Science.gov

Sample records for 2-year clinical outcomes

  1. Arthroscopic suprapectoral and open subpectoral biceps tenodesis: a comparison of minimum 2-year clinical outcomes.

    PubMed

    Werner, Brian C; Evans, Cody L; Holzgrefe, Russel E; Tuman, Jeffrey M; Hart, Joseph M; Carson, Eric W; Diduch, David R; Miller, Mark D; Brockmeier, Stephen F

    2014-11-01

    While a vast body of literature exists describing biceps tenodesis techniques and evaluating the biomechanical aspects of tenodesis locations or various implants, little literature presents useful clinical outcomes to guide surgeons in their decision to perform a particular method of tenodesis. To compare the clinical outcomes of open subpectoral biceps tenodesis (OSPBT) and arthroscopic suprapectoral biceps tenodesis (ASPBT). Our null hypothesis was that both methods would yield satisfactory results with regard to shoulder and biceps function, postoperative shoulder scores, pain relief, and complications. Cohort study; Level of evidence, 3. Patients who underwent either ASPBT or OSPBT for isolated superior labrum or long head of the biceps lesions with a minimum follow-up of 2 years were evaluated with several validated clinical outcome measures and physical examinations including range of motion and strength. Between 2007 and 2011, a total of 82 patients met all inclusion and exclusion criteria, which included 32 patients with ASPBT and 50 patients with OSPBT; 27 of 32 (84.4%) patients with ASPBT and 35 of 50 (70.0%) patients with OSPBT completed clinical follow-up. Overall outcomes for both procedures were satisfactory. No significant differences were noted in postoperative Constant-Murley (ASPBT: 90.7; OSPBT: 91.8; P = .755), American Shoulder and Elbow Surgeons (ASPBT: 90.1; OSPBT: 88.4; P = .735), Single Assessment Numeric Evaluation (ASPBT: 87.4; OSPBT: 86.8; P = .901), Simple Shoulder Test (ASPBT: 10.4; OSPBT: 10.6; P = .762), long head of the biceps (ASPBT: 91.6; OSPBT: 93.6; P = .481), or Veterans RAND 36-Item Health Survey (ASPBT: 81.0; OSPBT: 80.1; P = .789) scores. No significant range of motion or strength differences was noted between the procedures. Both ASPBT and OSPBT yield excellent clinical and functional results for the management of isolated superior labrum or long head of the biceps lesions. No significant differences in clinical outcomes as

  2. Clinical outcomes and mortality after hip fracture: a 2-year follow-up study.

    PubMed

    Baudoin, C; Fardellone, P; Bean, K; Ostertag-Ezembe, A; Hervy, F

    1996-03-01

    The aim of this study was to evaluate the burden of hip fractures, which occurred in the French region of Picardie, in 1992, among 1103 women and 356 men, whether the fractures occurred at home or in a community (i.e., patients who depended on a collective service). The data are part of the PICAROS study, which was designed to assess prospectively the outcome of patients as judged by clinical, economical, and quality of life factors. Patients and/or proxies were questioned during the 2nd or 3rd week following the fracture, and again at 3, 6, 12, and 24 months after the fracture. The survey was conducted by home interview. Recruitment criteria were: 1) all patients with a hip fracture as defined by the International Classification of Disease (ICD); 2) 20 years of age and over; 3) admitted to one of the 34 surgical units from the region, public and private, and had an operation or not. Patients with metastatic or myelomatous fractures or fractures on prothesis device were not included. For the present analysis, patients under 50 years of age were excluded. Among people aged 50 years and over, 3% of the general population lived in a community; 32% of hip fractures were from a community. Patients in a community, aged 60-69, had 15 times more risk of having a hip fracture than subjects of the same age at home. The excess risk decreased with age and stabilized over 85 years of age at two to threefold. During the 24 month follow-up, 394 women and 173 men died. Among those surviving, 87% were interviewed at 2 years. We analysed seven classes of complications, according to the ICD: (1) pressure sores and blisters; (2) pulmonary infections; (3) urinary infections; (4) surgical complications; (5) orthopedic complications; (6) thrombosis and embolisms; and (7) secondary hip fractures. Patients coming from a community had a higher risk of mortality, pressure sores, surgical complications, and pulmonary and urinary infections. From an economical perspective, the

  3. Methadone treatment for opiate dependent patients in general practice and specialist clinic settings: Outcomes at 2-year follow-up.

    PubMed

    Gossop, Michael; Stewart, Duncan; Browne, Nadine; Marsden, John

    2003-06-01

    Few studies have investigated methadone treatment of opiate dependent patients in primary health care settings. Using a prospective cohort design, the study investigated outcomes at 1 and 2 years for 240 patients treated by general practitioners (n = 79) or drug clinics (n = 161) at sites across England. Mean daily methadone dose for both groups was 50 mg. Reductions in illicit drug use, injecting, sharing injecting equipment, psychological and physical health problems, and crime, were found in both groups at follow-up. Patients treated in general practitioner (GP) settings reported less frequent benzodiazepine and stimulant use, and fewer psychological health problems at follow-up. Alcohol use outcomes were poor for both groups. Differences in treatment practices were found for GPs and clinics. Results show substantial reductions in a range of problems behaviours, among unselected samples of opiate dependent patients treated in GP and in clinic settings, which are sustained to 1-year and 2-year follow-up.

  4. Comparison of 2-year clinical outcomes between diabetic versus nondiabetic patients with acute myocardial infarction after 1-month stabilization

    PubMed Central

    Hur, Seung-Ho; Won, Ki-Bum; Kim, In-Cheol; Bae, Jang-Ho; Choi, Dong-Ju; Ahn, Young-Keun; Park, Jong-Seon; Kim, Hyo-Soo; Choi, Rak-Kyeong; Choi, Donghoon; Kim, Joon-Hong; Han, Kyoo-Rok; Park, Hun-Sik; Choi, So-Yeon; Yoon, Jung-Han; Gwon, Hyeon-Cheol; Rha, Seung-Woon; Jang, Wooyeong; Bae, Jang-Whan; Hwang, Kyung-Kuk; Lim, Do-Sun; Jung, Kyung-Tae; Oh, Seok-Kyu; Lee, Jae-Hwan; Shin, Eun-Seok; Kim, Kee-Sik

    2016-01-01

    Abstract This study assessed the 2-year clinical outcomes of patients with diabetes mellitus (DM) after acute myocardial infarction (AMI) in a cohort of the DIAMOND (DIabetic Acute Myocardial infarctiON Disease) registry. Clinical outcomes were compared between 1088 diabetic AMI patients in the DIAMOND registry after stabilization of MI and 1088 nondiabetic AMI patients from the KORMI (Korean AMI) registry after 1 : 1 propensity score matching using traditional cardiovascular risk factors. Stabilized patients were defined as patients who did not have any clinical events within 1 month after AMI. Primary outcomes were the 2-year rate of major adverse cardiac events (MACEs), a composite of all-cause death, recurrent MI (re-MI), and target vessel revascularization (TVR). Matched comparisons revealed that diabetic patients exhibited significantly lower left ventricular ejection fraction (LVEF) and estimated glomerular filtration rate and smaller stent size. Diabetic patients exhibited significantly higher 2-year rates of MACE (8.0% vs 3.7%), all-cause death (3.9% vs 1.4%), re-MI (2.8% vs 1.2%), and TVR (3.5% vs 1.3%) than nondiabetic patients (all P < 0.01), and higher cumulative rates in Kaplan–Meier analyses of MACE, all-cause death, and TVR (all P < 0.05). A multivariate Cox regression analysis revealed that chronic kidney disease, LVEF < 35%, and long stent were independent predictors of MACE, and large stent diameter and the use of drug-eluting stents were protective factors against MACE. The 2-year MACE rate beyond 1 month after AMI was significantly higher in DM patients than non-DM patients, and this rate was associated with higher comorbidities, coronary lesions, and procedural characteristics in DM. PMID:27336875

  5. Crestal Sinus Augmentation with Recombinant Human Bone Morphogenetic Protein 2: Clinical and Radiographic Outcomes of 2-Year Pilot Trial.

    PubMed

    Kuchler, Ulrike; Rudelstorfer, Claudia M; Barth, Barbara; Tepper, Gabor; Lidinsky, Dominika; Heimel, Patrick; Watzek, Georg; Gruber, Reinhard

    Recombinant human bone morphogenetic protein 2 (rhBMP-2) together with an absorbable collagen carrier (ACS) was approved for augmentation of the maxillary sinus prior to implant placement. The original registration trial was based on a lateral window approach. Clinical outcomes of crestal sinus augmentation with rhBMP-2 have not been reported so far. An uncontrolled pilot trial in which seven patients with a residual maxillary height below 5 mm were enrolled to receive crestal sinus augmentation with rhBMP-2/ACS was conducted. Elevation of the sinus mucosa was performed by gel pressure. Primary endpoints were the gain in augmentation height and volume measured by computed tomography after 6 months. Evaluation of bone quality at the time of implant placement was based on histology. Secondary endpoints were the clinical and radiologic evaluation of the implants and patient satisfaction by visual analog scale (VAS) at the 2-year follow-up. Median gain in augmentation height was 7.2 mm (range 0.0 to 17.5 mm). Five patients gained at least 5 mm of bone height. Two patients with a perforation of the sinus mucosa failed to respond to rhBMP-2/ACS and underwent lateral window augmentation. The median gain in augmentation volume of the five patients was 781.3 mm³ (range 426.9 to 1,242.8 mm³). Biopsy specimens showed a cancellous network consisting of primary plexiform bone with little secondary lamellar bone. After 2 years, implants were in function with no signs of inflammation or peri-implant bone loss. Patients were satisfied with the esthetic outcomes and chewing function. This pilot clinical trial supports the original concept that rhBMP-2/ACS supports bone formation, also in crestal sinus augmentation, and emphasizes the relevance of the integrity of the sinus mucosa to predict the bone gain.

  6. Anterior spinal fusion for thoracolumbar scoliosis: comprehensive assessment of radiographic, clinical, and pulmonary outcomes on 2-years follow-up.

    PubMed

    Verma, Kushagra; Auerbach, Joshua D; Kean, Kristin E; Chamas, Firas; Vorsanger, Matthew; Lonner, Baron S

    2010-01-01

    There is a continued role for anterior spinal fusion (ASF) in the treatment of thoracolumbar scoliosis. Despite numerous previous reports of ASF in the treatment of thoracolumbar scoliosis, no single study has simultaneously evaluated clinical, radiographic, and pulmonary function outcomes. Retrospective review of 31 consecutive thoracolumbar adolescent idiopathic scoliosis patients (Lenke type 5) who underwent ASF by a single surgeon. Patient records were comprehensively assessed for Scoliosis Research Society (SRS)-22 score, apical trunk rotation, radiographic changes, and pulmonary function before surgery and at 2-years follow-up. Thoracolumbar/lumbar curve correction averaged from 45 to 11 degrees (74%) and spontaneous correction of thoracic curves averaged from 26 to 15 degrees (42%). Instrumented segment lordosis increased by 11 degrees, whereas proximal junction kyphosis increased by 3 degrees. No significant changes were noted in T2-T12 kyphosis, distal junctional kyphosis, T12-S1 lumbar lordosis, or coronal balance. Thoracolumbar apical trunk rotation improved from 12 to 3 degrees. Average SRS scores significantly improved from 3.9 to 4.4. SRS assessments of self-image and pain also improved significantly from 3.6 to 4.5 and from 4.1 to 4.6, respectively. Absolute and percent predicted forced vital capacity and forced expiratory volume in 1 second were unchanged. Two patients suffered mild intercostal neuralgia postthoracotomy. There were no other complications. The thoracoabdominal anterior approach for thoracolumbar scoliosis facilitates excellent clinical and radiographic outcomes, minimal blood loss, powerful apical trunk rotation correction, relative maintenance of lordosis, relatively short fusion constructs, and improved SRS-22 performance, without significant pulmonary function impairment at 2 years. It continues to be an efficacious treatment for thoracolumbar scoliosis. Level IV.

  7. Academic Outcomes 2 Years After Working Memory Training for Children With Low Working Memory: A Randomized Clinical Trial.

    PubMed

    Roberts, Gehan; Quach, Jon; Spencer-Smith, Megan; Anderson, Peter J; Gathercole, Susan; Gold, Lisa; Sia, Kah-Ling; Mensah, Fiona; Rickards, Field; Ainley, John; Wake, Melissa

    2016-05-02

    Working memory training may help children with attention and learning difficulties, but robust evidence from population-level randomized controlled clinical trials is lacking. To test whether a computerized adaptive working memory intervention program improves long-term academic outcomes of children 6 to 7 years of age with low working memory compared with usual classroom teaching. Population-based randomized controlled clinical trial of first graders from 44 schools in Melbourne, Australia, who underwent a verbal and visuospatial working memory screening. Children were classified as having low working memory if their scores were below the 15th percentile on either the Backward Digit Recall or Mister X subtest from the Automated Working Memory Assessment, or if their scores were below the 25th percentile on both. These children were randomly assigned by an independent statistician to either an intervention or a control arm using a concealed computerized random number sequence. Researchers were blinded to group assignment at time of screening. We conducted our trial from March 1, 2012, to February 1, 2015; our final analysis was on October 30, 2015. We used intention-to-treat analyses. Cogmed working memory training, comprising 20 to 25 training sessions of 45 minutes' duration at school. Directly assessed (at 12 and 24 months) academic outcomes (reading, math, and spelling scores as primary outcomes) and working memory (also assessed at 6 months); parent-, teacher-, and child-reported behavioral and social-emotional functioning and quality of life; and intervention costs. Of 1723 children screened (mean [SD] age, 6.9 [0.4] years), 226 were randomized to each arm (452 total), with 90% retention at 1 year and 88% retention at 2 years; 90.3% of children in the intervention arm completed at least 20 sessions. Of the 4 short-term and working memory outcomes, 1 outcome (visuospatial short-term memory) benefited the children at 6 months (effect size, 0.43 [95% CI, 0

  8. Outcome of surgical treatment of peri-implantitis: results from a 2-year prospective clinical study in humans.

    PubMed

    Serino, Giovanni; Turri, Alberto

    2011-11-01

    The aim of the present study was to evaluate the outcome of a surgical procedure based on pocket elimination and bone re-contouring for the treatment of peri-implantitis. The 31 subjects involved in this study presented clinical signs of peri-implantitis at one or more dental implants (i.e. ≥6 mm pockets, bleeding on probing and/or suppuration and radiographic evidence of ≥2 mm bone loss). The patients were treated with a surgical procedure based on pocket elimination and bone re-contouring and plaque control before and following the surgery. At the time of surgery, the amount of bone loss at implants was recorded. Two years following treatment, 15 (48%) subjects had no signs of peri-implant disease; 24 patients (77%) had no implants with a probing pocket depth of ≥6 mm associated with bleeding and/or suppuration following probing. A total of 36 implants (42%) out of the 86 with initial diagnosis of peri-implantitis presented peri-implant disease despite treatment. The proportion of implants that became healthy following treatment was higher for those with minor initial bone loss (2-4 mm bone loss as assessed during surgery) compared with the implants with a bone loss of ≥5 mm (74% vs. 40%). Among the 18 implants with bone loss of ≥7 mm, seven were extracted. Between the 6-month and the 2-year examination, healthy implants following treatment tended to remain stable, while deepening of pockets was observed for those implants with residual pockets. The results of this study indicated that a surgical procedure based on pocket elimination and bone re-contouring and plaque control before and following surgery was an effective therapy for treatment of peri-implantitis for the majority of subjects and implants. However, complete disease resolution at the site level seems to depend on the initial bone loss at implants. Implants with no signs of peri-implantitis following treatment tended to remain healthy during the 2-year period, while a tendency for disease

  9. Clinical Features and Treatment Outcomes of Primary Immune Thrombocytopenic Purpura in Hospitalized Children Under 2-Years Old

    PubMed Central

    Farhangi, H; Ghasemi, A; Banihashem, A; Badiei, Z; Jarahi, L; Eslami, G; Langaee, T

    2016-01-01

    Background Immune thrombocytopenic purpura (ITP) is the most prevalent cause of thrombocytopenia in children. Despite the importance of ITP in children under 2-years old, only a few publications are available in the literature.ITP usually presents itself as isolated thrombocytopenia and mucocutaneous bleeding. Materials and Methods This study was conducted on 187 under 2-year-old children diagnosed with ITP and treated at Dr. Sheikh Hospital from 2004 to 2011.In this retrospective study, clinical symptoms, laboratory findings, history of viral infections, vaccination history, and treatment efficacy in children under 2-years old with ITP were investigated.Patients were followed for one year after being discharged from the hospital. Results The risk of the disease developing into chronic form was higher in older children (0.001). ITP in children under 3-months old was significantly associated with vaccination (p=0.007). There was no significant differences between male and female patients in regards to newly diagnosed ITP, persistent, and chronic disease status (p = 0.21). No significant difference in bleeding symptoms was observed between patients under 3-months old and 3 to 24-months old (p=0.18). Conclusion Infantile ITP respond favorably to treatment. The risk of the disease developing into chronic form is higher in 3-to-24-month-old children compared to under-three-month olds. PMID:27222699

  10. The Auckland Cataract Study: 2 year postoperative assessment of aspects of clinical, visual, corneal topographic and satisfaction outcomes

    PubMed Central

    Thompson, A M; Sachdev, N; Wong, T; Riley, A F; Grupcheva, C N; McGhee, C N

    2004-01-01

    Aim: To assess clinical, visual, computerised corneal topographic, and subjective satisfaction with visual acuity, in a cohort of subjects 2 years after phacoemulsification surgery in a public hospital in New Zealand. Methods: Prospective study of a representative sample of 97 subjects (20%) randomly selected from 480 subjects in the original Auckland Cataract Study (ACS) cohort. The clinical assessment protocol was identical to the ACS and included an extensive questionnaire to enable direct comparisons to be made between the two groups. Results: The study population was predominantly female (66%) with a mean age of 76.3 (SD 9.9) years. New systemic and ocular disease affected 18.4% and 10.3% of subjects respectively, and 10.3% required referral to either a general practitioner (2.1%) or ophthalmologist (8.2%). Mean best spectacle corrected visual acuity (BSCVA) was 0.2 (0.2) logMAR units (6/9 Snellen equivalent), with mean spherical equivalent −0.37 (1.01) dioptres (D) and astigmatism −1.07 (0.70) D 2 years postoperatively, compared to mean BSCVA 0.1 (0.2) logMAR units (6/7.5 Snellen equivalent), spherical equivalent −0.59 (1.07) D, and astigmatism −1.14 (0.77) D 4 weeks after surgery. 94.9% of subjects retained a BSCVA of 6/12 or better, irrespective of pre-existing ocular disease. The overall posterior capsule opacification (PCO) rate was 20.4% and this was visually insignificant in all but 3.1% of eyes that had already undergone Nd:YAG posterior capsulotomy. Orbscan II elevation technology demonstrated corneal stability 2 years after uncomplicated phacoemulsification. Although corneal astigmatism was eliminated in approximately half of the subjects 1 month postoperatively, astigmatism showed a tendency to regress towards the preoperative level with local corneal thickening at the site of incision 2 years after cataract surgery. Of fellow eyes, 61.2% had undergone cataract surgery. Overall, 75.3% of subjects were moderately to very satisfied with their

  11. Impact of preoperative depression on 2-year clinical outcomes following adult spinal deformity surgery: the importance of risk stratification based on type of psychological distress.

    PubMed

    Theologis, Alexander A; Ailon, Tamir; Scheer, Justin K; Smith, Justin S; Shaffrey, Christopher I; Bess, Shay; Gupta, Munish; Klineberg, Eric O; Kebaish, Khaled; Schwab, Frank; Lafage, Virginie; Burton, Douglas; Hart, Robert; Ames, Christopher P

    2016-10-01

    OBJECTIVE The objective of this study was to isolate whether the effect of a baseline clinical history of depression on outcome is independent of associated physical disability and to evaluate which mental health screening tool has the most utility in determining 2-year clinical outcomes after adult spinal deformity (ASD) surgery. METHODS Consecutively enrolled patients with ASD in a prospective, multicenter ASD database who underwent surgical intervention with a minimum 2-year follow-up were retrospectively reviewed. A subset of patients who completed the Distress and Risk Assessment Method (DRAM) was also analyzed. The effects of categorical baseline depression and DRAM classification on the Oswestry Disability Index (ODI), SF-36, and Scoliosis Research Society questionnaire (SRS-22r) were assessed using univariate and multivariate linear regression analyses. The probability of achieving ≥ 1 minimal clinically important difference (MCID) on the ODI based on the DRAM's Modified Somatic Perceptions Questionnaire (MSPQ) score was estimated. RESULTS Of 267 patients, 66 (24.7%) had self-reported preoperative depression. Patients with baseline depression had significantly more preoperative back pain, greater BMI and Charlson Comorbidity Indices, higher ODIs, and lower SRS-22r and SF-36 Physical/Mental Component Summary (PCS/MCS) scores compared with those without self-reported baseline depression. They also had more severe regional and global sagittal malalignment. After adjusting for these differences, preoperative depression did not impact 2-year ODI, PCS/MCS, or SRS-22r totals (p > 0.05). Compared with those in the "normal" DRAM category, "distressed somatics" (n = 11) had higher ODI (+23.5 points), lower PCS (-10.9), SRS-22r activity (-0.9), and SRS-22r total (-0.8) scores (p ≤ 0.01), while "distressed depressives" (n = 25) had lower PCS (-8.4) and SRS-22r total (-0.5) scores (p < 0.05). After adjusting for important covariates, each additional point on the

  12. Arthroscopic Latarjet Procedure With Anterior Capsular Reconstruction: Clinical Outcome and Radiologic Evaluation With a Minimum 2-Year Follow-Up.

    PubMed

    Zhu, Yi-Ming; Jiang, Chunyan; Song, Guanyang; Lu, Yi; Li, Fenglong

    2017-08-16

    To investigate the clinical and radiographic outcomes of the modified arthroscopic Latarjet procedure at a minimum of 2 years after surgery. Patients who had traumatic unidirectional anterior shoulder instability and treated with a modified arthroscopic Latarjet procedure were included. During surgery, the anterior capsule was preserved and repaired back to the glenoid after the coracoid transfer. The clinical results (range of motion, American Shoulder and Elbow Surgeons [ASES] score, Constant-Murley score, and Rowe score) and computed tomographic results were followed. From February 2013 to September 2014, 52 consecutive patients were included. The average duration of follow-up was 28.4 months (range, 24.0-41.7 months). At final follow-up, no recurrent dislocation had occurred. The ASES score and Rowe score improved significantly (ASES score from 85.6 ± 12.7 before surgery to 93.6 ± 5.4 after surgery, P < .0001; Rowe score from 41.5 ± 7.2 before surgery to 92.2 ± 8.7 after surgery, P < .0001). No significant change was found regarding range of motion and the Constant-Murley score. Bone union was achieved in all cases. The transferred coracoid was at the level of the glenoid in all cases. The transferred coracoid was placed below the equator in 48 of 52 cases (92.3%). The orientation of the screw was 22.6° ± 10.8°. Bone resorption around the proximal screw was significantly more prominent than that around the distal screw (P < .0001). The arthroscopic Latarjet procedure with concomitant anterior capsular reconstruction can achieve satisfactory clinical outcomes for the treatment of anterior shoulder instability with marked glenoid bone loss at a minimum of 2 years' follow-up. A satisfactory coracoid graft position, proper screw orientation, and high healing rate of the transferred coracoid can be expected. Bone resorption around the proximal screw is more severe than that around the distal screw. Level IV, therapeutic case series. Copyright © 2017

  13. Comparison of best versus worst clinical outcomes for adult spinal deformity surgery: a retrospective review of a prospectively collected, multicenter database with 2-year follow-up.

    PubMed

    Smith, Justin S; Shaffrey, Christopher I; Lafage, Virginie; Schwab, Frank; Scheer, Justin K; Protopsaltis, Themistocles; Klineberg, Eric; Gupta, Munish; Hostin, Richard; Fu, Kai-Ming G; Mundis, Gregory M; Kim, Han Jo; Deviren, Vedat; Soroceanu, Alex; Hart, Robert A; Burton, Douglas C; Bess, Shay; Ames, Christopher P

    2015-09-01

    Although recent studies suggest that average clinical outcomes are improved following surgery for selected adult spinal deformity (ASD) patients, these outcomes span a broad range. Few studies have specifically addressed factors that may predict favorable clinical outcomes. The objective of this study was to compare patients with ASD with best versus worst clinical outcomes following surgical treatment to identify distinguishing factors that may prove useful for patient counseling and optimization of clinical outcomes. This is a retrospective review of a prospectively collected, multicenter, database of consecutively enrolled patients with ASD who were treated operatively. Inclusion criteria were age > 18 years and ASD. For patients with a minimum of 2-year follow-up, those with best versus worst outcomes were compared separately based on Scoliosis Research Society-22 (SRS-22) and Oswestry Disability Index (ODI) scores. Only patients with a baseline SRS-22 ≤ 3.5 or ODI ≥ 30 were included to minimize ceiling/floor effects. Best and worst outcomes were defined for SRS-22 (≥ 4.5 and ≤ 2.5, respectively) and ODI (≤ 15 and ≥ 50, respectively). Of 257 patients who met the inclusion criteria, 227 (88%) had complete baseline and 2-year follow-up SRS-22 and ODI outcomes scores and radiographic imaging and were analyzed in the present study. Of these 227 patients, 187 had baseline SRS-22 scores ≤ 3.5, and 162 had baseline ODI scores ≥ 30. Forthe SRS-22, best and worst outcomes criteria were met at follow-up for 25 and 27 patients, respectively. For the ODI, best and worst outcomes criteria were met at follow-up for 43 and 51 patients, respectively. With respect to the SRS-22, compared with best outcome patients, those with worst outcomes had higher baseline SRS-22 scores (p < 0.0001), higher prevalence of baseline depression (p < 0.001), more comorbidities (p = 0.012), greater prevalence of prior surgery (p = 0.007), a higher complication rate (p = 0

  14. Comparison between single- and multi-level patients: clinical and radiological outcomes 2 years after cervical disc replacement.

    PubMed

    Huppert, J; Beaurain, J; Steib, J P; Bernard, P; Dufour, T; Hovorka, I; Stecken, J; Dam-Hieu, P; Fuentes, J M; Vital, J M; Vila, T; Aubourg, L

    2011-09-01

    In cervical multi-level degenerative pathology, considering the morbidity of the extensive fusion techniques, some authors advocate for the multilevel disc replacement. This study compared the safety and efficacy of disc replacement with an unconstrained prosthesis in multi- versus single-level patients. A total of 231 patients with cervical degenerative disc disease (DDD) who were treated with cervical disc replacement and completed their 24 months follow-up were analyzed prospectively: 175 were treated at one level, 56 at 2 levels or more. Comparison between both groups was based on usual clinical and radiological outcomes [Neck Disability Index (NDI), Visual Analog Scale (VAS), Range of Motion, satisfaction]. Safety assessments, including complication and subsequent surgeries, were also documented and compared. Mean NDI and VAS scores for neck and arm pain were improved in both groups similarly. Improvement of mobility at treated segments was also similar. Nevertheless, in the multi-level group, analgesic use was significantly higher and occurrence of Heterotopic Ossification significantly lower than in the single-level group. Subject satisfaction was nearly equal, as 94.2% of single-level group patients would undergo the surgery again versus 94.5% in the multi-level group. The overall success rate did not differ significantly. Multi-level DDD is a challenging indication in the cervical spine. This study showed no major significant clinical difference between the two groups. We need further studies to know more about the impact of multi-level arthroplasty, especially on the adjacent segments, but these results demonstrate initial safety and effectiveness in this patient sample.

  15. Prognostic Value of the Clinical SYNTAX Score on 2-Year Outcomes in Patients With Acute Coronary Syndrome Who Underwent Percutaneous Coronary Intervention.

    PubMed

    He, Chen; Song, Ying; Wang, Chuang-Shi; Yao, Yi; Tang, Xiao-Fang; Zhao, Xue-Yan; Gao, Run-Lin; Yang, Yue-Jin; Xu, Bo; Yuan, Jin-Qing

    2017-03-01

    This prospective, single-center, observational study evaluated prognostic value of clinical SYNTAX score (CSS) on 2-year outcomes in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI). The SYNTAX score (SS) is a scoring system based on the complexity and severity of coronary lesions and is thought to be a prognostic tool to predict long-term outcomes. However, SS was a sole angiographic grading tool only with no consideration for clinical factors. There are few studies investigating the prognostic value of CSS in patients with ACS who underwent PCI. From January 2013 to December 2013, 6,099 consecutive patients with ACS admitted to FuWai hospital and underwent PCI were enrolled in this study. Based on CSS, patients were divided into low CSS group (CSS ≤ 6.5; 2,012 patients), mid-CSS group (6.5 < CSS < 13.8; 2,056 patients), and high CSS group (CSS ≥ 13.8; 2,031 patients). At 2-year follow-up, rates of cardiac death and major adverse cardiac events (MACE) were significantly higher in the high CSS group. Compared with baseline SS, CSS demonstrated significantly improved performance for 2-year cardiac death (receiver-operating characteristic curve C-statistic: 0.74 vs 0.62, p <0.001) but not for MACE (receiver-operating characteristic curve C-statistic: 0.60 vs 0.59, p = 0.29). By multivariable analysis, the CSS combined with PCI history and hypertension were strong predictors for cardiac death and CSS, intra-aortic balloon pump support, diabetes, and successful PCI were independent predictors for MACE. In conclusion, compared with the anatomic SS, CSS was suitable in risk stratifying and predicting 2-year clinical outcome among ACS population.

  16. Final 2 year results of the vascular imaging of acute stroke for identifying predictors of clinical outcome and recurrent ischemic eveNts (VISION) study

    PubMed Central

    2011-01-01

    Among patients with ischemic stroke, little attention has been paid to differentiation between stroke progression and recurrence. We assessed the role of MR imaging in predicting stroke progression, recurrent stroke, and death within 2 years of symptom onset. Methods Ischemic stroke or TIA patients were prospectively enrolled. They were examined within 12 hours and had a stroke MR completed within 24 hours of symptom onset. Patients were closely followed neurologically and examined if there was any deterioration in neurological status. Relationships between baseline clinical and imaging factors and outcomes were assessed. We also examined whether baseline stroke/TIA severity (NIHSS 0-5 versus NIHSS > 5) modified these relationships. Results A total of 334 patients were enrolled. The overall rates of progression, 2-year recurrence, and 2-year death were 8.7%, 8.0%, and 6.6%, respectively. Event rates were similar among patients with mild compared to more severe strokes: 8.3% versus 9.5% (p = 0.73) for progression, and 7.3% versus 9.9% (p = 0.59) for recurrence. The effect of baseline glucose > 8 mmol/l was consistent in predicting stroke progression, recurrent stroke and death, regardless of baseline stroke severity. In multivariable analyses, DWI lesion and intracranial occlusion predicted stroke progression only in the minor stroke/TIA group; symptomatic Internal Carotid Artery (ICA) stenosis predicted stroke recurrence only in the minor stroke/TIA group. Conclusions In a prospective study with early assessment and imaging we have found that stroke progression is different than stroke recurrence. Different imaging factors predict stroke progression versus stroke recurrence. Baseline hyperglycemia, a potentially modifiable factor, consistently predicted all three outcomes (stroke progression, recurrent stroke or death) regardless of baseline stroke severity. PMID:21513559

  17. Clinical and radiographic outcomes of the use of four dressing materials in pulpotomized primary molars: a randomized clinical trial with 2-year follow-up.

    PubMed

    Fernández, Cristina Cuadros; Martínez, Sandra Sáez; Jimeno, Francisco Guinot; Lorente Rodríguez, Ana I; Mercadé, Montse

    2013-11-01

    Although multiple materials have been suggested for pulpotomized primary molars, there is no reliable evidence of the superiority of one particular type. To compare the effectiveness of formocresol (FC), mineral trioxide aggregate (MTA), ferric sulphate, and sodium hypochlorite (NaOCl) as pulp dressing agents in primary molars after 2 years. One hundred primary molars requiring pulp treatment were allocated randomly to the control (FC) and experimental groups (MTA, ferric sulphate, and NaOCl). Clinical and radiographic evaluations were performed at 6, 12, 18, and 24 months. Statistical analysis using Fischer's exact test was performed to determine the significant differences between groups. In the FC and MTA groups, 100% of the available teeth were clinically successful at all follow-up appointments. In the NaOCl group, one clinical failure was found at 18 months, and two clinical failures in the ferric sulphate group were noted at 12 and 24 months, but no significant differences were found among the groups (P = 0.41). No significant differences in radiographic success were found among all the groups at 24 months of follow-up (P = 0.303). No statistically significant differences among the four materials were found at 24 months suggesting that NaOCl may be an appropriate substitute for FC. © 2012 John Wiley & Sons Ltd, BSPD and IAPD.

  18. Is it best to expect the worst? Influence of patients' side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study.

    PubMed

    Nestoriuc, Y; von Blanckenburg, P; Schuricht, F; Barsky, A J; Hadji, P; Albert, U-S; Rief, W

    2016-10-01

    This study aims to determine the role of patient expectations as potentially modifiable factor of side-effects, quality of life, and adherence to endocrine treatment of breast cancer. A 2-year prospective clinical cohort study was conducted in routine primary care with postoperative patients with hormone-receptor-positive breast cancer, scheduled to start adjuvant endocrine treatment. Structured patient-reported assessments of side-effects, side-effect expectations, quality of life, and adherence took place during the first week post-surgery and after 3 and 24 months of endocrine treatment. Of 111 enrolled patients, at 3 and 24 months, 107 and 88 patients, respectively, were assessed. After 2 years of endocrine treatment, patients reported high rates of side-effects (arthralgia: 71.3%, weight gain: 53.4%, hot flashes: 46.5%), including symptoms not directly attributable to the medication (breathing problems: 28.1%, dizziness: 25.6%). Pre-treatment expectations significantly predicted patient-reported long-term side-effects and quality of life in multivariate models controlling for relevant medical and psychological variables. Relative risk of side-effects after 2 years of endocrine treatment was higher in patients with high negative expectations at baseline than in those with low negative expectations (RR = 1.833, CI 95%, 1.032-3.256). A significant interaction confirmed this expectation effect to be particularly evident in patients with high side-effects at 3 months. Furthermore, baseline expectations were associated with adherence at 24 months (r = -0.25, P = 0.006). Expectations are a genuine factor of clinical outcome from endocrine treatment for breast cancer. Negative expectations increase the risk of treatment-specific side-effects, nocebo side-effects, and non-adherence. Yet, controlled studies are needed to analyze potential causal relationships. Optimizing individual expectations might be a promising strategy to improve side-effect burden, quality of life

  19. Clinical and Functional Outcomes After 2 Years in the Early Detection and Intervention for the Prevention of Psychosis Multisite Effectiveness Trial

    PubMed Central

    McFarlane, William R.; Levin, Bruce; Travis, Lori; Lucas, F. Lee; Lynch, Sarah; Verdi, Mary; Williams, Deanna; Adelsheim, Steven; Calkins, Roderick; Carter, Cameron S.; Cornblatt, Barbara; Taylor, Stephan F.; Auther, Andrea M.; McFarland, Bentson; Melton, Ryan; Migliorati, Margaret; Niendam, Tara; Ragland, J. Daniel; Sale, Tamara; Salvador, Melina; Spring, Elizabeth

    2015-01-01

    Objective: To test effectiveness of the Early Detection, Intervention, and Prevention of Psychosis Program in preventing the onset of severe psychosis and improving functioning in a national sample of at-risk youth. Methods: In a risk-based allocation study design, 337 youth (age 12–25) at risk of psychosis were assigned to treatment groups based on severity of positive symptoms. Those at clinically higher risk (CHR) or having an early first episode of psychosis (EFEP) were assigned to receive Family-aided Assertive Community Treatment (FACT); those at clinically lower risk (CLR) were assigned to receive community care. Between-groups differences on outcome variables were adjusted statistically according to regression-discontinuity procedures and evaluated using the Global Test Procedure that combined all symptom and functional measures. Results: A total of 337 young people (mean age: 16.6) were assigned to the treatment group (CHR + EFEP, n = 250) or comparison group (CLR, n = 87). On the primary variable, positive symptoms, after 2 years FACT, were superior to community care (2 df, p < .0001) for both CHR (p = .0034) and EFEP (p < .0001) subgroups. Rates of conversion (6.3% CHR vs 2.3% CLR) and first negative event (25% CHR vs 22% CLR) were low but did not differ. FACT was superior in the Global Test (p = .0007; p = .024 for CHR and p = .0002 for EFEP, vs CLR) and in improvement in participation in work and school (p = .025). Conclusion: FACT is effective in improving positive, negative, disorganized and general symptoms, Global Assessment of Functioning, work and school participation and global outcome in youth at risk for, or experiencing very early, psychosis. PMID:25065017

  20. Clinical and functional outcomes after 2 years in the early detection and intervention for the prevention of psychosis multisite effectiveness trial.

    PubMed

    McFarlane, William R; Levin, Bruce; Travis, Lori; Lucas, F Lee; Lynch, Sarah; Verdi, Mary; Williams, Deanna; Adelsheim, Steven; Calkins, Roderick; Carter, Cameron S; Cornblatt, Barbara; Taylor, Stephan F; Auther, Andrea M; McFarland, Bentson; Melton, Ryan; Migliorati, Margaret; Niendam, Tara; Ragland, J Daniel; Sale, Tamara; Salvador, Melina; Spring, Elizabeth

    2015-01-01

    To test effectiveness of the Early Detection, Intervention, and Prevention of Psychosis Program in preventing the onset of severe psychosis and improving functioning in a national sample of at-risk youth. In a risk-based allocation study design, 337 youth (age 12-25) at risk of psychosis were assigned to treatment groups based on severity of positive symptoms. Those at clinically higher risk (CHR) or having an early first episode of psychosis (EFEP) were assigned to receive Family-aided Assertive Community Treatment (FACT); those at clinically lower risk (CLR) were assigned to receive community care. Between-groups differences on outcome variables were adjusted statistically according to regression-discontinuity procedures and evaluated using the Global Test Procedure that combined all symptom and functional measures. A total of 337 young people (mean age: 16.6) were assigned to the treatment group (CHR + EFEP, n = 250) or comparison group (CLR, n = 87). On the primary variable, positive symptoms, after 2 years FACT, were superior to community care (2 df, p < .0001) for both CHR (p = .0034) and EFEP (p < .0001) subgroups. Rates of conversion (6.3% CHR vs 2.3% CLR) and first negative event (25% CHR vs 22% CLR) were low but did not differ. FACT was superior in the Global Test (p = .0007; p = .024 for CHR and p = .0002 for EFEP, vs CLR) and in improvement in participation in work and school (p = .025). FACT is effective in improving positive, negative, disorganized and general symptoms, Global Assessment of Functioning, work and school participation and global outcome in youth at risk for, or experiencing very early, psychosis. © The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

  1. Outcome of an uncemented hydroxyapatite coated hemiarthroplasty for displaced femoral neck fractures: a clinical and radiographic 2-year follow-up study.

    PubMed

    Eschen, Jacob; Kring, Søren; Brix, Michael; Ban, Ilija; Troelsen, Anders

    2012-01-01

    Hemiarthroplasty is the preferred treatment for displaced femoral neck fractures (DFNF) in elderly patients. The use of uncemented stems remains controversial and issues regarding inferior fixation in osteoporotic bone, implant-related pain and decreased mobility have discouraged their use. There is limited evidence for the use of modern uncemented femoral stems in the treatment of DFNF, and we wished to investigate the clinical and radiographic performance of an uncemented hydroxyapatite coated hemiarthroplasty at 2-year follow-up. We included 97 consecutive patients who had an uncemented, hydroxyapatite coated hemiarthroplasty (Corail, Depuy) inserted during a 1-year period. Due to unwillingness or cognitive impairment (n = 6) and death before follow-up (n = 44), a total of 47 patients (39 females) with a mean age of 81 years were available. At two year follow-up 38 of 47 patients lived in their own homes and the median New Mobility Score was 6 (range: 2-9). The median Visual Analogue Scale pain score was 0 (range: 0-5) at rest and 0 (range: 0-8) when walking. Patient satisfaction was a score of 9 (range: 2-10) on the VAS. Anterior or lateral thigh pain or groin pain was reported by 15 patients. The EQ-5D index score at follow-up was 0.72 (range: 0.16-1.00) and the EQ-5D Visual Analogue Score was 70 (range: 15-100). There were no signs of implant loosening in any of the 37 hips undergoing radiographic evaluation at follow-up. The results suggest that an uncemented hydroxyapatite coated hemiarthroplasty can be used to treat displaced intracupsular femoral neck fractures with good clinical and radiographic outcomes at short term follow-up.

  2. Report of the Clinical and Functional Primary Outcomes in Men of the ACL-SPORTS Trial: Similar Outcomes in Men Receiving Secondary Prevention With and Without Perturbation Training 1 and 2 Years After ACL Reconstruction.

    PubMed

    Arundale, Amelia J H; Cummer, Kathleen; Capin, Jacob J; Zarzycki, Ryan; Snyder-Mackler, Lynn

    2017-02-21

    Athletes often are cleared to return to activities 6 months after anterior cruciate ligament (ACL) reconstruction; however, knee function measures continue to improve up to 2 years after surgery. Interventions beyond standard care may facilitate successful return to preinjury activities and improve functional outcomes. Perturbation training has been used in nonoperative ACL injury and preoperative ACL reconstruction rehabilitation, but has not been examined in postoperative ACL reconstruction rehabilitation, specifically return to sport rehabilitation. The purpose of this study was to determine whether there were differences at 1 and 2 years after ACL reconstruction between the male SAP (strengthening, agility, and secondary prevention) and SAP+PERT (SAP protocol with the addition of perturbation training) groups with respect to (1) quadriceps strength and single-legged hop limb symmetry; (2) patient-reported knee outcome scores; (3) the proportion who achieve self-reported normal knee function; and (4) the time from surgery to passing return to sport criteria. Forty men who had completed ACL reconstruction rehabilitation and met enrollment criteria (3-9 months after ACL reconstruction, > 80% quadriceps strength limb symmetry, no pain, full ROM, minimal effusion) were randomized into the SAP or SAP+PERT groups of the Anterior Cruciate Ligament-Specialised Post-Operative Return to Sports trial (ACL-SPORTS), a single-blind randomized clinical study of secondary prevention and return to sport. Quadriceps strength, single-legged hopping, the International Knee Documentation Committee (IKDC) 2000 subjective knee form, Knee Injury and Osteoarthritis Outcome Score (KOOS)-sports and recreation, and KOOS-quality-of-life subscales were collected 1 and 2 years after surgery by investigators blind to group. Athletes were categorized as having normal or abnormal knee function at each time point based on IKDC score, and the time until athletes passed strict return

  3. Clinical Outcomes of Posterior Lumbar Interbody Fusion for Patients 80 Years of Age and Older with Lumbar Degenerative Disease: Minimum 2 Years' Follow-Up

    PubMed Central

    Hayashi, Kazunori; Matsumura, Akira; Konishi, Sadahiko; Kato, Minori; Namikawa, Takashi; Nakamura, Hiroaki

    2016-01-01

    Study Design Retrospective study. Objective To compare clinical outcomes, radiographic evaluations including bony union rate and incidence of osteoporotic vertebral fractures (OVFxs), and perioperative complications following posterior lumbar interbody fusion (PLIF) between patients ≥80 years of age and those <80 years. Methods Ninety-six patients ≥70 years old who underwent PLIF were reviewed. We divided the patients into the two age groups, ≥80 group (n = 19) and <80 group (n = 77), and compared the clinical outcomes using Japanese Orthopaedics Association (JOA) scores and the Short-Form Health Survey (SF-36). We also evaluated bony union and the incidence of OVFxs in the both groups. Results The JOA score improved 47.6% in the ≥80 group and 49.1% in the <80 group. There were no significant differences between the two groups. Only the bodily pain component of the SF-36 improved significantly in the ≥80 group, and seven of eight components (exception was general health) improved significantly in the <80 group. Bony union rate was significantly superior in the <80 group (94.8%) compared with that of the ≥80 group (73.7%, p = 0.013). OVFx prevalence and incidence were not significantly different between the two groups, although postoperative OVFx worsened the JOA score improvement in the ≥80 group (38.8%, p = 0.02). Conclusions The present study indicated that surgical outcomes of PLIF in patients ≥80 years were comparable to those < 80 years. However, bony union rate was significantly lower and postoperative OVFx worsened the clinical outcomes in patients ≥80 years. PMID:27781186

  4. Impact of low high-density lipoprotein-cholesterol level on 2-year clinical outcomes after acute myocardial infarction in patients with diabetes mellitus.

    PubMed

    Joo, Hyung Joon; Cho, Sang-A; Hong, Soon Jun; Hur, Seung-Ho; Bae, Jang-Ho; Choi, Dong-Ju; Ahn, Young-Keun; Park, Jong-Seon; Choi, Rak-Kyeong; Choi, Donghoon; Kim, Joon-Hong; Han, Kyoo-Rok; Park, Hun-Sik; Choi, So-Yeon; Yoon, Jung-Han; Kwon, Hyeon-Cheol; Rha, Seung-Woon; Hwang, Kyung-Kuk; Jung, Kyung-Tae; Oh, Seok-Kyu; Lee, Jae-Hwan; Shin, Eun-Seok; Kim, Kee-Sik; Kim, Hyo-Soo; Lim, Do-Sun

    2016-11-18

    It is still unclear whether low high-density lipoprotein cholesterol (HDL-C) affects cardiovascular outcomes after acute myocardial infarction (AMI), especially in patients with diabetes mellitus. A total of 984 AMI patients with diabetes mellitus from the DIabetic Acute Myocardial InfarctiON Disease (DIAMOND) Korean multicenter registry were divided into two groups based on HDL-C level on admission: normal HDL-C group (HDL-C ≥ 40 mg/dL, n = 519) and low HDL-C group (HDL-C < 40 mg/dL, n = 465). The primary endpoint was 2-year major adverse cardiovascular events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), and target vessel revascularization (TVR). The median follow-up duration was 730 days. The 2-year MACE rates were significantly higher in the low HDL-C group than in the normal HDL-C group (MACE, 7.44% vs. 3.49%, p = 0.006; cardiac death, 3.72% vs. 0.97%, p = 0.004; non-fatal MI, 1.75% vs. 1.55%, p = 0.806; TVR, 3.50% vs. 0.97%, p = 0.007). Kaplan-Meier analysis revealed that the low HDL-C group had a significantly higher incidence of MACE compared to the normal HDL-C group (log-rank p = 0.013). After adjusting for conventional risk factors, Cox proportional hazards analysis suggested that low HDL-C was an independent risk predictor for MACE (hazard ratio [HR] 3.075, 95% confidence interval [CI] 1.034-9.144, p = 0.043). In patients with diabetes mellitus, low HDL-C remained an independent risk predictor for MACE after adjusting for multiple risk factors during 2-year follow-up of AMI. This study was the sub-analysis of the prospective multi-center registry of DIAMOND (Diabetic acute myocardial infarction Disease) in Korea. This is the observational study supported by Bayer HealthCare, Korea. Study number is 15614. First patient first visit was 02 April 2010 and last patient last visit was 09 December 2013.

  5. Neonatal Glycemia and Neurodevelopmental Outcomes at 2 Years.

    PubMed

    McKinlay, Christopher J D; Alsweiler, Jane M; Ansell, Judith M; Anstice, Nicola S; Chase, J Geoffrey; Gamble, Gregory D; Harris, Deborah L; Jacobs, Robert J; Jiang, Yannan; Paudel, Nabin; Signal, Matthew; Thompson, Benjamin; Wouldes, Trecia A; Yu, Tzu-Ying; Harding, Jane E

    2015-10-15

    Neonatal hypoglycemia is common and can cause neurologic impairment, but evidence supporting thresholds for intervention is limited. We performed a prospective cohort study involving 528 neonates with a gestational age of at least 35 weeks who were considered to be at risk for hypoglycemia; all were treated to maintain a blood glucose concentration of at least 47 mg per deciliter (2.6 mmol per liter). We intermittently measured blood glucose for up to 7 days. We continuously monitored interstitial glucose concentrations, which were masked to clinical staff. Assessment at 2 years included Bayley Scales of Infant Development III and tests of executive and visual function. Of 614 children, 528 were eligible, and 404 (77% of eligible children) were assessed; 216 children (53%) had neonatal hypoglycemia (blood glucose concentration, <47 mg per deciliter). Hypoglycemia, when treated to maintain a blood glucose concentration of at least 47 mg per deciliter, was not associated with an increased risk of the primary outcomes of neurosensory impairment (risk ratio, 0.95; 95% confidence interval [CI], 0.75 to 1.20; P=0.67) and processing difficulty, defined as an executive-function score or motion coherence threshold that was more than 1.5 SD from the mean (risk ratio, 0.92; 95% CI, 0.56 to 1.51; P=0.74). Risks were not increased among children with unrecognized hypoglycemia (a low interstitial glucose concentration only). The lowest blood glucose concentration, number of hypoglycemic episodes and events, and negative interstitial increment (area above the interstitial glucose concentration curve and below 47 mg per deciliter) also did not predict the outcome. In this cohort, neonatal hypoglycemia was not associated with an adverse neurologic outcome when treatment was provided to maintain a blood glucose concentration of at least 47 mg per deciliter. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others.).

  6. Latent rheumatic heart disease: outcomes 2 years after echocardiographic detection.

    PubMed

    Beaton, Andrea; Okello, Emmy; Aliku, Twalib; Lubega, Sulaiman; Lwabi, Peter; Mondo, Charles; McCarter, Robert; Sable, Craig

    2014-10-01

    Screening with portable echocardiography has uncovered a large burden of latent rheumatic heart disease (RHD) among asymptomatic children in endemic regions, the significance of which remains unclear. This study aimed to determine the 2-year outcomes for children with latent RHD diagnosed by echocardiographic screening. Children identified with latent RHD enrolled in a biannual follow-up program. Risk factors for disease persistence and progression were examined. Of 62 children, 51 (82 %) with latent RHD had a median follow-up period of 25 months. Of these 51 children, 17 (33.3 %) reported an interval sore throat or symptoms consistent with acute rheumatic fever (ARF). Of 43 children initially classified as having borderline RHD, 21 (49 %) remained stable, 18 (42 %) improved (to no RHD) and 4 (10 %) worsened to definite RHD. Of the 8 children initially classified as having definite RHD, 6 (75 %) remained stable, and 2 (25 %) improved to borderline RHD. Two children had confirmed episodes of recurrent ARF, one of which represented the sole case of clinical worsening. The risk factors for disease persistence or progression included younger age (p = 0.05), higher antistreptolysin O titers at diagnosis (p = 0.05), and more morphologic valve abnormalities (p = 0.01). After 2 years, most of the children had a benign course, with 91 % remaining stable or showing improvement. Education may improve recognition of streptococcal sore throat. Longer-term follow-up evaluation, however, is warranted to confirm disease progression and risk factor profile. This could help tailor screening protocols for those at highest risk.

  7. Impact of chronic kidney disease on 2-year clinical outcomes in patients treated with 6-month or 24-month DAPT duration: An analysis from the PRODIGY trial.

    PubMed

    Gargiulo, Giuseppe; Santucci, Andrea; Piccolo, Raffaele; Franzone, Anna; Ariotti, Sara; Baldo, Andrea; Esposito, Giovanni; Moschovitis, Aris; Windecker, Stephan; Valgimigli, Marco

    2017-10-01

    To assess whether moderate-to-severe CKD is a treatment modifier for benefit or harm in patients randomly allocated to 24-month versus 6-month DAPT. It is still unclear whether chronic kidney disease CKD should impact on the decision-making on optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). PRODIGY trial randomized 1970 all-comer patients at 24-month versus 6-month DAPT after PCI. Patients with moderate-to-severe CKD (n = 604; 30.7%) were older, more likely to be women, to have hypertension, diabetes, prior MI or PCI, with higher severity of coronary artery disease (CAD), but were less frequently smokers or presenting with stable CAD. After adjustment, the 2-year rates of primary endpoint (composite of death, myocardial infarction and cerebrovascular accident), as well as bleeding and net adverse clinical events were higher in patients with moderate-to-severe CKD. DAPT prolongation at 24-month did not reduce the primary endpoint in both CKD (adj. HR: 0.957; 95% CI 0.652-1.407; P = 0.825) and no-CKD (adj. HR: 1.341; 95% CI 0.861-2.086; P = 0.194) groups (Pint = 0.249), but increased bleeding in both groups (CKD: adj. HR: 1.999; 95% CI 1.100-3.632; P = 0.023; no-CKD: adj. HR: 2.880; 95% CI 1.558-5.326; P = 0.001; Pint = 0.407). Moderate-to-severe CKD did not modify the effect of a prolonged or shortened DAPT duration in largely unselected patients undergoing stent implantation. Our analysis suggests that CKD should not be a major driver in the decision-making on the duration of DAPT after stent implantation. This exploratory study is underpowered and should be considered hypothesis-generating only. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  8. Antimicrobial susceptibility profile, treatment outcome and serotype distribution of clinical isolates of Salmonella enterica subspecies enterica: a 2-year study from Kerala, South India

    PubMed Central

    Harichandran, Deepa; Dinesh, Kavitha Radhakrishnan

    2017-01-01

    Background/purpose Typhoid and paratyphoid fever continue to be important causes of illness and death in parts of Asia, being associated with poor sanitation and consumption of unsafe food and water. Antimicrobial resistance has emerged to traditional first-line drugs, namely, the fluoroquinolones, as well as to third-generation cephalosporins, posing challenges to treatment. Azithromycin has proven to be an effective alternative for treatment of uncomplicated typhoid fever. The purpose of this study was to determine the antimicrobial susceptibility, clinical outcome and serotype distribution pattern of clinical isolates belonging to Salmonella enterica subspecies enterica. Methodology All clinical isolates of S. enterica obtained from blood, sterile body fluids, as well as stool and urine samples at Amrita Institute of Medical Sciences and Research Centre, Kerala, India, between August 2011 and July 2013 were included in the study and processed based on standard microbiology protocols. Results A total of 118 isolates of Salmonella were obtained during the study period. Out of these, 79 were of S. Typhi (66.95%), followed by isolates of S. Paratyphi A (22; 18.64%) and S. Typhimurium 12 (10.17%). Five isolates could not be identified further. There was 100% susceptibility to ceftriaxone in all S. enterica subspecies. Ciprofloxacin susceptibility was 32.91% for S. Typhi and 40.90% for S. Paratyphi A as determined by the disk diffusion method. The susceptibility profile of S. Typhi isolates to different antimicrobials was as follows: chloramphenicol (94.93%), ampicillin (77.21%), cotrimoxazole (75.94%) and azithromycin (78.48%). For S. Typhi, the minimum inhibitory concentration (MIC) of ciprofloxacin required to inhibit the growth of 50% of organisms was 0.5 μg/mL (intermediate) and MIC required to inhibit the growth of 90% of organisms was 1 μg/mL (resistant). S. Typhimurium was 100% susceptible to cotrimoxazole, ampicillin, ceftriaxone, chloramphenicol, ofloxacin

  9. Cervical Stand-Alone Polyetheretherketone Cage versus Zero-Profile Anchored Spacer in Single-Level Anterior Cervical Discectomy and Fusion : Minimum 2-Year Assessment of Radiographic and Clinical Outcome

    PubMed Central

    Cho, Hyun-Jun; Hur, Junseok W.; Han, Jin-Sol; Cho, Tai-Hyoung; Park, Jung-Yul

    2015-01-01

    Objective We compared the clinical and radiographic outcomes of stand-alone polyetheretherketone (PEEK) cage and Zero-Profile anchored spacer (Zero-P) for single level anterior cervical discectomy and fusion (ACDF). Methods We retrospectively reviewed 121 patients who underwent single level ACDF within 2 years (Jan 2011-Jan 2013) in a single institute. Total 50 patients were included for the analysis who were evaluated more than 2-year follow-up. Twenty-nine patients were allocated to the cage group (m : f=19 : 10) and 21 for Zero-P group (m : f=12 : 9). Clinical (neck disability index, visual analogue scale arm and neck) and radiographic (Cobb angle-segmental and global cervical, disc height, vertebral height) assessments were followed at pre-operative, immediate post-operative, post-3, 6, 12, and 24 month periods. Results Demographic features and the clinical outcome showed no difference between two groups. The change between final follow-up (24 months) and immediate post-op of Cobb-segmental angle (p=0.027), disc height (p=0.002), vertebral body height (p=0.033) showed statistically better outcome for the Zero-P group than the cage group, respectively. Conclusion The Zero-Profile anchored spacer has some advantage after cage for maintaining segmental lordosis and lowering subsidence rate after single level anterior cervical discectomy and fusion. PMID:26361527

  10. Extracapsular cataract extraction in Nepal. 2-year outcome.

    PubMed

    Ruit, S; Robin, A L; Pokhrel, R P; Sharma, A; DeFaller, J

    1991-12-01

    We evaluated the 2-year outcome of extracapsular cataract surgery with posterior chamber intraocular lens insertion by a single fellowship-trained surgeon in Kathmandu, Nepal. Six hundred ten eyes were followed up for 2 years. Patients underwent manual irrigation and aspiration with the insertion of a modified J loop posterior chamber intraocular lens. Almost half of the patients had uncorrected visual acuities of 20/50 or better after surgery. Sight-threatening complications in seven eyes (1.2%) included retinal detachment, corneal decompensation, and endophthalmitis. Although this rate is comparable to that in developed countries, 21% of patients had posterior capsular opacification at follow-up. Extracapsular cataract surgery with intraocular lens insertion may be an alternative to intracapsular cataract surgery in developing nations, where aphakic spectacles are expensive, not easily obtainable, or difficult to replace.

  11. Return to recreational sport and clinical outcomes with at least 2years follow-up after arthroscopic repair of rotator cuff tears.

    PubMed

    Antoni, M; Klouche, S; Mas, V; Ferrand, M; Bauer, T; Hardy, P

    2016-09-01

    The main objective of the study was to assess return to sports in recreational athletes after arthroscopic repair of rotator cuff tear (RCT). A retrospective single-center study included all recreational athletes operated between 2008 and 2012 for arthroscopic repair of RCT, with regular sports activity, and aged less than 70 years. All were recontacted at a minimum follow-up of 2 years. The main outcome was return to sports (yes/no). The secondary criteria were return to sports, time to return to sports, number of hours per week of sports activity, and at the last follow-up the subjective assessment of sports level, patient satisfaction, and the Western Ontario Rotator Cuff (WORC) Index. Seventy-six patients (37 females, 39 males) with a mean age of 57.0±7.3 years were included. Of these 76 patients, 53 (69.7%) patients participated in a sport that specifically involved the upper limb. The mean follow-up was 45±14 months. Postoperatively, 67 of 76 (88.2%) patients returned to a sports activity, the same sport for 52 out of 76 (68.4%). The mean time to return to sports was 6±4.9 months. For patients who had taken up their sport again, the mean number of hours a week was not significantly modified (P=0.58). At the last follow-up, the subjective sports level was judged better or identical to the preoperative level by 52 of 67 (77.6%) patients. The factors significantly associated with absence of return to the previous sport were pain symptoms evolving for more than 9 months before surgery (OR=3.6 [1.01-12.5], P=0.04) and preoperative sports intensity less than 2h/week (OR=4.1 [1.4-12.3], P=0.01). At the last follow-up, the functional improvement evaluated by the WORC Index was strongly significant (P<0.00001) and 73 of 76 (96%) patients were satisfied. The majority of the recreational athletes returned to sports after arthroscopic rotator cuff repair, most often at the same level and with equivalent intensity compared to before surgery. IV, retrospective

  12. Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study.

    PubMed

    Braun, Jürgen; Baraliakos, Xenofon; Deodhar, Atul; Baeten, Dominique; Sieper, Joachim; Emery, Paul; Readie, Aimee; Martin, Ruvie; Mpofu, Shephard; Richards, Hanno B

    2017-06-01

    To evaluate the effect of secukinumab, an interleukin-17A inhibitor, on clinical signs and symptoms and radiographic changes through 2 years in patients with ankylosing spondylitis (AS). In the phase III MEASURE 1 study, patients were randomised to receive intravenous secukinumab 10 mg/kg (at baseline, week 2 and week 4) followed by subcutaneous secukinumab 150 mg (intravenous 150 mg; n=125) or 75 mg (intravenous 75 mg; n=124) every four weeks, or matched placebo (n=122). Placebo-treated patients were re-randomised to subcutaneous secukinumab 150 or 75 mg from week 16. Clinical efficacy assessments included Assessment of SpondyloArthritis international Society 20 (ASAS20) response rates through week 104. Radiographic changes at week 104 were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). 97 (77.6%) and 103 (83.1%) patients in the intravenous 150 mg and intravenous 75 mg groups, respectively, completed week 104. In the full analysis set (intent-to-treat), ASAS20 response rates at week 104 were 73.7% and 68.0% in the intravenous 150 mg and intravenous 75 mg groups, respectively. Among patients with evaluable X-rays who were originally randomised to secukinumab (n=168), mean change in mSASSS from baseline to week 104 was 0.30±2.53. Serious adverse events were reported in 12.2% and 13.4% of patients in the 150 mg and 75 mg groups, respectively. Secukinumab improved AS signs and symptoms through 2 years of therapy, with no unexpected safety findings. Data from this study suggest a low mean progression of spinal radiographic changes, which will need to be confirmed in longer-term controlled studies. NCT01358175. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  13. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program.

    PubMed

    Silber, Sigmund; Serruys, Patrick W; Leon, Martin B; Meredith, Ian T; Windecker, Stephan; Neumann, Franz-Josef; Belardi, Jorge; Widimsky, Petr; Massaro, Joe; Novack, Victor; Yeung, Alan C; Saito, Shigeru; Mauri, Laura

    2013-04-01

    The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes. The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%). The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. (The Medtronic RESOLUTE Clinical Trial; NCT00248079; Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084

  14. Is the radiographic subsidence of stand-alone cages associated with adverse clinical outcomes after cervical spine fusion? An observational cohort study with 2-year follow-up outcome scoring.

    PubMed

    Zajonz, Dirk; Franke, Anne-Catherine; von der Höh, Nicolas; Voelker, Anna; Moche, Michael; Gulow, Jens; Heyde, Christoph-Eckhard

    2014-01-01

    The stand-alone treatment of degenerative cervical spine pathologies is a proven method in clinical practice. However, its impact on subsidence, the resulting changes to the profile of the cervical spine and the possible influence of clinical results compared to treatment with additive plate osteosynthesis remain under discussion until present. This study was designed as a retrospective observational cohort study to test the hypothesis that radiographic subsidence of cervical cages is not associated with adverse clinical outcomes. 33 cervical segments were treated surgically by ACDF with stand-alone cage in 17 patients (11 female, 6 male), mean age 56 years (33-82 years), and re-examined after eight and twenty-six months (mean) by means of radiology and score assessment (Medical Outcomes Study Short Form (MOS-SF 36), Oswestry Neck Disability Index (ONDI), painDETECT questionnaire and the visual analogue scale (VAS)). Subsidence was observed in 50.5% of segments (18/33) and 70.6% of patients (12/17). 36.3% of cases of subsidence (12/33) were observed after eight months during mean time of follow-up 1. After 26 months during mean time of follow-up 2, full radiographic fusion was seen in 100%. MOS-SF 36, ONDI and VAS did not show any significant difference between cases with and without subsidence in the two-sample t-test. Only in one type of scoring (painDETECT questionnaire) did a statistically significant difference in t-Test emerge between the two groups (p = 0.03; α = 0.05). However, preoperative painDETECT score differ significantly between patients with subsidence (13.3 falling to 12.6) and patients without subsidence (7.8 dropped to 6.3). The radiological findings indicated 100% healing after stand-alone treatment with ACDF. Subsidence occurred in 50% of the segments treated. No impact on the clinical results was detected in the medium-term study period.

  15. Patient-Reported Outcomes and the Association With Clinical Response in Patients With Active Psoriatic Arthritis Treated With Golimumab: Findings Through 2 Years of a Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Kavanaugh, Arthur; McInnes, Iain B; Krueger, Gerald G; Gladman, Dafna; Beutler, Anna; Gathany, Tim; Mack, Michael; Tandon, Neeta; Han, Chenglong; Mease, Philip

    2013-01-01

    correlated with clinical improvement in signs and symptoms of peripheral arthritis and were sustained through 2 years. PMID:23666608

  16. 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

  17. The Bangladesh clubfoot project: audit of 2-year outcomes of Ponseti treatment in 400 children.

    PubMed

    Perveen, Roksana; Evans, Angela M; Ford-Powell, Vikki; Dietz, Frederick R; Barker, Simon; Wade, Paul W; Khan, Shariful I

    2014-01-01

    Congenital clubfoot deformity can cause significant disability, and if left untreated, may further impoverish those in developing countries, like Bangladesh. The Ponseti method has been strategically introduced in Bangladesh by a nongovernment organization, Walk For Life (WFL). WFL has provided free treatment for over 8000 Bangladeshi children with clubfeet, sustained by local ownership, and international support. This audit assesses the 2-year results in children for whom treatment began before the age of 3 years. The 10 largest WFL clinics, of the 24 across Bangladesh, were pragmatically accessed in this audit availing 1442 subjects meeting the study criteria, from which 400 children were randomly selected and examined. A specific assessment tool was developed and validated. Results for 400 cases were returned: 269 males, 131 females. Typical clubfeet comprised 79% of cases, and 55% were bilateral. A tenotomy rate of 79%, and brace use after 2 years of 85%, were notable findings. Functionally, most children could walk independently (99.0%), run (95.5%), squat (93.3%), and manage steps unassisted (93.0%). The ability to squat was the most indicative outcome measure, correlating with: less corrective casts, good and continued brace use, nonvarus heel position, good ankle range of motion, good Bangla clubfoot scores, and the ability to walk. Relapsing deformity was suspected with heel varus (18.0% left; 21.5% right). Parental satisfaction was very high, but cost of 3000 Taka ($US 38.48) was deemed unaffordable by 59%. The outcomes in young children after 2 years of Ponseti treatment for clubfoot deformity showed that 99% were able to walk independently. The assessment tool developed for this study avails ongoing monitoring. Without the patronage of WFL, most of these children would not have had access to treatment, and be unable to walk. Level II-lesser-quality prospective study.

  18. Kineflex (Centurion) Lumbar Disc Prosthesis: Insertion Technique and 2-Year Clinical Results in 100 Patients

    PubMed Central

    Weinberg, Ian R.; Sliwa, Karen; Sweet, Barry MBE; de Villiers, Malan

    2007-01-01

    Background The Kineflex lumbar disc is a mechanical, unconstrained, re-centering disc prosthesis developed in South Africa. The first implantation took place in October 2002. We present a single-center, prospective, longitudinal study of the first 100 patients treated with the Kineflex lumbar disc. Our objective was to evaluate the insertion technique, clinical outcomes, and patient satisfaction at 2 years postimplantation in 100 consecutive patients with 132 (68 single- and 32 2-level) Kineflex lumbar disc replacements. Methods We determined the exact central placement of all disc implants in the coronal and midsagittal planes. We measured clinical outcome with the Oswestry disability index (ODI), our own questionnaire, and the time needed to return to work. All patients received radiological and clinical follow-up assessments for 2 years after the index procedure. Results Forty-three patients were female. The mean age of the patients at operation was 44.9 years (range, 23–63 years). Postoperative hospitalization averaged 2.8 days (range, 2 to 8 days). All patients who were employed before surgery returned to work 31 ± 16.8 days after the operation. Fifty-six percent of operated disc levels had intervertebral disc heights of less than 5 mm. A 2-year clinical outcome was available for 98 of the 100 patients (58 excellent, 30 good, 7 fair, 3 poor). The ODI score improved from 47.8 ± 16.0 preoperatively to 14.2 ± 14.0 (P < .01) at 2 years. At 2 years, 95% of disc implants were radiologically in the ideal position. The insertion technique, with a released prosthetic mechanism for final placement, allowed ideal placement in the sagittal plane in 98% of discs. The radiographic placement accuracy achieved was equal in patients with preoperative intervertebral disc height below and above 5 mm. Conclusions Good short-term clinical results were achieved with the Kineflex disc in a heterogeneous patient group with a high number of patients with advanced disc

  19. Severe bronchiolitis in infants born very preterm and neurodevelopmental outcome at 2 years.

    PubMed

    Gouin, Marion; Nguyen, Sylvie; Savagner, Christophe; Troussier, Francoise; Gascouin, Géraldine; Rozé, Jean-Christophe; Flamant, Cyril

    2013-05-01

    Preterm infants are at greater risk of bronchopulmonary dysplasia, which is associated with neurodevelopmental impairment. These infants are also more likely to develop severe bronchiolitis, which can contribute to neurodevelopmental impairment. The aim of this study was to determine whether severe bronchiolitis in very preterm infants (born before 33 weeks of gestation) was associated with an increased risk of neurodevelopmental impairment at 2 years of age. We analyzed a population-based cohort of infants (the Loire Infant Follow-up Team cohort) born between 1 January 2003 and 31 December 2009. Severe bronchiolitis was defined as hospitalization due to bronchiolitis during the first year of life. Neurodevelopmental outcome was assessed at 2 years of corrected age. A total of 2,405 infants were included in this analysis and categorized based on neonatal respiratory status: 1,308 (54.4 %) received no respiratory assistance, 864(35.9 %) received oxygen for <28 days, and 167 (6.9 %) had mild and 66 (2.7) moderate or severe bronchopulmonary dysplasia. At 2 years, 502 children displayed non-optimal neurodevelopmental outcome (20.9 %). Moderate or severe bronchopulmonary dysplasia was significantly associated with non-optimal neurodevelopmental outcome at 2 years (adjusted odds ratios (OR) = 2.3 [95 % confidence interval (CI): 1.3-3.9], p = 0.003). In the first year, 318 infants acquired severe bronchiolitis (13.2 %), which was not associated with non-optimal neurodevelopmental outcome (adjusted OR = 1.0 [95 % CI: 0.8-1.4]; p = 0.88). In conclusion, respiratory status in the neonatal period was significantly associated with non-optimal neurodevelopmental outcome at 2 years, while severe bronchiolitis was not.

  20. Upper limb movements and outcome in intrauterine-growth-retarded infants at 2 years.

    PubMed

    Zuk, Luba; Harel, Shaul; Leitner, Yael; Jaffa, Ariel; Fattal-Valevski, Aviva

    2008-11-01

    This study aims to examine the usefulness of spontaneous upper limb movements (ULM) as an early marker for predicting neurodevelopmental outcome in infants with intrauterine-growth retardation (IUGR). The assessment of general movements (GMs) during the first 20 weeks is an accepted method for early detection of brain dysfunction. During this period, spontaneous upper limb movements were examined in 32 infants with IUGR and 32 appropriate-for-gestational-age-matched controls. ULM (arms, forearms and hands) were scored as optimal or suboptimal by sequential videotape recordings in the writhing (term-2 weeks: score 0-5); early fidgety (9-11 weeks: score 0-6); and late fidgety (14-16 weeks: score 0-6) periods, and correlated with neurodevelopmental score at 2 years of age. The mean ULM score was lower in the IUGR infants than the controls (p<0.05) and in the IUGR group was lower in the infants with abnormal outcome (p<0.05). Significant correlations were found between ULM and 2-year neurodevelopmental scores in the IUGR group. The ULM during late-fidgety period was most predictive for 2-year neurodevelopmental score. No difference was found in the mean ULM score between the pre-term and term IUGR infants. We conclude that ULM score can serve as an early predictor for neurodevelopmental outcome at 2 years of age in infants with IUGR.

