.1% vs. 14.9%, p < .01). This effect was moderated by ethnic minority status. Specifically, the impact of the intervention on divorce was strongest for minority couples. The findings add to the literature on who may benefit most from CRE. PMID:25419027

  5. Impact of Continued Mailed Fecal Tests in the Patient-Centered Medical Home: Year 3 of the Systems of Support to Increase Colon Cancer Screening and Follow-Up Randomized Trial

    PubMed Central

    Green, Beverly B.; Anderson, Melissa L.; Chubak, Jessica; Fuller, Sharon; Meenan, Richard T.; Vernon, Sally W.

    2016-01-01

    BACKGROUND The current study was conducted to determine the effect of continuing a centralized fecal occult blood test (FOBT) mailed program on screening adherence. METHODS A patient-level randomized controlled trial was conducted in 21 patient-centered medical home primary care clinics between January 2010 and November 2012. A total of 2208 patients ranging in age from 52 to 75 years in a substudy of the Systems of Support to Increase Colon Cancer Screening and Follow-Up (SOS) trial were randomized at year 3 to continued automated interventions (Continued group), which included mailed information regarding colorectal cancer (CRC) screening choices, and were mailed stool kit tests or to a group in which interventions were stopped (Stopped group). The main outcomes and measures were the completion of CRC screening in year 3 and by subgroup characteristics, respectively. RESULTS Adherence to CRC screening in year 3 was found to be significantly higher in patients in the Continued group compared with those in the Stopped group (53.3% vs 37.3%; adjusted net difference, 15.6% [P<.001]). This difference was entirely due to greater completion of FOBT (adjusted net difference, 18.0% [P<.001]). Year 3 CRC screening rates were highest in patients in the Continued group completing FOBT in both years 1 and 2 (77.2%), followed by patients completing only 1 FOBT in 1 of the 2 years (44.6%), with low rates of CRC testing reported among patients not completing any FOBT within the first 2 years (18.1%). CONCLUSIONS A centralized mailed FOBT CRC screening program continued to be more effective than patient-centered medical home usual-care interventions, but only for those patients who had previously completed FOBT testing. Research is needed regarding how to engage patients not completing CRC testing after being mailed at least 2 rounds of FOBT tests. PMID:26488332

  6. Initial Outcomes From a 4-Week Follow-Up Study of the Text4baby Program in the Military Women’s Population: Randomized Controlled Trial

    PubMed Central

    Wallace Bihm, Jasmine; Szekely, Daniel; Nielsen, Peter; Murray, Elizabeth; Abroms, Lorien; Snider, Jeremy

    2014-01-01

    Background The use of mobile phone technologies for health promotion and disease prevention has advanced rapidly in recent years. Text4baby is a theory-based mobile health (mHealth) program in which text messages are delivered to pregnant women and new mothers to improve their health care beliefs and behaviors and improve health status and clinical outcomes. Recent evaluations of Text4baby have found that it improves targeted health attitudes and beliefs, but effects on behavior have not yet been determined. Objective In this study, investigators aimed to evaluate Text4baby in the military women’s population. Methods Investigators conducted a randomized controlled trial at Madigan Army Medical Center in Tacoma, Washington, from December 2011 through September 2013. All participants were pregnant women first presenting for care at Madigan. Investigators conducted a baseline assessment using a 24-item, self-administered online survey of attitudes and behaviors related to Text4baby message content. Participants were randomized to Text4baby plus usual care (intervention) or usual care alone (control). Investigators analyzed treatment effects of Text4baby on short-term targeted outcomes 4 weeks post enrollment. Results For this study, 943 patients were randomized and completed a baseline assessment. The average patient age was 28 years and nearly 70% self-identified as Caucasian. 48.7% of enrollees (459/943) completed the first follow-up assessment. Higher rates of single and working/in-school patients dropped out of the intervention arm of the study, and we adjusted for this finding in subsequent models. However, while investigators were unable to re-survey these participants, only 1.9% of Text4baby enrollees (18/943) dropped the service during the study period. Adjusted and unadjusted logistic generalized estimating equation models were developed to assess intervention effects on measured outcomes. In the model adjusting for age, marital status, having had a

  7. Phase 1b Randomized Trial and Follow-Up Study in Uganda of the Blood-Stage Malaria Vaccine Candidate BK-SE36

    PubMed Central

    Yeka, Adoke; Balikagala, Betty; Suzuki, Nahoko; Shirai, Hiroki; Yagi, Masanori; Ito, Kazuya; Fukushima, Wakaba; Hirota, Yoshio; Nsereko, Christopher; Okada, Takuya; Kanoi, Bernard N.; Tetsutani, Kohhei; Arisue, Nobuko; Itagaki, Sawako; Tougan, Takahiro; Ishii, Ken J.; Ueda, Shigeharu; Egwang, Thomas G.; Horii, Toshihiro

    2013-01-01

    . Risk ratio for BKSE1.0 was 0.48 (95% CI, 0.24–0.98; p = 0.04). Conclusion BK-SE36 is safe and immunogenic. The promising potential of BK-SE36, observed in the follow-up study, warrants a double-blind phase 1/2b trial in children under 5 years. Trial Registration Controlled-Trials.com ISRCTN71619711 ISRCTN71619711 PMID:23724021

  8. Anthropometrics and Body Composition by Dual Energy X-Ray in Children of Obese Women: A Follow-Up of a Randomized Controlled Trial (the Lifestyle in Pregnancy and Offspring [LiPO] Study)

    PubMed Central

    Tanvig, Mette; Vinter, Christina A.; Jørgensen, Jan S.; Wehberg, Sonja; Ovesen, Per G.; Lamont, Ronald F.; Beck-Nielsen, Henning

    2014-01-01

    Objective In obese women, 1) to assess whether lower gestational weight gain (GWG) during pregnancy in the lifestyle intervention group of a randomized controlled trial (RCT) resulted in differences in offspring anthropometrics and body composition, and 2) to compare offspring outcomes to a reference group of children born to women with a normal Body Mass Index (BMI). Research design and methods The LiPO (Lifestyle in Pregnancy and Offspring) study was an offspring follow-up of a RCT with 360 obese pregnant women with a lifestyle intervention during pregnancy including dietary advice, coaching and exercise. The trial was completed by 301 women who were eligible for follow-up. In addition, to the children from the RCT, a group of children born to women with a normal BMI were included as a reference group. At 2.8 (range 2.5–3.2) years, anthropometrics were measured in 157 children of the RCT mothers and in 97 reference group children with Body Mass Index (BMI) Z-score as a primary outcome. Body composition was estimated by Dual Energy X-ray (DEXA) in 123 successful scans out of 147 (84%). Results No differences between randomized groups were seen in mean (95% C.I.) BMI Z-score (intervention group 0.06 [−0.17; 0.29] vs. controls −0.18 [−0.43; 0.05]), in the percentage of overweight or obese children (10.9% vs. 6.7%), in other anthropometrics, or in body composition values by DEXA. Outcomes between children from the RCT and the reference group children were not significantly different. Conclusions The RCT with lifestyle intervention in obese pregnant women did not result in any detectable effect on offspring anthropometrics or body composition by DEXA at 2.8 years of age. This may reflect the limited difference in GWG between intervention and control groups. Offspring of obese mothers from the RCT were comparable to offspring of mothers with a normal BMI. Trial registration clinicaltrials.gov NCT00530439, NCT01918319 and NCT01918423. URL: NCT00530439&quest

  9. Early ankle mobilization, Part II: A one-year follow-up of acute, lateral ankle sprains (a randomized clinical trial).

    PubMed

    Dettori, J R; Basmania, C J

    1994-01-01

    A 1-year follow-up of military members who received either early ankle mobilization or cast immobilization following a moderate or severe lateral ankle sprain was conducted to determine the long-term effects between these two forms of conservative treatment. Functional job- and sports-related disabilities together with subjective complaints were assessed. A significantly large proportion (44%) of all subjects were symptomatic at follow-up. Those receiving early ankle mobilization had slightly more residual subjective complaints compared with those receiving cast immobilization. There was, however, little effect on functional job- or sports-related disability, the early mobilization group having slightly fewer functional problems. There was no difference in subjective complaints or functional limitations by the degree of injury for moderate or severe lateral ankle sprains. PMID:8164861

  10. Prognostic Significance of VEGF after Twenty-Year Follow-up in a Randomized Trial of Fenretinide in Non-Muscle-Invasive Bladder Cancer.

    PubMed

    Puntoni, Matteo; Petrera, Marilena; Campora, Sara; Garrone, Elsa; Defferrari, Carlotta; Torrisi, Rosalba; Johansson, Harriet; Bruno, Silvia; Curotto, Antonio; DeCensi, Andrea

    2016-06-01

    Non-muscle-invasive bladder cancer (NMIBC) may progress to muscle-invasive disease, but no effective preventive treatments are available. In addition, no reliable prognostic biomarkers have been identified. We assessed the long-term effect of the oral retinoid fenretinide and the prognostic value of circulating VEGF levels. We updated through the Tumor Registry the vital status of 99 patients with resected Ta/T1 bladder tumors who were recruited in a randomized trial of 2 years of fenretinide or no treatment in 1993-1994. Serum VEGF levels measured at baseline and 12 months were available in a subgroup of 62 patients. After a median of 20.5 years, 54 subjects died, 35 of any cancer and 14 of bladder cancer. Neither overall survival (OS), nor cancer survival (CS) or bladder cancer survival (BCS) was affected by fenretinide (log-rank P ≥ 0.2). DNA aneuploidy in bladder washing was associated with shorter OS (P = 0.02), CS (P = 0.05), and BCS (P = 0.09). Subjects with baseline VEGF levels in the top quintile (≥350 pg/mL) had a significantly shorter OS (P = 0.01), CS (P = 0.02), and BCS (P = 0.008). The trend across quintiles of VEGF was significant for BCS (P = 0.007). Multivariate analyses showed that, in addition to smoking status, VEGF level in the top quintile was an independent prognostic factor for OS (HR = 2.7; 95% CI, 1.1-6.5), CS (HR = 3.3; 95% CI, 1.1-9.4) and BCS (HR = 8.9; 95% CI,1.3-61). Fenretinide did not affect the long-term outcome of patients with NMIBC. High serum VEGF level was a significant predictor of overall and cancer death and may help to identify high-risk subjects who may benefit from a preventive therapy. Cancer Prev Res; 9(6); 437-44. ©2016 AACR. PMID:27045034

  11. Actis Total Hip System 2 Year Follow-up

    ClinicalTrials.gov

    2016-08-09

    Osteoarthritis; Traumatic Arthritis; Rheumatoid Arthritis; Congenital Hip Dysplasia; Avascular Necrosis of the Femoral Head; Acute Traumatic Fracture of the Femoral Head or Neck; Certain Cases of Ankylosis; Non-union of Femoral Neck Fractures; Certain High Sub-Capital and Femoral Neck Fractures in the Elderly

  12. Effect of Self Care Education with and without Telephone Follow-Up on the Level of Hope in Renal Dialysis Patients: A Single-Blind Randomized Controlled Clinical Trial

    PubMed Central

    Poorgholami, Farzad; Mansoori, Parisa; Montaseri, Zohreh; Najafi, Kazem

    2016-01-01

    Background: Various strategies such as teaching self care to hemodialysis patients have been employed to increase the level of their hope. This study aimed at examining the effects of a telephone follow-up program on the level of hope in a self care education program. Methods: In this single-blind randomized controlled clinical trial, 75 hemodialysis patients, selected by convenient sampling, were randomly assigned to 3 groups (n=25 each) including a control, a self care education, or a self care education with telephone follow-up. The control group received the routine care. The self care education group received 5 instruction sessions. The telephone follow-up group had similar instructional sessions followed by telephone calls during the subsequent 2 months. Data, collected using demographic information list and Miller’s hope questionnaire, were analyzed using Chi-Square, t-test, and one-way ANOVA followed by Scheffee test. Results: There was no significant difference among the scores of hope in the three groups before the intervention (P=0.40). However, after the intervention, the level of hope in the self care education group and self care education plus telephone follow-up groups were significantly higher than that of the control group (P=0.001). Moreover, the level of hope in the group with self care education plus telephone follow-up was significantly (P=0.001) more than that of the self care education group. Conclusion: Our findings indicated that teaching followed by telephone follow-up was associated with higher levels of hope. Therefore, such a strategy may be employed to improve the quality of life of patients with renal dialysis. Trial Registration Number: IRCT2014042617440N1 PMID:27382592

  13. Substance Use and Delinquency among Middle School Girls in Foster Care: A Three-Year Follow-Up of a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Kim, Hyoun K.; Leve, Leslie D.

