Science.gov

Sample records for cuff disease randomised

  1. Rotator Cuff Disease and Injury--Evaluation and Management.

    ERIC Educational Resources Information Center

    Williams, Randy

    This presentation considers the incidence, evaluation, and management of rotator cuff disease and injury. Pathogenesis, symptoms, physical findings, treatment (therapeutic and surgical), and prevention are discussed. It is noted that rotator cuff problems, common in athletes, are usually related to an error in training or lack of training. They…

  2. Tests for diagnosing subacromial impingement syndrome and rotator cuff disease

    PubMed Central

    2014-01-01

    Clinical examination techniques need to allow the physician to determine the underlying pathology of a patient’s condition with confidence. This review examines the evidence for two common conditions: impingement and rotator cuff disease

  3. Improved apparatus for predictive diagnosis of rotator cuff disease

    NASA Astrophysics Data System (ADS)

    Pillai, Anup; Hall, Brittany N.; Thigpen, Charles A.; Kwartowitz, David M.

    2014-03-01

    Rotator cuff disease impacts over 50% of the population over 60, with reports of incidence being as high as 90% within this population, causing pain and possible loss of function. The rotator cuff is composed of muscles and tendons that work in tandem to support the shoulder. Heavy use of these muscles can lead to rotator cuff tear, with the most common causes is age-related degeneration or sport injuries, both being a function of overuse. Tears ranges in severity from partial thickness tear to total rupture. Diagnostic techniques are based on physical assessment, detailed patient history, and medical imaging; primarily X-ray, MRI and ultrasonography are the chosen modalities for assessment. The final treatment technique and imaging modality; however, is chosen by the clinician is at their discretion. Ultrasound has been shown to have good accuracy for identification and measurement of full-thickness and partial-thickness rotator cuff tears. In this study, we report on the progress and improvement of our method of transduction and analysis of in situ measurement of rotator cuff biomechanics. We have improved the ability of the clinician to apply a uniform force to the underlying musculotendentious tissues while simultaneously obtaining the ultrasound image. This measurement protocol combined with region of interest (ROI) based image processing will help in developing a predictive diagnostic model for treatment of rotator cuff disease and help the clinicians choose the best treatment technique.

  4. A randomised controlled feasibility study investigating the use of eccentric and concentric strengthening exercises in the treatment of rotator cuff tendinopathy

    PubMed Central

    Adams, Nicola

    2014-01-01

    Objectives: To conduct a feasibility study to compare concentric and eccentric rotator cuff strengthening exercises for rotator cuff tendinopathy. Methods: A total of 11 patients with rotator cuff tendinopathy who were on the waiting list for arthroscopic subacromial decompression surgery were randomised to perform eccentric rotator cuff strengthening exercises, concentric strengthening exercises or no exercises. Patients were evaluated in terms of levels of pain and function using the Oxford Shoulder Score and a Visual Analogue Scale initially, at 4 weeks and at 8 weeks. Results: The study design was found to be acceptable to patients and achieved a high level of 86% compliance. The drop-out rate was 0%. Two patients performing eccentric strengthening exercises improved sufficiently to cancel their planned surgery. Conclusion: Further research in this area is recommended. The study design was feasible and power calculations have been conducted to aid future research planning. PMID:26770702

  5. Dynamic Three-Dimensional Shoulder Mri during Active Motion for Investigation of Rotator Cuff Diseases

    PubMed Central

    Tempelaere, Christine; Pierrart, Jérome; Lefèvre-Colau, Marie-Martine; Vuillemin, Valérie; Cuénod, Charles-André; Hansen, Ulrich; Mir, Olivier; Skalli, Wafa; Gregory, Thomas