  1. Respiratory outcomes of children with BPD and gastrostomy tubes during the first 2 years of life.

    PubMed

    McGrath-Morrow, Sharon A; Hayashi, Madoka; Aherrera, Angela D; Collaco, Joseph M

    2014-06-01

    Infants with bronchopulmonary dysplasia (BPD) often undergo gastrostomy tube (GT) placement and/or Nissen fundoplication (Nissen) to improve weight gain and to attenuate chronic respiratory symptoms related to feeding difficulties. After initial hospitalization little is known how these children do with regard to respiratory symptoms when compared to children with BPD who did not receive GTs. This study was done to determine if differences in respiratory outcomes were associated with the presence of a GT or Nissen/GT in children with BPD during the first 2 years of life. Children (n = 398) were recruited from the Johns Hopkins BPD Outpatient Clinic. Medical charts were reviewed and acute care usage and respiratory symptoms were assessed by caregiver questionnaires. Ninety-two children with BPD had GTs, with the majority placed by 6 months of age. Of children with GTs, 64.7% also had Nissen fundoplication. Children with Nissen/GTs were more likely to have birth weights <10th percentile and to be discharged on supplemental oxygen. After initial hospitalization, children with GTs and Nissen/GTs weaned off supplemental oxygen at significantly older ages than children without GTs. Children with Nissen/GTs also had more hospitalizations than children without GTs. Caregivers of children with GTs and Nissen/GTs reported similar respiratory symptoms as caregivers of children without GTs. Weaning off supplemental oxygen occurred later in children with GTs and Nissen/GTs compared to children without GTs. Although children with Nissen/GTs had more re-hospitalizations, there were no differences in reported respiratory symptoms between any of the groups by caregiver questionnaire. © 2013 Wiley Periodicals, Inc.

  2. Preventive care at home for very preterm infants improves infant and caregiver outcomes at 2 years.

    PubMed

    Spittle, Alicia J; Anderson, Peter J; Lee, Katherine J; Ferretti, Carmel; Eeles, Abbey; Orton, Jane; Boyd, Roslyn N; Inder, Terrie; Doyle, Lex W

    2010-07-01

    The objective of this study was to determine the effects of preventive care at home on child development and primary caregiver mental health at 2 years of age. A total of 120 very preterm infants (<30 weeks) were assigned randomly to intervention (n = 61) or control (n = 59) groups. The intervention group received the preventive care program (9 home visits over the first year from a physiotherapist and a psychologist, focusing on the parent-infant relationship, the parents' mental health, and the infant's development); and the control group received standard care. At corrected age of 2 years, developmental outcomes were assessed, and primary caregivers completed the Infant-Toddler Social and Emotional Assessment. The mental health of the primary caregivers was assessed with the Hospital Anxiety and Depression Scale. At 2 years of age, 115 children (96%) were assessed with the Bayley Scales of Infant and Toddler Development III and 100 children (83%) with the Infant-Toddler Social and Emotional Assessment; and 91 (86%) of 106 caregivers completed the Hospital Anxiety and Depression Scale. There were no statistically significant differences in cognitive, language, or motor composite scores between the treatment groups. However, children in the intervention group were reported by their primary caregivers to exhibit less externalizing and dysregulation behaviors and increased competence, compared with control subjects. Primary caregivers in the intervention group reported less anxiety and depression. A preventive care program for very preterm infants and their families improved behavioral outcomes for infants and reduced anxiety and depression for primary caregivers.

  3. Applied behaviour analysis and standard treatment in intellectual disability: 2-year outcomes.

    PubMed

    Hassiotis, Angela; Canagasabey, Anton; Robotham, Daniel; Marston, Louise; Romeo, Renee; King, Michael

    2011-06-01

    Applied behaviour analysis by a specialist team plus standard treatment for adults with intellectual disability displaying challenging behaviour was reported to be clinically and cost-effective after 6 months. In a 2-year follow-up of the same trial cohort, participants receiving the specialist intervention had significantly lower total and subdomain Aberrant Behavior Checklist scores than those receiving usual care alone. After adjustment for baseline covariates there was no significant difference in costs between the trial arms.

  4. 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

  5. Autologous serum and plasma skin test to predict 2-year outcome in chronic spontaneous urticaria

    PubMed Central

    Sangasapaviliya, Atik

    2016-01-01

    Background Autologous serum skin test (ASST) and autologous plasma skin test (APST) are simple methods to diagnose autoimmune chronic urticaria. However, the association data of ASST or APST with disease severity and long-term outcome are still unclear. Objective The results of ASST and APST might be used to predict urticaria symptom severity and long-term outcomes among chronic spontaneous urticaria (CSU) patients. Methods We evaluated the prevalence of reactive ASST and APST in 128 CSU patients. The patients were characterized by 4 groups: negative, ASST positive, APST positive, and both ASST and APST positive. We observed remission rate among the CSU patients during 2 years. Results Forty-four of 128 CSU patients (34%) had negative autologous skin test. The CSU patients with positive ASST, positive APST, and both positive ASST and APST were 47 (37%), 6 (5%), and 31 (24%), respectively. No significant difference was found between the groups according to urticaria severity score (USS) and dermatology life quality index (DLQI). Mean wheal diameter of ASST showed positive correlation with DLQI. Also, mean wheal diameter of APST showed positive correlation with USS and DLQI. Both the positive ASST and APST groups had a high proportion of 4-fold dose of H1-antihistamine than the positive ASST (p = 0.03) and negative groups (p = 0.0009). The rate of remission over 2 years in the negative, positive ASST, positive APST, and both positive ASST and APST groups were 81.1%, 62.3%, 60%, and 46.1%, respectively. The urticaria remission rate in patients in the negative group was significantly higher compared with both positive ASST and APST groups (odds ratio, 5.0; 95% confidence interval, 1.61–15.44; p = 0.006). Conclusion ASST and APST results could predict remission rates among patients with CSU. Our results suggested investigating ASST and APST among CSU patients before starting treatment. PMID:27803883

  6. Racial Disparities in Allergic Outcomes in African Americans Emerge as Early as Age 2 Years

    PubMed Central

    Wegienka, Ganesa; Havstad, Suzanne; Joseph, Christine LM; Zoratti, Edward; Ownby, Dennis; Woodcroft, Kimberley; Johnson, Christine Cole

    2011-01-01

    BACKGROUND Racial disparities in allergic disease outcomes have been reported with African Americans suffering disproportionately compared to White individuals. OBJECTIVE Examine whether racial disparities are present as early as age 2 years in a racially diverse birth cohort in the Detroit metropolitan area. METHODS All children who were participants in a birth cohort study in the Detroit metropolitan area were invited for a standardized physician exam with skin prick testing and parental interview at age 2 years. Physicians made inquiries regarding wheezing and allergy symptoms and inspected for and graded any atopic dermatitis (AD). Skin testing was performed for Alternaria, cat, cockroach, dog, Dermatophagoides farinae (Der F), Short Ragweed, Timothy grass, egg, milk and peanut. Specific IgE was measured for these same allergens and total IgE was determined. RESULTS African American children (n=466) were more likely than White children (n=223) to have experienced any of the outcomes examined: at least 1 positive skin prick test from the panel of 10 allergens (21.7% versus 11.0%, p=0.001); at least one specific IgE ≥0.35 IU/mL (out of a panel of 10 allergens) (54.0% versus 42.9%, p=0.02); had AD (27.0% versus 13.5%, Chi-square p<0.001); and to ever have wheezed (44.9% versus 36.0%, p=0.03). African American children also tended to have higher total IgE (geometric means 23.4 IU/mL (95%CI 20.8, 27.6) versus 16.7 IU/mL (95%CI 13.6, 20.6 IU/mL), Wilcoxon Rank Sum p=0.004). With the exception of wheezing, the associations did not vary after adjusting for common social economic status variables (e.g.; household income), environmental variables (endotoxin; dog, cat and cockroach allergen in house dust) or variables that differed between the racial groups (e.g.; breastfeeding). After adjustment, the wheeze difference was ameliorated. CONCLUSIONS With disparities emerging as early as age 2 years, investigations into sources of the disparities should include the

  7. Prediction of response to treatment in a randomized clinical trial of couple therapy: a 2-year follow-up.

    PubMed

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

    2009-02-01

    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 explored as predictors of clinically significant change measured 2 years after treatment termination. Results demonstrated that power processes and expressed emotional arousal were the strongest predictors of 2-year response to treatment. Moderation analyses showed that these variables predicted differential treatment response to traditional versus integrative behavioral couple therapy and that more variables predicted 2-year response for couples who were less distressed when beginning treatment. Findings are discussed with regard to existing work on prediction of treatment response, and directions for further study are offered.

  8. Preschoolers with Autism Spectrum Disorder Followed for 2 Years: Those Who Gained and Those Who Lost the Most in Terms of Adaptive Functioning Outcome.

    PubMed

    Hedvall, Åsa; Westerlund, Joakim; Fernell, Elisabeth; Norrelgen, Fritjof; Kjellmer, Liselotte; Olsson, Martina Barnevik; Carlsson, Lotta Höglund; Eriksson, Mats A; Billstedt, Eva; Gillberg, Christopher

    2015-11-01

    Clinical predictors of 2-year outcome in preschoolers with ASD were studied in a population-based group of very young children with ASD (n = 208). Children who gained the most (n = 30) and lost the most (n = 23), i.e., increased or decreased their adaptive functioning outcome according to the Vineland Composite Score between study entry (T1) and follow-up (T2), 2 years later were compared. Individual factors that differed significantly between the two outcome groups were cognitive level, age at referral, not passing expected milestones at 18 months, autistic type behavior problems and regression. However, logistic regression analysis showed that only cognitive level at T1 (dichotomized into IQ < 70 and IQ ≥ 70) made a unique statistically significant contribution to outcome prediction (p = <.001) with an odds ratio of 18.01. The findings have significant clinical implications in terms of information at diagnosis regarding clinical prognosis in ASD.

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

    PubMed

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

    2009-06-01

    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 degrees 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 results

  10. Weight and Metabolic Outcomes After 2 Years on a Low-Carbohydrate Versus Low-Fat Diet

    PubMed Central

    Foster, Gary D.; Wyatt, Holly R.; Hill, James O.; Makris, Angela P.; Rosenbaum, Diane L.; Brill, Carrie; Stein, Richard I.; Mohammed, B. Selma; Miller, Bernard; Rader, Daniel J.; Zemel, Babette; Wadden, Thomas A.; Tenhave, Thomas; Newcomb, Craig W.; Klein, Samuel

    2010-01-01

    Background Previous studies comparing low-carbohydrate and low-fat diets have not included a comprehensive behavioral treatment, resulting in suboptimal weight loss. Objective To evaluate the effects of 2-year treatment with a low-carbohydrate or low-fat diet, each of which was combined with a comprehensive lifestyle modification program. Design Randomized parallel-group trial. (ClinicalTrials.gov registration number: NCT00143936) Setting 3 academic medical centers. Patients 307 participants with a mean age of 45.5 years (SD, 9.7 years) and mean body mass index of 36.1 kg/m2 (SD, 3.5 kg/m2). Intervention A low-carbohydrate diet, which consisted of limited carbohydrate intake (20 g/d for 3 months) in the form of low–glycemic index vegetables with unrestricted consumption of fat and protein. After 3 months, participants in the low-carbohydrate diet group increased their carbohydrate intake (5 g/d per wk) until a stable and desired weight was achieved. A low-fat diet consisted of limited energy intake (1200 to 1800 kcal/d; ≤30% calories from fat). Both diets were combined with comprehensive behavioral treatment. Measurements Weight at 2 years was the primary outcome. Secondary measures included weight at 3, 6, and 12 months and serum lipid concentrations, blood pressure, urinary ketones, symptoms, bone mineral density, and body composition throughout the study. Results Weight loss was approximately 11 kg (11%) at 1 year and 7 kg (7%) at 2 years. There were no differences in weight, body composition, or bone mineral density between the groups at any time point. During the first 6 months, the low-carbohydrate diet group had greater reductions in diastolic blood pressure, triglyceride levels, and very-low-density lipoprotein cholesterol levels, lesser reductions in low-density lipoprotein cholesterol levels, and more adverse symptoms than did the low-fat diet group. The low-carbohydrate diet group had greater increases in high-density lipoprotein cholesterol levels

  11. Brain Responses to Words in 2-Year-Olds with Autism Predict Developmental Outcomes at Age 6

    PubMed Central

    Kuhl, Patricia K.; Coffey-Corina, Sharon; Padden, Denise; Munson, Jeffrey; Estes, Annette; Dawson, Geraldine

    2013-01-01

    Autism Spectrum Disorder (ASD) is a developmental disability that affects social behavior and language acquisition. ASD exhibits great variability in outcomes, with some individuals remaining nonverbal and others exhibiting average or above average function. Cognitive ability contributes to heterogeneity in autism and serves as a modest predictor of later function. We show that a brain measure (event-related potentials, ERPs) of word processing in children with ASD, assessed at the age of 2 years (N = 24), is a broad and robust predictor of receptive language, cognitive ability, and adaptive behavior at ages 4 and 6 years, regardless of the form of intensive clinical treatment during the intervening years. The predictive strength of this brain measure increases over time, and exceeds the predictive strength of a measure of cognitive ability, used here for comparison. These findings have theoretical implications and may eventually lead to neural measures that allow early prediction of developmental outcomes as well as more individually tailored clinical interventions, with the potential for greater effectiveness in treating children with ASD. PMID:23734230

  12. Auxologic, biochemical and clinical (ABC) profile of low birth weight babies- a 2-year prospective study.

    PubMed

    Elizabeth, K E; Krishnan, Viji; Zachariah, Philip

    2007-12-01

    Low Birth Weight (LBW) is a key determinant of neonatal mortality, morbidity, subsequent growth and development as well as early onset of adulthood diseases. It represents a conflation of two outcomes-preterm- and term 'light for date' (LFD) babies. This study looks at key auxologic, biochemical and clinical (ABC) parameters of a cohort of LBW babies, both preterm- and term in comparison to a group of normal-term (control) babies. An attempt was also made to see how these parameters were at the end of a 2 year follow-up period with the currently available interventions. A cohort of 500 babies was selected at birth from a tertiary care teaching hospital in Kerala, India, key ABC indices were measured including relevant maternal data. The initial biochemical measurements were done using umbilical cord blood. Currently recommended nutritional interventions were provided to all the normal and LBW babies. At the end of 2 years, the measurements were repeated in a subset of babies available for follow-up (n = 147). From the cohort of 500 babies, two had to be eliminated as biochemical parameters could not be done due to technical reasons from the available umbilical cord blood. They were categorized into three groups: preterm-LBW (11.85%), term-LBW (38.55%) and normal-term controls (49.6%). The maternal characteristics like socio-economic status, maternal weight, height, BMI and hemoglobin levels were comparable in the three subsets. All of them belonged to middle or low-socio-economic status representing the non-affluent. In the initial group (n = 498), all the auxologic measurements and the nutrients measured namely, total protein, albumin, total cholesterol, triglycerides, calcium, magnesium, zinc and iron levels were significantly lower (p < 0.05) among LBW, lowest in preterm followed by term-LBW, compared to term controls. Total iron binding capacity showed inverse correlation with iron level. Protein, albumin, calcium and iron levels were low in many babies, and

  13. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents.

    PubMed

    Garot, Philippe; Morice, Marie-Claude; Tresukosol, Damras; Pocock, Stuart J; Meredith, Ian T; Abizaid, Alexandre; Carrié, Didier; Naber, Christoph; Iñiguez, Andres; Talwar, Suneel; Menown, Ian B A; Christiansen, Evald H; Gregson, John; Copt, Samuel; Hovasse, Thomas; Lurz, Philipp; Maillard, Luc; Krackhardt, Florian; Ong, Paul; Byrne, Jonathan; Redwood, Simon; Windhövel, Ute; Greene, Samantha; Stoll, Hans-Peter; Urban, Philip

    2017-01-17

    A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding. This study analyzed 2-year outcomes to determine whether these benefits are maintained. In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, anemia, raised plasma creatinine, and planned long-term anticoagulation. Correlates of the primary safety endpoint were age, anemia, congestive heart failure, multivessel disease, number of stents implanted, and use of a BMS rather than a DCS. Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the

  14. How Satisfied Are Patients with Arthroscopic Bankart Repair? A 2-Year Follow-up on Quality-of-Life Outcome.

    PubMed

    Saier, Tim; Plath, Johannes E; Waibel, Sabrina; Minzlaff, Philipp; Feucht, Matthias J; Herschbach, Peter; Imhoff, Andreas B; Braun, Sepp

    2017-06-29

    To report general life and health satisfaction after arthroscopic Bankart repair in patients with post-traumatic recurrent anterior glenohumeral instability and to investigate postoperative time lost to return to work at 2-year follow-up. Between 2011 and 2013 patients treated with arthroscopic Bankart repair in the beach chair position for acute shoulder instability were included in this study. Questions on Life Satisfaction Modules (FLZ(M)) and the Short Form 12 (SF-12) were used as quality-of-life outcome scales. Oxford Instability Score (OIS), Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), and self-reported American Shoulder and Elbow Surgeons (ASES) shoulder index were used as functional outcome scales. Return to work (months) was monitored and analyzed depending on physical workload. Data were assessed the day before surgery and prospectively monitored until 24 months postoperatively. Quality-of-life outcome was correlated with functional shoulder outcome and compared with normative age-adjusted data. Paired t-test, Wilcoxon test, Mann-Whitney U-Test, and Spearman's correlation coefficient were used for statistical analysis. Fifty-three patients were prospectively included. The mean age at surgery was 29.4 years. Satisfaction with general life and satisfaction with health (FLZ(M)) as well as physical component scale (SF-12) improved significantly to values above normative data within 6 to 12 months after surgery (each P < .001). OIS, QuickDASH, and ASES improved significantly from baseline until 24 months after surgery (each P < .001). For ASES, improvement above minimal clinically important difference was shown. There was a positive correlation between quality of life and functional outcome scores (P < .05; rho, 0.3-0.4). Mean time to return to work was 2 months (range, 0-10; standard deviation, 1.9), with significantly longer time intervals observed in patients with heavy physical workload (3.1 months; range, 0 to 10

  15. Mucogingival surgery. The subperiosteal vestibule extension. Clinical results 2 years after surgery.

    PubMed

    Schmid, M O; Mörmann, W; Bachmann, A

    1979-02-01

    A surgical technique to establish wide zones of attached mucosa was performed in 28 patients presenting with inadequate amounts of attached gingiva. The clinical results of the procedure were monitored over a period of 2 years. Biometric assessment of 112 mucogingival units immediately before and at 1, 3, 6, and 24 months after surgery revealed that the mean width of attached gingiva changed from 1.1 mm to 5.3 mm of attached tissue (gingiva plus vestibular mucosa). A surgically produced increase of 4.9 mm in width (P less than 0.001) and subsequent shrinkage of 0.7 mm or 14% (P less than 0.001) resulted in a total average gain of 4.2 mm of attached mucosa 2 years after surgery (P less than 0.001). A begin/end analysis of the coronal level of clinical periodontal attachment and the extent of gingival recession showed no clinically significant changes. The mean width of keratinized gingiva increased 0.8 mm during the 2-year postoperative period. The subperiosteal vestibule extension is recommended as an alternative to the free autogenous mucosa graft for establishing wide bands of attached mucosa in areas where loss of attached gingiva is associated with mechanical or microbial irritation of the marginal periodontium.

  16. Tic-Related Versus Tic-Free Obsessive-Compulsive Disorder: Clinical Picture and 2-Year Natural Course.

    PubMed

    de Vries, Froukje E; Cath, Danielle C; Hoogendoorn, Adriaan W; van Oppen, Patricia; Glas, Gerrit; Veltman, Dick J; van den Heuvel, Odile A; van Balkom, Anton J L M

    2016-10-01

    The tic-related subtype of obsessive-compulsive disorder (OCD) has a distinct clinical profile. The course of tic-related OCD has previously been investigated in treatment studies, with inconclusive results. This study aimed to compare clinical profiles between tic-related and tic-free OCD patients and to establish the influence of tics on the 2-year natural course in adult OCD patients. Within the Netherlands OCD Association cohort, 377 patients with a current DSM-IV diagnosis of OCD were divided into a tic-related group (28%) and a tic-free group and compared on clinical variables with t tests or χ² tests. Linear mixed-model analyses were used to compare the 2-year course between the groups, with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) as primary outcome measure. Data were collected from 2005 to 2007 and from 2007 to 2009. Compared to patients with tic-free OCD, those with tic-related OCD reported earlier disease onset (P = .009) and more symmetry/ordering symptoms (P = .002). Overall symptom severity was similar in both groups. Patients with tic-related OCD reported increased traits of attention-deficit hyperactivity (P < .001) and autism (P = .005) compared to the tic-free OCD group. Clinical improvement at 2-year follow-up (mean = 5.3-point decrease on the Y-BOCS, P < .001, 95% CI = 4.3 to 6.3) was not significantly moderated by tic status (P = .24). This remained unchanged after correcting for baseline differences. Tics do not critically affect the 2-year course of adult OCD, but tic-related OCD shows differences from tic-free OCD, such as early onset and increased autism and ADHD traits, that may indicate a neurodevelopmental subtype.

  17. Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial.

    PubMed

    Harris, Deborah L; Alsweiler, Jane M; Ansell, Judith M; Gamble, Gregory D; Thompson, Benjamin; Wouldes, Trecia A; Yu, Tzu-Ying; Harding, Jane E

    2016-03-01

    To determine neurodevelopmental outcome at 2 years' corrected age in children randomized to treatment with dextrose gel or placebo for hypoglycemia soon after birth (The Sugar Babies Study). This was a follow-up study of 184 children with hypoglycemia (<2.6 mM [47 mg/dL]) in the first 48 hours and randomized to either dextrose (90/118, 76%) or placebo gel (94/119, 79%). Assessments were performed at Kahikatea House, Hamilton, New Zealand, and included neurologic function and general health (pediatrician assessed), cognitive, language, behavior, and motor skills (Bayley Scales of Infant and Toddler Development, Third Edition), executive function (clinical assessment and Behaviour Rating Inventory of Executive Function-Preschool Edition), and vision (clinical examination and global motion perception). Coprimary outcomes were neurosensory impairment (cognitive, language or motor score below -1 SD or cerebral palsy or blind or deaf) and processing difficulty (executive function or global motion perception worse than 1.5 SD from the mean). Statistical tests were two sided with 5% significance level. Mean (± SD) birth weight was 3093 ± 803 g and mean gestation was 37.7 ± 1.6 weeks. Sixty-six children (36%) had neurosensory impairment (1 severe, 6 moderate, 59 mild) with similar rates in both groups (dextrose 38% vs placebo 34%, relative risk 1.11, 95% CI 0.75-1.63). Processing difficulty also was similar between groups (dextrose 10% vs placebo 18%, relative risk 0.52, 95% CI 0.23-1.15). Dextrose gel is safe for the treatment of neonatal hypoglycemia, but neurosensory impairment is common among these children. Australian New Zealand Clinical Trials Registry: ACTRN 12608000623392. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Early Postoperative Measures Predict 1- and 2-Year Outcomes After Unilateral Total Knee Arthroplasty: Importance of Contralateral Limb Strength

    PubMed Central

    Snyder-Mackler, Lynn

    2010-01-01

    Background Total knee arthroplasty (TKA) has been shown to be an effective surgical intervention for people with end-stage knee osteoarthritis. However, recovery of function is variable, and not all people have successful outcomes. Objective The aim of this study was to discern which early postoperative functional measures could predict functional ability at 1 year and 2 years after surgery. Design and Methods One hundred fifty-five people who underwent unilateral TKA participated in the prospective longitudinal study. Functional evaluations were performed at the initial outpatient physical therapy appointment and at 1 and 2 years after surgery. Evaluations consisted of measurements of height, weight, quadriceps muscle strength (force-generating capacity), and knee range of motion; the Timed “Up & Go” Test (TUG); the stair-climbing task (SCT); and the Knee Outcome Survey (KOS) questionnaire. The ability to predict 1- and 2-year outcomes on the basis of early postoperative measures was analyzed with a hierarchical regression. Differences in functional scores were evaluated with a repeated-measures analysis of variance. Results The TUG, SCT, and KOS scores at 1 and 2 years showed significant improvements over the scores at the initial evaluation (P<.001). A weaker quadriceps muscle in the limb that did not undergo surgery (“nonoperated limb”) was related to poorer 1- and 2-year outcomes even after the influence of the other early postoperative measures was accounted for in the regression. Older participants with higher body masses also had poorer outcomes at 1 and 2 years. Postoperative measures were better predictors of TUG and SCT times than of KOS scores. Conclusions Rehabilitation regimens after TKA should include exercises to improve the strength of the nonoperated limb as well as to treat the deficits imposed by the surgery. Emphasis on treating age-related impairments and reducing body mass also might improve long-term outcomes. PMID:19959653

  19. Is middle cerebral artery Doppler related to neonatal and 2-year infant outcome in early fetal growth restriction?

    PubMed

    Stampalija, Tamara; Arabin, Birgit; Wolf, Hans; Bilardo, Caterina M; Lees, Christoph

    2017-05-01

    Reduced fetal middle cerebral artery Doppler impedance is associated with hypoxemia in fetal growth restriction. It remains unclear as to whether this finding could be useful in timing delivery, especially in the third trimester. In this regard there is a paucity of evidence from prospective studies. The aim of this study was to determine whether there is an association between middle cerebral artery Doppler impedance and its ratio with the umbilical artery in relation to neonatal and 2 year infant outcome in early fetal growth restriction (26(+0)-31(+6) weeks of gestation). Additionally we sought to explore which ratio is more informative for clinical use. This is a secondary analysis from the Trial of Randomized Umbilical and Fetal Flow in Europe, a prospective, multicenter, randomized management study on different antenatal monitoring strategies (ductus venosus Doppler changes and computerized cardiotocography short-term variation) in fetal growth restriction diagnosed between 26(+0) and 31(+6) weeks. We analyzed women with middle cerebral artery Doppler measurement at study entry and within 1 week before delivery and with complete postnatal follow-up (374 of 503). The primary outcome was survival without neurodevelopmental impairment at 2 years corrected for prematurity. Neonatal outcome was defined as survival until first discharge home without severe neonatal morbidity. Z-scores were calculated for middle cerebral artery pulsatility index and both umbilicocerebral and cerebroplacental ratios. Odds ratios of Doppler parameter Z-scores for neonatal and 2 year infant outcome were calculated by multivariable logistic regression analysis adjusted for gestational age and birthweight p50 ratio. Higher middle cerebral artery pulsatility index at inclusion but not within 1 week before delivery was associated with neonatal survival without severe morbidity (odds ratio, 1.24; 95% confidence interval, 1.02-1.52). Middle cerebral artery pulsatility index Z-score and

  20. FFR guided PCI on long coronary lesions: 2-year clinical results with 2nd or newer generation DES

    PubMed Central

    Arvydas, Baranauskas; Vilhelmas, Bajoras; Povilas, Budrys; Aleksandras, Laucevičius; Giedrius, Davidavičius

    2016-01-01

    Background. Despite improvements in drug-eluting stent (DES) technology, treatment strategies for long coronary artery lesions remain a controversial issue. The aim of our study was to evaluate the long-term clinical results after FFR guided PCI on long coronary lesions. Materials and methods. A total of 74 consecutive patients with significant (mean FFR 0.61 ± 0.11) coronary artery lesions ≥30 mm in length were included in the prospective study. All patients were treated with FFR guided PCI implanting newer generation Biolimus, Everolimus or Zotarolimus eluting stents. Clinical endpoints – target vessel revascularization (TVR) and major adverse cardiac events (MACE) – were recorded at 1 and 2 years. Results. 100% angiographic procedure success was achieved, the mean post procedural FFR was 0.88 ± 0.06. At 2-year follow-up, 6 (8.1%) patients had ischemia driven TVR, all within the first 12 months. There were no target vessel related acute coronary syndromes and definite stent thromboses in the study group. At 2 years, the total MACE rate was 29.7%. There was a trend towards a higher TVR rate in patients with overlapping DES vs single DES implanted (9.6 vs 4.5%, p = 0.6). On regression analysis, the total stent length had no influence on the TVR rate. Conclusions. At 2 years after stenting long coronary lesions with newer generation DES the TVR rate was 8.1%, which is acceptable in the high cardiovascular risk population with diffuse coronary artery disease. The total stent length did not affect the long-term clinical outcomes. PMID:28356786

  1. 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.…

  2. 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.…

  3. Clinically significant behavior problems among young children 2 years after the Great East Japan Earthquake.

    PubMed

    Fujiwara, Takeo; Yagi, Junko; Homma, Hiroaki; Mashiko, Hirobumi; Nagao, Keizo; Okuyama, Makiko

    2014-01-01

    On March 11, 2011, a massive undersea earthquake and tsunami struck East Japan. Few studies have investigated the impact of exposure to a natural disaster on preschool children. We investigated the association of trauma experiences during the Great East Japan Earthquake on clinically significant behavior problems among preschool children 2 years after the earthquake. Participants were children who were exposed to the 2011 disaster at preschool age (affected area, n = 178; unaffected area, n = 82). Data were collected from September 2012 to June 2013 (around 2 years after the earthquake), thus participants were aged 5 to 8 years when assessed. Severe trauma exposures related to the earthquake (e.g., loss of family members) were assessed by interview, and trauma events in the physical environment related to the earthquake (e.g. housing damage), and other trauma exposure before the earthquake, were assessed by questionnaire. Behavior problems were assessed by caregivers using the Child Behavior Checklist (CBCL), which encompasses internalizing, externalizing, and total problems. Children who exceeded clinical cut-off of the CBCL were defined as having clinically significant behavior problems. Rates of internalizing, externalizing, and total problems in the affected area were 27.7%, 21.2%, and 25.9%, respectively. The rate ratio suggests that children who lost distant relatives or friends were 2.36 times more likely to have internalizing behavior problems (47.6% vs. 20.2%, 95% CI: 1.10-5.07). Other trauma experiences before the earthquake also showed significant positive association with internalizing, externalizing, and total behavior problems, which were not observed in the unaffected area. One in four children still had behavior problems even 2 years after the Great East Japan Earthquake. Children who had other trauma experiences before the earthquake were more likely to have behavior problems. These data will be useful for developing future interventions in

  4. Clinically Significant Behavior Problems among Young Children 2 Years after the Great East Japan Earthquake

    PubMed Central

    Fujiwara, Takeo; Yagi, Junko; Homma, Hiroaki; Mashiko, Hirobumi; Nagao, Keizo; Okuyama, Makiko

    2014-01-01

    Background On March 11, 2011, a massive undersea earthquake and tsunami struck East Japan. Few studies have investigated the impact of exposure to a natural disaster on preschool children. We investigated the association of trauma experiences during the Great East Japan Earthquake on clinically significant behavior problems among preschool children 2 years after the earthquake. Method Participants were children who were exposed to the 2011 disaster at preschool age (affected area, n = 178; unaffected area, n = 82). Data were collected from September 2012 to June 2013 (around 2 years after the earthquake), thus participants were aged 5 to 8 years when assessed. Severe trauma exposures related to the earthquake (e.g., loss of family members) were assessed by interview, and trauma events in the physical environment related to the earthquake (e.g. housing damage), and other trauma exposure before the earthquake, were assessed by questionnaire. Behavior problems were assessed by caregivers using the Child Behavior Checklist (CBCL), which encompasses internalizing, externalizing, and total problems. Children who exceeded clinical cut-off of the CBCL were defined as having clinically significant behavior problems. Results Rates of internalizing, externalizing, and total problems in the affected area were 27.7%, 21.2%, and 25.9%, respectively. The rate ratio suggests that children who lost distant relatives or friends were 2.36 times more likely to have internalizing behavior problems (47.6% vs. 20.2%, 95% CI: 1.10–5.07). Other trauma experiences before the earthquake also showed significant positive association with internalizing, externalizing, and total behavior problems, which were not observed in the unaffected area. Conclusions One in four children still had behavior problems even 2 years after the Great East Japan Earthquake. Children who had other trauma experiences before the earthquake were more likely to have behavior problems. These data will be

  5. Comparison of wear and clinical performance between amalgam, composite and open sandwich restorations: 2-year results.

    PubMed

    Sachdeo, A; Gray, Gordon B; Sulieman, M A; Jagger, Daryll C

    2004-03-01

    There has been some disquiet over the use of mercury containing restorative materials. The most commonly used alternative is composite resin but this has the potential disadvantage associated with wear and marginal leakage, which in turn, has proven to result in secondary caries and sensitivity. To overcome the shortcomings of a directly placed composite restoration, the glass-ionomer/composite open sandwich technique was introduced followed by the subsequent introduction of compomer systems. The aims of this study were to evaluate the wear and clinical performance of a control group of amalgam restorations compared with that of a group of posterior composite resin restorations fillings and a group of compomer/composite open sandwich restorations placed by a single general dental practitioner. The duration of the study was 2 years. One hundred and thirty three (71.4%) patients were successfully recalled and the wear and clinical performance of each restoration after 6, 12 and 24 months was measured, indirectly. There was no statistically significant difference recorded between the groups at 6 months or 1 year (p > 0.05). However, at the end of the 2-year study, there was a significantly lower rate of wear recorded for the control amalgam restorations compared with other two groups (p = 0.033). There was no statistically significant difference in wear recorded between the two groups of tooth-coloured restorations (p > 0.05). With regards to clinical performance of the restorations, occlusal and proximal contacts in each group of restoration remained satisfactory throughout the study.

  6. Arthroscopic Partial Repair of Irreparable Rotator Cuff Tears: Preoperative Factors Associated With Outcome Deterioration Over 2 Years.

    PubMed

    Shon, Min Soo; Koh, Kyoung Hwan; Lim, Tae Kang; Kim, Won Ju; Kim, Kyung Cheon; Yoo, Jae Chul

    2015-08-01

    Arthroscopic partial repair is a treatment option in irreparable large-to-massive rotator cuff tears without arthritic changes. However, there are indications that arthroscopic partial repair does not yield satisfactory outcomes. To report the clinical and radiographic results of arthroscopic partial repairs in patients with irreparable large-to-massive cuff tears. In addition, an analysis was performed regarding preoperative factors that may influence patient outcomes and patient-rated satisfaction over time. Case series; Level of evidence, 4. From 2005 to 2011, a total of 31 patients who underwent arthroscopic partial repair for irreparable large-to-massive cuff tears were retrospectively evaluated. Partial repair was defined as posterior cuff tissue repair with or without subscapularis tendon repair to restore the transverse force couple of the cuff. Pain visual analog scale (PVAS), questionnaire results (American Shoulder and Elbow Surgeons [ASES] and Simple Shoulder Test [SST]), and radiographic changes (acromiohumeral distance and degenerative change) were assessed preoperatively, at first follow-up (roughly 1 year postoperatively), and at final follow-up (>2 years postoperatively). Patients rated their satisfaction level at each postoperative follow-up as well. Preoperative factors that might influence outcomes, such as patient demographics, tear size, and fatty infiltration, were investigated. The preoperative, first follow-up, and final follow-up results for mean PVAS (5.13, 2.13, and 3.16, respectively) and questionnaires (ASES: 41.97, 76.37, and 73.78; SST: 3.61, 6.33, and 6.07, respectively) improved significantly (all P < .05). Radiographic evaluation showed no difference compared with preoperative status. Nevertheless, patient-rated satisfaction at final evaluation was inferior: 16 good responses ("very satisfied" and "satisfied") and 15 poor responses ("rather the same" and "dissatisfied"). Despite initial improvements in both groups (P < .05

  7. Orthopaedic trauma clinical research: is 2-year follow-up necessary? Results from a longitudinal study of severe lower extremity trauma.

    PubMed

    Castillo, Renan C; Mackenzie, Ellen J; Bosse, Michael J

    2011-12-01

    The ideal length of follow-up for orthopedic trauma research studies is unknown. This study compares 1- and 2-year complications, clinical recovery, and functional outcomes from a large prospective clinical study. Patients (n = 336) with limb threatening unilateral lower extremity injuries were followed at the 12, 24, and 84 months. Major outcomes observed were complications requiring hospital re-admission, fracture and wound healing, attainment of full weight bearing status, return to work, and self-reported functional outcome using the Sickness Impact Profile. The rate of newly observed complications beyond year 1 was small, ranging from 0 to <2%. In addition, 85% to 90% of the clinical recovery outcomes were attained by 1 year, and patients not achieving clinical recovery during the first year had significantly worse functional outcomes. Only 5% of patients returned to work between 1 year and 2 years. Although, a substantial number of patients achieved functional recovery between 1 year and 2 years, of the patients not achieving functional recovery at year 1, 85% of those who would go on to achieve functional recovery during the second year could be predicted using year 1 data. Although long-term follow-up provides a more complete picture of final outcomes and rate of recovery, follow-up beyond 1 year is difficult and expensive. In our study, it accounted for 20% of the total cost. The analysis of our data suggests that 1-year data were sufficient to address our major study hypotheses.

  8. 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…

  9. 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…

  10. Unexplained Pain Post Total Knee Arthroplasty With an Oxford Knee Score ≥20 at 6 Months Predicts Good 2-Year Outcome.

    PubMed

    Seah, Renyi Benjamin; Lim, Winston Shang Rong; Lo, Ngai Nung; Yew, Andy Khye Soo; Chong, Hwei Chi; Yeo, Seng Jin

    2017-03-01

    Total knee arthroplasty (TKA) is an effective procedure for end-stage osteoarthritis of the knee. Some patients experience persistent unexplained pain post-TKA despite normal investigations. The purpose of this study is to identify which of these patients are likely to improve without any surgical intervention. We hypothesize that patients with unexplained persistent pain and a poor 6-month Oxford knee score (OKS) post-TKA can improve at 2 years. Prospectively collected data for all primary unilateral TKA performed from June 2004 to January 2012 were analyzed to identify which patients with unexplained pain at 6 months will improve at 2 years. Patients were included if they had persistent pain and an OKS <27 at 6 months; normal radiological and clinical investigations; no infection identified; surgery performed for primary osteoarthritis. Two hundred sixty patients with OKS <27 at 6 months were analyzed. These patients were subdivided into 2 groups (group 1: 6-month OKS 20-26, group 2: 6-month OKS less than 20). One hundred ninety-one out of 208 (92%) patients in group 1 experienced improvement in pain and outcome at 2 years. Most of the group 1 patients attained a minimal clinically important difference in OKS of at least 5 (P < .001) at 2 years. Group 1 patients also reported better Knee Society Functional Score and Short Form Survey 36 mean scores at 2 years. In patients with unexplained pain, an OKS of at least 20 at 6 months predicts good functional outcome at 2 years. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Ligneous conjunctivitis in a plasminogen-deficient dog: clinical management and 2-year follow-up.

    PubMed

    Torres, María-Dolores; Leiva, Marta; Tabar, María-Dolores; Naranjo, Carolina; Pastor, Josep; Peña, Teresa

    2009-01-01

    A 1-year-old-female Yorkshire Terrier was referred to the Veterinary Teaching Hospital of the Autonomous University of Barcelona (VTH-UAB) (Spain) with a 6-month history of unilateral chronic proliferative conjunctivitis and intermittent vomiting and cough. Several medical and surgical treatment efforts to manage conjunctival lesions had resulted in no improvement of the clinical signs. Complete general and ophthalmic examinations revealed several proliferative 'wood-like' masses in the conjunctiva, oral cavity and an interscapular subcutaneous nodule. Conjunctival and buccal biopsies were performed as diagnostic procedures. A diagnosis of ligneous conjunctivitis was made on the basis of histopathology findings and clinical presentation. The only biochemical abnormalities found were severe proteinuria and low plasminogen activity in plasma. No other analytical abnormalities were observed. Topical treatment with heparin and anti-inflammatory and immunosuppressive drugs have controlled the ophthalmological clinical signs. To our knowledge, this is the first case report of a dog with plasminogen deficiency and ligneous conjunctivitis with a long survival period and 2-year follow-up.

  12. 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. PMID:27622149

  13. The likelihood of reaching minimum clinically important difference and substantial clinical benefit at 2 years following a 3-column osteotomy: analysis of 140 patients.

    PubMed

    Fakurnejad, Shayan; Scheer, Justin K; Lafage, Virginie; Smith, Justin S; Deviren, Vedat; Hostin, Richard; Mundis, Gregory M; Burton, Douglas C; Klineberg, Eric; Gupta, Munish; Kebaish, Khaled; Shaffrey, Christopher I; Bess, Shay; Schwab, Frank; Ames, Christopher P

    2015-09-01

    Three-column osteotomies (3COs) are technically challenging techniques for correcting severe rigid spinal deformities. The impact of these interventions on outcomes reaching minimum clinically important difference (MCID) or substantial clinical benefit (SCB) is unclear. The objective of this study was to determine the rates of MCID and SCB in standard health-related quality of life (HRQOL) measures after 3COs in patients with adult spinal deformity (ASD). The impacts of location of the uppermost instrumented vertebra (UIV) on clinical outcomes and of maintenance on sagittal correction at 2 years postoperatively were also examined. The authors conducted a retrospective multicenter analysis of the records from adult patients who underwent 3CO with complete 2-year radiographic and clinical follow-ups. Cases were categorized according to established radiographic thresholds for pelvic tilt (> 22°), sagittal vertical axis (> 4.7 cm), and the mismatch between pelvic incidence and lumbar lordosis (> 11°). The cases were also analyzed on the basis of a UIV in the upper thoracic (T1-6) or thoracolumbar (T9-L1) region. Patient-reported outcome measures evaluated preoperatively and 2 years postoperatively included Oswestry Disability Index (ODI) scores, the Physical Component Summary and Mental Component Summary (MCS) scores of the 36-Item Short Form Health Survey, and Scoliosis Research Society-22 questionnaire (SRS-22) scores. The percentages of patients whose outcomes for these measures met MCID and SCB were compared among the groups. Data from 140 patients (101 women and 39 men) were included in the analysis; the average patient age was 57.3 ± 12.4 years (range 20-82 years). Of these patients, 94 had undergone only pedicle subtraction osteotomy (PSO) and 42 only vertebral column resection (VCR); 113 patients had a UIV in the upper thoracic (n = 63) orthoracolumbar region (n = 50). On average, 2 years postoperatively the patients had significantly improved in all HRQOL

  14. 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

  15. A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years

    PubMed Central

    Marlow, Neil; Morris, Timothy; Brocklehurst, Peter; Carr, Robert; Cowan, Frances M; Patel, Nishma; Petrou, Stavros; Redshaw, Maggie E; Modi, Neena; Dore, Caroline

    2013-01-01

    Objective The authors performed a randomised trial in very preterm small-for-gestational age (SGA) babies to determine if prophylaxis with granulocyte-macrophage colony-stimulating factor (GM-CSF) improves outcomes (the PROGRAMS trial). Despite increased neutrophil counts following GM-CSF, the authors reported no significant difference in neonatal sepsis-free survival. Patients and methods 280 babies born <31 weeks of gestation and SGA were entered into the trial. Outcome was determined at 2 years to determine neurodevelopmental and general health outcomes, including economic costs. Results The authors found no significant differences in health outcomes or health and social care costs between the trial groups. In the GM-CSF arm, 87 of 134 (65%) babies survived to 2 years without severe disability compared with 87 of 131 (66%) controls (RR: 1·0, 95% CI 0·8 to 1·2). Marginally, more children receiving GM-CSF were reported to have cough (RR 1·7, 95% CI 1·1 to 2·6) and had signs of chronic respiratory disease (Harrison's sulcus; RR 2·0, 95% CI 1·0 to 3·9) though this was not reflected in bronchodilator use or need for hospitalisation for respiratory disease. Overall, the rate of neurologic abnormality (7%–9%) was similar but mean overall developmental scores were lower than expected for gestational age. Conclusions The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse outcomes at 2 years of age. The apparent excess of developmental impairment in the entire PROGRAMS cohort, without corresponding increase in neurological abnormality, may represent diffuse brain injury attributable to intrauterine growth restriction. PMID:22542709

  16. Multiple courses of antenatal corticosteroids for preterm birth study: 2-year outcomes.

    PubMed

    Asztalos, Elizabeth V; Murphy, Kellie E; Hannah, Mary E; Willan, Andrew R; Matthews, Stephen G; Ohlsson, Arne; Kelly, Edmond N; Saigal, Saroj; Ross, Susan; Delisle, Marie-France; Amankwah, Kofi; Guselle, Patricia; Gafni, Amiram; Lee, Shoo K; Armson, B Anthony; Sananes, Renee; Tomat, Laura

    2010-11-01

    The aim of this study was to determine the effects of repeated courses of prenatal corticosteroid therapy versus placebo on death or neurologic impairment among the children enrolled in the Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study, at 18 to 24 months of age. A total of 2305 infants were eligible for follow-up evaluation; 2104 infants (1069 in the prenatal corticosteroid therapy group and 1035 in the placebo group) were monitored. The primary outcome was death or neurologic impairment, defined as either cerebral palsy or cognitive delay, at 18 to 24 months of age. The secondary outcomes were measurements of growth (height, weight, and head circumference). Children exposed to multiple courses of prenatal corticosteroid therapy had similar rates of death or neurologic impairment, compared with children exposed to placebo (148 children [13.8%] vs 142 children [13.7%]; odds ratio: 1.001[95% confidence interval: 0.75-1.30]; P = .95). They had a mean weight of 11.94 kg, compared with 12.14 kg in the placebo group (P = .04), a mean height of 85.51 cm, compared with 85.46 cm (P = .87), and a mean head circumference of 48.18 cm, compared with 48.25 cm (P = .45). Multiple courses of prenatal corticosteroid therapy, given every 14 days, did not increase or decrease the risk of death or neurologic impairment at 18 to 24 months of age, compared with a single course of prenatal corticosteroid therapy. Continued follow-up monitoring of these children is necessary to assess neurobehavioral function, school performance, and possible susceptibility to disease.

  17. Long-term outcomes of a Web-based diabetes prevention program: 2-year results of a single-arm longitudinal study.

    PubMed

    Sepah, S Cameron; Jiang, Luohua; Peters, Anne L

    2015-04-10

    Digital therapeutics are evidence-based behavioral treatments delivered online that can increase accessibility and effectiveness of health care. However, few studies have examined long-term clinical outcomes of digital therapeutics. The objective of this study was to conduct a 2-year follow-up on participants in the Internet-based Prevent diabetes prevention program pilot study, specifically examining the effects on body weight and A1c, which are risk factors for diabetes development. A quasi-experimental research design was used, including a single-arm pre- and post-intervention assessment of outcomes. Participants underwent a 16-week weight loss intervention and an ongoing weight maintenance intervention. As part of the program, participants received a wireless scale, which was used to collect body weight data on an ongoing basis. Participants also received A1c test kits at baseline, 0.5 year, 1 year, and 2-year time points. Participants previously diagnosed with prediabetes (n=220) were originally enrolled in the pilot study. A subset of participants (n=187) met Centers for Disease Control and Prevention (CDC) criteria for starting the program (starters), and a further subset (n=155) met CDC criteria for completing the program (completers) and were both included in analyses. Program starters lost an average of 4.7% (SD 0.4) of baseline body weight after 1 year and 4.2% (SD 0.8) after 2 years, and reduced A1c by mean 0.38% (SD 0.07) after 1 year and 0.43% (SD 0.08) after 2 years. Program completers lost mean 4.9% (SD 0.5) of baseline body weight after 1 year and 4.3% (SD 0.8) after 2 years, and reduced A1c by 0.40% (SD 0.07) after 1 year and 0.46% (SD 0.08) after 2 years. For both groups, neither 2-year weight loss nor A1c results were significantly different from 1-year results. Users of the Prevent program experienced significant reductions in body weight and A1c that are maintained after 2 years. Contrary to the expected progression from prediabetes to

  18. [Occupational outcome of patients with schizophrenia after first request for disability status: a 2-year follow-up study].

    PubMed

    Verdoux, H; Goumilloux, R; Monello, F; Cougnard, A

    2010-12-01

    To assess occupational outcome of persons with schizophrenia over the 2 years following the first request of disability status. This study was carried out in collaboration with the Commission Technique d'Orientation et de Reclassement Professionnel (COTOREP) (technical commission for occupational guidance and rehabilitation of the disabled) de la Gironde (Bordeaux region, South Western France). Persons with schizophrenia or schizoaffective disorder requesting for the first time in 2006 a disability allowance or the status of disabled worker were assessed using a standardized questionnaire collecting data on clinical, occupational and income history. Information on occupational outcome over the 2 years after the first request was collected at the end of the follow-up using multiple sources of information. We used a broad definition of work, including moonlighting and episodic activities (baby-sitting or grape-harvesting), as well as study periods. Of the 121 patients included at baseline, direct or indirect information was available for 108 (90%) at the 24-month assessment. Persons lost to follow-up were less likely to have worked before first request of disability status compared to persons with information available at the end of the follow-up, but did not differ regarding the other characteristics. Nearly half of the persons (41.7%) had worked over the follow-up, irrespective of the type and duration of the occupation. The working periods were of short duration (median duration 14.5 days, interquartile range 6.5-47.5) and most (98%) were done in low-qualified jobs. Nearly half of the persons reported that they had benefitted from support for starting or returning to work, mainly from recruitment agencies specialized in supporting disabled workers. Persons with the status of disabled worker (Reconnaissance de la qualité de travailleur handicapé) (RTH) were more likely to have worked over the follow-up period (66.7% vs 33.3%; OR=3.9; 95%IC 1.3-11.3; p<0.01) as

  19. Neurodevelopmental and behavioral outcome of very low birth weight babies at corrected age of 2 years.

    PubMed

    Mukhopadhyay, Kanya; Malhi, Prahbhjot; Mahajan, Rama; Narang, Anil

    2010-09-01

    Neurodevelopmental and behavioral assessment of very low birth weight babies (VLBW) at corrected age (CA) of 2 years. 127, 110, 99 and 101 babies ≤34 weeks and ≤1500 g were followed at CA of 3, 6, 9, 12 months respectively for developmental and neurological assessment. DASII (Developmental assessment scale for Indian infants) was used at CA of 18 months and preschool behavioural checklist (PBCL) at CA 2 years. Of 101 VLBW babies available for follow up at CA 1 year, 3 (3%) babies had Cerebral Palsy (CP) and 3% (n = 3) had suspect abnormality (mild hypotonia), 11% (n = 11) had gross motor and 8% (n = 8) had language abnormality. Their mean mental (MeDQ) and motor (MoDQ) quotients were 80.4 ± 10.7 and 77.2 ± 13.3 and a score of < 70 was found in 17% (MeDQ) and 25.7% (MoDQ) VLBW babies. High PBCL score (mean 16.8 ± 5.4) was seen in 84%VLBW babies. On subgroup analysis, 2 babies (5%) in subgroup1 ( n = 54, ≤1200 g,) and 1 (1.6%) in subgroup 2 (n = 78, 1201-1500 g) had CP. Twelve (29%) in subgroup 1 had significant language delay (p = 0.004) as compared to 4 (15%) in subgroup 2 at 1 year. BSID and PBCL scores were comparable. Amongst ELBW babies (<1000 g), 6.6% (n = 1) had CP, 25% (n = 3) and 42% (n = 5) had low MeDQ and MoDQ respectively and all of them had high PBCL score. AGA and SGA had similar outcome. VLBW babies need close and longer follow up due to high risk of neurodevelopmental and behavioral abnormality.

  20. Rehabilitation outcomes in children with cerebral palsy during a 2 year period

    PubMed Central

    İçağasıoğlu, Afitap; Mesci, Erkan; Yumusakhuylu, Yasemin; Turgut, Selin Turan; Murat, Sadiye

    2015-01-01

    [Purpose] To observe motor and functional progress of children with cerebral palsy during 2 years. [Subjects and Methods] Pediatric cerebral palsy patients aged 3–15 years (n = 35/69) with 24-month follow-up at our outpatient cerebral palsy clinic were evaluated retrospectively. The distribution of cerebral palsy types was as follows: diplegia (n = 19), hemiplegia (n = 4), and quadriplegia (n = 12). Participants were divided into 3 groups according to their Gross Motor Functional Classification System scores (i.e., mild, moderate, and severe). All participants were evaluated initially and at the final assessment 2 years later. During this time, patients were treated 3 times/week. Changes in motor and functional abilities were assessed based on Gross Motor Function Measure-88 and Wee Functional Independence Measure. [Results] Significant improvements were observed in Gross Motor Function Measure-88 and Wee Functional Independence Measure results in all 35 patients at the end of 2 years. The Gross Motor Function Measure-88 scores correlated with Wee Functional Independence Measure Scores. Marked increases in motor and functional capabilities in mild and moderate cerebral palsy patients were observed in the subgroup assessments, but not in those with severe cerebral palsy. [Conclusion] Rehabilitation may greatly help mild and moderate cerebral palsy patients achieve their full potential. PMID:26644677

  1. Clinical Results of Lateral Unicompartmental Knee Arthroplasty: Minimum 2-Year Follow-up

    PubMed Central

    Kim, Kyung Tae; Lee, Song; Kim, Jin Woo; Kang, Min Su

    2016-01-01

    Background We investigated the clinical results and early complications after lateral unicompartmental knee arthroplasty (UKA) using the Zimmer unicompartmental high-flex knee (ZUK) prosthesis with a minimum follow-up of 2 years. Methods Twenty-seven patients (30 cases) who underwent lateral UKA with the ZUK prosthesis between January 2011 and February 2014 were selected for this study. The mean age of the patients was 63.3 years at the time of surgery, and the mean followup was 3 years and 2 months (range, 24 to 48 months). A retrospective investigation method was used to evaluate the clinical and radiographic results with use of the Knee Society (KS) clinical rating system and plain radiography. Results The mean KS pain score was improved from 17.9 points (range, 10 to 30 points) preoperatively to 40.5 points (range, 30 to 45 points) at the final follow-up (p < 0.001). The mean KS knee score and function score significantly increased from 63.2 points (range, 48 to 70 points) and 68.6 points (range, 35 to 80 points), respectively, preoperatively to 86.0 points (range, 74 to 95 points) and 92.4 points (range, 60 to 100 points), respectively, at the final follow-up (p < 0.001). The mean range of motion of the knee was recovered from 127.1° (range, 110° to 135°) preoperatively to 131.6° (range, 120° to 135°) at the final follow-up. The mean tibiofemoral angle changed from 6.2° of valgus (range, 0.1° to 11.4° of valgus) preoperatively to 3.4°of valgus (range, 0.2° to 9.5° of valgus) at the final follow-up. The overall results classified based on the KS knee score were "excellent" in 21 cases and "good" in 8 cases. Revision total knee arthroplasty was required in one case because of consistent pain on the medial side of the knee after surgery. Conclusions The early clinical results of lateral UKA using the ZUK prosthesis were satisfactory for improvement of pain, knee score, function score, and recovery of knee motion. Therefore, the lateral UKA could be a

  2. Symptomatic and functional outcomes of substance use disorder persistence 2 years after admission to a first-episode psychosis program.

    PubMed

    Abdel-Baki, Amal; Ouellet-Plamondon, Clairélaine; Salvat, Émilie; Grar, Kawthar; Potvin, Stéphane

    2017-01-01

    Substance use disorders (SUD) in first-episode psychosis (FEP) are highly prevalent and linked with poor outcomes. However, most longitudinal studies investigating their impacts in FEP have not reported proportions of patients who ceased SUD. Our aim was to examine the influence of SUD course on functional and symptomatic outcomes as well as service use in FEP. We performed a 2-year longitudinal study of 212 FEP patients, aged between 18 and 30 years, admitted to 2 early psychosis services in Montréal, Québec, Canada. We observed that cannabis was the first substance abused (42.9% at baseline), followed by alcohol (19.3%). The SUD rate decreased by approximately 30% during the first year. Patients with persistent SUD had worse functional outcomes (Quality of Life Scale, Social and Occupational Functioning Assessment Scale, employment), more symptoms (Positive and Negative Symptoms Scale) and heavier service use (emergency and hospitalization). SUD persistence was associated with illness severity, homelessness and cluster-B personality. Those living with their parents and financially supported by them were more likely to cease SUD. Our results indicate that SUD course was more significant than having SUD at admission; persistent SUD was associated with worse outcomes. SUD decreased during a general early psychosis intervention program (with no specialized SUD treatment). An integrated, specialized approach targeting FEP patients with predictive factors of SUD persistence during the first years of treatment might increase SUD cessation and possibly improve outcomes.

  3. Substance use outcomes 51/2 years past baseline for partnership-based, family-school preventive interventions.

    PubMed

    Spoth, Richard L; Randall, G Kevin; Trudeau, Linda; Shin, Chungyeol; Redmond, Cleve

    2008-07-01

    This article reports adolescent substance use outcomes of universal family and school preventive interventions 5(1/2) years past baseline. Participants were 1677 7th grade students from schools (N=36) randomly assigned to the school-based Life Skills Training plus the Strengthening Families Program: For Parents and Youth 10-14 (LST+SFP 10-14), LST-alone, or a control condition. Self-reports were collected at baseline, 6 months later following the interventions, then yearly through the 12th grade. Measures included initiation-alcohol, cigarette, marijuana, and drunkenness, along with a Substance Initiation Index (SII)-and measures of more serious use-frequency of alcohol, cigarette, and marijuana use, drunkenness frequency, monthly poly-substance use, and advanced poly-substance use. Analyses ruled out differential attrition. For all substance initiation outcomes, one or both intervention groups showed significant, positive point-in-time differences at 12th grade and/or significant growth trajectory outcomes when compared with the control group. Although no main effects for the more serious substance use outcomes were observed, a higher-risk subsample demonstrated significant, positive 12th grade point-in-time and/or growth trajectory outcomes for one or both intervention groups on all measures. The observed pattern of results likely reflects a combination of predispositions of the higher-risk subsample, the timing of the interventions, and baseline differences between experimental conditions favoring the control group.

  4. A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years

    PubMed Central

    Few, Julius; Cox, Sue Ellen; Paradkar-Mitragotri, Deepali; Murphy, Diane K.

    2015-01-01

    Background Juvéderm Voluma XC is a volumizing hyaluronic acid filler used for correction of age-related midface volume deficit (MVD). Objectives The effectiveness of Juvéderm Voluma XC was examined from the patient perspective. Methods Patients with moderate to severe age-related MVD (N = 235) received Juvéderm Voluma XC. At quarterly follow-up visits for 2 years, patients rated treatment outcomes on the Global Aesthetic Improvement Scale (GAIS), overall satisfaction with facial appearance, satisfaction with midfacial regions, achievement of treatment goal, Look and Feel of the Midface (LAFM), and Self-Perception of Age (SPA). Patients recorded treatment-site responses in 30-day diaries. Results At 6 months and 2 years after treatment, 92.8% and 79.0% of patients, respectively, rated their cheek volume as improved/much improved on the GAIS. Improvement in satisfaction with facial appearance was noted by 89.8% of patients at 6 months and 75.8% at 2 years. Increased satisfaction with outer and lower cheek areas and cheek-bone projection and clinically significant improvements in LAFM were noted through month 24. Treatment goals were achieved by 67.8% of patients at 6 months and 49.0% at 2 years. Patients reported looking, on average, 5 years younger at 6 months and 3 years younger at 2 years. The most common treatment site responses were tenderness, swelling, firmness, and lumps/bumps; most were mild to moderate in severity and lasted ≤2 weeks. Conclusions Juvéderm Voluma XC for age-related MVD is effective and well-tolerated from the patient perspective, with results lasting up to 2 years. Level of Evidence 4 Therapeutic PMID:25964628

  5. Motor Testing at 1 Year Improves the Prediction of Motor and Mental Outcome at 2 Years after Perinatal Hypoxic-Ischaemic Encephalopathy

    ERIC Educational Resources Information Center

    van Schie, Petra Em; Becher, Jules G.; Dallmeijer, Annet J.; Barkhof, Frederik; van Weissenbruch, Mirjam M.; Vermeulen, R. Jeroen

    2010-01-01

    Aim: To investigate the predictive value of motor testing at 1 year for motor and mental outcome at 2 years after perinatal hypoxic-ischaemic encephalopathy (HIE) in term neonates. Method: Motor and mental outcome at 2 years was assessed with the Bayley Scales of Infant Development, 2nd edition (BSID-II) in 32 surviving children (20 males, 12…

  6. Motor Testing at 1 Year Improves the Prediction of Motor and Mental Outcome at 2 Years after Perinatal Hypoxic-Ischaemic Encephalopathy

    ERIC Educational Resources Information Center

    van Schie, Petra Em; Becher, Jules G.; Dallmeijer, Annet J.; Barkhof, Frederik; van Weissenbruch, Mirjam M.; Vermeulen, R. Jeroen

    2010-01-01

    Aim: To investigate the predictive value of motor testing at 1 year for motor and mental outcome at 2 years after perinatal hypoxic-ischaemic encephalopathy (HIE) in term neonates. Method: Motor and mental outcome at 2 years was assessed with the Bayley Scales of Infant Development, 2nd edition (BSID-II) in 32 surviving children (20 males, 12…

  7. Outcome of Treatment of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial 2-Year Results.

    PubMed

    Tomkins-Netzer, Oren; Lightman, Susan; Drye, Lea; Kempen, John; Holland, Gary N; Rao, Narsing A; Stawell, Richard J; Vitale, Albert; Jabs, Douglas A

    2015-11-01

    To evaluate the 2-year outcomes of uveitic macular edema. Longitudinal follow-up of a randomized cohort. At baseline, 148 eyes of 117 patients enrolled in the Multicenter Uveitis Steroid Treatment (MUST) Trial had macular edema, and 134 eyes of 108 patients completed 2-year follow-up. Patients enrolled in the study were randomized to either systemic immunosuppression or intravitreal fluocinolone acetonide implant therapy. Macular edema was defined as thickening of the retina (center point thickness≥240 μm) on time-domain optical coherence tomography (OCT) of macula. Improvement in macular edema (≥20% reduction in central point thickness on OCT), resolution of macular edema (normalization of thickness on OCT), and best-corrected visual acuity (BCVA). Between randomization and 2-years' follow-up, 62% and 25% of eyes in the systemic and implant groups, respectively, received at least 1 supplemental regional corticosteroid injection. By 2-years' follow-up, macular edema improved in 71% of eyes and resolved in 60%. There were no differences between treatment groups in the proportion of eyes with macular edema improving (systemic therapy vs. implant, 65% vs. 77%; P=0.20) and resolving (52% vs. 68%; P=0.28), but eyes randomized to implant had more improvement in macular thickness (median decrease of 180 vs. 109 μm in the systemic therapy group; P=0.04). Eyes with baseline fluorescein angiographic leakage were more likely to improve than those without (76% vs. 58%; P=0.03). Overall, there was a mean 5-letter (1 line) improvement in BCVA at 2 years. Mean changes in BCVA from baseline at 2 years by macular edema response status were: resolution, +10 letters; improvement without resolution, +10 letters (P=0.92); little to no change, 6 letters (P=0.19); and worsening, -16 letters (worsening acuity; P=0.0003). About two thirds of eyes with uveitic macular edema were observed to experience improvement in the edema and visual acuity with implant or systemic treatment

  8. Outcomes of a new residential scheme for adults with intellectual disabilities in Taiwan: a 2-year follow-up.

    PubMed

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

    2011-09-01

    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. A one-group repeated-measures analysis was conducted for five interviews after the adults with intellectual disabilities entered the new environment. Forty-nine adults were initially studied (T1) and 29 adults remained in the homes until the end of the study (T5). This study found significant improvements over the 2 years in the residents' quality of life and family contact. The results also highlight a decrease in maladaptive behaviour among the residents moving from institution and an increase in choice making and family contact among the residents moving from family. No significant changes in adaptive behaviour and community inclusion were found. Results revealed that further policy changes and financial support including service quality assurance are required in order to improve service outcomes for adults living in the new residential scheme. © 2011 The Authors. Journal of Intellectual Disability Research © 2011 Blackwell Publishing Ltd.

  9. Relationships between 2-Year Survival, Costs, and Outcomes following Carotid Endarterectomy in Asymptomatic Patients in the Vascular Quality Initiative.

    PubMed

    Wallaert, Jessica B; Newhall, Karina A; Suckow, Bjoern D; Brooke, Benjamin S; Zhang, Min; Farber, Adrienne E; Likosky, Donald; Goodney, Philip P

    2016-08-01

    Carotid endarterectomy (CEA) for asymptomatic patients with limited life expectancy may not be beneficial or cost-effective. The purpose of this study was to examine relationships among survival, outcomes, and costs within 2 years following CEA among asymptomatic patients. Prospectively collected data from 3097 patients undergoing CEA for asymptomatic disease from Vascular Quality Initiative VQI registry were linked to Medicare. Models were used to identify predictors of 2-year mortality following CEA. Patients were classified as low, medium, or high risk of death based on this model. Next, we examined costs related to cerebrovascular care, occurrence of stroke, rehospitalization, and reintervention within 2 years following CEA across risk strata. Overall, 2-year mortality was 6.7%. Age, diabetes, smoking, congestive heart failure (CHF), chronic obstructive pulmonary disease, renal insufficiency, absence of statin use, and contralateral internal carotid artery (ICA) stenosis were independently associated with a higher risk of death following CEA. In-hospital costs averaged $7500 among patients defined as low risk for death, and exceeded $10,800 among high risk patients. Although long-term costs related to cerebrovascular disease were 2 times higher in patients deemed high risk for death compared with low risk patents ($17,800 vs. $8800, P = 0.001), high risk of death was not independently associated with a high probability of high cost. Predictors of high cost at 2 years were severe contralateral ICA stenosis, dialysis dependence, and American Society for Anesthesia Class 4. Both statin use and CHF were protective of high cost. Greater than 90% of patients undergoing CEA live long enough to realize the benefits of their procedure. Moreover, the long-term costs are supported by the effectiveness of this procedure at all levels of patient risk. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. DIAGNOSTIC IMAGING IN A DIRECT-ACCESS SPORTS PHYSICAL THERAPY CLINIC: A 2-YEAR RETROSPECTIVE PRACTICE ANALYSIS.

    PubMed

    Crowell, Michael S; Dedekam, Erik A; Johnson, Michael R; Dembowski, Scott C; Westrick, Richard B; Goss, Donald L

    2016-10-01

    While advanced diagnostic imaging is a large contributor to the growth in health care costs, direct-access to physical therapy is associated with decreased rates of diagnostic imaging. No study has systematically evaluated with evidence-based criteria the appropriateness of advanced diagnostic imaging, including magnetic resonance imaging (MRI), when ordered by physical therapists. The primary purpose of this study was to describe the appropriateness of magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA) exams ordered by physical therapists in a direct-access sports physical therapy clinic. Retrospective observational study of practice. Greater than 80% of advanced diagnostic imaging orders would have an American College of Radiology (ACR) Appropriateness Criteria rating of greater than 6, indicating an imaging order that is usually appropriate. A 2-year retrospective analysis identified 108 MRI/MRA examination orders from four physical therapists. A board-certified radiologist determined the appropriateness of each order based on ACR appropriateness criteria. The principal investigator and co-investigator radiologist assessed agreement between the clinical diagnosis and MRI/surgical findings. Knee (31%) and shoulder (25%) injuries were the most common. Overall, 55% of injuries were acute. The mean ACR rating was 7.7; scores from six to nine have been considered appropriate orders and higher ratings are better. The percentage of orders complying with ACR appropriateness criteria was 83.2%. Physical therapist's clinical diagnosis was confirmed by MRI/MRA findings in 64.8% of cases and was confirmed by surgical findings in 90% of cases. Physical therapists providing musculoskeletal primary care in a direct-access sports physical therapy clinic appropriately ordered advanced diagnostic imaging in over 80% of cases. Future research should prospectively compare physical therapist appropriateness and utilization to other groups of providers and

  11. DIAGNOSTIC IMAGING IN A DIRECT-ACCESS SPORTS PHYSICAL THERAPY CLINIC: A 2-YEAR RETROSPECTIVE PRACTICE ANALYSIS

    PubMed Central

    Dedekam, Erik A.; Johnson, Michael R.; Dembowski, Scott C.; Westrick, Richard B.; Goss, Donald L.

    2016-01-01

    Background While advanced diagnostic imaging is a large contributor to the growth in health care costs, direct-access to physical therapy is associated with decreased rates of diagnostic imaging. No study has systematically evaluated with evidence-based criteria the appropriateness of advanced diagnostic imaging, including magnetic resonance imaging (MRI), when ordered by physical therapists. The primary purpose of this study was to describe the appropriateness of magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA) exams ordered by physical therapists in a direct-access sports physical therapy clinic. Study Design Retrospective observational study of practice. Hypothesis Greater than 80% of advanced diagnostic imaging orders would have an American College of Radiology (ACR) Appropriateness Criteria rating of greater than 6, indicating an imaging order that is usually appropriate. Methods A 2-year retrospective analysis identified 108 MRI/MRA examination orders from four physical therapists. A board-certified radiologist determined the appropriateness of each order based on ACR appropriateness criteria. The principal investigator and co-investigator radiologist assessed agreement between the clinical diagnosis and MRI/surgical findings. Results Knee (31%) and shoulder (25%) injuries were the most common. Overall, 55% of injuries were acute. The mean ACR rating was 7.7; scores from six to nine have been considered appropriate orders and higher ratings are better. The percentage of orders complying with ACR appropriateness criteria was 83.2%. Physical therapist's clinical diagnosis was confirmed by MRI/MRA findings in 64.8% of cases and was confirmed by surgical findings in 90% of cases. Conclusions Physical therapists providing musculoskeletal primary care in a direct-access sports physical therapy clinic appropriately ordered advanced diagnostic imaging in over 80% of cases. Future research should prospectively compare physical therapist

  12. Regenerative Endodontic Procedures: Clinical Outcomes.

    PubMed

    Diogenes, Anibal; Ruparel, Nikita B

    2017-01-01

    Immature teeth are at risk for pulp necrosis, resulting in arrested root development and poor long-term prognosis. There is growing evidence that regenerative endodontic procedures promote desirable clinical outcomes. Despite significant advances in the field of regenerative endodontics and acceptable clinical outcomes, current evidence suggests that the tissues formed following currently used procedures do not completely recapitulate the former pulp-dentin complex. Further research is needed to identify prognostic factors and predictors of successful outcomes and to develop different treatment strategies to better predictably achieve all identified clinical outcomes, while favoring tissue formation that more closely resembles the pulp-dentin complex. Copyright © 2016. Published by Elsevier Inc.

  13. Myopia Control with a Novel Peripheral Gradient Soft Lens and Orthokeratology: A 2-Year Clinical Trial

    PubMed Central

    Pauné, Jaime; Morales, Hari; Armengol, Jesús; Quevedo, Lluisa; Faria-Ribeiro, Miguel; González-Méijome, José M.