    2011-01-01

    Objective: The present study evaluated the efficacy of the Middle School Success intervention (MSS) for reducing substance use and delinquency among girls in foster care, using a randomized controlled trial design. The program was designed to fill a service gap during the summer prior to the middle school transition and to prevent delinquency,…

  14. A randomized, controlled clinical trial of standard, group and brief cognitive-behavioral therapy for panic disorder with agoraphobia: a two-year follow-up.

    PubMed

    Marchand, André; Roberge, Pasquale; Primiano, Sandra; Germain, Vanessa

    2009-12-01

    A randomized controlled clinical trial with a wait-list control group was conducted to examine the effectiveness of three modalities (brief, group, and standard) of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants meeting DSM-IV criteria were randomly assigned to each treatment condition: a 14-session standard CBT (n=33), a 14-session group CBT (n=35) and a 7-session brief CBT (n=32). Participants received a self-study manual and were assigned weekly readings and exercises. The results indicate that regardless of the treatment condition, CBT for moderate to severe PDA is beneficial in medium and long term. To this effect, all three-treatment conditions significantly reduced the intensity of symptoms, increased participants' quality of life, offered high effect sizes, superior maintenance of gains over time, and lower rates of relapse, compared to the wait-list control. PMID:19709851

  15. Long Term Follow-Up after a Randomized Integrated Educational and Psychosocial Intervention in Patient-Partner Dyads Affected by Heart Failure

    PubMed Central

    2015-01-01

    Background To date, contemporary heart failure care remains patient-focused, but awareness of the partners’ and families’ situation is increasing. Randomized studies have mainly evaluated the short-term effects of dyadic interventions. Therefore, the aim of this study was to determine the 24-month effects of an intervention with psych-educational support in dyads of heart failure patients and their partners. Methods This study used a randomized study design and 155 patient-partner dyads were enrolled. The intervention included a nurse-led program of three sessions addressing psychoeducational support. Results The intervention did not have any effect on health, depressive symptoms or perceived control among the patient-partner dyads after 24 months. Furthermore, time to first event did not differ significantly between the intervention group and the control patients. Conclusion This study may be regarded as a first step in trying to understand dyads’ need for supportive care. Individualized and more targeted interventions seem necessary to achieve a higher impact on dyad outcomes. Trial Registration ClinicalTrials.gov NCT02398799 PMID:26406475

  16. Splenic irradiation before hematopoietic stem cell transplantation for chronic myeloid leukemia: long-term follow-up of a prospective randomized study.

    PubMed

    Gratwohl, Alois; Iacobelli, Simona; Bootsman, Natalia; van Biezen, Anja; Baldomero, Helen; Arcese, William; Arnold, Renate; Bron, Dominique; Cordonnier, Catherine; Ernst, Peter; Ferrant, Augustin; Frassoni, Francesco; Gahrton, Gösta; Richard, Carlos; Kolb, Hans Jochem; Link, Hartmut; Niederwieser, Dietger; Ruutu, Tapani; Schattenberg, Anton; Schmitz, Norbert; Torres-Gomez, Antonio; Zwaan, Ferry; Apperley, Jane; Olavarria, Eduardo; Kröger, Nicolaus

    2016-05-01

    In the context of discussions on the reproducibility of clinical studies, we reanalyzed a prospective randomized study on the role of splenic irradiation as adjunct to the conditioning for hematopoietic stem cell transplantation (HSCT) for chronic myeloid leukemia (CML). Between 1986 and 1989, a total of 229 patients with CML were randomized; of these, 225 (98 %; 112 with, 113 without splenic irradiation) could be identified in the database and their survival updated. Results confirmed the early findings with no significant differences in all measured endpoints (overall survival at 25 years: 42.7 %, 32.0-52.4 % vs 52.9 %, 43.2-62.6 %; p = 0.355, log rank test). Additional splenic irradiation failed to reduce relapse incidence. It did not increase non-relapse mortality nor the risk of late secondary malignancies. Comforting are the long-term results from this predefined consecutive cohort of patients: more than 60 % were alive at plus 25 years when they were transplanted with a low European Society for Blood and Marrow Transplantation (EBMT) risk sore. This needs to be considered today when treatment options are discussed for patients who failed initial tyrosine kinase inhibitor therapy and have an available low risk HLA-identical donor. PMID:26994010

  17. Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial

    PubMed Central

    Peterson, Arthur V.; Marek, Patrick M.; Kealey, Kathleen A.; Bricker, Jonathan B.; Ludman, Evette J.; Heffner, Jaimee L.

    2016-01-01

    Background The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. Methods High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. Results No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. Conclusions There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post

  18. A Randomized controlled trial comparing patellar retention versus patellar resurfacing in primary total knee arthroplasty: 5–10 year follow-up

    PubMed Central

    2012-01-01

    Background The primary purpose of this randomized controlled trial (RCT) was to compare knee-specific outcomes (stiffness, pain, function) between patellar retention and resurfacing up to 10 years after primary total knee arthroplasty (TKA). Secondarily, we compared re-operation rates. Methods 38 subjects with non-inflammatory arthritis were randomized at primary TKA surgery to receive patellar resurfacing (n = 21; Resurfaced group) or to retain their native patella (n = 17; Non-resurfaced group). Evaluations were performed preoperatively, one, five and 10 years postoperatively by an evaluator who was blinded to group allocation. Self-reported knee-specific stiffness, pain and function, the primary outcomes, were measured by the Western Ontario McMaster Osteoarthritis Index (WOMAC). Revision rate was determined at each evaluation and through hospital record review. Results 30 (88%) and 23 (72%) of available subjects completed the five and 10-year review respectively. Knee-specific scores continued to improve for both groups over the 10-years, despite diminishing overall health with no significant group differences seen. All revisions occurred within five years of surgery (three Non-resurfaced subjects; one Resurfaced subject) (p = 0.31). Two revisions in the Non-resurfaced group were due to persistent anterior knee pain. Conclusions We found no differences in knee-specific results between groups at 5–10 years postoperatively. The Non-resurfaced group had two revisions due to anterior knee pain similar to rates reported in other studies. Knee-specific results provide useful postoperative information and should be used in future studies comparing patellar management strategies. ClinicalTrials.gov identifier NCT01500252 PMID:22676495

  19. Six-Month Follow-Up of a Randomized Controlled Trial Augmenting Serotonin Reuptake Inhibitor Treatment With Exposure and Ritual Prevention for Obsessive-Compulsive Disorder

    PubMed Central

    Foa, Edna B.; Simpson, Helen Blair; Liebowitz, Michael R.; Powers, Mark B.; Rosenfield, David; Cahill, Shawn P.; Campeas, Raphael; Franklin, Martin; Hahn, Chang-Gyu; Hembree, Elizabeth A.; Huppert, Jonathan D.; Schmidt, Andrew B.; Vermes, Donna; Williams, Monnica T.

    2014-01-01

    Objective This article describes the long-term effects of augmenting serotonin reuptake inhibitors (SRIs) with exposure and ritual prevention or stress management training in patients with DSM-IV obsessive-compulsive disorder (OCD). Method Between November 2000 and November 2006, 111 OCD patients from 2 academic outpatient centers with partial SRI response were randomized to the addition of exposure and ritual prevention or stress management training, delivered twice weekly for 8 weeks (acute phase); 108 began treatment. Responders (38 of 52 in the exposure and ritual prevention condition, 11 of 52 in the stress management training condition) entered a 24-week maintenance phase. The Yale-Brown Obsessive Compulsive Scale (YBOCS) was the primary outcome measure. Results After 24 weeks, patients randomized to and receiving exposure and ritual prevention versus stress management training had significantly better outcomes (mean YBOCS scores of 14.69 and 21.37, respectively; t = 2.88, P = .005), higher response rates (decrease in YBOCS scores ≥ 25%: 40.7% vs 9.3%, Fisher exact test P < .001), and higher rates of excellent response (YBOCS score ≤ 12: 24.1% vs 5.6%, Fisher exact test P = .01). During the maintenance phase, the slope of change in YBOCS scores was not significant in either condition (all P values ≥ .55), with no difference between exposure and ritual prevention and stress management training (P > .74). Better outcome was associated with baseline variables: lower YBOCS scores, higher quality of life, fewer comorbid Axis I diagnoses, and male sex. Conclusions Augmenting SRIs with exposure and ritual prevention versus stress management training leads to better outcome after acute treatment and 24 weeks later. Maintenance outcome, however, was primarily a function of OCD severity at entrance. Greater improvement during the acute phase influences how well patients maintain their gains, regardless of treatment condition. PMID:23759449

  20. Effectiveness of Comprehensive Health Education Combining Lifestyle Education and Hot Spa Bathing for Male White-Collar Employees: A Randomized Controlled Trial with 1-Year Follow-Up

    PubMed Central

    Kamioka, Hiroharu; Nakamura, Yosikazu; Okada, Shinpei; Kitayuguchi, Jun; Kamada, Masamitsu; Honda, Takuya; Matsui, Yuzuru; Mutoh, Yoshiteru

    2009-01-01

    Background Physical activity is known to prevent obesity and metabolic syndrome in middle-aged and elderly people; however, the effectiveness of a comprehensive health education program for male white-collar employees is uncertain. Methods Forty-three men volunteered to participate in this study and were randomly assigned into 2 groups. The intervention group participated in a 2-hour program comprising comprehensive health education and hot spa bathing, offered once every 2 weeks, in addition to individualized programs once a week, for 24 weeks. The control group received only general health guidance. We compared their lifestyle characteristics and physical and mental health criteria at baseline, immediately after the intervention, and 1 year after the end of the intervention. Results Rates of adherence to individualized programs were 60.0 ± 27.2% and 30.5 ± 29.6% at the end of the intervention and at 1 year after the end of the intervention, respectively. Significant (P < 0.05) interaction of criteria was observed for cluster of differentiation 4+ (CD4+) cells and the ratio of cluster of differentiation 4+ to 8+ (CD4/8) cells, which were used to represent the participants' immunological function. We divided the intervention group into 2 subgroups on the basis of their attendance. Among the resulting 3 groups, significant interaction of criteria was observed for CD4+ and CD4/8 cells. In addition, the high attendance group had the highest CD4+ count and CD4/8 ratio. Conclusions Participants who attended classes and/or performed the supplementary individualized programs tended to maintain their immunological function and to experience a decrease in body fat percentage. However, few effects were noted in participants with poor adherence, even in the intervention group. PMID:19687610

  1. Prospective Randomized Study Comparing Combined Phaco-ExPress and Phacotrabeculectomy in Open Angle Glaucoma Treatment: 12-Month Follow-Up

    PubMed Central

    Konopińska, Joanna; Deniziak, Marta; Saeed, Emil; Bartczak, Agnieszka; Zalewska, Renata; Mariak, Zofia; Rękas, Marek

    2015-01-01

    Purpose of the Study. To compare the efficacy and safety of phacotrabeculectomy (P-Trab) and phacoemulsification with the ExPress (P-ExPress) mini glaucoma shunt implantation. Study Plan. Prospective randomized study. Material and Methods. 85 eyes with cataract and unregulated open angle glaucoma. There were 46 eyes in the P-ExPress and 39 the P-Trab group. Intraocular pressure (IOP), the number of antiglaucoma medications, qualified and complete surgical success (defined as IOP ≤ 18.0 mmHg), visual acuity (CDVA), the number of endothelial cells, and postoperative complications and additional procedures were assessed. Results. After 12 months of observation, the average IOP in the P-Express group went from 26.4 ± 9.3 down to 17.1 ± 5 mmHg (P < 0.05) and from 27.9 ± 12.9 down to 15.9 ± 2.7 mmHg in the P-Trab group (P < 0.05). No significant differences in the amount of medications used after surgery and CDVA were discovered between the groups. In the P-ExPress group, greater loss of endothelial cells was noted (CDloss%), compared to the P-Trab group. Conclusions. Both P-ExPress and P-Trab have comparable efficacy and similar early postoperative complication profile. The presence of additional implant (as is the case of the ExPress mini glaucoma shunt implantation) may cause progressive loss of endothelial cells. PMID:26137318

  2. Intravenous corticotrophin vs. hydrocortisone in the treatment of hospitalized patients with Crohn's disease: a randomized double-blind study and follow-up.