    2016-01-01

    Background MRI is the standard methodology in diagnosis of rotator cuff diseases. However, many patients continue to have pain despite treatment, and MRI of a static unloaded shoulder seems insufficient for best diagnosis and treatment. This study evaluated if Dynamic MRI provides novel kinematic data that can be used to improve the understanding, diagnosis and best treatment of rotator cuff diseases. Methods Dynamic MRI provided real-time 3D image series and was used to measure changes in the width of subacromial space, superior-inferior translation and anterior-posterior translation of the humeral head relative to the glenoid during active abduction. These measures were investigated for consistency with the rotator cuff diseases classifications from standard MRI. Results The study included: 4 shoulders with massive rotator cuff tears, 5 shoulders with an isolated full-thickness supraspinatus tear, 5 shoulders with tendinopathy and 6 normal shoulders. A change in the width of subacromial space greater than 4mm differentiated between rotator cuff diseases with tendon tears (massive cuff tears and supraspinatus tear) and without tears (tendinopathy) (p = 0.012). The range of the superior-inferior translation was higher in the massive cuff tears group (6.4mm) than in normals (3.4mm) (p = 0.02). The range of the anterior-posterior translation was higher in the massive cuff tears (9.2 mm) and supraspinatus tear (9.3 mm) shoulders compared to normals (3.5mm) and tendinopathy (4.8mm) shoulders (p = 0.05). Conclusion The Dynamic MRI enabled a novel measure; ‘Looseness’, i.e. the translation of the humeral head on the glenoid during an abduction cycle. Looseness was better able at differentiating different forms of rotator cuff disease than a simple static measure of relative glenohumeral position. PMID:27434235

  6. Evidence for an Inherited Predisposition Contributing to the Risk for Rotator Cuff Disease

    PubMed Central

    Tashjian, Robert Z.; Farnham, James M.; Albright, Frederick S.; Teerlink, Craig C.; Cannon-Albright, Lisa A.

    2009-01-01

    Background: A genetic predisposition has been suggested to contribute to the risk for development of rotator cuff disease on the basis of observed family clusters of close relatives. We used a population-based resource combining genealogical data for Utah with clinical diagnosis data from a large Utah hospital to test the hypothesis of excess familial clustering for rotator cuff disease. Methods: The Utah Population Database contains combined health and genealogical data on over two million Utah residents. Current Procedural Terminology, Fourth Revision, codes (29827, 23412, 23410, and 23420) and International Classification of Diseases, Ninth Revision, codes (726.1, 727.61, and 840.4) entered in patient records were used to identify patients with rotator cuff disease. We tested the hypothesis of excess familial clustering using two well-established methods (the Genealogical Index of Familiality test and the estimation of relative risks in relatives) in the overall study group (3091 patients) and a subgroup of the study group diagnosed before the age of forty years (652 patients). Results: The Genealogical Index of Familiality test in patients diagnosed before the age of forty years showed significant excess relatedness for individuals with rotator cuff disease in close and distant relationships (as distant as third cousins) (p = 0.001). The relative risk of rotator cuff disease in the relatives of patients diagnosed before the age of forty years was significantly elevated for second degree (relative risk = 3.66, p = 0.0076) and third degree (relative risk = 1.81, p = 0.0479) relatives. Conclusions: We analyzed a set of patients with diagnosed rotator cuff disease and a known genealogy to describe the familial clustering of affected individuals. The observations of significant excess relatedness of patients and the significantly elevated risks to both close and distant relatives of patients strongly support a heritable predisposition to rotator cuff disease

  7. Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: A protocol for a randomised, double-blind, placebo-controlled trial

    PubMed Central

    Bennell, Kim; Coburn, Sally; Wee, Elin; Green, Sally; Harris, Anthony; Forbes, Andrew; Buchbinder, Rachelle

    2007-01-01

    Background Chronic rotator cuff pathology (CRCP) is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there is little conclusive evidence to support or refute its effectiveness and no formal evaluation of its cost-effectiveness. Methods/Design This randomised, double-blind, placebo-controlled trial will involve 200 participants with CRCP recruited from medical practices, outpatient departments and the community via print and radio media. Participants will be randomly allocated to a physiotherapy or placebo group using concealed allocation stratified by treating physiotherapist. Both groups will receive 10 sessions of individual standardised treatment over 10 weeks from one of 10 project physiotherapists. For the following 12 weeks, the physiotherapy group will continue a home exercise program and the placebo group will receive no treatment. The physiotherapy program will comprise shoulder joint and spinal mobilisation, soft tissue massage, postural taping, and home exercises for scapular control, posture and rotator cuff strengthening. The placebo group will receive inactive ultrasound and gentle application of an inert gel over the shoulder region. Blinded assessment will be conducted at baseline and at 10 weeks and 22 weeks after randomisation. The primary outcome measures are self reported questionnaires including the shoulder pain and disability index (SPADI), average pain on an 11-point numeric rating scale and participant perceived global rating of change. Secondary measures include Medical Outcomes Study 36-item short form (SF-36), Assessment of Quality of Life index, numeric rating scales for shoulder pain and stiffness, participant perceived rating of change for pain, strength and stiffness, and manual muscle testing for shoulder strength using a handheld dynamometer. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log