    2015-01-01

    Objective. To evaluate the degree of axial elongation with soft radial refractive gradient (SRRG) contact lenses, orthokeratology (OK), and single vision (SV) spectacle lenses (control) during a period of 1 year before treatment and 2 years after treatment. Methods. This was a prospective, longitudinal, nonrandomized study. The study groups consisted of 30, 29, and 41 children, respectively. The axial length (AL) was measured during 2 years after recruitment and lens fitting. Results. The baseline refractive sphere was correlated significantly (Spearman's Rho (ρ) correlation = 0.542; P < 0.0001) with the amount of myopia progression before baseline. After 2 years, the mean myopia progression values for the SRRG, OK, and SV groups were −0.56 ± 0.51, −0.32 ± 0.53, and −0.98 ± 0.58 diopter, respectively. The results represent reductions in myopic progression of 43% and 67% for the SRRG and OK groups, respectively, compared to the SV group. The AL increased 27% and 38% less in the SRRG and OK groups, respectively compared with the SV group at the 2-year visit (P < 0.05). Axial elongation was not significantly different between SRRG and OK (P = 0.430). Conclusion. The SRRG lens significantly decreased AL elongation compared to the SV control group. The SRRG lens was similarly effective to OK in preventing myopia progression in myopic children and adolescent. PMID:26605331

  14. Myopia Control with a Novel Peripheral Gradient Soft Lens and Orthokeratology: A 2-Year Clinical Trial.

    PubMed

    Pauné, Jaime; Morales, Hari; Armengol, Jesús; Quevedo, Lluisa; Faria-Ribeiro, Miguel; González-Méijome, José M

    2015-01-01

    To evaluate the degree of axial elongation with soft radial refractive gradient (SRRG) contact lenses, orthokeratology (OK), and single vision (SV) spectacle lenses (control) during a period of 1 year before treatment and 2 years after treatment. This was a prospective, longitudinal, nonrandomized study. The study groups consisted of 30, 29, and 41 children, respectively. The axial length (AL) was measured during 2 years after recruitment and lens fitting. The baseline refractive sphere was correlated significantly (Spearman's Rho (ρ) correlation = 0.542; P < 0.0001) with the amount of myopia progression before baseline. After 2 years, the mean myopia progression values for the SRRG, OK, and SV groups were -0.56 ± 0.51, -0.32 ± 0.53, and -0.98 ± 0.58 diopter, respectively. The results represent reductions in myopic progression of 43% and 67% for the SRRG and OK groups, respectively, compared to the SV group. The AL increased 27% and 38% less in the SRRG and OK groups, respectively compared with the SV group at the 2-year visit (P < 0.05). Axial elongation was not significantly different between SRRG and OK (P = 0.430). The SRRG lens significantly decreased AL elongation compared to the SV control group. The SRRG lens was similarly effective to OK in preventing myopia progression in myopic children and adolescent.

  15. Bilateral Moyamoya Disease in a 2-Year-Old Pakistani Male Treated with Bilateral Encephaloduroarteriosynangiosis: A Positive Outcome

    PubMed Central

    Khoja, Adeel; Rameez, Mansoor Ali Merchant; Khan, Ariba; Ishaque, Noman

    2016-01-01

    Background. We present a rare case of bilateral moyamoya disease presenting as multiple strokes and neurological deficits, treated with the neurosurgical procedure, encephaloduroarteriosynangiosis (EDAS), in a 2-year-old male Pakistani minor. A positive outcome was achieved and the patient recovered fully. Case Summary. Our patient presented with a history of seizures and multiple episodes of hemiparesis (on and off weakness) at the age of 2 years. He had a delayed speech development and could not speak more than a few words. He had a slight slurring of speech too. He was diagnosed with bilateral moyamoya disease on Computed Tomography Angiography (CTA). Bilateral EDAS was done in the same year, after which his symptoms improved and patient had moderate functional recovery. Conclusion. A rare disease, moyamoya has been left unexplored in Pakistan; physicians and surgeons when dealing with cases in the pediatric population presenting with symptoms of stroke, signs of generalized weakness, and seizures should consider moyamoya disease as a possibility. Furthermore, this case demonstrates the effectiveness of EDAS procedure for the treatment of moyamoya disease. PMID:28101388

  16. Bilateral Moyamoya Disease in a 2-Year-Old Pakistani Male Treated with Bilateral Encephaloduroarteriosynangiosis: A Positive Outcome.

    PubMed

    Magsi, Shahvaiz; Khoja, Adeel; Rameez, Mansoor Ali Merchant; Khan, Ariba; Ishaque, Noman

    2016-01-01

    Background. We present a rare case of bilateral moyamoya disease presenting as multiple strokes and neurological deficits, treated with the neurosurgical procedure, encephaloduroarteriosynangiosis (EDAS), in a 2-year-old male Pakistani minor. A positive outcome was achieved and the patient recovered fully. Case Summary. Our patient presented with a history of seizures and multiple episodes of hemiparesis (on and off weakness) at the age of 2 years. He had a delayed speech development and could not speak more than a few words. He had a slight slurring of speech too. He was diagnosed with bilateral moyamoya disease on Computed Tomography Angiography (CTA). Bilateral EDAS was done in the same year, after which his symptoms improved and patient had moderate functional recovery. Conclusion. A rare disease, moyamoya has been left unexplored in Pakistan; physicians and surgeons when dealing with cases in the pediatric population presenting with symptoms of stroke, signs of generalized weakness, and seizures should consider moyamoya disease as a possibility. Furthermore, this case demonstrates the effectiveness of EDAS procedure for the treatment of moyamoya disease.

  17. Microcytosis is associated with low cognitive outcomes in healthy 2-year-olds in a high-resource setting.

    PubMed

    McCarthy, Elaine K; Kiely, Mairead E; Hannon, Geraldine; Ahearne, Caroline; Kenny, Louise C; Hourihane, Jonathan O'B; Irvine, Alan D; Murray, Deirdre M

    2017-09-01

    Fe deficiency in early childhood is associated with long-term consequences for cognitive, motor and behavioural development; however explorations in healthy children from low risk, high-resource settings have been limited. We aimed to explore associations between Fe status and neurodevelopmental outcomes in low risk, healthy 2-year-olds. This study was a secondary analysis of a nested case-control subgroup from the prospective, maternal-infant Cork Babies after Screening for Pregnancy Endpoints: Evaluating the Longitudinal Impact using Neurological and Nutritional Endpoints (BASELINE) Birth Cohort Study. At 2 years, serum ferritin, Hb and mean corpuscular volume (MCV) were measured and neurodevelopment was assessed using the Bayley Scales of Infant and Toddler Development (n 87). Five children had Fe deficiency (ferritin <12 µg/l) and no child had Fe deficiency anaemia (Hb<110 g/l+ferritin<12 µg/l). Children with microcytosis (MCV<74 fl, n 13) had significantly lower mean cognitive composite scores (88·5 (sd 13·3) v. 97·0 (sd 7·8), P=0·04, Cohen's d effect size=0·8) than those without microcytosis. The ferritin concentration which best predicted microcytosis was calculated as 18·4 µg/l (AUC=0·87 (95% CI 0·75, 0·98), P<0·0001, sensitivity 92 %, specificity 75 %). Using 18·5 µg/l as a threshold, children with concentrations <18·5 µg/l had significantly lower mean cognitive composite scores (92·3 (sd 10·5) v. 97·8 (sd 8·1), P=0·012, Cohen's d effect size=0·6) compared with those with ferritin ≥18·5 µg/l. All associations were robust after adjustment for potential confounding factors. Despite a low prevalence of Fe deficiency using current diagnostic criteria in this healthy cohort, microcytosis was associated with lower cognitive outcomes at 2 years. This exploratory study emphasises the need for re-evaluation of the diagnostic criteria for Fe deficiency in young children, with further research in adequately powered studies warranted.

  18. Associations between weather conditions and clinical symptoms in patients with hip osteoarthritis: a 2-year cohort study.

    PubMed

    Dorleijn, Desirée M J; Luijsterburg, Pim A J; Burdorf, Alex; Rozendaal, Rianne M; Verhaar, Jan A N; Bos, Pieter K; Bierma-Zeinstra, Sita M A

    2014-04-01

    The goal of this study was to assess whether there is an association between ambient weather conditions and patients' clinical symptoms in patients with hip osteoarthritis (OA). The design was a cohort study with a 2-year follow-up and 3-monthly measurements and prospectively collected data on weather variables. The study population consisted of 222 primary care patients with hip OA. Weather variables included temperature, wind speed, total amount of sun hours, precipitation, barometric pressure, and relative humidity. The primary outcomes were severity of hip pain and hip disability as measured with the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) pain and function subscales. Associations between hip pain and hip disability and the weather variables were assessed using crude and multivariate adjusted linear mixed-model analysis for repeated measurements. On the day of questionnaire completion, mean relative humidity was associated with WOMAC pain (estimate 0.1; 95% confidence interval=0.0-0.2; P=.02). Relative humidity contributed < or = 1% to the explained within-patient variance and between-patient variance of the WOMAC pain score. Mean barometric pressure was associated with WOMAC function (estimate 0.1; 95% confidence interval=0.0-0.1; P=.02). Barometric pressure contributed < or = 1% to the explained within-patient variance and between-patient variance of the WOMAC function score. The other weather variables were not associated with the WOMAC pain or function score. Our results support the general opinion of OA patients that barometric pressure and relative humidity influence perceived OA symptoms. However, the contribution of these weather variables (< or = 1%) to the severity of OA symptoms is not considered to be clinically relevant. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

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

    PubMed

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

    2014-12-01

    To investigate the perceived clinical outcome and parents' satisfaction after dental rehabilitation under general anesthesia over a follow-up period of 2 years. 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. 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. 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.

  20. 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

  1. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.

    PubMed

    Davidson, Andrew J; Disma, Nicola; de Graaff, Jurgen C; Withington, Davinia E; Dorris, Liam; Bell, Graham; Stargatt, Robyn; Bellinger, David C; Schuster, Tibor; Arnup, Sarah J; Hardy, Pollyanna; Hunt, Rodney W; Takagi, Michael J; Giribaldi, Gaia; Hartmann, Penelope L; Salvo, Ida; Morton, Neil S; von Ungern Sternberg, Britta S; Locatelli, Bruno Guido; Wilton, Niall; Lynn, Anne; Thomas, Joss J; Polaner, David; Bagshaw, Oliver; Szmuk, Peter; Absalom, Anthony R; Frawley, Geoff; Berde, Charles; Ormond, Gillian D; Marmor, Jacki; McCann, Mary Ellen

    2016-01-16

    Preclinical data suggest that general anaesthetics affect brain development. There is mixed evidence from cohort studies that young children exposed to anaesthesia can have an increased risk of poor neurodevelopmental outcome. We aimed to establish whether general anaesthesia in infancy has any effect on neurodevelopmental outcome. Here we report the secondary outcome of neurodevelopmental outcome at 2 years of age in the General Anaesthesia compared to Spinal anaesthesia (GAS) trial. In this international assessor-masked randomised controlled equivalence trial, we recruited infants younger than 60 weeks postmenstrual age, born at greater than 26 weeks' gestation, and who had inguinal herniorrhaphy, from 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand. Infants were randomly assigned (1:1) to receive either awake-regional anaesthesia or sevoflurane-based general anaesthesia. Web-based randomisation was done in blocks of two or four and stratified by site and gestational age at birth. Infants were excluded if they had existing risk factors for neurological injury. The primary outcome of the trial will be the Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III) Full Scale Intelligence Quotient score at age 5 years. The secondary outcome, reported here, is the composite cognitive score of the Bayley Scales of Infant and Toddler Development III, assessed at 2 years. The analysis was as per protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. This trial is registered with ANZCTR, number ACTRN12606000441516 and ClinicalTrials.gov, number NCT00756600. Between Feb 9, 2007, and Jan 31, 2013, 363 infants were randomly assigned to receive awake-regional anaesthesia and 359 to general anaesthesia. Outcome data were available for 238 children in the awake-regional group and 294 in the general anaesthesia group. In the

  2. Minimum 2-year outcomes and return to sport following resection arthroplasty for the treatment of sternoclavicular osteoarthritis.

    PubMed

    Katthagen, J Christoph; Tahal, Dimitri S; Menge, Travis J; Horan, Marilee P; Millett, Peter J

    2017-02-01

    The aim of this study was to assess the effect of open resection arthroplasty for osteoarthritis of the sternoclavicular (SC) joint on pain levels, functional outcomes, and return to sport. Patients from a single surgeon's practice who underwent open resection arthroplasty (maximum 10-mm resection) for SC osteoarthritis or prearthritic changes between November 2006 and November 2013 were retrospectively reviewed. This was an outcomes study with prospectively collected data. Preoperative and postoperative American Shoulder and Elbow Surgeons score, Quick Disabilities of the Arm, Shoulder, and Hand score, Single Assessment Numeric Evaluation score, several pain scores, and level of sport intensity were assessed. Seventeen SC joints in 16 patients (9 female, 7 male) met inclusion criteria. Mean age at time of surgery way 41.1 years (range, 12-66 years). One patient refused participation in the study. Three SC joint resections (17.7%) required SC joint revision surgery. Minimum 2-year outcomes data were available for 11 of the remaining 13 SC joints (84.6%). The mean time to follow-up was 3.3 years (range, 2.0-8.8 years). Pain at its worst (P = .026), pain at competition (P = .041), the Quick Disabilities of the Arm, Shoulder, and Hand score (P = .034), and the ability to sleep on the affected shoulder (P = .038) showed significant improvement postoperatively. The average postoperative American Shoulder and Elbow Surgeons score was 83.3. The level of sports participation (P = .042) as well as strength and endurance when participating in sport (P = .039) significantly increased postoperatively. Resection arthroplasty of the medial end of the clavicle in patients with osteoarthritis of the SC joint without instability results in pain reduction, functional improvement, and a high rate of return to sport at midterm follow-up. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  3. Clinical outcome measures of psoriasis.

    PubMed

    Bonifati, C; Berardesca, E

    2007-01-01

    Several tools have been introduced in clinical trials to quantify the severity and the response to a given therapeutic regimen of both psoriasis and psoriatic arthritis. Each method present specific advantages and limitations. Here we will discuss some of the most popular clinical outcome measures of both psoriasis (Psoriasis Severity Index, Physician Global Assessment, National Psoriasis Fundation-Psoriasis Score, Dermatology Life Quality Index) and psoriatic arthritis (American College Rheumatology response criteria, Psoriatic Arthritis Response Criteria).

  4. Impact of baseline anti-cyclic citrullinated peptide-2 antibody concentration on efficacy outcomes following treatment with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial

    PubMed Central

    Sokolove, Jeremy; Schiff, Michael; Fleischmann, Roy; Weinblatt, Michael E; Connolly, Sean E; Johnsen, Alyssa; Zhu, Jin; Maldonado, Michael A; Patel, Salil; Robinson, William H

    2016-01-01

    Objectives To examine whether baseline anti-cyclic citrullinated peptide-2 (CCP2) antibody status and concentration correlated with clinical outcomes in patients treated with abatacept or adalimumab on background methotrexate (MTX) in the 2-year AMPLE (Abatacept versus adaliMumab comParison in bioLogic-naïvE rheumatoid arthritis subjects with background MTX) study. Methods In this exploratory analysis, anti-CCP2 antibody concentration was measured at baseline, and antibody-positive patients were divided into equal quartiles, Q1–Q4, representing increasing antibody concentrations. Clinical outcomes analysed by baseline anti-CCP2 status and quartile included change from baseline in disease activity and disability and remission rates. Results Baseline characteristics were generally comparable across quartiles and treatment groups. In both treatment groups, anti-CCP2 antibody-negative patients responded less well than antibody-positive patients. At year 2, improvements in disease activity and disability and remission rates were similar across Q1–Q3, but were numerically higher in Q4 in the abatacept group; in contrast, treatment effects were similar across all quartiles in the adalimumab group. Conclusions In AMPLE, baseline anti-CCP2 positivity was associated with a better response for abatacept and adalimumab. Patients with the highest baseline anti-CCP2 antibody concentrations had better clinical response with abatacept than patients with lower concentrations, an association that was not observed with adalimumab. Trial registration number NCT00929864. PMID:26359449

  5. Clinical performance of a nanofilled resin composite with and without an intermediary layer of flowable composite: a 2-year evaluation.

    PubMed

    Stefanski, Sebastian; van Dijken, Jan W V

    2012-02-01

    The objective of this prospective clinical follow-up was to evaluate the 2-year clinical performance of a nanofilled resin composite in class II restorations. The restorations were made with and without intermediary layer of a nanofilled flowable resin composite studied in an intraindividual comparison. Each participant received at least two, as similar as possible, class II restorations of the nanofilled resin composite. One restoration of each pair (54) was chosen at random to be restored with an intermediary layer with flowable nanofilled resin composite. The other was restored without. The restorations were evaluated with slightly modified US Public Health Services criteria at baseline, 1, and 2 years. Ninety-two restorations, 46 pairs, were evaluated at 2 years. A prediction of the caries risk showed that 22 of the evaluated 48 patients were considered as high-risk patients. Two failures were observed, one in each group, resulting in a 2.2% failure rate. No statistical difference was seen between the restorations restored with and without layer of flowable resin composite. The nanofilled resin composite showed very good surface characteristics and color match, which did not change significantly during the follow-up period. The nanofilled resin composite showed a good clinical performance with a 2.2% failure rate after 2 years. No differences were observed between the restorations with and without the nanofilled flowable resin intermediary layer.

  6. The 'straight to test' initiative reduces both diagnostic and treatment waiting times for colorectal cancer: outcomes after 2 years.

    PubMed

    Mukherjee, S; Fountain, G; Stalker, M; Williams, J; Porrett, T R C; Lunniss, P J

    2010-10-01

    This study aimed to determine whether a 'straight to test'(STT) strategy for 2-week wait (2 wk) referrals for suspected colorectal cancer (CRC) reduced the time to diagnosis and treatment for patients with CRC. Consecutive 2-week referrals for suspected CRC over a period of 2 years from February 2007 were analysed. The times to the first diagnostic test and treatment and the cancers identified were analysed for those going to STT or the outpatient clinic. Of 662 patients having a 2 wk referral, 519 (78.4%) were suitable for the hospital colorectal telephone triage service, 121 (18.3%) patients went to STT and 502 (75.8%) were seen in the clinic. Of these 401 (79.8%) underwent diagnostic tests and 25 (6.2%) had CRC and in 12 (2.9%) patients other cancers were detected. In the STT group, 7 (5.8%) patients were diagnosed with CRC. The median time to first diagnostic test was 12 days (IQR 9-13) in the STT pathway, compared with 23 days (17-31) in those seen in the clinic (P < 0.0001). The median time to first treatment was 40 (32-48) days for those via STT, compared to 46 (28-55) days for those seen in the clinic (P = 0.004). A total of 162 CRC were diagnosed during the study period of whom 34 (20.9%) were 2 wk referrals (5.1% of all suspected CRC 2 wk referrals), and 14 (2.1%) other cancers were detected via this pathway. STT speeds up the patient pathway by reducing the time to diagnosis and treatment for patients with CRC. © 2010 The Authors. Colorectal Disease © 2010 The Association of Coloproctology of Great Britain and Ireland.

  7. Clinical effectiveness of a one-step self-etch adhesive in non-carious cervical lesions at 2 years.

    PubMed

    Ermis, R Banu; Van Landuyt, Kirsten L; Cardoso, Marcio Vivan; De Munck, Jan; Van Meerbeek, Bart; Peumans, Marleen

    2012-06-01

    A 2-year randomized, controlled prospective study evaluated the clinical effectiveness of a one-step self-etch adhesive and a "gold-standard" three-step etch-and-rinse adhesive in non-carious Class-V lesions. The null hypothesis tested was that the one-step self-etch adhesive does perform clinically equally well as the three-step etch-and-rinse adhesive. A total of 161 lesions in 26 patients were restored with Clearfil AP-X (Kuraray). The restorations were bonded either with the "all-in-one" adhesive Clearfil S3 Bond (Kuraray) or with the three-step etch-and-rinse adhesive Optibond FL (Kerr). The restorations were evaluated at baseline and after 6 months, 1 and 2 years, regarding their retention, marginal adapation, marginal discoloration, caries occurrence, preservation of tooth vitality and post-operative sensivity. Retention loss, severe marginal defects and/or discoloration that needed intervention (repair or replacement) and the occurrence of caries were considered as clinical failures. The recall rate at 2 years was 93.8%. Only one Clearfil S3 Bond restoration was lost at the 2-year recall. All other restorations were clinically acceptable. The number of restorations with defect-free margins decreased severely during the 2-year study period (to 6.7% and 25.3% for Clearfil S3 Bond and Optibond FL, respectively). The Clearfil S3 Bond restorations presented significantly more small marginal defects at the enamel side than the Optibond FL restorations (Clearfil S3 Bond: 93.3%; Optibond FL: 73.3%; p = 0.000). Superficial marginal discoloration increased in both groups (to 53.3% and 36% for Clearfil S3 Bond and Optibond FL, respectively) and was also more pronounced in the Clearfil S3 Bond group (p = 0.007). After 2 years, the simplified one-step self-etch adhesive Clearfil S3 Bond and the three-step etch-and-rinse adhesive Optibond FL were clinically equally successful, even though both adhesives were characterized by progressive degradation in marginal

  8. Evaluation of patient-reported outcomes data in structured diabetes education intervention: 2-year follow-up data of patient empowerment programme.

    PubMed

    Wong, Carlos K H; Lam, Cindy L K; Wan, Eric Y F; Chan, Anca K C; Pak, C H; Chan, Frank W K; Wong, William C W

    2016-11-01

    To examine the effects of a structured group-based education programme, patient empowerment programme (PEP), compared with usual care on 2-year changes in patient-reported outcomes (PRO) in patients with diabetes mellitus (DM). A prospective observational study of 715 patients (PEP/non-PEP: 390/325) was conducted to complete the baseline PRO survey and followed up for 2 years. Health-related quality of life (HRQOL) was measured using the short-form 12 at baseline and annually at two follow-up assessments, which yielded physical and mental component summary and SF-6D preference-based scores. Perceived control over diabetes and general health status were measured using the patient enablement instrument (PEI) and global rating scale (GRS) at follow-ups. When compared with non-PEP, PEP participants significantly reported improvement in health condition (GRS score > 0; 24.55 % vs 10.16 %; odds ratio = 2.502; P = 0.018) in 2 years and enabled the self-perceived control over diabetes (PEI score > 0; 72.20 % vs 38.40 %; odds ratio = 3.25; P < 0.001) in 1-year follow-up but no sustained effects in year 2 (52.65 % vs 39.04 %; odds ratio = 1.366; P = 0.265). There were no significant differences between PEP and non-PEP groups in the changes in quality of life scores (all P > 0.05) at 1 year. Although HRQOL scores deteriorated over 2-year period in both groups, PEP participants reported similar changes in HRQOL scores to that of non-PEP. PEP for DM patients preserved self-perceived disease control and health condition, whereas PEP participants perceived their HRQOL similar to that of non-PEP participants. Findings of PRO should be considered alongside clinical outcomes when evaluating the overall benefits of PEP.

  9. Abnormal sensory reactivity in preterm infants during the first year correlates with adverse neurodevelopmental outcomes at 2 years of age.

    PubMed

    Chorna, Olena; Solomon, Jessica E; Slaughter, James C; Stark, Ann R; Maitre, Nathalie L

    2014-11-01

    Sensory experience is the basis for learning in infancy. In older children, abnormal sensory reactivity is associated with behavioural and developmental disorders. We hypothesised that in preterm infants, abnormal sensory reactivity during infancy would be associated with perinatal characteristics and correlate with 2-year neurodevelopmental outcomes. We conducted a prospective observational study of infants with birth weight ≤1500 g using the Test of Sensory Function in Infants (TSFI) in the first year. Infants with gestational age ≤30 weeks were tested with the Bayley Scales of Infant and Toddler Development III (BSID III) at 24 months. Of the 72 participants evaluated at 4-12 months corrected age (median 8 months), 59 (82%) had a least one TSFI score concerning for abnormal sensory reactivity. Lower gestational age was associated with abnormal reactivity to deep pressure and vestibular stimulation (p<0.001). Poor ocular-motor control predicted worse cognitive and motor scores in early childhood (OR 16.7; p=0.004), but was tightly correlated to the presence of severe white matter injury. Poor adaptive motor function in response to tactile stimuli predicted worse BSID III motor (p=0.01) and language scores (p=0.04) at 2 years, even after adjusting for confounders. Abnormal sensory reactivity is common in preterm infants; is associated with immaturity at birth, severe white matter injury and lower primary caregiver education; and predicts neurodevelopmental delays. Early identification of abnormal sensory reactivity of very preterm infants may promote parental support and education and may facilitate improved neurodevelopment. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  10. CAD/CAM Zirconia vs. slip-cast glass-infiltrated Alumina/Zirconia all-ceramic crowns: 2-year results of a randomized controlled clinical trial.

    PubMed

    Cehreli, Murat Cavit; Kökat, Ali Murat; Akça, Kivanç

    2009-01-01

    The aim of this randomized controlled clinical trial was to compare the early clinical outcome of slip-cast glass-infiltrated Alumina/Zirconia and CAD/CAM Zirconia all-ceramic crowns. A total of 30 InCeram Zirconia and Cercon Zirconia crowns were fabricated and cemented with a glass ionomer cement in 20 patients. At baseline, 6-month, 1-year, and 2-year recall appointments, Californian Dental Association (CDA) quality evaluation system was used to evaluate the prosthetic replacements, and plaque and gingival index scores were used to explore the periodontal outcome of the treatments. No clinical sign of marginal discoloration, persistent pain and secondary caries was detected in any of the restorations. All InCeram Zirconia crowns survived during the 2-year period, although one nonvital tooth experienced root fracture coupled with the fracture of the veneering porcelain of the restoration. One Cercon Zirconia restoration fractured and was replaced. According to the CDA criteria, marginal integrity was rated excellent for InCeram Zirconia (73%) and Cercon Zirconia (80%) restorations, respectively. Slight color mismatch rate was higher for InCeram Zirconia restorations (66%) than Cercon Zirconia (26%) restorations. Plaque and gingival index scores were mostly zero and almost constant over time. Time-dependent changes in plaque and gingival index scores within and between groups were statistically similar (p>0.05). This clinical study demonstrates that single-tooth InCeram Zirconia and Cercon Zirconia crowns have comparable early clinical outcome, both seem as acceptable treatment modalities, and most importantly, all-ceramic alumina crowns strengthened by 25% zirconia can sufficiently withstand functional load in the posterior zone.

  11. CAD/CAM ZIRCONIA VS. SLIP-CAST GLASS-INFILTRATED ALUMINA/ZIRCONIA ALL-CERAMIC CROWNS: 2-YEAR RESULTS OF A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Çehreli, Murat Cavit; Kökat, Ali Murat; Akça, Kivanç

    2009-01-01

    The aim of this randomized controlled clinical trial was to compare the early clinical outcome of slip-cast glass-infiltrated Alumina/Zirconia and CAD/CAM Zirconia all-ceramic crowns. A total of 30 InCeram® Zirconia and Cercon® Zirconia crowns were fabricated and cemented with a glass ionomer cement in 20 patients. At baseline, 6-month, 1-year, and 2-year recall appointments, Californian Dental Association (CDA) quality evaluation system was used to evaluate the prosthetic replacements, and plaque and gingival index scores were used to explore the periodontal outcome of the treatments. No clinical sign of marginal discoloration, persistent pain and secondary caries was detected in any of the restorations. All InCeram® Zirconia crowns survived during the 2-year period, although one nonvital tooth experienced root fracture coupled with the fracture of the veneering porcelain of the restoration. One Cercon® Zirconia restoration fractured and was replaced. According to the CDA criteria, marginal integrity was rated excellent for InCeram® Zirconia (73%) and Cercon® Zirconia (80%) restorations, respectively. Slight color mismatch rate was higher for InCeram® Zirconia restorations (66%) than Cercon® Zirconia (26%) restorations. Plaque and gingival index scores were mostly zero and almost constant over time. Time-dependent changes in plaque and gingival index scores within and between groups were statistically similar (p>0.05). This clinical study demonstrates that single-tooth InCeram® Zirconia and Cercon® Zirconia crowns have comparable early clinical outcome, both seem as acceptable treatment modalities, and most importantly, all-ceramic alumina crowns strengthened by 25% zirconia can sufficiently withstand functional load in the posterior zone. PMID:19148406

  12. [Recanalization of the peripheral arteries by laser thermal balloon angioplasty. 2 years of clinical experience].

    PubMed

    Riambau Alonso, V; Masotti Centol, M; Latorre Vilallonga, J; Viver Manresa, E; Crexells Figueres, C; Oriol Palou, A

    1991-01-01

    Laser angioplasty represents an attractive alternative to overcome the limitations of balloon angioplasty. We describe our results with laser thermal balloon angioplasty (LTBA) in the treatment of atherosclerosis obliterans in the lower limbs after two years clinical follow up. We also analyse the influence of lesion characteristics on immediate results. Thirty seven patients (34 men), whose mean age was 58 +/- 9 years, were included in this study. Occlusive arterial disease (Fontaine stage II-IV), with 39 significant haemodynamic arterial lesions were present in all of them. Ankle/brachial Doppler index was O,51 +/- 0,17. Eighteen lesions were located in the iliac area (13 stenoses 2,3 +/- 1 cm of length and 5 occlusions 4,2 +/- 3 cm) and 21 lesions in femoro-popliteal area (5 stenoses 2,6 +/- 2 cm and 16 occlusions 5,7 +/- 3 cm). A percutaneous procedure was used in 38 cases and only in one case a femoral dissection was necessary. The laser source was argon in 26 cases and Nd-YAG in 13. The overall immediate angiographic and clinical success was 85% (89% in iliac lesions and 81% in femoropopliteal lesions; 100% in stenoses and 70% in occlusions). The presence of occlusion (p less than 0,01) and/or calcium (p less than O,05) influenced negatively the immediate results. No major complications were observed. Seven (17%) minor complications occurred, but no emergency surgery was necessary. The ankle/brachial Doppler index after treatment was 0,82 +/- 0,21. Cumulative clinical patency was 91% for successfully treated patients after two years follow up. We conclude that LTBA represents an effective and less aggressive way to treat atherosclerosis obliterans.(ABSTRACT TRUNCATED AT 250 WORDS)

  13. Change in Diabetic Retinopathy Through 2 Years: Secondary Analysis of a Randomized Clinical Trial Comparing Aflibercept, Bevacizumab, and Ranibizumab.

    PubMed

    Bressler, Susan B; Liu, Danni; Glassman, Adam R; Blodi, Barbara A; Castellarin, Alessandro A; Jampol, Lee M; Kaufman, Paul L; Melia, Michele; Singh, Harinderjit; Wells, John A

    2017-06-01

    Anti-vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME) favorably affects diabetic retinopathy (DR) improvement and worsening. It is unknown whether these effects differ across anti-VEGF agents. To compare changes in DR severity during aflibercept, bevacizumab, or ranibizumab treatment for DME. Preplanned secondary analysis of data from a comparative effectiveness trial for center-involved DME was conducted in 650 participants receiving aflibercept, bevacizumab, or ranibizumab. Retinopathy improvement and worsening were determined during 2 years of treatment. Participants were randomized in 2012 through 2013, and the trial concluded on September 23, 2015. Random assignment to aflibercept, 2.0 mg; bevacizumab, 1.25 mg; ranibizumab, 0.3 mg, up to every 4 weeks through 2 years following a retreatment protocol. Percentages with retinopathy improvement at 1 and 2 years and cumulative probabilities for retinopathy worsening through 2-year without adjustment for multiple outcomes. A total of 650 participants (495 [76.2%] nonproliferative DR [NPDR], 155 proliferative DR [PDR]) were analyzed; 302 (46.5%) were women and mean (SD) age was 61 (10) years; 425 (65.4%) were white. At 1 year, among 423 NPDR eyes, 44 of 141 (31.2%) treated with aflibercept, 29 of 131 (22.1%) with bevacizumab, and 57 of 151 (37.7%) with ranibizumab had improvement of DR severity (adjusted difference: 11.7%; 95% CI, 2.9% to 20.6%; P = .004 for aflibercept vs bevacizumab; 8.9%; 95% CI, 1.7% to 16.1%; P = .01 for ranibizumab vs bevacizumab; and 2.9%; 95% CI, -5.7% to 11.4%; P = .51 for aflibercept vs ranibizumab). At 2 years, 33 eyes (24.8%) in the aflibercept group, 25 eyes (22.1%) in the bevacizumab group, and 40 eyes (31.0%) in the ranibizumab group had DR improvement; no treatment group differences were identified. For 93 eyes with PDR at baseline, 1-year improvement rates were 75.9% for aflibercept, 31.4% for bevacizumab, and 55.2% for ranibizumab

  14. Comparison between visual clinical examination and the replica method for assessments of sealant retention over a 2-year period.

    PubMed

    Hu, Xuan; Chen, Xi; Ye, Lu; Fan, Ming-Wen; Huysmans, Marie-Charlotte; Frencken, Jo E

    2014-06-01

    To compare the levels of agreement and the survival rates of sealant retention for different sealing materials over a 2-year period assessed using the visual clinical examination and replica methods, sealant retention data were obtained by visual clinical examination and from replicas of the same sealed tooth at baseline and at 0.5-, 1- and 2-year evaluation points in 407 children and were compared for agreement using kappa coefficients. Survival curves of retained sealants on occlusal surfaces were created using modified categorisation (fully retained sealants and those having all pits and fissures partly covered with the sealant material versus completely lost sealants that included pit and fissure systems that had ≥1 pit re-exposed) according to the Kaplan-Meier method. The kappa coefficient for the agreement between both assessment methods over the three evaluation time points combined was 0.38 (95% confidence interval (CI): 0.35-0.41). More sealant retention was observed from replicas than through visual clinical examination. Cumulative survival curves at the three evaluation times were not statistically significantly higher when assessed from replicas (P=0.47). Using the replica method, more retained sealant material was observed than through visual clinical examination during the 2-year period. This finding did not result in a difference in the survival rates of sealants assessed by the two assessment methods. When replicas cast in die stone are used for assessing sealant retention, the level of reliability of the data is higher than that of data obtained through the commonly used visual clinical examination, particularly if such assessments are conducted over time.

  15. Transforaminal lumbar interbody fusion (TLIF) versus posterolateral instrumented fusion (PLF) in degenerative lumbar disorders: a randomized clinical trial with 2-year follow-up.

    PubMed

    Høy, Kristian; Bünger, Cody; Niederman, Bent; Helmig, Peter; Hansen, Ebbe Stender; Li, Haisheng; Andersen, Thomas

    2013-09-01

    The aim of the present study was to analyze outcome, with respect to functional disability, pain, fusion rate, and complications of patients treated with transforaminal lumbar interbody fusion (TLIF) in compared to instrumented poserolateral fusion (PLF) alone, in low back pain. Spinal fusion has become a major procedure worldwide. However, conflicting results exist. Theoretical circumferential fusion could improve functional outcome. However, the theoretical advantages lack scientific documentation. Prospective randomized clinical study with a 2-year follow-up period. From November 2003 to November 2008 100 patients with severe low back pain and radicular pain were randomly selected for either posterolateral lumbar fusion [titanium TSRH (Medtronic)] or transforaminal lumbar interbody fusion [titanium TSRH (Medtronic)] with anterior intervertebral support by tantalum cage (Implex/Zimmer). The primary outcome scores were obtained using Dallas Pain Questionnaire (DPQ), Oswestry disability Index, SF-36, and low back pain Rating Scale. All measures assessed the endpoints at 2-year follow-up after surgery. The overall follow-up rate was 94 %. Sex ratio was 40/58. 51 patients had TLIF, 47 PLF. Mean age 49(TLIF)/45(PLF). No statistic difference in outcome between groups could be detected concerning daily activity, work leisure, anxiety/depression or social interest. We found no statistic difference concerning back pain or leg pain. In both the TLIF and the PLF groups the patients had significant improvement in functional outcome, back pain, and leg pain compared to preoperatively. Operation time and blood loss in the TLIF group were significantly higher than in the PLF group (p < 0.001). No statistic difference in fusion rates was detected. Transforaminal interbody fusion did not improve functional outcome in patients compared to posterolateral fusion. Both groups improved significantly in all categories compared to preoperatively. Operation time and blood loss were

  16. Ultrasonographic predictors for clinical and radiological progression in knee osteoarthritis after 2 years of follow-up.

    PubMed

    Bevers, Karen; Vriezekolk, Johanna E; Bijlsma, Johannes W J; van den Ende, Cornelia H M; den Broeder, Alfons A

    2015-11-01

    The aim of this study was to investigate the association between a set of US features and radiographic and clinical progression of knee OA after 2 years of follow-up. A total of 125 patients fulfilling ACR clinical criteria for knee OA underwent US examination of the most symptomatic knee. The US protocol included assessment of synovial hypertrophy, joint effusion, infrapatellar bursitis, Baker's cyst, medial meniscus protrusion and cartilage thickness. Clinical progression was defined using the inverse Osteoarthritis Research Society International responder criteria or progression to total knee replacement. Radiological progression was defined as a ≥2 point increase in Altman score or progression to total knee replacement. Regression analyses were performed with baseline ultrasonographic features as independent variables and progression (two separate models for clinical progression and radiographic progression) as the dependent variable. A total of 31 (25%) patients fulfilled the criteria of clinical progression and 60 (48%) patients fulfilled the criteria of radiological progression. The presence of Baker's cyst showed a statistically significant association with clinical [odds ratio (OR) 3.07 (95% CI 1.21, 7.78)] as well as radiological [OR 2.84 (95% CI 1.17, 6.90)] progression. Synovial hypertrophy showed a weaker but consistent association with clinical as well as radiological progression [OR 2.11 (95% CI 0.80, 5.57)]. We demonstrated a longitudinal association between Baker's cyst (and to a lesser extent synovial hypertrophy) at baseline and radiological and clinical progression after 2 years. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  17. Early MRI in term infants with perinatal hypoxic-ischaemic brain injury: interobserver agreement and MRI predictors of outcome at 2 years.

    PubMed

    Goergen, S K; Ang, H; Wong, F; Carse, E A; Charlton, M; Evans, R; Whiteley, G; Clark, J; Shipp, D; Jolley, D; Paul, E; Cheong, J L Y

    2014-01-01

    To compare diffusion-weighted imaging (DWI) and non-DWI magnetic resonance imaging (MRI), proton MR spectroscopy (1H-MRS), and clinical biomarkers for prediction of 2 year developmental outcome in term infants with perinatal hypoxic-ischaemic encephalopathy (HIE). Nineteen infants ≥36 weeks gestation with HIE were recruited and MRI performed day 3-7 (mean = 5). MRI was scored independently by three radiologists using a standardized scoring system. Lactate-to-N-acetylaspartate ratio (Lac:NAA) in the lentiform nucleus was calculated. Developmental assessment was performed at 2 years using the Bayley Scales of Infant and Toddler Development (BSID-III). Interobserver agreement about abnormality in 10 brain regions was measured. Univariate analysis was performed to determine variables associated with adverse outcome (i.e., death or Bayley score for any domain <70). Good interobserver agreement (kappa = 0.61-0.69) on scores for DWI was obtained for the cortex, putamen, and brainstem, but not for any region on non-DWI. A significant association was found between outcome and Lac:NAA (p < 0.003) and DWI scores for lentiform nucleus, thalamus, cortex, posterior limb of the internal capsule (PLIC), and paracentral white matter (p = 0.001-0.013), but for non-DWI score only in the vermis or brainstem. A combination of Lac:NAA ≥0.25 or DWI/apparent diffusion coefficient (ADC) signal abnormality in the PLIC had 100% specificity and sensitivity for poor outcome. Interobserver agreement for non-DWI performed during the first week is poor. Agreement by three radiologists about the presence of abnormal signal within the PLIC on ADC/DWI images or elevation of Lac:NAA above 0.25 improved sensitivity without reducing the prognostic specificity of MRS in the 19 patients, but this requires validation in a larger group of infants with HIE who have been treated with hypothermia. Copyright © 2013 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

  18. Time to remission for eating disorder patients: a 2(1/2)-year follow-up study of outcome and predictors.

    PubMed

    Clausen, Loa

    2008-01-01

    The aim of the present study was to analyse outcome, time to remission, and predictors of time to remission in a cohort of Danish eating disorder patients. Seventy-eight patients (35 anorexic, 30 bulimic and 13 unspecified eating disorder patients) were interviewed 2(1/2) years after initial assessment. Method of assessment was Eating Disorder Examination (EDE), Longitudinal Interval Follow-up Evaluation of Eating Disorders (LIFE-EAT-II), Eating Disorder Inventory (EDI), Symptom Check List (SCL-90R), Present State Examination (PSE) and the Structured Clinical Interview for DSM-III-R Axis-II (SCID-II). Method of analysis was Kaplan-Meier estimate of survival, Log Rank test and Cox regression analysis. In total 48.7% reached remission with mean time to remission at 27 months. A trend difference between the diagnostic groups when measuring time to remission was found, i.e. patients with unspecified eating disorders remitted faster than bulimic (BN) patients who in turn remitted faster than anorexic (AN) patients. Body mass index (BMI) at baseline was the best predictor of time to remission for the total sample. Predictors differed when looking at diagnostic groups separately. Final outcome was comparable with earlier studies while relapse frequency was low. Patients with AN remitted faster than found in earlier survival analysis studies, while the remission rate for BN patients was comparable with earlier studies. Despite the prognostic value of BMI for the total sample, predictor analysis implied more disorder diversity than homogeneity.

  19. Impact of baseline anti-cyclic citrullinated peptide-2 antibody concentration on efficacy outcomes following treatment with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial.

    PubMed

    Sokolove, Jeremy; Schiff, Michael; Fleischmann, Roy; Weinblatt, Michael E; Connolly, Sean E; Johnsen, Alyssa; Zhu, Jin; Maldonado, Michael A; Patel, Salil; Robinson, William H

    2016-04-01

    To examine whether baseline anti-cyclic citrullinated peptide-2 (CCP2) antibody status and concentration correlated with clinical outcomes in patients treated with abatacept or adalimumab on background methotrexate (MTX) in the 2-year AMPLE (Abatacept versus adaliMumab comParison in bioLogic-naïvE rheumatoid arthritis subjects with background MTX) study. In this exploratory analysis, anti-CCP2 antibody concentration was measured at baseline, and antibody-positive patients were divided into equal quartiles, Q1-Q4, representing increasing antibody concentrations. Clinical outcomes analysed by baseline anti-CCP2 status and quartile included change from baseline in disease activity and disability and remission rates. Baseline characteristics were generally comparable across quartiles and treatment groups. In both treatment groups, anti-CCP2 antibody-negative patients responded less well than antibody-positive patients. At year 2, improvements in disease activity and disability and remission rates were similar across Q1-Q3, but were numerically higher in Q4 in the abatacept group; in contrast, treatment effects were similar across all quartiles in the adalimumab group. In AMPLE, baseline anti-CCP2 positivity was associated with a better response for abatacept and adalimumab. Patients with the highest baseline anti-CCP2 antibody concentrations had better clinical response with abatacept than patients with lower concentrations, an association that was not observed with adalimumab. NCT00929864. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  20. Implementation of a rapid learning platform: Predicting 2-year survival in laryngeal carcinoma patients in a clinical setting

    PubMed Central

    Lustberg, Tim; Bailey, Michael; Thwaites, David I.; Miller, Alexis; Carolan, Martin; Holloway, Lois; Velazquez, Emmanuel Rios; Hoebers, Frank; Dekker, Andre

    2016-01-01

    Background and Purpose To improve quality and personalization of oncology health care, decision aid tools are needed to advise physicians and patients. The aim of this work is to demonstrate the clinical relevance of a survival prediction model as a first step to multi institutional rapid learning and compare this to a clinical trial dataset. Materials and Methods Data extraction and mining tools were used to collect uncurated input parameters from Illawarra Cancer Care Centre's (clinical cohort) oncology information system. Prognosis categories previously established from the Maastricht Radiation Oncology (training cohort) dataset, were applied to the clinical cohort and the radiotherapy only arm of the RTOG-9111 (trial cohort). Results Data mining identified 125 laryngeal carcinoma patients, ending up with 52 patients in the clinical cohort who were eligible to be evaluated by the model to predict 2-year survival and 177 for the trial cohort. The model was able to classify patients and predict survival in the clinical cohort, but for the trial cohort it failed to do so. Conclusions The technical infrastructure and model is able to support the prognosis prediction of laryngeal carcinoma patients in a clinical cohort. The model does not perform well for the highly selective patient population in the trial cohort. PMID:27095578

  1. Randomized Clinical Trial of a Self-Adhering Flowable Composite for Class I Restorations: 2-Year Results

    PubMed Central

    Dagher, S.; El Osta, N.; Souhaid, P.

    2017-01-01

    Objectives. To compare the clinical performances of a self-adhering resin composite and a conventional flowable composite with a self-etch bonding system on permanent molars. The influence of using rubber dam versus cotton roll isolation was also investigated. Materials and Methods. Patients aged between 6 and 12 years and presenting at least two permanent molars in need of small class I restorations were selected. Thirty-four pairs of restorations were randomly placed by the same operator. Fifteen patients were treated under rubber dam and nineteen using cotton rolls isolation and saliva ejector. They were evaluated according to the modified USPHS criteria at baseline, 6 months, and 1 and 2 years by two independent evaluators. Results. All patients attended the two-year recall. For all measured variables, there was no significant difference between rubber dam and cotton after 2 years of restoration with Premise Flowable or Vertise Flow (p value > 0.05). The percentage of restorations scored alpha decreased significantly over time with Premise Flowable and Vertise Flow for marginal adaptation and surface texture as well as marginal discoloration while it did not vary significantly for color matching. After 2 years, Vertise Flow showed a similar behaviour to the Premise Flowable used with a self-adhesive resin system. PMID:28348594

  2. Health-Related Quality of Life 2 Years After Treatment With Radical Prostatectomy, Prostate Brachytherapy, or External Beam Radiotherapy in Patients With Clinically Localized Prostate Cancer

    SciTech Connect

    Ferrer, Montserrat Suarez, Jose Francisco; Guedea, Ferran; Fernandez, Pablo; Macias, Victor; Marino, Alfonso; Hervas, Asuncion; Herruzo, Ismael; Ortiz, Maria Jose; Villavicencio, Humberto; Craven-Bratle, Jordi; Garin, Olatz; Aguilo, Ferran

    2008-10-01

    Purpose: To compare treatment impact on health-related quality of life (HRQL) in patients with localized prostate cancer, from before treatment to 2 years after the intervention. Methods and Materials: This was a longitudinal, prospective study of 614 patients with localized prostate cancer treated with radical prostatectomy (134), three-dimensional external conformal radiotherapy (205), and brachytherapy (275). The HRQL questionnaires administered before and after treatment (months 1, 3, 6, 12, and 24) were the Medical Outcomes Study 36-Item Short Form, the Functional Assessment of Cancer Therapy (General and Prostate Specific), the Expanded Prostate Cancer Index Composite (EPIC), and the American Urological Association Symptom Index. Differences between groups were tested by analysis of variance and within-group changes by univariate repeated-measures analysis of variance. Generalized estimating equations (GEE) models were constructed to assess between-group differences in HRQL at 2 years of follow-up after adjusting for clinical variables. Results: In each treatment group, HRQL initially deteriorated after treatment with subsequent partial recovery. However, some dimension scores were still significantly lower after 2 years of treatment. The GEE models showed that, compared with the brachytherapy group, radical prostatectomy patients had worse EPIC sexual summary and urinary incontinence scores (-20.4 and -14.1; p < 0.001), and external radiotherapy patients had worse EPIC bowel, sexual, and hormonal summary scores (-3.55, -5.24, and -1.94; p < 0.05). Prostatectomy patients had significantly better EPIC urinary irritation scores than brachytherapy patients (+4.16; p < 0.001). Conclusions: Relevant differences between treatment groups persisted after 2 years of follow-up. Radical prostatectomy had a considerable negative effect on sexual functioning and urinary continence. Three-dimensional conformal radiotherapy had a moderate negative impact on bowel

  3. Vertebral Derotation by Vertebral Column Manipulator Improves Postoperative Radiographs Outcomes of Lenke 5C Patients for Follow-up of Minimum 2 Years.

    PubMed

    Huang, Zifang; Wang, Qifei; Yang, Junlin; Yang, Jingfan; Li, Fobao

    2016-04-01

    This was a retrospective study. The aim of this study was to compare radiographic outcomes of Lenke 5C adolescent idiopathic scoliosis (AIS) patients treated by vertebral column manipulator (VCM) or simple rod derotation (SRD) maneuver. The direct vertebral rotation (DVR) technique has demonstrated better rotational and coronal correction than SRD, but clinical radiographic outcomes for Lenke 5C AIS following DVR using a VCM derotational device have not been described. A retrospective study was carried out in 39 Lenke 5C AIS patients treated by VCM (n=20) or SRD (n=19) techniques between April 2008 and June 2011. All patients had complete clinical record and radiographic data. Nine radiographic variables were collected and compared at 3 time points (preoperative, immediate postoperative, and minimum 2-year follow-up) between both groups. Scoliosis was successfully corrected in both groups. All patients obtained good coronal and sagittal balance, and no severe complications occurred. The postoperative apical rotation corrective rate of the VCM and SRD groups were 55.1% and 25.5%, respectively (P < 0.05). Lowest instrumented vertebra and stable vertebra (LIV-SV) was statistically significant between the VCM and SRD groups, the mean values were 1.2 ± 0.4 level and 0.7 ± 0.5 level (P < 0.05). The main curve corrective rates and LIV-tilt angle correction rates were not significantly different between groups, but it showed a spontaneous correction for the coronal LIV-tilt angle for both groups at the last follow-up. VCM improved postoperative apical axial rotational correction and lessened the lumbar fusion segment compared with the SRD technique, which might have a potential trend to reserve lumbar mobility.

  4. Latino Adolescents' Experiences of Discrimination across the First 2 Years of High School: Correlates and Influences on Educational Outcomes

    ERIC Educational Resources Information Center

    Benner, Aprile D.; Graham, Sandra

    2011-01-01

    Changes in perceptions of discrimination were examined with 668 Latino students (62% Mexican American; 56% female; M[subscript age] = 14.6 years). Adolescents' reports of discrimination increased across the first 2 years of high school. Perceptions of discrimination were higher for boys and for primary language brokers, as well as for adolescents…

  5. Latino Adolescents' Experiences of Discrimination across the First 2 Years of High School: Correlates and Influences on Educational Outcomes

    ERIC Educational Resources Information Center

    Benner, Aprile D.; Graham, Sandra

    2011-01-01

    Changes in perceptions of discrimination were examined with 668 Latino students (62% Mexican American; 56% female; M[subscript age] = 14.6 years). Adolescents' reports of discrimination increased across the first 2 years of high school. Perceptions of discrimination were higher for boys and for primary language brokers, as well as for adolescents…

  6. Couple and individual adjustment for 2 years following a randomized clinical trial comparing traditional versus integrative behavioral couple therapy.

    PubMed

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

    2006-12-01

    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 IBCT couples and 60% of TBCT couples). Both treatments showed a "hockey-stick" pattern of change in which satisfaction dropped immediately after treatment termination but then increased for most of follow-up. The break point when couples reversed courses and gained in satisfaction occurred sooner for IBCT than TBCT couples, and those couples who stayed together generally fared better in IBCT than in TBCT. Finally, there was evidence of greater stability during follow-up in IBCT than in TBCT couples. There was little change in individual functioning over follow-up, but when change occurred it was strongly related to change in marital satisfaction. Given that this sample was selected for its significant and chronic distress, the data are encouraging about the long-term impact of behavioral couple therapy. ((c) 2006 APA, all rights reserved).

  7. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial.

    PubMed

    Tandjung, Kenneth; Sen, Hanim; Lam, Ming Kai; Basalus, Mounir W Z; Louwerenburg, J Hans W; Stoel, Martin G; van Houwelingen, K Gert; de Man, Frits H A F; Linssen, Gerard C M; Saïd, Salah A M; Nienhuis, Mark B; Löwik, Marije M; Verhorst, Patrick M J; van der Palen, Job; von Birgelen, Clemens

    2013-06-18

    The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months. Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents. The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694). Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00). After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650). Copyright © 2013 American College of Cardiology Foundation

  8. Digital workflow in full-arch implant rehabilitation with segmented minimally veneered monolithic zirconia fixed dental prostheses: 2-year clinical follow-up.

    PubMed

    Papaspyridakos, Panos; Kang, Kiho; DeFuria, Catherine; Amin, Sarah; Kudara, Yukio; Weber, Hans-Peter

    2017-08-09

    To illustrate a digital workflow in full-arch implant rehabilitation with minimally veneered monolithic zirconia and to report the outcomes including technical complications. Three patients (5 edentulous arches) received full-arch fixed implant rehabilitation with monolithic zirconia and mild facial porcelain veneering involving a digital workflow. The incisal edges and occluding surface areas were milled out of monolithic zirconia to reduce the possibility of chipping. Porcelain veneering was applied on the facial aspect to improve the esthetic result. Outcomes and technical complications are reported after 2 years of clinical and radiographic follow-up. Implant and prosthesis survival rates were 100% after a short-term follow-up of 2 years. Technical complications were encountered in one patient. They did not adversely affect prosthesis survival or patient satisfaction and were easily addressed. A digital workflow for the design and fabrication of full-arch monolithic zirconia implant fixed implant prostheses has benefits, but caution is necessary during CAD planning of the prosthesis to ensure a successful outcome. Long-term clinical studies are needed to corroborate the findings discussed in this report. This article presents an integrated digital workflow that was implemented for the implant-prosthodontic rehabilitation of three edentulous patients with monolithic zirconia prostheses. Monolithic zirconia has been successfully incorporated in implant prosthodontics in an effort to reduce the technical complications associated with bilayered ceramics. This workflow simplifies design and fabrication of the zirconia prostheses. However, caution should be taken during CAD planning of the prosthesis to make sure the zirconia cylinder is sufficiently thick at the interface with the titanium insert. Additionally, when cutback is planned for facial porcelain veneering, the functional occluding cusps and incisal edges should be fabricated in monolithic zirconia to avoid

  9. Alcoholics anonymous involvement and positive alcohol-related outcomes: cause, consequence, or just a correlate? A prospective 2-year study of 2,319 alcohol-dependent men.

    PubMed

    McKellar, John; Stewart, Eric; Humphreys, Keith

    2003-04-01

    A positive corelation between Alcoholics Anonymous (AA) involvement and better alcohol-related outcomes has been identified in research studies, but whether this correlation reflects a causal relationship remains a subject of meaningful debate. The present study evaluated the question of whether AA affiliation appears causally related to positive alcohol-related outcomes in a sample of 2,319 male alcohol-dependent patients. An initial structural equation model indicated that 1-year posttreatment levels of AA affiliation predicted lower alcohol-related problems at 2-year follow-up, whereas level of alcohol-related problems at 1-year did not predict AA affiliation at 2-year follow-up. Additional models found that these effects were not attributable to motivation or psychopathology. The findings are consistent with the hypothesis that AA participation has a positive effect on alcohol-related outcomes.

  10. Bifurcation treatment with novel, highly flexible drug-eluting coronary stents in all-comers: 2-year outcome in patients of the DUTCH PEERS trial.

    PubMed

    van der Heijden, Liefke C; Kok, Marlies M; Lam, Ming Kai; Danse, Peter W; Schramm, Alexander R; Jessurun, Gillian A J; Tjon Joe Gin, R Melvyn; van Houwelingen, K Gert; Hautvast, Raymond W M; Linssen, Gerard C M; Sen, Hanim; Löwik, Marije M; IJzerman, Maarten J; Doggen, Carine J M; von Birgelen, Clemens

    2016-03-01

    Percutaneous coronary intervention (PCI) in bifurcated lesions with second-generation drug-eluting stents (DES) was associated with increased myocardial infarction (MI) rates. Flexible stent designs that accommodate well to vessel tapering may be of benefit in challenging anatomies such as bifurcated target lesions, but so far data are scarce. We analyzed the 2-year follow-up data of the DUTCH PEERS (TWENTE II) trial, which randomized 1811 all-comer patients to PCI with newer generation resolute integrity zotarolimus-eluting (Medtronic) or promus element everolimus-eluting stents (Boston Scientific). In bifurcated lesions, provisional stenting was generally performed. Target vessel failure is a composite endpoint, consisting of cardiac death, target vessel MI, or target vessel revascularization. Patients with at least one bifurcated lesion (n = 465, 25.7 %) versus patients with non-bifurcated target lesions only (n = 1346, 74.3 %) showed similar rates of clinical endpoints including target vessel failure (9.2 versus 7.9 %, p = 0.36) and definite stent thrombosis (0.4 versus 1.0 %, p = 0.38). Target vessel MI was more common in patients with bifurcated lesions (3.4 versus 1.6 %, p = 0.02); but after multivariate analysis with propensity score adjustment, bifurcation treatment was found not to be an independent predictor of target vessel MI (HR 1.40, 95 % CI 0.71-2.76; p = 0.34). Among patients with bifurcated lesions, DES type and side-branch size did not affect outcome, but periprocedural MI occurred more often after two-stent approaches (9.0 versus 2.1 %; p = 0.002). All-comer patients treated for bifurcated and non-bifurcated target lesions showed similar and low rates of clinical endpoints, suggesting that the DES used are efficacious and safe for treating bifurcated target lesions.

  11. Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

    ERIC Educational Resources Information Center

    Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2011-01-01

    Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

  12. Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

    ERIC Educational Resources Information Center

    Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2011-01-01

    Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

  13. Impact of Nonvascular Thoracic MR Imaging on the Clinical Decision Making of Thoracic Surgeons: A 2-year Prospective Study.

    PubMed

    Ackman, Jeanne B; Gaissert, Henning A; Lanuti, Michael; Digumarthy, Subba R; Shepard, Jo-Anne O; Halpern, Elkan F; Wright, Cameron D

    2016-08-01

    Purpose To determine the impact of nonvascular thoracic magnetic resonance (MR) imaging on the clinical decision making and diagnostic certainty of thoracic surgeons. Materials and Methods Seven thoracic surgeons at Massachusetts General Hospital, an academic quaternary referral hospital, participated in this 2-year, prospective, institution review board-approved, HIPAA-compliant pre- and post-MR imaging survey study after completing a one-time demographic survey. Between July 16, 2013, and July 13, 2015, each time a thoracic surgeon ordered a nonvascular thoracic MR imaging study via radiology order entry, he or she was sent a link to the pre-test survey that ascertained the clinical rationale for MR imaging, the clinical management plan if MR imaging was not an option, and pre-test diagnostic certainty. Upon completion of the MR imaging report, the surgeon was sent a link to the post-test survey assessing if/how MR imaging changed clinical management, the surgeon's comfort with the clinical management plan, and post-test diagnostic certainty. Data were analyzed with Student t, Wilcoxon, and McNemar tests. Results A total of 99 pre- and post-test surveys were completed. Most MR imaging studies (64 of 99 [65%]) were requested because of indeterminate computed tomographic findings. The use of MR imaging significantly reduced the number of planned surgical interventions (P < .001), modified the surgical approach in 54% (14 of 26) of surgical cases, and increased surgeon comfort with the patient management plan in 95% (94 of 99) of cases. Increased diagnostic certainty as a result of MR imaging was highly significant (P < .0001). In 21% (21 of 99) of cases, definitive MR imaging results warranted no further follow-up or clinical care. Conclusion In appropriate cases, assessment with nonvascular thoracic MR imaging substantially affects the clinical decision making and diagnostic certainty of thoracic surgeons. (©) RSNA, 2016 Online supplemental material is available

  14. Clinical results of endoscopic sciatic nerve decompression for deep gluteal syndrome: mean 2-year follow-up.

    PubMed

    Park, Myung-Sik; Yoon, Sun-Jung; Jung, Sung-Yeop; Kim, Seung-Ho

    2016-05-20

    The purpose of this study is to assess the effectiveness of endoscopic sciatic nerve decompression and evaluated the differences of clinical results between atraumatic and traumatic groups. Sixty consecutive patients. We retrospectively reviewed sixty consecutive patients without major trauma (45 hips) or with major trauma (15 hips) groups to compare the outcomes of endoscopic treatment.). The mean follow-up period was 24 ± 2.6 months (range, 24-38.4 months). The mean duration of symptoms was 14.1 months (range, 12 to 32 months). Compromising structures were piriformis muscle, fibrovascular bundles, and adhesion with scar tissues. The mean VAS score for pain decreased from 7.4 ± 1.5 to 2.6 ± 1.5 (P = .001). The mean mHHS increased from 81.7 ± 9.6 to 91.8 ± 7.6 (P = .003). Clinically, positive paresthesia and seated piriformis test were statistically significant to diagnosis sciatic entrapment syndrome. Paresthesia and sitting pain were significantly improved at the final follow-up (P = .002). More favorable outcome was observed a group without major trauma. No complication was observed. Endoscopic sciatic nerve decompression is a safe and effective procedure for the management of DGS. Patients with major trauma could have poor clinical outcome. Seated piriformis test, FADIR, and tenderness of sciatic notch are maybe useful guide for pre and postoperative evaluation of DGS.

  15. The Anaconda AAA stent graft system: 2-year clinical and technical results of a multicentre clinical evaluation.

    PubMed

    Rödel, S G J; Geelkerken, R H; Prescott, R J; Florek, H J; Kasprzak, P; Brunkwall, J

    2009-12-01

    This study reports the technical and mid-term clinical results of the second-generation Anaconda AAA Stent Graft System endovascular device for treatment of abdominal aortic aneurysm (AAA). The design of the Anaconda AAA Stent Graft System is characterised by a three-piece system consisting of two proximal independent saddle-shaped nitinol self-expandable rings with hooks fixation, zero body support and vacuum-cleaner tube leg design. From July 2002 to April 2005, a total of 61 patients with AAA were enrolled in a multicentre, prospective, non-randomised controlled design study. All patients received a second-generation Anaconda AAA Stent Graft System. They entered a standard follow-up protocol at discharge for 3, 6, 12 and 24 months. Follow-up data included survival; rupture-free survival; incidence of aneurysm rupture, death from aneurysm rupture, aneurysm-related death; freedom from aneurysm expansion; freedom from Types I and III endoleaks; endograft patency and technical and clinical success rates. Successful access to the arterial system was achieved in all patients. The primary technical success was 59 out of 61 and the primary assisted technical success was 60 out of 61. All endovascular grafts were patent without significant twists, kinks or obstructions. Migration was not observed in any of the grafts. During the first 30-day period, two serious adverse events (3%), both not related to the procedure, were observed. Nine patients (15%) needed a secondary intervention; two of these interventions were related to stent graft (3%). The mean aneurysm sac diameter decreased significantly from 57 mm pre-operative to 45mm after 24 months, without aneurysm growth. There was one Type I endoleak at initial implantation, which was corrected using a proximal extension cuff. In total, three Type II endoleaks were still present after 24 months without any signs of aneurysm growth. The design features of the second-generation Anaconda AAA Stent Graft System are effective

  16. Clinical Outcome of Hypertensive Uveitis

    PubMed Central

    Lewkowicz, Deborah; Willermain, François; Relvas, Lia Judice; Makhoul, Dorine; Janssens, Sarah; Janssens, Xavier; Caspers, Laure

    2015-01-01

    Purpose. To review the clinical outcome of patients with hypertensive uveitis. Methods. Retrospective review of uveitis patients with elevated intraocular pressure (IOP) > 25 mmHg and >1-year follow-up. Data are uveitis type, etiology, viral (VU) and nonviral uveitis (NVU), IOP, and medical and/or surgical treatment. Results. In 61 patients, IOP values are first 32.9 mmHg (SD: 9.0), highest 36.6 mmHg (SD: 9.9), 3 months after the first episode 19.54 mmHg (SD: 9.16), and end of follow-up 15.5 mmHg (SD: 6.24). Patients with VU (n = 25) were older (50.6 y/35.7 y, p = 0.014) and had more unilateral disease (100%/72.22%  p = 0.004) than those with NVU (n = 36). Thirty patients (49.2%) had an elevated IOP before topical corticosteroid treatment. Patients with viral uveitis might have higher first elevated IOP (36.0/27.5 mmHg, p = 0,008) and maximal IOP (40.28/34.06 mmHg, p = 0.0148) but this was not significant when limited to the measurements before the use of topical corticosteroids (p = 0.260 and 0.160). Glaucoma occurred in 15 patients (24.59%) and was suspected in 11 (18.03%) without difference in viral and nonviral groups (p = 0.774). Conclusion. Patients with VU were older and had more unilateral hypertensive uveitis. Glaucoma frequently complicates hypertensive uveitis. Half of the patients had an elevated IOP before topical corticosteroid treatment. PMID:26504598

  17. Clinical and radiological investigations of mandibular overdentures supported by conventional or mini-dental implants: A 2-year prospective follow-up study.

    PubMed

    Temizel, Sonay; Heinemann, Friedhelm; Dirk, Cornelius; Bourauel, Christoph; Hasan, Istabrak

    2017-02-01

    primary and secondary stability values for conventional dental implants were -4.0 and -4.9, respectively. The primary and secondary stability values for the mini-dental implants were -0.3 and -1.4, respectively. The Periotest values of the primary (measured immediately after implant insertion) and secondary implant stabilities (measured 6 months after implant insertion) were significantly higher for the conventional dental implants than for the mini-dental implants (P<.001). Based on this 2-year clinical trial, patients receiving mini-dental implants had clinical outcomes similar to those of patients receiving conventional dental implants to support overdenture prostheses. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  18. Cementless anatomical prosthesis for the treatment of 3-part and 4-part proximal humerus fractures: cadaver study and prospective clinical study with minimum 2 years followup

    PubMed Central

    Obert, Laurent; Saadnia, Rachid; Loisel, François; Uhring, Julien; Adam, Antoine; Rochet, Séverin; Clappaz, Pascal; Lascar, Tristan

    2016-01-01

    Introduction: The purpose of this study was to evaluate the functional and radiological outcomes of a cementless, trauma-specific locked stem for 3- and 4-part proximal humeral fractures. Materials and methods: This study consisted of two parts: a cadaver study with 22 shoulders and a multicenter prospective clinical study of 23 fracture patients evaluated at least 2 years after treatment. In the cadaver study, the locked stem (HumelockTM, FX Solutions) and its instrumentation were evaluated. In the clinical study, five senior surgeons at four different hospitals performed the surgical procedures. An independent surgeon evaluated the patients using clinical (Constant score, QuickDASH) and radiological (X-rays, CT scans) outcome measures. Results: The cadaver study allowed us to validate the height landmarks relative to the pectoralis major tendon. In the clinical study, at the review, abduction was 95° (60–160), forward flexion was 108° (70–160), external rotation (elbow at body) was 34° (0–55), the QuickDASH was 31 (4.5–59), the overall Constant score was 54 (27–75), and the weighted Constant score was 76 (31.5–109). Discussion: This preliminary study of hemiarthroplasty (HA) with a locked stem found results that were at least equivalent to published series. As all patients had at least a 2-year follow-up, integration of the locked stem did not cause any specific complications. These results suggest that it is possible to avoid using cement when hemiarthroplasty is performed for the humeral stem. This implant makes height adjustment and transosseous suturing of the tuberosities more reproducible. PMID:27194107

  19. Phase II trial of hypofractionated VMAT-based treatment for early stage breast cancer: 2-year toxicity and clinical results.

    PubMed

    De Rose, Fiorenza; Fogliata, Antonella; Franceschini, Davide; Navarria, Piera; Villa, Elisa; Iftode, Cristina; D'Agostino, Giuseppe; Cozzi, Luca; Lobefalo, Francesca; Mancosu, Pietro; Tomatis, Stefano; Scorsetti, Marta

    2016-09-17

    To report toxicity and early clinical outcomes of hypofractionated simultaneous integrated boost (SIB) approach with Volumetric Modulated Arc Therapy (VMAT) as adjuvant treatment after breast-conserving surgery. Patients presenting early-stage breast cancer were enrolled in a phase II trial. age > 18 years old, invasive cancer or ductal carcinoma in situ (DCIS), Stage I-II (T < 3 cm and N ≤ 3), breast-conserving surgery without oncoplastic reconstruction. Any systemic therapy was allowed in neoadjuvant or adjuvant setting. All patients underwent VMAT-SIB technique to irradiate the whole breast and the tumor bed. Doses to whole breast and surgical bed were 40.5 Gy and 48 Gy, respectively, delivered in 15 fractions over 3 weeks. Acute and late skin toxicities were recorded. Cosmetic outcome was assessed as excellent/good or fair/poor. The present study focused on results of a cohort of 144 patients with a minimum follow-up of 24 months (median 37, range 24-55 months). Median age was 62 years old (range 30-88). All patients had an invasive carcinoma (no patients with DCIS were present in this subset). At one year, the highest reported skin toxicity was G1, in 14 % of the patients; this data dropped to 4 % at the last follow-up, after more than 2 years. Breast pain was recorded in 21.6 % of the patients 6 months after treatment, while it was present in 3.5 % of the patients at the last follow-up, showing a significant improvement with time. Correlation between liponecrosis and boost target volume was found not significant. Breast pain was correlated with breast volume. No pulmonary or cardiological toxicities were recorded. After an early evaluation of clinical outcomes, only one case presented disease relapse, as liver metastases. The 3-week VMAT-SIB course as adjuvant treatment after breast-conserving surgery showed to be well tolerated and was associated with optimal local control. Long-term follow-up data are needed to assess late toxicity

  20. The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for women at 2 years

    PubMed Central

    2007-01-01

    Objective The aim of this study was to assess long-term effects for women following the use of magnesium sulphate for pre-eclampsia. Design Assessment at 2–3 years after delivery for women recruited to the Magpie Trial (recruitment in 1998–2001, ISRCTN 86938761), which compared magnesium sulphate with placebo for pre-eclampsia. Setting Follow up after discharge from hospital at 125 centres in 19 countries across five continents. Population A total of 7927 women were randomised at the follow-up centres. Of these women, 2544 were not included for logistic reasons and 601 excluded (109 at a centre where <20% of women were contacted, 466 discharged without a surviving child and 26 opted out). Therefore, 4782 women were selected for follow-up, of whom 3375 (71%) were traced. Methods Questionnaire assessment was administered largely by post or in a dedicated clinic. Interview assessment of selected women was performed. Main outcome measures Death or serious morbidity potentially related to pre-eclampsia at follow up, other morbidity and use of health service resources. Results Median time from delivery to follow up was 26 months (interquartile range 19–36). Fifty-eight of 1650 (3.5%) women allocated magnesium sulphate died or had serious morbidity potentially related to pre-eclampsia compared with 72 of 1725 (4.2%) women allocated placebo (relative risk 0.84, 95% CI 0.60–1.18). Conclusions The reduction in the risk of eclampsia following prophylaxis with magnesium sulphate was not associated with an excess of death or disability for the women after 2 years. PMID:17166220

  1. The role of youth mental health services in the treatment of young people with serious mental illness: 2-year outcomes and economic implications.

    PubMed

    Brimblecombe, Nicola; Knapp, Martin; Murguia, Silvia; Mbeah-Bankas, Henrietta; Crane, Steve; Harris, Abi; Evans-Lacko, Sara; Ardino, Vittoria; Iemmi, Valentina; King, Derek

    2017-10-01

    This study aims to evaluate the outcomes and economic case for a UK innovative youth-specific mental health service for 16-25 year olds. A pre-, during- and post-treatment comparative design for 20 young people at high risk of developing psychosis who received 2 years' treatment with the service, using outcomes that concurred with the service aims: changes in mental health, employment rates and service use. Forty-five percent of those at risk and with symptoms of serious mental illness commencing treatment were not receiving mental health services at baseline. Compared with service use prior to treatment at the youth-specific service, hospital admissions, Accident and Emergency, and criminal justice system use appear to decrease over the 2 years of treatment and the year after treatment, with potential cost differences of £473 000. Mental health improved or stayed the same, compared with baseline. Employment rates improved, although the sample size for this is very small. Potential cost differences associated with service users moving into employment over the 2 years are £148 000. The estimated cost over 2 years of providing the youth-specific mental health service to these young people was £106 000. Given the extensive long-term negative consequences and high costs of untreated mental illness in the 16-25 age group and the documented problems young people have in receiving appropriate services, this youth-specific, age-appropriate service model appears to be successful, with improved outcomes and cost differences in the short-term, and with encouraging implications for the longer term. © 2015 Wiley Publishing Asia Pty Ltd.