    PubMed

    Chun, A; Chadi, R M; Korelitz, B I; Colonna, T; Felder, J B; Jackson, M H; Morgenstern, E H; Rubin, S D; Sacknoff, A G; Gleim, G M

    1998-08-01

    Adrenocorticotrophic hormone (ACTH) and corticosteroids have no maintenance values for inflammatory bowel disease but serve to reduce the severity of disease. The effectiveness of intravenous corticotrophin versus hydrocortisone in ulcerative colitis has been determined including whether previous steroid therapy influenced the better response to one rather than the other, but no such studies have ever been done in Crohn's disease. Eighty-eight patients hospitalized with moderate-to-severe Crohn's disease (Present-Korelitz [P-K] Index -3 to -2 and the International Organisation for the Study of Inflammatory Bowel Disease-Crohn's & Colitis Foundation of America [IOIBD-CCFA] Index, mean 14, range 5-23) were treated in a prospective, randomized, double-blind clinical trial to receive either continuous intravenous infusion of 120 U/day of ACTH (44 patients) or hydrocortisone 300 mg/day (44 patients). Patients were also subdivided into those who received oral steroids during the 30 days prior to intravenous therapy and those who had not. Response was followed on a daily basis and tabulated at 3, 5, and 10 days. Patients were followed from 1-3 years to determine the later status. After 10 days of intravenous therapy 36 of 44 patients (82%) who received ACTH and 41 of 44 patients (93%) who received hydrocortisone fully responded (P-K index +3 and IOIBD-CCFA Index mean of 3). At the end of the study, response to intravenous ACTH and hydrocortisone was not statistically different whether or not patients received oral steroids during the 30 days prior to admission, although the response to IV ACTH tended to be faster at 3 days in those who had received previous steroid therapy. Intravenous ACTH and hydrocortisone are equally effective in achieving therapeutic goals in patients with Crohn's disease who have not achieved results with oral medications. Moreover the response rate was high (mean 88%), serving to buy time for establishment of successful maintenance programs of

  3. Results at 24 months from the prospective, randomized, multicenter Investigational Device Exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients

    PubMed Central

    Delamarter, Rick B.; Murrey, Daniel; Janssen, Michael E.; Goldstein, Jeffrey A.; Zigler, Jack; Tay, Bobby K-B; Darden, Bruce

    2010-01-01

    Background Cervical total disk replacement (TDR) is intended to address pain and preserve motion between vertebral bodies in patients with symptomatic cervical disk disease. Two-year follow-up for the ProDisc-C (Synthes USA Products, LLC, West Chester, Pennsylvania) TDR clinical trial showed non-inferiority versus anterior cervical discectomy and fusion (ACDF), showing superiority in many clinical outcomes. We present the 4-year interim follow-up results. Methods Patients were randomized (1:1) to ProDisc-C (PDC-R) or ACDF. Patients were assessed preoperatively, and postoperatively at 6 weeks and 3, 6, 12, 18, 24, 36, and 48 months. After the randomized portion, continued access (CA) patients also underwent ProDisc-C implantation, with follow-up visits up to 24 months. Evaluations included Neck Disability Index (NDI), Visual Analog Scale (VAS) for pain/satisfaction, and radiographic and physical/neurologic examinations. Results Randomized patients (103 PDC-R and 106 ACDF) and 136 CA patients were treated at 13 sites. VAS pain and NDI score improvements from baseline were significant for all patients (P < .0001) but did not differ among groups. VAS satisfaction was higher at all time points for PDC-R versus ACDF patients (P = .0499 at 48 months). The percentage of patients who responded yes to surgery again was 85.6% at 24 months and 88.9% at 48 months in the PDC-R group, 80.9% at 24 months and 81.0% at 48 months in the ACDF group, and 86.3% at 24 months in the CA group. Five PDC-R patients (48 months) and no CA patients (24 months) had index-level bridging bone. By 48 months, approximately 4-fold more ACDF patients required secondary surgery (3 of 103 PDC-R patients [2.9%] vs 12 of 106 ACDF patients [11.3%], P = .0292). Of these, 6 ACDF patients (5.6%) required procedures at adjacent levels. Three CA patients required secondary procedures (24 months). Conclusions Our 4-year data support that ProDisc-C TDR and ACDF are viable surgical options for symptomatic cervical

  4. Can municipality-based post-discharge follow-up visits including a general practitioner reduce early readmission among the fragile elderly (65+ years old)? A randomized controlled trial

    PubMed Central

    Thygesen, Lau Caspar; Fokdal, Sara; Gjørup, Thomas; Taylor, Rod S.

    2015-01-01

    Objective. To evaluate how municipality-based post-discharge follow-up visits including a general practitioner and municipal nurse affect early readmission among high-risk older people discharged from a hospital department of internal medicine. Design and setting. Centrally randomized single-centre pragmatic controlled trial comparing intervention and usual care with investigator-blinded outcome assessment. Intervention. The intervention was home visits with a general practitioner and municipal nurse within seven days of discharge focusing on medication, rehabilitation plan, functional level, and need for further health care initiatives. The visit was concluded by planning one or two further visits. Controls received standard health care services. Patients. People aged 65 + years discharged from Holbæk University Hospital, Denmark, in 2012 considered at high risk of readmission. Main outcome measures. The primary outcome was readmission within 30 days. Secondary outcomes at 30 and 180 days included readmission, primary health care, and municipal services. Outcomes were register-based and analysis used the intention-to-treat principle. Results. A total of 270 and 261 patients were randomized to intervention and control groups, respectively. The groups were similar in baseline characteristics. In all 149 planned discharge follow-up visits were carried out (55%). Within 30 days, 24% of the intervention group and 23% of the control group were readmitted (p = 0.93). No significant differences were found for any other secondary outcomes except that the intervention group received more municipal nursing services. Conclusion. This municipality-based follow-up intervention was only feasible in half the planned visits. The intervention as delivered had no effect on readmission or subsequent use of primary or secondary health care services. PMID:26059872

  5. Thymoglobulin prevents chronic graft-versus-host disease, chronic lung dysfunction, and late transplant-related mortality: long-term follow-up of a randomized trial in patients undergoing unrelated donor transplantation.

    PubMed

    Bacigalupo, Andrea; Lamparelli, Teresa; Barisione, Giovanni; Bruzzi, Paolo; Guidi, Stefano; Alessandrino, Paolo Emilio; di Bartolomeo, Paolo; Oneto, Rosi; Bruno, Barbara; Sacchi, Nicoletta; van Lint, Maria Teresa; Bosi, Alberto

    2006-05-01

    This is an update of a randomized study on antithymocyte globulin (ATG; Thymoglobulin) before transplantation in patients undergoing unmanipulated marrow transplantation from unrelated donors. The median follow-up for surviving patients is 5.7 years. At last follow-up, chronic graft-versus-host disease (GVHD) was scored in 60% of non-ATG and in 37% of ATG patients (P=.05), and extensive chronic GVHD was present in 41% and 15%, respectively (P=.01). Chronic lung dysfunction was diagnosed in 51% versus 19% of patients (P=.005). Forced vital capacity decreased significantly with time in non-ATG patients (P=.005), but not in patients who received ATG (P=.30). The proportion of patients with Karnofsky scores of >or=90% at 4 years was 57% versus 89% in non-ATG versus ATG patients (P=.03). The actuarial 6-year survival for all patients randomized was 31% versus 44% (non-ATG versus ATG; P=.80). The cumulative incidence of transplant-related mortality was 51% versus 41% (P=.70) and of relapse was 32% versus 40% (P=.90). For patients who survived 1 year, transplant-related mortality was 25% versus 3% (P=.03), and actuarial survival was 58% versus 85% (P=.09). In conclusion, the addition of ATG to cyclosporine/methotrexate provides significant protection against extensive chronic GVHD and chronic lung dysfunction, reduces late transplant mortality, and improves quality of life in patients undergoing unrelated donor transplantation. PMID:16635791

  6. Nurse-Led, Telephone-Based, Secondary Preventive Follow-Up after Stroke or Transient Ischemic Attack Improves Blood Pressure and LDL Cholesterol: Results from the First 12 Months of the Randomized, Controlled NAILED Stroke Risk Factor Trial

    PubMed Central

    Irewall, Anna-Lotta; Ögren, Joachim; Bergström, Lisa; Laurell, Katarina; Söderström, Lars; Mooe, Thomas

    2015-01-01

    Background Enhanced secondary preventive follow-up after stroke or transient ischemic attack (TIA) is necessary for improved adherence to recommendations regarding blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) levels. We investigated whether nurse-led, telephone-based follow-up was more efficient than usual care at improving BP and LDL-C levels at 12 months after hospital discharge. Methods We randomized 537 patients to either nurse-led, telephone-based follow-up (intervention) or usual care (control). BP and LDL-C measurements were performed at 1 month (baseline) and 12 months post-discharge. Intervention group patients who did not meet target values at baseline received additional follow-up, including titration of medication and lifestyle counselling, to reach treatment goals (BP < 140/90 mmHg, LDL-C < 2.5 mmol/L). Results At 12 months, mean systolic BP, diastolic BP and LDL-C was 3.3 (95% CI 0.3 to 6.3) mmHg, 2.3 mmHg (95% CI 0.5 to 4.2) and 0.3 mmol/L (95% CI 0.1 to 0.4) lower in the intervention group compared to controls. Among participants with values above the treatment goal at baseline, the difference in systolic BP and LDL-C was more pronounced (8.0 mmHg, 95% CI 4.0 to 12.1, and 0.6 mmol/L, 95% CI 0.4 to 0.9). A larger proportion of the intervention group reached the treatment goal for systolic BP (68.5 vs. 56.8%, p = 0.008) and LDL-C (69.7% vs. 50.4%, p < 0.001). Conclusions Nurse-led, telephone-based secondary preventive follow-up, including medication adjustment, was significantly more efficient than usual care at improving BP and LDL-C levels by 12 months post-discharge. Trial Registration ISRCTN Registry ISRCTN23868518 PMID:26474055

  7. RANDOMIZED PROSPECTIVE STUDY ON TRAUMATIC PATELLAR DISLOCATION: CONSERVATIVE TREATMENT VERSUS RECONSTRUCTION OF THE MEDIAL PATELLOFEMORAL LIGAMENT USING THE PATELLAR TENDON, WITH A MINIMUM OF TWO YEARS OF FOLLOW-UP

    PubMed Central

    Bitar, Alexandre Carneiro; D'Elia, Caio Oliveira; Demange, Marco Kawamura; Viegas, Alexandre Christo; Camanho, Gilberto Luis

    2015-01-01

    Objective: The aim of this study was to compare the surgical results from reconstruction of the medial patellofemoral ligament (MPFL) with non-operative treatment of primary patellar dislocation. Methods: Thirty-nine patients (41 knees) with patellar dislocation were randomized into two groups. One group was treated conservatively (immobilization and physiotherapy) and other was treated surgically with reconstruction of the MPFL, and the results were evaluated with a minimum follow-up of two years. The Kujala questionnaire was applied to assess pain and quality of life, and recurrences were evaluated. Pearson's chi-square test and Fisher's exact test were used in the statistical evaluation. Results: The statistical analysis showed that the mean Kujala score was significantly lower in the conservative group (70.8), compared with the mean value in the surgical group (88.9), with p = 0.001. The surgical group presented a higher percentage of “good/excellent” Kujala score results (71.43%) than in the conservative group (25.0%), with p = 0.003. The conservative group presented a greater number of recurrences (35% of the cases), while in the surgical group there were no reports of recurrences and/or subluxation. Conclusions: Treatment with reconstruction of the medial patellofemoral ligament using the patellar tendon produced better results, based on the analysis of post-treatment recurrences and the better final results from the Kujala questionnaire after a minimum follow-up period of two years. PMID:27027072

  8. Long-term follow-up of moderately hypercholesterolemic hypertensive patients following randomization to pravastatin vs. usual care: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT)

    PubMed Central

    Margolis, Karen L.; Davis, Barry R.; Baimbridge, Charles; Ciocon, Jerry O.; Cuyjet, Aloysius B.; Dart, Richard A.; Einhorn, Paula T.; Ford, Charles E.; Gordon, David; Hartney, Thomas J; Haywood, L. Julian; Holtzman, Jordan; Mathis, David E.; Oparil, Suzanne; Probstfield, Jeffrey L.; Simpson, Lara M.; Stokes, John D.; Wiegmann, Thomas B.; Williamson, Jeff D.