  8. Towards predictive diagnosis and management of rotator cuff disease: using curvelet transform for edge detection and segmentation of tissue

    NASA Astrophysics Data System (ADS)

    Pai Raikar, Vipul; Kwartowitz, David M.

    2016-04-01

    Degradation and injury of the rotator cuff is one of the most common diseases of the shoulder among the general population. In orthopedic injuries, rotator cuff disease is only second to back pain in terms of overall reduced quality of life for patients. Clinically, this disease is managed via pain and activity assessment and diagnostic imaging using ultrasound and MRI. Ultrasound has been shown to have good accuracy for identification and measurement of rotator cuff tears. In our previous work, we have developed novel, real-time techniques to biomechanically assess the condition of the rotator cuff based on Musculoskeletal Ultrasound. Of the rotator cuff tissues, supraspinatus is the first that sees degradation and is the most commonly affected. In our work, one of the challenges lies in effectively segmenting and characterizing the supraspinatus. We are exploring the possibility of using curvelet transform for improving techniques to segment tissue in ultrasound. Curvelets have been shown to give optimal multi-scale representation of edges in images. They are designed to represent edges and singularities along curves in images which makes them an attractive proposition for use in ultrasound segmentation. In this work, we present a novel approach to the possibility of using curvelet transforms for automatic edge and feature extraction for the supraspinatus.

  9. A randomised controlled trial comparing continuous supraclavicular and interscalene brachial plexus blockade for open rotator cuff surgery.

    PubMed

    Koh, W U; Kim, H J; Park, H S; Choi, W J; Yang, H S; Ro, Y J

    2016-06-01

    Continuous interscalene block is an approved modality for postoperative pain control, but it may cause hemidiaphragmatic paresis. In this study we aimed to determine whether continuous supraclavicular block would provide postoperative analgesia comparable to that of continuous interscalene block and reduce the incidence of hemidiaphragmatic paresis. Patients scheduled for open rotator cuff repair were randomly allocated to receive continuous interscalene (n = 38) or supraclavicular block (n = 37). Both participants and assessing clinicians were blinded to the group allocation. The primary endpoint was the mean pain intensity 24 h after the surgery. Postoperative mean (SD) pain scores at 24 h were similar in the supraclavicular and interscalene groups (2.57 (1.71) vs 2.84 (1.75) respectively; p = 0.478). The incidence of complete or partial hemidiaphragmatic paresis was lower in the supraclavicular group at 1 h after admission to the postanaesthetic care unit and 24 h after the surgery [25 (68%) vs 38 (100%); p = 0.001 and 14 (38%) vs 27 (71%) respectively; p = 0.008]. Continuous supraclavicular block provided comparable analgesia compared with interscalene block with a reduced incidence of complete or partial hemidiaphragmatic paresis for 24 h following surgery. PMID:26954669

  10. Patient Reported Outcomes for Rotator Cuff Disease - Which PRO Should You Use?

    PubMed Central

    Makhni, Eric Chugh; Hamamoto, Jason Taizo; Higgins, John; Patterson, Taylor; Romeo, Anthony A.; Verma, Nikhil N.