  2. An observational study on surgically treated adult idiopathic scoliosis patients' quality of life outcomes at 1- and 2-year follow-ups and comparison to controls.

    PubMed

    Theis, Jennifer C; Grauers, Anna; Diarbakerli, Elias; Savvides, Panayiotis; Abbott, Allan; Gerdhem, Paul

    2017-01-01

    Prospective data on health-related quality of life in patients with idiopathic scoliosis treated surgically as adults is needed. We compared preoperative and 1- and 2-year follow-up data in surgically treated adults with idiopathic scoliosis with juvenile or adolescent onset. Results were compared to untreated adults with scoliosis and population normative data. A comparison of preoperative and 1- and 2-year follow-up data of 75 adults surgically treated for idiopathic scoliosis at a mean age of 28 years (range 18 to 69) from a prospective national register study, as well as a comparison with age- and sex-matched data from 75 untreated adults with less severe scoliosis and 75 adults without scoliosis, was made. Outcome measures were EuroQol-5 dimensions (EQ-5D) and Scoliosis Research Society (SRS)-22r questionnaire. In the surgically treated, EQ-5D and SRS-22r scores had statistically significant improvements at both 1- and 2-year follow-ups (all p  < 0.015). The effect size of surgery on EQ-5D at 1-year follow-up was large (r = -0.54) and small-medium (r = -0.20) at 2-year follow-up. The effect size of surgery on SRS-22r outcomes was medium-large at 1- and 2-year follow-ups (r = -0.43 and r = -0.42 respectively). At the 2-year follow-up, the EQ-5D score and the SRS-22r subscore were similar to the untreated scoliosis group (p = 0.56 and p = 0.91 respectively), but lower than those in the adults without scoliosis (p < 0.001 for both comparisons). Adults with idiopathic scoliosis experience an increase in health-related quality of life following surgery at 2-year follow-up, approaching the health-related quality of life of untreated individuals with less severe scoliosis, but remain lower than normative population data.

  3. Outcome Prediction in Clinical Treatment Processes.

    PubMed

    Huang, Zhengxing; Dong, Wei; Ji, Lei; Duan, Huilong

    2016-01-01

    Clinical outcome prediction, as strong implications for health service delivery of clinical treatment processes (CTPs), is important for both patients and healthcare providers. Prior studies typically use a priori knowledge, such as demographics or patient physical factors, to estimate clinical outcomes at early stages of CTPs (e.g., admission). They lack the ability to deal with temporal evolution of CTPs. In addition, most of the existing studies employ data mining or machine learning methods to generate a prediction model for a specific type of clinical outcome, however, a mathematical model that predicts multiple clinical outcomes simultaneously, has not yet been established. In this study, a hybrid approach is proposed to provide a continuous predictive monitoring service on multiple clinical outcomes. More specifically, a probabilistic topic model is applied to discover underlying treatment patterns of CTPs from electronic medical records. Then, the learned treatment patterns, as low-dimensional features of CTPs, are exploited for clinical outcome prediction across various stages of CTPs based on multi-label classification. The proposal is evaluated to predict three typical classes of clinical outcomes, i.e., length of stay, readmission time, and the type of discharge, using 3492 pieces of patients' medical records of the unstable angina CTP, extracted from a Chinese hospital. The stable model was characterized by 84.9% accuracy and 6.4% hamming-loss with 3 latent treatment patterns discovered from data, which outperforms the benchmark multi-label classification algorithms for clinical outcome prediction. Our study indicates the proposed approach can potentially improve the quality of clinical outcome prediction, and assist physicians to understand the patient conditions, treatment inventions, and clinical outcomes in an integrated view.

  4. Minimally Invasive Periodontal Treatment Using the Er,Cr: YSGG Laser. A 2-year Retrospective Preliminary Clinical Study

    PubMed Central

    Dyer, Bret; Sung, Eric C.

    2012-01-01

    Minimally invasive surgery (MIS) using the erbium, chromium: yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser (Waterlase MD, Biolase, Irvine, CA) to treat moderate to advanced periodontal disease is presented as an alternative to conventional therapies. To date, there are few short- or long-term studies to demonstrate the effects of this laser in treating and maintaining periodontal health. Electronic clinical records from 16 patients – total of 126 teeth, with pocket depths ranging from 4 mm to 9 mm – were treated with the same protocol using the Er,Cr:YSGG laser. The mean baseline probing depths (PD) were 5 mm and clinical attachment levels (CAL) were 5 mm in the 4 - 6 mm pretreated laser group. The mean baseline probing depths were 7.5 and 7.6 mm for PD and CAL respectfully in the 7 – 9 mm pretreatment laser group. At the 2 year mark, the average PD was 3.2 ± 1.1 mm for the 4-6 mm pocket group and the 7-9 mm pocket group had a mean PD of 3.7 ± 1.2 mm. mean CAL was 3.1 ± 1.1 mm for the 4-6 mm group and 3.6 ± 1.2 for the 7-9 mm group with an overall reduction of 1.9 mm and 4.0 mm respectively. At one and two years, both groups remained stable with PD comparable to the three-month gains. The CAL measurements at one and two years were also comparable to the three-month gains. PMID:22615717

  5. Predictive value of General Movement Assessment for preterm infants' development at 2 years - implementation in clinical routine in a non-academic setting.

    PubMed

    De Bock, Freia; Will, Heike; Behrenbeck, Ulrike; Jarczok, Marc N; Hadders-Algra, Mijna; Philippi, Heike

    2017-03-01

    General movements (GM) are used in academic settings to predict developmental outcome in infants born preterm. However, little is known about the implementation and predictive value of GM in non-academic settings. The aim of this study is twofold: To document the implementation of GM assessment (GMA) in a non-academic setting and to assess its predictive value in infants born preterm. We documented the process of implementing GMA in a non-academic outpatient clinic. In addition, we assessed the predictive value of GMA at 1 and 3 months' corrected age for motor and cognitive development at 2 years in 122 children born <33 weeks' gestation. Outcome at two years was based upon the Bayley Scales of Infant Development-II (mental/psychomotor developmental index (MDI, PDI)) and a neurological examination. The infants' odds of atypical outcome (MDI or PDI ≤70 or diagnosis CP) and the predictive accuracy of abnormal GMA were calculated in a clinical routine scenario, which used all available GM information (primarily at 3 months or at 1 month, when 3 months were not available). In addition, separate analysis was undertaken for the samples of GMA at 1 and 3 months. Tips to facilitate GMA implementation are described. In our clinical routine scenario, children with definitely abnormal GM were more likely to have an atypical two-year outcome than children with normal GM (OR 13.2 (95% CI 1.56; 112.5); sensitivity 55.6%, specificity 82.1%). Definitely abnormal GM were associated with reduced MDI (-12.0, 95% CI -23.2; -0.87) and identified all children with cerebral palsy (CP) in the sample of GMA at 3 months only. GMA can be successfully implemented in a non-academic outpatient setting. In our clinical routine scenario, GMA allowed for adequate prediction of neurodevelopment in infants born preterm, thereby allaying concerns about diagnostic accuracy in non-academic settings. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Admission to psychiatric hospital for mental illnesses 2 years prechildbirth and postchildbirth in Scotland: a health informatics approach to assessing mother and child outcomes

    PubMed Central

    Martin, Julie Langan; McLean, Gary; Martin, Daniel; Cantwell, Roch; Smith, Daniel J

    2017-01-01

    Objective To identify factors associated with: admission to a specialist mother and baby unit (MBU) and the impact of perinatal mental illness on early childhood development using a data linkage approach in the 2 years prechildbirth and postchildbirth. Methods Scottish maternity records (SMR02) were linked to psychiatric hospital admissions (SMR04). 3290 pregnancy-related psychiatric admissions for 1730 women were assessed. To investigate factors associated with MBU admission, the group of mothers admitted to an MBU were compared with those admitted to general psychiatric wards. To assess the impact of perinatal mental illness on early child development, a pragmatic indicator for ‘at potential risk of adversity’, defined as a child who was recorded as requiring intensive treatment at any time under the health plan indicators (HPI) and/or who had no record of completing three doses of the 5-in-1 vaccine by 12 months was generated. Logistic regression models were used to describe the association between each variable and the risk of admission between those with a history of prior psychiatric admission and those without. Results Women admitted to an MBU were significantly more likely to be admitted with non-affective psychosis (OR=1.97, 95% CI 1.22 to 3.18), affective psychosis (OR=2.44, 95% CI 1.37 to 4.33) and non-psychotic depressive episodes (OR=1.93, 95% CI 1.42 to 2.63). They were less likely to come from deprived areas (OR=0.68 95% CI 0.49 to 0.93). Women with a previous history of psychiatric admission were significantly more likely to be located in the two most deprived quintiles. Almost one-third (29%) of children born to mothers with a pregnancy-related psychiatric admission were assessed as ‘at potential risk of adversity.’ Conclusions A health informatics approach has potential for improving understanding of social and clinical factors, which contribute to the outcomes of perinatal mental illness, as well as potential adverse developmental

  7. Admission to psychiatric hospital for mental illnesses 2 years prechildbirth and postchildbirth in Scotland: a health informatics approach to assessing mother and child outcomes.

    PubMed

    Martin, Julie Langan; McLean, Gary; Martin, Daniel; Cantwell, Roch; Smith, Daniel J

    2017-09-01

    To identify factors associated with: admission to a specialist mother and baby unit (MBU) and the impact of perinatal mental illness on early childhood development using a data linkage approach in the 2 years prechildbirth and postchildbirth. Scottish maternity records (SMR02) were linked to psychiatric hospital admissions (SMR04). 3290 pregnancy-related psychiatric admissions for 1730 women were assessed. To investigate factors associated with MBU admission, the group of mothers admitted to an MBU were compared with those admitted to general psychiatric wards. To assess the impact of perinatal mental illness on early child development, a pragmatic indicator for 'at potential risk of adversity', defined as a child who was recorded as requiring intensive treatment at any time under the health plan indicators (HPI) and/or who had no record of completing three doses of the 5-in-1 vaccine by 12 months was generated. Logistic regression models were used to describe the association between each variable and the risk of admission between those with a history of prior psychiatric admission and those without. Women admitted to an MBU were significantly more likely to be admitted with non-affective psychosis (OR=1.97, 95% CI 1.22 to 3.18), affective psychosis (OR=2.44, 95% CI 1.37 to 4.33) and non-psychotic depressive episodes (OR=1.93, 95% CI 1.42 to 2.63). They were less likely to come from deprived areas (OR=0.68 95% CI 0.49 to 0.93). Women with a previous history of psychiatric admission were significantly more likely to be located in the two most deprived quintiles. Almost one-third (29%) of children born to mothers with a pregnancy-related psychiatric admission were assessed as 'at potential risk of adversity.' A health informatics approach has potential for improving understanding of social and clinical factors, which contribute to the outcomes of perinatal mental illness, as well as potential adverse developmental outcomes for offspring. © Article author

  8. Treatment costs associated with interventional cancer clinical trials conducted at a single UK institution over 2 years (2009-2010).

    PubMed

    Liniker, E; Harrison, M; Weaver, J M J; Agrawal, N; Chhabra, A; Kingshott, V; Bailey, S; Eisen, T G G; Corrie, P G

    2013-10-15

    The conduct of clinical trials should be an integral part of routine patient care. Treating patients in trials incurs additional costs over and above standard of care (SOC), but the extent of the cost burden is not known. We undertook a retrospective cost attribution analysis to quantitate the treatment costs associated with cancer clinical trial protocols conducted over a 2 year period. All patients entered into oncology (non-haematology) clinical trials involving investigational medicinal products in 2009 and 2010 in a single UK institution were identified. The trial protocols on which they were treated were analysed to identify the treatment costs for the experimental arm(s) of the trial and the equivalent SOC had the patient not been entered in the trial. The treatment cost difference was calculated by subtracting the experimental treatment cost from SOC cost. For randomised trials, an average treatment cost was estimated by taking into account the number of arms and randomisation ratio. An estimate of the annual treatment costs was calculated. A total of 357 adult oncology patients were treated on 53 different trial protocols: 40 phase III, 2 randomised II/III and 11 phase II design. A total of 27 trials were academic, non-commercial sponsored trials and 26 were commercial sponsored trials. When compared with SOC, the average treatment cost per patient was an excess of £431 for a non-commercial trial (range £6393 excess to £6005 saving) and a saving of £9294 for a commercial trial (range £0 to £71,480). There was an overall treatment cost saving of £388,719 in 2009 and £496,556 in 2010, largely attributable to pharmaceutical company provision of free drug supplies. On an average, non-commercial trial protocols were associated with a small per patient excess treatment cost, whereas commercial trials were associated with a substantially higher cost saving. Taking into account the total number of patients recruited annually, treatment of patients on

  9. The use of temporary vascular shunts in military extremity wounds: a preliminary outcome analysis with 2-year follow-up.

    PubMed

    Borut, L T Jeffrey; Acosta, Capt José A; Tadlock, L C D R Matthew; Dye, Judy L; Galarneau, Michael; Elshire, Capt Donnel

    2010-07-01

    The use of temporary vascular shunts (TVS)s in the management of wartime extremity vascular injuries has received an increasing amount of attention. However, the overall impact of this adjunct remains incompletely defined. The objective of this study is to characterize outcomes of those patients who suffered wartime extremity vascular injuries managed with TVSs. This is a retrospective review of the Navy and Marine Corps Combat Trauma Registry examining peripheral vascular injuries treated during the military conflicts in the Middle East. Patient demographics, injury severity score, mechanism of injury, and vessels injured were recorded. Operative reports were reviewed for use of TVSs, type of definitive repair, the need for amputation, and survival. Eighty patients were included. Forty-six (57%) had TVSs placed and 34 (43%) underwent repair at initial presentation. The mean injury severity score for the TVS group and the non-TVS groups were 15.0 +/- 5.05 and 12.9 +/- 10.18, respectively, (p = 0.229). There were a total of 13 amputations, 6 (13%) in the TVS group and 7 (21%) in the non-TVS group (p = 0.38). There was no difference in amputation rates between either group. There were no recorded mortalities in either group. Median patient follow-up was 24.5 months (range, 3-48 months). This study demonstrates the importance and utility of TVSs in the management of wartime extremity vascular injury. When used to restore perfusion to an injured extremity, there seems to be no adverse effects or overall increase in limb loss rates and therefore a useful adjunct in the surgery for limb salvage.

  10. Psychosocial outcomes in patients with recurrent major depressive disorder during 2 years of maintenance treatment with venlafaxine extended release

    PubMed Central

    Trivedi, Madhukar H.; Dunner, David L.; Kornstein, Susan G.; Thase, Michael E.; Zajecka, John M.; Rothschild, Anthony J.; Friedman, Edward S.; Shelton, Richard C.; Keller, Martin B.; Kocsis, James H.; Gelenberg, Alan

    2013-01-01

    Background Psychosocial outcomes from the Prevention of Recurrent Episodes of Depression with Venlafaxine ER for Two Years (PREVENT) study were evaluated. Methods Adult outpatients with recurrent major depressive disorder (MDD) and response or remission following 6-month continuation treatment with venlafaxine extended release (ER) were randomized to receive venlafaxine ER or placebo for 1 year. Patients without recurrence on venlafaxine ER during year 1 were randomized to venlafaxine ER or placebo for year 2. Psychosocial functioning was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire—Short Form (Q-LES-Q), Life EnjoymentScale—Short Version (LES-S), Social Adjustment Scale—Self-Report (SAS-SR) total and individual factors, Short Form Health Survey (SF-36) (vitality, social functioning, and role function-emotional items), and Longitudinal Interval Follow-up Evaluation (LIFE). Results At year 1 end, better overall psychosocial functioning was seen among patients randomly assigned to venlafaxine ER (n=129) vs placebo (n=129), with significant differences at end point on SF-36 role function-emotional, Q-LES-Q, and SAS-SR total, and work, house work, social/leisure, and extended-family factor scores (p≤0.05). At year 2 end, significant differences favored venlafaxine ER (n=43) vs placebo (n=40)on SF-36 vitality and rolefunction-emotional, Q-LES-Q, LES-S, LIFE, and SAS-SR total, social/leisure, and extended-family factor scores (p≤0.05). Limitations Patients with chronic MDD or treatment resistance were excluded and long-term specialist care was a financial incentive for treatment compliance. Discontinuation-related adverse events may have compromised the integrity of the treatment blind. Conclusions For patients with recurrent MDD, 2 years’ maintenance therapy with venlafaxine ER may improve psychosocial functioning vs placebo. PMID:20510459

  11. EFFECTS OF CONVERSION TO A BICARBONATE/LACTATE-BUFFERED, NEUTRAL-PH, LOW-GDP PD REGIMEN IN PREVALENT PD: A 2-YEAR RANDOMIZED CLINICAL TRIAL.

    PubMed

    Farhat, Karima; Douma, Caroline; Ferrantelli, Evelina; Ter Wee, Pieter M; Beelen, Robert H; van Ittersum, Frans J

    2017-03-27

    ♦ Background: The use of pH-neutral peritoneal dialysis (PD) fluids low in glucose degradation products (GDP) may better preserve the peritoneal membrane and have fewer systemic effects. The effects of conversion from conventional to neutral-pH, low-GDP PD fluids in prevalent patients are unclear. Few studies on the role of neutral-pH, low-GDP PD have studied residual renal function, ultrafiltration, peritonitis incidence and technique failure, transport characteristics, and local and systemic markers of inflammation in prevalent PD patients. ♦ Methods: In a multi-center open-label randomized clinical trial (RCT), we randomly assigned 40 of 78 stable continuous ambulatory PD (CAPD) and automated PD (APD) patients to treatment with bicarbonate/lactate, neutral-pH, low-GDP PD fluid (Physioneal; Baxter Healthcare Corporation, Deerfield, IL, USA) and compared them with 38 patients continuing their current standard lactate-buffered PD fluid (PDF) (Dianeal; Baxter Healthcare Corporation, Deerfield, IL, USA) during 2 years. Primary outcome was residual renal function (RRF) and ultrafiltration (UF) during peritoneal equilibration test (PET); peritonitis incidence was a secondary outcome. Furthermore, clinical parameters as well as several biomarkers in effluents and serum were measured. ♦ Results: During follow-up, RRF did not differ between the groups. In the Physioneal group ultrafiltration (UF) during PET remained more or less stable (-20 mL [confidence interval (CI):-163.5 - 123.5 mL]; p = 0.7 over 24 months), whereas it declined in the Dianeal group (-243 mL [CI: -376.6 to -109.4mL]; p < 0.0001 over 24 months), resulting in a difference of 233.7mL [95% CI 41.0 - 425.5 mL]; p = 0.017 between the groups at 24months. The peritonitis rate was lower in the Physioneal group: adjusted odds ratio (OR) 0.38 (0.15 - 0.97) p = 0.043. No differences were observed between the 2 groups in peritoneal adequacy or transport characteristics nor effluent markers of local

  12. 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

  13. Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial.

    PubMed

    Cooper, Sue; Taggar, Jaspal; Lewis, Sarah; Marlow, Neil; Dickinson, Anne; Whitemore, Rachel; Coleman, Tim

    2014-09-01

    The SNAP (Smoking and Nicotine in Pregnancy) trial compared nicotine replacement therapy (NRT) patches with placebo in pregnant smokers; although NRT doubled cessation rates in the first 4 weeks, by delivery no differences in maternal smoking or birth outcomes were noted. As a result, NRT used in standard doses during pregnancy is considered ineffective for smoking cessation. Subsequent effects of NRT on the children of treated mothers are unknown because no trials have investigated the effect of gestational NRT use beyond birth. To assess whether NRT use in pregnancy might cause harm to infants, we aimed to compare effects of NRT and placebo on infant development 2 years after delivery. 1050 pregnant smokers aged 16-45 years, at 12-24 weeks' gestation, and smoking at least five cigarettes per day were recruited from seven hospitals in England between May 1, 2007, and Feb 26, 2010, and followed up until their infants were 2 years old. Participants were randomly assigned (1:1) to receive up to 8-weeks treatment with NRT (15 mg/16 h transdermal patches) or identically packaged and visually matched placebo patches (all patches manufactured by and purchased at market rate from United Pharmaceuticals, Amman, Jordan), issued as two 4-week supplies (521 for NRT group, 529 for placebo group) [Corrected]. Randomisation was stratified by site with participants, health-care professionals, and research staff masked to treatment allocation. The primary results for participants and infants at delivery were published in 2012; we present results from the trial cohort 2 years after birth. After delivery, questionnaires were posted to participants and, if there was no response, to family physicians. The primary outcome at 2 years was infants' survival without developmental impairment (ie, no disability or problems with behaviour or development). Treatment groups were compared on an intention-to-treat basis. The trial is registered with Controlled-Trials.com, number ISRCTN07249128

  14. Outcome and structural integrity of rotator cuff after arthroscopic treatment of large and massive tears with double row technique: a 2-year followup.

    PubMed

    Carbonel, Ignacio; Martínez, Angel A; Aldea, Elisa; Ripalda, Jorge; Herrera, Antonio

    2013-01-01

    Purpose. The purpose of this study was to evaluate the functional outcome and the tendon healing after arthroscopic double row rotator cuff repair of large and massive rotator cuff tears. Methods. 82 patients with a full-thickness large and massive rotator cuff tear underwent arthroscopic repair with double row technique. Results were evaluated by use of the UCLA, ASES, and Constant questionnaires, the Shoulder Strength Index (SSI), and range of motion. Follow-up time was 2 years. Magnetic resonance imaging (MRI) studies were performed on each shoulder preoperatively and 2 years after repair. Results. 100% of the patients were followed up. UCLA, ASES, and Constant questionnaires showed significant improvement compared with preoperatively (P < 0.001). Range of motion and SSI in flexion, abduction, and internal and external rotation also showed significant improvement (P < 0.001). MRI studies showed 24 cases of tear after repair (29%). Only 8 cases were a full-thickness tear. Conclusions. At two years of followup, in large and massive rotator cuff tears, an arthroscopic double row rotator cuff repair technique produces an excellent functional outcome and structural integrity.

  15. Outcome and Structural Integrity of Rotator Cuff after Arthroscopic Treatment of Large and Massive Tears with Double Row Technique: A 2-Year Followup

    PubMed Central

    Carbonel, Ignacio; Martínez, Angel A.; Aldea, Elisa; Ripalda, Jorge

    2013-01-01

    Purpose. The purpose of this study was to evaluate the functional outcome and the tendon healing after arthroscopic double row rotator cuff repair of large and massive rotator cuff tears. Methods. 82 patients with a full-thickness large and massive rotator cuff tear underwent arthroscopic repair with double row technique. Results were evaluated by use of the UCLA, ASES, and Constant questionnaires, the Shoulder Strength Index (SSI), and range of motion. Follow-up time was 2 years. Magnetic resonance imaging (MRI) studies were performed on each shoulder preoperatively and 2 years after repair. Results. 100% of the patients were followed up. UCLA, ASES, and Constant questionnaires showed significant improvement compared with preoperatively (P < 0.001). Range of motion and SSI in flexion, abduction, and internal and external rotation also showed significant improvement (P < 0.001). MRI studies showed 24 cases of tear after repair (29%). Only 8 cases were a full-thickness tear. Conclusions. At two years of followup, in large and massive rotator cuff tears, an arthroscopic double row rotator cuff repair technique produces an excellent functional outcome and structural integrity. PMID:23533788

  16. Joint unloading implant modifies subchondral bone trabecular structure in medial knee osteoarthritis: 2-year outcomes of a pilot study using fractal signature analysis

    PubMed Central

    Miller, Larry E; Sode, Miki; Fuerst, Thomas; Block, Jon E

    2015-01-01

    Background Knee osteoarthritis (OA) is largely attributable to chronic excessive and aberrant joint loading. The purpose of this pilot study was to quantify radiographic changes in subchondral bone after treatment with a minimally invasive joint unloading implant (KineSpring® Knee Implant System). Methods Nine patients with unilateral medial knee OA resistant to nonsurgical therapy were treated with the KineSpring System and followed for 2 years. Main outcomes included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function, and stiffness subscores and independent core laboratory determinations of joint space width and fractal signature of the tibial cortex. Results WOMAC scores, on average, improved by 92% for pain, 91% for function, and 79% for stiffness over the 2-year follow-up period. Joint space width in the medial compartment of the treated knee significantly increased from 0.9 mm at baseline to 3.1 mm at 2 years; joint space width in the medial compartment of the untreated knee was unchanged. Fractal signatures of the vertically oriented trabeculae in the medial compartment decreased by 2.8% in the treated knee and increased by 2.1% in the untreated knee over 2 years. No statistically significant fractal signature changes were observed in the horizontally oriented trabeculae in the medial compartment or in the horizontal or vertical trabeculae of the lateral compartment in the treated knee. Conclusion Preliminary evidence suggests that the KineSpring System may modify knee OA disease progression by increasing joint space width and improving subchondral bone trabecular integrity, thereby reducing pain and improving joint function. PMID:25670891

  17. A Retrospective 2-Year Clinical Study of Immediate Prosthetic Rehabilitation of Edentulous Jaws with Four Implants and Prefabricated Bars.

    PubMed

    Sannino, Gianpaolo; Bollero, Patrizio; Barlattani, Alberto; Gherlone, Enrico

    2017-07-01

    The purpose of this retrospective investigation was to evaluate the use of a prefabricated bar system for immediately loaded implants placed and restored according to the All-on-Four concept with up to 24-month follow-up. A total of 51 patients (31 males and 20 females; mean age 63.4 years) presented with edentulous or partially edentulous jaws with severe atrophy of the posterior regions. All patients were treated with full-arch fixed prostheses (28 maxillary, 34 mandibular) each supported by four implants (two vertical, two distally tilted). The implants were immediately loaded with screw-retained full-arch restorations. Each prosthesis was supported by a prefabricated metal bar combined with high-density acrylic resin. Follow-up visits were scheduled at 6, 12, and 24 months after initial prosthetic loading. Intraoral radiographs were obtained immediately after surgery and at each follow-up visit by using a custom radiograph holder and parallel technique. Marginal bone levels were assessed using digital image analysis. Implant and prosthetic survival and success rates were evaluated. Patient satisfaction was further assessed using a 100-mm visual analog scale (VAS). Data were compared by means of the Mantel-Haenszel test. No drop-outs occurred. The overall implant survival rates were 100% and 98.38% for the vertical and tilted implants respectively. Two of the 62 definitive fixed prostheses were lost during the observation period due to implant failure. Since restoration replacement due to implant failure was not judged a prosthodontic failure according to the survival criteria provided in this study, the overall prosthetic survival rate was 100%. No statistically significant differences in marginal bone levels between vertical and tilted implants were detected at 24-month follow-up evaluation in either jaw. All participants were functionally and esthetically satisfied with their definitive restorations after 2 years functioning, as confirmed by the average VAS

  18. Ab-interno goniotrabeculotomy versus mitomycin C trabeculectomy for adult open-angle glaucoma: a 2-year randomized clinical trial.

    PubMed

    Quaranta, L; Hitchings, R A; Quaranta, C A

    1999-07-01

    To evaluate the effect of ab-interno goniotrabeculotomy (AIGT) on the intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG), compared with the effects of mitomycin C trabeculectomy (MT). Prospective, randomized, clinical trial. Thirty-two eyes of 32 patients with medically uncontrolled POAG. Standard limbus-based trabeculectomy with adjunct mitomycin C (0.3 mg/mL for 3 minutes) in 16 eyes of 16 patients; AIGT was performed in 16 eyes of 16 patients. The groups were matched for age, preoperative IOP, duration of preoperative antiglaucoma treatment, use of preoperative beta-blockers and parasympathomimetics, and use of beta-blockers in the fellow eye. The IOP (average of the two highest values measured in the diurnal curve, from 8 AM to 6 PM, every 2 hours) and complications were recorded 1, 3, 6, 12, 18, and 24 months after surgery. Identification of complications and IOP. All patients were followed up for 24 months. More postoperative complications occurred in the MT group during the 2-year follow-up. One month after surgery, IOP was 10 +/- 1.46 mmHg (range, 8-13) in the MT group and 12.12 +/- 1.63 mmHg (range, 8-14) in the AIGT group (Student's t test, P = 0.001). Three months after surgery, IOP was 11.5 +/- 1.59 mmHg (range, 8-14) and 12.75 +/- 1.57 mmHg (range, 10-16) in the MT and AIGT groups, respectively (Student's t test, P = 0.033). From the 6th to the 24th postoperative month, no statistically significant difference in IOP was found between the two groups. At the end of follow-up, 14 of 16 eyes (87.5%) of the AIGT group and 13 of the 16 eyes (81.25%) of the MT group showed an IOP < or = 14 mmHg. Ab-interno goniotrabeculotomy appears to be a viable and safe surgical treatment for adult POAG. More extended follow-up, however, and a larger series of patients are needed to ascertain the actual effectiveness of this procedure in adult POAG.

  19. Assessing depression outcomes in group practice clinics.

    PubMed Central

    Braswell, H R; Williamson, J W

    1979-01-01

    The application of a protocol for the initial assessment of medical care outcomes of geriatric depression management in four multispecialty group practice clinics is described. The clinical findings of this study are limited, but the protocol for the assessment of depression outcomes was found to be feasible, practical and acceptable in all four clinics. The success of the study has positive implications both for improving management of depressed clinic patients and for adapting this quality assurance approach to other health conditions and care settings. PMID:507262

  20. Clinical tuberculosis and treatment outcomes.

    PubMed

    Jordan, T S; Davies, P D

    2010-06-01

    The global targets for tuberculosis (TB) control set by the World Health Assembly (WHA) in 1991 were detection of at least 70% and cure of at least 85% of new sputum smear-positive TB cases by 2000, later revised to 2005. The DOTS strategy was introduced in the mid-1990s, and later became the cornerstone of the Stop TB Strategy, which was launched along with the Global Plan to Stop TB 2006-2015 in 2006. The Global Plan sets out how and to what extent the Stop TB Strategy should be implemented between 2006 and 2015 to achieve the TB-related Millennium Development Goal (MDG) to halt and reverse the incidence of TB by 2015 and the Stop TB Partnership targets to reduce TB prevalence and death rates to 50% of 1990 levels by 2015, and to eliminate TB as a public health concern by 2050. Treatment success and case detection rates are outcome indicators used to measure the effectiveness of TB control along with the impact indicators incidence, prevalence and death rates. Globally, the rate of treatment success for smear-positive cases treated exceeded the WHA global target of 85% for the first time in 2007. This review focuses on articles related to treatment outcome in TB published in the International Journal of Tuberculosis and Lung Disease in 2009.

  1. Evaluation of the XIENCE V everolimus eluting coronary stent system in the Asian population of the SPIRIT V single arm study. 2-year clinical follow-up data.

    PubMed

    Kaul, Upendra; Patel, Tejas M; Zambahari, Robaayah; Mullasari, Ajit S; Bahl, Vinay K; Stuteville, Marrianne; Dorange, Cécile; Veldhof, Susan; Grube, Eberhard

    2011-01-01

    Asian patients have a uniquely high risk for heart disease compared to other ethnicities. Past drug eluting stent trials have examined mainly populations of European heritage. As a significant proportion of the real world population in the SPIRIT V single arm study is Asian, the study provides insight into how this population responds to stenting with the XIENCE V Everolimus Eluting Coronary Stent (EES). 2,700 patients were enrolled at 93 sites in Europe, Asia Pacific and Canada between November 2006 and November 2007. 698 (26%) patients were recruited from Asian sites in India, China, Hong Kong, Malaysia, Singapore and Thailand. De novo coronary artery lesions of all patients were to be treated with up to 4 planned EES. Up to 2 year follow-up, major adverse cardiac events, myocardial infarction and target lesion revascularization rates were lower in the Asian subgroup than in the non-Asian subgroup. These results were mainly driven by better clinical outcomes in the Indian population. All populations showed similar low stent thrombosis rates. These findings demonstrate the safety and efficacy of the EES when used in a real-world Asian population, known to be at higher risk for heart disease.

  2. The SNAP trial: a randomised placebo-controlled trial of nicotine replacement therapy in pregnancy--clinical effectiveness and safety until 2 years after delivery, with economic evaluation.

    PubMed

    Cooper, Sue; Lewis, Sarah; Thornton, James G; Marlow, Neil; Watts, Kim; Britton, John; Grainge, Matthew J; Taggar, Jaspal; Essex, Holly; Parrott, Steve; Dickinson, Anne; Whitemore, Rachel; Coleman, Tim

    2014-08-01

    Smoking during pregnancy causes many adverse pregnancy and birth outcomes. Nicotine replacement therapy (NRT) is effective for cessation outside pregnancy but efficacy and safety in pregnancy are unknown. We hypothesised that NRT would increase smoking cessation in pregnancy without adversely affecting infants. To compare (1) at delivery, the clinical effectiveness and cost-effectiveness for achieving biochemically validated smoking cessation of NRT patches with placebo patches in pregnancy and (2) in infants at 2 years of age, the effects of maternal NRT patch use with placebo patch use in pregnancy on behaviour, development and disability. Randomised, placebo-controlled, parallel-group trial and economic evaluation with follow-up at 4 weeks after randomisation, delivery and until infants were 2 years old. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1 : 1 ratio. Participants, site pharmacies and all study staff were blind to treatment allocation. Seven antenatal hospitals in the Midlands and north-west England. Women between 12 and 24 weeks' gestation who smoked ≥ 10 cigarettes a day before and ≥ 5 during pregnancy, with an exhaled carbon monoxide (CO) reading of ≥ 8 parts per million (p.p.m.). NRT patches (15 mg per 16 hours) or matched placebo as an 8-week course issued in two equal batches. A second batch was dispensed at 4 weeks to those abstinent from smoking. self-reported, prolonged abstinence from smoking between a quit date and childbirth, validated at delivery by CO measurement and/or salivary cotinine (COT) (primary outcome). Infants, at 2 years: absence of impairment, defined as no disability or problems with behaviour and development. Economic: cost per 'quitter'. One thousand and fifty women enrolled (521 NRT, 529 placebo). There were 1010 live singleton births and 12 participants had live twins, while there were 14 fetal deaths and no birth data for 14

  3. Thinking About Clinical Outcomes in Medicaid

    PubMed Central

    Weimar, Dawn; Gray, Jeffrey; Davies, Bud

    2016-01-01

    As Medicaid expands in scope and influence, it is evolving toward being a “purchaser” of quality health care. This commentary discusses measurement and incentivization of clinical outcomes in Medicaid. Advantages and disadvantages of outcome versus process measures are discussed. Distinctions are drawn between the roles of Medicare and Medicaid, including the implications of the growth in Medicaid managed care. Medicaid's influence is particularly notable for obstetric, pediatric, newborn, and long-term care. We provide data on 3 Medicaid outcomes: potentially preventable hospital admissions, readmissions, and complications. The commentary concludes with suggestions for choosing and implementing outcome-oriented value-based purchasing initiatives in Medicaid. PMID:26945295

  4. Outcome instruments for prosthetics: clinical applications.

    PubMed

    Heinemann, Allen W; Connelly, Lauri; Ehrlich-Jones, Linda; Fatone, Stefania

    2014-02-01

    Outcome measurement is crucial to assuring high-quality patient services and improving the quality of services provided by prosthetists. This article summarizes recent evidence on the measurement properties of outcome measures, and updates previously published summaries of outcome instruments. The review focuses on measures of mobility, functional status, quality of life, and patient satisfaction, and includes both performance-based and patient-reported outcomes. Amputation-specific and general measures that are suitable for patients served by prosthetists are discussed. It is encouraging that responsiveness of measures is often reported, as this information is needed to improve clinical utility.

  5. Disability benefits and clinical outcomes among homeless veterans with psychiatric and substance abuse problems.

    PubMed

    Mares, Alvin S; Rosenheck, Robert A

    2007-02-01

    This study examined the relationship between disability payment status and clinical outcomes among 305 homeless veterans entering VA treatment. Disability status and clinical outcomes were characterized using self-report data at program entry, and quarterly for 2 years thereafter. Seeking or already receiving disability benefits at program entry was not associated with any of the 8 clinical outcomes examined. Those seeking or receiving disability benefits during the 2 years that followed showed more serious mental health problems and lower levels of mental health functioning, but no greater risk of substance use or not being employed nor worse housing outcomes than those who remained uninterested in applying for disability benefits. This study does not, therefore, support the notion that disability orientation results in poorer clinical outcomes, at least not among homeless veterans.

  6. Cognition in Patients With a Clinical Diagnosis of Parkinson Disease and Scans Without Evidence of Dopaminergic Deficit (SWEDD): 2-Year Follow-Up.

    PubMed

    Wyman-Chick, Kathryn A; Martin, Phillip K; Minár, Michal; Schroeder, Ryan W

    2016-12-01

    More than 10% of patients clinically diagnosed with Parkinson disease demonstrate normal dopamine uptake on dopamine transporter single-photon emission computed tomography (DaTscan), but little is known about how cognitive function differs between patients with dopamine deficiency on DaTscan and patients with scans without evidence of dopaminergic deficit (SWEDD). We compared the cognitive function of these two groups of patients over 2 years. We retrospectively analyzed data obtained from the Parkinson's Progression Markers Initiative on 309 participants clinically diagnosed with idiopathic Parkinson disease who had scored in the normal range on the Montreal Cognitive Assessment at baseline and had completed 1- and 2-year follow-up visits. We compared the Montreal Cognitive Assessment scores at 1 and 2 years between the 42 participants with SWEDD and the 267 with dopamine deficiency. Mean cognitive scores did not differ significantly between groups at 1 year, but at 2 years the participants with SWEDD performed more poorly. At 2 years, 31% of the participants with SWEDD versus 15% of those with dopamine deficiency had statistically reliable cognitive impairment. This study provides evidence that some individuals clinically diagnosed with idiopathic Parkinson disease but with SWEDD demonstrate early cognitive decline. The results also suggest that recently diagnosed patients with SWEDD may be at even greater risk for cognitive decline than patients with DaTscan-confirmed early-stage Parkinson disease. While patients with SWEDD likely represent a heterogeneous group of etiologies, our results highlight the need to monitor these patients' cognitive function over time.

  7. Hand bone loss as an outcome measure in established rheumatoid arthritis: 2-year observational study comparing cortical and total bone loss

    PubMed Central

    Hoff, Mari; Haugeberg, Glenn; Kvien, Tore K

    2007-01-01

    The aim of this 2-year longitudinal observational study was to explore hand bone loss as a disease outcome measure in established rheumatoid arthritis (RA). A cohort of 215 patients with RA (170 women and 45 men, aged 20–70 years) were recruited from the Oslo RA registry and studied for changes in hand bone mass during a 2-year follow-up. Digital X-ray radiogrammetry (DXR) was used to measure cortical hand bone mineral density (BMD) and metacarpal cortical index, whereas dual-energy X-ray absorptiometry (DXA) was used to assess whole hand BMD, which measures total cortical and trabecular bone. DXA-BMD total hip and spine and informative data for disease and therapy were also collected. Hand bone loss could be revealed over a 2-year follow-up measured by DXR-BMD (-0.90%, P < 0.01), but not by DXA-BMD (0.00%, P = 0.87). DXA-BMD hand bone loss was only observed in patients with disease duration ≤3 years and not in patients with longer disease duration (-0.96% versus 0.24%, P < 0.01), whereas loss of DXR-BMD was independent of disease duration. Disease activity (measured by the disease activity score including 28 joints) independently predicted loss of DXR-BMD but not changes in the DXA-BMD hand in the multivariate analysis. The change in DXR metacarpal cortical index was highly correlated to DXR-BMD (r = 0.94, P < 0.001). These data suggest that DXR-BMD may be a more appropriate technique to identify RA-related bone involvement in hands compared with DXA-BMD measurement, but further studies are needed to explore this hypothesis. PMID:17705865

  8. Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.

    PubMed

    Hodi, F Stephen; Chesney, Jason; Pavlick, Anna C; Robert, Caroline; Grossmann, Kenneth F; McDermott, David F; Linette, Gerald P; Meyer, Nicolas; Giguere, Jeffrey K; Agarwala, Sanjiv S; Shaheen, Montaser; Ernstoff, Marc S; Minor, David R; Salama, April K; Taylor, Matthew H; Ott, Patrick A; Horak, Christine; Gagnier, Paul; Jiang, Joel; Wolchok, Jedd D; Postow, Michael A

    2016-11-01

    ClinicalTrials.gov, number NCT01927419, and is ongoing but no longer enrolling patients. Between Sept 16, 2013, and Feb 6, 2014, we screened 179 patients and enrolled 142, randomly assigning 95 patients to nivolumab plus ipilimumab and 47 to ipilimumab alone. In each treatment group, one patient no longer met the study criteria following randomisation and thus did not receive study drug. At a median follow-up of 24·5 months (IQR 9·1-25·7), 2-year overall survival was 63·8% (95% CI 53·3-72·6) for those assigned to nivolumab plus ipilimumab and 53·6% (95% CI 38·1-66·8) for those assigned to ipilimumab alone; median overall survival had not been reached in either group (hazard ratio 0·74, 95% CI 0·43-1·26; p=0·26). Treatment-related grade 3-4 adverse events were reported in 51 (54%) of 94 patients who received nivolumab plus ipilimumab compared with nine (20%) of 46 patients who received ipilimumab alone. The most common treatment-related grade 3-4 adverse events were colitis (12 [13%] of 94 patients) and increased alanine aminotransferase (ten [11%]) in the combination group and diarrhoea (five [11%] of 46 patients) and hypophysitis (two [4%]) in the ipilimumab alone group. Serious grade 3-4 treatment-related adverse events were reported in 34 (36%) of 94 patients who received nivolumab plus ipilimumab (including colitis in ten [11%] of 94 patients, and diarrhoea in five [5%]) compared with four (9%) of 46 patients who received ipilimumab alone (including diarrhoea in two [4%] of 46 patients, colitis in one [2%], and hypophysitis in one [2%]). No new types of treatment-related adverse events or treatment-related deaths occurred in this updated analysis. Although follow-up of the patients in this study is ongoing, the results of this analysis suggest that the combination of first-line nivolumab plus ipilimumab might lead to improved outcomes compared with first-line ipilimumab alone in patients with advanced melanoma. The results suggest encouraging survival

  9. Assessment of clinical competence of medical students using the objective structured clinical examination: first 2 years' experience in Taipei Veterans General Hospital.

    PubMed

    Huang, Chin-Chou; Chan, Cho-Yu; Wu, Chun-Lien; Chen, Ya-Lin; Yang, Hui-Wen; Huang, Chia-Chang; Chen, Chen-Huan; Huang, William J; Lee, Fa-Yauh; Lin, Shing-Jong; Chen, Jaw-Wen

    2010-11-01

    Competence-oriented education is currently the mainstream method of teaching clinical medical education. The objective structured clinical examination (OSCE) is a widely employed and accepted tool to measure the clinical competence of medical students. We describe the first 2 years' experience of OSCE in Taipei Veterans General Hospital. At Taipei Veterans General Hospital, every 7(th)-year medical student has taken the OSCE since 2006. There were 15 stations in the first 2 years' OSCEs. In years 1 and 2, 133 and 132 students were assessed by the OSCE, respectively. The content of the OSCE included internal medicine, surgery, pediatrics, obstetrics and gynecology, communication, and emergency training. All categories and results of examinees' evaluation at each station were recorded inclusively and compared statistically. The average scores of students from the 15 stations ranged from 47.7 ± 16.4 to 93.7 ± 8.5 in 2007. The score for communication skills was the lowest, whereas the score for Micro-Sim was the highest. Communication skills and electrocardiography interpretation were the 2 categories in which most of the students failed. A reliability analysis was conducted of the 2007 OSCE questions. The overall score and reliability (Cronbach's reliability) was 0.641. The difference between the impacts on reliability after deleting a test item ranged from 0.59 to 0.65 for all stations. This meant that every station had a similar impact on reliability after being deleted. The squared multiple correlation, R(2), of the reliability of each item was between 0.12 and 0.49, with chest X-ray interpretation being the lowest. The item-total correlation was between 0.10 and 0.41, with interactive case being the lowest. The OSCE is an effective method for assessing the clinical competence of medical students. The OSCE could be improved further by modifying the examination questions and promoting effective training for standardized patients and examiners. Copyright © 2010

  10. 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

  11. Comparable Outcomes After Bucket-Handle Meniscal Repair and Vertical Meniscal Repair Can Be Achieved at a Minimum 2 Years' Follow-up.

    PubMed

    Moatshe, Gilbert; Cinque, Mark E; Godin, Jonathan A; Vap, Alexander R; Chahla, Jorge; LaPrade, Robert F

    2017-08-01

    Meniscal tears can lead to significant pain and disability, necessitating surgical treatment. Nondisplaced vertical tears are usually smaller in size and can be repaired in most cases; however, bucket-handle tears are usually larger and displaced, and the repair of these tears can be challenging. Purpose/Hypothesis: The purpose was to report the outcomes after inside-out vertical mattress suture meniscal repair of bucket-handle tears and to compare these outcomes with those of patients who underwent repair of nondisplaced vertical meniscal tears with a minimum of 2 years' follow-up. The hypothesis was that the outcomes of bucket-handle tear repair would be comparable with those of nondisplaced vertical meniscal tear repair. Cohort study; Level of evidence, 3. Patients who underwent inside-out repair of a bucket-handle meniscal tear or a nondisplaced vertical meniscal tear with a minimum 2 years' follow-up were included in this study. Patients were excluded if they had a diagnosis of a meniscal root tear, underwent a concomitant procedure for a chondral injury, or underwent previous surgical treatment of the same meniscus. Subjective questionnaires were administered preoperatively and postoperatively, including the Lysholm score, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Short Form-12 (SF-12) physical component summary (PCS) and mental component summary (MCS), the Tegner activity scale, and patient satisfaction. Thirty-two patients underwent repair for vertical meniscal tears (mean, 7 sutures), while 38 patients underwent repair for bucket-handle meniscal tears (mean, 11 sutures), with a mean follow-up of 3.1 years (range, 2-6 years). There were no significant differences in the preoperative outcome scores between the 2 groups. Significant improvements in patient-reported outcome scores from preoperatively to postoperatively were found in both groups. A direct comparison of the bucket-handle tear group to the vertical tear group

  12. Amplitude-Integrated Electroencephalography Improves the Identification of Infants with Encephalopathy for Therapeutic Hypothermia and Predicts Neurodevelopmental Outcomes at 2 Years of Age.

    PubMed

    Skranes, Janne Helen; Løhaugen, Gro; Schumacher, Eva Margrethe; Osredkar, Damjan; Server, Andres; Cowan, Frances Mary; Stiris, Tom; Fugelseth, Drude; Thoresen, Marianne

    2017-08-01

    To examine whether using an amplitude-integrated electroencephalography (aEEG) severity pattern as an entry criterion for therapeutic hypothermia better selects infants with hypoxic-ischemic encephalopathy and to assess the time-to-normal trace for aEEG and magnetic resonance imaging (MRI) lesion load as 24-month outcome predictors. Forty-seven infants meeting Norwegian therapeutic hypothermia guidelines were enrolled prospectively. Eight-channel EEG/aEEG was recorded from 6 hours until after rewarming, and read after discharge. Neonatal MRI brain scans were scored for summated (range 0-11) regional lesion load. A poor outcome at 2 years was defined as death or a Bayley Scales of Infant-Toddler Development cognitive or motor composite score of <85 or severe hearing or visual loss. Three severity groups were defined from the initial aEEG; continuous normal voltage (CNV; n = 15), discontinuous normal voltage (DNV; n = 18), and a severe aEEG voltage pattern (SEVP; n = 14). Any seizure occurrence was 7% CNV, 50% DNV, and 100% SEVP. Infants with SEVP with poor vs good outcome had a significantly longer median (IQR) time-to-normal trace: 58 hours (9-79) vs 18 hours (12-19) and higher MRI lesion load: 10 (3-10) vs 2 (1-5). A poor outcome was noted in 3 of 15 infants with CNV, 4 of 18 infants with DNV, and 8 of 14 infants with SEVP. Using multiple stepwise linear regression analyses including only infants with abnormal aEEG (DNV and SEVP), MRI lesion load significantly predicted cognitive and motor scores. For the SEVP group alone, time-to-normal trace was a stronger outcome predictor than MRI score. No variable predicted outcome in infants with CNV. Selection of infants with encephalopathy for therapeutic hypothermia after perinatal asphyxia may be improved by including only infants with an early moderate or severely depressed background aEEG trace. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Near-Infrared Spectroscopy Monitoring, Superior Vena Cava Flow, and Neurodevelopmental Outcome at 2 years in a Cohort of Very Low-Birth-Weight Infants.

    PubMed

    Cerbo, Rosa Maria; Orcesi, Simona; Scudeller, Luigia; Borellini, Martina; Croci, Carolina; Ravelli, Claudia; Masa, Giulia; Paolillo, Piermichele; Manzoni, Paolo; Balottin, Umberto; Stronati, Mauro

    2016-09-01

    Objective We aimed at assessing the association between superior vena cava flow (SVCf), regional (cerebral) tissue oxygen saturation (rSO2), and cerebral fractional oxygen extraction (CFOE) during the first 48 hours of life and 2-years neurodevelopmental outcome of very low-birth-weight infants (VLBW). Methods We prospectively studied 60 VLBW infants admitted to our neonatal intensive care unit; rSO2 was continuously monitored with near-infrared spectroscopy during the first 48 hours of life, SVCf was measured at 4 to 6, 12, 24, and 48 hours, and CFOE was calculated. Neurodevelopmental outcome was assessed at 24 months corrected age. Results The mean gestational age at birth was 27.9 weeks (standard deviation: 2.4); 8 infants died in the first 3 months of life, 6 were lost to follow-up, 46 survived and were followed up. At 24 months, 6 (13%) and 7 (15.2%) infants developed minor and major sequelae, respectively. Infants who died had higher CFOE (p < 0.001) and lower SVCf (p < 0.001) than infants surviving with sequelae. In turn, these had higher SVCf between 24 and 48 hours than those without sequelae (p < 0.001). Conclusion SVCf, rSO2, and CFOE patterns in the first days of life suggest cerebral hyperperfusion, related to loss of autoregulation and/or use of inotropic drugs, as a potential mechanism of cerebral injury.

  14. Neurodevelopmental outcome at 2 years for preterm children born at 22 to 34 weeks’ gestation in France in 2011: EPIPAGE-2 cohort study

    PubMed Central

    Marchand-Martin, Laetitia; Arnaud, Catherine; Kaminski, Monique; Resche-Rigon, Matthieu; Lebeaux, Cécile; Bodeau-Livinec, Florence; Morgan, Andrei S; Goffinet, François; Marret, Stéphane; Ancel, Pierre-Yves

    2017-01-01

    Objectives To describe neurodevelopmental outcomes at 2 years corrected age for children born alive at 22-26, 27-31, and 32-34 weeks’ gestation in 2011, and to evaluate changes since 1997. Design Population based cohort studies, EPIPAGE and EPIPAGE-2. Setting France. Participants 5567 neonates born alive in 2011 at 22-34 completed weeks’ gestation, with 4199 survivors at 2 years corrected age included in follow-up. Comparison of outcomes reported for 3334 (1997) and 2418 (2011) neonates born alive in the nine regions participating in both studies. Main outcome measures Survival; cerebral palsy (2000 European consensus definition); scores below threshold on the neurodevelopmental Ages and Stages Questionnaire (ASQ; at least one of five domains below threshold) if completed between 22 and 26 months corrected age, in children without cerebral palsy, blindness, or deafness; and survival without severe or moderate neuromotor or sensory disabilities (cerebral palsy with Gross Motor Function Classification System levels 2-5, unilateral or bilateral blindness or deafness). Results are given as percentage of outcome measures with 95% confidence intervals. Results Among 5170 liveborn neonates with parental consent, survival at 2 years corrected age was 51.7% (95% confidence interval 48.6% to 54.7%) at 22-26 weeks’ gestation, 93.1% (92.1% to 94.0%) at 27-31 weeks’ gestation, and 98.6% (97.8% to 99.2%) at 32-34 weeks’ gestation. Only one infant born at 22-23 weeks survived. Data on cerebral palsy were available for 3599 infants (81.0% of the eligible population). The overall rate of cerebral palsy at 24-26, 27-31, and 32-34 weeks’ gestation was 6.9% (4.7% to 9.6%), 4.3% (3.5% to 5.2%), and 1.0% (0.5% to 1.9%), respectively. Responses to the ASQ were analysed for 2506 children (56.4% of the eligible population). The proportion of children with an ASQ result below threshold at 24-26, 27-31, and 32-34 weeks’ gestation were 50.2% (44.5% to 55.8%), 40.7% (38

  15. 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…

  16. A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study.

    PubMed

    Pagliarini, Sergio; Beatty, Stephen; Lipkova, Blandina; Perez-Salvador Garcia, Eduardo; Reynders, Stefaan; Gekkieva, Margarita; Si Bouazza, Abdelkader; Pilz, Stefan

    2014-01-01

    Purpose. To assess the safety profile of ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice. Methods. This 2-year, multicentre, observational study was conducted to capture real-world early practice and outcomes across Europe, shortly after European licensing of ranibizumab for nAMD. Being observational in nature, the study did not impose diagnostic/therapeutic interventions/visit schedule. Patients were to be treated as per the EU summary of product characteristics (SmPC) in effect during the study. Key outcome measures were incidence of selected adverse events (AEs), treatment exposure, bilateral treatment, compliance to the EU SmPC, and best-corrected visual acuity (BCVA) over 2 years. Results. 755 of 770 patients received treatment. Ranibizumab was generally well tolerated with low incidence of selected AEs (0%-1.9%). Patients received 6.2 (mean) injections and 133 patients received bilateral treatment over 2 years. Protocol deviation to treatment compliance was reported in majority of patients. The observed decline in mean BCVA (Month 12, +1.5; Month 24, -1.3 letters) may be associated with undertreatment as suggested by BCVA subgroup analysis. Conclusion. The EPICOHORT study conducted in routine clinical practice reinforces the well-established safety profile of ranibizumab in nAMD. In early European practice it appeared that the nAMD patients were undertreated.

  17. [Can epidemiological factors affect the 2-year outcomes after surgery for degenerative lumbar disease in terms of quality of life, disability and post-surgical pain?].

    PubMed

    Lozano-Álvarez, C; Pérez-Prieto, D; Saló-Bru, G; Molina, A; Lladó, A; Cáceres, E; Ramírez, M

    2014-01-01

    To evaluate the influence of epidemiological factors on the outcomes of surgery for degenerative lumbar disease in terms of quality of life, disability and chronic pain. A total of 263 patients who received surgery for degenerative lumbar disease (2005-2008) were included in the study. The epidemiological data collected were age, gender, employment status, and co-morbidity. The SF-36, Oswestry Disability Index (ODI), Core Outcomes Measures Index (COMI), and VAS score for lumbar and sciatic pain were measure before and 2 years after surgery. The correlation between epidemiological data and questionnaire results, as well as any independent prognostic factors, were assessed in the data analysis. The mean age of the patients was 54.0 years (22-86), and 131 were female (49.8%). There were 42 (16%) lost to follow-up. Statistically significant correlations (P<.05) were observed between age, gender, co-morbidity, permanent sick leave, and pre-operative pain with changes in the ODI, COMI, physical and SF-36 mental scales, and lumbar and sciatic VAS. Linear regression analysis showed permanent sick leave and age as predictive factors of disability (β=14.146; 95% CI: 9.09 - 29.58; P<.01 and β=0.334; 95% CI: 0.40 - 0.98, P<.05, respectively), and change in quality of life (β=-8.568; 95% CI: -14.88 - -2.26; p<.01 and β=-0.228, IC 95% CI: -0.40 - -0.06, P<.05, respectively). Based on our findings, age and permanent sick leave have to be considered as negative epidemiologic predictive factors of the outcome of degenerative lumbar disease surgery. Copyright © 2012 SECOT. Published by Elsevier Espana. All rights reserved.

  18. Exhaled nitric oxide measurements in the first 2 years of life: methodological issues, clinical and epidemiological applications

    PubMed Central

    Gabriele, Carmelo; de Benedictis, Fernando M; de Jongste, Johan C

    2009-01-01

    Fractional exhaled nitric oxide (FeNO) is a useful tool to diagnose and monitor eosinophilic bronchial inflammation in asthmatic children and adults. In children younger than 2 years of age FeNO has been successfully measured both with the tidal breathing and with the single breath techniques. However, there are a number of methodological issues that need to be addressed in order to increase the reproducibility of the FeNO measurements within and between infants. Indeed, a standardized method to measure FeNO in the first 2 years of life would be extremely useful in order to meaningfully interpret FeNO values in this age group. Several factors related to the measurement conditions have been found to influence FeNO, such as expiratory flow, ambient NO and nasal contamination. Furthermore, the exposure to pre- and postnatal risk factors for respiratory morbidity has been shown to influence FeNO values. Therefore, these factors should always be assessed and their association with FeNO values in the specific study population should be evaluated and, eventually, controlled for. There is evidence consistently suggesting that FeNO is increased in infants with family history of atopy/atopic diseases and in infants with recurrent wheezing. These findings could support the hypothesis that eosinophilic bronchial inflammation is present at an early stage in those infants at increased risk of developing persistent respiratory symptoms and asthma. Furthermore, it has been shown that FeNO measurements could represent a useful tool to assess bronchial inflammation in other airways diseases, such as primary ciliary dyskinesia, bronchopulmonary dysplasia and cystic fibrosis. Further studies are needed in order to improve the reproducibility of the measurements, and large prospective studies are warranted in order to evaluate whether FeNO values measured in the first years of life can predict the future development of asthma or other respiratory diseases. PMID:19712438

  19. Early postoperative systemic inflammatory response is an important determinant for adverse 2-year neurodevelopment-associated outcomes after the Norwood procedure.

    PubMed

    Li, Xiaohui; Robertson, Charlene M T; Yu, Xiaoyang; Cheypesh, Andriy; Dinu, Irina A; Li, Jia

    2014-07-01

    This study investigated the relationship between early postoperative serum C-reactive protein (CRP) levels, a marker of systemic inflammatory response, and 2-year neurodevelopment-associated outcomes among survivors after undergoing the Norwood procedure. Among 53 neonates with hypoplastic left heart syndrome undergoing the Norwood procedure during 2003-2009, CRP was measured in 43 patients twice weekly within postoperative day 20. Two-year cognition, language, and motor scores were assessed with Bayley Scales of Infant and Toddler Development III in 26 patients (9 deaths, 2 lost, and 6 assessed with Bayley Scales of Infant Development II). Peak CRP levels of the 26 patients were recorded, with peak total and differential white blood cell counts (lowest lymphocytes) and glucose. Demographic data included age at surgery, socioeconomic status of the families, durations of cardiopulmonary bypass and aortic crossclamp, deep hypothermic circulatory arrest, and intensive care unit stay. The cognitive score was 91 ± 13, language score was 86 ± 13, and motor score was 85 ± 17. The peak CRP level was 79 ± 37 mg/L. Univariate regression showed that the cognitive score significantly and negatively correlated with peak CRP level (P = .004), and trended to a negative correlation with age at surgery (P = .097). The language score significantly and negatively correlated with peak CRP level (P < .0001) and age (P = .005). The motor score trended to a negative correlation with age (P = .08). Multivariate regression showed that both cognitive and language scores significantly and negatively correlated only with peak CRP level (P < .01 for both). The magnitude of systemic inflammatory response, among the perioperative factors examined, may be an important determinant for adverse 2-year cognition and language outcomes after the Norwood procedure. Confirmatory studies in larger populations, including those undergoing other types of cardiac surgeries, are

  20. Randomized controlled trial of the 2-year clinical performance of a silorane-based resin composite in class 1 posterior restorations.

    PubMed

    Efes, Begüm Güray; Yaman, Batu Can; Gurbuz, Ozge; Gumuştaş, Burak

    2013-02-01

    To compare the 2-year clinical performance of a silorane-based resin composite with that of an established nanoceramic resin composite for class 1 posterior restorations. In this randomized controlled study, 100 class 1 molar cavities were prepared in 50 subjects. Each subject received a restoration with Filtek Silorane and Ceram.X Duo in different quadrants. The restorations were evaluated using the modified USPHS criteria at baseline and 6, 12, and 24 months. Parametric changes over the 2-year period were assessed with the Friedman test. The baseline and recall scores were compared by using the Wilcoxon signed-rank test (P < 0.05). No subject developed secondary caries or postoperative sensitivity. Further, the resin composites showed no significant differences in all the evaluated parameters over 2 years (P > 0.05). At 2 years, four Filtek Silorane and seven Ceram.X Duo restorations had Bravo scores for anatomic form, marginal adaptation, and surface texture (P < 0.05); however, these changes were mainly the effect of scoring shifts from Alfa to Bravo. Overall, both materials showed good clinical results with predominantly Alfa scores.

  1. Walk-in telemental health clinics improve access and efficiency: a 2-year follow-up analysis.

    PubMed

    Neufeld, Jonathan; Case, Ruth

    2013-12-01

    Telemedicine has demonstrated potential to improve access and quality of mental health services in underserved areas. Use of telemedicine to deliver health services may enable a range of synergistic innovations in care practices, but such innovations will require rigorous evaluation. We evaluated a telemental health program designed to increase access by eliminating clinician travel time in a multisite rural community mental health center. The program included both traditionally scheduled and "open scheduled" clinics provided via telemedicine. An initial 13-month evaluation showed better access, quality, and sustainability compared with similar services delivered using traditional methods available elsewhere within the organization. A 24-month follow-up analysis was undertaken to determine if initial findings remained consistent. Telemedicine clinics continued to show remarkably consistent advantages in both access and quality compared with traditional services. Cost-efficiency gains were also robust, maintaining a 20-percentage-point advantage in conversion of scheduled time to billable time over traditional clinics. Much of this advantage was attributable to the 20% of clinic volume that was open-scheduled or "walk-in" in nature. This study confirms earlier findings that telemedicine technology can support synergistic innovations in service format (such as "open scheduling") and maintain measurable advantages in access and quality along with cost-efficiencies past the initial implementation period.

  2. Walk-In Telemental Health Clinics Improve Access and Efficiency: A 2-Year Follow-Up Analysis

    PubMed Central

    Case, Ruth

    2013-01-01

    Abstract Introduction: Telemedicine has demonstrated potential to improve access and quality of mental health services in underserved areas. Use of telemedicine to deliver health services may enable a range of synergistic innovations in care practices, but such innovations will require rigorous evaluation. Materials and Methods: We evaluated a telemental health program designed to increase access by eliminating clinician travel time in a multisite rural community mental health center. The program included both traditionally scheduled and “open scheduled” clinics provided via telemedicine. An initial 13-month evaluation showed better access, quality, and sustainability compared with similar services delivered using traditional methods available elsewhere within the organization. A 24-month follow-up analysis was undertaken to determine if initial findings remained consistent. Results: Telemedicine clinics continued to show remarkably consistent advantages in both access and quality compared with traditional services. Cost-efficiency gains were also robust, maintaining a 20-percentage-point advantage in conversion of scheduled time to billable time over traditional clinics. Much of this advantage was attributable to the 20% of clinic volume that was open-scheduled or “walk-in” in nature. Conclusions: This study confirms earlier findings that telemedicine technology can support synergistic innovations in service format (such as “open scheduling”) and maintain measurable advantages in access and quality along with cost-efficiencies past the initial implementation period. PMID:24050609

  3. Coronally positioned flap for root coverage in smokers and non-smokers: stability of outcomes between 6 months and 2 years.

    PubMed

    Silva, Cléverson O; de Lima, Antônio Fernando Martorelli; Sallum, Antônio Wilson; Tatakis, Dimitris N

    2007-09-01

    Smoking adversely affects the short-term outcomes of coronally positioned flap (CPF) root coverage procedures, but the long-term stability of this procedure in smokers has not been studied. The objective of this study was to evaluate the effect of smoking on the long-term outcomes of CPF in recession treatment. CPF was used to treat a Miller Class I defect in a maxillary canine or premolar in 10 current smokers (> or =10 cigarettes daily for > or =5 years) and 10 non-smokers (never smokers). At baseline and 6, 12, and 24 months, clinical parameters, including probing depth (PD), clinical attachment level (CAL), recession depth (RD), and width of keratinized tissue (KT), were determined. Intragroup analysis showed that CPF failed to maintain the gingival margin at the initially achieved position. RD significantly increased in smokers (from 0.84 +/- 0.49 to 1.28 +/- 0.58 mm) and in non-smokers (from 0.22 +/- 0.29 to 0.50 +/- 0.41 mm) between 6 and 24 months. Further analysis showed that 50% of smokers and 10% of non-smokers lost between 0.5 and 1.0 mm of root coverage in the same period. Intergroup analysis showed that smokers had significantly greater residual recession (P = 0.001) at 24 months. Both smokers and non-smokers lost CAL and experienced decreases in KT. The long-term stability of CPF outcomes is less than desirable, particularly in smokers. Two years after a CPF procedure, smokers have significantly greater residual recession compared to non-smokers both statistically and clinically.

  4. Fundamentals of Clinical Outcomes Assessment for Spinal Disorders: Clinical Outcome Instruments and Applications.

    PubMed

    Vavken, Patrick; Ganal-Antonio, Anne Kathleen B; Quidde, Julia; Shen, Francis H; Chapman, Jens R; Samartzis, Dino

    2015-08-01

    Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of "personalized spine care."

  5. Fundamentals of Clinical Outcomes Assessment for Spinal Disorders: Clinical Outcome Instruments and Applications

    PubMed Central

    Vavken, Patrick; Ganal-Antonio, Anne Kathleen B.; Quidde, Julia; Shen, Francis H.; Chapman, Jens R.; Samartzis, Dino

    2015-01-01

    Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of “personalized spine care.” PMID:26225283

  6. Genotypic identification of mycobacteria by nucleic acid sequence determination: report of a 2-year experience in a clinical laboratory.

    PubMed Central

    Kirschner, P; Springer, B; Vogel, U; Meier, A; Wrede, A; Kiekenbeck, M; Bange, F C; Böttger, E C

    1993-01-01

    Clinical isolates of Mycobacterium spp. were identified by direct sequence determination of 16S rRNA gene fragments amplified by polymerase chain reaction. Identification was based on a hypervariable region within the 16S rRNA gene in which mycobacterial species are characterized by species-specific nucleotide sequences. A manually aligned data base including the signature sequences of 52 species of mycobacteria easily allowed rapid and correct identification. The results of this study demonstrate that polymerase chain reaction-mediated direct sequence determination can be used as a rapid and reliable method for the identification of mycobacteria in the clinical laboratory. In addition, the prompt recognition of previously undescribed species is now feasible. PMID:7505291

  7. A 2-year clinical evaluation of fluoride-containing pit and fissure sealants placed with an invasive technique.

    PubMed

    do Rego, M A; de Araújo, M A

    1996-02-01

    The aim of this study was to clinically evaluate fluoride-containing sealants in teeth subjected to minimal enamel reduction (preventive resin restorations). Two hundred fourteen sealants (109 FluroShield and 105 Delton Fluor) were applied in 153 teeth of 32 subjects. The sealants were evaluated for superficial irregularities, marginal adaptation, retention, and caries after 6, 12, 18, and 24 months. After 6, 12, and 18 months, the attendance at recall was 100.00%. After 24 months, 93.75% of subjects returned for reevaluation. Although total or partial loss of sealant occurred in a few instances, no occlusal caries was found in any tooth at any recall. No statistically significant differences in the results of the clinical evaluation were found between sealant in the maxillary and mandibular dentitions.

  8. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial

    PubMed Central

    Lam, Carly Siu Yin; Tang, Wing Chun; Tse, Dennis Yan-Yin; Tang, Ying Yung; To, Chi Ho

    2014-01-01

    Aims To determine if ‘Defocus Incorporated Soft Contact’ (DISC) lens wear slows childhood myopia progression. Methods A 2-year double-blind randomised controlled trial was carried out in 221 children aged 8–13 years, with myopia between −1.00 and −5.00 Dioptres (D) and astigmatism ≤1.00 D. Subjects were randomly assigned to the DISC (n=111) or single vision (SV; n=110) contact lens group. DISC lenses incorporated concentric rings, which provided an addition of +2.50 D, alternating with the normal distance correction. Refractive error (cycloplegic autorefraction) and axial length were measured at 6-month intervals. Differences between groups were analysed using unpaired t test. Results In total, 128 children completed the study, n=65 in the DISC group and n=63 in the SV group. Myopia progressed 25% more slowly for children in the DISC group compared with those in the control group (0.30 D/year; 95% CI −0.71 to −0.47 vs 0.4 D/year; 95% CI −0.93 to −0.65, p=0.031). Likewise, there was less axial elongation for children in the DISC versus SV groups (0.13 mm/year; 95% CI 0.20 to 0.31 vs 0.18 mm/year; 95% CI 0.30 to 0.43, p=0.009). Treatment effect correlated positively with DISC lens wearing time (r=0.342; p=0.005). Indeed, myopia in children who wore the DISC lenses for five or more hours/day progressed 46% (mean difference=−0.382 D, p=0.001; 95% CI −0.59 to −0.17) less than those in the SV group. Conclusions The daily wearing of DISC lens significantly slowed myopia progression and axial elongation in Hong Kong schoolchildren. The findings demonstrated that simultaneous clear vision with constant myopic defocus can retard myopia progression. PMID:24169657

  9. Report of the Primary Outcomes for Gait Mechanics in Men of the ACL-SPORTS Trial: Secondary Prevention With and Without Perturbation Training Does Not Restore Gait Symmetry in Men 1 or 2 Years After ACL Reconstruction.

    PubMed

    Capin, Jacob John; Zarzycki, Ryan; Arundale, Amelia; Cummer, Kathleen; Snyder-Mackler, Lynn

    2017-02-21

    Movement asymmetries during walking are common after anterior cruciate ligament (ACL) injury and reconstruction and may influence the early development of posttraumatic osteoarthritis. Preoperative neuromuscular training (like perturbation training, which is neuromuscular training requiring selective muscle activation in response to surface perturbations) improves gait asymmetries and functional outcomes among people who are ACL-deficient, but the effect of postoperative perturbation training on gait mechanics after ACL reconstruction is unknown. Among men undergoing ACL reconstruction, we sought to compare strength, agility, and secondary prevention (SAP) treatment with SAP plus perturbation training (SAP+PERT) with respect to (1) gait mechanics; and (2) elimination of gait asymmetries 1 and 2 years after ACL reconstruction. Forty men were randomized into a SAP group or a SAP+PERT group after ACL reconstruction and before returning to preinjury activities. Participants were required to achieve ≥ 80% quadriceps muscle strength symmetry, minimal knee effusion, full ROM, no reports of pain, and completion of a running progression (all between 3 and 9 months postoperatively) before enrollment. Of 94 potentially eligible athletic male patients evaluated < 9 months after ACL reconstruction, 54 were excluded for prespecified reasons. Participants underwent motion analysis during overground walking at 1 and 2 years postoperatively. Variables of interest included (1) sagittal and frontal plane hip and knee angles and moments at peak knee flexion angle; (2) sagittal plane hip and knee angles and moments at peak knee extension angle; (3) sagittal plane hip and knee excursion during weight acceptance; and (4) sagittal plane hip and knee excursion during midstance. We also calculated the proportion of athletes in each group who walked with clinically meaningful interlimb asymmetry in sagittal plane hip and knee variables and compared these proportions using odds ratios

  10. Implant-connected versus tooth-connected implant-supported partial dentures: 2-year clinical and radiographic comparative evaluation.