    2015-01-01

    A randomized, controlled, multicenter trial assigned well-controlled hypertensive participants ≥55 years, with moderate hypercholesterolemia to receive pravastatin (n=5170) or usual care (n=5185) for 4-8 years, when trial therapy was discontinued. Passive surveillance using national databases to ascertain deaths and hospitalizations continued for total follow-up of 8-13 years to assess whether mortality and morbidity differences persisted or new differences developed. During the post-trial period, fatal and nonfatal outcomes were available for 98% and 64% of participants, respectively. Primary outcome was all-cause mortality; secondary outcomes included cardiovascular mortality, coronary heart disease (CHD), stroke, heart failure, cardiovascular disease, and end-stage renal disease. No significant differences appeared in mortality for pravastatin versus usual care (hazard ratio [HR], 0.96; 95% confidence interval [CI], 0.89-1.03), or other secondary outcomes. Similar to the previously reported in-trial result, there was a significant treatment effect for CHD in Blacks (HR, 0.79; 95% CI, 0.64-0.98). However, the in-trial result showing a significant treatment by race effect did not remain significant over the entire follow-up (P=.08). These findings are consistent with evidence from other large trials that show statins prevent CHD and add evidence that they are effective for CHD prevention in Blacks. PMID:23889716

  9. Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial

    PubMed Central

    Lauryssen, Carl; Davis, Reginald J.; Bae, Hyun W.; Peloza, John H.; Guyer, Richard D.; Zigler, Jack E.; Ohnmeiss, Donna D.; Leary, Scott

    2016-01-01

    Introduction If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. Methods This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex® Interlaminar Stabilization® device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. Results At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height

  10. Hyper Cold Systems follow up

    NASA Astrophysics Data System (ADS)

    Berges, Jean Claude; Beltrando, Gerard; Cacault, Philippe

    2016-04-01

    The follow up of intense precipitation system is a key information for climate studies. Whereas some rainfall measurement series cover more than one century they cannot retrieve these phenomena in their spatial and temporal continuity. The geostationary satellite data offer a good trade-off between the length of data series and the retrieval accuracy. However a difficulty arise from ambiguous interpretation of the lone infrared signal in nephanalysis. Hence the tropopause temperature is used as a proxy to characterize extreme precipitation event. That does not mean that the more intense rain-rate will be always collocated with the coldest temperature but that most of these intense events is produced by systems whose a part is colder than tropopause. Computations have been carried out on 38 months of MSG and Meteosat/IODC. System follow up is achieved by a simple 3D connexity algorithm, the time being considered as the third dimension. This algorithm produce three dimension clusters from where the main system parameters can be easily extracted. Thus the systems can be classified trajectory characteristic (duration, speed ans size variation). A drawback of this simple threshold method relies is some over-segmentation. In most of case the bias is minor as unconnected clusters are small and short-lived. However an aggregating algorithm have been developed to retrieve the most complex system trajectories. To assess the efficiency of this method three regional studies are displayed: the North African Maghreb, the West African Sahel and the Indian Ocean. On Maghreb, the location of system initialization shows a dramatic difference between the eastern and western parts. Whereas in Tunisia a significant part of these systems are generated on sea and most have no clear relation with relief, the Morocco is mainly characterized with land initiated system with a strong orographic effect on system triggering. Another difference relies on the low level wind shear impact which

  11. Incidence rate of and factors associated with loss-to-follow-up in a longitudinal cohort of anti-retroviral treated HIV-infected persons: an AIDS Clinical Trials Group (ACTG) Longitudinal Linked Randomized Trials (ALLRT) analysis

    PubMed Central

    Krishnan, S; Wu, K; Smurzynski, M; Bosch, RJ; Benson, CA; Collier, AC; Klebert, MK; Feinberg, J; Koletar, SL

    2011-01-01

    Purpose Examine incidence and factors associated with loss to follow-up (LTFU) in the AIDS Clinical Trials Group (ACTG) Longitudinal Linked Randomized Trials (ALLRT) cohort. Method ALLRT is a prospective cohort of HIV-infected persons randomized to ARV regimens/strategies in ACTG trials and followed long-term after the trial ends. Person-years were calculated from ALLRT entry until LTFU (defined using off-study reasons or ≥3 consecutive missed visits), death/severe debilitation/site closures, or June 2009 (censored). Poisson regression was used to examine LTFU factors separately among participants who were ARV-naïve or ARV-experienced at trial entry. Results Among 4630 participants (22,524 person-years), 1140 were lost to follow-up, 237 died, 29 were severely debilitated, and 443 were at sites that closed. The LTFU incidence was 5.5 and 4.2 per 100 person-years among previously ARV-naïve and ARV-experienced participants, respectively. In both groups, age≤50, site location, being off-ARVs and viral load ≥400 copies/ml were associated with a higher risk of LTFU. Among ARV-naïves, male sex, education<16 years, IV drug use and cigarette smoking were also associated with LTFU. Conclusion Knowledge of differential LTFU can help researchers identify participants at risk of LTFU in longitudinal HIV cohorts and design retention strategies, thereby limiting study bias. The identified factors should be included in inverse probability of weighting models to account for LTFU. PMID:22044855

  12. Effects of Innovative WALKBOT Robotic-Assisted Locomotor Training on Balance and Gait Recovery in Hemiparetic Stroke: A Prospective, Randomized, Experimenter Blinded Case Control Study With a Four-Week Follow-Up.

    PubMed

    Kim, Soo-Yeon; Yang, Li; Park, In Jae; Kim, Eun Joo; JoshuaPark, Min Su; You, Sung Hyun; Kim, Yun-Hee; Ko, Hyun-Yoon; Shin, Yong-Il

    2015-07-01

    The present clinical investigation was to ascertain whether the effects of WALKBOT-assisted locomotor training (WLT) on balance, gait, and motor recovery were superior or similar to the conventional locomotor training (CLT) in patients with hemiparetic stroke. Thirty individuals with hemiparetic stroke were randomly assigned to either WLT or CLT. WLT emphasized on a progressive, conventional locomotor retraining practice (40 min) combined with the WALKBOT-assisted, haptic guidance and random variable locomotor training (40 min) whereas CLT involved conventional physical therapy alone (80 min). Both intervention dosages were standardized and provided for 80 min, five days/week for four weeks. Clinical outcomes included function ambulation category (FAC), Berg balance scale (BBS), Korean modified Barthel index (K-MBI), modified Ashworth scale (MAS), and EuroQol-5 dimension (EQ-5D) before and after the four-week program as well as at follow-up four weeks after the intervention. Two-way repeated measure ANOVA showed significant interaction effect (time × group) for FAC (p=0.02), BBS (p=0.03) , and K-MBI (p=0.00) across the pre-training, post-training, and follow-up tests, indicating that WLT was more beneficial for balance, gait and daily activity function than CLT alone. However, no significant difference in other variables was observed. This is the first clinical trial that highlights the superior, augmented effects of the WALKBOT-assisted locomotor training on balance, gait and motor recovery when compared to the conventional locomotor training alone in patients with hemiparetic stroke. PMID:25850089

  13. Randomized, Multicenter Trial on the Effect of Radiation Therapy on Plantar Fasciitis (Painful Heel Spur) Comparing a Standard Dose With a Very Low Dose: Mature Results After 12 Months' Follow-Up

    SciTech Connect

    Niewald, Marcus; Micke, Oliver; Graeber, Stefan; Schaefer, Vera; Scheid, Christine; Fleckenstein, Jochen; Licht, Norbert; Ruebe, Christian

    2012-11-15

    Purpose: To conduct a randomized trial of radiation therapy for painful heel spur, comparing a standard dose with a very low dose. Methods and Materials: Sixty-six patients were randomized to receive radiation therapy either with a total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy twice weekly (standard dose) or with a total dose of 0.6 Gy applied in 6 fractions of 0.1 Gy twice weekly (low dose). In all patients lateral opposing 4- to 6-MV photon beams were used. The results were measured using a visual analogue scale, the Calcaneodynia score, and the SF12 health survey. The fundamental phase of the study ended after 3 months, and the follow-up was continued up to 1 year. Patients with insufficient pain relief after 3 months were offered reirradiation with the standard dosage at any time afterward. Results: Of 66 patients, 4 were excluded because of withdrawal of consent or screening failures. After 3 months the results in the standard arm were highly significantly superior compared with those in the low-dose arm (visual analogue scale, P=.001; Calcaneodynia score, P=.027; SF12, P=.045). The accrual of patients was stopped at this point. Further evaluation after 12 months' follow-up showed the following results: (1) highly significant fewer patients were reirradiated in the standard arm compared with the low-dose arm (P<.001); (2) the results of patients in the low-dose arm who were reirradiated were identical to those in the standard arm not reirradiated (reirradiation as a salvage therapy if the lower dose was ineffective); (3) patients experiencing a favorable result after 3 months showed this even after 12 months, and some results even improved further between 3 and 12 months. Conclusions: This study confirms the superior analgesic effect of radiation therapy with 6-Gy doses on painful heel spur even for a longer time period of at least 1 year.

  14. Multicomponent physical exercise with simultaneous cognitive training to enhance dual-task walking of older adults: a secondary analysis of a 6-month randomized controlled trial with 1-year follow-up

    PubMed Central

    Eggenberger, Patrick; Theill, Nathan; Holenstein, Stefan; Schumacher, Vera; de Bruin, Eling D

    2015-01-01

    Background About one-third of people older than 65 years fall at least once a year. Physical exercise has been previously demonstrated to improve gait, enhance physical fitness, and prevent falls. Nonetheless, the addition of cognitive training components may potentially increase these effects, since cognitive impairment is related to gait irregularities and fall risk. We hypothesized that simultaneous cognitive–physical training would lead to greater improvements in dual-task (DT) gait compared to exclusive physical training. Methods Elderly persons older than 70 years and without cognitive impairment were randomly assigned to the following groups: 1) virtual reality video game dancing (DANCE), 2) treadmill walking with simultaneous verbal memory training (MEMORY), or 3) treadmill walking (PHYS). Each program was complemented with strength and balance exercises. Two 1-hour training sessions per week over 6 months were applied. Gait variables, functional fitness (Short Physical Performance Battery, 6-minute walk), and fall frequencies were assessed at baseline, after 3 months and 6 months, and at 1-year follow-up. Multiple regression analyses with planned comparisons were carried out. Results Eighty-nine participants were randomized to three groups initially; 71 completed the training and 47 were available at 1-year follow-up. DANCE/MEMORY showed a significant advantage compared to PHYS in DT costs of step time variability at fast walking (P=0.044). Training-specific gait adaptations were found on comparing DANCE and MEMORY: DANCE reduced step time at fast walking (P=0.007) and MEMORY reduced gait variability in DT and DT costs at preferred walking speed (both trend P=0.062). Global linear time effects showed improved gait (P<0.05), functional fitness (P<0.05), and reduced fall frequency (−77%, P<0.001). Only single-task fast walking, gait variability at preferred walking speed, and Short Physical Performance Battery were reduced at follow-up (all P<0.05 or

  15. Prompt GRB optical follow-up experiments

    SciTech Connect

    Park, H-S; Williams, G; Ables, E; Band, D; Barthelmy, S; Bionta, R; Cline, T; Gehrels, N; Hartmann, D; Hurley, K; Kippen, M; Nemiroff, R; Pereira, W; Porrata, R

    2000-11-13

    Gamma Ray Bursts (GRBs) are brief, randomly located, releases of gamma-ray energy from unknown celestial sources that occur almost daily. The study of GRBs has undergone a revolution in the past three years due to an international effort of follow-up observations of coordinates provided by Beppo/SAX and IPN GRB. These follow-up observations have shown that GRBs are at cosmological distances and interact with surrounding material as described by the fireball model. However, prompt optical counterparts have only been seen in one case and are therefore very rare or much dimmer than the sensitivity of the current instruments. Unlike later time afterglows, prompt optical measurements would provide information on the GRB progenitor. LOTIS is the very first automated and dedicated telescope system that actively utilizes the GRB Coordinates Network (GCN) and it attempts to measure simultaneous optical light curve associated with GRBs. After 3 years of running, LOTIS has responded to 75 GRB triggers. The lack of any optical signal in any of the LOTIS images places numerical limits on the surrounding matter density, and other physical parameters in the environment of the GRB progenitor. This paper presents LOTIS results and describes other prompt GRB follow-up experiments including the Super-LOTIS at Kitt Peak in Arizona.