    2016-01-01

    Objectives: Patient reported outcomes (PRO) are important clinical and research tools that are utilized by orthopedic surgeons in order to assess health outcomes following treatment. This is particularly so in the setting of rotator cuff pathology, in which several different validated patient reported outcomes exist. However, multiple recent studies have demonstrated a lack of standardization in the utilization of these scores. Moreover, many of these scores contain numerous components, thereby making them difficult to administer in a busy ambulatory setting. The goal of this study was to quantitatively assess the commonly used PRO for rotator cuff disease in order to identify the most efficient and comprehensive ones available for clinicians. Methods: Fifteen different PROs commonly used for rotator cuff pathology were selected for review. These outcome tools were assessed by the study team and reviewed for comprehensiveness with regards to assessment of pain, strength, activity, motion, and quality of life. The comprehensiveness and efficiency of each tool was evaluated by inclusion of questions addressing each domain. PROs were also evaluated with a focus of pain criteria (night pain, baseline/general pain, pain during activities of daily living, pain during sport, and pain during work). Finally, all PROs were assessed with regards to comprehensiveness in assessing activity scores (motion/stiffness, activities of daily living, sport, and work). Comprehensiveness scores were calculated by dividing the number of domains or subdomains present by the total domains or subdomains possible. Efficiency was calculated by dividing the number of domains present by the number of questions contained in each PRO. Results: The UCLA, Western Ontario Rotator Cuff Index (WORC), Disabilities of the Arm, Shoulder, and Hand (DASH), PENN, Shoulder Rating Questionnaire (SRQ), and Korean Shoulder Score (KSS) had an overall comprehensiveness score of 1.00 indicating all domains were

  11. The Role of the Peripheral and Central Nervous Systems in Rotator Cuff Disease

    PubMed Central

    Bachasson, Damien; Singh, Anshuman; Shah, Sameer; Lane, John G.; Ward, Samuel R.

    2015-01-01

    Rotator cuff (RC) disease is an extremely common condition associated with shoulder pain, reduced functional capacities and impaired quality of life. It primarily involves alterations in tendon health and mechanical properties that can ultimately lead to tendon failure. RC tendon tears induce progressive muscular changes that negatively impact surgical reparability of the RC tendons and clinical outcomes. At the same time, a significant base of clinical data suggests a relatively weak relationship between RC integrity and clinical presentation, emphasizing the multifactorial aspects of RC disease. This review aims to summarize the potential contribution of peripheral, spinal and supraspinal neural factors that may: (i) exacerbate structural and functional muscle changes induced by tendon tear, (ii) compromise the reversal of these changes during surgery and rehabilitation, (iii) contribute to pain generation and persistence of pain, iv) impair shoulder function through reduced proprioception, kinematics and muscle recruitment, and iv) help to explain interindividual differences and response to treatment. Given the current clinical and scientific interest in peripheral nerve injury in the context of RC disease and surgery, we carefully reviewed this body of literature with a particular emphasis for suprascapular neuropathy that has generated a large number of studies in the past decade. Within this process, we highlight the gaps in current knowledge and suggest research avenues for scientists and clinicians. PMID:26189809

  12. Effects of therapeutic ultrasound and exercise on pain, function, and isokinetic shoulder rotator strength of patients with rotator cuff disease

    PubMed Central

    Analan, Pınar Doruk; Leblebici, Berrin; Adam, Mehmet

    2015-01-01

    [Purpose] The aim of this prospective, double-blind, randomized, placebo-controlled study was to evaluate the effects of therapeutic continuous ultrasound (US) on patients with rotator cuff disease. [Subjects and Methods] Twenty-two patients were treated with a standard physiotherapy program consisting of a hot-pack, transcutaneous electrical nerve stimulation (TENS), exercises, and US that was supervised by the same physiotherapist. The patients were randomly assigned to either a group that received true US (n=11) or one that received sham US (n=11). [Results] There were significant differences between the pre- and post-intervention UCLA Shoulder Rating Scale and Constant-Murley Shoulder Outcome scores, VAS, and external rotation (ER) peak torque 60°/second values for both the true and sham US groups. However, the between-group differences were not statistically significant. [Conclusion] In patients with rotator cuff disease, physiotherapy interventions effectively treat the pain, improve the clinical status, and increase the muscle strength of the shoulder ER at a low constant angular velocity, with functional improvement being seen immediately after treatment. However, at the end of the intervention, the US had yielded no additional efficacy to the physiotherapy treatment regimen of the patients with rotator cuff disease. PMID:26644656

  13. Maintaining endotracheal tube cuff pressure at 20 mm Hg to prevent dysphagia after anterior cervical spine surgery; protocol of a double-blind randomised controlled trial