    PubMed

    Mostafa, Tamer Mohamed; El-Sheikh, Mohamed M; Abd El-Fattah, Fadel

    2015-01-01

    The purpose of this study was to clinically and radiographically compare implant-connected and tooth-connected implant-supported fixed-detachable mandibular partial dentures. Twenty partially edentulous patients (age range: 25 to 50 years) with mandibular Kennedy Class II configurations were equally divided into two groups receiving a three-unit, fixed-detachable, screw-retained partial denture. Group 1 comprised patients with unilateral missing mandibular molars and premolars. Two implants were placed at the mandibular first premolar and first molar areas. Group 2 comprised patients with missing mandibular molars and second premolars. An implant was placed at the mandibular first molar area, the first premolar was prepared, and a coping was cemented to the tooth with permanent cement. Each case was evaluated clinically and radiographically at baseline (partial denture insertion) and after 6, 12, and 24 months. Data were collected and statistically analyzed using repeated-measures one-way and two-way analysis of variance tests. There was no statistically significant difference between the two groups (P > .05). The implant-tooth-supported prosthesis provided an equally predictable treatment option compared to the totally implant-supported prosthesis in terms of implant survival and loss of marginal bone.

  11. Risedronate Prevents Bone Loss in Breast Cancer Survivors: A 2-Year, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Greenspan, Susan L.; Brufsky, Adam; Lembersky, Barry C.; Bhattacharya, Rajib; Vujevich, Karen T.; Perera, Subashan; Sereika, Susan M.; Vogel, Victor G.

    2014-01-01

    Purpose Limited data are available on the efficacy of oral bisphosphonate therapy in breast cancer survivors. Our goal was to examine prevention of breast cancer–related bone loss in this cohort. Patients and Methods Eighty-seven postmenopausal women after chemotherapy for breast cancer were randomly assigned to once-weekly risedronate 35 mg or placebo for 24 months. Outcomes included bone mineral density (BMD) and turnover markers. Results At study initiation, 13% of patients were on an aromatase inhibitor (AI). After 24 months, there were differences of 1.6 to 2.5% (P < .05) at the spine and hip BMD between the placebo and risedronate groups. At study completion, 44% were on an AI. Adjusting for an AI, women on placebo plus AI had a decrease in BMD of (mean ± SE) 4.8% ± 0.8% at the spine and 2.8% ± 0.5% at the total hip (both P < .001). In women on risedronate + AI, the spine decreased by 2.4% ± 1.1% (P < .05) and was stable at the hip. Women in the placebo group not on an AI, maintained BMD at the spine, and had a 1.2% ± 0.5% loss at the total hip (P < .05). Women who received risedronate but no AI had the greatest improvement in BMD of 2.2% ± 0.9% (P < .05) at the total hip. Bone turnover was reduced with risedronate. There were no differences in adverse events between the groups. Conclusion We conclude that in postmenopausal women with breast cancer with or without AI therapy, once-weekly oral risedronate was beneficial for spine and hip BMD, reduced bone turnover, and was well tolerated. PMID:18427147

  12. Clinical characteristics and outcomes of septic bursitis.

    PubMed

    Lieber, Sarah B; Fowler, Mary Louise; Zhu, Clara; Moore, Andrew; Shmerling, Robert H; Paz, Ziv

    2017-05-29

    Limited data guide practice in evaluation and treatment of septic bursitis. We aimed to characterize clinical characteristics, microbiology, and outcomes of patients with septic bursitis stratified by bursal involvement, presence of trauma, and management type. We conducted a retrospective cohort study of adult patients admitted to a single center from 1998 to 2015 with culture-proven olecranon and patellar septic bursitis. Baseline characteristics, clinical features, microbial profiles, operative interventions, hospitalization lengths, and 60-day readmission rates were determined. Patients were stratified by bursitis site, presence or absence of trauma, and operative or non-operative management. Of 44 cases of septic bursitis, patients with olecranon and patellar bursitis were similar with respect to age, male predominance, and frequency of bursal trauma; patients managed operatively were younger (p = 0.05). Clinical features at presentation and comorbidities were similar despite bursitis site, history of trauma, or management. The most common organism isolated from bursal fluid was Staphylococcus aureus. Patients managed operatively were discharged to rehabilitation less frequently (p = 0.04). This study of septic bursitis is among the largest reported. We were unable to identify presenting clinical features that differentiated patients treated surgically from those treated conservatively. There was no clear relationship between preceding trauma or bursitis site and clinical course, management, or outcomes. Patients with bursitis treated surgically were younger. Additional study is needed to identify patients who would benefit from early surgical intervention for septic bursitis.

  13. Clinical outcomes following osteochondral autologous transplantation (OATS).

    PubMed

    Lahav, Amit; Burks, Robert T; Greis, Patrick E; Chapman, Andrew W; Ford, Gregory M; Fink, Barbara P

    2006-07-01

    This study evaluated the clinical outcome in 21 patients (22 knees) undergoing osteochondral autologous transplantation (OATS) in the knee over a 5-year period. Sixteen knees in 15 patients were available for follow-up at an average of 40 months after the procedure. The clinical outcome was analyzed using the IKDC and Knee and Osteoarthritis Outcome Score (KOOS) evaluation forms, a subjective questionnaire, and a clinical examination. At final follow-up, the average KOOS result for pain was 80.6 (range: 56-94), symptoms 53.6 (range: 25-71), function of activities of daily living 93.4 (range: 79-100), function of sports and recreational activities 65.3 (range: 20-100), and quality of life 51.0 (range: 6-88). The average IKDC score was 68.2. On our subjective questionnaire, the average preoperative grade given was 3.1 (range: 1-7) with an improvement at the most recent follow-up to a grade of 8.0 (range: 5-10) (P < .00001). Thirteen (86%) patients reported that they would have the surgery again if they had to make the decision a second time. Age did not correlate with subjective results on the IKDC evaluation (P = .7048) or score difference on our questionnaire (P = .9175). This procedure provides an option for articular resurfacing of the femoral condyles for focal areas of chondral defects with promising results regarding subjective improvement.

  14. The association of maternal vitamin D status with infant birth outcomes, postnatal growth and adiposity in the first 2 years of life in a multi-ethnic Asian population: the Growing Up in Singapore Towards healthy Outcomes (GUSTO) cohort study.

    PubMed

    Ong, Yi Lin; Quah, Phaik Ling; Tint, Mya Thway; Aris, Izzuddin M; Chen, Ling Wei; van Dam, Rob M; Heppe, Denise; Saw, Seang-Mei; Godfrey, Keith M; Gluckman, Peter D; Chong, Yap Seng; Yap, Fabian; Lee, Yung Seng; Foong-Fong Chong, Mary

    2016-08-01

    Maternal vitamin D status during pregnancy has been associated with infant birth and postnatal growth outcomes, but reported findings have been inconsistent, especially in relation to postnatal growth and adiposity outcomes. In a mother-offspring cohort in Singapore, maternal plasma vitamin D was measured between 26 and 28 weeks of gestation, and anthropometric measurements were obtained from singleton offspring during the first 2 years of life with 3-month follow-up intervals to examine birth, growth and adiposity outcomes. Associations were analysed using multivariable linear regression. Of a total of 910 mothers, 13·2 % were vitamin D deficient (<50 nmol/l) and 26·5 % were insufficient (50-75 nmol/l). After adjustment for potential confounders and multiple testing, no statistically significant associations were observed between maternal vitamin D status and any of the birth outcomes - small for gestational age (OR 1·00; 95 % CI 0·56, 1·79) and pre-term birth (OR 1·16; 95 % CI 0·64, 2·11) - growth outcomes - weight-for-age z-scores, length-for-age z-scores, circumferences of the head, abdomen and mid-arm at birth or postnatally - and adiposity outcomes - BMI, and skinfold thickness (triceps, biceps and subscapular) at birth or postnatally. Maternal vitamin D status in pregnancy did not influence infant birth outcomes, postnatal growth and adiposity outcomes in this cohort, perhaps due to the low prevalence (1·6 % of the cohort) of severe maternal vitamin D deficiency (defined as of <30·0 nmol/l) in our population.

  15. Clinical features and surgical outcomes of primary canaliculitis with concretions.

    PubMed

    Xiang, Shengjin; Lin, Bin; Pan, Qintuo; Zheng, Meiqin; Qin, Xiaoyi; Wang, Youpei; Zhang, Zongduan

    2017-03-01

    The purpose of our study is to analyze the clinical, ultrasonic, microbiologic, and histopathologic characteristics, management, and outcomes in a series of primary canaliculitis with concretions patients who underwent canaliculotomy with curettage.Thirty-six patients were reviewed for age, sex, location and laterality, duration of symptoms, clinical symptoms, ultrasonic signs, result of microbiologic culture and histopathologic examination, treatment, and outcomes. Main outcomes were the clinical, ultrasonic, and microbiological characteristics of the canalicular concretions; the histopathologic profiles; and the treatment effect.Thirty-six patients were identified with concretions in all 37 cases of the patients with canaliculitis. There were 30 (83.3%) female patients with a mean age of 54.2 years. Twenty-eight (77.8%) patients were misdiagnosed or delayed diagnosed, and the mean duration was 17.1 months. The common most clinical presentations were discharge (100%), epiphora (66.7%), erythema (52.8%), and swelling (47.2%), and concretions were found in 31 of 37 patients by typical clinical manifestations and in 5 of 6 patients by ultrasonic. Actinomyces was found in 8 of 13 histopathologic specimens, and microbiological cultures were positive in 13 of 24 patients. All patients underwent canaliculotomy with curettage to completely remove all concretions and contents; 35 of 36 patients' symptoms improved and 1 recurred after treatment at a median of 21.7 months follow-up according to the telephonic questionnaires.Canalicular concretions play an important role in primary canaliculitis. Canaliculotomy with curettage is a standard therapy with canalicular concretions, and the surgical removal of all possible concretions is essential for cure.

  16. Clinical features and surgical outcomes of primary canaliculitis with concretions

    PubMed Central

    Xiang, Shengjin; Lin, Bin; Pan, Qintuo; Zheng, Meiqin; Qin, Xiaoyi; Wang, Youpei; Zhang, Zongduan

    2017-01-01

    Abstract The purpose of our study is to analyze the clinical, ultrasonic, microbiologic, and histopathologic characteristics, management, and outcomes in a series of primary canaliculitis with concretions patients who underwent canaliculotomy with curettage. Thirty-six patients were reviewed for age, sex, location and laterality, duration of symptoms, clinical symptoms, ultrasonic signs, result of microbiologic culture and histopathologic examination, treatment, and outcomes. Main outcomes were the clinical, ultrasonic, and microbiological characteristics of the canalicular concretions; the histopathologic profiles; and the treatment effect. Thirty-six patients were identified with concretions in all 37 cases of the patients with canaliculitis. There were 30 (83.3%) female patients with a mean age of 54.2 years. Twenty-eight (77.8%) patients were misdiagnosed or delayed diagnosed, and the mean duration was 17.1 months. The common most clinical presentations were discharge (100%), epiphora (66.7%), erythema (52.8%), and swelling (47.2%), and concretions were found in 31 of 37 patients by typical clinical manifestations and in 5 of 6 patients by ultrasonic. Actinomyces was found in 8 of 13 histopathologic specimens, and microbiological cultures were positive in 13 of 24 patients. All patients underwent canaliculotomy with curettage to completely remove all concretions and contents; 35 of 36 patients’ symptoms improved and 1 recurred after treatment at a median of 21.7 months follow-up according to the telephonic questionnaires. Canalicular concretions play an important role in primary canaliculitis. Canaliculotomy with curettage is a standard therapy with canalicular concretions, and the surgical removal of all possible concretions is essential for cure. PMID:28248874

  17. Surgical Predictors of Clinical Outcomes After Revision Anterior Cruciate Ligament Reconstruction.

    PubMed

    Allen, Christina R; Anderson, Allen F; Cooper, Daniel E; DeBerardino, Thomas M; Dunn, Warren R; Haas, Amanda K; Huston, Laura J; Lantz, Brett Brick A; Mann, Barton; Nwosu, Sam K; Spindler, Kurt P; Stuart, Michael J; Wright, Rick W; Albright, John P; Amendola, Annunziato Ned; Andrish, Jack T; Annunziata, Christopher C; Arciero, Robert A; Bach, Bernard R; Baker, Champ L; Bartolozzi, Arthur R; Baumgarten, Keith M; Bechler, Jeffery R; Berg, Jeffrey H; Bernas, Geoffrey A; Brockmeier, Stephen F; Brophy, Robert H; Bush-Joseph, Charles A; Butler, J Brad; Campbell, John D; Carey, James L; Carpenter, James E; Cole, Brian J; Cooper, Jonathan M; Cox, Charles L; Creighton, R Alexander; Dahm, Diane L; David, Tal S; Flanigan, David C; Frederick, Robert W; Ganley, Theodore J; Garofoli, Elizabeth A; Gatt, Charles J; Gecha, Steven R; Giffin, James Robert; Hame, Sharon L; Hannafin, Jo A; Harner, Christopher D; Harris, Norman Lindsay; Hechtman, Keith S; Hershman, Elliott B; Hoellrich, Rudolf G; Hosea, Timothy M; Johnson, David C; Johnson, Timothy S; Jones, Morgan H; Kaeding, Christopher C; Kamath, Ganesh V; Klootwyk, Thomas E; Levy, Bruce A; Ma, C Benjamin; Maiers, G Peter; Marx, Robert G; Matava, Matthew J; Mathien, Gregory M; McAllister, David R; McCarty, Eric C; McCormack, Robert G; Miller, Bruce S; Nissen, Carl W; O'Neill, Daniel F; Owens, Brett D; Parker, Richard D; Purnell, Mark L; Ramappa, Arun J; Rauh, Michael A; Rettig, Arthur C; Sekiya, Jon K; Shea, Kevin G; Sherman, Orrin H; Slauterbeck, James R; Smith, Matthew V; Spang, Jeffrey T; Svoboda, Steven J; Taft, Timothy N; Tenuta, Joachim J; Tingstad, Edwin M; Vidal, Armando F; Viskontas, Darius G; White, Richard A; Williams, James S; Wolcott, Michelle L; Wolf, Brian R; York, James J

    2017-09-01

    Revision anterior cruciate ligament (ACL) reconstruction has been documented to have worse outcomes compared with primary ACL reconstruction. Certain factors under the control of the surgeon at the time of revision surgery can both negatively and positively affect outcomes. Case-control study; Level of evidence, 3. Patients undergoing revision ACL reconstruction were identified and prospectively enrolled between 2006 and 2011. Data collected included baseline demographics, intraoperative surgical technique and joint disorders, and a series of validated patient-reported outcome instruments (International Knee Documentation Committee [IKDC] subjective form, Knee Injury and Osteoarthritis Outcome Score [KOOS], Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC], and Marx activity rating scale) completed before surgery. Patients were followed up for 2 years and asked to complete an identical set of outcome instruments. Regression analysis was used to control for age, sex, body mass index (BMI), activity level, baseline outcome scores, revision number, time since last ACL reconstruction, and a variety of previous and current surgical variables to assess the surgical risk factors for clinical outcomes 2 years after revision ACL reconstruction. A total of 1205 patients (697 male [58%]) met the inclusion criteria and were successfully enrolled. The median age was 26 years, and the median time since their last ACL reconstruction was 3.4 years. Two-year follow-up was obtained on 82% (989/1205). Both previous and current surgical factors were found to be significant contributors toward poorer clinical outcomes at 2 years. Having undergone previous arthrotomy (nonarthroscopic open approach) for ACL reconstruction compared with the 1-incision technique resulted in significantly poorer outcomes for the 2-year IKDC ( P = .037; odds ratio [OR], 2.43; 95% CI, 1.05-5.88) and KOOS pain, sports/recreation, and quality of life (QOL) subscales ( P ≤ .05; OR range, 2

  18. The 2-Year Outcomes Comparison between Ischemic Stroke Patients with Intracranial Arterial Stenosis without Significant Extracranial Carotid Stenosis and Patients with Extracranial Carotid Stenosis.

    PubMed

    Methawasin, Kulthida; Suwanwela, Nijasri C; Phanthumchinda, Kamnnant

    2015-10-01

    The risk of recurrent ischemic stroke and acute coronary syndrome increased in the large artery atherosclerotic subtype. The purpose of this study was to compare 2-year outcomes between the ischemic stroke patients with intracranial arterial stenosis without significant extracranial carotid stenosis and the patients with extracranial carotid stenosis. This study prospectively compared 123 ischemic stroke patients: 71 patients with intracranial arterial stenosis without significant extracranial carotid stenosis and 52 patients with extracranial carotid stenosis. Neurologic and radiologic investigations were performed at the beginning of the study. All of them were treated as regular outpatients of the neurology unit with a mean follow-up of 24 months. Recurrent stroke, myocardial infarction, and death were recorded. Fifteen patients of the extracranial carotid stenosis group and eighteen patients ofthe intracranial arterial stenosis without significant extracranial carotid stenosis group developed recurrent stroke during follow-up (p = 0.40). Acute coronary syndrome occurred in eight patients of the extracranial carotid stenosis group and only one of the intracranial arterial stenosis without significant extracranial carotidstenosis group (p = 0.004). Causes of death were end stage cancers, stroke and related conditions, and acute coronary syndrome. The multivariate analysis showed that symptomatic extracranial carotid stenosis is an important risk factor of the acute coronary syndrome (p = 0.03, OR = 10.81, 95% CI 1.23-94.77). There was no significant difference of recurrent ischemic stroke and recurrent stroke between patients with intracranial arterial stenosis without extracranial carotid stenosis and patients with extracranial carotid stenosis. On the other hand, patients with extracranial carotid stenosis had more incidences of acute coronary syndrome significantly than patients with intracranial arterial stenosis.

  19. Clinical Impact of T1 Slope Minus Cervical Lordosis Following Multilevel Posterior Cervical Fusion Surgery: A Minimum 2-year Follow-Up Data.

    PubMed

    Hyun, Seung-Jae; Kim, Ki-Jeong; Jahng, Tae-Ahn; Kim, Hyun-Jib

    2017-05-25

    Retrospective study. To assess the longer term relationship between sagittal alignment of the cervical spine and patient-reported health-related quality-of-life (HRQOL) scores following multilevel posterior cervical fusion, and to explore whether an analog of T1 slope - C2-C7 lordosis ('T1S-CL') impacts on patients' clinical outcomes. A 6-month follow-up study demonstrated that, similar to the thoracolumbar spine, the severity of disability increases with sagittal malalignment following cervical reconstruction surgery. From 2007-2014, 31 consecutive patients having multilevel posterior cervical fusion for cervical stenosis, myelopathy, and deformities met inclusion criteria. To determine the true impact of the alignment on HRQOL, patients who have pseudarthrosis, a misplaced screw, junctional pathologies, or adjacent level disc herniation were excluded. Radiographic measurements included: C0-C2 lordosis, C2-C7 lordosis, C2-C7 sagittal vertical axis (SVA), T1 slope, and T1S-CL. Pearson correlation coefficients were calculated between pairs of radiographic measures and HRQOL. C2-C7 SVA positively correlated with neck disability index (NDI) scores (r = 0.550). For significant correlations between C2-C7 SVA and NDI scores, regression models predicted a threshold C2-C7 SVA value of 43.5 mm, beyond which correlations were most significant. The T1S-CL also correlated positively with C2-C7 SVA and NDI scores (r = 0.827 and r = 0.618, respectively). Results of the regression analysis indicated that a C2-C7 SVA value of 43.5 mm corresponded to a T1S-CL value of 22.2°. This minimum 2-year follow-up study showed that disability of the neck increased with cervical sagittal malalignment following surgical reconstruction and a greater T1S-CL mismatch was associated with a greater degree of cervical malalignment. Specifically, a T1S-CL mismatch greater than 22.2° corresponded to severe disability (NDI>25) and positive cervical sagittal malalignment, defined as C2

  20. Association of Baseline Characteristics and Early Vision Response with 2-Year Vision Outcomes in the Comparison of AMD Treatments Trials (CATT).

    PubMed

    Ying, Gui-shuang; Maguire, Maureen G; Daniel, Ebenezer; Ferris, Frederick L; Jaffe, Glenn J; Grunwald, Juan E; Toth, Cynthia A; Huang, Jiayan; Martin, Daniel F

    2015-12-01

    To evaluate the association of baseline characteristics and early visual acuity (VA) response with visual outcomes at years 1 or 2 in the Comparison of Age-Related Macular Degeneration (AMD) Treatments Trials (CATT). Secondary analysis of CATT. The 1185 CATT participants with baseline VA of 20/25 to 20/320. Participants were assigned to ranibizumab or bevacizumab and to 1 of 3 dosing regimens. Associations of baseline characteristics and early VA response (week 4 or 12) with VA response at years 1 or 2 were assessed by R(2) from linear regression analyses. Patients who had a poor initial response (VA 20/40 or worse with persistent fluid and without ≥1-line VA gain) were defined as candidates for changing treatment. Visual acuity change from baseline. Statistically significant (P < 0.05) baseline predictors for less VA gain at year 2 were older age, VA of 20/40 or better, larger choroidal neovascularization area, presence of geographic atrophy, total foveal thickness ≤325 μm or ≥425 μm, and elevation of retinal pigment epithelium. Among 176 eyes gaining ≥3 lines at week 12, 78% had a ≥3-line gain at year 2, whereas among 113 eyes losing ≥1 line at week 12, 27% improved to a ≥1-line gain at year 2. Visual acuity response at week 12 was more predictive of VA response at year 2 (R(2) = 0.30) than VA response at week 4 (R(2) = 0.17) and baseline predictors (R(2) = 0.13; P < 0.0001). Among 126 candidates for changing treatment drug at week 12, mean VA improved by 2.8 letters (P = 0.050), mean total retinal thickness decreased 53 μm (P < 0.0001), and fluid resolved in 33% (P < 0.0001) between week 12 and year 1 with continued use of the same drug and regimen. Similar improvements were observed among 83 candidates for changing drugs at week 24. Visual acuity response at week 12 is more predictive of 2-year vision outcomes than either several baseline characteristics or week 4 response. Eyes with poor initial response may benefit from continued treatment

  1. The clinical efficacy of Diphoterine® in the management of cutaneous chemical burns: a 2-year evaluation study.

    PubMed

    Zack-Williams, S D L; Ahmad, Z; Moiemen, N S

    2015-03-31

    Diphoterine(®) is an amphoteric irrigating agent for the treatment of chemical burns and rapidly neutralises both acids and alkalis faster than water alone. Diphoterine(®) is widely used as a first aid agent in a wide range of industries globally. This is a retrospective review of the clinical use of Diphoterine(®) on chemical burns in an adult tertiary referral burn centre, often with a delay of several hours after the injury. patients admitted with chemical burns within 24 hours of the incident with an abnormal wound pH or in pain, were treated with Diphoterine(®) spray. Over a 32-month period, 1,875 burn referrals were admitted of which 131 (7%) were chemical burns. Diphoterine(®) was used in 47 patients (36%). The male to female ratio for the 131 patients was 4:1. Alkaline burns were the commonest (55%). patients who received Diphoterine(®) were significantly younger (38 vs 43 years; p=0.05) and presented earlier (0.5 vs 2.55 days; p=0.004). There was a significant change in the wound pH pre- and post-application of Diphoterine(®), compared to patients who were treated with water irrigation only, with a pH change of 1.076 vs 0.4 (p <0.05). There was no significant difference in the time to healing, the length of hospital stay, or need for surgery. in conclusion, based on our retrospective cohort, Diphoterine(®) could be a valuable tool for use in hospital settings to neutralise both alkaline and acid burns.

  2. Comparison of SFA lesion treatment with Zilver PTX in diabetics vs. non-diabetics: 2-year clinical and functional results.

    PubMed

    Oberto, Sara; Cetta, Francesco; Trabattoni, Piero; Zoli, Stefano; Tavano, Davide; Rossi, Filippo; Clerici, Giacomo; Airoldi, Flavio; Spirito, Rita; Losa, Sergio

    2017-08-01

    Prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting nitinol stent (Zilver PTX), and focused in particular on the treatment of complex lesions and/or diabetic patients. Between May 2010 and March 2012, 67 patients (78% males) were treated by Zilver PTX, because of stenosis or occlusions of the superficial femoral artery in one of two centers. The mean age of patients was 70.1±8 years. Thirty-two of 67 (48%) were diabetics, 14 (21%) active smokers and 11 (14.6%) had chronic renal failure (end stage renal disease). The average length of lesions was 104±60 mm. Occlusion was complete in 46.3% of cases, whereas severely calcified lesions were present in 30% of patients (18.8% in diabetics and 31.4% in non-diabetics). Twenty-six patients (39%) had type C or D lesions according to TASC 2. One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4). All patients had successful stent placement. Primary patency, evaluated by Kaplan-Meier method was 88±0.06% at 12 months, and 68±0.1% at 24 months. In particular, the difference between diabetics (D) and non-diabetics (non-D) was not significant (P=0.07, Log-Rank). Patients turned from 4.2±1.3 to 1.6±1.3 Rutherford class. There were 5 deaths due to systemic comorbidities. There also were 3 major amputations, all of them also in the D group. Among the other patients, differences between D and non-D patients were not significant in terms of wound healing, bipedal stay and spontaneous ambulation. The mean follow-up length was 28±5 months (range 24-36 months). There was only one patient who had fracture and stent migration (1.5%). In 13 diabetic patients, tibial PTA was also associated. Additional treatment was required in 6 D and 1 non-D. The use of Zilver PTX is safe and effective in the treatment of SFA lesions. In particular, both stent patency and functional results on the basis of both clinical and instrumental tools were similar in

  3. Impact of Patient Sex on Clinical Outcomes

    PubMed Central

    Teitsma, Xavier M.; van der Hoeven, Henk; Tamminga, Rob; de Bie, Rob A.

    2014-01-01

    Background: The Combined Quality Care Anterior Cruciate Ligament registry provides data for clinical research regarding primary anterior cruciate ligament (ACL) surgery. Purpose: To explore the data with regard to the clinical outcomes between sexes after ACL reconstruction in a Dutch population. Study Design: Cohort study; Level of evidence, 3. Methods: Data involving patients diagnosed with an ACL tear and eligible for surgery were recorded. Isokinetic muscle strength, functional muscle performance, and anterior-posterior translation of the knee joint were documented preoperatively and at 3, 6, 9, and 12 months postoperatively. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and Tegner rating scales during each examination using a web-based questionnaire. Results: Approximately 90% of ACL injuries occurred during sport activities. The mean (SD) age at surgery was 28 (11) years for both men and women, and the majority of patients were treated with hamstring tendon autografts (94%). Four percent received bone–patellar tendon–bone autografts, and 2% of the patients received other grafts. Preoperatively, the KOOS, Lysholm, and Tegner scores were significantly higher in males. Twelve months postoperatively, both sexes showed comparable isokinetic strength (P = .336), knee laxity (P = .680), and hop test for distance (P = .122) when comparing the injured with the uninjured side. Self-reported knee function was comparable between sexes as assessed by the KOOS (P = .202), Lysholm (P = .872), and Tegner (P = .767) questionnaires during the 12-month follow-up. Conclusion: One year after ACL surgery, all patients had improved greatly, showing only minor differences between sexes. The male group showed slightly better results when evaluating self-reported knee questionnaires. Comparable outcomes and knee function between sexes can therefore be presumed with patients who are treated with hamstring tendon autografts in a Dutch

  4. Clinical outcome measures in juvenile idiopathic arthritis.

    PubMed

    Consolaro, Alessandro; Giancane, Gabriella; Schiappapietra, Benedetta; Davì, Sergio; Calandra, Serena; Lanni, Stefano; Ravelli, Angelo

    2016-04-18

    Juvenile idiopathic arthritis (JIA), as a chronic condition, is associated with significant disease- and treatment-related morbidity, thus impacting children's quality of life. In order to optimize JIA management, the paediatric rheumatologist has begun to regularly use measurements of disease activity developed, validated and endorsed by international paediatric rheumatology professional societies in an effort to monitor the disease course over time and assess the efficacy of therapeutic interventions in JIA patients.A literature review was performed to describe the main outcome measures currently used in JIA patients to determine disease activity status.The Juvenile Disease Activity Score (JADAS), in its different versions (classic JADAS, JADAS-CRP and cJADAS) and the validated definitions of disease activity and response to treatment represent an important tool for the assessment of clinically relevant changes in disease activity, leading more and more to a treat-to-target strategy, based on a tight and thorough control of the patient condition. Moreover, in recent years, increasing attention on the incorporation of patient-reported or parent-reported outcomes (PRCOs), when measuring the health state of patients with paediatric rheumatic diseases has emerged.We think that the care of JIA patients cannot be possible without taking into account clinical outcome measures and, in this regard, further work is required.

  5. Vitamin D and Clinical Outcomes in Dialysis

    PubMed Central

    Parikh, Coral; Gutgarts, Victoria; Eisenberg, Elliot; Melamed, Michal L.

    2016-01-01

    Most dialysis patients are vitamin D deficient, including deficiencies in both activated vitamin D (1, 25-dihydroxyvitamin D) and the less active 25-hydroxyvitamin D. These and other abnormalities associated with chronic kidney disease (CKD), if they remain untreated, lead to secondary hyperparathyroidism and bone changes, such as osteitis fibrosa cystica. Activated vitamin D has been proven to decrease parathyroid hormone (PTH) levels in dialysis patients and is currently used for this indication. There are multiple other potential “pleotrophic” effects associated with vitamin D therapy. These include associations with lower all-cause and cardiovascular mortality, lower rates of infections and improved glycemic indexes. Meta-analyses of multiple observational studies have shown activated vitamin D therapy to be associated with improved survival. Observational data also suggest fewer infections and better glucose control. There have been no randomized clinical trials powered to evaluate mortality or other clinical outcomes. Small trials of nutritional vitamin D (ergocalciferol and cholecalciferol) showed increases in 25-hydroxyvitamin D levels without hypercalcemia or hyperphosphatemia, even when given in addition to activated vitamin D therapy. While activated vitamin D therapy is associated with improved outcomes, it also leads to higher fibroblast growth factor 23 (FGF-23) levels, which may be detrimental in dialysis patients. Further research is needed to evaluate whether activated or nutritional vitamin D therapy are beneficial in dialysis patients for outcomes other than secondary hyperparathyroidism. PMID:26424141

  6. The Clinical Outcome Study for dysferlinopathy

    PubMed Central

    Harris, Elizabeth; Bladen, Catherine L.; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E.; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X.; Blamire, Andrew M.; Bravver, Elena; Carlier, Pierre G.; Day, John W.; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J.; Lochmüller, Hanns; Mendell, Jerry R.; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M.C.

    2016-01-01

    Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design. PMID:27602406

  7. Cervical restoration and the amount of soft tissue coverage achieved by coronally advanced flap: a 2-year follow-up randomized-controlled clinical trial.

    PubMed

    Santamaria, Mauro Pedrine; da Silva Feitosa, Daniela; Nociti, Francisco Humberto; Casati, Marcio Zaffalon; Sallum, Antonio Wilson; Sallum, Enilson Antônio

    2009-05-01

    The aim of this study was to evaluate the 2-year follow-up success of the treatment of gingival recession associated with non-carious cervical lesions by a coronally advanced flap (CAF) alone or in combination with a resin-modified glass ionomer restoration (CAF+R). Sixteen patients with bilateral Miller Class I buccal gingival recessions, associated with non-carious cervical lesions, were selected. The defects received either CAF or CAF+R. Bleeding on probing (BOP), probing depth (PD), relative gingival recession (RGR), clinical attachment level (CAL) and cervical lesion height (CLH) coverage were measured at the baseline and 6, 12 and 24 months after the treatment. Both groups showed statistically significant gains in CAL and soft tissue coverage. The differences between groups were not statistically significant in BOP, PD, RGR and CAL, after 2 years. The percentages of CLH covered were 51.57 +/- 17.2% for CAF+R and 53.87 +/- 12.6% for CAF (p>0.05). The estimated root coverage was 80.37 +/- 25.44% for CAF+R and 83.46 +/- 20.79% for CAF (p>0.05). Within the limits of the present study, it can be concluded that both procedures provide acceptable soft tissue coverage after 2 years, with no significant differences between the two approaches.

  8. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes.

    PubMed

    Staerk, Laila; Sherer, Jason A; Ko, Darae; Benjamin, Emelia J; Helm, Robert H

    2017-04-28

    The past 3 decades have been characterized by an exponential growth in knowledge and advances in the clinical treatment of atrial fibrillation (AF). It is now known that AF genesis requires a vulnerable atrial substrate and that the formation and composition of this substrate may vary depending on comorbid conditions, genetics, sex, and other factors. Population-based studies have identified numerous factors that modify the atrial substrate and increase AF susceptibility. To date, genetic studies have reported 17 independent signals for AF at 14 genomic regions. Studies have established that advanced age, male sex, and European ancestry are prominent AF risk factors. Other modifiable risk factors include sedentary lifestyle, smoking, obesity, diabetes mellitus, obstructive sleep apnea, and elevated blood pressure predispose to AF, and each factor has been shown to induce structural and electric remodeling of the atria. Both heart failure and myocardial infarction increase risk of AF and vice versa creating a feed-forward loop that increases mortality. Other cardiovascular outcomes attributed to AF, including stroke and thromboembolism, are well established, and epidemiology studies have championed therapeutics that mitigate these adverse outcomes. However, the role of anticoagulation for preventing dementia attributed to AF is less established. Our review is a comprehensive examination of the epidemiological data associating unmodifiable and modifiable risk factors for AF and of the pathophysiological evidence supporting the mechanistic link between each risk factor and AF genesis. Our review also critically examines the epidemiological data on clinical outcomes attributed to AF and summarizes current evidence linking each outcome with AF. © 2017 American Heart Association, Inc.

  9. Associated lumbar scoliosis does not affect outcomes in patients undergoing focal minimally invasive surgery-transforaminal lumbar interbody fusion (MISTLIF) for neurogenic symptoms-a minimum 2-year follow-up study.

    PubMed

    Tay, Kae Sian; Bassi, Anupreet; Yeo, William; Yue, Wai Mun

    2017-01-01

    There is no current literature comparing outcomes of patients with and without lumbar scoliosis having neurologic symptoms undergoing minimally invasive surgery-transforaminal lumbar interbody fusion (MISTLIF) technique. This study aimed to determine whether associated lumbar scoliosis will result in different clinical, radiological, and operative outcomes in patients undergoing focal MISTLIF for neurogenic symptoms, without specific correction of the scoliosis. A retrospective case comparison study from prospectively collected hospital registry data was carried out. Two hundred and thirty eligible patients were evaluated and divided into two groups: Scoliosis Group (SG; n=57) with Cobb angle >10 degrees on anterioposterior (AP) plain lumbar spine radiographs and Non-Scoliosis Group (NSG; n=173) consisting of the remaining patients. Clinical outcomes were assessed using the Oswestry Disability Index, the North American Spine Society (NASS) Neurogenic Symptom Score, the NASS Satisfaction with Surgery Rating, the 36-Item Short-Form Health Survey (SF-36), and the Numerical Pain Rating Scale for back and leg pain. Radiological findings included Cobb angle, fusion, implant failure or loosening, and adjacent segment degeneration (ASD). Both groups were compared for demographics, perioperative parameters, complications, clinical, and radiological outcomes. Interobserver agreement (kappa statistics) for measurement of Cobb angle was calculated on all cases of both groups by two authors. Patients were evaluated preoperatively, at 6 months, and 2 years after surgery. The average follow-up was 2.88±1.47 years in the SG and 2.71±1.34 years in the NSG (p=.444). Differences in mean age (SG: 62.9±10.9 years and NSG: 57.6±13.1 years), estimated related risk of death (SG: 3.05±2.13 and NSG: 2.41±1.74), and gender (female=SG: 87.7% and NSG: 64.2%) were statistically significant (p<.05), whereas race distribution, body mass index |(BMI), spinal levels operated, number of levels

  10. Early loading of implants with fixed dental prostheses in edentulous mandibles: 7.2-year clinical results from a prospective study.

    PubMed

    Schwarz, Stefanie; Bernhart, Gunda; Eiffler, Constantin; Hassel, Alexander Jochen; Lehmann, Franziska; Rammelsberg, Peter

    2014-12-01

    The purpose of this prospective follow-up study was to evaluate survival and success of early-loaded implants placed in the edentulous mandible and the survival of the fixed dental prostheses (FDPs) after in mean 7.2 years. Thirty-seven patients (mean age 64.5 years, 18.9% male) received 185 implants in the intraforaminal area of the edentulous mandible (five implants per patient). Within 2 weeks, all implants were early loaded with fixed dental prostheses. The patients were recalled once a year for clinical and radiographic examinations. The 17 patients (79 implants) attending the recall in 2012 were additionally asked for their satisfaction of functional and aesthetic aspects. During a mean observation time of 7.2 years, 20 implants were lost in 11 patients, resulting in implant survival of 89.2%. Eight of all implants (4.3%) had too much marginal bone loss to satisfy the criteria of success. A total of 19 prosthetic complications and aftercare measurements had to be performed between in mean 4.5 to 7.2 years of observation. The survival of the original FDPs decreased to 83.8%. Of the 17 patients attending the recall in 2012, a total 59.5% had a satisfactory oral hygiene. According to the criteria of Albrektsson, the success rate for the remaining 79 implants was 89.9% after in mean 11.7 years. Patient satisfaction for assessment of functional and aesthetic aspects was in median 9 and 8 on the numeric rating scales. Long-term observation of in mean 7.2 years showed satisfactory results for both implant and superstructure survival. Prosthetic complications were easy to repair in most cases, but patients' ability for oral hygiene was reduced after the longer observation period. Especially in elderly patients, their attitudes and manual skills should be considered when planning the design of a new superstructure. © 2013 Wiley Periodicals, Inc.

  11. Clinical Outcomes Following Revision Anterior Shoulder Stabilization

    PubMed Central

    Frank, Rachel M.; Mellano, Chris; Shin, Jason J.; Feldheim, Terrence F.; Mascarenhas, Randhir; Yanke, Adam Blair; Cole, Brian J.; Nicholson, Gregory P.; Romeo, Anthony A.; Verma, Nikhil N.

    2015-01-01

    Objectives: The purpose of this study was to determine the clinical outcomes following revision anterior shoulder stabilization performed either via all-arthroscopic soft tissue repair or via Latarjet coracoid transfer. Methods: A retrospective review of prospectively collected data on 91 shoulders undergoing revision anterior shoulder stabilization was performed. All patients underwent prior soft tissue stabilization; those with prior open bone grafting procedures were excluded. For patients with 25% glenoid bone loss, Latarjet was performed (n=28). Patients were queried regarding recurrent instability (subluxation or dislocation). Clinical outcomes were evaluated using validated patient reported outcome questionnaires including the American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), visual analog scale (VAS) for pain, and Western Ontario Shoulder Instability Index (WOSI). Results: A total of 63 shoulders in 62 patients (46 males, 16 females) with an average age of 23.2 ± 6.9 years were included in the revision arthroscopy group. At an average follow-up of 46.9 ± 16.8 months (range, 15 to 78), the mean WOSI score was 80.1 (range, 15.0 to 100), and there were significant improvements (p<0.001) in ASES (63.7 to 85.1), SST (6.2 to 9.1), and VAS pain scores (2.89 to 0.81). Recurrent instability occurred in 12 of 63 shoulders (19%); the number of prior surgeries and baseline hyperlaxity were significant risk factors for failure (p<0.001 and p=0.04, respectively). No patients developed clinical or radiographic evidence of arthritis. A total of 28 shoulders in 28 patients (21 male, 7 female) with an average age of 27.5 years (range 14 to 45) were included in the Latarjet group. Thirteen (46%) had more than one previous stabilization attempt. ), the average WOSI score was 71.9, and there were significant improvements (p<0.001) in ASES (65.7 to 87.0), SST (7.2 to 10.3), and VAS (3.1 to 1.1). Recurrent instability occurred in 2 of 28 shoulders

  12. Pregnancy Outcomes after Clinical Recovery from AKI.

    PubMed

    Tangren, Jessica Sheehan; Powe, Camille E; Ankers, Elizabeth; Ecker, Jeffrey; Bramham, Kate; Hladunewich, Michelle A; Karumanchi, S Ananth; Thadhani, Ravi

    2017-05-01

    The effect of clinically recovered AKI (r-AKI) on future pregnancy outcomes is unknown. We retrospectively studied all women who delivered infants between 1998 and 2007 at Massachusetts General Hospital to assess whether a previous episode of r-AKI associated with subsequent adverse maternal and fetal outcomes, including preeclampsia. AKI was defined as rise in serum creatinine concentration to 1.5-fold above baseline. We compared pregnancy outcomes in women with r-AKI without history of CKD (eGFR>90 ml/min per 1.73 m(2) before conception; n=105) with outcomes in women without kidney disease (controls; n=24,640). The r-AKI and control groups had similar prepregnancy serum creatinine measurements (0.70±0.20 versus 0.69±0.10 mg/dl; P=0.36). However, women with r-AKI had increased rates of preeclampsia compared with controls (23% versus 4%; P<0.001). Infants of women with r-AKI were born earlier than infants of controls (37.6±3.6 versus 39.2±2.2 weeks; P<0.001), with increased rates of small for gestational age births (15% versus 8%; P=0.03). After multivariate adjustment, r-AKI associated with increased risk for preeclampsia (adjusted odds ratio [aOR], 5.9; 95% confidence interval [95% CI], 3.6 to 9.7) and adverse fetal outcomes (aOR, 2.4; 95% CI, 1.6 to 3.7). When women with r-AKI and controls were matched 1:2 by age, race, body mass index, diastolic BP, parity, and diabetes status, r-AKI remained associated with preeclampsia (OR, 4.7; 95% CI, 2.1 to 10.1) and adverse fetal outcomes (OR, 2.1; 95% CI, 1.2 to 3.7). Thus, a past episode of AKI, despite return to normal renal function before pregnancy, associated with adverse outcomes in pregnancy. Copyright © 2017 by the American Society of Nephrology.

  13. Spinal radiosurgery: technology and clinical outcomes.

    PubMed

    Avanzo, M; Romanelli, P

    2009-01-01

    The development of computer-based image guidance has allowed stereotactic radiosurgery and radiotherapy to be freed from the constraints imposed by the stereotactic frames once required for intracranial radiosurgery. This freedom has led to the application of radiosurgery to targets outside the brain. In this paper, we briefly review the technologies, treatment parameters, and clinical outcomes of radiosurgical treatment for spinal pathology, including metastatic tumors and rare but challenging lesions such as arteriovenous malformations and benign tumors. A special emphasis is put on the newest development, fiducial-less robotic radiosurgery. Spinal radiosurgery is associated with excellent rates of tumor control and pain relief with a good dose sparing of the highly sensitive spinal cord. Further research is required to optimize treatment strategies and to assess clinical benefits and toxicity in the long term.

  14. Does sagittal position of the CTDR-related centre of rotation influence functional outcome? Prospective 2-year follow-up analysis.

    PubMed

    Suchomel, P; Jurák, L; Antinheimo, J; Pohjola, J; Stulik, J; Meisel, H-J; Čabraja, M; Woiciechowsky, C; Bruchmann, B; Shackleford, I; Arregui, R; Sola, S

    2014-05-01

    Recent studies describe significant rates of heterotopic ossification (HO) after cervical total disc replacement (CTDR). Little is known about the reasons, and one aspect that requires further in vivo investigation is the biomechanical alteration after CTDR and the role of the implant-related centre of rotation (CORi) in particular. The role of the sagittal position of the CORi on functional outcome in two versions of a semi-constrained disc prosthesis with sagittally different CORi is the topic of this study. Patients were candidates for single-level CTDR between C3 and C7 who suffered from CDDD and received a standard or flat version of activ C™ (Aesculap AG, Tuttlingen). Clinical and radiographic assessments were determined preoperatively, intraoperatively, at discharge and again at 6 weeks, 6 months, 1 and 2 years. Radiographic examinations were performed independently using specialized quantitative motion analysis software. Clinical outcome improved significantly regarding NDI as well as VAS on neck and arm pain with no differences in mean improvement by study group. Segmental angle measures show a significantly better lordotic alignment for both groups after surgery, but the degree of correction achieved is higher in the flat group. Correlation analysis proves that the more anterior the CORi is positioned, the higher the lordotic correction is achieved (Pearson rho -0.385). Segmental ROM decreased in the standard group but was maintained for flat implants. At present, our data do not demonstrate a correlation between CORi and ROM at 2 years. Two years after surgery, severe HO grade III-IV was present in 31.6 % standard and 13.1 % flat cases with significant differences. Grouping according to HO severity showed comparable sagittal positions of CORi for flat implants but a more posterior position in the severe HO group for standard implants. Our results confirm the influence of CORi location on segmental alignment, kinematics and HO for a semi

  15. Pediatric multiple sclerosis: Clinical features and outcome.

    PubMed

    Waldman, Amy; Ness, Jayne; Pohl, Daniela; Simone, Isabella Laura; Anlar, Banu; Amato, Maria Pia; Ghezzi, Angelo

    2016-08-30

    Multiple sclerosis (MS) in children manifests with a relapsing-remitting MS (RRMS) disease course. Acute relapses consist of new neurologic deficits persisting greater than 24 hours, in the absence of intercurrent illness, and occur with a higher frequency early in the disease as compared to adult-onset RRMS. Most pediatric patients with MS recover well from these early relapses, and cumulative physical disability is rare in the first 10 years of disease. Brainstem attacks, poor recovery from a single attack, and a higher frequency of attacks portend a greater likelihood of future disability. Although prospective pediatric-onset MS cohorts have been established in recent years, there remains very limited prospective data detailing the longer-term clinical outcome of pediatric-onset MS into adulthood. Whether the advent of MS therapies, and the largely off-label access to such therapies in pediatric MS, has improved prognosis is unknown. MS onset during the key formative academic years, concurrent with active cognitive maturation, is an important determinant of long-term outcome, and is discussed in detail in another article in this supplement. Finally, increasing recognition of pediatric MS worldwide, recent launch of phase III trials for new agents in the pediatric MS population, and the clear imperative to more fully appreciate health-related quality of life in pediatric MS through adulthood highlight the need for standardized, validated, and robust outcome measures.

  16. Biceps tenotomy versus tenodesis: clinical outcomes.

    PubMed

    Slenker, Nicholas R; Lawson, Kevin; Ciccotti, Michael G; Dodson, Christopher C; Cohen, Steven B

    2012-04-01

    We present a systematic review of the current literature regarding the use of the 2 most common surgical treatments for lesions of the long head of the biceps brachii, tenotomy or tenodesis. Currently, there is no consensus management in the literature because most studies lack high levels of evidence. PubMed was systematically reviewed for eligible articles relating to biceps tenotomy or tenodesis. Level I to IV evidence and English-language studies reporting on the clinical outcomes of these 2 procedures were included. The primary clinical outcome measurements for each study were determined and were normalized and reported as the percentage of "excellent/good" versus "poor" results based on criteria laid out in each study. Sixteen studies met the inclusion criteria. All articles reviewed were of Level IV evidence, except for one Level II prospective cohort study.(10) All studies, a total of 433 tenodesis procedures resulted in an excellent/good outcome in 74% of patients, with an 8% rate of cosmetic deformity. A total of 699 tenotomy procedures resulted in an excellent/good outcome in 77% of patients, with a 43% occurrence of cosmetic deformity. Postoperative bicipital pain was found in 43 of 226 cases (19%) of tenotomy and 18 of 74 cases (24%) of tenodesis. The 4 studies that compared the procedures directly did not show any significant clinical differences between the groups other than a cosmetic deformity being present more frequently after tenotomy. Tenotomy and tenodesis have comparably favorable results in the literature, with the only major difference being a higher incidence of cosmetic deformity with biceps tenotomy. However, there is currently no consensus regarding the use of tenotomy versus tenodesis for the treatment of lesions of the long head of the biceps brachii. The lack of prospective, randomized trials limits our ability to recommend 1 technique over the other. There is a great need for controlled trials to investigate the differences between

  17. Clinical and Radiographic Results of Indirect Decompression and Posterior Cervical Fusion for Single-Level Cervical Radiculopathy Using an Expandable Implant with 2-Year Follow-Up.

    PubMed

    Siemionow, Kris; Janusz, Piotr; Phillips, Frank M; Youssef, Jim A; Isaacs, Robert; Tyrakowski, Marcin; McCormack, Bruce

    2016-11-01

    Background Indirect posterior cervical nerve root decompression and fusion performed by placing bilateral posterior cervical cages in the facet joints from a posterior approach has been proposed as an option to treat select patients with cervical radiculopathy. The purpose of this study was to report 2-year clinical and radiologic results of this treatment method. Methods Patients who failed nonsurgical management for single-level cervical radiculopathy were recruited. Surgical treatment involved a posterior approach with decortication of the lateral mass and facet joint at the treated level followed by placement of the DTRAX Expandable Cage (Providence Medical Technology, Lafayette, California, United States) into both facet joints. Iliac crest bone autograft was mixed with demineralized bone matrix and used in all cases. The Neck Disability Index (NDI), visual analog scale (VAS) for neck and arm pain, and SF-12 v.2 questionnaire were evaluated preoperatively and 2 years postoperatively. Segmental (treated level) and overall C2-C7 cervical lordosis, disk height, adjacent segment degeneration, and fusion were assessed on computed tomography scans and radiographs acquired preoperatively and 2 years postoperatively. Results Overall, 53 of 60 enrolled patients were available at 2-year follow-up. There were 35 females and 18 males with a mean age of 53 years (range: 40-75 years). The operated level was C3-C4 (N = 3), C4-C5 (N = 6), C5-C6 (N = 36), and C6-C7 (N = 8). The mean preoperative and 2-year scores were NDI: 32.3 versus 9.1 (p < 0.0001); VAS Neck Pain: 7.4 versus 2.6 (p < 0.0001); VAS Arm Pain: 7.4 versus 2.6 (p < 0.0001); SF-12 Physical Component Summary: 34.6 versus 43.6 (p < 0.0001), and SF-12 Mental Component Summary: 40.8 versus 51.4 (p < 0.0001). No significant changes in overall or segmental lordosis were noted after surgery. Radiographic fusion rate was 98.1%. There was no device failure, implant lucency, or

  18. Clinical outcomes of revision biceps tenodesis

    PubMed Central

    Gregory, J. M.; Harwood, D. P.; Gochanour, E.; Sherman, S. L.; Romeo, A. A.

    2012-01-01

    Purpose: Biceps tenotomy and tenodesis are effective treatment options for biceps pathology, but outcomes of revision surgery are not known. This study examines the clinical outcomes of patients who have undergone a revision biceps tenodesis. Materials and Methods: A retrospective review of all patients since 2004 (N = 21) who had undergone a revision biceps tenodesis with greater than 6-month follow-up was completed. A follow-up survey was carried out, and the visual analog scale (VAS), Single Assessment Numeric Evaluation (SANE), Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons (ASES), and University of California – Los Angeles (UCLA) scores were obtained, along with SF-12 Mental (MCS-12) and Physical Component Summaries (PCS-12). Results: Indications for revision surgery were continued pain (14) and ruptured biceps (7). Complete follow-up examinations were performed in 15 of 21 patients (71.4%). Average follow-up was 33.4 ± 23.5 months. The mean postoperative scores were 1.9 out of 10, VAS; 79 out of 100, SANE; 10.2 out of 12, SST; 83 out of 100, ASES; 29 out of 35, UCLA; 44, PCS- 12; and 47.1, MCS- 12. Five patients were considered failures with a UCLA score below 27. Seventeen of twenty-one patient underwent concomitant procedures. Complete preoperative and postoperative data were collected for 14 patients. All scores demonstrated highly significant improvement from preoperative levels (P < 0.005), except for the MCS-12. There was no statistically significant difference in the outcomes of revision due to rupture and revision due to persistent pain. Conclusions: The results suggest that revision subpectoral biceps tenodesis provides significant pain relief and improvement in functional outcomes at a mean follow-up of 33.4 months. Level of Evidence: Case Series, Level 4. PMID:22787333

  19. Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials.

    PubMed

    Campos, Carlos M; Caixeta, Adriano; Franken, Marcelo; Bartorelli, Antonio L; Whitbourn, Robert J; Wu, Chiung-Jen; Li Paul Kao, Hsien; Rosli, Mohd Ali; Carrie, Didier; De Bruyne, Bernard; Stone, Gregg W; Serruys, Patrick W; Abizaid, Alexandre

    2017-05-04

    to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups. In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  20. Outcomes for bipolar patients assessed in the French expert center network: A 2-year follow-up observational study (FondaMental Advanced Centers of Expertise for Bipolar Disorder [FACE-BD]).

    PubMed

    Henry, Chantal; Godin, Ophelia; Courtet, Philippe; Azorin, Jean-Michel; Gard, Sébastien; Bellivier, Frank; Polosan, Mircea; Kahn, Jean-Pierre; Roux, Paul; Aubin, Valerie; Costagliola, Dominique; Leboyer, Marion; Etain, Bruno

    2017-09-12

    A new health care system for patients with bipolar disorders was established in France under the auspices of Fondation FondaMental, based on thorough clinical assessment of patients and on close collaborations between expert centers and referring practitioners. We report the results of outcomes after 2 years of observational follow-up of adult patients assessed within the network. A total of 984 patients were included in the study. We compared several parameters (e.g., mood episodes and hospitalization) 1 year before inclusion and after 2 years of observational follow-up using the patient as his or her own control. Other outcomes were compared at baseline and during follow-up. We estimated the evolution of these parameters over a period of 2 years using mixed models for continuous parameters and a generalized estimating equation (GEE) model for categorical variables, adjusting for potential confounding factors. Mean age was 42.7 (±12.5) years and 58.8% were women. The number of hospitalization days decreased by 55% when comparing 1 year before inclusion vs the follow-up period. In addition, patients showed a clear functional improvement associated with a reduction of residual mood symptoms, diminished psychiatric comorbidities, improvement of sleep and a better adherence to treatment. This study demonstrates an overall improvement of patients followed for 2 years after an assessment in expert centers for bipolar disorders. This new organization based on a thorough clinical assessment and on personalized recommendations (drug treatments, psycho-social strategies and lifestyle measures) sent to health care professionals, and actively involving patients and families, improves the prognosis of BD patients. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  1. Academic Transfer Shock and Social Integration: A Comparison of Outcomes for Traditional and Nontraditional Students Transferring from 2-Year to 4-Year Institutions

    ERIC Educational Resources Information Center

    Strahn-Koller, Brooke Lindsey

    2012-01-01

    The purpose of this study was to explore whether traditional and nontraditional students who transferred from 2-year to 4-year institutions experienced differences in transfer shock, academic integration, and social integration. A substantial body of knowledge comparing transfer students to native students on transfer shock exists, while only a…

  2. Academic Transfer Shock and Social Integration: A Comparison of Outcomes for Traditional and Nontraditional Students Transferring from 2-Year to 4-Year Institutions

    ERIC Educational Resources Information Center

    Strahn-Koller, Brooke Lindsey

    2012-01-01

    The purpose of this study was to explore whether traditional and nontraditional students who transferred from 2-year to 4-year institutions experienced differences in transfer shock, academic integration, and social integration. A substantial body of knowledge comparing transfer students to native students on transfer shock exists, while only a…

  3. The clinical outcome of childhood masturbation.

    PubMed

    Unal, F

    2000-01-01

    This study was performed to investigate the clinical outcome of childhood masturbation. For this purpose 50 children (mean age = 48.7 +/- 24.5 months, 34 girls females and 16 boys males) with masturbation symptoms were examined at first visit to the Department of Child Psychiatry and two years thereafter with psychiatric interviews. The mean masturbation frequency at the initial interview was significantly decreased after two years. It was noted that 39 children (78%) were completely recovered and 11 children (22%) continued to masturbate after two years. Children who did not recover were significantly younger, began to masturbate earlier and masturbated more frequently than others at the time of initial evaluation. It was concluded that the findings about the beneficial effect of sedative drugs in combination with parental guidance, education and means for behavior modification were promising.

  4. Functional heartburn: clinical characteristics and outcome.

    PubMed

    Surdea Blaga, Teodora; Dumitrascu, Dan; Galmiche, Jean-Paul; Bruley des Varannes, Stanislas

    2013-03-01

    Patients with heartburn and normal upper gastrointestinal endoscopy, normal oesophageal acid exposure, no symptom-reflux association and who fail to respond to a proton-pump inhibitor are classified as having functional heartburn (FH). This study aimed (i) to characterize the symptoms and functional abnormalities of patients with FH and (ii) to describe their clinical outcome. Among all patients referred for 24 h multichannel intraluminal impedance-pH (MII-pH), patients with FH were identified. The clinical characteristics and high-resolution oesophageal pressure topography recordings of FH patients were analyzed at the time of the 24-h MII-pH test. A symptom-related and health-related quality-of-life questionnaire was then sent to FH patients to assess the long-term outcome. Forty patients fulfilled the criteria for FH, representing 8.5% of the referred population. Twenty-two months after initial testing, 66% of patients still suffered from heartburn. The rate of mixed reflux (liquid/gas) was higher in patients with persisting heartburn at the final evaluation (63 vs. 50%, P=0.04). Sixty-six per cent of patients had one or more manometric abnormalities. Acid clearance time in MII-pH was significantly higher in patients with weak peristalsis than patients with normal peristalsis (60 ± 45 vs. 31 ± 19 s, P=0.03). A high rate of mixed reflux and/or a manometric abnormality were associated with a higher risk of persistent heartburn. FH is a chronic disorder with persisting symptoms in two-thirds of patients. An increased rate of mixed reflux and/or the presence of manometric abnormalities are associated with a higher risk of persisting symptoms and may help to identify the population with unmet therapeutic needs.

  5. A Comprehensive Single Institutional Review of 2 Years in a Designated Fast-Track Sarcoma Diagnostic Clinic Linked with a Sarcoma Specialist Advisory Group: Meeting the Target but Failing the Task?

    PubMed Central

    Davidson, Dochka; Wong, Han Hsi; Horan, Gail; Bearcroft, Philip W. P.; Grant, Ian; Grimer, Robert; Hopper, Melanie A.; Hatcher, Helen; Earl, Helena

    2016-01-01

    Background. National guidelines prompted the implementation of a designated two-week wait referral pathway to facilitate the early diagnosis of sarcomas, to improve treatment outcomes. Methods. Patients referred to the Cambridge Sarcoma Diagnostic Clinic between January 2013 and December 2014 were identified through the electronic appointments system. Information was retrospectively retrieved about patient characteristics and details of the diagnostic pathway. Results. 17.3% of patients referred (69/397) were diagnosed with a malignancy. Of these, 59.3% (41/69) had primary sarcomas, 17.4% (12/69) had metastatic cancer, and 23.2% (16/69) had a different primary malignancy. 15% of the 41 sarcomas were <5 cm, 34% in the 5–10 cm range, and 51% >10 cm. Sarcomas diagnosed through this clinic represented 13% (41/315) of sarcomas managed at the centre during the same 2 years. Conclusion. While we achieved the target of 10% (41/397) sarcoma diagnosis rate in the rapid access clinic, only 15% of these were <5 cm better prognosis lesions. This calls into question the “real world” impact of such diagnostic clinics on early diagnosis of sarcomas. In order to enhance generic cancer diagnostic skills, training in these diagnostic clinics could be usefully integrated into national training curricula for both surgical and nonsurgical oncologists. PMID:27340367

  6. Longitudinal observations of typical English voicing acquisition in a 2-year-old child: Stability of the contrast and considerations for clinical assessment.

    PubMed

    Hitchcock, Elaine R; Koenig, Laura L

    2015-01-01

    Early assessment of phonetic and phonological development requires knowledge of typical versus atypical speech patterns, as well as the range of individual developmental trajectories. The nature of data reporting in previous literature on typical voicing acquisition left aspects of the developmental process unclear and limited clinical applicability. This work extends a previous four-month group study to present data for one child over 12 months. Words containing initial /b p d t/ were elicited from a monolingual English-speaking 2-year-old child biweekly for 25 sessions. Voice onset time (VOT) was measured for each stop. For each consonant and recording session, we measured range as well as accuracy, overshoot and discreteness calculated for means and individual tokens. The results underscore the value of token-by-token analyses. They further reveal that typical development may involve an extended period of fluctuating voicing patterns, suggesting that the voiced/voiceless contrast may take months or years to stabilise.

  7. Long-Term Outcome of a Hepatocellular Carcinoma 71/2 Years After Surgery and Repeated Radiofrequency Ablation: Case Report and Review of the Literature

    SciTech Connect

    Thanos, L. Mylona, S.; Nikita, A.; Ptohis, N.; Kelekis, D.A.

    2007-04-15

    An interesting case is presented of a 78-year-old patient with cirrhosis who was managed with combined treatment (surgery and radiofrequency (RF) ablation) for hepatocellular carcinoma (HCC) and has survived for 71/2 years. Elevation of the {alpha}-FP (alpha-fetoprotein) levels was noted 2 years after surgery. CT demonstrated two lesions: one central at the remaining right liver lobe, and the other at the excision site. Biopsy of the lesions confirmed the diagnosis of HCC for both of them. RF ablation of these two lesions was performed in one session with technical success. Four and a half years after the first RF ablation a new recurrence was demonstrated at the CT follow-up control. RF ablation was again applied successfully. The imaging findings and the therapeutic percutaneous management of this patient along with the natural course of HCC and its recurrence are discussed, and the literature concerning risk factors is reviewed.

  8. Influence of Roux-en-Y gastric bypass surgery on vitamin C, myeloperoxidase, and oral clinical manifestations: a 2-year follow-up study.

    PubMed

    Netto, Bárbara Dal Molin; Moreira, Emilia Addison Machado; Patiño, Juliana Sedrez Reis; Benincá, Jucélia Pizzetti; Jordão, Alceu Afonso; Fröde, Tânia Silvia

    2012-02-01

    Bariatric surgery influences the intake and absorption of nutrients, which, when associated with vomiting, can damage the oral cavity. The serum concentrations of vitamin C and myeloperoxidase (MPO) and oral clinical manifestations were examined in patients 2 years after Roux-en-Y gastric bypass (RYGB). Clinical prospective study with control group (CG; n = 26), assessed only once, and the bariatric group (BG; n = 26), assessed in the basal period and at 12 and 24 months after surgery. The mean ages in the CG and BG were 37.8 ± 1.51 and 39.6 ± 1.93 years, respectively, and their body mass indices were 22.07 ± 0.29 and 45.62 ± 1.46 kg/m(2), respectively. At 12 months after surgery, increased episodes of vomiting (P < .001) and dental hypersensitivity (P = .012) were observed, with a reduction in the saliva-buffering capacity of 21.3% ± 2.9% (P = .004). At 24 months after RYGB, a significant reduction in serum vitamin C was detected (32.9% ± 5.3%, P < .001), and MPO values were higher than in the basal period (P = .032). With regard to oral hygiene habits, 92.3% of patients reported frequent tooth brushing and 96.1% used fluoride, which were similar across the 2 years. However, dental hypersensitivity (P = .048) was significantly increased than baseline. The results demonstrated that vitamin C deficiency and increased vomiting after gastric bypass for morbid obesity may contribute to increased periodontal disease. The fact that it is impossible to determine which factor or factors (diet, poor compliance with supplementation, vomiting, poor oral hygiene) contributed to the dental problems in these patients is a shortcoming of the report.

  9. The National Anesthesia Clinical Outcomes Registry.

    PubMed

    Liau, Adrian; Havidich, Jeana E; Onega, Tracy; Dutton, Richard P

    2015-12-01

    The Anesthesia Quality Institute (AQI) was chartered in 2008 by the American Society of Anesthesiologists to develop the National Anesthesia Clinical Outcomes Registry (NACOR). In this Technical Communication, we will describe how data enter NACOR, how they are authenticated, and how they are analyzed and reported. NACOR accepts case-level administrative, clinical, and quality capture data from voluntarily participating anesthesia practices and health care facilities in the United States. All data are transmitted to the AQI in summary electronic files generated by billing, quality capture, and electronic health care record software, typically on a monthly basis. All data elements are mapped to fields in the NACOR schema in accordance with a publicly available data dictionary. Incoming data are loaded into NACOR by AQI technologists and are subject to both manual and automated review to identify systematically missing elements, miscoding, and inadvertent corruption. Data are deidentified in compliance with Health Insurance Portability and Accountability Act regulations. The database server of AQI, which houses the NACOR database, is protected by 2 firewalls within the American Society of Anesthesiologists' network infrastructure; this system has not been breached. The NACOR Participant User File, a deidentified case-level dataset of information from NACOR, is available to researchers at participating institutions. NACOR architecture and the nature of the Participant User File include both strengths and weaknesses.

  10. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  11. Cinacalcet and Clinical Outcomes in Dialysis.

    PubMed

    Komaba, Hirotaka; Fukagawa, Masafumi

    2015-01-01

    Secondary hyperparathyroidism (SHPT) is a common complication of end-stage renal disease and is one of the most prominent causes of a markedly increased risk of death and cardiovascular disease in this patient population. Cinacalcet hydrochloride is a new option for the treatment of SHPT, and the efficacy and effectiveness to lower parathyroid hormone levels and to improve control of mineral metabolism, even in patients with severe disease, has been well established in many clinical trials and observational studies. Currently, the focus has moved to the impact of cinacalcet on hard clinical outcomes, and two randomized controlled trials, ADVANCE and EVOLVE, have been performed to assess the effects of cinacalcet on cardiovascular calcification and the risk of cardiovascular events and mortality, respectively. Although the primary analysis of both trials did not find significant effects of cinacalcet, the benefit of cinacalcet was suggested in the subanalyses in which the potential problems of the trials were taken into account. These positive results are consistent with experimental studies showing favorable effects of cinacalcet on bone metabolism and vascular calcification, providing plausibility to support the beneficial effects of cinacalcet. Definitive evidence is, however, still lacking, and further efforts should be made to establish the optimal role of cinacalcet in the treatment of SHPT.

  12. Imipramine blood levels and clinical outcome.

    PubMed

    Rigal, J G; Albin, H C; Duchier, A R; D'Aulnay, J M; Fenelon, J H; Vincon, G A; Demotes-Mainard, F M

    1987-08-01

    Fifty-one depressed inpatients, after 1 drug-free week, were treated for 5 weeks with imipramine 4 mg/kg day. Plasma levels of imipramine (IMI) and its active metabolite desmethylimipramine (DMI) were measured weekly, 15 hours after the last drug intake. Steady state blood levels (IMI + DMI) ranged from 60 to 585 ng/ml. The mean value for plasma concentration (IMI + DMI) at day 42 was 271 ng/ml. In the same way, therapeutic effectiveness was assessed every week using the Hamilton Rating Scale for Depression (HDRS). There was a significant correlation between plasma concentration and the decrease of Hamilton scores. The IMI/DMI ratio showed a responder-nonresponder difference; 86% patients with a ratio between 0.4 and 1 were responders. Conversely, most patients with a ratio below 0.4 or above 1 were nonresponders. The ideal ratio for clinical response would be 0.68. The ratio is a subject-specific feature, able to be an early predictor of clinical outcome.

  13. Clinical Features and Outcome of Mucormycosis

    PubMed Central

    Camara-Lemarroy, Carlos Rodrigo; González-Moreno, Emmanuel Irineo; Rodríguez-Gutiérrez, René; Rendón-Ramírez, Erick Joel; Ayala-Cortés, Ana Sofía; Fraga-Hernández, Martha Lizeth; García-Labastida, Laura; Galarza-Delgado, Dionicio Ángel

    2014-01-01

    Mucormycosis (MCM) is a life-threatening infection that carries high mortality rates despite recent advances in its diagnosis and treatment. The objective was to report 14 cases of mucormycosis infection and review the relevant literature. We retrospectively analyzed the demographic and clinical data of 14 consecutive patients that presented with MCM in a tertiary-care teaching hospital in northern Mexico. The mean age of the patients was 39.9 (range 5–65). Nine of the patients were male. Ten patients had diabetes mellitus as the underlying disease, and 6 patients had a hematological malignancy (acute leukemia). Of the diabetic patients, 3 had chronic renal failure and 4 presented with diabetic ketoacidosis. All patients had rhinocerebral involvement. In-hospital mortality was 50%. All patients received medical therapy with polyene antifungals and 11 patients underwent surgical therapy. Survivors were significantly younger and less likely to have diabetes than nonsurvivors, and had higher levels of serum albumin on admission. The clinical outcome of patients with MCM is poor. Uncontrolled diabetes and age are negative prognostic factors. PMID:25210515

  14. Clinical outcome parameters for necrotizing otitis externa.

    PubMed

    Verim, Ayşegül; Naiboğlu, Bariş; Karaca, Çigdem Tepe; Seneldir, Lütfü; Külekçi, Semra; Oysu, Çağatay

    2014-02-01

    To investigate the duration of time elapsed between the onset of symptoms for necrotizing external otitis (NEO) and admission to hospital that may play a role in patient outcome. Retrospective case review. Tertiary referral center. Fourteen consecutive male patients with NEO with no improvement from the previous course of antibiotherapy and with findings of osteomyelitis on temporal bone CT, MRI, and positive detection of Tc-99m methylene diphosphonate on temporal bone, admitted as inpatients between 2008 and 2012. Medical treatment of NEO and surgical debridement. Patients were divided into 2 groups according to median time elapsed between onset of symptoms and hospitalization (<30 d or >30 d). HbA1c, fasting blood sugar, erythrocyte sedimentation rate, C-reactive protein, pain intensity, radiologic grade, improvement since diagnosis, and total time to cure were compared according to the groups. The relationships between the laboratory data were analyzed to determine the parameters associated with time to recovery. Otalgia was significantly worse in patients who were admitted to hospital greater than 30 days after symptom onset (Mann-Whitney U test, p < 0.002). Blood glucose increased related to delayed admission time (p < 0.001). CRP results were independently elevated from the admission time (p < 0.112). There was a statistically significant difference between groups according to ESR levels and recovery time (Mann-Whitney U test, p < 0.004 and p < 0.01). There was a positive correlation between HbA1c levels and recovery time in Group 1 and between ESR levels and recovery time in Group 2 (r = 0.872, p = 0.044; r = 0.630, p = 0.039). Clinical, laboratory, and outcome data worsen later than 30 days in NEO.