  16. Three-Year Follow-Up Results of Photodynamic Therapy vs. Imiquimod vs. Fluorouracil for Treatment of Superficial Basal Cell Carcinoma: A Single-Blind, Noninferiority, Randomized Controlled Trial.

    PubMed

    Roozeboom, Marieke H; Arits, Aimee H M M; Mosterd, Klara; Sommer, Anja; Essers, Brigitte A B; de Rooij, Michette J M; Quaedvlieg, Patricia J F; Steijlen, Peter M; Nelemans, Patty J; Kelleners-Smeets, Nicole W J

    2016-08-01

    A randomized controlled trial including 601 patients previously showed that the effectiveness of imiquimod and fluorouracil cream were not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) in patients with superficial basal cell carcinoma after 1 year of follow-up. We now present the 3-year follow-up results. The probability of tumor-free survival at 3 years post-treatment was 58.0% for MAL-PDT (95% confidence interval [CI] = 47.8-66.9), 79.7% for imiquimod (95% CI = 71.6-85.7), and 68.2% for fluorouracil (95% CI = 58.1-76.3). The hazard ratio for treatment failure comparing imiquimod with MAL-PDT was 0.50 (95% CI = 0.33-0.76, P = 0.001). Comparison of fluorouracil with MAL-PDT and fluorouracil with imiquimod showed hazard ratios of 0.73 (95% CI = 0.51-1.05, P = 0.092) and 0.68 (95% CI = 0.44-1.06, P = 0.091), respectively. Subgroup analysis showed a higher probability of treatment success for imiquimod versus MAL-PDT in all subgroups with the exception of elderly patients with superficial basal cell carcinoma on the lower extremities. In this subgroup, the risk difference in tumor-free survival was 57.6% in favor of MAL-PDT. In conclusion, according to results at 3 years post-treatment, imiquimod is superior and fluorouracil not inferior to MAL-PDT in treatment of superficial basal cell carcinoma. PMID:27113429

  17. ACT Internet-based vs face-to-face? A randomized controlled trial of two ways to deliver Acceptance and Commitment Therapy for depressive symptoms: an 18-month follow-up.

    PubMed

    Lappalainen, Päivi; Granlund, Anna; Siltanen, Sari; Ahonen, Suvi; Vitikainen, Minna; Tolvanen, Asko; Lappalainen, Raimo

    2014-10-01

    The aim of the present study was to investigate two interventions based on Acceptance and Commitment Therapy (ACT) for depressive symptoms: A face-to-face treatment (ACT group) was compared to a guided self-help treatment delivered via the Internet consisting of two assessment sessions (pre and post) and an ACT-based Internet program (iACT). Outpatients experiencing at least mild depressive symptoms were randomized to either approach. The iACT treatment group received access to an ACT-based Internet program and supportive web-based contact over a period of 6 weeks. The face-to-face group received ACT-based treatment once a week over the same period of time. In both groups, the results showed a significant effect on depression symptomatology, and general wellbeing after treatment and at the 18-month follow-up. However, the data indicated that the iACT group changed differently regarding depressive symptoms and wellbeing as compared to the face-to face ACT group. Results showed large pre-treatment to 18-month follow-up within-group effect sizes for all symptom measures in the iACT treatment group (1.59-2.08), and for most outcome measures in the face-to-face ACT group (1.12-1.37). This non-inferiority study provides evidence that guided Internet-delivered ACT intervention can be as effective as ACT-based face-to-face treatment for outpatients reporting depressive symptoms, and it may offer some advantages over a face-to-face intervention. PMID:25127179

  18. The Role of Pretreatment FDG-PET in Treating Cervical Cancer Patients With Enlarged Pelvic Lymph Node(s) Shown on MRI: A Phase 3 Randomized Trial With Long-Term Follow-Up

    SciTech Connect

    Lin, Shinn-Yn; Tsai, Chien-Sheng; Chang, Yu-Chen; Ng, Koon-Kwan; Chang, Ting-Chang; Kao, Wei-Heng; Lai, Chyong-Huey; Hong, Ji-Hong

    2015-07-01

    Purpose: This report is the second analysis of a prospective randomized trial to investigate the impact of {sup 18}F-fluorodeoxyglucose positron emission tomography (FDG-PET) on cervical cancer patients with enlarged pelvic lymph nodes identified by magnetic resonance imaging. Methods and Materials: Patients with newly diagnosed cervical cancer with enlarged pelvic lymph nodes but free of enlarged para-aortic lymph nodes (PALN) were eligible. Patients were randomized to receive either pretreatment FDG-PET (PET arm) or not (control arm). The whole pelvis was the standard irradiation field for all patients except those with FDG-avid extrapelvic findings. Results: In all, 129 patients were enrolled. Pretreatment PET detected extrapelvic metastases in 7 patients. No new patient experienced treatment failure during the additional 4-year follow-up period. There were no significant differences between the PET arm and the control arm regarding overall survival, disease-free survival, and freedom from extrapelvic metastasis. In the control arm, 8 of 10 patients with PALN relapse had limited extrapelvic nodal failures; their 5-year disease-specific survival was 34.3%. By contrast, only 1 of 5 patients with PALN relapse in the PET arm experienced such limited failures; their 5-year survival rate was 0%. Conclusions: Although the pretreatment detection of PALN did not translate into survival benefit, it indeed decreased the need for extended-field concurrent chemoradiation therapy.

  19. Five Year Follow-Up of a Randomized Controlled Trial on Warming and Humidification of Insufflation Gas in Laparoscopic Colonic Surgery—Impact on Small Bowel Obstruction and Oncologic Outcomes

    PubMed Central

    Sammour, Tarik; Hill, Andrew G.

    2015-01-01

    Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA. PMID:25875541

  20. Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in uganda: study protocol

    PubMed Central

    2011-01-01

    Background There is now convincing evidence that in industrialized countries therapeutic hypothermia for perinatal asphyxial encephalopathy increases survival with normal neurological function. However, the greatest burden of perinatal asphyxia falls in low and mid-resource settings where it is unclear whether therapeutic hypothermia is safe and effective. Aims Under the UCL Uganda Women's Health Initiative, a pilot randomized controlled trial in infants with perinatal asphyxia was set up in the special care baby unit in Mulago Hospital, a large public hospital with ~20,000 births in Kampala, Uganda to determine: (i) The feasibility of achieving consent, neurological assessment, randomization and whole body cooling to a core temperature 33-34°C using water bottles (ii) The temperature profile of encephalopathic infants with standard care (iii) The pattern, severity and evolution of brain tissue injury as seen on cranial ultrasound and relation with outcome (iv) The feasibility of neurodevelopmental follow-up at 18-22 months of age Methods/Design Ethical approval was obtained from Makerere University and Mulago Hospital. All infants were in-born. Parental consent for entry into the trial was obtained. Thirty-six infants were randomized either to standard care plus cooling (target rectal temperature of 33-34°C for 72 hrs, started within 3 h of birth) or standard care alone. All other aspects of management were the same. Cooling was performed using water bottles filled with tepid tap water (25°C). Rectal, axillary, ambient and surface water bottle temperatures were monitored continuously for the first 80 h. Encephalopathy scoring was performed on days 1-4, a structured, scorable neurological examination and head circumference were performed on days 7 and 17. Cranial ultrasound was performed on days 1, 3 and 7 and scored. Griffiths developmental quotient, head circumference, neurological examination and assessment of gross motor function were obtained at 18

  1. 5-year Follow-up of a Randomized Controlled Trial of Immediate versus Delayed Zoledronic Acid for Prevention of Bone Loss in Postmenopausal Women with Breast Cancer Starting Letrozole after Tamoxifen: N03CC (Alliance)

    PubMed Central

    Wagner-Johnston, Nina D.; Sloan, Jeff A.; Liu, Heshan; Kearns, Ann E.; Hines, Stephanie L.; Puttabasavaiah, Suneetha; Dakhil, Shaker R.; Lafky, Jacqueline M.; Perez, Edith A.; Loprinzi, Charles L.

    2015-01-01

    Background Postmenopausal women with breast cancer (BC) receiving aromatase inhibitors are at increased risk for bone loss. The current study was undertaken to determine whether upfront versus delayed treatment with zoledronic acid (ZA) impacted bone loss. This report describes the 5-year follow-up results. Methods 551 postmenopausal women with BC completing tamoxifen and undergoing daily letrozole treatment were randomized to upfront (274) or delayed (277) ZA 4 mg IV every 6 months. In the delayed arm, ZA was initiated for post-baseline bone mineral density (BMD) T-score < -2.0 or fracture. Results The incidence of a 5% decrease in total lumbar spine BMD at 5 years was 10.2% in the upfront arm versus 41.2% in the delayed arm, p < 0.0001. 41 patients in the delayed arm were eventually started on ZA. With the exception of increased grade 1/2 elevated creatinine and fever in the upfront arm and cerebrovascular ischemia in the delayed arm, there were no significant differences between arms with respect to the most common adverse events of arthralgia and back pain. Osteoporosis occurred less frequently in the upfront arm (2 versus 8 cumulative cases) though this difference was not statistically significant. Bone fractures occurred in 24 patients in the upfront arm versus 25 patients in the delayed arm. Conclusions Immediate treatment with ZA prevented bone loss compared with delayed treatment in postmenopausal women on letrozole and these differences were maintained at 5 years. The incidence of osteoporosis or fractures was not different between arms. PMID:25930719

  2. A comparative study of diode laser and plasmakinetic in transurethral enucleation of the prostate for treating large volume benign prostatic hyperplasia: a randomized clinical trial with 12-month follow-up.