    PubMed Central

    2013-01-01

    Background In anterior cervical spine surgery a retractor is obligatory to approach the spine. Previous studies showed an increase of endotracheal tube cuff pressure after placement of a retractor. It is known that high endotracheal tube cuff pressure increases the incidence of postoperative dysphagia, hoarseness, and sore throat. However, until now no evidence supports the fact whether adjusting the endotracheal tube cuff pressure during anterior cervical spine surgery will prevent this comorbidity. We present the design of a randomized controlled trial to determine whether adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery will prevent postoperative dysphagia. Methods/design 177 patients (aged 18–90 years) scheduled for anterior cervical spine surgery on 1 or more levels will be included. After intubation, endotracheal tube cuff pressure is manually inflated to 20 mm Hg in all patients. Patients will be randomized into two groups. In the control group endotracheal tube cuff pressure is not adjusted after retractor placement. In the intervention group endotracheal tube cuff pressure after retractor placement is maintained at 20 mm Hg and air is withdrawn when cuff pressure exceeds 20 mm Hg. Endotracheal tube cuff pressure is measured after intubation, before and after placement and removal of the retractor. Again air is inflated if cuff pressure sets below 20 mmHg after removal of the retractor. The primary outcome measure is postoperative dysphagia. Other outcome measures are postoperative hoarseness, postoperative sore throat, degree of dysphagia, length of hospital stay, and pneumonia. The study is a single centre double blind randomized trial in which patients and research nurses will be kept blinded for the allocated treatment during the follow-up period of 2 months. Discussion Postoperative dysphagia occurs frequently after anterior cervical spine surgery. This may be related to high

  14. A systematic review of the histological and molecular changes in rotator cuff disease

    PubMed Central

    Dean, B. J. F.; Franklin, S. L.; Carr, A. J.

    2012-01-01

    Introduction The pathogenesis of rotator cuff disease (RCD) is complex and not fully understood. This systematic review set out to summarise the histological and molecular changes that occur throughout the spectrum of RCD. Methods We conducted a systematic review of the scientific literature with specific inclusion and exclusion criteria. Results A total of 101 studies met the inclusion criteria: 92 studies used human subjects exclusively, seven used animal overuse models, and the remaining two studies involved both humans and an animal overuse model. A total of 58 studies analysed supraspinatus tendon exclusively, 16 analysed subacromial bursal tissue exclusively, while the other studies analysed other tissue or varying combinations of tissue types including joint fluid and muscle. The molecular biomarkers that were altered in RCD included matrix substances, growth factors, enzymes and other proteins including certain neuropeptides. Conclusions The pathogenesis of RCD is being slowly unravelled as a result of the significant recent advances in molecular medicine. Future research aimed at further unlocking these key molecular processes will be pivotal in developing new surgical interventions both in terms of the diagnosis and treatment of RCD. PMID:23610686

  15. Rotator Cuff Injuries

    MedlinePlus

    ... others can be very painful. Treatment for a torn rotator cuff depends on age, health, how severe ... is, and how long you've had the torn rotator cuff. Treatment for torn rotator cuff includes: ...

  16. Rotator cuff problems

    MedlinePlus

    ... days, such as in painting and carpentry Poor posture over many years Aging Rotator cuff tears TEARS ... also help prevent rotator cuff problems. Practice good posture to keep your rotator cuff tendons and muscles ...

  17. Rotator Cuff Injuries

    MedlinePlus

    ... cuff are common. They include tendinitis, bursitis, and injuries such as tears. Rotator cuff tendons can become ... cuff depends on age, health, how severe the injury is, and how long you've had the ...

  18. Effect of Angiogenesis-Related Cytokines on Rotator Cuff Disease: The Search for Sensitive Biomarkers of Early Tendon Degeneration

    PubMed Central

    Savitskaya, Yulia A.; Izaguirre, Aldo; Sierra, Luis; Perez, Francisco; Cruz, Francisco; Villalobos, Enrique; Almazan, Arturo; Ibarra, Clemente