  15. Clinical outcomes of laparoscopic versus open appendectomy.

    PubMed

    Shaikh, Abdul Razak; Sangrasi, Ahmed Khan; Shaikh, Gulshan Ara

    2009-01-01

    Appendectomy, being the most common surgical procedure performed in general surgery, is still being performed by both open and laparoscopic methods due to a lack of consensus as to which is the most appropriate method. Because further trials are necessary and few such studies have been performed in developing countries, we decided to evaluate the outcomes of the 2 procedures to share our experience with the international community. Consecutive patients with suspected acute appendicitis who underwent laparoscopic (LA) (n=48) and open (n=52) appendectomy (OA) over a period of 3 years were studied. Clinical outcomes were compared between the 2 groups in relation to operative time, analgesia used, length of hospital stay, return to work, resumption of a regular diet, and postoperative complications. Mean age of patients was 25.8 years in the laparoscopic and 25.5 years in the open group. Patient demographics were similar in both groups (P>0.05). There was significantly less need for analgesia (1.0+/-0.5 in LA and 1.5+/-0.6 doses in OA), a short hospital stay (1.4+/-0.7 in LA and 3.4+/-1.0 days in OA), early return to work (12.6+/-3.3 in LA and 19.1+/-3.1 days in OA), and less time needed to return to a regular diet (20.1+/-2.9 in LA and 22.0+/-4.7, P<0.05 in OA) in the laparoscopic appendectomy group. Operative time was significantly shorter (54.9+/-14.7 in LA and 13.6+/-12.6 minutes in OA) in the open group. Total number of complications was less in the laparoscopic group; however, there was no statistically significant difference. The laparoscopic technique is a safe and clinically beneficial operative procedure. It provides certain advantages over open appendectomy, including short hospital stay, decreased requirement of postoperative analgesia, early food tolerance, and earlier return to normal activities. Where feasible, laparoscopy should be undertaken as the initial procedure of choice for most cases of suspected appendicitis.

  16. 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

  17. Incidence and Clinical Outcome of Hypophosphatemia in Pediatric Burn Patients.

    PubMed

    Leite, Heitor Pons; Pinheiro Nogueira, Larissa Araújo; Teodosio, Ariane Helena Calassa

    The objective of this study is to investigate the factors associated with serum phosphate concentrations in severely burned children and whether hypophosphatemia is associated with outcome. Seventy-eight children with a total body surface area of 24% (6.0-68.5) were retrospectively analyzed for serum phosphate concentrations during the first 10 days of stay in the intensive care unit (ICU). The method of generalized estimating equations was used to evaluate the effect of the exposure variables for serum phosphate concentrations during the study period. Outcome variables were the probability of ICU discharge at 30 days and time on mechanical ventilation. Potential explanatory variables for clinical outcome were hypophosphatemia (serum phosphate <3.8 mg/dL for children <2 years and <3.5 mg/dL for older children), age, sex, percent total body surface area burn, inhalation injury, and severe sepsis and/or septic shock. Competing-risk analysis was applied to calculate the probability of ICU discharge at 30 days, and death was assumed as the competing event. The rate of hypophosphatemia was 79.5%. Serum phosphate concentrations were associated with C-reactive protein (coefficient: -0.63; 95% confidence interval [CI]: -0.96 to -0.30; P = .001). Hypophosphatemia was independently associated with a 68% decrease in the probability of ICU discharge at 30 days (subhazard ratio: -0.32; 95% CI: 0.20, 0.53; P = .001) and an increase of 2.9 days in mechanical ventilation (coefficient: 2.91; 95% CI: 1.16, 4.66; P = .001). Serum phosphate concentrations in pediatric burn patients are associated with the magnitude of inflammatory response. Hypophosphatemia is associated with decreased probability of ICU discharge and increased time on mechanical ventilation.

  18. CLINICAL FEATURES OF TREATED AND UNTREATED TYPE 1 IDIOPATHIC MACULAR TELANGIECTASIA WITHOUT THE OCCURRENCE OF SECONDARY CHOROIDAL NEOVASCULARIZATION FOLLOWED FOR 2 YEARS IN JAPANESE PATIENTS.

    PubMed

    Osaka, Rie; Shiragami, Chieko; Ono, Aoi; Kobayashi, Mamoru; Takasago, Yukari; Yamashita, Ayana; Tsujikawa, Akitaka

    2017-05-24

    To evaluate the clinical features of Type 1 idiopathic macular telangiectasia (IMT) followed up for 2 years. Forty-nine patients with unilateral Type 1 IMT were examined. Thirty-one IMT eyes were treated with direct laser photocoagulation and/or intravitreal bevacizumab; the remaining 18 eyes, with good vision or slight macular edema, were untreated. Changes in best-corrected visual acuity and central retinal thickness between baseline and 24 months after the initial visit were examined. Of 49 eyes, nine were treated with direct laser photocoagulation, 12 with laser photocoagulation and intravitreal bevacizumab, 10 with intravitreal bevacizumab monotherapy, whereas 18 did not receive any treatment. The mean logarithm of the minimum angle of resolution best-corrected visual acuity was 0.20 ± 0.19 (median, 20/29) and 0.13 ± 0.22 (median, 20/25) at baseline and 24 months, respectively (P = 0.023). The mean central retinal thickness was 375.0 ± 94.5 μm and 315.3 ± 78.5 μm at baseline and 24 months, respectively (P < 0.001). Retinal vein occlusion and retinal macroaneurysm occurred in six eyes and one eye, respectively, during follow-up. Treatment with laser photocoagulation and/or intravitreal bevacizumab may be effective for Type 1 IMT, 36.7% of IMT eyes required no treatment over a 2-year follow-up, and other retinal vascular events were not uncommon.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

  19. Employment outcome and predictors of competitive employment at 2-year follow-up of a vocational rehabilitation programme for individuals with schizophrenia in a high-income welfare society.

    PubMed

    Evensen, Stig; Ueland, Torill; Lystad, June Ullevoldsæter; Bull, Helen; Klungsøyr, Ole; Martinsen, Egil W; Falkum, Erik

    2017-04-01

    Employment is an important part of recovery for individuals with schizophrenia. The employment rate for this group is as low as 10% in Norway, and major system related barriers to employment are evident. This study reports the competitive employment outcome at 2-year follow-up of a vocational rehabilitation study augmented with cognitive remediation (CR) or elements from cognitive behaviour therapy (CBT) for individuals with schizophrenia spectrum disorders. It also investigates if global functioning, self-esteem, and depression at baseline predicts employment outcome, and if change in these variables during the intervention period is associated with employment outcome. One hundred and forty-eight participants with schizophrenia spectrum disorders in six Norwegian counties received 10 months vocational rehabilitation augmented with either CBT (n = 84) or CR (n = 64). Both competitive and sheltered workplaces were used. Participants were assessed at baseline, at the end of the intervention period, and at 2-year follow-up. At 2-year follow-up, 21.2% had obtained competitive employment. A further 25.3% had work placements in competitive workplaces. Significant improvements were found in global functioning, self-esteem, and depression during the intervention period, but no significant differences between the two intervention groups. High baseline global functioning and self-esteem, as well as positive change in these variables during the intervention period, were significantly associated with higher competitive employment outcome at 2-year follow-up. The results add to existing evidence that competitive employment is attainable for individuals with schizophrenia. High global functioning and self-esteem were strongly associated with competitive employment outcome.

  20. Clinical outcomes of lung transplant recipients with telomerase mutations.

    PubMed

    Tokman, Sofya; Singer, Jonathan P; Devine, Megan S; Westall, Glen P; Aubert, John-David; Tamm, Michael; Snell, Gregory I; Lee, Joyce S; Goldberg, Hilary J; Kukreja, Jasleen; Golden, Jeffrey A; Leard, Lorriana E; Garcia, Christine K; Hays, Steven R

    2015-10-01

    Successful lung transplantation for patients with pulmonary fibrosis from telomerase mutations may be limited by systemic complications of telomerase dysfunction, including myelosuppression, cirrhosis, and malignancy. We describe clinical outcomes in 14 lung transplant recipients with telomerase mutations. Subjects underwent lung transplantation between February 2005 and April 2014 at 5 transplant centers. Data were abstracted from medical records, focusing on outcomes reflecting post-transplant treatment effects likely to be complicated by telomerase mutations. The median age of subjects was 60.5 years (interquartile range = 52.0-62.0), 64.3% were male, and the mean post-transplant observation time was 3.2 years (SD ± 2.9). A mutation in telomerase reverse transcriptase was present in 11 subjects, a telomerase RNA component mutation was present in 2 subjects, and an uncharacterized mutation was present in 1 subject. After lung transplantation, 10 subjects were leukopenic and 5 did not tolerate lymphocyte anti-proliferative agents. Six subjects developed recurrent lower respiratory tract infections, 7 developed acute cellular rejection (A1), and 4 developed chronic lung allograft dysfunction. Eight subjects developed at least 1 episode of acute renal failure and 10 developed chronic renal insufficiency. In addition, 3 subjects developed cancer. No subjects had cirrhosis. At data censorship, 13 subjects were alive. The clinical course for lung transplant recipients with telomerase mutations is complicated by renal disease, leukopenia with intolerance of lymphocyte anti-proliferative agents, and recurrent lower respiratory tract infections. In contrast, cirrhosis was absent, acute cellular rejection was mild, and development of chronic lung allograft dysfunction was comparable to other lung transplant recipients. Although it poses challenges, lung transplantation may be feasible for patients with pulmonary fibrosis from telomerase mutations. Copyright © 2015

  1. Clinical Outcomes of Lung Transplantation in Patients with Telomerase Mutations

    PubMed Central

    Tokman, Sofya; Singer, Jonathan P.; Devine, Megan S.; Westall, Glen P.; Aubert, John-David; Tamm, Michael; Snell, Gregory I.; Lee, Joyce S.; Goldberg, Hilary J.; Kukreja, Jasleen; Golden, Jeffrey A.; Leard, Lorriana E.; Garcia, Christine K.; Hays, Steven R.

    2017-01-01

    Background Successful lung transplantation (LT) for patients with pulmonary fibrosis from telomerase mutations is limited by systemic complications of telomerase dysfunction including myelosuppression, cirrhosis, and malignancy. We describe clinical outcomes among 14 LT recipients with telomerase mutations. Methods Subjects underwent LT between February 2005 and April 2014 at 5 LT centers. We abstracted data from medical records, focusing on outcomes reflecting post-LT treatment effects likely to be complicated by telomerase mutations. Results The median age of subjects was 60.5 years (IQR 52.0–62.0), 64.3% were male, and the mean post-LT observation time was 3.2 years (SD ±2.9). Eleven subjects had a mutation in telomerase reverse transcriptase, 2 in telomerase RNA component, and 1 had an uncharacterized mutation. Ten subjects were leukopenic post-LT; leukopenia prompted cessation of mycophenolate mofetil in 5 and treatment with filgrastim in 4. Six subjects had recurrent lower respiratory tract infections (LRTI), 7 had acute cellular rejection (ACR) (A1), and 4 developed chronic lung allograft dysfunction (CLAD). Ten LT recipients developed chronic renal insufficiency and 8 experienced acute, reversible renal failure. Three developed cancer, none had cirrhosis. Thirteen subjects were alive at data censorship. Conclusions The clinical course for LT recipients with telomerase mutations is complicated by renal disease, leukopenia prompting a change in the immunosuppressive regimen, and recurrent LTRI. In contrast, cirrhosis was absent, ACR was mild, and development of CLAD was comparable to other LT populations. While posing challenges, lung transplantation may be feasible for patients with pulmonary fibrosis due to telomerase mutations. PMID:26169663

  2. Effect of 2 Years of Treatment With Sublingual Grass Pollen Immunotherapy on Nasal Response to Allergen Challenge at 3 Years Among Patients With Moderate to Severe Seasonal Allergic Rhinitis: The GRASS Randomized Clinical Trial.

    PubMed

    Scadding, Guy W; Calderon, Moises A; Shamji, Mohamed H; Eifan, Aarif O; Penagos, Martin; Dumitru, Florentina; Sever, Michelle L; Bahnson, Henry T; Lawson, Kaitie; Harris, Kristina M; Plough, Audrey G; Panza, Joy Laurienzo; Qin, Tielin; Lim, Noha; Tchao, Nadia K; Togias, Alkis; Durham, Stephen R

    2017-02-14

    Sublingual immunotherapy and subcutaneous immunotherapy are effective in seasonal allergic rhinitis. Three years of continuous treatment with subcutaneous immunotherapy and sublingual immunotherapy has been shown to improve symptoms for at least 2 years following discontinuation of treatment. To assess whether 2 years of treatment with grass pollen sublingual immunotherapy, compared with placebo, provides improved nasal response to allergen challenge at 3-year follow-up. A randomized double-blind, placebo-controlled, 3-parallel-group study performed in a single academic center, Imperial College London, of adult patients with moderate to severe seasonal allergic rhinitis (interfering with usual daily activities or sleep). First enrollment was March 2011, last follow-up was February 2015. Thirty-six participants received 2 years of sublingual immunotherapy (daily tablets containing 15 µg of major allergen Phleum p 5 and monthly placebo injections), 36 received subcutaneous immunotherapy (monthly injections containing 20 µg of Phleum p 5 and daily placebo tablets) and 34 received matched double-placebo. Nasal allergen challenge was performed before treatment, at 1 and 2 years of treatment, and at 3 years (1 year after treatment discontinuation). Total nasal symptom scores (TNSS; range; 0 [best] to 12 [worst]) were recorded between 0 and 10 hours after challenge. The minimum clinically important difference for change in TNSS within an individual is 1.08. The primary outcome was TNSS comparing sublingual immunotherapy vs placebo at year 3. Subcutaneous immunotherapy was included as a positive control. The study was not powered to compare sublingual immunotherapy with subcutaneous immunotherapy. Among 106 randomized participants (mean age, 33.5 years; 34 women [32.1%]), 92 completed the study at 3 years. In the intent-to-treat population, mean TNSS score for the sublingual immunotherapy group was 6.36 (95% CI, 5.76 to 6.96) at pretreatment and 4.73 (95% CI, 3.97 to 5

  3. Relationship between management philosophy and clinical outcomes.

    PubMed

    Khatri, Naresh; Halbesleben, Jonathon R B; Petroski, Gregory F; Meyer, Wilbert

    2007-01-01

    Medical research continues to focus overwhelmingly on biomedical interventions, such as drugs, devices, and procedures. The dysfunctional health care cultures and systems need more attention for quality of care to improve further. The existing health services management research has not used a systematic theoretical framework to predict the effects of organizational variables on clinical outcomes. This study tests the theoretical model proposed by N. Khatri, A. Baveja, S. Boren, and A. Mammo (2006). This study surveyed employees from hospitals in Missouri. The sample consisted of 77 respondents from 16 hospitals. The control-based management approach (Management Control and Silos) was found to be positively associated with Culture of Blame and negatively with Learning From Mistakes. In contrast, the commitment-based approach (Fair Management Practices and Employee Participation) was negatively associated with Culture of Blame and positively with Learning From Mistakes, Camaraderie, and Motivation. Mediating variables of Learning From Mistakes and Camaraderie showed a significant negative relationship with Medical Errors. Learning From Mistakes, Camaraderie, and Motivation all showed a significant positive relationship with Quality of Patient Care. The mediating variables had much stronger relationships with Medical Errors and Quality of Patient Care than did the independent variables, lending support to the proposed mediation. Health care organizations can improve the quality of care and reduce medical errors significantly by enhancing learning from mistakes and boosting camaraderie and morale of their employees. They can do so by breaking down silos in their structures, implementing just and fair management practices, and involving employees in decision making.

  4. Biocompatible Peritoneal Dialysis Fluids: Clinical Outcomes

    PubMed Central

    Cho, Yeoungjee; Badve, Sunil V.; Hawley, Carmel M.; Wiggins, Kathryn; Johnson, David W.

    2012-01-01

    Peritoneal dialysis (PD) is a preferred home dialysis modality and has a number of added advantages including improved initial patient survival and cost effectiveness over haemodialysis. Despite these benefits, uptake of PD remains relatively low, especially in developed countries. Wider implementation of PD is compromised by higher technique failure from infections (e.g., PD peritonitis) and ultrafiltration failure. These are inevitable consequences of peritoneal injury, which is thought to result primarily from continuous exposure to PD fluids that are characterised by their “unphysiologic” composition. In order to overcome these barriers, a number of more biocompatible PD fluids, with neutral pH, low glucose degradation product content, and bicarbonate buffer have been manufactured over the past two decades. Several preclinical studies have demonstrated their benefit in terms of improvement in host cell defence, peritoneal membrane integrity, and cytokine profile. This paper aims to review randomised controlled trials assessing the use of biocompatible PD fluids and their effect on clinical outcomes. PMID:23251801

  5. Clinical outcome of surgical treatment of the symptomatic accessory navicular.

    PubMed

    Kopp, Franz J; Marcus, Randall E

    2004-01-01

    When conservative treatment fails to provide relief for a symptomatic accessory navicular, surgical intervention may be necessary. Numerous studies have been published, reporting the results of the traditional Kidner procedure and alternative surgical techniques, all of which produce mostly satisfactory clinical outcomes. The purpose of this study was to report the clinical results, utilizing the American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Scale, of surgical management for symptomatic accessory navicular with simple excision and anatomic repair of the tibialis posterior tendon. The authors retrospectively reviewed the results of 13 consecutive patients (14 feet) who underwent surgical treatment for symptomatic accessory navicular. The patients ranged in age from 16 to 64 years (average, 34.1 years; mean, 28.2 years) at the time of surgery. All patients had a type II accessory navicular. The average follow-up of the patients involved in the study was 103.4 months (range, 45-194 months). The AOFAS Midfoot Scale was utilized to determine both preoperative and postoperative clinical status of the 14 feet included in the study. The average preoperative AOFAS score was 48.2 (range, 20-75; mean, 38.8). The average postoperative AOFAS score was 94.5 (range, 83-100; mean, 94.3). At last follow-up, 13 of 14 feet were without any pain, no patients had activity limitations, and only two of 14 feet required shoe insert modification. Postoperatively, no patients had a clinically notable change in their preoperative midfoot longitudinal arch alignment. All of the patients in the study were satisfied with the outcome of their surgery and would undergo the same operation again under similar circumstances. When conservative measures fail to relieve the symptoms of a painful accessory navicular, simple excision of the accessory navicular and anatomic repair of the posterior tibialis tendon is a successful intervention. Overall, the procedure provides reliable pain

  6. Children who screen positive for autism at 2.5 years and receive early intervention: a prospective naturalistic 2-year outcome study

    PubMed Central

    Spjut Jansson, Birgitta; Miniscalco, Carmela; Westerlund, Joakim; Kantzer, Anne-Katrin; Fernell, Elisabeth; Gillberg, Christopher

    2016-01-01

    Background Previous research has stressed the importance of early identification and intervention for children with autism spectrum disorders. Methods Children who had screened positive for autism at the age of 2.5 years in a general population screening and then received a diagnosis of autism spectrum disorder were enrolled in an intervention program provided by Swedish habilitation services. The following interventions were available: a comprehensive intervention based on Applied Behavior Analysis – Intensive Learning (IL) – in two settings, which included home- and preschool-based (IL Regular) and only home-based (IL Modified) and eclectic interventions. Results There was considerable variability in terms of outcome, but intervention group status was not associated with any of the chosen outcome variables. Conclusion The main finding was that the type of intervention was not critical for outcome of adaptive or global functioning. The variability in outcome demonstrates the need for continuous assessments and evaluation of the child’s function and behavior throughout the intervention period. PMID:27621636

  7. Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up.

    PubMed

    Löfgren, Håkan; Engquist, M; Hoffmann, P; Sigstedt, B; Vavruch, L

    2010-03-01

    A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A-P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4 degrees . Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23

  8. Thyroid Surgery in Children: Clinical Outcomes.

    PubMed

    Sinha, C K; Decoppi, Paolo; Pierro, Agostino; Brain, Caroline; Hindmarsh, Peter; Butler, Gary; Dattani, Mehul; Spoudeas, Helen; Kurzawinski, Tom R

    2015-10-01

    The aim of this study was to review the outcomes of thyroid surgery in children operated for both benign and malignant conditions. Demography, clinical features, and surgical outcomes were noted retrospectively for operations performed during the last 23 years. Results were analyzed using Fisher exact test and Woolf (logit) method with p value < 0.05 considered as significant. In total, 61 children (43 girls and 18 boys) underwent thyroidectomy for benign (70%) and malignant (30%) conditions. Median follow-up period was 1.4 years. In the benign group, 84% children had Graves disease and 16% had other conditions. In this study, 42% children had total, 22% had near-total, 27% had subtotal, and 9% had type 2 hemithyroidectomy. In the malignant group, 50% had multiple endocrine neoplasia, 33% had papillary, 11% had follicular cancer, and 6% had B-cell lymphoma. Fifty percent children had prophylactic thyroidectomy, 44% had total thyroidectomy plus lymphadenectomy, and 6% had hemithyroidectomy. At the time of surgery, children with benign conditions were older than those with malignancy (median, 12 vs. 7.5 years). There were no incidents of postoperative bleeding or infection. Hypocalcemia was significantly more frequent in the malignant group (39 vs. 9%, p value = 0.01). The type of recurrent laryngeal nerve (RLN) injury was more serious in the benign group (one bilateral and one unilateral permanent injury) than in the malignant group (transient hoarseness in three). Overall rate of complications was higher for operations for malignancy (56 vs. 28%, p value = 0.07). In Graves disease, the subtotal thyroidectomies had a recurrence of 30% but no recurrence was seen following total or near-total thyroidectomy group (p value = 0.01). There was no recurrence in the malignant group. Children operated after 2000 were younger than those operated before 2000 (median age, 9 vs. 14 years). Malignant conditions were more common in children operated after 2000 in

  9. Clinical outcomes after posterolateral lumbar fusion in workers' compensation patients: a case-control study.

    PubMed

    Carreon, Leah Y; Glassman, Steven D; Kantamneni, Neha R; Mugavin, Mark O; Djurasovic, Mladen

    2010-09-01

    Case-control propensity matched. To compare clinical outcomes after lumbar fusion in patients receiving workers' compensation with a case-matched control group who are not on workers' compensation. Previous studies have demonstrated poor outcomes in patients receiving workers' compensation after lumbar fusion. However, a case-control study where patients are matched for covariates known to affect outcomes after lumbar fusion, including baseline clinical outcome measures, has not been done. From 783 patients who underwent posterolateral fusion with complete preoperative and 2-year postoperative outcome measures, 60 patients who were receiving workers' compensation were identified. Outcome measures included the Oswestry Disability Index (ODI), Short Form-36 (SF-36), and back and leg pain numerical rating scales. Propensity scoring technique was used to match these patients with a control group not receiving workers' compensation using sex, age, smoking status, body mass index, diagnosis, number of levels fused, preoperative ODI, SF-36 Physical Component Summary (PCS), SF-36 Mental Component Summary, and back and leg pain scores, producing 58 matched pairs. There were no significant differences between the demographics, job classification, and preoperative outcome scores in the two groups. At 2 years after operation, patients not receiving workers' compensation had a significantly greater improvement in ODI (P=0.009) and SF-36 PCS (P=0.007) compared with those receiving workers' compensation. Although patients not receiving workers' compensation had greater improvements in back and leg pain compared with those receiving workers' compensation, this did not reach statistical significance (P=0.079). The mean 2-year ODI, SF-36 PCS, and back pain raw scores of patients receiving workers' compensation were significantly lower than those not receiving workers' compensation. Only 19% of workers' compensation patients achieved minimum clinically important difference in terms

  10. The primary outcome measure and its importance in clinical trials.

    PubMed

    Andrade, Chittaranjan

    2015-10-01

    The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed. There are 2 reasons for this: it reduces the risk of false-positive errors resulting from the statistical testing of many outcomes, and it reduces the risk of a false-negative error by providing the basis for the estimation of the sample size necessary for an adequately powered study. This article discusses the setting of the primary outcome measure, the need for it, the increased risk of false-positive and false-negative errors in secondary outcome results, how to regard articles that do not state the primary outcome, how to interpret results when secondary outcomes are statistically significant but not the primary outcome, and limitations of the concept of a primary outcome measure in clinical trial research.

  11. Adolescent acromegaly: clinical parameters and treatment outcome.

    PubMed

    Bhansali, A; Upreti, V; Dutta, P; Mukherjee, K K; Nahar, U; Santosh, R; Das, S; Walia, R; Pathak, A

    2010-10-01

    Adolescent acromegaly is a rare disorder and these patients present with tall stature/gigantism, tumor mass effects and menstrual irregularities. 34 consecutive (26 males) patients having onset of disease prior to 21 years of age were included in this retrospective analysis. Their clinical features and treatment outcome were studied. Mean age and lag time at presentation were 21.6 +/- 3.9 years and 5.1 +/- 3.5 years respectively. Common presenting manifestations included acral enlargement, tumor mass effects and menstrual irregularities. Mean height at presentation was 174.6 +/- 13.7 cms (range: 150-210 cm) and one third had gigantism (height > or =97th percentile, WHO growth charts). Hypertension and glucose intolerance were seen in 15% and 23.5% respectively. Mean nadir GH after glucose load was 58.2 +/- 13.7 ng/ml and IGF -1 was 534.8 +/- 132.8 ng/ml. Half of the patients had concomitant hyperprolactinemia. Almost all (97%) had macroadenoma and anterior pituitary hormone deficiencies were frequent (75%). Patients with gigantism were younger (19.6 +/- 4.9 vs. 22.6 +/- 2.9 years; p = 0.001), had higher GH values (66.68 +/- 27.22 vs. 53.98 +/- 15.99 ng/ml; p = 0.04) and hypogonadism was more common (90.9% vs. 56.5%, p = 0.03) than those with normal stature. 32 patients (94.1%) were treated primarily with surgery, 7 (21.9%) received post operative radiotherapy. Mean duration of follow up was 33.1 +/- 10.1 months. Only 30% had nadir GH values of <1 ng/ml. One third of adolescent patients had acrogigantism. These patients were younger, had higher GH levels and concurrent hypogonadism was more common. Cure could be achieved only in about one third of the patients.

  12. Timing of Intubation and Clinical outcomes in Adults with ARDS

    PubMed Central

    Kangelaris, Kirsten Neudoerffer; Ware, Lorraine B.; Wang, Chen Yu; Janz, David R.; Hanjing, Zhuo; Matthay, Michael A.; Calfee, Carolyn S.

    2016-01-01

    Objective The incidence, clinical characteristics and outcomes of critically-ill, non-intubated patients with evidence of the acute respiratory distress syndrome (ARDS) remain inadequately characterized. Design Secondary analysis of a prospective observational cohort study. Setting Vanderbilt University Medical Center. Patients Among adult patients enrolled in a large, multi-intensive care unit prospective cohort study between the years of 2006 and 2011, we studied intubated and non-intubated patients with ARDS as defined by acute hypoxemia (PaO2/FiO2 ≤ 300 or SpO2/FiO2 ≤ 315) and bilateral radiographic opacities not explained by cardiac failure. We excluded patients not committed to full respiratory support. Interventions None. Measurements and Main Results Of 457 patients with ARDS, 106 (23%) were not intubated at the time of meeting all other ARDS criteria. Non-intubated patients had lower morbidity and severity of illness compared to intubated patients; however, mortality at 60 days was the same (36%) in both groups (P=0.91). Of the 106 non-intubated patients, 36 (34%) required intubation within the subsequent 3 days of follow-up; this “late” intubation subgroup had significantly higher 60-day mortality (56%) compared to both the “early” intubation group (36%, P<0.03) and to patients never requiring intubation (26%, P=0.002). Increased mortality in the “late” intubation group persisted at 2 years follow-up. Adjustment for baseline clinical and demographic differences did not change the results. Conclusions A substantial proportion of critically ill adults with ARDS were not intubated in their initial days of intensive care, and many were never intubated. Late intubation was associated with increased mortality. Criteria defining ARDS prior to need for positive pressure ventilation are needed so that these patients can be enrolled in clinical trials and to facilitate early recognition and treatment of ARDS. PMID:26474112

  13. Effect of case management on glycemic control and behavioral outcomes for chinese people with type 2 diabetes: A 2-year study.

    PubMed

    Yuan, Xiaodan; Wang, Fengmei; Fish, Anne Folta; Xue, Cunyi; Chen, Tao; Liu, Chao; Lou, Qingqing

    2016-08-01

    To examine the effect of case management on glycemic control and behavioral outcomes in adults with Type 2 diabetes in China. Participants were randomly assigned to a 1-year case management (CM) group (n=60) or control group (n=60). Monthly case management visits included identifying individuals' diabetes-related problems, setting goals, planning self-care, and evaluating progress. During a 1-year follow-up, all participants attended visits every 3 months without intervention. In the CM vs. the control group, HbA1c was reduced at 6 months compared to baseline (P=0.034), with trends at 12 and 24 months, and empowerment ability improved (P<0.05). Also in the CM vs. controls, total self-care behaviors, the frequency of exercise, blood glucose testing, and foot care were higher (P<0.001) at 12 months, and the percentage of individuals with HbA1c ≤7.0% was higher (P=0.035) at 24 months. The case management intervention in China was effective at 6 months and, based on trends in HbA1c at 12 and 24 months and results for behavioral outcomes, the intervention shows promise and warrants more research. A case management approach can enhance behavior change and glycemic control in Chinese with diabetes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  14. Temporal Relation Extraction in Outcome Variances of Clinical Pathways.

    PubMed

    Yamashita, Takanori; Wakata, Yoshifumi; Hamai, Satoshi; Nakashima, Yasuharu; Iwamoto, Yukihide; Franagan, Brendan; Nakashima, Naoki; Hirokawa, Sachio

    2015-01-01

    Recently the clinical pathway has progressed with digitalization and the analysis of activity. There are many previous studies on the clinical pathway but not many feed directly into medical practice. We constructed a mind map system that applies the spanning tree. This system can visualize temporal relations in outcome variances, and indicate outcomes that affect long-term hospitalization.

  15. Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

    PubMed

    Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

    2013-02-15

    Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

  16. Minimum 2-year outcome of cervical laminoplasty with deep extensor muscle-preserving approach: impact on cervical spine function and quality of life

    PubMed Central

    Abumi, Kuniyoshi; Ito, Manabu; Sudo, Hideki; Takahata, Masahiko; Ohshima, Shigeki; Hojo, Yoshihiro; Minami, Akio

    2009-01-01

    In this retrospective cohort study, two surgical methods of conventional open-door laminoplasty and deep extensor muscle-preserving laminoplasty were allocated for the treatment of cervical myelopathy, and were specifically compared in terms of axial pain, cervical spine function, and quality of life (QOL) with a minimum follow-up period of 2 years. Eighty-four patients were divided into two groups and received either a conventional open-door laminoplasty (CL group) or laminoplasty using a deep extensor muscle-preserving approach (MP group). The latter approach was performed by preserving multifidus and semispinalis cervicis attachments followed by open-door laminoplasty and re-suture of the bisected spinous processes at each decompression level. The average follow-up period was 38 months (25–53 months). The preoperative and follow-up evaluations included the original Japanese Orthopaedic Association (JOA) score, the new tentative JOA score including cervical spine function and QOL, and the visual analogue scale (VAS) of axial pain. Radiological analyses included cervical lordosis and flexion–extension range of motion (flex–ext ROM) (C2–7), and deep extensor muscle areas on MR axial images. The JOA recovery rates were statistically equivalent between two groups. The MP group demonstrated a statistically superior cervical spine function (84% vs 63%) and QOL (61% vs 45%) when compared to the CL group at final follow-up (P < 0.05). The average VAS scores at final follow-up were 2.3 and 4.9 in MP and CL groups (P < 0.05). The cervical lordosis and flex–ext ROM were statistically equivalent. The percent deep muscle area on MRI demonstrated a significant atrophy in CL group compared to that in MP group (56% vs 88%; P < 0.01). Laminoplasty employing the deep extensor muscle-preserving approach appeared to be effective in reducing the axial pain and deep muscle atrophy as well as improving cervical spine function and QOL when compared to conventional open

  17. Adjuvant adenoidectomy in persistent bilateral otitis media with effusion: hearing and revision surgery outcomes through 2 years in the TARGET randomised trial.

    PubMed

    2012-04-01

    To determine the adjuvant effects of adenoidectomy with short-stay ventilation tubes to hearing and revision surgery in children over 3.5 years with persistent otitis media with effusion. Randomised controlled three armed trial: observation, short-stay ventilation tube or ventilation tubes with adjuvant adenoidectomy. Five follow-up visits over 2 years. Eleven UK Otorhinolaryngology Departments. Children with bilateral otitis media with effusion and better ear hearing level (HL) ≥20 dB persistent for 3 months. Of the 425 eligible children, 376 (88%) accepted randomisation. Pure-tone hearing thresholds, eligibility for and actual revision surgery rates, otoscopic sequelae and complications of adenoidectomy. Loss to follow-up at 3, 12 and 24 months was 2%, 6% and 5% respectively. Of the 376 randomised children, 253 (67%) had complete data for all five follow-up visits. Adenoidectomy did not add to the benefit to hearing thresholds of ventilation tubes of 8.8 dB (CI: 7.1-10.5) averaged over 3-6 months postoperatively. Averaged over 12, 18 and 24 months, adenoidectomy provided 4.2 dB of benefit (CI: 2.6-5.7) whilst ventilation tubes gave no benefit. Standardised effect sizes through two years showed equal benefit from ventilation tubes (0.50 sd) and adenoidectomy (0.61 sd) which are additive (1.11 sd). Adenoidectomy halved the numbers meeting a 25 dB HL bilateral cut-off for eligibility for repeat tube surgery from 31% to 14% at 12 months and from 33% to 15% at 18 months. The actual reduction in re-insertion surgery (absolute risk difference) was 21%. In tubed ears, tympanosclerosis occurred in 27%, but otorrhoea in only <2% and permanent perforations in <1%. These events did not occur in control ears. In children that had adenoidectomy, one of 165 (0.6%) had haemorrhage that required return to theatre. Adjuvant adenoidectomy doubles benefit from short-stay ventilation tubes by extending better hearing through the second year in children aged 3.25-6.75 years with

  18. Minimum 2-year outcome of cervical laminoplasty with deep extensor muscle-preserving approach: impact on cervical spine function and quality of life.

    PubMed

    Kotani, Yoshihisa; Abumi, Kuniyoshi; Ito, Manabu; Sudo, Hideki; Takahata, Masahiko; Ohshima, Shigeki; Hojo, Yoshihiro; Minami, Akio

    2009-05-01

    In this retrospective cohort study, two surgical methods of conventional open-door laminoplasty and deep extensor muscle-preserving laminoplasty were allocated for the treatment of cervical myelopathy, and were specifically compared in terms of axial pain, cervical spine function, and quality of life (QOL) with a minimum follow-up period of 2 years. Eighty-four patients were divided into two groups and received either a conventional open-door laminoplasty (CL group) or laminoplasty using a deep extensor muscle-preserving approach (MP group). The latter approach was performed by preserving multifidus and semispinalis cervicis attachments followed by open-door laminoplasty and re-suture of the bisected spinous processes at each decompression level. The average follow-up period was 38 months (25-53 months). The preoperative and follow-up evaluations included the original Japanese Orthopaedic Association (JOA) score, the new tentative JOA score including cervical spine function and QOL, and the visual analogue scale (VAS) of axial pain. Radiological analyses included cervical lordosis and flexion-extension range of motion (flex-ext ROM) (C2-7), and deep extensor muscle areas on MR axial images. The JOA recovery rates were statistically equivalent between two groups. The MP group demonstrated a statistically superior cervical spine function (84% vs 63%) and QOL (61% vs 45%) when compared to the CL group at final follow-up (P < 0.05). The average VAS scores at final follow-up were 2.3 and 4.9 in MP and CL groups (P < 0.05). The cervical lordosis and flex-ext ROM were statistically equivalent. The percent deep muscle area on MRI demonstrated a significant atrophy in CL group compared to that in MP group (56% vs 88%; P < 0.01). Laminoplasty employing the deep extensor muscle-preserving approach appeared to be effective in reducing the axial pain and deep muscle atrophy as well as improving cervical spine function and QOL when compared to conventional open-door laminoplasty.

  19. Does crossover innervation really affect the clinical outcome? A comparison of outcome between unilateral and bilateral digital nerve repair.

    PubMed

    Oruç, Melike; Ozer, Kadri; Çolak, Özlem; Kankaya, Yüksel; Koçer, Uğur

    2016-09-01

    Digital nerve injuries are the mostly detected nerve injury in the upper extremity. However, since the clinical phenomenon of crossover innervation at some degree from uninjured digital nerve to the injured side occurs after digital nerve injuries is sustained, one could argue that this concept might even result in the overestimation of the outcome of the digital nerve repair. With this knowledge in mind, this study aimed to present novel, pure, focused and valuable clinical data by comparing the outcomes of bilateral and unilateral digital nerve repair. A retrospective review of 28 fingers with unilateral or bilateral digital nerve repair using end-to-end technique in 19 patients within 2 years was performed. Weber's two-point discrimination, sharp/dull discrimination, warm/cold sensation and Visual Analog Scale scoring were measured at final 12-month follow ups in all patients. There was no significant difference in recovery of sensibility after unilateral and bilateral digital nerve repairs. Though there is crossover innervation microscopically, it is not important in the clinical evaluation period. According to clinical findings from this study, crossover innervations appear to be negligible in the estimation of outcomes of digital neurorrhaphy.

  20. The distribution of outcomes research papers across clinical journals.

    PubMed

    Goldsack, Jennifer; McLaughlin, Chris; Bristol, Mirar N; Loeb, Alex; Bergey, Meredith; Sonnad, Seema S

    2011-06-01

    This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies.

  1. Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial

    PubMed Central

    Kasang, Christa; Kalluvya, Samuel; Majinge, Charles; Kongola, Gilbert; Mlewa, Mathias; Massawe, Irene; Kabyemera, Rogatus; Magambo, Kinanga; Ulmer, Albrecht; Klinker, Hartwig; Gschmack, Eva; Horn, Anne; Koutsilieri, Eleni; Preiser, Wolfgang; Hofmann, Daniela; Hain, Johannes; Müller, Andreas; Dölken, Lars; Weissbrich, Benedikt; Rethwilm, Axel; Stich, August; Scheller, Carsten

    2016-01-01

    Background HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients. Methods Double-blind, placebo-controlled randomized clinical trial including 326 HIV-patients in a resource-limited setting in Tanzania (clinicaltrials.gov NCT01299948). Inclusion criteria were a CD4 count above 300 cells/μl, the absence of AIDS-defining symptoms and an ART-naïve therapy status. Study participants received 5 mg prednisolone per day or placebo for 2 years. Primary endpoint was time to progression to an AIDS-defining condition or to a CD4-count below 200 cells/μl. Results No significant change in progression towards the primary endpoint was observed in the intent-to-treat (ITT) analysis (19 cases with prednisolone versus 28 cases with placebo, p = 0.1407). In a per-protocol (PP)-analysis, 13 versus 24 study participants progressed to the primary study endpoint (p = 0.0741). Secondary endpoints: Prednisolone-treatment decreased immune activation (sCD14, suPAR, CD38/HLA-DR/CD8+) and increased CD4-counts (+77.42 ± 5.70 cells/μl compared to -37.42 ± 10.77 cells/μl under placebo, p < 0.0001). Treatment with prednisolone was associated with a 3.2-fold increase in HIV viral load (p < 0.0001). In a post-hoc analysis stratifying for sex, females treated with prednisolone progressed significantly slower to the primary study endpoint than females treated with placebo (ITT-analysis: 11 versus 21 cases, p = 0.0567; PP-analysis: 5 versus 18 cases, p = 0.0051): No changes in disease progression were observed in men. Conclusions This study could not detect any significant effects of prednisolone on disease progression in antiretroviral-untreated HIV infection within the intent-to-treat population. However, significant effects were observed on CD4 counts, immune activation and HIV viral load. This study contributes to a better understanding of the role of immune

  2. Long-term outcome of pharmacological and psychological treatment for panic disorder with agoraphobia: a 2-year naturalistic follow-up.

    PubMed

    de Beurs, E; van Balkom, A J; Van Dyck, R; Lange, A

    1999-01-01

    Two years after completion of a controlled outcome study of treatments for panic disorder with agoraphobia, patients were revisited and interviewed about their complaints. In the initial study, four treatments had been compared: (i) fluvoxamine combined with exposure; (ii) placebo medication plus exposure; (iii) psychological panic management plus exposure; and (iv) exposure alone. Comparison of the results at post-test had revealed superior efficacy of fluvoxamine combined with exposure over the other three treatments in reducing agoraphobic avoidance. The current naturalistic follow-up study investigated the long-term efficacy of the treatments with regard to abatement of complaints and reduced demand for further treatment. In addition, we examined whether patients were able to taper off the study medication without a recurrence of complaints. In total, 71 of the 76 patients of the original trial (93%) were interviewed. Comparison of the mean level of psychopathology at follow-up revealed no difference between the original treatment groups. The effect in the fluvoxamine plus exposure group was maintained, but was no longer superior, due to further improvements in the other treatment groups. Most patients received additional treatment during the follow-up period, usually because the 12 treatment sessions in the controlled study had yielded insufficient improvement. There was a trend for patients who received the fluvoxamine plus exposure treatment to require less aftercare than those who received the other treatments. Finally, almost 50% of the patients who had received medication in the original trial were able to taper off the use of fluvoxamine without a recurrence of complaints.

  3. Clinical audit results in earlier nutritional intervention in malnourished children with cystic fibrosis with improved outcome.

    PubMed

    Ledder, Oren; Oliver, Mark R; Heine, Ralf G; Graham, Joanne; Volders, Evelyn; Robinson, Philip J

    2015-10-01

    The association between nutritional status, pulmonary function and survival in cystic fibrosis (CF) is well established. A previous case series from the Royal Children's Hospital, Melbourne (RCH), demonstrated suboptimal referral practices and highlighted the importance of early nutritional interventions in children with CF. Various qualitative changes were made to our CF service, and this study assesses the effects of these practice changes timing of gastrostomy and clinical outcome in patients who underwent gastrostomy insertion. Clinical audit of all CF patients who had undergone gastrostomy insertion from 2002 to 2010 at Royal Children's Hospital. Clinical data, including nutritional parameters, respiratory function and survival, were collected at 2 years prior and 2 years post gastrostomy insertion. Data were compared with the previous study from 1989 to 1997. Patients with CF who underwent gastrostomy insertion between 2002 and 2010 (n = 22) had higher weight-for-age scores (-1.5 ± 0.68 vs. -2.67 ± 1.06; P = 0.0001) and higher forced expiratory volume in 1 s (68% ± 22 vs. 52% ± 18.5; P = 0.006), compared with the cohort from 1989 to 1997 (n = 37). These differences were maintained at 2-year follow-up. Pseudomonas aeruginosa colonisation rate was 100% in 1989-1997 vs. 41% in 2002-2010; P = 0.0001. The 2-year survival post-gastrostomy insertion improved from 70% to 100%; P = 0.004. Earlier referral of patients in the recent cohort resulted in sustained improvements in weight-for-age and lung function. Survival at 2 years post-procedure was significantly improved. This study confirms the value of clinical audits and subsequent re-evaluation of clinical services. © 2015 The Authors. Journal of Paediatrics and Child Health © 2015 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  4. Anterior shoulder stabilization by Bristow-Latarjet procedure in athletes: return-to-sport and functional outcomes at minimum 2-year follow-up.

    PubMed

    Beranger, Jean Sébastien; Klouche, Shahnaz; Bauer, Thomas; Demoures, Thomas; Hardy, Philippe

    2016-04-01

    The aim of this study was to assess return-to-sport outcomes following the Latarjet-Bristow procedure. This retrospective study included all athletes <50 years old, who underwent a Latarjet-Bristow procedure for anterior shoulder instability in 2009-2012. Main criteria assessments were the number of athletes returning to any sport and the number returning to the same sport at their preinjury level. The main follow-up was 46.8 ± 9.7 months. Forty-seven patients were analyzed, 46 men/1 women, mean age 27.9 ± 7.9 years. Eighteen patients practiced competitive sports and 29 recreational sports. None of them were professional athletes. One hundred percent returned to sports after a mean 6.3 ± 4.3 months. Thirty/47 (63.8 %) patients returned to the same sport at the same level at least and 10/47 (21.3 %) patients changed sport because of their shoulder. Compared to patients who returned to the same sport at the same level, patients who changed sports or returned to a lower level had practiced overhead or forced overhead sports [OR = 4.7 (1.3-16.9), p = 0.02] before surgery, experienced avoidance behavior at the final follow-up (p = 0.002), apprehension (p = 0.00001) and had a worse Western Ontario Shoulder Instability Index score and sub-items (p = 0.003) except for daily activities (p = 0.21). At the final follow-up, 45/47 (95.7 %) patients were still practicing a sport. All the patients returned to sports, most to their preinjury sport at the same level. Patients who practiced an overhead sport were more likely to play at a lower level or to change sport postoperatively. IV, retrospective study-Case series with no comparison group.

  5. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M,; Foy, M. H.; Dulchavsky, S. A.; Gibson, C. R.

    2015-01-01

    The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capabilities (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities". Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes.

  6. No difference in postoperative complications, pain, and functional outcomes up to 2 years after incidental durotomy in lumbar spinal fusion: a prospective, multi-institutional, propensity-matched analysis of 1,741 patients.

    PubMed

    Adogwa, Owoicho; Huang, Mary I; Thompson, Paul M; Darlington, Timothy; Cheng, Joseph S; Gokaslan, Ziya L; Gottfried, Oren N; Bagley, Carlos A; Anderson, Greg D; Isaacs, Robert E

    2014-09-01

    Incidental durotomies occur in up to 17% of spinal operations. Controversy exists regarding the short- and long-term consequences of durotomies. The primary aim of this study was to assess the effect of incidental durotomies on the immediate postoperative complications and patient-reported outcome measures. Prospective study. A total of 1,741 patients undergoing index lumbar spine fusion were selected from a multi-institutional prospective data registry. Patient-reported outcome measures used in this study included back pain (BP-Visual Analog Scale), leg pain (LP-Visual Analog Scale), and Oswestry Disability Index. A total of 1,741 patients were selected from a multi-institutional prospective data registry, who underwent primary lumbar fusion for low back pain and/or radiculopathy between January 2003 and December 2010. We collected and analyzed data on patient demographics, postoperative complications, back pain, leg pain, and functional disability over 2 years, with risk-adjusted propensity score modeling. Incidental durotomies occurred in 70 patients (4%). Compared with the control group (n=1,671), there was no significant difference in postoperative infection (p=.32), need for reoperation (p=.85), or symptomatic neurologic damage (p=.66). At 1- and 2-year follow-up, there was no difference in patient-reported outcomes of back pain (BP-Visual Analog Scale), leg pain (LP-Visual Analog Scale), or functional disability (Oswestry Disability Index) (p>.3), with results remaining consistent in the propensity-matched cohort analysis (p>.4). Within the context of an on-going debate on the consequences of incidental durotomy, we found no difference in neurologic symptoms, infection, reoperation, back pain, leg pain, or functional disability over a 2-year follow-up period. Published by Elsevier Inc.

  7. Long-term clinical outcome of neonatal EEG findings.

    PubMed

    Almubarak, Salah; Wong, Peter K H

    2011-04-01

    The aim of the study is to determine how specific EEG findings during neonatal period correlate with clinical outcome on follow-up. This is a retrospective study of 118 term newborns who had EEG in the first month of life and subsequent clinical assessment between 4 and 16 years. Clinical neurologic outcome was classified into "favorable" when patients had no or only mild limitation in assessment, "unfavorable" when patients had moderate to severe abnormalities in assessment, and "epilepsy" when patients had seizures. Of the 118 neonates, 36 (30.5%) had favorable and 82 (69.5%) had unfavorable outcome; 89 (75.4%) had epilepsy and 28 (23.7%) had not. Sixty-seven (57%) had abnormal EEG background of which 56 had both unfavorable outcome and epilepsy; 102 (86%) had sharp transient discharges of which 75 had unfavorable outcome; 20 (17%) had ictal epileptiform discharges of which 18 had unfavorable outcome; 98 (83%) had abnormal overall EEG impression of which 77 had unfavorable outcome and 80 had epilepsy. Abnormal EEG background (particularly suppression) during neonatal period may be predictive of Unfavorable outcome. Overall impression of EEG may be predictive of clinical outcome, even when individual parameters were not predictive. Other findings did not appear to be predictive.

  8. Clinical outcomes in overweight heart transplant recipients.

    PubMed

    Jalowiec, Anne; Grady, Kathleen L; White-Williams, Connie

    2016-01-01

    Few studies have examined the impact of patient weight on heart transplant (HT) outcomes. Nine outcomes were compared in 2 groups of HT recipients (N = 347) based on their mean body mass index (BMI) during the first 3 years post-HT. Group 1 consisted of 108 non-overweight patients (BMI <25; mean age 52; 29.6% females; 16.7% minorities). Group 2 consisted of 239 overweight patients (BMI ≥25; mean age 52; 15.9% females; 13.8% minorities). Outcomes were: survival, re-hospitalization, rejections, infections, cardiac allograft vasculopathy (CAV), stroke, renal dysfunction, diabetes, and lymphoma. Non-overweight patients had shorter survival, were re-hospitalized more days after the HT discharge, and had more lymphoma and severe renal dysfunction. Overweight patients had more CAV, steroid-induced diabetes, and acute rejections. Overweight HT patients had better survival, but more rejections, CAV, and diabetes. Non-overweight HT patients had worse survival, plus more re-hospitalization time, lymphoma, and renal dysfunction. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Associations between the schizophrenia susceptibility gene ZNF804A and clinical outcomes in psychosis

    PubMed Central

    Wickramasinghe, A; Tulloch, A D; Hayes, R D; Chang, C-K; Broadbent, M; Di Forti, M; Murray, R M; Iyegbe, C; Stewart, R

    2015-01-01

    We sought to test the hypothesis that the rs1344706 A allele will be associated with worse clinical outcome in first-episode psychosis. A data linkage was set up between a large systematic study of first-episode psychosis and an electronic health-record case register at the South London and Maudsley NHS Foundation Trust—a large provider of secondary mental-health care. A sample of 291 patients, who presented with a first psychotic episode (ICD10 diagnoses F20–29 or F30–33) and in whom the rs1344706 genotype had been assayed, were followed to examine the duration of mental-health in-patient care during the 2 years following first service contact, as a primary outcome. Secondary outcome measures were whether or not an in-patient episode occurred and the number of in-patient episodes during this period. A strong association was found between the number of rs1344706 A alleles and the cumulative duration of mental-health in-patient stay over the 2 years since initial presentation. In the 84.2% who experienced an in-patient episode during this period, the mean duration of admission was an additional 38 days for each A allele increment. Therefore, in addition to its potential role as a risk factor for psychosis, the ZNF804A rs1344706 A allele is associated with worse clinical outcome. PMID:26670283

  10. Development and Clinical Outcomes of a Dialectical Behavior Therapy Clinic

    ERIC Educational Resources Information Center

    Lajoie, Travis; Sonkiss, Joshua; Rich, Anne

    2011-01-01

    Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…

  11. Development and Clinical Outcomes of a Dialectical Behavior Therapy Clinic

    ERIC Educational Resources Information Center

    Lajoie, Travis; Sonkiss, Joshua; Rich, Anne

    2011-01-01

    Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…

  12. Review of Clinical Mental Health Counseling Process and Outcome Research.

    ERIC Educational Resources Information Center

    Kelly, Kevin R.

    1996-01-01

    Summarizes important advances in clinical knowledge regarding mental health counseling processes and outcomes of treatment as appeared in four major journals in 1994. Findings are summarized by topic and implications for practice are provided. Delineates current lines of inquiry. (EMK)

  13. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, Doug; Byrne, Vicky; Cole, Richard; Dulchavsky, Scott; Foy, Millennia; Garcia, Kathleen; Gibson, Robert; Ham, David; Hurst, Victor; Kerstman, Eric; McGuire, Kerry; Sargsyan, Ashot

    2015-01-01

    The objective of this research is to develop and use clinical outcome metrics and training tools to quantify the differences in performance of a physician vs non-physician crew medical officer (CMO) analogues during simulations.

  14. Single Case Research Results as Clinical Outcomes

    ERIC Educational Resources Information Center

    Parker, Richard I.; Hagan-Burke, Shanna

    2007-01-01

    The movement toward evidence-based treatments, interventions, or practices pressures single case research (SCR) to use statistical summaries which have broad credibility. These summaries also need to be easily understood and useful in schools and clinics. To date the effect size families, "proportion of variance"…

  15. Outpatient clinic referrals and their outcome.

    PubMed

    Sullivan, F M; Hoare, T; Gilmour, H

    1992-03-01

    A cohort of 392 patients referred to six outpatient clinics by general practitioners during 1987 with diagnoses of rheumatoid arthritis, osteoarthritis, peripheral vascular disease, psoriasis or eczema, were studied from the time of their first attendance until up to two years later. Six consultant clinics were studied in the three specialties: rheumatology, vascular surgery and dermatology. For each specialty a clinic in both a teaching hospital and a district general hospital were included. The cohort members were predominantly middle-aged or elderly people, with a greater proportion of women, except at the vascular surgery clinic where 65% of patients were men. The 392 patients made a total of 936 visits (median two, range one-eight) during the study period; 91 patients were still attending up to two years after the first visit. Patients referred by their general practitioner for therapy were less likely to be discharged than those referred for other reasons. The principal reason for continuing attendance as perceived by patients, general practitioners and hospital doctors was the necessity for consultant supervision, although agreement was far from complete in individual cases. Junior staff tended to see a higher proportion of patients at follow-up visits than did consultants, and were found to have lower discharge rates than consultants. Analyses of data showed that at the first visit, diagnosis, disease severity and the grade of doctor seeing the patient in the clinic was significantly associated with patient discharge at the P < 0.05 level of significance. Patients considered that their visits had produced improvement in their condition in 38% of cases.(ABSTRACT TRUNCATED AT 250 WORDS)

  16. 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.

  17. Clinical evaluation of three months' nightguard vital bleaching on tetracycline-stained teeth using Polanight 10% carbamide gel: 2-year follow-up study.

    PubMed

    Tsubura, Shuichi

    2010-07-01

    Nightguard vital bleaching (NGVB) has been applied as a safe and effective bleaching procedure with a wide variety of commercial products consisting of carbamide peroxide-based gels, but there have been few reports on tooth bleaching for tetracycline-stained teeth. The purpose of this study was to evaluate the bleaching effects on teeth discolored by tetracycline with 3 months' active treatment, and to investigate the participant satisfaction, the shade stability, and the post-treatment side effects 2 years after the treatment. A custom-made tray with Polanight 10% carbamide peroxide gel was applied to both the incisal and premolar teeth (10 teeth of each participant), and the participants were directed to wear the tray every night over the course of the 3 months. The whiteness-blackness difference (L*) became lighter within 3 months and the lightness remained until 2 years later. Tooth color changes were remarkable in both redness-greenness difference (a*) and yellowness-blueness difference (b*). No obvious shade change or slight darkening was recognized 2 years post-treatment. The means of the color difference (DeltaE*) at 3 months, 6 months, 1 year, and 2 years were 13.74, 14.02, 12.17, and 11.81, respectively. All participants were satisfied with the shade change of their teeth, but three participants complained of slight hypersensitivity. One participant complained of cold or hot pain in daily life until 6 months after the treatment. These side effects were alleviated within 1 year. The results suggested that the standard treatment period of NGVB with Polanight for tetracycline-discolored teeth may be determined to be 3 months.

  18. Standards for clinical trials in sexual dysfunctions of women: research designs and outcomes assessment.

    PubMed

    Heiman, Julia R; Guess, Marsha K; Connell, Kathleen; Melman, Arnold; Hyde, Janet Shibley; Segraves, R Taylor; Wyllie, Michael G

    2004-07-01

    Clinical trials on sexual dysfunctions in women are limited in spite of the fact that sexual dysfunctions are likely more common in women than in men. Currently there are no medications approved for treatment in women, and limited data on drug efficacy or psychological efficacy in well-controlled studies. To provide recommendations/guidelines concerning state-of-the-art knowledge for the research design and outcome assessment standards for clinical trials in women's sexual dysfunctions. An International Consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. Concerning the Standards for Clinical Trials in Women's Sexual Dysfunctions Committee, there were seven experts from two countries. Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. A comprehensive update was created which included references and recommended guidelines for rationale and design of clinical trials, study populations, outcome assessments, protocol design and implementation, data analysis and reporting, as well as ethical and clinical issues related to sexual dysfunction research. There is a need for more research in developing standards to be used when performing clinical trials and outcomes assessment research in sexual dysfunctions of women.

  19. Outcomes of Hip Arthroscopic Surgery in Patients With Tönnis Grade 1 Osteoarthritis With a Minimum 2-Year Follow-up: Evaluation Using a Matched-Pair Analysis With a Control Group With Tönnis Grade 0.

    PubMed

    Chandrasekaran, Sivashankar; Gui, Chengcheng; Darwish, Nader; Lodhia, Parth; Suarez-Ahedo, Carlos; Domb, Benjamin G

    2016-07-01

    There are limited studies on the effect of mild osteoarthritis (OA) on outcomes of hip arthroscopic surgery. To conduct a matched-pair analysis with a minimum 2-year follow-up to evaluate outcomes after hip arthroscopic surgery in patients with Tönnis grade 1 OA. Cohort study; Level of evidence, 3. Data were prospectively collected on patients who underwent hip arthroscopic surgery between April 2008 and December 2012. Patients were excluded if they had previous hip conditions. The remaining patients were divided into either Tönnis 0 or 1 grade OA groups and were matched in a 1-to-1 ratio according to age within 5 years, sex, body mass index category, labral treatment, and capsular treatment. Four patient-reported outcome (PRO) scores, as well as the visual analog scale (VAS) score for pain, patient satisfaction, and rates of revision arthroscopic surgery and conversion to total hip arthroplasty (THA), were recorded. A total of 1412 hip arthroscopic procedures were performed during the study period, of which 1036 met the inclusion criteria and 892 (86.1%) had 2-year follow-up. There were 738 and 154 patients with Tönnis grade 0 and 1, respectively; 93 patients were matched in each group. The Tönnis grade 0 group had a mean follow up of 28.7 months (range, 23.5-67.9 months), and the Tönnis grade 1 group had a mean follow up of 31.5 months (range, 23.6-63.5 months). Both groups demonstrated a significant improvement in all PROs and the VAS at a minimum 2-year follow-up. For the Tönnis grade 0 group, the improvements (in points) in the PROs were as follows: modified Harris Hip Score (mHHS), 15.51; Nonarthritic Hip Score (NAHS), 20.65; Hip Outcome Score-Activities of Daily Living (HOS-ADL), 16.83; and Hip Outcome Score-Sport-Specific Subscale (HOS-SSS), 20.91. The VAS score for the Tönnis grade 0 group decreased by 2.82 points. For the Tönnis grade 1 group, the improvements (in points) in the PROs were as follows: mHHS, 19.52; NAHS, 20.96; HOS-ADL, 18.20; and

  20. Estimating fetal weight for best clinical outcome

    PubMed Central

    2015-01-01

    Clinical decisions are often based on the results of third trimester sonograms, particularly with small or large babies and so accuracy of estimating fetal weight (EFW) is essential. There are numerous EFW formula available and yet in Australia no one formula has been recommended for use due to the lack of clinical evidence as to their accuracy. Objectives: 1 To assess inter/intra observer error for fetal parameter measurements with multiple observers. 2 To compare six of the most commonly used EFW formulae and analyse inter/intra formulae variations for different weight range. Method: EFW of 121 pregnancies assessed within 7 days of birth by measuring the BPD, OFD, HC, AC, FL and comparing to actual birth weight. Results: Inter‐observer error: 1.3 to 3.1%. Intra‐observer error: 1.1 to 1.9% depending on fetal parameter. Accuracy of each EFW formula changed with different weight ranges. For all formulae the highest random error occurred in the macrosomic group. The lowest random error in all weight groups was the Hadlock B formula incorporating the HC/AC/FL (7.7%). Conclusion: Considering the possible problems of head moulding this study suggests the use of: Hadlock FP et al (1982) – Formula B – incorporating HC/AC/FL. PMID:28191133

  1. Air Embolism: Diagnosis, Clinical Management and Outcomes

    PubMed Central

    McCarthy, Colin J.; Behravesh, Sasan; Naidu, Sailendra G.; Oklu, Rahmi

    2017-01-01

    Air embolism is a rare but potentially fatal complication of surgical procedures. Rapid recognition and intervention is critical for reducing morbidity and mortality. We retrospectively characterized our experience with air embolism during medical procedures at a tertiary medical center. Electronic medical records were searched for all cases of air embolism over a 25-year period; relevant medical and imaging records were reviewed. Sixty-seven air embolism cases were identified; the mean age was 59 years (range, 3–89 years). Ninety-four percent occurred in-hospital, of which 77.8% were during an operation/invasive procedure. Vascular access-related procedures (33%) were the most commonly associated with air embolism. Clinical signs and symptoms were related to the location the air embolus; 36 cases to the right heart/pulmonary artery, 21 to the cerebrum, and 10 were attributed to patent foramen ovale (PFO). Twenty-one percent of patients underwent hyperbaric oxygen therapy (HBOT), 7.5% aspiration of the air, and 63% had no sequelae. Mortality rate was 21%; 69% died within 48 hours. Thirteen patients had immediate cardiac arrest where mortality rate was 53.8%, compared to 13.5% (p = 0.0035) in those without. Air emboli were mainly iatrogenic, primarily associated with endovascular procedures. High clinical suspicion and early treatment are critical for survival. PMID:28106717

  2. A Five-Phase Model for Clinical-Outcome Research

    ERIC Educational Resources Information Center

    Robey, Randall R.

    2004-01-01

    Through a variety of approaches, speech-language pathologists and audiologists have produced strong evidence that treatments are generally potent. However, we have largely ignored the accepted standards for clinical-outcome testing used throughout the broader research community (e.g., by other clinical disciplines, federal regulators, and…

  3. Clinical and Statistical Issues Related to Predicting Therapeutic Outcome.

    ERIC Educational Resources Information Center

    Ghiselli, William B.

    1983-01-01

    Studied predictability of therapeutic outcome of an alcoholism treatment program. Data analyzed by a mathematically oriented linear regression approach and by a clinically oriented retrospective parametric approach showed different predictors. Suggested that the parametric clinical approach be used to explain why therapy succeeded or failed.…

  4. The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature.

    PubMed

    Khan, Safdar N; Mermer, Matthew J; Myers, Elizabeth; Sandhu, Harvinder S

    2008-12-01

    Compared with nonfunded or peer-reviewed funded projects, industry-sponsored clinical trials have traditionally been associated with more positive results. This relationship has been extensively studied in the nonsurgical literature. Although a few authors have addressed specialties, little has been reported on orthopedic clinical trials and their association with funding, study outcome, and efforts to reduce bias after randomization across journals of multiple subspecialties. For the study reported here, we selected 5 major orthopedic subspecialty journals: Journal of Bone and Joint Surgery (American Volume), Spine, Journal of Arthroplasty, Journal of Orthopaedic Trauma, and American Journal of Sports Medicine. We chose a 2-year limit for investigation (2002-2004); included all original randomized clinical trials reported in these 5 journals; and examined these trials for their study design, funding source, outcome, bias potential, and conclusion reached. Support for the 100 eligible orthopedic clinical trials was stated as coming from industry (26 trials, 26%), nonprofit sources (19 trials, 19%), and mixed sources (5 trials, 5%); no support was stated in 46 trials (46%), and support was not reported in 4 trials (4%). Of the 26 trials reporting industry support, 22 (85%) were graded as indicating an outcome favorable to the new treatment. The association between industry funding and favorable outcome was strong and significant (P<.001). In almost half of the studies reported in Journal of Bone and Joint Surgery and Spine, measures taken to reduce bias were not documented.

  5. Levothyroxine Poisoning - Symptoms and Clinical Outcome.

    PubMed

    Nygaard, Birgitte; Saedder, Eva A; Dalhoff, Kim; Wikkelsoe, Mette; Jürgens, Gesche

    2015-10-01

    Levothyroxine (LT), T4, poisoning is rarely associated with a severe outcome. However, cases with significant complications have been reported. The aim of this study was to identify factors associated with symptoms of poisoning including late-onset symptoms. All enquiries to the Danish Poison Information Centre (DPIC) concerning LT poisoning between March 2007 and September 2012 were reviewed and the following parameters were recorded: age, dose, time from ingestion, multiple drug intake and symptoms. To evaluate the frequency of late-onset symptoms, a subgroup of patients without initial symptoms were contacted. A total of 181 patients were registered (112 children). Ingested LT dose ranged from 10 to 9000 mcg (median 275 mcg). A total of 29 of 181 (16%) patients were symptomatic at the time of enquiry, and there was no difference in ingested LT dose between asymptomatic and symptomatic patients, neither in children nor in adults (age 16-92 years) (p < 0.68 and p < 0.47, respectively). In total, 153 of 181 (85%) patients did not have symptoms of poisoning at the time of enquiry; however, in 9 of 21 (43%) patients, we were able to contact, late-onset symptoms existed. In none of the cases, hospital contact was needed and there were no reports of long-term sequelae. Acute LT poisoning often follows a benign course. The occurrence of symptoms appears not to be dose dependent. Late-onset symptoms seem to be common. However, all symptoms resolved spontaneously without need of medical care.

  6. Educational intervention to improve adherence to the Mediterranean diet among parents and their children aged 1-2 years. EniM clinical trial.

    PubMed

    Roset-Salla, Margarita; Ramon-Cabot, Joana; Salabarnada-Torras, Jordi; Pera, Guillem; Dalmau, Albert

    2016-04-01

    The objective of the present study was to evaluate the effectiveness of an educational programme on healthy alimentation, carried out in day-care centres and aimed at the parents of children from 1 to 2 years of age, regarding the acquisition of healthy eating habits among themselves and their children. We performed a multicentre, multidisciplinary, randomized controlled study in a community setting. The EniM study (nutritional intervention study among children from Mataró) was performed in twelve day-care centres in Mataró (Spain). Centres were randomized into a control group (CG) and an intervention group (IG). IG received four or five educational workshops on diet, CG did not have workshops. Children, not exclusively breast-fed, from 1 to 2 years of age, in the participating day-care centres and the persons responsible for their alimentation (mother or father). Thirty-five per cent of the IG did not attend the minimum of three workshops and were excluded. The CG included seventy-four children and seventy-two parents and the IG seventy-five children and sixty-seven parents. Both groups were comparable at baseline. Basal adherence to the Mediterranean diet was 56·4 % in parents (Gerber index) and 7·7 points in children (Kidmed test). At 8 months, Mediterranean diet adherence had improved in the IG by 5·8 points in the Gerber index (P=0·01) and 0·6 points in the Kidmed test (P=0·02) compared with the CG. This educational intervention performed in parents at the key period of incorporation of a 1-2-year-old child to the family table showed significant increases in adherence of the parents to the Mediterranean diet, suggesting future improvement in different indicators of health and an expected influence on the diet of their children.

  7. Developing core outcome sets for clinical trials: issues to consider.

    PubMed

    Williamson, Paula R; Altman, Douglas G; Blazeby, Jane M; Clarke, Mike; Devane, Declan; Gargon, Elizabeth; Tugwell, Peter

    2012-08-06

    The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.

  8. [Orbital dermoid cysts: Clinical spectrum and outcome].

    PubMed

    Knani, L; Gatfaoui, F; Krifa, F; Mahjoub, H; Daldoul, N; Ben Hadj Hamida, F

    2015-12-01

    Dermoid cysts are benign congenital orbital tumors, they are classified as choristomas. Clinical manifestations vary according to location and size. We retrospectively analyzed 43 cases of dermoid cysts surgically treated between July 1998 and March 2009. Mean patient age was 18.64 years. Among patients, 48.83% were male. Preseptal location was most common (41 cases). One of the two cases of intraorbital location required orbitotomy. We observed no complications or recurrence. Dermoid cysts are most often seen in young patients. The mean age of our patients was relatively high. The majority of dermoid cysts are periorbital in location. Superficial orbital dermoid cysts are more frequent, present earlier in life and are more easily identified than deep dermoid cysts. Imaging plays a major role in the management of deep orbital tumors. Complete surgical excision has remained the mainstay of treatment. Dermoid cysts are benign orbital tumors. Superficial dermoid cysts are the most common type. Deeper cysts require a more challenging diagnostic and therapeutic approach. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  9. Heparin monitoring: clinical outcome and practical approach.

    PubMed

    Despas, Noémie; Larock, Anne-Sophie; Jacqmin, Hugues; Douxfils, Jonathan; Chatelain, Bernard; Chatelain, Marc; Mullier, François

    2016-12-01

    Traditional anticoagulant agents such as unfractionated heparin (UFH), low molecular weight heparins (LMWHs), fondaparinux, danaparoid and bivalirudine are used in the prevention and treatment of thromboembolic diseases. However, these agents have limitations: their constraining parenteral route of administration and the need for regular coagulation monitoring for HNF. The LMWHs, with their more predictable anticoagulant response, don't require a systematic monitoring. The usefulness of LMWHs monitoring in several clinical situations such as pregnancy, obesity and renal insufficiency is a matter of debate. Indeed, there is no agreement between French and American recommendations on this question. Others aspects are also controversial: the measure of trough anti-Xa activity during pregnancy and the optimal monitoring of LMWHs for patients with antithrombin deficiency (hepatic disease, new-borns). Different tests are available to ensure the monitoring of these drugs, we will see in this review their principle, their advantages and inconvenients. The management of heparin induced thrombocytopenia also needs parenteral anticoagulants: danaparoïd, bivalirudine or argatroban. The modalities of their monitoring are relatively unknown and are presented. Furthermore, platelet monitoring is capital. This article aims to provide guidance about laboratory testing of classic parenteral anticoagulants.

  10. Development of Task-Based Learning Outcomes according to Clinical Presentations for Clinical Clerkships.

    PubMed

    Roh, HyeRin; Rhee, Byoung Doo; Lee, Jong Tae; Bae, Sang Kyun

    2012-03-01

    The aim of the study was to introduce our experience of establish task-based learning outcomes for core clinical clerkships. We first define our educational goal and objectives of the clinical clerkship curriculum according to knowledge, cognitive function and skill, and attitude. We selected clinical presentations and related diseases with expert panels and allocated them to core clinical departments. We classified doctor's tasks into 6 categories: history taking, physical examination, diagnostic plan, therapeutic plan, acute and emergent management, and prevention and patient education. We described learning outcomes by task using behavioral terms. We established goals and objectives for students to achieve clinical competency on a primary care level. We selected 75 clinical presentations and described 377 learning outcomes. Our process can benefit medical schools that offer outcome-based medical education, especially for clinical clerkships. To drive effective clerkships, a supportive system including assessment and faculty development should be implemented.

  11. Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

    PubMed

    Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

    2016-07-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Outcomes assessment of clinical information system implementation: a practical guide.

    PubMed

    Nahm, Eun-Shim; Vaydia, Vinay; Ho, Danny; Scharf, Barbara; Seagull, Jake

    2007-01-01

    Healthcare information systems (HIS) play a vital role in quality of care and the organization's daily operations. Consequently, increasing numbers of clinicians have been involved in HIS implementation, particularly for clinical information systems (CIS). Implementation of these systems is a major organizational investment, and its outcomes must be assessed. The purpose of this article is to provide clinicians and frontline informaticians with a practical guide to assess these outcomes, focusing on outcome variables, assessment methods, and timing of assessment. Based on in-depth literature reviews and their empirical experiences, the authors identified 3 frequently used outcomes: user satisfaction, clinical outcomes, and financial impact. These outcomes have been assessed employing various methods, including randomized controlled trials, pre- and post-test studies, time and motion studies, surveys, and user testing. The timing for outcomes assessments varied depending on several factors, such as learning curves or patients conditions. In conclusion, outcomes assessment is essential for the success of healthcare information technology, and the CIS implementation team members must be prepared to conduct and/or facilitate these studies.