    PubMed

    Wu, Gang; Hong, Zhe; Li, Chao; Bian, Cuidong; Huang, Shengsong; Wu, Denglong

    2016-05-01

    The objective of this study is to compare the efficacy and safety of diode laser enucleation of the prostate (DiLEP) with plasmakinetic enucleation of the prostate (PKEP) for symptomatic benign prostatic hyperplasia (BPH) patients with large prostate (volume > 80 ml). From January 2013 to June 2014, 80 consecutive patients were randomized treated with DiLEP (n = 40) or PKEP (n = 40). Perioperative and postoperative outcome data were assessed during a 1-year follow-up. There were no significant preoperative differences between the two surgical groups. The mean prostate volumes in the DiLEP and PKEP groups were 98.6 and 93.3 ml, respectively. DiLEP was equivalent to PKEP in improvement in International Prostate Symptom Score (IPSS), quality of life scores, and maximum flow rate. Compared with PKEP, patients treated with DiLEP showed a lower risk of blood loss (P < 0.01), shorter bladder irrigation and catheterization times (P < 0.01), as well as shorter hospital stays (P < 0.01). Moreover, the DiLEP group was significantly superior to bipolar plasmakinetic group in the irritative symptoms. However, the operation time of the DiLEP group was longer than that of PKEP group (P = 0.02). Both DiLEP and PKEP are safe and effective methods for the treatment of BPH in large prostates (volume > 80 ml). Compared with PKEP, DiLEP provides a decreased risk of hemorrhage, reduced bladder irrigation, and catheterization times, as well as shorter hospital stays. PMID:26822403

  3. Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial

    PubMed Central

    Bonati, Leo H; Ederle, Jörg; McCabe, Dominick JH; Dobson, Joanna; Featherstone, Roland L; Gaines, Peter A; Beard, Jonathan D; Venables, Graham S; Markus, Hugh S; Clifton, Andrew; Sandercock, Peter; Brown, Martin M

    2009-01-01

    Summary Background In the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), early recurrent carotid stenosis was more common in patients assigned to endovascular treatment than it was in patients assigned to endarterectomy (CEA), raising concerns about the long-term effectiveness of endovascular treatment. We aimed to investigate the long-term risks of restenosis in patients included in CAVATAS. Methods 413 patients who were randomly assigned in CAVATAS and completed treatment for carotid stenosis (200 patients had endovascular treatment and 213 patients had endarterectomy) had prospective clinical follow-up at a median of 5 years and carotid duplex ultrasound at a median of 4 years. We investigated the cumulative long-term incidence of carotid restenosis after endovascular treatment and endarterectomy, the effect of the use of stents on restenosis after endovascular treatment, risk factors for the development of restenosis, and the effect of carotid restenosis on the risk of recurrent cerebrovascular events. Analysis was by intention to treat. This study is registered, number ISRCTN01425573. Findings Severe carotid restenosis (≥70%) or occlusion occurred significantly more often in patients in the endovascular arm than in patients in the endarterectomy arm (adjusted hazard ratio [HR] 3·17, 95% CI 1·89–5·32; p<0·0001). The estimated 5-year incidence of restenosis was 30·7% in the endovascular arm and 10·5% in the endarterectomy arm. Patients in the endovascular arm who were treated with a stent (n=50) had a significantly lower risk of developing restenosis of 70% or greater compared with those treated with balloon angioplasty alone (n=145; HR 0·43, 0·19–0·97; p=0·04). Current smoking or a history of smoking was a predictor of restenosis of 70% or more (2·32, 1·19–4·54; p=0·01) and the early finding of moderate stenosis (50–69%) up to 60 days after treatment was associated with the risk of progression to restenosis of 70

  4. Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: first report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial

    PubMed Central

    2014-01-01

    Background Dose-dense sequential chemotherapy including anthracyclines and taxanes has been established in the adjuvant setting of high-risk operable breast cancer. However, the preferable taxane and optimal schedule of administration in a dose-dense regimen have not been defined yet. Methods From July 2005 to November 2008, 1001 patients (990 eligible) were randomized to receive, every 2 weeks, 3 cycles of epirubicin 110 mg/m2 followed by 3 cycles of paclitaxel 200 mg/m2 followed by 3 cycles of intensified CMF (Arm A; 333 patients), or 3 cycles of epirubicin followed by 3 cycles of CMF, as in Arm A, followed 3 weeks later by 9 weekly cycles of docetaxel 35 mg/m2 (Arm B; 331), or 9 weekly cycles of paclitaxel 80 mg/m2 (Arm C; 326). Trastuzumab was administered for one year to HER2-positive patients post-radiation. Results At a median follow-up of 60.5 months, the 3-year disease-free survival (DFS) rate was 86%, 90% and 88%, for Arms A, B and C, respectively, while the 3-year overall survival (OS) rate was 96% in all arms. No differences were found in DFS or OS between the combined B and C Arms versus Arm A (DFS: HR = 0.81, 95% CI: 0.59-1.11, P = 0.20; OS: HR = 0.84, 95% CI: 0.55-1.30, P = 0.43). Among the 255 patients who received trastuzumab, 189 patients (74%) completed 1 year of treatment uneventfully. In all arms, the most frequently reported severe adverse events were neutropenia (30% vs. 27% vs. 26%) and leucopenia (12% vs. 13% vs. 12%), while febrile neutropenia occurred in fifty-one patients (6% vs. 4% vs. 5%). Patients in Arm A experienced more often severe pain (P = 0.002), neurological complications (P = 0.004) and allergic reactions (P = 0.004), while patients in Arm B suffered more often from severe skin reactions (P = 0.020). Conclusions No significant differences in survival between the regimens were found in the present phase III trial. Taxane scheduling influenced the type of severe toxicities. HER2

  5. Environmental Modifications and 2-Year Measured and Self-reported Stair-Use: A Worksite Randomized Trial

    PubMed Central

    Linde, Jennifer A.; Cousins, Julie M.; Jeffery, Robert W.

    2014-01-01

    Environmental modifications have been shown to increase short-term stair use, longer-term success is unclear. This study assessed the 2-year effectiveness of an environmental intervention promoting worksite stair use. We assessed stair use at work by means of self-reports and infrared beam counters (which send a safe and invisible beam of infrared light from one side of a stairwell to a reflector on the other side; when an individual uses the stairs, the infrared beam is disrupted and an instance of stair use is recorded) at six worksites (three intervention, three control) in a group randomized, controlled worksite weight-gain prevention trial in Minneapolis/St. Paul, MN. Intervention modifications were signs encouraging stair use, music, and art posters in stairwells. We collected data before environmental modifications (2006–2007) and at the end of the 2-year intervention (2008–2009). The intervention had a significant positive effect on stair use measured both objectively and via self-report, with greatest increases reported among those participants who used the stairs least at baseline. Following 2-years of continuously-maintained stairwell modifications, increases in both objectively-measured and self-reported stair use were significantly larger at intervention than control worksites. Study findings suggest that the positive impact of environmental modifications on stair use persist over a longer time period than has been previously demonstrated. Results also indicate that infrequent stair users may be most amenable to the behavior changes encouraged by these environmental enhancements. PMID:23979097

  6. Internet-based treatment of stress urinary incontinence: 1- and 2-year results of a randomized controlled trial with a focus on pelvic floor muscle training

    PubMed Central

    Sjöström, Malin; Umefjord, Göran; Stenlund, Hans; Carlbring, Per; Andersson, Gerhard; Samuelsson, Eva

    2015-01-01

    Objectives To evaluate the long-term effects of two non-face-to-face treatment programmes for stress urinary incontinence (SUI) based on pelvic floor muscle training (PFMT). Subjects and Methods The present study was a randomized controlled trial with online recruitment of 250 community-dwelling women aged 18–70 years with SUI ≥ one time/week. Diagnosis was based on validated self-assessed questionnaires, 2-day bladder diary and telephone interview with a urotherapist. Consecutive computer-generated block randomization was carried out with allocation by an independent administrator to 3 months of treatment with either an internet-based treatment programme (n = 124) or a programme sent by post (n = 126). Both interventions focused mainly on PFMT. The internet group received continuous e-mail support from a urotherapist, whereas the postal group trained on their own. Follow-up was performed after 1 and 2 years via self-assessed postal questionnaires. The primary outcomes were symptom severity (International Consultation on Incontinence Questionnaire Short Form [ICIQ-UI SF]) and condition-specific quality of life (ICIQ-Lower Urinary Tract Symptoms Quality of Life [ICIQ-LUTSqol]). Secondary outcomes were the Patient Global Impression of Improvement, health-specific quality of life (EQ-visual analogue scale [EQ-VAS]), use of incontinence aids, and satisfaction with treatment. There was no face-to-face contact with the participants at any time. Analysis was based on intention-to-treat. Results We lost 32.4% (81/250) of participants to follow-up after 1 year and 38.0% (95/250) after 2 years. With both interventions, we observed highly significant (P < 0.001) improvements with large effect sizes (>0.8) for symptoms and condition-specific quality of life (QoL) after 1 and 2 years, respectively. No significant differences were found between the groups. The mean (sd) changes in symptom score were 3.7 (3.3) for the internet group and 3.2 (3.4) for the postal group (P = 0

  7. Follow-up Cost Study. TEX-SIS FOLLOW-UP SC5.

    ERIC Educational Resources Information Center

    Baugh, Ronald C.

    This report presents data on the costs of follow-up studies, based on 29 separate follow-up studies conducted by eight public community/junior colleges in Texas. The purpose of this study, conducted by Navarro College as a subcontractor of Project FOLLOW-UP, was to provide data and information regarding the cost of follow-up studies that would be…

  8. Francoise, a Fifteen-Year Follow Up.

    ERIC Educational Resources Information Center

    Rondal, J. A.; Elbouz, M.; Ylieff, M.; Docquier, L.

    2003-01-01

    This paper reports on a 15-year follow-up of the linguistic and cognitive profile of a woman with standard trisomy 21 (Down syndrome). The follow-up found recent rapid deterioration in receptive and productive language skills. However, basic phonological and morphosyntactic skills are preserved. Her changing profile mirrors that found in aging…

  9. Towards sustainability assessment follow-up

    SciTech Connect

    Morrison-Saunders, Angus; Pope, Jenny; Bond, Alan; Retief, Francois

    2014-02-15

    This paper conceptualises what sustainability assessment follow-up might entail for three models of sustainability assessment: EIA-driven integrated assessment, objectives-led integrated assessment and the contribution to sustainability model. The first two are characterised by proponent monitoring and evaluation of individual impacts and indicators while the latter takes a holistic view based around focused sustainability criteria relevant to the context. The implications of three sustainability challenges on follow-up are also examined: contested time horizons and value changes, trade-offs, and interdisciplinarity. We conclude that in order to meet these challenges some form of adaptive follow-up is necessary and that the contribution to sustainability approach is the best approach. -- Highlights: • We explore sustainability follow-up for three different sustainability models. • Long-time frames require adaptive follow-up and are a key follow-up challenge. • Other key challenges include interdisciplinarity, and trade-offs. • Sustainability follow-up should be a direction of travel and not an outcome. • Only the follow-up for contribution to sustainability model addresses sustainability challenges sufficiently.

  10. Cancer follow-up care. Patients' perspectives.

    PubMed Central

    Miedema, Baukje; MacDonald, Ian; Tatemichi, Sue

    2003-01-01

    OBJECTIVE: To assess family physicians' and specialists' involvement in cancer follow-up care and how this involvement is perceived by cancer patients. DESIGN: Self-administered survey. SETTING: A health region in New Brunswick. PARTICIPANTS: A nonprobability cluster sample of 183 participants. MAIN OUTCOME MEASURES: Patients' perceptions of cancer follow-up care. RESULTS: More than a third of participants (36%) were not sure which physician was in charge of their cancer follow-up care. As part of follow-up care, 80% of participants wanted counseling from their family physicians, but only 20% received it. About a third of participants (32%) were not satisfied with the follow-up care provided by their family physicians. In contrast, only 18% of participants were dissatisfied with the follow-up care provided by specialists. Older participants were more satisfied with cancer follow-up care than younger participants. CONCLUSION: Cancer follow-up care is increasingly becoming part of family physicians' practices. Family physicians need to develop an approach that addresses patients' needs, particularly in the area of emotional support. PMID:12901486

  11. Extended Follow-up Confirms Early Vaccine-Enhanced Risk of HIV Acquisition and Demonstrates Waning Effect Over Time Among Participants in a Randomized Trial of Recombinant Adenovirus HIV Vaccine (Step Study)

    PubMed Central

    Duerr, Ann; Huang, Yunda; Buchbinder, Susan; Coombs, Robert W.; Sanchez, Jorge; del Rio, Carlos; Casapia, Martin; Santiago, Steven; Gilbert, Peter; Corey, Lawrence; Robertson, Michael N.

    2012-01-01

    Background. The Step Study tested whether an adenovirus serotype 5 (Ad5)–vectored human immunodeficiency virus (HIV) vaccine could prevent HIV acquisition and/or reduce viral load set-point after infection. At the first interim analysis, nonefficacy criteria were met. Vaccinations were halted; participants were unblinded. In post hoc analyses, more HIV infections occurred in vaccinees vs placebo recipients in men who had Ad5-neutralizing antibodies and/or were uncircumcised. Follow-up was extended to assess relative risk of HIV acquisition in vaccinees vs placebo recipients over time. Methods. We used Cox proportional hazard models for analyses of vaccine effect on HIV acquisition and vaccine effect modifiers, and nonparametric and semiparametric methods for analysis of constancy of relative risk over time. Results. One hundred seventy-two of 1836 men were infected. The adjusted vaccinees vs placebo recipients hazard ratio (HR) for all follow-up time was 1.40 (95% confidence interval [CI], 1.03–1.92; P = .03). Vaccine effect differed by baseline Ad5 or circumcision status during first 18 months, but neither was significant for all follow-up time. The HR among uncircumcised and/or Ad5-seropositive men waned with time since vaccination. No significant vaccine-associated risk was seen among circumcised, Ad5-negative men (HR, 0.97; P = 1.0) over all follow-up time. Conclusions. The vaccine-associated risk seen in interim analysis was confirmed but waned with time from vaccination. Clinical Trials Registration. NCT00095576. PMID:22561365

  12. [Follow-up of endometrial cancer].