    2011-01-01

    Background: Hallmarks of the pathogenesis of rotator cuff disease (RCD) include an abnormal immune response, angiogenesis, and altered variables of vascularity. Degenerative changes enhance production of pro-inflammatory, anti-inflammatory, and vascular angiogenesis-related cytokines (ARC) that play a pivotal role in the immune response to arthroscopic surgery and participate in the pathogenesis of RCD. The purpose of this study was to evaluate the ARC profile, ie, interleukin (IL): IL-1β, IL-6, IL-8, IL-10, vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and angiogenin (ANG), in human peripheral blood serum and correlate this with early degenerative changes in patients with RCD. Methods: Blood specimens were obtained from 200 patients with RCD and 200 patients seen in the orthopedic clinic for nonrotator cuff disorders. Angiogenesis imaging assays was performed using power Doppler ultrasound to evaluate variables of vascularity in the rotator cuff tendons. Expression of ARC was measured by commercial Bio-Plex Precision Pro Human Cytokine Assays. Results: Baseline concentrations of IL-1β, IL-8, and VEGF was significantly higher in RCD patients than in controls. Significantly higher serum VEGF levels were found in 85% of patients with RCD, and correlated with advanced stage of disease (r = 0.75; P < 0.0005), average microvascular density (r = 0.68, P < 0.005), and visual analog score (r = 0.75, P < 0.0002) in RCD patients. ANG and IL-10 levels were significantly lower in RCD patients versus controls. IL-1β and ANG levels were significantly correlated with degenerative tendon grade in RCD patients. No difference in IL-6 and bFGF levels was observed between RCD patients and controls. Patients with degenerative changes had markedly lower ANG levels compared with controls. Power Doppler ultrasound showed high blood vessel density in patients with tendon rupture. Conclusion: The pathogenesis of RCD is associated with an imbalance

  19. Ultrasound-Guided Myofascial Trigger Point Injection Into Brachialis Muscle for Rotator Cuff Disease Patients With Upper Arm Pain: A Pilot Study

    PubMed Central

    Suh, Mi Ri; Chang, Won Hyuk; Choi, Hyo Seon

    2014-01-01

    Objective To assess the efficacy of trigger point injection into brachialis muscle for rotator cuff disease patients with upper arm pain. Methods A prospective, randomized, and single-blinded clinical pilot trial was performed at university rehabilitation hospital. Twenty-one patients clinically diagnosed with rotator cuff disease suspected of having brachialis myofascial pain syndrome (MPS) were randomly allocated into two groups. Effect of ultrasound (US)-guided trigger point injection (n=11) and oral non-steroidal anti-inflammatory drug (NSAID) (n=10) was compared by visual analog scale (VAS). Results US-guided trigger point injection of brachialis muscle resulted in excellent outcome compared to the oral NSAID group. Mean VAS scores decreased significantly after 2 weeks of treatment compared to the baseline in both groups (7.3 vs. 4.5 in the injection group and 7.4 vs. 5.9 in the oral group). The decrease of the VAS score caused by injection (ДVAS=-2.8) was significantly larger than caused by oral NSAID (ДVAS=-1.5) (p<0.05). Conclusion In patients with rotator cuff disease, US-guided trigger point injection of the brachialis muscle is safe and effective for both diagnosis and treatment when the cause of pain is suspected to be originated from the muscle. PMID:25379497

  20. Plasma urate concentration and risk of coronary heart disease: a Mendelian randomisation analysis

    PubMed Central

    White, Jon; Sofat, Reecha; Hemani, Gibran; Shah, Tina; Engmann, Jorgen; Dale, Caroline; Shah, Sonia; Kruger, Felix A; Giambartolomei, Claudia; Swerdlow, Daniel I; Palmer, Tom; McLachlan, Stela; Langenberg, Claudia; Zabaneh, Delilah; Lovering, Ruth; Cavadino, Alana; Jefferis, Barbara; Finan, Chris; Wong, Andrew; Amuzu, Antoinette; Ong, Ken; Gaunt, Tom R; Warren, Helen; Davies, Teri-Louise; Drenos, Fotios; Cooper, Jackie; Ebrahim, Shah; Lawlor, Debbie A; Talmud, Philippa J; Humphries, Steve E; Power, Christine; Hypponen, Elina; Richards, Marcus; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Ben-Shlomo, Yoav; Day, Ian N; Whincup, Peter; Morris, Richard; Strachan, Mark W J; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Plagnol, Vincent; Whittaker, John C; Smith, George Davey; Dudbridge, Frank; Casas, Juan P; Holmes, Michael V; Hingorani, Aroon D