  13. Aggressive Chordomas: Clinical Outcome of 13 Patients.

    PubMed

    Mavrogenis, Andreas F; Angelini, Andrea; Panagopoulos, Georgios N; Pala, Elisa; Calabrò, Teresa; Igoumenou, Vasilios G; Katzouraki, Galatia; Megaloikonomos, Panayiotis D; Pneumaticos, Spyros G; Papagelopoulos, Panayiotis J; Ruggieri, Pietro

    2017-03-01

    The authors reviewed the files of all patients with chordomas who were admitted and treated at their institutions from 1975 to 2012. Patients were categorized by early local recurrence and metastasis. Aggressive clinical behavior was defined as local recurrence and metastasis within 24 months of diagnosis and adequate treatment (wide en bloc resection with microscopically negative tumor margins). According to these criteria, 13 patients (14.3%) had aggressive chordomas, including 7 men and 6 women, with mean age of 54 years (range, 37-65 years) at diagnosis and treatment. All patients had preoperative tumor biopsy, followed by resection with partial (7 patients) or total sacrectomy (6 patients). In all cases, biopsy and histologic analysis of resected tumor specimens showed conventional chordomas. Resection margins were wide (grossly negative) in 6 patients and wide contaminated in 7 patients. Mean maximum tumor diameter was 11.8 cm (range, 5-21 cm). Mean follow-up was 43 months (range, 8-131 months). Rates of local recurrence, metastasis, and death were evaluated. At the last follow-up, all patients had local recurrence at a mean of 13 months (range, 5-22 months). Histologic examination of recurrent tumors showed a dedifferentiated chordoma with a fibrosarcoma component in 2 patients and no histologic change in the remaining patients. In addition, 8 patients had metastases at a mean of 13 months (range, 4-24 months) and died of their disease. All histologic findings of metastatic lesions were similar to those of primary tumors. Early diagnosis of aggressive tumors requires close follow-up of patients with chordomas. Metastasis is common, with resultant poor survival. [Orthopedics. 2017; 40(2):e248-e254.].

  14. Proteinuria and clinical outcome in CHD patients.

    PubMed

    Martínez-Quintana, Efrén; Rodríguez-González, Fayna

    2015-08-01

    CHD patients, especially those with associated hypoxaemia, usually have some level of renal function impairment, even though they are relatively young. The aim of the study was to evaluate those clinical and analytical factors that may contribute to microalbuminuria and determine the association of 24-hour proteinuria with thrombotic events and mortality. A total of 251 CHD patients were studied and demographic characteristics, blood test, and 24-hour urinalysis were analysed. Of the patients, 221 were non-hypoxaemic, and 30 were hypoxaemic (oxygen saturation of 84.3±5.9%). Of the non-hypoxaemic patients, 30 (13.6%), and of the hypoxaemic patients 9 (30%), showed proteinuria (>0.15 g/24 hours) (p=0.028). Hypoxaemic CHD patients also showed higher haematocrit (%) (50.7 (34.6; 72.1) versus 42.8 (34.6; 48.9), p<0.001), serum creatinine (mg/dl) (1.07±0.2 versus 0.96±1.9, p=0.004), microalbuminuria (mg/dl/24 hours) (1.2 (0.0; 261.5) versus 0.5 (0.0; 4.37), p<0.001), proteinuria (gr/24 hours) (1.0 (0.4; 3.1) versus 0.08 (0.04; 0.52), p=0.043), and N-terminal pro-B-type natriuretic peptide (pg/ml) (417.8 (35.7; 8534.0) versus 44.9 (0.0; 670.5), p<0.001) concentrations than non-hypoxaemic CHD patients. During a median follow-up of 26.0 (16.9; 57.7) months, five patients died - one patient had 24-hour proteinuria and four patients did not (p=0.581) - and three patients had some type of thrombosis - two patients had 24-hour proteinuria and one patient did not (p=0.014). Kaplan-Meier survival analysis showed no significant difference between CHD patients with and without 24-hour proteinuria (p=0.631). CHD patients with proteinuria have significantly more thrombosis and more hypoxaemia than those patients without proteinuria.

  15. Addressing missing participant outcome data in dental clinical trials.

    PubMed

    Spineli, Loukia M; Fleming, Padhraig S; Pandis, Nikolaos

    2015-06-01

    Missing outcome data are common in clinical trials and despite a well-designed study protocol, some of the randomized participants may leave the trial early without providing any or all of the data, or may be excluded after randomization. Premature discontinuation causes loss of information, potentially resulting in attrition bias leading to problems during interpretation of trial findings. The causes of information loss in a trial, known as mechanisms of missingness, may influence the credibility of the trial results. Analysis of trials with missing outcome data should ideally be handled with intention to treat (ITT) rather than per protocol (PP) analysis. However, true ITT analysis requires appropriate assumptions and imputation of missing data. Using a worked example from a published dental study, we highlight the key issues associated with missing outcome data in clinical trials, describe the most recognized approaches to handling missing outcome data, and explain the principles of ITT and PP analysis.

  16. Influence of Obesity on Clinical Outcomes in Hospitalized Children

    PubMed Central

    Bechard, Lori J.; Rothpletz-Puglia, Pamela; Touger-Decker, Riva; Duggan, Christopher; Mehta, Nilesh M.

    2015-01-01

    Importance Obesity is prevalent among hospitalized children. Knowledge of the relationship between obesity and outcomes in hospitalized children will enhance nutrition assessment and provide opportunities for interventions. Objective To systematically review the existing literature concerning the impact of obesity on clinical outcomes in hospitalized children. Evidence Acquisition PubMed, Web of Science, and EMBASE databases were searched for studies of hospitalized children aged 2 to 18 years with identified obesity and at least 1 of the following clinical outcomes: all-cause mortality, incidence of infections, and length of hospital stay. Cohort and case-control studies were included. Cross-sectional studies, studies of healthy children, and those without defined criteria for classifying weight status were excluded. The Newcastle-Ottawa Scale was used to assess study quality. Results Twenty-eight studies (26 retrospective; 24 cohort and 4 case-control) were included. Of the 21 studies that included mortality as an outcome, 10 reported a significant positive relationship between obesity and mortality. The incidence of infections was assessed in 8 of the 28 studies; 2 reported significantly more infections in obese compared with nonobese patients. Of the 11 studies that examined length of stay, 5 reported significantly longer lengths of hospital stay for obese children. Fifteen studies (53%) had a high quality score. Larger studies observed significant relationships between obesity and outcomes. Studies of critically ill, oncologic or stem cell transplant, and solid organ transplant patients showed a relationship between obesity and mortality. Conclusions and Relevance The available literature on the relationship between obesity and clinical outcomes is limited by subject heterogeneity, variations in criteria for defining obesity, and outcomes examined. Childhood obesity may be a risk factor for higher mortality in hospitalized children with critical illness

  17. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M.; Reyes, D.; Young, M.

    2016-01-01

    Introduction: The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capability's (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-Flight Medical Capabilities." Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes. Methods: Medical simulations will systematically compare success of individual diagnostic and therapeutic procedure simulations performed by physician and non-physician crew medical officer (CMO) analogs using clearly defined short-term (individual procedure) outcome metrics. In the subsequent step of the project, the procedure simulation outcomes will be used as input to a modified version of the NASA Integrated Medical Model (IMM) to analyze the effect of the outcome (degree of success) of individual procedures (including successful, imperfectly performed, and failed procedures) on overall long-term clinical outcomes and the consequent mission impacts. The procedures to be simulated are endotracheal intubation, fundoscopic examination, kidney/urinary ultrasound, ultrasound-guided intravenous catheter insertion, and a differential diagnosis exercise. Multiple assessment techniques will be used, centered on medical procedure simulation studies occurring at 3, 6, and 12 months after initial training (as depicted in the following flow diagram of the experiment design). Discussion: Analysis of procedure outcomes in the physician and non-physician groups and their subsets (tested at different elapsed times post training) will allow the team to 1) define differences between physician and non-physician CMOs in terms of both procedure performance

  18. Smoking Status Influences Clinical Outcome in Collagenous Colitis.

    PubMed

    Münch, Andreas; Tysk, Curt; Bohr, Johan; Madisch, Ahmed; Bonderup, Ole K; Mohrbacher, Ralf; Mueller, Ralph; Greinwald, Roland; Ström, Magnus; Miehlke, Stephan

    2016-04-01

    The relationship between clinical and histological parameters in collagenous colitis (CC) is poorly understood. Smoking is a risk factor for CC, whereas its impact on clinical activity and outcome is not well known. In a post hoc analysis of pooled data from two randomized controlled trials we assessed the association between demographic data (gender, age, smoking habits, family history of inflammatory bowel disease), clinical variables (duration of symptoms, mean number of stools/watery stools per day, abdominal pain, clinical remission) and histological data (thickness of the collagen band, inflammation of the lamina propria, total numbers of intraepithelial lymphocytes, degeneration). Moreover, we analysed the predictive value of baseline parameters for clinical outcome in a logistic regression model. Pooled data were available from 202 patients with active CC, of whom 36% were current smokers, 29% former smokers and 35% non-smokers. Smoking status was associated with decreased ability to achieve clinical remission (current smokers vs non-smokers: odds ratio [OR] 0.31, 95% confidence interval [CI] 0.10-0.98, p = 0.045; former smokers vs non-smokers: OR 0.19, 95% CI 0.05-0.73, p = 0.016). Current smokers had an increased mean number of watery stools at baseline compared with non-smokers (p = 0.051) and increased mean number of watery stools per se was associated with decreased likelihood of obtaining clinical remission (OR 0.63, 95% CI 0.47-0.86, p = 0.003). Patient characteristics and histology at baseline had no association with clinical parameters and no predictive value for clinical outcome. Smoking worsens clinical symptoms in CC and is associated with an increased number of watery stools and decreased likelihood of achieving clinical remission. There is no significant association between histology and clinical data. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For

  19. [Clinical studies on multimodal pain therapy : Standardized measurement of therapy outcomes with a core outcome set].

    PubMed

    Deckert, S; Sabatowski, R; Schmitt, J; Kaiser, U

    2016-12-01

    Decision making in evidence-based medicine is based on general data on therapy outcomes as well as the effectiveness and safety in specific patient populations. Typically, findings concerning therapy outcomes from different studies are aggregated for a final conclusion. In this context a comparison of results is hampered by studies in which therapy outcomes are heterogeneously measured. Such methodological challenges exist for almost all areas of medical treatment, as well as for multimodal pain therapy (MMPT). Through establishing core outcome sets (COS) the required standardization of measurement of therapy outcomes in clinical research can be achieved. A COS is an evidence-based and consented minimum set consisting of outcome domains (i.e. partial aspects of the medical condition to be investigated, which have to be measured in order to give the best possible demonstration of therapy outcome of an intervention) accomplished by valid, reliable and sensitive measurement instruments which should be applied in each clinical trial. No such COS has so far been found for MMPT. The aim of this article is to give an overview about currently recommended methodological approaches to develop a COS accompanied by a brief introduction about existing COS initiatives focusing on chronic pain. The existing COS recommendations are discussed and conclusions are drawn on whether existing recommendations could also be applied for MMPT. Finally, the impact of healthcare research in Germany on a standardized assessment of therapy outcome in MMPT is outlined.

  20. Long-Term Clinical Outcomes Following Drug-eluting and Bare Metal Stenting in Massachusetts

    PubMed Central

    Mauri, Laura; Silbaugh, Treacy S; Wolf, Robert E; Zelevinsky, Katya; Lovett, Ann; Zhou, Zheng; Resnic, Frederic S; Normand, Sharon-Lise T

    2010-01-01

    Background Drug-eluting stents (DES) reduce the need for repeat revascularization, but their long term safety relative to bare metal stents (BMS) in general use remains uncertain. We sought to compare the clinical outcome of patients treated with DES vs. BMS. Methods and Results All adults undergoing percutaneous coronary intervention (PCI) with stenting between April 1, 2003 and September 30, 2004 at non-US governmental hospitals in Massachusetts were identified from a mandatory state database. Patients were classified according to stent types used from the index admission. Clinical and procedural risk factors were collected prospectively. Risk-adjusted mortality, myocardial infarction, and revascularization rate differences (DES-BMS) were estimated through propensity score matching without replacement. 11556 patients were treated with DES and 6237 treated with BMS with unadjusted 2 year mortality of 7.0% and 12.6% respectively (p<0.0001). In 5549 DES patients matched to 5549 BMS patients, 2 year risk-adjusted mortality rates were 9.8% and 12.0% (p=0.0002), myocardial infarction, 8.3% vs. 10.3% (p=0.0005), and target vessel revascularization, 11.0% vs. 16.8% (p<0.0001). Conclusions DES treatment was associated with lower mortality, myocardial infarction, and target vessel revascularization compared with BMS treatment in similar patients in a matched population based study. Comprehensive follow-up in this inclusive population is warranted to identify if similar safety and efficacy remain beyond 2 years. PMID:18852368

  1. Diode laser (980 nm) vaporization in comparison with transurethral resection of the prostate for benign prostatic hyperplasia: randomized clinical trial with 2-year follow-up.

    PubMed

    Razzaghi, Mohammad Reza; Mazloomfard, Mohammad Mohsen; Mokhtarpour, Hooman; Moeini, Aida

    2014-09-01

    To compare outcomes of diode laser vaporization of prostate with transurethral resection of the prostate (TURP) as a gold-standard treatment. A total number of 115 patients with benign prostatic hyperplasia underwent TURP and 980-nm diode vaporization of prostate in a balanced randomization (1:1) from 2010 to 2012 and were followed up for 24 months. Baseline characteristics of the patients, perioperative data, and postoperative outcomes were compared. The primary end point of the study was assessing the values of International Prostate Symptom Score (IPSS), and maximum flow rate (Qmax) to predict the functional improvement of each group. The trial is registered at http://www.irct.ir (number IRCT201202138146N3). The mean age (± standard deviation) of the patients was 68.2 ± 7.8 years in TURP and 68.5 ± 8.8 in diode groups. In TURP and diode groups, the operation time was 54.9 ± 15.3 vs 60.6 ± 22.6 minutes (P = .14), Foley catheterization time was 88.9 ± 22.5 vs 20.1 ± 4.6 hours (P = .0001) and postoperative hospital stay was 59.9 ± 14.4 vs 25.8 ± 9.2 hours (P = .0001) respectively. Outcome with regard to increase in Qmax, decrease in IPSS, and decrease in postvoid residual urine volume showed a dramatic improvement in both groups during the first 6 months. In the TURP group, the values of IPSS and Qmax were respectively lower and higher than diode patients at 12 and 24 months of follow-up. According to our study, diode laser vaporization (980 nm) offers a safe and feasible procedure in the management of patients with symptomatic benign prostatic hypertrophy; however, at longer follow-up the functional outcome of diode laser vaporization has been less efficient than TURP. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Outcome Measures in Clinical Trials for Multiple Sclerosis.

    PubMed

    van Munster, Caspar E P; Uitdehaag, Bernard M J

    2017-02-09

    Due to the heterogeneous nature of the disease, it is a challenge to capture disease activity of multiple sclerosis (MS) in a reliable and valid way. Therefore, it can be difficult to assess the true efficacy of interventions in clinical trials. In phase III trials in MS, the traditionally used primary clinical outcome measures are the Expanded Disability Status Scale and the relapse rate. Secondary outcome measures in these trials are the number or volume of T2 hyperintense lesions and gadolinium-enhancing T1 lesions on magnetic resonance imaging (MRI) of the brain. These secondary outcome measures are often primary outcome measures in phase II trials in MS. Despite several limitations, the traditional clinical measures are still the mainstay for assessing treatment efficacy. Newer and potentially valuable outcome measures increasingly used or explored in MS trials are, clinically, the MS Functional Composite and patient-reported outcome measures, and on MRI, brain atrophy and the formation of persisting black holes. Several limitations of these measures have been addressed and further improvements will probably be proposed. Major improvements are the coverage of additional functional domains such as cognitive functioning and assessment of the ability to carry out activities of daily living. The development of multidimensional measures is promising because these measures have the potential to cover the full extent of MS activity and progression. In this review, we provide an overview of the historical background and recent developments of outcome measures in MS trials. We discuss the advantages and limitations of various measures, including newer assessments such as optical coherence tomography, biomarkers in body fluids and the concept of 'no evidence of disease activity'.

  3. Germline determinants of clinical outcome of cutaneous melanoma.

    PubMed

    Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

    2016-01-01

    Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase in melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication.

  4. Clinical instructors' perception of a faculty development programme promoting postgraduate year-1 (PGY1) residents' ACGME six core competencies: a 2-year study

    PubMed Central

    Lee, Fa-Yauh; Hsu, Hui-Chi; Chuang, Chiao-Lin; Lee, Wei-Shin; Chang, Ching-Chih; Huang, Chia-Chang; Chen, Jaw-Wen; Cheng, Hao-Min; Jap, Tjin-Shing

    2011-01-01

    Objective The six core competencies designated by Accreditation Council for Graduate Medical Education (ACGME) are essential for establishing a patient centre holistic medical system. The authors developed a faculty programme to promote the postgraduate year 1 (PGY1) resident, ACGME six core competencies. The study aims to assess the clinical instructors' perception, attitudes and subjective impression towards the various sessions of the ‘faculty development programme for teaching ACGME competencies.’ Methods During 2009 and 2010, 134 clinical instructors participated in the programme to establish their ability to teach and assess PGY1 residents about ACGME competencies. Results The participants in the faculty development programme reported that the skills most often used while teaching were learnt during circuit and itinerant bedside, physical examination teaching, mini-clinical evaluation exercise (mini-CEX) evaluation demonstration, training workshop and videotapes of ‘how to teach ACGME competencies.’ Participants reported that circuit bedside teaching and mini-CEX evaluation demonstrations helped them in the interpersonal and communication skills domain, and that the itinerant teaching demonstrations helped them in the professionalism domain, while physical examination teaching and mini-CEX evaluation demonstrations helped them in the patients' care domain. Both the training workshop and videotape session increase familiarity with teaching and assessing skills. Participants who applied the skills learnt from the faculty development programme the most in their teaching and assessment came from internal medicine departments, were young attending physician and had experience as PGY1 clinical instructors. Conclusions According to the clinical instructors' response, our faculty development programme effectively increased their familiarity with various teaching and assessment skills needed to teach PGY1 residents and ACGME competencies, and these clinical

  5. Clinical instructors' perception of a faculty development programme promoting postgraduate year-1 (PGY1) residents' ACGME six core competencies: a 2-year study.

    PubMed

    Lee, Fa-Yauh; Yang, Ying-Ying; Hsu, Hui-Chi; Chuang, Chiao-Lin; Lee, Wei-Shin; Chang, Ching-Chih; Huang, Chia-Chang; Chen, Jaw-Wen; Cheng, Hao-Min; Jap, Tjin-Shing

    2011-01-01

    Objective The six core competencies designated by Accreditation Council for Graduate Medical Education (ACGME) are essential for establishing a patient centre holistic medical system. The authors developed a faculty programme to promote the postgraduate year 1 (PGY(1)) resident, ACGME six core competencies. The study aims to assess the clinical instructors' perception, attitudes and subjective impression towards the various sessions of the 'faculty development programme for teaching ACGME competencies.' Methods During 2009 and 2010, 134 clinical instructors participated in the programme to establish their ability to teach and assess PGY(1) residents about ACGME competencies. Results The participants in the faculty development programme reported that the skills most often used while teaching were learnt during circuit and itinerant bedside, physical examination teaching, mini-clinical evaluation exercise (mini-CEX) evaluation demonstration, training workshop and videotapes of 'how to teach ACGME competencies.' Participants reported that circuit bedside teaching and mini-CEX evaluation demonstrations helped them in the interpersonal and communication skills domain, and that the itinerant teaching demonstrations helped them in the professionalism domain, while physical examination teaching and mini-CEX evaluation demonstrations helped them in the patients' care domain. Both the training workshop and videotape session increase familiarity with teaching and assessing skills. Participants who applied the skills learnt from the faculty development programme the most in their teaching and assessment came from internal medicine departments, were young attending physician and had experience as PGY(1) clinical instructors. Conclusions According to the clinical instructors' response, our faculty development programme effectively increased their familiarity with various teaching and assessment skills needed to teach PGY(1) residents and ACGME competencies, and these clinical

  6. Association between inflammatory cytokines and the risk of post-stroke depression, and the effect of depression on outcomes of patients with ischemic stroke in a 2-year prospective study

    PubMed Central

    Jiao, Jian-Tong; Cheng, Chao; Ma, Ying-Jun; Huang, Jin; Dai, Min-Chao; Jiang, Chen; Wang, Cheng; Shao, Jun-Fei

    2016-01-01

    The association between inflammatory cytokines and the risk of post-stroke depression (PSD) remains unclear. The aim of the present study was to investigate this association and the effect of PSD on the outcomes of ischemic stroke patients. A total of 355 patients who had experienced ischemic stroke participated in inflammatory cytokine detection by ELISA, in addition to depression, quality of life (QOL) and body performance testing. Cox regression was used to evaluate the associations between PSD risk, inflammatory cytokines and the outcomes of patients. Measurement data was evaluated using Student's t test, and counted data was measured by χ2 test. The incidence of PSD during the 2-year follow-up was 23.1%. The risk of PSD elevated with increased interleukin (IL)-6 expression levels [hazard ratio (HR)=3.18; 95% confidence interval (CI), 1.37–7.36] following the adjustment of confounders. However, no significant associations were identified between PSD and other inflammatory cytokines. QOL and body performance in the depressed group were significantly worse compared with those in the non-depressed group. The risk of stroke recurrence in patients with depression increased two-fold compared with patients without depression (HR=2.020; 95% CI, 1.123–3.635; Ptrend=0.019). No significant associations between PSD and the risk of mortality (HR=1.497; 95% CI, 0.547–4.098) were observed. In conclusion, depression is prevalent in patients following ischemic stroke. IL-6 is positively associated with the risk of PSD, and may predict its development in patients following ischemic stroke. PSD correlates with outcomes of patients, and the effective management of PSD may improve the prognosis of patients. PMID:27588080

  7. SU-E-T-529: Is MFO-IMPT Robust Enough for the Treatment of Head and Neck Tumors? A 2-Year Outcome Analysis Following Proton Therapy On the First 50 Oropharynx Patients at the MD Anderson Cancer Center

    SciTech Connect

    Frank, S; Garden, A; Anderson, M; Rosenthal, D; Morrison, W; Gunn, B; Fuller, C; Phan, J; Zhang, X; Poenisch, F; Wu, R; Li, H; Gautam, A; Sahoo, N; Gillin, M; Zhu, X

    2015-06-15

    Purpose: Multi-field optimization intensity modulated proton therapy (MFO-IMPT) for oropharyngeal tumors has been established using robust planning, robust analysis, and robust optimization techniques. While there are inherent uncertainties in proton therapy treatment planning and delivery, outcome reporting are important to validate the proton treatment process. The purpose of this study is to report the first 50 oropharyngeal tumor patients treated de-novo at a single institution with MFO-IMPT. Methods: The data from the first 50 patients with squamous cell carcinoma of the oropharynx treated at MD Anderson Cancer Center from January 2011 to December 2014 on a prospective IRB approved protocol were analyzed. Outcomes were analyzed to include local, regional, and distant treatment failures. Acute and late toxicities were analyzed by CTCAE v4.0. Results: All patients were treated with definitive intent. The median follow-up time of the 50 patients was 25 months. Patients by gender were male (84%) and female (16%). The average age was 61 years. 50% of patients were never smokers and 4% were current smokers. Presentation by stage; I–1, II–0, III– 9, IVA–37 (74%), IVB–3. 88% of patients were HPV/p16+. Patients were treated to 66–70 CGE. One local failure was reported at 13 months following treatment. One neck failure was reported at 12 months. 94% of patients were alive with no evidence of disease. One patient died without evidence of disease. There were no Grade 4 or Grade 5 toxicities. Conclusion: MFO-IMPT for oropharyngeal tumors is robust and provides excellent outcomes 2 years after treatment. A randomized trial is underway to determine if proton therapy will reduce chronic late toxicities of IMRT.

  8. Multisystemic Therapy(®) : Clinical Overview, Outcomes, and Implementation Research.

    PubMed

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

    Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes.

  9. Clinical trials in systemic sclerosis: lessons learned and outcomes

    PubMed Central

    Matucci-Cerinic, Marco; Steen, Virginia D; Furst, Daniel E; Seibold, James R

    2007-01-01

    The pathogenesis of systemic sclerosis (SSc) is complex and largely unclear. The clinical heterogeneity of the disease and its progression over a number of years makes the choice of endpoints in the design of clinical trials difficult. The overwhelming need in this disease is to diagnose it early and identify those patients who will benefit most from early, aggressive treatment that potentially can alter the clinical disease course. To achieve this, innumerable challenges must be overcome. This article reviews data from recent clinical trials and the lessons derived from retrospective observational studies, databases, and patient registries. Taken together, these observations will help to improve our understanding of the diverse clinical course of SSc and permit refinement of existing outcome measures for the design of future clinical trials, in which the likelihood of observing a positive treatment effect with the drugs at our disposal will be maximized. PMID:17767745

  10. Outcome Markers for Clinical Trials in Cerebral Amyloid Angiopathy

    PubMed Central

    Greenberg, Steven M.; Rustam Al-Shahi, Salman; Biessels, Geert Jan; van Buchem, Mark; Cordonnier, Charlotte; Lee, Jin-Moo; Montaner, Joan; Schneider, Julie A.; Smith, Eric E; Vernooij, Meike; Werring, David J.

    2014-01-01

    Efforts are underway for early-phase trials of candidate therapies for cerebral amyloid angiopathy (CAA), an untreatable cause of hemorrhagic stroke and vascular cognitive impairment. A major barrier to these trials is the lack of consensus on measuring treatment effectiveness. We review a range of potential outcome markers for CAA against the ideal criteria of being clinically meaningful, closely reflective of biological progression, efficient for smaller/shorter trials, reliably measurable, and cost effective. In practice, outcomes tend either to have high clinical salience but relatively low statistical efficiency and thus more applicability for later phase studies, or greater statistical efficiency but more limited clinical meaning. The most statistically efficient outcomes are those that are potentially reversible with treatment, though their clinical significance remains unproven. Many of the candidate outcomes for CAA trials are likely to be applicable to other small vessel brain diseases as well. Considerations emerging from this review outline a path towards rapid and efficient testing of emerging candidate therapies for CAA and other small vessel diseases. PMID:24581702

  11. A critical examination of the mode of action of quinacrine in the reproductive tract in a 2-year rat cancer bioassay and its implications for human clinical use.

    PubMed

    Haseman, Joseph K; Growe, Roger G; Zeiger, Errol; McConnell, Ernest E; Luster, Michael I; Lippes, Jack

    2015-04-01

    A rat carcinogenicity bioassay (CaBio) of quinacrine was reanalyzed to investigate its mode of tumor induction. Quinacrine's effects in the rat uterus when administered as a slurry in methylcellulose were contrasted with the human clinical experience which uses a solid form of the drug, to determine the relevance of the tumors produced in the rat to safe clinical use of quinacrine for permanent contraception (QS). A review was performed of the study report, dose feasibility studies, and clinical evaluations of women who had undergone the QS procedure. The top three doses of quinacrine in the CaBio exceeded the maximum tolerated dose, and produced chronic damage, including inflammation, resulting in reproductive tract tumors. Chronic inflammation was significantly correlated with the tumors; there was no evidence of treatment-related tumors in animals without chronic inflammation or other reproductive system toxicity. Because such permanent uterine damage and chronic toxicity have not been observed in humans under therapeutic conditions, we conclude that this mode of action for tumor production will not occur at clinically relevant doses in women who choose quinacrine for permanent contraception.

  12. Multilevel analysis of clinical parameters in chronic periodontitis after root planing/scaling, surgery, and systemic and local antibiotics: 2-year results

    PubMed Central

    Mdala, Ibrahimu; Haffajee, Anne D.; Socransky, Sigmund S.; de Blasio, Birgitte Freiesleben; Thoresen, Magne; Olsen, Ingar; Goodson, J. Max

    2012-01-01

    Aim Find the periodontal treatment that best maintained clinical results over time evaluated by changes in pocket depth (PD) and clinical attachment level (CAL). Methods 229 patients with chronic periodontitis from USA (n=134) and Sweden (n=95) were randomly assigned to eight groups receiving (1) scaling+root planing (SRP) alone or combined with (2) surgery (SURG)+systemic amoxicillin (AMOX)+systemic metronidazole (MET); (3) SURG+local tetracycline (TET); (4) SURG; (5) AMOX+MET+TET; (6) AMOX+MET; (7) TET; and (8) SURG+AMOX+MET+TET. Antibiotics were given immediately after SRP. Plaque, gingival redness, bleeding on probing, suppuration, PD, and CAL were recorded at baseline and after 3, 6, 12, 18, and 24 months. Treatment effects were evaluated by linear multilevel regression and logistic multilevel regression models. We considered only data from sites with a baseline PD of at least 5 mm of 187 patients completing the study. Results Surgically treated patients experienced most CAL loss. Adjunctive therapy including SURG was most effective in reducing PD. Combining SURG with AMOX, MET, and TET gave significant clinical benefits. Past and current smoking habits were significant predictors of deeper PD. Only current smoking was a significant predictor of CAL loss. Bleeding, accumulation of plaque, gingival redness, and suppuration were significant predictors of further CAL loss and deeper PD. Conclusions Both surgical and non-surgical therapies can be used to arrest chronic periodontitis. SURG+AMOX+MET+TET gave best maintenance of clinical results. PMID:22545190

  13. Evaluation of the Clinical Decisions Made for 2-Year-Olds Referred for Speech and Language Therapy: A Follow-Up Study

    ERIC Educational Resources Information Center

    Emanuel, Rosemary; Chiat, Shula; Roy, Penny

    2007-01-01

    Background: Clinicians in the UK rely mainly on informal observations and structured and semi-structured tasks rather than standardized testing in their assessments of pre-school children referred with speech and language difficulties. The informal nature of the clinical decision-making process at this age is unsurprising given the dearth of…

  14. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure

    PubMed Central

    Trujillo, Adriana; Feixas, Guillem; Bados, Arturo; García-Grau, Eugeni; Salla, Marta; Medina, Joan Carles; Montesano, Adrián; Soriano, José; Medeiros-Ferreira, Leticia; Cañete, Josep; Corbella, Sergi; Grau, Antoni; Lana, Fernando; Evans, Chris

    2016-01-01

    Objective The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk. Method Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192) from different mental health and primary care centers; and the nonclinical sample (n=452), which included a student and a community sample. Results The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment. Conclusion The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients. PMID:27382288

  15. Clinical Outcomes Comparing Capsular Repair vs. No Repair Following Hip Arthroscopy: A Prospective, Randomized, Control Study

    PubMed Central

    Sugarman, Etan P.; Birns, Michael E.; Fishman, Matthew; Patel, Deepan N.; Goldsmith, Laura; Greene, Renee Shirley; Banffy, Michael B.

    2017-01-01

    Objectives: As hip arthroscopy procedures become more common there is increasing concern of iatrogenic instability from excessive capsulotomy during surgery. As a result, greater attention is being focused preserving hip capsule integrity following surgery. To date, there are no large scale prospective blinded studies that address whether capsular closure has any detrimental effect on outcomes. Our goal is to evaluate outcomes in patients undergoing interportal capsulotomy repair compared to outcomes when not repairing the capsule. The purpose of this study is to demonstrate a clinical/functional difference at 1 & 2 year follow up between patients who undergo capsular repair vs no repair following hip arthroscopy. Our hypothesis is that restoration of normal capsular anatomy with interportal repair will achieve similar clinical outcomes as the “no repair” group without functional deficits from over-constraint. Methods: Adult patients were recruited from November 2013 to July 2015 who were scheduled to undergo hip arthroscopy for femoral acetabular. Subjects were randomized into either the capsular repair (CR) or no repair (NR) groups. Standard AP/Dunn view radiographs were evaluated and alpha angle (AA) /center-edge (CEA) angle measurements were performed for all patients preoperatively. All patients underwent standard hip arthroscopy with labral repair +/- CAM/pincer lesion resection. Primary clinical outcomes were measured via the Hip Outcome Score Activities of Daily Living (HOS-ADL) and Sport-Specific (HOS-SS) subscales at 3 months, 6 months and 1 year. Secondary outcome measures included the modified Harris Hip Score (mHHS), visual analog scale (VAS), the international hip outcome tool (iHOT-12), and the Veterans RAND 12 Item Health Survey (VR-12) scores. Results: A total of 56 patients were included in this study (30 male, 26 females) with a mean age of 33 years. Follow up was available for 49 patients at 6 months, 41 patients at 1 year and 26 patients at

  16. 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.

  17. Clinical Evaluation of the Regenerative Potential of EMD and NanoHA in Periodontal Infrabony Defects: A 2-Year Follow-Up

    PubMed Central

    Zeza, Blerina; Ambrosca, Marco; Paolantonio, Michele; Sammartino, Gilberto; Mongardini, Claudio

    2014-01-01

    Introduction. The aim of this retrospective study was to compare the clinical efficacy of four different surgical techniques in promoting periodontal regeneration in patients with infrabony defects: open flap debridement, application of enamel matrix derivatives (EMD), nanohydroxyapatite (nanoHA) application, and combined nanoHA and EMD application. Probing attachment level (PAL), pocket depth (PD), and position of gingival margin at completion of therapy (REC) were measured. Materials and Methods. Data were collected from 64 healthy patients (34 women and 30 men, mean age 37,7 years). Clinical indices were measured by a calibrated examiner at baseline and at 12, 18, and 24 months. The values obtained for each treatment were compared using nonparametric tests. Results. All treatments resulted in a tendency toward PD reduction over time, with improvements in REC and PAL. The differences in PD, REC, and PAL values at baseline compared with values after 12, 18, and 24 months were statistically significant for all treatments. Statistically significant differences in PAL and PD were detected between nanoHA and nanoHA + EMD at 12, 18, and 24 months. Conclusion. In this study, EMD and nanoHA used together in patients with infrabony periodontal lesions had better clinical efficacy than nanoHA alone, EMD alone, or open flap debridement. PMID:25276793

  18. Effectiveness of a group outpatient visit model for chronically ill older health maintenance organization members: a 2-year randomized trial of the cooperative health care clinic.

    PubMed

    Scott, John C; Conner, Douglas A; Venohr, Ingrid; Gade, Glenn; McKenzie, Marlene; Kramer, Andrew M; Bryant, Lucinda; Beck, Arne

    2004-09-01

    To compare the effectiveness of Cooperative Health Care Clinic ((CHCC) group outpatient model for chronically ill, older health maintenance organization (HMO) patients) with usual care. Two-year, randomized, controlled trial conducted with recruitment from February 1995 through July of 1996. Nonprofit group model HMO. Two hundred ninety-four adults (145 intervention and 149 usual care), aged 60 and older (mean age 74.1) with 11 or more outpatient visits in the prior 18 months, one or more self-reported chronic conditions, and expressed interest in participating in a group clinic. Monthly group meetings held by patients' primary care physicians. Differences in clinic visits, inpatient admissions, emergency room visits, hospital outpatient services, professional services, home health, and skilled nursing facility admissions; measures of patient satisfaction, quality of life, self-efficacy, and activities of daily living (ADLs). Outpatient, pharmacy services, home health, and skilled nursing facility use did not differ between groups, but CHCC patients had fewer hospital admissions (P=.012), emergency visits (P=.008), and professional services (P=.005). CHCC patients' costs were $41.80 per member per month less than those of control patients. CHCC patients reported higher satisfaction with their primary care physician (P=.022), better quality of life (P=.002), and greater self-efficacy (P=.03). Health status and ADLs did not differ between groups. The CHCC model resulted in fewer hospitalizations and emergency visits, increased patient satisfaction, and self-efficacy, but no effect on outpatient use, health, or functional status. Copyright 2004 American Geriatrics Society

  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. Predictors of Clinical Outcomes in Sexually Abused Adolescents.

    PubMed

    Tocker, Lotem; Ben-Amitay, Galit; Horesh-Reinman, Netta; Lask, Michal; Toren, Paz

    2017-01-01

    This cross-sectional, case control study examines the association between child sexual abuse and interpersonal and intrapersonal outcomes among 54 adolescents, examining specific clinical measures (depression, anxiety, dissociation, and posttraumatic stress disorder, attachment patterns, self-esteem, self-disclosure, and family environment characteristics). The research results point to a correlation between sexual abuse and higher levels of the clinical measures. In addition, a correlation was found between sexual abuse and level of avoidant attachment, self-esteem, and family environment characteristics. Stepwise hierarchical regressions were conducted to examine how adolescent attributes predicted depression, anxiety, and dissociation beyond the prediction based on sexual abuse. A combination of self-esteem, anxiety attachment, and family cohesiveness made sexual abuse insignificant when predicting levels of depression, anxiety, and dissociation. This study contributes to characterizing the emotional, personal, and family attributes of adolescents who experienced sexual abuse. It also raises questions about the clinical outcomes usually associated with sexual abuse.

  1. Patient-reported outcomes in gastroenterology: clinical and research applications.

    PubMed

    Spiegel, Brennan M R

    2013-04-01

    Patient-generated reports, also known as Patient-Reported Outcomes (PROs), capture the patients' illness experience in a structured format and may help bridge the gap between patients and providers. PROs measure any aspect of patient-reported health (e.g., physical, emotional or social symptoms) and can help to direct care and improve clinical outcomes. When clinicians systematically collect patient-reported data in the right place at the right time, PRO measurement can effectively aid in detection and management of conditions, improve satisfaction with care and enhance the patient-provider relationship. This review article summarizes the latest approaches to PRO measuring for clinical trials and clinical practice, with a focus on use of PROs in gastroenterology.

  2. Strategic clinical networks in Alberta: Structures, processes, and early outcomes.

    PubMed

    Noseworthy, Tom; Wasylak, Tracy; O'Neill, Blair

    2015-11-01

    In June 2012, Alberta Health Services introduced Strategic Clinical Networks (SCNs) as engines of innovation. The SCNs are collaborative clinical teams, with a provincial strategic mandate and with goals of achieving best outcomes, seeking greatest value for money and engaging clinicians in all aspects of the work. The SCNs are led by clinicians, driven by clinical needs, based on measurement and best evidence, and supported by research expertise, infrastructure, quality improvement, and analytic resources. Eleven SCNs are operational, with five others planned. Early measurable value is demonstrable in each. Examples include improving care and outcomes following stroke, reducing use of anti-psychotics in Long-Term Care (LTC), and improving surgical safety through effective implementation of the Safe Surgery Checklist. © 2015 The Canadian College of Health Leaders.

  3. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    PubMed Central

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minute walk and accelerometry, show promise in augmenting current measures. MS therapeutics is a quickly advancing field which requires sensitive clinical outcome measures that can detect small changes in disability that reliably reflect long-term changes in sustained disease progression in a complex population. A single clinical outcome measure of sustained disease progression may remain elusive. Rather, an integration of current and new outcome measures may be most appropriate and utilization of different measures depending on the MS population and stage of the disease may be preferred. PMID:21179614

  4. Clinical and esthetic outcomes of implants placed in postextraction sites.

    PubMed

    Chen, Stephen T; Buser, Daniel

    2009-01-01

    The aim of this review was to evaluate the clinical outcomes for the different time points of implant placement following tooth extraction. A PubMed search and a hand search of selected journals were performed to identify clinical studies published in English that reported on outcomes of implants in postextraction sites. Only studies that included 10 or more patients were accepted. For implant success/survival outcomes, only studies with a mean follow-up period of at least 12 months from the time of implant placement were included. The following outcomes were identified: (1) change in peri-implant defect dimension, (2) implant survival and success, and (3) esthetic outcomes. Of 1,107 abstracts and 170 full-text articles considered, 91 studies met the inclusion criteria for this review. Bone augmentation procedures are effective in promoting bone fill and defect resolution at implants in postextraction sites, and are more successful with immediate (type 1) and early placement (type 2 and type 3) than with late placement (type 4). The majority of studies reported survival rates of over 95%. Similar survival rates were observed for immediate (type 1) and early (type 2) placement. Recession of the facial mucosal margin is common with immediate (type 1) placement. Risk indicators included a thin tissue biotype, a facial malposition of the implant, and a thin or damaged facial bone wall. Early implant placement (type 2 and type 3) is associated with a lower frequency of mucosal recession compared to immediate placement (type 1).

  5. Lipidomic analysis enables prediction of clinical outcomes in burn patients

    PubMed Central

    Qi, Peter; Abdullahi, Abdikarim; Stanojcic, Mile; Patsouris, David; Jeschke, Marc G.

    2016-01-01

    Recent discoveries have highlighted the novel metabolic functions of adipose tissue in enhancing hypermetabolism after trauma. As the exact function and expression profiles of serum lipids and free fatty acids (FFA) are essentially unknown, we determined the lipidomic expression profile after burn in correlation to clinical outcomes to identify important lipid mediators affecting post-burn outcomes. We conducted a prospective cohort study with 46 adult burn patients and 5 healthy controls at the Ross Tilley Burn Center in Toronto, Canada. Patients were stratified based on major demographic and clinical variables, including age, burn severity, mortality, and sepsis. Serum FFAs and inflammatory markers were measured during acute hospital stay. We found that FFAs were acutely elevated post-burn and returned to baseline over time. Greater burn severity and age were associated with an impaired acute response in unsaturated FFAs and pro-inflammatory cytokines. Elevations in saturated and mono-unsaturated FFAs correlated significantly to increased mortality. In summary, persistent elevation of unsaturated lipids was associated with a functionally altered inflammatory-immunological milieu and worse clinical outcomes. The present lipidomic analysis indicates profound alterations in the lipid profile after burn by characterizing key lipids as potential diagnostic and outcome indicators in critically injured patients. PMID:27982130

  6. Effectiveness of the clinical teaching associate model to improve clinical learning outcomes: a randomized controlled trial.

    PubMed

    Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh

    2014-01-01

    This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.

  7. Do Ligamentum Teres Tears Portend Inferior Outcomes in Patients With Borderline Dysplasia Undergoing Hip Arthroscopic Surgery? A Match-Controlled Study With a Minimum 2-Year Follow-up.

    PubMed

    Chaharbakhshi, Edwin O; Perets, Itay; Ashberg, Lyall; Mu, Brian; Lenkeit, Christopher; Domb, Benjamin G

    2017-09-01

    Arthroscopic surgery in borderline dysplastic hips remains controversial, but the role of the ligamentum teres (LT) has not been studied in this setting. Borderline dysplastic patients with LT tears have worse short-term outcomes than those without LT tears. Cohort study; Level of evidence, 3. Data were prospectively collected on patients who underwent arthroscopic surgery between February 2008 and April 2014. The inclusion criteria were borderline dysplasia (lateral center-edge angle [LCEA], 18°-25°) and labral tears; arthroscopic treatments including labral preservation and capsular plication; and preoperative patient-reported outcome scores including the modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score-Sport-Specific Subscale, and visual analog scale for pain. Patients were excluded for preoperative Tönnis osteoarthritis grade >0, workers' compensation claims, previous ipsilateral hip surgery and conditions, or frank dysplasia (LCEA <18°). Patients with LT tears were pair-matched to patients without tears for sex, age at surgery ±10 years, body mass index (<30 kg/m(2) vs ≥30 kg/m(2)), labral treatment type, and microfracture. Of 68 eligible patients, 63 (93%) had a minimum 2-year follow-up, and 30 (48%) had LT tears. Twenty patients in each group were pair-matched. The mean follow-up time was 54.3 months (range, 24.2-83.8 months) for the LT tear group and 38.6 months (range, 24.6-70.6 months) for the control group ( P = .002). Ninety percent were female. There were no significant differences regarding demographics or intra-operative procedures. The LT tear group trended toward lower postoperative mHHS ( P = .09) and NAHS ( P = .09) values. Mean satisfaction was 8.1 for the LT tear group and 7.9 for the control group. Preoperative and follow-up scores were not significantly different between the groups. The LT tear group had 5 revisions, with 1 revision in the control group. Three patients (15%) in the LT tear group

  8. Physicians' empathy and clinical outcomes for diabetic patients.

    PubMed

    Hojat, Mohammadreza; Louis, Daniel Z; Markham, Fred W; Wender, Richard; Rabinowitz, Carol; Gonnella, Joseph S

    2011-03-01

    To test the hypothesis that physicians' empathy is associated with positive clinical outcomes for diabetic patients. A correlational study design was used in a university-affiliated outpatient setting. Participants were 891 diabetic patients, treated between July 2006 and June 2009, by 29 family physicians. Results of the most recent hemoglobin A1c and LDL-C tests were extracted from the patients' electronic records. The results of hemoglobin A1c tests were categorized into good control (<7.0%) and poor control (>9.0%). Similarly, the results of the LDL-C tests were grouped into good control (<100) and poor control (>130). The physicians, who completed the Jefferson Scale of Empathy in 2009, were grouped into high, moderate, and low empathy scorers. Associations between physicians' level of empathy scores and patient outcomes were examined. Patients of physicians with high empathy scores were significantly more likely to have good control of hemoglobin A1c (56%) than were patients of physicians with low empathy scores (40%, P < .001). Similarly, the proportion of patients with good LDL-C control was significantly higher for physicians with high empathy scores (59%) than physicians with low scores (44%, P < .001). Logistic regression analyses indicated that physicians' empathy had a unique contribution to the prediction of optimal clinical outcomes after controlling for physicians' and patients' gender and age, and patients' health insurance. The hypothesis of a positive relationship between physicians' empathy and patients' clinical outcomes was confirmed, suggesting that physicians' empathy is an important factor associated with clinical competence and patient outcomes.

  9. Clinical characteristics and outcome of children stung by scorpion.

    PubMed

    Mohamad, Ismail Lotfy; Elsayh, Khalid I; Mohammad, Hanaa A; Saad, Khaled; Zahran, Asmaa M; Abdallah, Alameldin M; Tawfeek, M S K; Monazea, Eman M

    2014-06-01

    Scorpion envenomation is a health problem in children in tropical and subtropical regions. The aim of this study was to evaluate demographic and clinical characteristics as well as outcomes in referred children to Assiut University Children Hospital during the year 2012 with a history of scorpion sting. The medical files of these patients were reviewed retrospectively for demographic data, time and site of biting, and clinical manifestations. Laboratory investigations of the patients were reviewed for complete blood count (CBC), liver function tests, creatinine phosphokinase (CPK), lactate dehydrogenase (LDH), arterial blood gases, and serum electrolytes. Results showed 111 children with a history of scorpion sting; 69 males and 42 females with a median age of 5 years. Out of the studied patients, 53.2 % were classified as class III of clinical severity with recorded pulmonary edema in 33.3 %, cardiogenic shock in 46.8 %, and severe neurological manifestations in 22.8 %. Twelve patients (10.8 %) were classified as class II with mild systemic manifestations, and 36 % of the patients were classified as class I with only local reaction. Outcomes of these patients were discharge without sequelae in 55.8 %, discharge with sequelae in 26.1 %, and death in 18.1 %. more than half of stung children had a severe clinical presentation and about one fifth died. Aggressive treatment regimens are recommended for such patients to improve the outcome.

  10. Outcome Measures for Clinical Trials in Fragile X Syndrome

    PubMed Central

    Berry-Kravis, Elizabeth; Hessl, David; Abbeduto, Leonard; Reiss, Allan L.; Beckel-Mitchener, Andrea; Urv, Tiina K.

    2013-01-01

    Objective Progress in basic neuroscience has led to identification of molecular targets for treatment in fragile X syndrome (FXS) and other neurodevelopmental disorders, however, there is a gap in translation to targeted therapies in humans. One major obstacle to the demonstration of efficacy in human trials has been the lack of generally accepted endpoints to assess improvement in function in individuals with FXS. To address this problem, the NIH convened a meeting of leading scientists and clinicians with the goal of identifying and standardizing outcome measures for use as potential endpoints in clinical trials in FXS. Methods Participants in the meeting included FXS experts, experts in the design and implementation of clinical trials and measure development, and representatives from advocacy groups, industry, and federal agencies. Results The group generated recommendations for optimal outcome measures in cognitive, behavioral, and biomarker/medical domains, including additional testing and validation of existing measures, and development of new measures in areas of need. Although no one endpoint or set of endpoints could be identified that met all criteria as an optimal measure, recommendations are presented in this report. Conclusion The report is expected to guide the selection of measures in clinical trials and lead to the use of a more consistent battery of measures across trials. Further, this will help to direct research toward gaps in the development of validated FXS-specific outcome measures, and to assist with interpretation of clinical trial data by creating templates for measurement of treatment efficacy. PMID:24042082

  11. Hearing and facial function outcomes for neurofibromatosis 2 clinical trials

    PubMed Central

    Ardern-Holmes, Simone L.; Barker, Fred G.; Blakeley, Jaishri O.; Evans, D. Gareth; Ferner, Rosalie E.; Hadlock, Tessa A.; Halpin, Chris

    2013-01-01

    Objectives: Vestibular schwannomas are the hallmark of neurofibromatosis 2 (NF2), occurring in >95% of patients. These tumors develop on the vestibulocochlear nerve and are associated with significant morbidity due to hearing loss, tinnitus, imbalance, facial weakness, and risk of early mortality from brainstem compression. Although hearing loss and facial weakness have been identified as important functional outcomes for patients with NF2, there is a lack of consensus regarding appropriate endpoints in clinical trials. Methods: The functional outcomes group reviewed existing endpoints for hearing and facial function and developed consensus recommendations for response evaluation in NF2 clinical trials. Results: For hearing endpoints, the functional group endorsed the use of maximum word recognition score as a primary endpoint, with the 95% critical difference as primary hearing outcomes. The group recommended use of the scaled measurement of improvement in lip excursion (SMILE) system for studies of facial function. Conclusions: These recommendations are intended to provide researchers with a common set of endpoints for use in clinical trials of patients with NF2. The use of common endpoints should improve the quality of clinical trials and foster comparison among studies for hearing loss and facial weakness. PMID:24249803

  12. A long term clinical outcome of the Medial Pivot Knee Arthroplasty System.

    PubMed

    Macheras, George A; Galanakos, Spyridon P; Lepetsos, Panagiotis; Anastasopoulos, Panagiotis P; Papadakis, Stamatios A

    2017-03-01

    The ideal total knee arthroplasty (TKA) should provide maximum range of motion and functional stability for all desired daily activities and, if possible, to replicate normal knee kinematics and function. The ADVANCE® Medial Pivot (AMP) Knee System was designed with a highly congruent medial compartment and a less conforming lateral compartment to more closely mimic the kinematics of the normal knee and to offer more stability through out of range of motion (ROM). The purpose of this study was to evaluate the long-term clinical and radiographic outcomes of this TKA system. Three hundred and twenty-five (325) patients (347 knees) with knee osteoarthritis underwent a TKA using the AMP prosthesis in our Department. For evaluation, objective and subjective clinical rating systems along with radiograph series were used. The average follow-up was 15.2years. All patients showed a statistically significant improvement (p<0.0005) in the Knee Society clinical rating system, Western Ontario and McMaster Universities Osteoarthritis Index questionnaire, SF-12® questionnaire, and Oxford knee score. The majority of patients (94%) were able to perform age-appropriate activities with a mean knee flexion of 120° (range, 105°-135°) at final follow-up. Survival analysis showed a cumulative success rate of 98.8% at 17years. The obtained results demonstrate excellent long-term clinical outcome for this knee design. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  13. Beyond the Basics of Clinical Outcomes Assessment: Selecting Appropriate Patient-Rated Outcomes Instruments for Patient Care

    ERIC Educational Resources Information Center

    Valier, Alison R.; Lam, Kenneth C.

    2015-01-01

    The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…

  14. Beyond the Basics of Clinical Outcomes Assessment: Selecting Appropriate Patient-Rated Outcomes Instruments for Patient Care

    ERIC Educational Resources Information Center

    Valier, Alison R.; Lam, Kenneth C.

    2015-01-01

    The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…

  15. Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.

    PubMed

    Maahs, David M; Buckingham, Bruce A; Castle, Jessica R; Cinar, Ali; Damiano, Edward R; Dassau, Eyal; DeVries, J Hans; Doyle, Francis J; Griffen, Steven C; Haidar, Ahmad; Heinemann, Lutz; Hovorka, Roman; Jones, Timothy W; Kollman, Craig; Kovatchev, Boris; Levy, Brian L; Nimri, Revital; O'Neal, David N; Philip, Moshe; Renard, Eric; Russell, Steven J; Weinzimer, Stuart A; Zisser, Howard; Lum, John W

    2016-07-01

    Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.

  16. Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report

    PubMed Central

    Maahs, David M.; Buckingham, Bruce A.; Castle, Jessica R.; Cinar, Ali; Damiano, Edward R.; Dassau, Eyal; DeVries, J. Hans; Doyle, Francis J.; Griffen, Steven C.; Haidar, Ahmad; Heinemann, Lutz; Hovorka, Roman; Jones, Timothy W.; Kollman, Craig; Kovatchev, Boris; Levy, Brian L.; Nimri, Revital; O’Neal, David N.; Philip, Moshe; Renard, Eric; Russell, Steven J.; Weinzimer, Stuart A.; Zisser, Howard

    2016-01-01

    Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes. PMID:27330126

  17. Analyzing Multiple Outcomes in Clinical Research Using Multivariate Multilevel Models

    PubMed Central

    Baldwin, Scott A.; Imel, Zac E.; Braithwaite, Scott R.; Atkins, David C.

    2014-01-01

    Objective Multilevel models have become a standard data analysis approach in intervention research. Although the vast majority of intervention studies involve multiple outcome measures, few studies use multivariate analysis methods. The authors discuss multivariate extensions to the multilevel model that can be used by psychotherapy researchers. Method and Results Using simulated longitudinal treatment data, the authors show how multivariate models extend common univariate growth models and how the multivariate model can be used to examine multivariate hypotheses involving fixed effects (e.g., does the size of the treatment effect differ across outcomes?) and random effects (e.g., is change in one outcome related to change in the other?). An online supplemental appendix provides annotated computer code and simulated example data for implementing a multivariate model. Conclusions Multivariate multilevel models are flexible, powerful models that can enhance clinical research. PMID:24491071

  18. Oedema is associated with clinical outcome following emergency abdominal surgery

    PubMed Central

    Vaughan-Shaw, PG; Saunders, J; Smith, T; King, AT

    2013-01-01

    Introduction Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. Methods A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Results Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24kg/m2 vs 27kg/m2, p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ2=13.1, df=1, p=0.001). Conclusions Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery. PMID:24025285

  19. Oedema is associated with clinical outcome following emergency abdominal surgery.

    PubMed

    Vaughan-Shaw, P G; Saunders, J; Smith, T; King, A T; Stroud, M A

    2013-09-01

    Oedema is observed frequently following surgery and may be associated with worse outcomes. To date, no study has investigated the role of oedema in the emergency surgical patient. This study assesses the incidence of oedema following emergency abdominal surgery and the value of early postoperative oedema measurement in predicting clinical outcome. A prospective cohort study of patients undergoing emergency abdominal surgery at a university unit over a two-month period was undertaken. Nutritional and clinical outcome data were collected and oedema was measured in the early postoperative period. Predictors of oedema and outcomes associated with postoperative oedema were identified through univariate and multivariate analysis. Overall, 55 patients (median age: 66 years) were included in the study. Postoperative morbidity included ileus (n=22) and sepsis (n=6) with 12 deaths at follow-up. Postoperative oedema was present in 19 patients and was associated with prolonged perioperative fasting (107 vs 30 hours, p=0.009) but not with body mass index (24 kg/m(2) vs 27 kg/m(2), p=0.169) or preadmission weight loss (5% vs 3%, p=0.923). On multivariate analysis, oedema was independently associated with gastrointestinal recovery (B=6.91, p=0.038), artificial nutritional support requirement (odds ratio: 6.91, p=0.037) and overall survival (χ(2) =13.1, df=1, p=0.001). Generalised oedema is common after emergency abdominal surgery and appears to independently predict gastrointestinal recovery, the need for artificial nutritional support and survival. Oedema is not associated with commonly applied markers of nutritional status such as body mass index or recent weight loss. Measurement of oedema offers utility in identifying those at risk of poor clinical outcome or those requiring artificial nutritional support following emergency abdominal surgery.

  20. Novel Outcome Measures for Clinical Trials in Cystic Fibrosis

    PubMed Central

    Tiddens, Harm AWM; Puderbach, Michael; Venegas, Jose G; Ratjen, Felix; Donaldson, Scott H; Davis, Stephanie D; Rowe, Steven M; Sagel, Scott D; Higgins, Mark; Waltz, David A

    2015-01-01

    Cystic fibrosis (CF) is a common inherited condition caused by mutations in the gene encoding the CF transmembrane regulator protein. With increased understanding of the molecular mechanisms underlying CF and the development of new therapies there comes the need to develop new outcome measures to assess the disease, its progression and response to treatment. As there are limitations to the current endpoints accepted for regulatory purposes, a workshop to discuss novel endpoints for clinical trials in CF was held in Anaheim, California in November 2011. The pros and cons of novel outcome measures with potential utility for evaluation of novel treatments in CF were critically evaluated. The highlights of the 2011 workshop and subsequent advances in technologies and techniques that could be used to inform the development of clinical trial endpoints are summarized in this review. Pediatr Pulmonol. © 2014 The Authors. Pediatric Pulmonology published by Wiley Periodicals, Inc. PMID:25641878

  1. Severe Acute Respiratory Syndrome: Clinical Outcome and Prognostic Correlates1

    PubMed Central

    Kwok, Man Leung; Yuen, Hon; Lai, Sik To

    2003-01-01

    Severe acute respiratory syndrome (SARS) poses a major threat to the health of people worldwide. We performed a retrospective case series analysis to assess clinical outcome and identify pretreatment prognostic correlates of SARS, managed under a standardized treatment protocol. We studied 127 male and 196 female patients with a mean age of 41±14 (range 18–83). All patients, except two, received ribavirin and steroid combination therapy. In 115 (36%) patients, the course of disease was limited. Pneumonitis progressed rapidly in the remaining patients. Sixty-seven (21%) patients required intensive care, and 42 (13%) required ventilator support. Advanced age, high admission neutrophil count, and high initial lactate dehydrogenase level were independent correlates of an adverse clinical outcome. SARS-associated coronavirus caused severe illnesses in most patients, despite early treatment with ribavirin and steroid. This study has identified three independent pretreatment prognostic correlates. PMID:14519241

  2. Outcome Measures for Clinical Trials in Down Syndrome.

    PubMed

    Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina; Group, Outcome Measures Working

    2017-05-01

    Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

  3. Midterm clinical outcomes following arthroscopic transosseous rotator cuff repair

    PubMed Central

    Flanagin, Brody A.; Garofalo, Raffaele; Lo, Eddie Y.; Feher, LeeAnne; Castagna, Alessandro; Qin, Huanying; Krishnan, Sumant G.

    2016-01-01

    Purpose: Arthroscopic transosseous (TO) rotator cuff repair has recently emerged as a new option for surgical treatment of symptomatic rotator cuff tears. Limited data is available regarding outcomes using this technique. This study evaluated midterm clinical outcomes following a novel arthroscopic TO (anchorless) rotator cuff repair technique. Materials and Methods: A consecutive series of 107 patients and 109 shoulders underwent arthroscopic TO (anchorless) rotator cuff repair for a symptomatic full-thickness tear. Pre and postoperative range of motion (ROM) was compared at an average of 11.8 months. Postoperative outcome scores were obtained at an average of 38.0 months. Statistical analysis was performed to compare pre and postoperative ROM data. Univariate analysis was performed using Student's t-test to compare the effect of other clinical characteristics on final outcome. Results: Statistically significant improvements were noted in forward flexion, external rotation and internal rotation (P < 0.0001). Average postoperative subjective shoulder value was 93.7, simple shoulder test 11.6, and American Shoulder and Elbow Surgeons (ASES) score 94.6. According to ASES scores, results for the 109 shoulders available for final follow-up were excellent in 95 (87.1%), good in 8 (7.3%), fair in 3 (2.8%), and poor in 3 (2.8%). There was no difference in ROM or outcome scores in patients who underwent a concomitant biceps procedure (tenodesis or tenotomy) compared with those who did not. Furthermore, there was no significant difference in outcome between patients who underwent either biceps tenodesis or tenotomy. Age, history of injury preceding the onset of pain, tear size, number of TO tunnels required to perform the repair, and presence of fatty infiltration did not correlate with postoperative ROM or subjective outcome measures at final follow-up. Two complications and four failures were noted. Conclusions: Arthroscopic TO rotator cuff repair technique leads to

  4. Panayiotopoulos syndrome: epidemiological and clinical characteristics and outcome.

    PubMed

    Durá-Travé, T; Yoldi-Petri, M E; Gallinas-Victoriano, F

    2008-04-01

    The aim of this study was to analyse the epidemiological, clinical and evolutional characteristics of Panayiotopoulos syndrome (PS) in order to facilitate the diagnosis in daily clinical practice. Thirty-seven medical records of patients diagnosed with PS were reviewed and the epidemiological and clinical features, results of complementary studies and evolutional data were collected. Mean age at diagnosis was 5.4 years. Female/male ratio was 2.1. The majority of seizures occurred during sleep (67.2%). They usually begin with autonomic manifestations or vomiting (70.1%). Ictal eye and/or cephalic deviation and progression to partial or generalized convulsions were also quite frequent. EEG showed occipital spikes in 28 patients (75.7%). Besides, 71.3% of recurrences were observed in the first 6 months after diagnosis, and 82.9% of the patients had no seizures beyond 2 years from diagnosis. One patient with an atypical development was recorded. The PS is a relatively frequent epileptic syndrome in paediatric age, especially in pre-school children. Although its semiological sequence is fairly typical, the unspecific clinical and neurological characteristics complicate the diagnostic suspicion. Prognosis is excellent; however, it would be convenient to keep a strict evolutional follow-up in these patients as an atypical evolution might occur.

  5. Clinical characteristics and outcomes of neonatal pertussis: a comparative study.

    PubMed

    Castagnini, Luis A; Munoz, Flor M

    2010-03-01

    We describe the features and outcomes of neonatal pertussis and compare these with neonates with non-pertussis acute respiratory illness from July 2000 through December 2007. Patients with pertussis had a more severe course of disease as evidenced by the clinical presentation, length of hospitalization, and oxygen requirement. Clinicians should have a high index of suspicion so that appropriate supportive care can be initiated promptly.

  6. Candida Virulence Properties and Adverse Clinical Outcomes in Neonatal Candidiasis

    PubMed Central

    Bliss, Joseph M.; Wong, Angela Y.; Bhak, Grace; Laforce-Nesbitt, Sonia S.; Taylor, Sarah; Tan, Sylvia; Stoll, Barbara J.; Higgins, Rosemary D.; Shankaran, Seetha; Benjamin, Daniel K.

    2012-01-01

    Objective To determine if premature infants with invasive Candida infection caused by strains with increased virulence properties have worse clinical outcomes than those infected with less virulent strains. Study design Clinical isolates were studied from 2 populations; premature infants colonized with Candida (commensal, n=27), and those with invasive candidiasis (n=81). Individual isolates of C. albicans and C. parapsilosis were tested for virulence in each of 3 assays: phenotypic switching, adhesion, and cytotoxicity. Invasive isolates were considered to have enhanced virulence if they measured more than 1 SD above the mean for the commensal isolates in at least 1 assay. Outcomes of patients with invasive isolates with enhanced virulence were compared with those with invasive isolates lacking enhanced virulence characteristics. Results 61% of invasive isolates of C. albicans and 42% of invasive isolates of C. parapsilosis had enhanced virulence. All C. albicans cerebrospinal fluid (CSF) isolates (n=6) and 90% of urine isolates (n=10) had enhanced virulence, compared with 48% of blood isolates (n=40). Infants with more virulent isolates were younger at the time of positive culture and had higher serum creatinine. Conclusions Individual isolates of Candida species vary in their virulence properties. Strains with higher virulence are associated with certain clinical outcomes. PMID:22504098

  7. Renal involvement in AA amyloidosis: clinical outcomes and survival.

    PubMed

    Yilmaz, Murvet; Unsal, Abdulkadir; Sokmen, Mehmet; Kaptanogullari, Ozlem Harmankaya; Alkim, Canan; Kabukcuoglu, Fevziye; Ozagari, Aysim; Bor, Emire

    2013-01-01

    The natural history of AA amyloidosis is typically progressive, leading to multiple organ failure and death. We analyzed the etiology as well as clinical and laboratory features of patients with biopsy-proven AA amyloidosis and evaluated the ultimate outcome. Seventy-three patients (24 female; mean age 41.85±15.89 years) were analyzed retrospectively. Demographic, clinical and laboratory features were studied and the outcome was assessed. Familial Mediterranean Fever and tuberculosis were the most frequent causes of amyloidosis. Mean serum creatinine and proteinuria at diagnosis were 4.65±4.89 mg/dl and 8.04±6.09 g/day, respectively; and stage I, II, III, IV and V renal disease were present in 19.2%, 13.7%, 16.4%, 11%, and 39.7% of the patients, respectively. ESRD developed in 16 patients during the follow-up period. All of the ESRD patients started a dialysis programme. Thirty patients (41%) died during the follow-up period; median patient survival was 35.9±6.12 months. Old age, tuberculosis etiology, advanced renal disease and low serum albumin levels were associated with a worse prognosis. Serum albumin was a predictor of mortality in logistic regression analysis. The ultimate outcome of the patients with AA amyloidosis is poor, possibly due to the late referral to the nephrology clinics. Early referral may be helpful to improve prognosis. Copyright © 2013 S. Karger AG, Basel.

  8. Stakeholders in outcome measures: review from a clinical perspective.

    PubMed

    Brinker, Mark R; O'Connor, Daniel P

    2013-11-01

    Modern interest in patient-reported outcomes measures (PROMs) in orthopaedics dates back to the mid-1980s. While gradual growth of activity in this area has occurred over the past 25 years, the extent to which this research methodology is applied in clinical practice to improve patient care is unclear. WHERE ARE WE NOW?: Historically, clinical research in orthopaedics has focused on the technical success of treatment, and objective indicators such as mortality, morbidity, and complications. By contrast, the PROMs framework focuses on effects of treatment described in terms of relief of symptoms, restoring functional ability, and improving quality of life. PROMs can be used to study the relative effects of disease, injury, and treatment across different health conditions. WHERE DO WE NEED TO GO?: All clinical research should begin with identifying clear and meaningful research questions so that the resources and efforts required for data collection result in useful data. Different consumers of research data have different perspectives on what comprises meaningful information. Involving stakeholders such as patients, providers, payers, and policy-makers when defining priorities in the larger research endeavor is one way to inform what type of data should be collected in a particular study. HOW DO WE GET THERE?: Widespread collection of outcomes data would potentially aid these stakeholders by identifying best practices, benefits and costs, and important patient or practice characteristics related to outcomes. Several initiatives currently underway may help systematic collection of PROMs, create efficient systems, and foster collaborations to provide support and resources to minimize costs.

  9. TIAM1 variants improve clinical outcome in neuroblastoma.

    PubMed

    Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L; Cañete, Adela; Castel, Victoria; Font de Mora, Jaime

    2017-07-11

    Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma.

  10. TIAM1 variants improve clinical outcome in neuroblastoma

    PubMed Central

    Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L.; Cañete, Adela; Castel, Victoria; de Mora, Jaime Font

    2017-01-01

    Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma. PMID:28423360

  11. Association between dog guardianship and HIV clinical outcomes

    PubMed Central

    Saberi, Parya; Neilands, Torsten B.; Johnson, Mallory O.

    2014-01-01

    Despite numerous potential health outcomes of dog guardianship, their value has not been examined in the HIV-positive population. The study objective was to examine the relationship between dog guardianship and HIV clinical outcomes (antiretroviral adherence [≥95% versus <95%], HIV viral load [≥48copies/mL versus <48copies/mL], and CD4+ cell count) among HIV-positive individuals. We conducted a secondary analysis of baseline data of 370 HIV-positive men on antiretrovirals enrolled in the Duo Project. Generalized estimating equations were used for inferential regression analyses, while controlling for the focal dog guardianship variable and non-focal covariates. Current dog guardianship was reported in 28.7% of participants. Dog guardianship may be associated with higher CD4+ (coefficient=60.6, p=0.052) and adherence ≥95% (OR=1.80, p=0.048); however, having a detectable viral load was not related to dog guardianship (OR=0.94, p=0.85). Further clinical research with detailed dog guardianship data is needed to further examine the association between dog guardianship and HIV clinical outcomes. PMID:25436253

  12. Clinical and economic outcomes assessment in nuclear cardiology.

    PubMed

    Shaw, L J; Miller, D D; Berman, D S; Hachamovitch, R

    2000-06-01

    The future of nuclear medicine procedures, as understood within our current economic climate, depends upon its ability to provide relevant clinical information at similar or lower comparative costs. With an ever-increasing emphasis on cost containment, outcome assessment forms the basis of preserving the quality of patient care. Today, outcomes assessment encompasses a wide array of subjects including clinical, economic, and humanistic (i.e., quality of life) outcomes. For nuclear cardiology, evidence-based medicine would require a threshold level of evidence in order to justify the added cost of any test in a patient's work-up. This evidence would include large multicenter, observational series as well as randomized trial data in sufficiently large and diverse patient populations. The new movement in evidence-based medicine is also being applied to the introduction of new technologies, in particular when comparative modalities exist. In the past 5 years, we have seen a dramatic shift in the quality of outcomes data published in nuclear cardiology. This includes the use of statistically rigorous risk-adjusted techniques as well as large populations (i.e., > 500 patients) representing multiple diverse medical care settings. This has been the direct result of the development of multiple outcomes databases that have now amassed thousands of patients worth of data. One of the benefits of examining outcomes in large patient datasets is the ability to assess individual endpoints (e.g., cardiac death) as compared with smaller datasets that often assess combined endpoints (e.g., death, myocardial infarction, or unstable angina). New technologies for the diagnosis of coronary artery disease have contributed to the rising costs of care. In the United States and in Europe, costs of care have risen dramatically, consuming an ever-increasing amount of available resources. The overuse of diagnostic angiography often leads to unnecessary revascularization that does not lead to

  13. Bonding to oxide ceramics—laboratory testing versus clinical outcome.

    PubMed

    Kern, Matthias

    2015-01-01

    Despite a huge number of published laboratory bonding studies on dental oxide ceramics clinical long-term studies on resin bonded oxide ceramic restorations are rare. The purpose of this review is to present the best available clinical evidence for successful bonding of dental oxide ceramic restorations. Clinical trials with resin-bonded restorations that had no or only limited mechanical retention and were made from alumina or zirconia ceramic were identified using an electronic search in PubMed database. Overall 10 publications with clinical trials could be identified. Their clinical outcome was compared with that laboratory bond strength studies. Clinical data provide strong evidence that air-abrasion at a moderate pressure in combination with using phosphate monomer containing primers and/or luting resins provide long-term durable bonding to glass-infiltrated alumina and zirconia ceramic under the humid and stressful oral conditions. As simple and clinically reliable bonding methods to oxide ceramics exist, the rationale for development of alternative bonding methods might be reconsidered especially when these methods are more time consuming or require rather complicated and/or technique sensitive procedures. Copyright © 2014 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  14. Clinical and radiographic outcomes of cervical disc replacement with a new prosthesis.