    PubMed

    Gauthier, Tristan; Siegerth, François; Monteil, Jacques; Jammet, Isabelle; Saidi, Nadira; Tubiana-Mathieu, Nicole; Aubard, Yves

    2014-01-01

    Available data on appropriate follow-up in endometrial cancer highlight the need of well-conducted studies. Most recurrences tend to occur within three years and involve symptoms. Routine tests are not advocated without symptoms. In case of suspicious recurrence, TEP/CT seems to be the most sensitive and specific method. There is limited evidence to decide whether follow-up schedules with multiple visits result in survival benefits. An appropriate follow-up should be discussed based upon the risk of recurrence. Counselling on the potential symptoms of recurrence should be a major aim. PMID:25025796

  13. Robotic Follow-Up for Human Exploration

    NASA Technical Reports Server (NTRS)

    Fong, Terrence; Bualat, Maria; Deans, Matthew C.; Adams, Byron; Allan, Mark; Altobelli, Martha; Bouyssounouse, Xavier; Cohen, Tamar; Flueckiger, Lorenzo; Garber, Joshua; Palmer, Elizabeth; Heggy, Essam; Jurgens, Frank; Kennedy, Tim; Kobayashi, Linda; Lee, Pascal; Lee, Susan Y.; Lees, David; Lundy, Mike; Park, Eric; Pedersen, Liam; Smith, Trey; To, Vinh; Utz, Hans; Wheeler, Dawn

    2010-01-01

    We are studying how "robotic follow-up" can improve future planetary exploration. Robotic follow-up, which we define as augmenting human field work with subsequent robot activity, is a field exploration technique designed to increase human productivity and science return. To better understand the benefits, requirements, limitations and risks associated with this technique, we are conducting analog field tests with human and robot teams at the Haughton Crater impact structure on Devon Island, Canada. In this paper, we discuss the motivation for robotic follow-up, describe the scientific context and system design for our work, and present results and lessons learned from field testing.

  14. Comparison of single-bundle versus double-bundle anterior cruciate ligament reconstruction after a minimum of 3-year follow-up: a meta-analysis of randomized controlled trials

    PubMed Central

    Chen, Gang; Wang, Shouguo

    2015-01-01

    Both single-bundle (SB) and double-bundle (DB) procedures have been widely used in the treatment of anterior cruciate ligament (ACL) rupture; however, the optimal repair strategy remains considerably controversial. In this meta-analysis of published studies, we compared the results of these two techniques. After systematic review of electronic databases and websites, a total of 8 RCTs reporting data on 941 subjects were included. The objective and subjective functional recovery outcomes were meta-analyzed. The methodological quality was evaluated using the CBRG scale. The overall pooled data showed superiority in rotational stability, the degree of osteoarthritis (OA) changes, and subjective function score postoperatively in patients managed with DB compared with the SB procedure (pivot shift test, P = 0.02; degree of OA, P = 0.02; Lysholm score, P = 0.04; and Tegner scale, P = 0.002, respectively). However, subgroup analysis suggested no difference between the treatment procedures at long-term follow-up. This meta-analysis demonstrated that the DB technique could result in better rotational stability and higher subjective function score and was effective in preventing OA compared to SB in the mid-term treatment of the injured ACL. Further studies with better design involving larger sample sizes and longer-term follow-up are required. PMID:26628943

  15. Diabetes Nurse Case Management and Motivational Interviewing for Change (DYNAMIC): Results of a 2-year Randomized Controlled Pragmatic Trial

    PubMed Central

    Gabbay, Robert A.; Añel-Tiangco, Raquel M.; Dellasega, Cheryl; Mauger, David T.; Adelman, Alan; Van Horn, Deborah H.A.

    2013-01-01

    Objective To determine if the addition of nurse case managers (NCMs) trained in motivational interviewing (MI) to usual care would result in improved outcomes in high risk type 2 diabetes patients. Methods A 2-year randomized controlled pragmatic trial randomized 545 patients to usual care control (n=313) or those who received the intervention (n= 232) with additional practice embedded NCM care, including MI-guided behavior change counseling. NCMs received intensive MI training with ongoing fidelity assessment. Results Systolic BP was better in the intervention group (131±15.9 vs. 135±18.2, p < 0.05). HbA1c, LDL, and diastolic BP improved in both groups: HbA1c (control group 9.1% to 8.0%, intervention group 8.8% to 7.8%), LDL (control group 127 to 100 mg/dL, intervention group 128 to 102 mg/dL), diastolic BP (control group 78 to 74 mm Hg, intervention group 80 to 74 mm Hg). Depression symptom scores were better in the intervention group. The reduction in diabetes-related distress approached statistical significance. Conclusions NCMs and MI improved systolic BP and complications screening. The large decrease in HbA1C and LDL in the control group may have obscured any further intervention effect. Although nurses prompted providers for medication titration, strategies to reduce provider clinical inertia might also be needed. Significant findings of the study In patients with type 2 diabetes, an intervention with nurse case management and motivational interviewing improves systolic blood pressure, depression, and screening for complications. What this study adds First study to look at the benefit of the addition of motivational interviewing to nurse case management in the care of the high-risk adult with type 2 diabetes. Particular attention was given to ensuring fidelity to the motivational interviewing approach. PMID:23368423

  16. Renal Function Following Three Distinct Weight Loss Dietary Strategies During 2 Years of a Randomized Controlled Trial

    PubMed Central

    Tirosh, Amir; Golan, Rachel; Harman-Boehm, Ilana; Henkin, Yaakov; Schwarzfuchs, Dan; Rudich, Assaf; Kovsan, Julia; Fiedler, Georg M.; Blüher, Matthias; Stumvoll, Michael; Thiery, Joachim; Stampfer, Meir J.; Shai, Iris

    2013-01-01

    OBJECTIVE This study addressed the long-term effect of various diets, particularly low-carbohydrate high-protein, on renal function on participants with or without type 2 diabetes. RESEARCH DESIGN AND METHODS In the 2-year Dietary Intervention Randomized Controlled Trial (DIRECT), 318 participants (age, 51 years; 86% men; BMI, 31 kg/m2; mean estimated glomerular filtration rate [eGFR], 70.5 mL/min/1.73 m2; mean urine microalbumin-to-creatinine ratio, 12:12) with serum creatinine <176 μmol/L (eGFR ≥30 mL/min/1.73 m2) were randomized to low-fat, Mediterranean, or low-carbohydrate diets. The 2-year compliance was 85%, and the proportion of protein intake significantly increased to 22% of energy only in the low-carbohydrate diet (P < 0.05 vs. low-fat and Mediterranean). We examined changes in urinary microalbumin and eGFR, estimated by Modification of Diet in Renal Disease and Chronic Kidney Disease Epidemiology Collaboration formulas. RESULTS Significant (P < 0.05 within groups) improvements in eGFR were achieved in low-carbohydrate (+5.3% [95% CI 2.1–8.5]), Mediterranean (+5.2% [3.0–7.4]), and low-fat diets (+4.0% [0.9–7.1]) with similar magnitude (P > 0.05) across diet groups. The increased eGFR was at least as prominent in participants with (+6.7%) or without (+4.5%) type 2 diabetes or those with lower baseline renal function of eGFR <60 mL/min/1.73 m2 (+7.1%) versus eGFR ≥60 mL/min/1.73 m2 (+3.7%). In a multivariable model adjusted for age, sex, diet group, type 2 diabetes, use of ACE inhibitors, 2-year weight loss, and change in protein intake (confounders and univariate predictors), only a decrease in fasting insulin (β = −0.211; P = 0.004) and systolic blood pressure (β = −0.25; P < 0.001) were independently associated with increased eGFR. The urine microalbumin-to-creatinine ratio improved similarly across the diets, particularly among participants with baseline sex-adjusted microalbuminuria, with a mean change of −24.8 (P < 0

  17. Diabetic Amyotrophy: A Follow-up Study

    PubMed Central

    Casey, E. B.; Harrison, M. J. G.

    1972-01-01

    A clinical follow-up study of 12 patients with diabetic amyotrophy is reported. Re-examination after an interval indicated that improvement had occurred in all but one instance, and had been maintained over an average follow-up period of four and a half years. Improvement in the neurological syndrome appeared to follow improvement in diabetic control or institution of treatment in those whose diabetes had not previously been diagnosed. Seven patients made a good functional recovery, three no longer having any muscular weakness. Five showed significant residual disability. PMID:5015293

  18. Suicide Prevention and Follow-Up Services: A Narrative Review.

    PubMed

    Ghanbari, Behrooz; Malakouti, Seyed Kazem; Nojomi, Marzieh; Alavi, Kaveh; Khaleghparast, Shiva

    2016-01-01

    Previous suicide attempt is the most important predictor of death by suicide. Thus preventive interventions after attempting to suicide is essential to prevent reattempts. This paper attempts to determine whether phone preventive interventions or other vehicles (postal cards, email and case management) are effective in reattempt prevention and health promotion after discharge by providing an overview of studies on suicide reattempts. The research investigated in this review conducted from 1995 to 2014. A total of 26 cases related to the aim of this research were derived from 36 English articles with the aforementioned keywords Research shows that providing comprehensive aids, social support, and follow-up after discharge can significantly prevent suicide reattempts. Several studies showed that follow-up support (phone calls, crisis cards, mails, postal cards.) after discharge can significantly decrease the risk of suicide. More randomized controlled trials (RCT) are required to determine what factors of follow-up are more effective than other methods. PMID:26652085

  19. Suicide Prevention and Follow-Up Services: A Narrative Review

    PubMed Central

    Ghanbari, Behrooz; Malakouti, Seyed Kazem; Nojomi, Marzieh; Alavi, Kaveh; Khaleghparast, Shiva

    2016-01-01

    Previous suicide attempt is the most important predictor of death by suicide. Thus preventive interventions after attempting to suicide is essential to prevent reattempts. This paper attempts to determine whether phone preventive interventions or other vehicles (postal cards, email and case management) are effective in reattempt prevention and health promotion after discharge by providing an overview of studies on suicide reattempts. The research investigated in this review conducted from 1995 to 2014. A total of 26 cases related to the aim of this research were derived from 36 English articles with the aforementioned keywords Research shows that providing comprehensive aids, social support, and follow-up after discharge can significantly prevent suicide reattempts. Several studies showed that follow-up support (phone calls, crisis cards, mails, postal cards.) after discharge can significantly decrease the risk of suicide. More randomized controlled trials (RCT) are required to determine what factors of follow-up are more effective than other methods. PMID:26652085

  20. A Randomized Controlled Trial to Examine the Effect of 2-Year Vitamin B12 and Folic Acid Supplementation on Physical Performance, Strength, and Falling: Additional Findings from the B-PROOF Study.