    PubMed

    Miao, Jinhao; Yu, Fengbin; Shen, Ye; He, Naya; Kuang, Yong; Wang, Xinwei; Chen, Deyu

    2014-06-01

    .3, and 14.9, whereas the mean VAS overall pain score was 1.9, 1.7, 1.8, and 1.4, respectively. Mean JOA and VAS scores showed statistical improvements in the postoperative period. Seven patients had mild dysphagia within the first month after operation. According to Odom's scale, 52 patients had excellent outcomes, 25 patients had good outcomes, and 2 patients had fair outcomes at 2-year follow-up. The Mean preoperative ADH and PDH of the operative segment were 4.9 mm and 3.1 mm. Compared with preoperative, there were significantly increased and maintenance well at 2- (7.5 mm, 5.1 mm), 6- (7.5 mm, 5.0 mm), 12- (7.4 mm, 4.9 mm) and 24-month (7.2 mm, 5.0 mm) follow-up. Range of motion of the operative segment in the postoperative follow-up was slightly increased than the preoperative follow-up but not statistically significant. Heterotopic ossification was presented in six replaced levels at 1-year follow-up including 4 Grade I and 2 Grade II and 18 replaced levels at the follow-up more than 2 years including 8 grade I and 10 grade II. No prosthesis subsidence or excursion was identified. The use of Discover prostheses in our study resulted in satisfactory clinical and radiographic outcomes. The prostheses can restore and maintain interbody height, while preserve the motion of the treated segment. Although the results of this study demonstrate initial safety and effectiveness in a Chinese population, we need further studies to know more about the impact of CDR with Discover prosthesis, especially on HO and adjacent segment degeneration. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Gender differences in clinical outcomes for cocaine dependence: Randomized clinical trials of behavioral therapy and disulfiram✩

    PubMed Central

    DeVito, Elise E.; Babuscio, Theresa A.; Nich, Charla; Ball, Samuel A.; Carroll, Kathleen M.

    2014-01-01

    Background Despite extensive research on gender differences in addiction, there are relatively few published reports comparing treatment outcomes for women versus men based on evidence-based treatments evaluated in randomized clinical trials. Methods An aggregate sample comprised of data from five randomized clinical trials of treatment for cocaine dependence (N = 434) was evaluated for gender differences in clinical outcomes. Secondary analyses compared gender differences in outcome by medication condition (disulfiram versus no medication) and across multiple behavioral treatment conditions. Results Women, compared with men, had poorer treatment outcomes on multiple measures of cocaine use during treatment and at post-treatment follow-up. These results appear to be primarily accounted for by disulfiram being less effective in women compared with men. There was no evidence of meaningful gender differences in outcome as a function of the behavioral therapies evaluated. Conclusions These findings suggest that women and men may benefit to similar degrees from some empirically validated behavioral treatments for addiction. Conversely, some addiction pharmacotherapies, such as disulfiram, may be associated with poorer outcomes among women relative to men and point to the need for careful assessment of pharmacological treatments in both sexes prior to widespread clinical implementation. PMID:25457739

  16. Clinical manifestations and outcomes of pulmonary aspergillosis: experience from Pakistan

    PubMed Central

    Iqbal, Nousheen; Irfan, Muhammad; Zubairi, Ali Bin Sarwar; Jabeen, Kauser; Awan, Safia; Khan, Javaid A

    2016-01-01

    Introduction Pulmonary aspergillosis has variable course of illness, severity and outcomes depending on underlying conditions. There is limited data available on the clinical manifestations and outcome of pulmonary aspergillosis from Pakistan. Methods To determine the clinical manifestations and outcome of pulmonary aspergillosis in a tertiary care hospital a retrospective study was conducted from 2004 to 2014 in patients admitted with pulmonary aspergillosis at the Aga Khan University Hospital Karachi, Pakistan. Results Of the 280 cases with provisional diagnosis of aspergillosis 69 met the inclusion criteria. The mean age was 45±15.7 years, 48 (69.6%) were men and 21 (30.4%) had diabetes mellitus (DM). The average length of hospital stay (LOS) was 10.61±9.08 days. Aspergillus fumigatus was the most common (42.0%), followed by Aspergillus flavus (28.9%). More than one-third of patients previously had tuberculosis (TB) (39.13%). The commonest pulmonary manifestation was chronic pulmonary aspergillosis (CPA) 47 (68.1%) followed by invasive pulmonary aspergillosis (IPA) 12 (17.4%) and subacute invasive aspergillosis (SAIA) 8 (11.6%). Surgical excision was performed in 28 patients (40.57%). Intensive care unit admission was required for 18 patients (26.08%). Case fatality rate was 14/69 (20.3%). DM, mean LOS and hypoxic respiratory failure were identified as independent risk factors of mortality on multivariate analysis. Conclusion A. fumigatus was the most frequent species found especially in patients with prior TB. CPA was the commonest pulmonary manifestation seen as post TB sequel. Diabetes, hypoxic respiratory failure and increased LOS were independent predictors of poor outcomes. Overall patients had good outcome with CPA compared with SAIA and IPA. PMID:28074136

  17. The Oregon experiment--effects of Medicaid on clinical outcomes.

    PubMed

    Baicker, Katherine; Taubman, Sarah L; Allen, Heidi L; Bernstein, Mira; Gruber, Jonathan H; Newhouse, Joseph P; Schneider, Eric C; Wright, Bill J; Zaslavsky, Alan M; Finkelstein, Amy N

    2013-05-02

    Despite the imminent expansion of Medicaid coverage for low-income adults, the effects of expanding coverage are unclear. The 2008 Medicaid expansion in Oregon based on lottery drawings from a waiting list provided an opportunity to evaluate these effects. Approximately 2 years after the lottery, we obtained data from 6387 adults who were randomly selected to be able to apply for Medicaid coverage and 5842 adults who were not selected. Measures included blood-pressure, cholesterol, and glycated hemoglobin levels; screening for depression; medication inventories; and self-reported diagnoses, health status, health care utilization, and out-of-pocket spending for such services. We used the random assignment in the lottery to calculate the effect of Medicaid coverage. We found no significant effect of Medicaid coverage on the prevalence or diagnosis of hypertension or high cholesterol levels or on the use of medication for these conditions. Medicaid coverage significantly increased the probability of a diagnosis of diabetes and the use of diabetes medication, but we observed no significant effect on average glycated hemoglobin levels or on the percentage of participants with levels of 6.5% or higher. Medicaid coverage decreased the probability of a positive screening for depression (-9.15 percentage points; 95% confidence interval, -16.70 to -1.60; P=0.02), increased the use of many preventive services, and nearly eliminated catastrophic out-of-pocket medical expenditures. This randomized, controlled study showed that Medicaid coverage generated no significant improvements in measured physical health outcomes in the first 2 years, but it did increase use of health care services, raise rates of diabetes detection and management, lower rates of depression, and reduce financial strain.

  18. Clinical Outcomes of Ruptured Periorbital and Orbital Dermoid Cysts.

    PubMed

    Siah, We Fong; Al-Muhaylib, Ahmed A; Rajak, Saul; Ziahosseini, Kimia; Selva, Dinesh; Malhotra, Raman; Alsuhaibani, Adel H

    To evaluate the clinical outcomes of ruptured dermoid cysts. A multicenter, retrospective study of all cases of periorbital and orbital dermoid cysts with histopathological evidence of rupture, including those with clinical rupture, was performed over a 10-year period. Demographics and clinical outcomes of ruptured dermoid cysts were recorded. Persistent inflammation was defined as the presence of edema, erythema, and discomfort for at least 28 days. Eighty-six cases of dermoid cysts were identified. Median age was 5.5 (range, 1-63) years. Location of cyst was either periorbital (n = 60, 70%) or orbital (n = 26, 30%). There were 29 cases with clinically apparent rupture: 27 surgically ruptured (93%) and 2 spontaneous rupture (7%). Persistent inflammation was found in 1 spontaneous cyst rupture case (50%) and 1 surgically ruptured cyst (3.7%). Older age (p = 0.01) and bony attachment (p = 0.001) were significant factors for cyst rupture, while there was no influence from cyst location (p = 0.14). Persistent inflammation is uncommon after surgical rupture of dermoid cysts, but likely after spontaneous rupture. Older age and bony attachment are risk factors for cyst rupture.

  19. Fusarium keratitis: genotyping, in vitro susceptibility and clinical outcomes

    PubMed Central

    Oechsler, Rafael A; Feilmeier, Michael R; Miller, Darlene; Shi, Wei; Hofling-Lima, Ana Luisa; Alfonso, Eduardo C

    2012-01-01

    Purpose To determine differences in the clinical characteristics and antifungal susceptibility patterns among molecularly characterized ocular Fusarium sp isolates. Methods 58 Fusarium isolates obtained from 52 eyes of 52 patients were retrieved from the Bascom Palmer Eye Institute’s (BPEI) ocular microbiology laboratory and grown in pure culture. These isolates were characterized based on DNA sequence analysis of the ITS1/2 and rDNA regions. Antifungal susceptibilities were determined for each isolate using broth microdilution methods and the corresponding medical records were reviewed to determine clinical outcomes. Results Fusarium (F.) solani isolates had significantly higher voriconazole MIC90 values than F. non-solani organisms (16 and 4ug/ml, respectively). F. solani isolates also exhibited a significantly longer time to cure (65 vs 40.5 days), a worse follow up BCVA (20/118 vs 20/36), and increased need for urgent surgical management (7 vs 0 penetrating keratoplasties) when compared to F. non-solani isolates. Conclusions This is the first report to examine the correlation between ocular genotyped Fusarium species and clinical outcomes. It supports the overall worse prognosis for F. solani versus F. non-solani isolates, including higher voriconazole resistance by the former. The clinical implementation of molecular-based diagnostics and antifungal efficacy testing, may yield important prognostic and therapeutic information that could improve the management of fungal ocular infections. PMID:23343947

  20. CLINICAL OUTCOME AFTER INFECTED TOTAL KNEE AND TOTAL HIP ARTHROPLASTY.

    PubMed

    Mittag, Falk; Leichtle, Carmen Ina; Schlumberger, Michael; Leichtle, Ulf Gunther; Wünschel, Markus

    2016-01-01

    Infection after total hip (THA) and knee arthroplasty (TKA) is a serious complication which typically leads to a long lasting and intensive surgical and medicamentous treatment. The aim of this study was to identify factors that influence outcome after revision surgery caused by prosthetic infection. We retrospectively analyzed 64 patients who had revision surgery between 1989 and 2009 due to periprosthetic infection. We examined a total of 69 joints (TKA: 36%, THA: 64%), follow-up 5.1 years (0.5-21 years) after the initial surgical intervention. The mean patient age at time of surgery was 67 years old (43-79 years old). Clinical data and scores including the Western Ontario and McMaster Universities (WOMAC)-Index, the Harris Hip Score (HHS) and the Hospital for Special Surgery Score (HSS) were surveyed. There was no difference in clinical scores regarding treatment between a single and a multiple stage treatment regime. Infections with multiple microorganisms and Enterococcus spp. lead to a significantly higher number of interventions. Using a modified Tsukayama system we classified 24% as type I, 34% type II and 42% type III- infections, with no differences in clinical outcome. Overweight patients had a significantly lower HHS and WOMAC-score. Immunosuppression leads to a worse WOMAC and HSS-Score. An increased number of procedures was associated to a limping gait. Thorough surgical technique leads to good clinical results independent of infection-type and treatment philosophy. Level of Evidence III, Case Control Study.

  1. Topical Treatment of Onychomycosis and Clinically Meaningful Outcomes.

    PubMed

    Gupta, Aditya K; Korotzer, Andrew

    2016-10-01

    Although a completely normal nail would be the ideal outcome when treating onychomycosis, this is not always achievable and long treatment courses or patient expectations can impact patient adherence. We analyzed cure rates from a number of subpopulations derived from the two pivotal phase III studies with efinaconazole topical solution (10%) to provide some insights into clinically meaningful treatment outcomes and support for effective long-term management programs. Efinaconazole affords greater efficacy in milder disease, female patients, and those patients whose disease is relatively recent and confined to the great toenail, following 48 weeks' treatment. With longer treatment courses, similar results may be achieved in other subpopulations. Clinically meaningful results (a 40% improvement in the involvement of the diseased nail) were achieved with efinaconazole within six months in half the patients treated, and in over 90% of patients by study end. A greater proportion of female patients achieved clinically meaningful results at six months, although treatment success did not seem to be influenced by baseline disease severity. The majority of patients treated with efinaconazole could expect to see clinically meaningful results within six months.

    J Drugs Dermatol. 2016;15(10):1260-1266.

  2. Germline determinants of clinical outcome of cutaneous melanoma

    PubMed Central

    Vogelsang, Matjaz; Wilson, Melissa; Kirchhoff, Tomas

    2016-01-01

    Cutaneous melanoma (CM) is the most lethal form of skin cancer. Despite the constant increase of melanoma incidence, which is in part due to incremental advances in early diagnostic modalities, mortality rates have not improved over the last decade and for advanced stages remain steadily high. While conventional prognostic biomarkers currently in use find significant utility for predicting overall general survival probabilities, they are not sensitive enough for a more personalized clinical assessment on an individual level. In recent years, the advent of genomic technologies has brought the promise of identification of germline DNA alterations that may associate with CM outcomes and hence represent novel biomarkers for clinical utilization. This review attempts to summarize the current state of knowledge of germline genetic factors studied for their impact on melanoma clinical outcomes. We also discuss ongoing problems and hurdles in validating such surrogates, and we also project future directions in discovery of more powerful germline genetic factors with clinical utility in melanoma prognostication. PMID:26342156

  3. A neighborhood-centered clinical project: improving diabetes and cardiovascular outcomes in Hispanic women.

    PubMed

    Baldwin, Sara A

    2015-03-01

    Neighborhood-centered disease prevention programs have become a growing means of introducing baccalaureate nursing students to health care systems. This article reports diabetes and cardiovascular clinical outcomes and health behavior changes made following a 2-year baccalaureate community/public health clinical project and partnership with an urban Hispanic neighborhood. This pilot study used a pretest-posttest design without comparators. The healthy lifestyle consisted of health coaching, physical activity, and lifestyle modification. Thirty-eight women completed the 12-week program. Results revealed significant reductions in diabetes and cardiovascular total risk scores, glycated hemoglobin, body mass index, and physical activity (α = 0.05). Students gained learning opportunities in research and public health competencies, while providing clinical practice, research, and scholarship opportunities for nurse educators. Insights from these programs can help faculty, students, and communities identify new approaches that are consistent with the National Prevention Strategy and the Patient Protection and Affordable Care Act to improve diabetes and cardiovascular outcomes among Hispanic women.

  4. Disruptive behavior and clinical outcomes: perceptions of nurses and physicians.

    PubMed

    Rosenstein, Alan H; O'Daniel, Michelle

    2005-01-01

    Providing safe, error-free care is the number-one priority of all health care professionals. Excellent outcomes have been associated with procedural efficiency, the implementation of evidence-based standards, and the use of tools designed to reduce the likelihood of medical error (such as computerized medication orders and bar-coded patient identification). But the impact of work relationships on clinical outcomes isn't as well documented. The current survey was designed as a follow-up to a previous VHA West Coast survey that examined the prevalence and impact of physicians' disruptive behavior on the job satisfaction and retention of nurses (see "Nurse-Physician Relationships: Impact on Nurse Satisfaction and Retention," June 2002). Based on the findings of that survey and subsequent comments on it, the follow-up survey examined the disruptive behavior of both physicians and nurses, as well as both groups' and administrators' perceptions of its effects on providers and its impact on clinical outcomes. Surveys were distributed to 50 VHA hospitals across the country, and results from more than 1,500 survey participants were evaluated. Nurses were reported to have behaved disruptively almost as frequently as physicians. Most respondents perceived disruptive behavior as having negative or worsening effects, in both nurses and physicians, on stress, frustration, concentration, communication, collaboration, information transfer, and workplace relationships. Even more disturbing was the respondents' perceptions of negative or worsening effects of disruptive behavior on adverse events, medical errors, patient safety, patient mortality, the quality of care, and patient satisfaction. These findings suggest that the consequences of disruptive behavior go far beyond nurses' job satisfaction and morale, affecting communication and collaboration among clinicians, which may well, in turn, have a negative impact on clinical outcomes. Strategies aimed at reducing the incidence and

  5. Clinical outcomes resulting from telemedicine interventions: a systematic review

    PubMed Central

    2001-01-01

    Background The use of telemedicine is growing, but its efficacy for achieving comparable or improved clinical outcomes has not been established in many medical specialties. The objective of this systematic review was to evaluate the efficacy of telemedicine interventions for health outcomes in two classes of application: home-based and office/hospital-based. Methods Data sources for the study included deports of studies from the MEDLINE, EMBASE, CINAHL, and HealthSTAR databases; searching of bibliographies of review and other articles; and consultation of printed resources as well as investigators in the field. We included studies that were relevant to at least one of the two classes of telemedicine and addressed the assessment of efficacy for clinical outcomes with data of reported results. We excluded studies where the service did not historically require face-to-face encounters (e.g., radiology or pathology diagnosis). All included articles were abstracted and graded for quality and direction of the evidence. Results A total of 25 articles met inclusion criteria and were assessed. The strongest evidence for the efficacy of telemedicine in clinical outcomes comes from home-based telemedicine in the areas of chronic disease management, hypertension, and AIDS. The value of home glucose monitoring in diabetes mellitus is conflicting. There is also reasonable evidence that telemedicine is comparable to face-to-face care in emergency medicine and is beneficial in surgical and neonatal intensive care units as well as patient transfer in neurosurgery. Conclusions Despite the widespread use of telemedicine in virtually all major areas of health care, evidence concerning the benefits of its use exists in only a small number of them. Further randomized controlled trials must be done to determine where its use is most effective. PMID:11737882

  6. Clinical outcome of deep wound infection after instrumented posterior spinal fusion: a matched cohort analysis.

    PubMed

    Mok, James M; Guillaume, Tenner J; Talu, Ufuk; Berven, Sigurd H; Deviren, Vedat; Kroeber, Markus; Bradford, David S; Hu, Serena S

    2009-03-15

    Retrospective case control study. Determine the impact of infection on clinical outcome in patients undergoing posterior spinal fusion surgery. The outcome of patients treated for infection after spinal surgery is not well established because of variability in cohort identification, definition of infection, outcomes instrument, use of a control group, and/or sample size. Thirty-two patients were included. Sixteen patients ("infection group") met inclusion criteria of deep wound infection after spinal fusion with posterior segmental instrumentation (including combined approach). A 1:1 matched cohort ("control group") was created based on primary or revision status, length of fusion, diagnosis, and age. Postoperative patient outcomes were evaluated using the physical components of SF-36 v2.0 with minimum 2-year follow-up. No significant difference in the Physical Function, Role Physical, Bodily Pain, and General Health domains was detected between the infection group and control group. Mean follow-up was 62 months. Mean Physical Component Summary was 41.4 in the infection group and 44.3 in the control group (P = 0.6). Infection occurred early in 12 patients and late in 4 patients. Most common organisms isolated were Staphylococcus epidermidis, Enterococcus sp., and Staphylococcus aureus. Multiple debridements were significantly associated with polymicrobial infections and later pseudarthrosis requiring reoperation. An aggressive approach to deep wound infection emphasizing early irrigation and debridement allowed preservation of instrumentation and successful fusion in most cases. At the conclusion of treatment, patients can expect a medium-term clinical outcome similar to patients in whom this complication did not occur.

  7. Reverse shoulder arthroplasty. Part 1: Systematic review of clinical and functional outcomes

    PubMed Central

    Samitier, Gonzalo; Alentorn-Geli, Eduard; Torrens, Carlos; Wright, Thomas W.

    2015-01-01

    Many factors influence the outcomes of reverse shoulder arthroplasty (RSA). The purpose of this study was to compare the clinical and functional outcomes of RSA depending on the surgical approach, type of prosthesis, and indication for surgery through a comprehensive, systematic review. A literature search was conducted (1985 to June 2012) using PubMed, CINAHL, EBSCO–SPORTDiscus, and Cochrane Central Register of Controlled Trials. Levels I–IV evidence, in-vivo human studies (written in English with minimum of 2 years of follow-up and sample size of 10 patients) reporting clinical and/or functional outcomes after RSA were included. The outcomes were analyzed depending on the surgical approach, type of prosthesis (with medialized or lateralized center of rotation), or indication for surgery. A total of 35 studies were included involving 2049 patients (mean [SD] percentage of females, age, and follow-up of 71.6% [13.4], 71.5 years [3.7], and 43.1 months [18.8], respectively). Studies using deltopectoral approach with lateralized prostheses demonstrated greater improvement in external rotation compared with medialized prostheses with the same approach (mean 22.9° and 5°, respectively). In general, RSA for cuff tear arthropathy demonstrated higher improvements in Constant and American Shoulder and Elbow Society scores, and range of motion compared with revision of anatomic prosthesis, failed rotator cuff repair, and fracture sequelae. Lateralized prostheses provided more improvement in external rotation compared to medialized prostheses. Indications of RSA for cuff tear arthropathy demonstrated higher improvements in the outcomes compared with other indications. RSA demonstrated high patient's satisfaction regardless of the type of prosthesis or indication for surgery. Level of Evidence: Level IV. PMID:25709242

  8. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    SciTech Connect

    Schwartz, David L.; Garden, Adam S.; Thomas, Jimmy; Chen Yipei; Zhang Yongbin; Lewin, Jan; Chambers, Mark S.; Dong, Lei

    2012-07-01

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  9. Clinical outcome of collateral ligament injuries of the tarsus

    PubMed Central

    Lamb, Lauren; Zubrod, Chad; Hague, Brent; Brakenhoff, Jeff; Major, Michael

    2012-01-01

    The significance of collateral ligament desmitis of the tarsocrural joint is often clinically underestimated, because it is an uncommon injury with a guarded prognosis for athletic soundness. The objective of this study was to describe the clinical presentation, treatment, and outcome of 12 horses with collateral ligament desmitis, along with tarsocrural joint synovitis secondary to hemarthrosis. Criteria for inclusion in this study included clinical signs of tarsocrural joint synovitis and sonographic evidence of collateral ligament desmitis. This retrospective study evaluated horses over an 8-year period. Median follow-up after treatment was 5.5 years. Four horses in the study returned to their previous level of performance, 6 horses remained lame due to pain in the tarsus, 1 was euthanized, and 1 is in convalescence. This study highlights the importance of collateral ligament desmitis, and emphasizes the need for early, aggressive treatment to prevent the development of osteoarthritis. PMID:23115364

  10. Social Development:: 2 Year Olds

    MedlinePlus

    ... Español Text Size Email Print Share Social Development: 2 Year Olds Page Content Article Body By nature, ... probably are acting the same way. At age two, children view the world almost exclusively through their ...

  11. ADCOMS: a composite clinical outcome for prodromal Alzheimer's disease trials

    PubMed Central

    Wang, Jinping; Logovinsky, Veronika; Hendrix, Suzanne B; Stanworth, Stephanie H; Perdomo, Carlos; Xu, Lu; Dhadda, Shobha; Do, Ira; Rabe, Martin; Luthman, Johan; Cummings, Jeffrey; Satlin, Andrew

    2016-01-01

    Background Development of new therapies for Alzheimer's disease (AD) is increasingly focused on more mildly affected populations, and requires new assessment and outcome strategies. Patients in early stages of AD have mild cognitive decline and no, or limited, functional impairment. To respond to these assessment challenges, we developed a measurement approach based on established scale items that exhibited change in previous amnestic Mild Cognitive Impairment (aMCI) trials. Methods Partial least squares regression with a longitudinal clinical decline model identified items from commonly used clinical scales with the highest combined sensitivity to change over time in aMCI and weighted these items according to their relative contribution to detecting clinical progression in patients’ early stages of AD. The resultant AD Composite Score (ADCOMS) was assessed for its ability to detect treatment effect in aMCI/prodromal AD (pAD) clinical trial populations. Results ADCOMS consists of 4 Alzheimer's Disease Assessment Scale–cognitive subscale items, 2 Mini-Mental State Examination items, and all 6 Clinical Dementia Rating—Sum of Boxes items. ADCOMS demonstrated improved sensitivity to clinical decline over individual scales in pAD, aMCI and in mild AD dementia. ADCOMS also detected treatment effects associated with the use of cholinesterase inhibitors in these populations. Improved sensitivity predicts smaller sample size requirements when ADCOMS is used in early AD trials. Conclusions ADCOMS is proposed as new standard outcome for pAD and mild AD dementia trials, and is progressing in a CAMD-sponsored qualification process for use in registration trials of pAD. PMID:27010616

  12. Looking beyond historical patient outcomes to improve clinical models.

    PubMed

    Chia, Chih-Chun; Rubinfeld, Ilan; Scirica, Benjamin M; McMillan, Sean; Gurm, Hitinder S; Syed, Zeeshan

    2012-04-25

    Conventional algorithms for modeling clinical events focus on characterizing the differences between patients with varying outcomes in historical data sets used for the model derivation. For many clinical conditions with low prevalence and where small data sets are available, this approach to developing models is challenging due to the limited number of positive (that is, event) examples available for model training. Here, we investigate how the approach of developing clinical models might be improved across three distinct patient populations (patients with acute coronary syndrome enrolled in the DISPERSE2-TIMI33 and MERLIN-TIMI36 trials, patients undergoing inpatient surgery in the National Surgical Quality Improvement Program registry, and patients undergoing percutaneous coronary intervention in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry). For each of these cases, we supplement an incomplete characterization of patient outcomes in the derivation data set (uncensored view of the data) with an additional characterization of the extent to which patients differ from the statistical support of their clinical characteristics (censored view of the data). Our approach exploits the same training data within the derivation cohort in multiple ways to improve the accuracy of prediction. We position this approach within the context of traditional supervised (2-class) and unsupervised (1-class) learning methods and present a 1.5-class approach for clinical decision-making. We describe a 1.5-class support vector machine (SVM) classification algorithm that implements this approach, and report on its performance relative to logistic regression and 2-class SVM classification with cost-sensitive weighting and oversampling. The 1.5-class SVM algorithm improved prediction accuracy relative to other approaches and may have value in predicting clinical events both at the bedside and for risk-adjusted quality of care assessment.

  13. Pediatric atlanto-occipital dissociation: radiographic findings and clinical outcome

    PubMed Central

    du Plessis, Jean-Pierre; Dix-Peek, Stewart; Hoffman, Eduard Bernard; Wieselthaler, Nicky; Dunn, Robert Neil

    2012-01-01

    Study design: Retrospective diagnostic feasibility study and clinical review. Objectives: To evaluate the feasibility of making an initial atlanto-occipital dissociation (AOD) diagnosis from four radiological measurements of the craniocervical relationship on lateral cervical spine x-rays and to assess the AOD patients' clinical outcomes relative to their magnetic resonance imaging (MRI) findings. Methods: The Powers ratio, Wackenheim line, basion-dens distance (BDD), and the C1/2:C2/3 interspinous ratio were measured in 58 pediatric controls and ten MRI-confirmed patients with AOD. The ability to identify the required anatomical landmarks and make the measurements was noted and sensitivity and specificity calculated. The correspondence between the clinical presentation and outcomes for patients with AOD and their MRI features was investigated. Results: Clear landmarks for measuring interspinous ratio and Wackenheim line were confirmed by all x-rays. The BDD was measureable in 90% and the Powers ratio could be calculated in only possible in 59%. The interspinous ratio and BDD offered high sensitivities and specificity. Although the Wackenheim line was consistantly measured, it conferred a low sensitivity but reasonable specificity. The Powers ratio offered high specificity with low sensitivity. On MRI, all patients with AOD had apical ligament disruption, with a high rate of interspinous ligamentous injury (8/9); prevertebral swelling (7/9); retroclival hematoma (6/9); and tectorial membrane injury (4/9). The only MRI feature associated with poor outcome was that of altered cord signal. Both patients who died had cord signal changes on T1- and T2-weighted images. The third patient with cord signal change was limited to T2 changes with a normal T1. He had a C5-L3 sensory deficit that resolved. The degree of tectorial membrane injury did not appear to influence outcome. Conclusions: The BDD and interspinous ratio offer the best measures for initial x

  14. The clinical outcomes of 234 spiral family implants.

    PubMed

    Danza, Matteo; Fromovich, Ophir; Guidi, Riccardo; Carinci, Francesco

    2009-09-01

    Spiral family implants (SFIs) are a new type of implant fixture with a conical internal helix and a variable thread design. The aim of this retrospective study was to evaluate the clinical outcomes of a series of SFIs. A total of 234 SFIs were placed in 86 patients (55 females and 31 males, median age 53 years) during the period between May 2004 and November 2007. The mean follow-up was 13 months. Several host, surgery, and implant-related factors were investigated, and the Kaplan Meier algorithm and the Cox regression were used to detect variables associated with the clinical outcome. Only nine out of 234 implants were lost (i.e., survival rate (SVR) of 96.2%) and no differences were detected among the studied variables. SFIs have a high SVR similar to those reported in previous studies on different implant types. SFIs demonstrated a very high primary stability which offers the potential for use of a specific implant device for immediate loading. However, additional studies are necessary to verify their outcome on the medium/long period.

  15. Clinical profile and outcome of acute respiratory failure.

    PubMed

    Karande, Sunil; Murkey, Rajneesh; Ahuja, Sanjeev; Kulkarni, Madhuri

    2003-11-01

    To examine the etiological factors, clinical features, treatment modalities and outcome of acute respiratory failure in children. This hospital-based prospective observational study was conducted over 15 months. Fifty children with acute respiratory failure, diagnosed by serial arterial blood gas analysis, were consecutively enrolled. Ventilation therapy was initiated when the FiO2 requirement went above 0.6. Pulmonary diseases accounted for majority (68%) of cases, followed by nervous system (12%); and cardiovascular and skeletal muscle system diseases (10%, each). Bronchopneumonia was the commonest cause of acute respiratory failure (11 cases). The majority of cases were in the age group 1 month to < 1 year (26 cases). The commonest signs were altered depth and pattern of respiration (100%), chest wall retractions (88%), flaring of alae nasae (88%), tachypnea (84%), tachycardia (82%), and irritability (64%). Cyanosis was noticed in only 26 (52%) cases. Thirty-six (72%) children required ventilation therapy. The overall mortality was 58%. The mortality was high (55.9% to 66.7%), irrespective of the primary system involved. Significantly higher mortality was associated with co-existent malnutrition (p<0.001), Type I failure (p=0.039) and ventilation therapy (p<0.0001). Acute respiratory failure has varied etiology and clinical manifestations, and a high mortality. Its outcome is independent of age of the child and the primary system involved. Malnutrition and Type I failure are factors associated with a poor outcome.

  16. The clinical, occupational and financial outcomes associated with a bespoke specialist clinic for military aircrew—a cohort study

    PubMed Central

    Pavitt, A.J.; Pavitt, C.W.; Harron, K.; Jones, M.; Timperley, A.C.; Reid, A.N.C.; Mcloughlin, D.; d'Arcy, J.

    2016-01-01

    Objectives: To assess the clinical, occupational and financial outcomes of a new Clinical Aviation Medicine Service (CAMS) for UK military personnel. Methods: Consecutive patients over a 2 year period were included. Predictors of flying restrictions at referral and final outcome following consultation were modelled using logistic regression. National Health Service (NHS) Payment by Results tariffs and Defence capitation data were used to assess the financial impact of the service. Results: Eight hundred and sixteen new referrals (94.5% male, median age 45 years (range 19–75)) were received and 1025 consultations performed. Cardiovascular disease was the commonest reason for referral. CAMS clinical activity cost at NHS tariff was £453 310 representing a saving of £316 173 (£137 137 delivery cost). In total, 310/816 (38%) patients had employment restrictions on referral and 49.0% of this group returned to full employment following their initial consultation. Compared with cardiology, general medicine and respiratory patients were more likely to have been occupationally restricted prior to referral (50 vs. 35%, OR 1.81; 95% CI 1.18–2.76, P values=0.006 and 53 vs. 35%, OR 2.12; 95% CI 1.15–3.90, P values = 0.016, respectively). Overall 581/816 (71.2%) of patients returned to unrestricted employment while 98/816 (12.0%) were unable to continue in any aircrew role. The service saved 7000 lost working days per year at an estimated occupational saving of ∼£1 million per annum. Conclusions: This bespoke service has allowed rapid, occupationally relevant clinical care to be delivered with both time and financial savings. The model may have significant occupational and financial relevance for other environmental and occupational medical organizations. PMID:26424788

  17. The etiology of short stature affects the clinical outcome of lower limb lengthening using external fixation

    PubMed Central

    2014-01-01

    Background and purpose Distraction osteogenesis (DO) has been used to gain height in short statured individuals. However, there have been no studies comparing the clinical outcome of limb lengthening based on the etiology of the short stature. We assessed whether different underlying diagnoses are associated with varied clinical outcomes in these patients. Methods We performed a systematic review of the literature pertaining to lower limb lengthening using external fixation for short stature. Clinical outcomes including amount of lengthening, healing index (HI), and complications based on the underlying diagnosis for the short stature were documented. Results 18 clinical studies were included, with 547 patients who underwent 1,581 lower limb segment lengthening procedures. Mean follow-up was 4.3 years. The average age at lengthening was less for individuals with achondroplasia/hypochondroplasia (A/H) (14.5 years) than for those with Turner’s syndrome (TS) (18.2 years) or with constitutional short stature (CSS) (21.7 years). Mean height gained was greater in patients with A/H (9.5 cm) than in those with TS (7.7 cm) or CSS (6.1 cm) group. The HI was better in A/H (30.8 days/cm) and CSS (32 days/cm) than in TS (45.1 days/cm). The reported complication rate per segment was lower for A/H (0.68) and TS (0.71) than for CSS (1.06). Interpretation Patients with A/H tolerated larger amounts of lengthening with fewer complications than those with other diagnoses. PMID:24650027

  18. RASCH ANALYSIS OF CLINICAL OUTCOME MEASURES IN SPINAL MUSCULAR ATROPHY

    PubMed Central

    CANO, STEFAN J.; MAYHEW, ANNA; GLANZMAN, ALLAN M.; KROSSCHELL, KRISTIN J.; SWOBODA, KATHRYN J.; MAIN, MARION; STEFFENSEN, BIRGIT F.; BÉRARD, CAROLE; GIRARDOT, FRANÇOISE; PAYAN, CHRISTINE A.M.; MERCURI, EUGENIO; MAZZONE, ELENA; ELSHEIKH, BAKRI; FLORENCE, JULAINE; HYNAN, LINDA S.; IANNACCONE, SUSAN T.; NELSON, LESLIE L.; PANDYA, SHREE; ROSE, MICHAEL; SCOTT, CHARLES; SADJADI, REZA; YORE, MACKENSIE A.; JOYCE, CYNTHIA; KISSEL, JOHN T.

    2015-01-01

    Introduction Trial design for SMA depends on meaningful rating scales to assess outcomes. In this study Rasch methodology was applied to 9 motor scales in spinal muscular atrophy (SMA). Methods Data from all 3 SMA types were provided by research groups for 9 commonly used scales. Rasch methodology assessed the ordering of response option thresholds, tests of fit, spread of item locations, residual correlations, and person separation index. Results Each scale had good reliability. However, several issues impacting scale validity were identified, including the extent that items defined clinically meaningful constructs and how well each scale measured performance across the SMA spectrum. Conclusions The sensitivity and potential utility of each SMA scale as outcome measures for trials could be improved by establishing clear definitions of what is measured, reconsidering items that misfit and items whose response categories have reversed thresholds, and adding new items at the extremes of scale ranges. PMID:23836324

  19. Rasch analysis of clinical outcome measures in spinal muscular atrophy.

    PubMed

    Cano, Stefan J; Mayhew, Anna; Glanzman, Allan M; Krosschell, Kristin J; Swoboda, Kathryn J; Main, Marion; Steffensen, Birgit F; Bérard, Carole; Girardot, Françoise; Payan, Christine A M; Mercuri, Eugenio; Mazzone, Elena; Elsheikh, Bakri; Florence, Julaine; Hynan, Linda S; Iannaccone, Susan T; Nelson, Leslie L; Pandya, Shree; Rose, Michael; Scott, Charles; Sadjadi, Reza; Yore, Mackensie A; Joyce, Cynthia; Kissel, John T

    2014-03-01

    Trial design for SMA depends on meaningful rating scales to assess outcomes. In this study Rasch methodology was applied to 9 motor scales in spinal muscular atrophy (SMA). Data from all 3 SMA types were provided by research groups for 9 commonly used scales. Rasch methodology assessed the ordering of response option thresholds, tests of fit, spread of item locations, residual correlations, and person separation index. Each scale had good reliability. However, several issues impacting scale validity were identified, including the extent that items defined clinically meaningful constructs and how well each scale measured performance across the SMA spectrum. The sensitivity and potential utility of each SMA scale as outcome measures for trials could be improved by establishing clear definitions of what is measured, reconsidering items that misfit and items whose response categories have reversed thresholds, and adding new items at the extremes of scale ranges. Copyright © 2013 Wiley Periodicals, Inc.

  20. Spontaneous Primary Intraventricular Hemorrhage: Clinical Features and Early Outcome

    PubMed Central

    Arboix, Adrià; García-Eroles, Luis; Vicens, Adela; Oliveres, Montserrat; Massons, Joan

    2012-01-01

    Purpose. Primary hemorrhage in the ventricular system without a recognizable parenchymal component is very rare. This single-center retrospective study aimed to further characterize the clinical characteristics and early outcome of this stroke subtype. Methods. All patients with primary intraventricular hemorrhage included in a prospective hospital-based stroke registry over a 19-year period were assessed. A standardized protocol with 161 items, including demographics, risk factors, clinical data, neuroimaging findings, and outcome, was used for data collection. A comparison was made between the groups of primary intraventricular hemorrhage and subcortical intracerebral hemorrhage. Predictors of primary intraventricular hemorrhage were identified by logistic regression analysis. Results. There were 12 patients with primary intraventricular hemorrhage (0.31% of all cases of stroke included in the database) and 133 in the cohort of subcortical hemorrhage. Very old age (≥85 years) (odds ratio (OR) 9.89), atrial fibrillation (OR 8.92), headache (OR 6.89), and altered consciousness (OR 4.36) were independent predictors of intraventricular hemorrhage. The overall in-hospital mortality rate was 41.7% (5/12) but increased to 60% (3/5) in patients aged 85 years or older. Conclusion. Although primary intraventricular hemorrhage is uncommon, it is a severe clinical condition with a high early mortality. The prognosis is particularly poor in very old patients. PMID:22966468

  1. Tuberculous spondylodiscitis: epidemiology, clinical features, treatment, and outcome.

    PubMed

    Trecarichi, E M; Di Meco, E; Mazzotta, V; Fantoni, M

    2012-04-01

    Tuberculous spondylodiscitis (TS) is a rare but serious clinical condition which may lead to severe deformity and early or late neurological complications. To discuss certain aspects of the approach to TSs, focusing upon epidemiology, diagnosis, and treatment outcome. For the purpose of this review, a literature search was performed using the Pubmed database through to 19th October 2011 to identify studies published in the last 20 years, concerned in epidemiological, clinical, diagnostic, and therapeutical aspects of TS in adults. Only studies drafted in English language and reporting case series of more than 20 patients have been included. TS has been reported to accounts for 1-5% of all TB cases, and for about 50% of the cases of articulo-skeletal TB infections. Despite the actual availability of more effective diagnostic tools, early recognition of TS remains difficult and a high index of suspicion is needed due to the chronic nature of the disease and its insidious and variable clinical presentation. A prompt diagnosis is required to improve long term outcome, and a microbiological confirmation is recommended to enable appropriate choice of anti-mycobacterial agents. Surgery has an important role in alleviating pain, correcting deformities and neurological impairment, and restoring function. Further studies are required to assess the appropriate duration of anti-microbial treatment, also in regarding of a combined surgical approach.

  2. Clinical symptoms and microbiological outcomes in tuberculosis treatment trials.

    PubMed

    Bark, C M; Dietze, R; Okwera, A; Quelapio, M I; Thiel, B A; Johnson, J L

    2011-11-01

    During a recent Food and Drug Administration workshop on clinical trials to evaluate new TB drugs, questions were raised regarding the use of bacteriologic endpoints such as treatment failure and relapse as measures of improvement in health status and long term outcome after treatment. FDA scientists asked how patients' clinical signs and symptoms changed during therapy, noting that while such information is usually collected during clinical trials, it is not often reported. We analyzed data from an international phase 3 TB treatment trial that included systematic assessments of symptoms. The percentage of subjects with self-reported symptoms at baseline ranged from 30% for dyspnea to 81% for cough, with 51% reporting fever. During therapy, fever, sweats, and dyspnea decreased most rapidly, with near resolution by the end of therapy. Chest pain and cough resolved more slowly; 13% of subjects reported cough at six months. Symptom resolution during treatment did not differ between those who relapsed and those who did not. Among those with microbiological relapse, symptoms returned with significant increases in the proportion with fever, cough, and chest pain. At the time of relapse, cough was the most frequent symptom, occurring in 75% of subjects who relapsed but only 12% of those who did not. Our data support the continued use of bacteriologic endpoints based on sputum culture as surrogate measures of the relief of symptoms, improvement in health status and favorable long term treatment outcome in TB drug trials. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. Enrollment in clinical cancer trials: how are we doing and what are the obstacles to improving enrollment rates? A 2-year retrospective review of pediatric cancer trial enrollment in New Zealand.

    PubMed

    Dodgshun, Andrew J; De Silva, Mandy P; Bradbeer, Peter; Cross, Siobhan

    2014-11-01

    Clinical trials contribute to the establishment of the best therapy for children with cancer. This study looks at rates of enrollment in therapeutic clinical trials over a 2-year period in New Zealand and examines the reasons for nonenrollment. All new diagnoses of cancer in children aged 16 or younger over the period of 1 January, 2009 to 31 December, 2010 were identified through the New Zealand Child Cancer Registry. Clinical trial enrollment status was identified from the medical records. For those not enrolled, the reason for nonenrollment was ascertained. A total of 28% of children diagnosed with cancer who received chemotherapy with curative intent in this time period were enrolled on clinical trials. The 2 most common reasons for nonenrollment in this study were that no study was open locally in which to enroll children (27%) or that previously open-clinical trials were closed to accrual at the time of the child's diagnosis (20%). In New Zealand, enrollment rates on clinical trials for children with cancer are lower than expected.

  4. A clinical risk score of myocardial fibrosis predicts adverse outcomes in aortic stenosis

    PubMed Central

    Chin, Calvin W.L.; Messika-Zeitoun, David; Shah, Anoop S.V.; Lefevre, Guillaume; Bailleul, Sophie; Yeung, Emily N.W.; Koo, Maria; Mirsadraee, Saeed; Mathieu, Tiffany; Semple, Scott I.; Mills, Nicholas L.; Vahanian, Alec; Newby, David E.; Dweck, Marc R.

    2016-01-01

    Aims Midwall myocardial fibrosis on cardiovascular magnetic resonance (CMR) is a marker of early ventricular decompensation and adverse outcomes in aortic stenosis (AS). We aimed to develop and validate a novel clinical score using variables associated with midwall fibrosis. Methods and results One hundred forty-seven patients (peak aortic velocity (Vmax) 3.9 [3.2,4.4] m/s) underwent CMR to determine midwall fibrosis (CMR cohort). Routine clinical variables that demonstrated significant association with midwall fibrosis were included in a multivariate logistic score. We validated the prognostic value of the score in two separate outcome cohorts of asymptomatic patients (internal: n = 127, follow-up 10.3 [5.7,11.2] years; external: n = 289, follow-up 2.6 [1.6,4.5] years). Primary outcome was a composite of AS-related events (cardiovascular death, heart failure, and new angina, dyspnoea, or syncope). The final score consisted of age, sex, Vmax, high-sensitivity troponin I concentration, and electrocardiographic strain pattern [c-statistic 0.85 (95% confidence interval 0.78–0.91), P < 0.001; Hosmer–Lemeshow χ2 = 7.33, P = 0.50]. Patients in the outcome cohorts were classified according to the sensitivity and specificity of this score (both at 98%): low risk (probability score <7%), intermediate risk (7–57%), and high risk (>57%). In the internal outcome cohort, AS-related event rates were >10-fold higher in high-risk patients compared with those at low risk (23.9 vs. 2.1 events/100 patient-years, respectively; log rank P < 0.001). Similar findings were observed in the external outcome cohort (31.6 vs. 4.6 events/100 patient-years, respectively; log rank P < 0.001). Conclusion We propose a clinical score that predicts adverse outcomes in asymptomatic AS patients and potentially identifies high-risk patients who may benefit from early valve replacement. PMID:26491110

  5. Outcome reporting among drug trials registered in ClinicalTrials.gov.

    PubMed

    Bourgeois, Florence T; Murthy, Srinivas; Mandl, Kenneth D

    2010-08-03

    to 56.2% among nonprofit or nonfederal organization-funded trials without industry contributions (P = 0.005 across groups). The publication status of a trial could not always be confirmed, which could result in misclassification. Additional information on study protocols and comprehensive trial results were not available to further explore underlying factors for the association between funding source and outcome reporting. In this sample of registered drug trials, those funded by industry were less likely to be published within 2 years of study completion and were more likely to report positive outcomes than were trials funded by other sources. National Library of Medicine and National Institute of Child Health and Human Development, National Institutes of Health.

  6. Clinical Outcomes of Anatomical Total Shoulder Arthroplasty in a Young, Active Population.

    PubMed

    Kusnezov, Nicholas; Dunn, John C; Parada, Stephen A; Kilcoyne, Kelly; Waterman, Brian R

    2016-01-01

    Glenohumeral arthritis in young, active patients poses many treatment challenges, and significant concerns about component loosening and failure limit the available surgical options. We conducted a study of the clinical outcomes of total shoulder arthroplasty (TSA) for glenohumeral arthritis in a young, high-demand population. We searched the Military Health System Management Analysis and Reporting Tool database to retrospectively review the cases of all US military service members who had undergone anatomical TSA (Current Procedural Terminology code 23472) between 2007 and 2014. Demographic information, occupational parameters, and clinical outcomes were extracted from electronic medical records. Twenty-four service members (26 shoulders) met the inclusion criteria. The cohort was predominantly male (n = 25). Mean age was 45.8 years (range, 35-54 years). The most common etiology of glenohumeral arthritis was post-instability arthropathy (50.0%). At mean follow-up of 41 months, 9 patients had a total of 12 complications (46.2%), including 6 component failures caused by neurologic injury (2 cases), adhesive capsulitis (2), and venous thrombosis (2). The reoperation rate for all component failures was 23.1% (6 cases, 5 patients). Ten patients (41.7%) remained on active duty at 2 years, and 5 (20.8%) were subsequently deployed. Ultimately, 9 patients (37.5%) underwent medical discharge for persistent shoulder disability. TSA in young, active patients provides reliable improvements in range of motion and pain. However, roughly one-third of patients in this study were unable to continue high-demand activities by 2 years after surgery. The short-term complication profile (46.2%) and reoperation rate for component failure (23.1%) should be emphasized during preoperative counseling.

  7. Treatment of chronic stuttering: outcomes from a student training clinic.

    PubMed

    Block, Susan; Onslow, Mark; Packman, Ann; Gray, Belinda; Dacakis, Georgia

    2005-01-01

    It has been suggested that one way to increase speech pathologists' confidence in working with people who stutter is to provide them with relevant and stimulating clinical experiences during their professional preparation. This paper describes a treatment programme for adults who stutter that is conducted by speech pathology students, under supervision, in an Australian university setting. The aim of the research presented here was to establish speech outcomes for this programme, and to determine whether the programme meets benchmarks set by reports of similar programmes, in addition to providing mentorship for student clinicians. Participants were 78 adults who were treated in one of five consecutive treatment programmes during a 3-year period. The treatment was a traditional intensive speech restructuring treatment known as Smooth Speech, conducted over a 5-day period. Speech assessments were conducted 1 week and 1 day before the start of the treatment programme. Post-treatment assessments were conducted immediately following the intensive component of the programme, and 3 months, 12 months and 3.5-5 years post-treatment. The student clinic treatment model in this report produced objective speech data for more subjects in one outcome study than has ever been reported before. Data for 87% (68/78) of participants were available at 3.5-5-year follow-up. Results showed that outcomes for stuttering, speech naturalness, and client self-reports were all comparable with existing reports of similar programmes. The present results were attained with a student/supervisor ratio of around 8:1. We conclude that a clinician-supervised student clinic has the potential to supply services for those with chronic stuttering, as well as providing effective clinical education for student clinicians during their professional preparation. The student clinic treatment model produced varied, objective speech data for more subjects than has ever been reported before in one study. The

  8. The clinical outcomes of chronic hepatitis C in South Korea

    PubMed Central

    Ok, Kyeong Sam; Jeong, Sook-Hyang; Jang, Eun Sun; Kim, Young Seok; Lee, Youn Jae; Kim, In Hee; Cho, Sung Bum; Bae, Si Hyun; Lee, Han Chu

    2016-01-01

    Abstract This prospective cohort study aimed to elucidate the clinical outcome and its related factors of chronic hepatitis C in a hepatitis B-dominant Asian region. From January 2007 to October 2012, 382 patients with chronic hepatitis C without liver cirrhosis were prospectively enrolled at 6 university hospitals, and regularly followed until Apr 2014 to identify the development of liver cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC), and overall survival. During the median follow-up of 39.0 months (range 18.0–81.0 months), liver cirrhosis, hepatic decompensation, and HCC developed in 42 patients (11.0%), 4 patients (1.0%), and 12 patients (3.1%), respectively. The cumulative probability of development of cirrhosis at 3 years and at 5 years was 9.6% and 16.7%, respectively. That of HCC at 3 and 5 years was 1.6% and 4.5%, respectively. The 3-year and 5-year overall survival rate was 99.7% and 96.0%, respectively. Pegylated interferon-based antiviral therapy was undertaken in 237 patients (62.0%) with a sustained virologic response (SVR) rate of 74.3%. The factors related to the overall clinical outcomes were age ≥55 years (HR 2.924, P = 0.016), platelet counts <150  × 109/L (HR 3.195, P = 0.007), and the achievement of SVR (HR 0.254, P = 0.002). The clinical outcomes of this Korean chronic hepatitis C cohort were modest with minimal mortality, but significant disease progression occurred in the patients with old age, low platelet, and non-SVR after interferon-based antiviral treatment or no treatment, suggesting priority for direct acting antiviral therapy. PMID:27583874

  9. Clinical and functional outcomes after augmented hip abductor tendon repair.

    PubMed

    Ebert, Jay R; Bucher, Thomas A; Mullan, Conor J; Janes, Gregory C

    2017-09-21

    Hip abductor tendon (HAT) tearing is commonly implicated in greater trochanteric pain syndrome. Surgical studies are often reported in small cohorts and with limited information on functional improvement. This study reports the clinical and functional outcomes after HAT repair. 112 patients with symptomatic HAT tears, diagnosed via magnetic resonance imaging, underwent open bursectomy, V-Y lengthening of the iliotibial band, debridement of the diseased tendon, decortication of the trochanteric foot-plate and reattachment of the tendon with suture anchors, augmented with a LARS ligament through a trans-osseous tunnel. Patients were evaluated pre-surgery and at 3, 6 and 12 months post-surgery using the Harris (HHS) and Oxford (OHS) Hip Scores, SF-12, hip range of motion, 6-minute walk and 30-second single leg stance tests. Maximal isometric hip abduction strength (HAS) was assessed and limb symmetry indices (LSIs) were calculated between the operated and non-operated limbs. Patient satisfaction and perceived global rating of change (GRC) was evaluated. Analysis of variance evaluated improvement over time. There was a significant improvement (p<0.05) in all clinical and functional measures. HAS significantly improved over time (p<0.002) and all LSIs were >85% at 12 months. At 12 months, a mean GRC score of 3.5 (range -1 to 5) was reported, while 96% of patients were satisfied with their surgical outcome. There was a 2.7% (n = 3) failure rate at 12 months. HAT reconstruction, augmented with a synthetic ligament, demonstrated significantly improved clinical and functional outcomes, high levels of patient satisfaction and a low failure rate to 12 months post-surgery.

  10. Outcomes of videotape instruction in clinic waiting area.

    PubMed

    Oermann, Marilyn H; Webb, Sue A; Ashare, Jo Ann

    2003-01-01

    The purpose of our study was to examine the effectiveness of general health-promotion teaching for patients in the waiting room of a clinic, using focused videotape instruction. An experimental design was used. Subjects were patients (N = 215) in the waiting rooms of clinics in a university medical center in the Midwest. Patients were randomly assigned to two groups: focused videotape instruction in the clinic (n = 106) and control (no instruction in the clinic waiting area) (n = 109). The outcome measures included patient learning about a health education topic and patient satisfaction with overall care, explanations by the provider, and education received during the clinic visit. There was a significant gain in knowledge for patients who viewed the videotape in the waiting room (t = 5.43, df = 213, p < .0001), and they were more satisfied with their education compared with the control group (t = 4.73, df = 213, p < .0001). This study supports focused video instruction as an effective and efficient teaching intervention for disseminating health information in the waiting area.

  11. Anesthesia clinical performance outcomes: does teaching method make a difference?

    PubMed

    McLain, Nina E; Biddle, Chuck; Cotter, J James

    2012-08-01

    The purpose of this study was to compare traditional methods of instruction to the use of audiovisual patient safety vignettes in terms of their impact on student registered nurse anesthetists' recall and subsequent clinical performance. These vignettes used simulated, crisis-oriented anesthetic events known to be associated with catastrophic patient outcomes. Using a randomized controlled crossover trial, 24 student registered nurse anesthetists encountered either a malfunctioning suction device vignette or a stuck expiratory unidirectional valve vignette. Recall and clinical performances were measured after exposure to a lecture and written case studies or to lecture and patient safety vignettes. Of the 24 students, 23 were able to recognize the malfunctioning components and take corrective action. In this research study, memory and clinical performance were significantly affected when the anesthesia provider incorporated the correct anesthesia apparatus checkout process and crisis management skills into practice. This research demonstrated that under the conditions of this study, teaching methods had an impact on some areas of clinical performance. In this study, crisis-oriented, anesthesia patient safety vignettes had the potential to affect recall and clinical performance in a simulated environment.

  12. Comparing Clinical Outcomes of a Pharmacist-Managed Diabetes Clinic to Usual Physician-Based Care.

    PubMed

    Schultz, Jordan L; Horner, Kathleen E; McDanel, Deanna L; Miller, Michelle L; Beranek, Randi L; Jacobsen, Ryan B; Sly, Nichole J; Miller, Aaron C; Mascardo, Lisa A

    2017-01-01

    This study analyzed the impact of a pharmacist-managed diabetes clinic on clinical outcomes compared to usual care received from primary care providers (PCPs). This comparison may more definitively demonstrate the value of pharmacist management of chronic disease states. Retrospective observational cohort study conducted in patients referred to a pharmacist-managed pharmacotherapy (PT) clinic from July 2009 to October 2014. For the primary outcome, the absolute change in A1c during the usual care phase was +1.53% (95% confidence interval [CI]: 1.10-1.96, P < .0001) versus an absolute change of -1.63% (95% CI: -1.28 to -1.97, P < .0001) in the intervention phase. For secondary outcomes, diabetes-related hospitalizations (10 vs 6, P = .104) and emergency room (ER) visits (27 vs 8, P = .049) decreased in the intervention phase compared to the usual care phase. The rate of diabetes-related interventions made per patient per year in the usual care phase was 2.7 versus 11.1 in the intervention phase ( P < .0001). Patients referred to the PT clinic had worsening blood glucose control prior to referral, and their control improved after referral to the clinic. Furthermore, there was an improvement in all diabetes-related outcomes in the intervention phase compared to the usual care phase.

  13. Malnutrition Predicts Clinical Outcome in Patients with Neuroendocrine Neoplasia.

    PubMed

    Maasberg, Sebastian; Knappe-Drzikova, Barbora; Vonderbeck, Dorothée; Jann, Henning; Weylandt, Karsten H; Grieser, Christian; Pascher, Andreas; Schefold, Jörg C; Pavel, Marianne; Wiedenmann, Bertram; Sturm, Andreas; Pape, Ulrich-Frank

    2017-01-01

    Malnutrition is a common problem in oncological diseases, influencing treatment outcomes, treatment complications, quality of life and survival. The potential role of malnutrition has not yet been studied systematically in neuroendocrine neoplasms (NEN), which, due to their growing prevalence and additional therapeutic options, provide an increasing clinical challenge to diagnosis and management. The aim of this cross-sectional observational study, which included a long-term follow-up, was therefore to define the prevalence of malnutrition in 203 patients with NEN using various methodological approaches, and to analyse the short- and long-term outcome of malnourished patients. A detailed subgroup analysis was also performed to define risk factors for poorer outcome. When applying malnutrition screening scores, 21-25% of the NEN patients were at risk of or demonstrated manifest malnutrition. This was confirmed by anthropometric measurements, by determination of serum surrogate parameters such as albumin as well as by bioelectrical impedance analysis (BIA), particularly phase angle α. The length of hospital stay was significantly longer in malnourished NEN patients, while long-term overall survival was highly significantly reduced. Patients with high-grade (G3) neuroendocrine carcinomas, progressive disease and undergoing chemotherapy were at particular risk of malnutrition associated with a poorer outcome. Multivariate analysis confirmed the important and highly significant role of malnutrition as an independent prognostic factor for NEN besides proliferative capacity (G3 NEC). Malnutrition is therefore an underrecognized problem in NEN patients which should systematically be diagnosed by widely available standard methods such as Nutritional Risk Screening (NRS), serum albumin assessment and BIA, and treated to improve both short- and long-term outcomes. © 2015 S. Karger AG, Basel.

  14. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    PubMed

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  15. Clinical outcomes of management of myofacial pain dysfunction syndrome.

    PubMed

    Khatun, S; Huq, M Z; Islam, M A; Uddin, M W; Asaduzzaman, M; Hossain, M M

    2012-04-01

    The purpose of the present study was to investigate two years clinical outcome of patients having myofacial pain dysfunction syndrome (MPDS). A total of 50 patients (male: 15, Female: 35, age: raged from 20 to 65 years) were included for this study. Clinical diagnosis for the assessment of anxiety and depression of each patient was performed by Hospital anxiety and depression (HAD) scale. Patients were then received either one of the following treatments: Occlusion correction only (n=14), Muscle Relaxant + anti-depressant drug (n=26), Physiotherapy + antidepressant drug + muscle relaxant (n=6) and Appliance + muscle relaxant (n= 4). Following two years observation, it was revealed that the treatment was apparently successful in 95% case; only 5% case was not successful due to their irregular visit. It can be concluded that MPDS is not primarily related to occlusal factors and a complex psycho physiological mechanism is involved in this type of pain problems.

  16. Clinical Outcomes of Daptomycin for Vancomycin-resistant Enterococcus Bacteremia.

    PubMed

    Moise, Pamela A; Sakoulas, George; McKinnell, James A; Lamp, Kenneth C; DePestel, Daryl D; Yoon, Min J; Reyes, Katherine; Zervos, Marcus J

    2015-07-01

    In light of recent evidence suggesting enhancement of daptomycin activity against vancomycin-resistant Enterococcus (VRE) by ampicillin and other β-lactam antibiotics, we evaluated the safety profile and clinical efficacy of daptomycin with and without concomitant β-lactam antimicrobials in the treatment of VRE (faecium or faecalis) bacteremia from multiple centers across the United States. Data were collected retrospectively as part of a larger multicenter registry (The Cubicin Outcomes Registry and Experience). Efficacy and clinical outcomes in patients with VRE bacteremia who received at least 3 days of daptomycin with or without concomitant β-lactams were analyzed. Although all the cases involved daptomycin-susceptible VRE, additional analysis was performed to examine whether the adjunctive β-lactam would play a more pivotal role in cases where the daptomycin MIC was in the upper limit of the susceptibility range, indicating that daptomycin monotherapy efficacy may be relatively compromised compared with cases with lower daptomycin MICs. Two hundred sixty-two patients from 33 hospitals were evaluated. Most patients had at least one significant comorbidity, such as solid-organ or bone marrow transplantation (16%), neutropenia (36%), dialysis dependency (20%), or critical illness (36%) requiring care in an intensive care unit. Overall treatment success was 86% (n = 225/262), and treatment success for patients taking concomitant β-lactams was 86% (n = 105/122). Logistic regression identified treatment failure to be associated with sepsis (odds ratio = 3.42; P = 0.009) and an elevated daptomycin MIC (3-4 µg/mL) (odds ratio = 3.23, P = 0.013). No significant increase in clinical failure was seen among patients with elevated daptomycin MIC who received concomitant β-lactam therapy (clinical success, 88% vs 79% for MIC ≤2 vs 3-4 µg/mL, respectively; P = 0.417). Of 262 patients, 33 (13%) experienced ≥1 adverse event possibly related to daptomycin (increased

  17. CLINICAL OUTCOME AFTER INFECTED TOTAL KNEE AND TOTAL HIP ARTHROPLASTY

    PubMed Central

    Mittag, Falk; Leichtle, Carmen Ina; Schlumberger, Michael; Leichtle, Ulf Gunther; Wünschel, Markus

    2016-01-01

    ABSTRACT Objective: Infection after total hip (THA) and knee arthroplasty (TKA) is a serious complication which typically leads to a long lasting and intensive surgical and medicamentous treatment. The aim of this study was to identify factors that influence outcome after revision surgery caused by prosthetic infection. Methods: We retrospectively analyzed 64 patients who had revision surgery between 1989 and 2009 due to periprosthetic infection. We examined a total of 69 joints (TKA: 36%, THA: 64%), follow-up 5.1 years (0.5-21 years) after the initial surgical intervention. The mean patient age at time of surgery was 67 years old (43-79 years old). Clinical data and scores including the Western Ontario and McMaster Universities (WOMAC)-Index, the Harris Hip Score (HHS) and the Hospital for Special Surgery Score (HSS) were surveyed. Results: There was no difference in clinical scores regarding treatment between a single and a multiple stage treatment regime. Infections with multiple microorganisms and Enterococcus spp. lead to a significantly higher number of interventions. Using a modified Tsukayama system we classified 24% as type I, 34% type II and 42% type III- infections, with no differences in clinical outcome. Overweight patients had a significantly lower HHS and WOMAC-score. Immunosuppression leads to a worse WOMAC and HSS-Score. An increased number of procedures was associated to a limping gait. Conclusion: Thorough surgical technique leads to good clinical results independent of infection-type and treatment philosophy. Level of Evidence III, Case Control Study. PMID:26997914

  18. Atrial flutter – clinical risk factors and adverse outcomes in the Framingham Heart Study

    PubMed Central

    Rahman, Faisal; Wang, Na; Yin, Xiaoyan; Ellinor, Patrick T.; Lubitz, Steven A.; LeLorier, Paul A.; McManus, David D.; Sullivan, Lisa M.; Seshadri, Sudha; Vasan, Ramachandran S.; Benjamin, Emelia J.; Magnani, Jared W.

    2015-01-01

    Background Few epidemiological cohort studies have evaluated atrial flutter (flutter) as an arrhythmia distinct from atrial fibrillation (AF). Objective To examine the clinical correlates of flutter and its associated outcomes to distinguish them from those associated with AF in the Framingham Heart Study. Methods We reviewed and adjudicated electrocardiograms previously classified as flutter or AF/flutter and another 100 electrocardiograms randomly selected from AF cases. We examined the clinical correlates of flutter by matching up to 5 AF and 5 referents to each flutter case using a nested case-referent design. We determined the 10-year outcomes associated with flutter with Cox models. Results During mean follow-up of 33.0±12.2 years, 112 participants (mean age 72±10 years, 30% women) developed flutter. In multivariable analyses, smoking (odds ratio [OR] 2.84; 95% confidence interval [CI], 1.54 to 5.23), increased PR interval (OR 1.28 per SD; 95% CI, 1.03 to 1.60), myocardial infarction (OR 2.25; 95% CI, 1.05 to 4.80) and heart failure (OR 5.22; 95% CI, 1.26 to 21.64) were associated with incident flutter. In age- and sex-adjusted models, flutter (vs. referents) was associated with 10-year increased risk of AF (hazard ratio [HR] 5.01; 95% CI, 3.14 to 7.99), myocardial infarction (HR 3.05; 95% CI, 1.42 to 6.59), heart failure (HR 4.14; 95% CI, 1.90 to 8.99), stroke (HR 2.17; 95% CI, 1.13 to 4.17), and mortality (HR 2.00; 95% CI, 1.44 to 2.79). Conclusions We identified the clinical correlates associated with flutter and observed that flutter was associated with multiple adverse outcomes. PMID:26226213

  19. Atrial flutter: Clinical risk factors and adverse outcomes in the Framingham Heart Study.

    PubMed

    Rahman, Faisal; Wang, Na; Yin, Xiaoyan; Ellinor, Patrick T; Lubitz, Steven A; LeLorier, Paul A; McManus, David D; Sullivan, Lisa M; Seshadri, Sudha; Vasan, Ramachandran S; Benjamin, Emelia J; Magnani, Jared W

    2016-01-01

    Few epidemiologic cohort studies have evaluated atrial flutter (flutter) as an arrhythmia distinct from atrial fibrillation (AF). The purpose of this study was to examine the clinical correlates of flutter and its associated outcomes to distinguish them from those associated with AF in the Framingham Heart Study. We reviewed and adjudicated electrocardiograms (ECGs) previously classified as flutter or AF/flutter and another 100 ECGs randomly selected from AF cases. We examined the clinical correlates of flutter by matching up to 5 AF and 5 referents to each flutter case using a nested case referent design. We determined the 10-year outcomes associated with flutter with Cox models. During mean follow-up of 33.0 ± 12.2 years, 112 participants (mean age 72 ± 10 years, 30% women) developed flutter. In multivariable analyses, smoking (odds ratio [OR] 2.84, 95% confidence interval [CI] 1.54-5.23), increased PR interval (OR 1.28 per SD, 95% CI 1.03-1.60), myocardial infarction (OR 2.25, 95% CI 1.05-4.80) and heart failure (OR 5.22, 95% CI 1.26-21.64) were associated with incident flutter. In age- and sex-adjusted models, flutter (vs referents) was associated with 10-year increased risk of AF (hazard ratio [HR] 5.01, 95% CI 3.14-7.99), myocardial infarction (HR 3.05, 95% CI 1.42-6.59), heart failure (HR 4.14, 95% CI 1.90-8.99), stroke (HR 2.17, 95% CI 1.13-4.17), and mortality (HR 2.00, 95% CI 1.44-2.79). We identified the clinical correlates associated with flutter and observed that flutter was associated with multiple adverse outcomes. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  20. Clinical outcome of relapsing remitting multiple sclerosis among Hong Kong Chinese.

    PubMed

    Chan, K H; Tsang, K L; Ho, P W L; Tse, C T; Kwan, J S C; Ho, J W M; Chu, A C Y; Chang, R S K; Ho, S L

    2011-10-01

    Clinical outcome of Chinese relapsing remitting multiple sclerosis (RRMS) patients is uncertain. To study the long-term clinical outcome of Chinese RRMS patients. RRMS patients with duration of 10 years or longer followed up in our hospital is retrospectively studied. 61 RRMS patients (75% female) were studied. Their mean symptom onset age was 25.9 years and mean duration was 20.6 years (range 10-33); 36% patients had received β-interferon and 30% azathioprine. Their mean EDSS scores were 3.3 (range 1-7) and 4.7 (range 1-8) at 10 years and latest follow-up (mean duration 20.6 years) respectively. At 10 years, 30% patients had EDSS score ≤2, 34% EDSS 2.5-3.5, 20% EDSS 4.0-5.5 and 16% ≥6; 18% developed SPMS. At latest follow-up, 15% patients had EDSS ≤2, 20% EDSS 2.5-3.5, 19% EDSS 4.0-5.5 and 46% ≥6.0; 53% developed SPMS. The median time from symptom onset to EDSS 6 was 22 years. No differences were detected in demographic characteristics, presenting neurological features, number of attacks in first 2 years, neuroradiological findings and disease modifying therapies between patients with EDSS <6 and ≥6 at ten years. EDSS scores at 10 years and latest follow-up were similar for patients who had received β-interferon and those who had not. Hong Kong Chinese RRMS patients may have worse long-term clinical outcome than Caucasian patients. Copyright © 2011 Elsevier B.V. All rights reserved.

  1. Clinical and radiological outcomes of two-level endoscopic posterior cervical foraminotomy.

    PubMed

    Youn, Myung Soo; Shon, Myeong Hwan; Seong, Yoon Jae; Shin, Jong Ki; Goh, Tae Sik; Lee, Jung Sub

    2017-03-23

    The efficacy and safety of endoscopic posterior cervical foraminotomy (EPCF) have been demonstrated for single-level cervical radiculopathy, but no report in the medical literature has described the clinical results of two-level EPCF. The aim of this study was to assess the clinical and radiological outcomes of two-level EPCF performed in patients with cervical radiculopathy. Twenty-two consecutive patients (9 females and 13 males) that underwent two-level EPCF with cervical radiculopathy from January 2012 to January 2014 were included in this study. Clinical outcomes were assessed before surgery and at 1, 3, 6, 12, and 24 months postoperatively using visual analogue scale for neck and arm, neck pain and disability scale (NPDS), and neck disability index (NDI) scores. Radiological outcomes were assessed by measuring segmental lordosis (SL), C2-7 lordosis, and disc height index (DHI) before surgery and at 12 and 24 months postoperatively. Mean VAS, NPDS, and NDI scores were significant improved at 1 month postoperatively versus preoperative values and these improvements were maintained at 2 years after surgery. SL and C2-7 lordosis were significantly increased after surgery, and no instability in dynamic view was observed during the 2-year follow-up period. Percentage DHIs of operated discs were also maintained without significant change at 2 years after surgery. One patient suffered from transient motor palsy due to root retraction. Two-level EPCF can be safely preformed and should be considered an alternative to two-level anterior cervical discectomy and fusion or open posterior cervical foraminotomy in selected patients.

  2. Adolescent pregnancy diagnosis and outcomes: a six-year clinical sample.

    PubMed

    Aruda, Mary M; McCabe, Margaret; Litty, Carolyn; Burke, Pamela

    2008-02-01

    To explore pregnancy diagnosis, outcome choice, and time to referral appointment for adolescents. A descriptive study using retrospective chart review and clinical logs of all positive pregnancy tests between January 2000 and December 2005. Adolescent clinic in a hospital-based academic center. 625 pregnant teens were identified. Thirteen teens (2%) were lost to follow-up. Exclusion criteria included teens with advanced pregnancy, 22 weeks gestation or older at initial pregnancy diagnosis (n=11). All pregnant teens participated in a multidisciplinary tracking program. Outcome choice and time interval to prenatal or termination appointment. The 601 pregnant teens had a mean age of 18.2 years with a range of 13 to 23 years. Pregnancy outcomes indicate 48.2% (N=290) opted to continue their pregnancy and entered prenatal care, 45% (N=275) chose to terminate, and 6% (N=36) experienced a miscarriage. Adolescents who continued their pregnancy presented with a mean gestational age of 7.98 weeks versus 7.20 weeks for teens choosing to terminate (P < or = 0.001). They also had a significantly longer time interval to their referral site, averaging 24 days until a prenatal appointment, compared to 17 days for a termination (P < or = 0.05). Over the six-year study period, the number of adolescent pregnancies diagnosed within this clinical site remained constant. Adolescents who chose to continue their pregnancy were more likely to present later for diagnosis and experienced a longer wait time to their referral appointment for prenatal care. Pregnant adolescents may delay entry into timely reproductive health services.