    PubMed

    Swart, Karin M A; Ham, Annelies C; van Wijngaarden, Janneke P; Enneman, Anke W; van Dijk, Suzanne C; Sohl, Evelien; Brouwer-Brolsma, Elske M; van der Zwaluw, Nikita L; Zillikens, M Carola; Dhonukshe-Rutten, Rosalie A M; van der Velde, Nathalie; Brug, Johannes; Uitterlinden, André G; de Groot, Lisette C P G M; Lips, Paul; van Schoor, Natasja M

    2016-01-01

    Elevated homocysteine concentrations are associated with a decline in physical function in elderly persons. Homocysteine-lowering therapy may slow down this decline. This study aimed to examine the effect of a 2-year intervention of vitamin B12 and folic acid supplementation on physical performance, handgrip strength, and risk of falling in elderly subjects in a double-blind, randomized placebo-controlled trial. Participants aged ≥65 years with elevated plasma homocysteine concentrations [12-50 µmol/L (n = 2919)] were randomly assigned to daily supplementation of 500 µg vitamin B12, 400 µg folic acid, and 600 IU vitamin D3, or to placebo with 600 IU vitamin D3. Physical performance (range 0-12) and handgrip strength (kg) were measured at baseline and after 2 years. Falls were reported prospectively on a research calendar. Intention-to-treat (primary) and per-protocol (secondary) analyses were performed. Physical performance level and handgrip strength significantly decreased during the follow-up period, but this decline did not differ between groups. Moreover, time to first fall was not significantly different (HR: 1.0, 95% CI 0.9-1.2). Secondary analyses on a per-protocol base identified an interaction effect with age on physical performance. In addition, the treatment was associated with higher follow-up scores on the walking test (cumulative OR: 1.3, 95% CI 1.1-1.5). Two-year supplementation of vitamin B12 and folic acid was neither effective in reducing the age-related decline in physical performance and handgrip strength, nor in the prevention of falling in elderly persons. Despite the overall null-effect, the results provide indications for a positive effect of the intervention on gait, as well as on physical performance among compliant persons >80 years. These effects should be further tested in future studies. PMID:26412463

  1. Follow-Up Research on Agoraphobics.

    ERIC Educational Resources Information Center

    Chambless, Dianne L.

    In vivo exposure is the most commonly used and generally the most effective behavioral treatment for agoraphobia. Follow-up studies are difficult to interpret because additional treatment does not necessarily indicate relapse and non-treatment does not necessarily indicate non-relapse. Relapse rates are difficult to estimate because of lack of…

  2. Follow-up of differentiated thyroid carcinoma.

    PubMed

    Bournaud, C; Raverot, V

    2015-02-01

    The aim of follow-up of differentiated thyroid carcinoma (CTD) is the assessment of remission, and, in further steps, the early recognition of patients who develop a recurrence. Tools for the follow-up of CTD include the assessment of thyroglobulin and imaging procedures. Thyroglobulin (Tg) is a strong marker of persistent or recurrent disease, but it must be known that Tg antibodies may give falsely low Tg concentration. TSH stimulation, mainly by the mean of recombinant human TSH, improves the sensitivity of Tg determination. New highly sensitive assays may preclude the need for TSH stimulation, at least in some situations. In the last decades, (131)iodine whole body scan gave place to neck ultrasonography (US) as the most performing imaging procedure in the follow-up of CTD. Criteria to identify cervical lymph node suspect of metastasis have been described, and standardized procedures proposed. Finally, the proof of tumoral invasion is brought by cytological analysis of fine needle biopsies of suspicious lymph nodes. (18)FDG PET is a valuable tool for diagnosis and prognosis in metastatic patients, especially with negative (131)I WBS. Initial response to therapy, assessed by Tg determination and neck US, allows re-stratification of the risk of relapse. According to this "reassessed risk", adapted rhythms and modalities of follow-up have been recently proposed. PMID:26826480

  3. 1984 Graduate Follow-Up Study.

    ERIC Educational Resources Information Center

    John Tyler Community Coll., Chester, VA. Office of Institutional Research.

    A follow-up study is conducted of each graduating class of John Tyler Community College (JTCC) to document student successes in the job market and in pursuit of advanced studies, provide feedback to administrators and faculty for upgrading educational offerings and services, and provide a summary of student opinions to improve services. A…

  4. WCTC Graduate Follow-Up Report, 2002.

    ERIC Educational Resources Information Center

    Waukesha County Technical Coll., Pewaukee, WI.

    This paper reports on a survey of 2001-02 graduates of Waukesha County Technical College (WCTC), Wisconsin. The report indicates 1,257 students were awarded Associate's Degrees, technical diplomas, and apprenticeship certificates by WCTC in 2001-02. Of those graduates, 702 (56%) responded to the Graduate Follow-up Survey. Also, 84% of all…

  5. Employer Follow-Up Survey Report, 1997.

    ERIC Educational Resources Information Center

    Trident Technical Coll., Charleston, SC.

    In 1998, Trident Technical College conducted the 1997 Employer Follow-Up Survey to collect information from employers of 1997 graduates. A total of 373 employers of graduates were identified, of which 243 were contacted and interviewed. Findings indicate that employers rate graduates average or above average in most technical and personal skills.…

  6. Influence of General Self-Efficacy on the Effects of a School-Based Universal Primary Prevention Program of Depressive Symptoms in Adolescents: A Randomized and Controlled Follow-up Study

    ERIC Educational Resources Information Center

    Possel, Patrick; Baldus, Christiane; Horn, Andrea B.; Groen, Gunter; Hautzinger, Martin

    2005-01-01

    Background: Depressive disorders in adolescents are a widespread and increasing problem. Prevention seems a promising and feasible approach. Methods: We designed a cognitive-behavioral school-based universal primary prevention program and followed 347 eighth-grade students participating in a randomized controlled trial for three months. Results:…

  7. Outcomes of follow-up visits to chronic nonmalignant pain patients.

    PubMed

    Frich, Liv M H; Sorensen, Jan; Jacobsen, Susanne; Fohlmann, Bente; Højsted, Jette

    2012-12-01

    Follow-up visits by clinical nurse specialists are beneficial for patients with various chronic conditions. It is unknown whether patients with chronic nonmalignant pain can achieve similar benefit. The aim of this study was to assess outcomes of follow-up visits by clinical nurse specialists to chronic nonmalignant pain patients regarding health-related quality of life (HRQoL), pain, opioid treatment, quality of sleep, and depression. A total of 102 patients were enrolled in a prospective randomized controlled trial during a 2-year period after discharge from multidisciplinary pain treatment and randomized to intervention or control group. Intervention group patients (n = 52) received home visits every fourth month for 2 years. The findings showed that HRQoL improved generally more in the intervention group. Statistically significant improvements were observed for physical function and bodily pain. Whereas the intervention group maintained the pain level on a visual analog scale, the control group reported more pain. During the observation period, the control group increased dosage of opioids whereas the intervention group maintained stable dosage. No significant effect on quality of life was found. Nurses identified signs of depression in 80% of their patients scoring depression on the simultaneous depression questionnaire, and thereby could refer patients to early treatment. Follow-up visits by clinical nurse specialists appeared to offer positive benefits to patients with chronic nonmalignant pain after discharge from multidisciplinary pain treatment. The intervention improved physical functioning, reduced bodily pain and pain intensity and prevented opioid dosage increase. Most episodes of depression were identified and referred to relevant treatment. PMID:23158704

  8. A randomized blinded controlled trial of mobile phone reminders on the follow-up medical care of HIV-exposed and HIV-infected children in Cameroon: study protocol (MORE CARE)

    PubMed Central

    2013-01-01

    Background In Cameroon, only two-thirds of children with HIV exposure or infection receive appropriate HIV-directed medical care. Mortality, antiretroviral therapy resistance and suboptimal virological response are strongly related to missed opportunities for treatment, and, more specifically, to skipped scheduled medical appointments. The present trial, MORE CARE (Mobile Reminders for Cameroonian Children Requiring HIV Care) seeks to determine if reminders sent by text message (SMS), phone call, or concomitant SMS and phone calls most increase the presence at medical appointments of HIV-infected or -exposed children (efficacy), and which is the most efficient related to working time and financial cost (efficiency). Methods/Design We will carry out a multicenter single-blind, randomized, factorial controlled trial. A randomization list will be electronically generated using random block sizes. Central allocation will be determined by sequentially numbered. A total of 224 subjects will be randomized into four groups (SMS, Call, SMS + Call, and Control) with an allocation ratio of 1:1:1:1. SMS and calls will be sent between 48 and 72 hours before the scheduled appointment. A medical assistant will send out text messages and will call participants. Our primary outcome is appointment measured by efficacy and efficiency of interventions. We hypothesize that two reminders (concomitant use of SMS and phone calls) as an appointment reminder is more effective to improve appointment compared to one reminder (only SMS or only call), and that the most efficient is use of only SMS. The analysis will be intention to treat. Discussion This trial investigates the potential of SMS and phone calls as motivational reminders to improve children’s adherence to medical appointments for HIV-related care in Cameroon. The intervention will act to end missed appointment due to forgetfulness. Trial registration Pan African Clinical Trials Registry: PACTR201304000528276 PMID:24066735

  9. The LCOGT NEO Follow-up Network

    NASA Astrophysics Data System (ADS)

    Lister, Tim A.; Greenstreet, S.; Gomez, E.; Christensen, E.; Larson, S.

    2016-01-01

    Las Cumbres Observatory Global Telescope Network (LCOGT) has deployed a homogeneous telescope network of nine 1-meter telescopes to four locations in the northern and southern hemispheres, with a planned network size of twelve 1-meter telescopes at 6 locations. This network is very versatile and is designed to respond rapidly to target of opportunity events and also to perform long term monitoring of slowly changing astronomical phenomena. The global coverage of the network and the apertures of telescope available make LCOGT ideal for follow-up and characterization of Solar System objects (e.g. asteroids, Kuiper Belt Objects, comets, Near-Earth Objects (NEOs)) and additionally for the discovery of new objects. We are using the LCOGT network to confirm newly detected NEO candidates produced by the major sky surveys such as Catalina Sky Survey (CSS) and PanSTARRS (PS1&2) and several hundred targets are now being followed per year. An increasing amount of time is being spent to obtain follow-up astrometry and photometry for radar-targeted objects and those on the Near-Earth Object Human Space Flight Accessible Targets Study (NHATS) or Asteroid Retrieval Mission (ARM) lists in order to improve the orbits, determine the light curves and rotation periods and improve the characterization. This will be extended to obtain more light curves of other NEOs which could be targets. Recent results have included the first period determinations for several of the Goldstone-targeted NEOs. We are in the process of building a NEO follow-up portal which will allow professionals, amateurs and Citizen Scientists to plan, schedule and analyze NEO imaging and spectroscopy observations and data using the LCOGT Network and to act as a co-ordination hub for the NEO follow-up efforts.

  10. Effects of galantamine in a 2-year, randomized, placebo-controlled study in Alzheimer’s disease

    PubMed Central

    Hager, Klaus; Baseman, Alan S; Nye, Jeffrey S; Brashear, H Robert; Han, John; Sano, Mary; Davis, Bonnie; Richards, Henry M

    2014-01-01

    Background Currently available treatments for Alzheimer’s disease (AD) can produce mild improvements in cognitive function, behavior, and activities of daily living in patients, but their influence on long-term survival is not well established. This study was designed to assess patient survival and drug efficacy following a 2-year galantamine treatment in patients with mild to moderately severe AD. Methods In this multicenter, double-blind study, patients were randomized 1:1 to receive galantamine or placebo. One primary end point was safety; mortality was assessed. An independent Data Safety Monitoring Board monitored mortality for the total deaths reaching prespecified numbers, using a time-to-event method and a Cox-regression model. The primary efficacy end point was cognitive change from baseline to month 24, as measured by the Mini-Mental State Examination (MMSE) score, analyzed using intent-to-treat analysis with the ‘last observation carried forward’ approach, in an analysis of covariance model. Results In all, 1,024 galantamine- and 1,021 placebo-treated patients received study drug, with mean age ~73 years, and mean (standard deviation [SD]) baseline MMSE score of 19 (4.08). A total of 32% of patients (661/2,045) completed the study, 27% (554/2,045) withdrew, and 41% (830/2,045) did not complete the study and were discontinued due to a Data Safety Monitoring Board-recommended early study termination. The mortality rate was significantly lower in the galantamine group versus placebo (hazard ratio [HR] =0.58; 95% confidence interval [CI]: 0.37; 0.89) (P=0.011). Cognitive impairment, based on the mean (SD) change in MMSE scores from baseline to month 24, significantly worsened in the placebo (−2.14 [4.34]) compared with the galantamine group (−1.41 [4.05]) (P<0.001). Functional impairment, based on mean (SD) change in the Disability Assessment in Dementia score (secondary end point), at month 24 significantly worsened in the placebo (−10.81 [18