    2016-01-01

    Summary Background Increased circulating plasma urate concentration is associated with an increased risk of coronary heart disease, but the extent of any causative effect of urate on risk of coronary heart disease is still unclear. In this study, we aimed to clarify any causal role of urate on coronary heart disease risk using Mendelian randomisation analysis. Methods We first did a fixed-effects meta-analysis of the observational association of plasma urate and risk of coronary heart disease. We then used a conventional Mendelian randomisation approach to investigate the causal relevance using a genetic instrument based on 31 urate-associated single nucleotide polymorphisms (SNPs). To account for potential pleiotropic associations of certain SNPs with risk factors other than urate, we additionally did both a multivariable Mendelian randomisation analysis, in which the genetic associations of SNPs with systolic and diastolic blood pressure, HDL cholesterol, and triglycerides were included as covariates, and an Egger Mendelian randomisation (MR-Egger) analysis to estimate a causal effect accounting for unmeasured pleiotropy. Findings In the meta-analysis of 17 prospective observational studies (166 486 individuals; 9784 coronary heart disease events) a 1 SD higher urate concentration was associated with an odds ratio (OR) for coronary heart disease of 1·07 (95% CI 1·04–1·10). The corresponding OR estimates from the conventional, multivariable adjusted, and Egger Mendelian randomisation analysis (58 studies; 198 598 individuals; 65 877 events) were 1·18 (95% CI 1·08–1·29), 1·10 (1·00–1·22), and 1·05 (0·92–1·20), respectively, per 1 SD increment in plasma urate. Interpretation Conventional and multivariate Mendelian randomisation analysis implicates a causal role for urate in the development of coronary heart disease, but these estimates might be inflated by hidden pleiotropy. Egger Mendelian randomisation analysis, which accounts for

  1. Comparison of effects of ProSeal LMA™ laryngeal mask airway cuff inflation with air, oxygen, air:oxygen mixture and oxygen:nitrous oxide mixture in adults: A randomised, double-blind study

    PubMed Central

    Sharma, Mona; Sinha, Renu; Trikha, Anjan; Ramachandran, Rashmi; Chandralekha, C

    2016-01-01

    Background and Aims: Laryngeal mask airway (LMA) cuff pressure increases when the air is used for the cuff inflation during oxygen: nitrous oxide (O2:N2O) anaesthesia, which may lead to various problems. We compared the effects of different gases for ProSeal LMA™ (PLMA) cuff inflation in adult patients for various parameters. Methods: A total of 120 patients were randomly allocated to four groups, according to composition of gases used to inflate the PLMA cuff to achieve 40 cmH2 O cuff pressure, air (Group A), 50% O2 :air (Group OA), 50% O2:N2O (Group ON) and 100% O2 (Group O). Cuff pressure, cuff volume and ventilator parameters were monitored intraoperatively. Pharyngolaryngeal parameters were assessed at 1, 2 and 24 h postoperatively. Statistical analysis was performed using ANOVA, Fisher's exact test and step-wise logistic regression. Results: Cuff pressure significantly increased at 10, 15 and 30 min in Group A, OA and O from initial pressure. Cuff pressure decreased at 5 min in Group ON (36.6 ± 3.5 cmH2 O) (P = 0.42). PLMA cuff volume increased in Group A, OA, O, but decreased in Group ON (6.16 ± 2.8 ml [P < 0.001], 4.7 ± 3.8 ml [P < 0.001], 1.4 ± 3.19 ml [P = 0.023] and − 1.7 ± 4.9 ml [P = 0.064], respectively), from basal levels. Ventilatory parameters were comparable in all four groups. There was no significant association between sore throat and cuff pressure, with odds ratio 1.002. Conclusion: Cuff inflation with 50% O2:N2O mixture provided more stable cuff pressure in comparison to air, O2 :air, 100% O2 during O2:N2O anaesthesia. Ventilatory parameters did not change with variation in PLMA cuff pressure. Post-operative sore throat had no correlation with cuff pressure. PMID:27601739

  2. Arthroscopic rotator cuff repair.

    PubMed

    Burkhart, Stephen S; Lo, Ian K Y

    2006-06-01

    Arthroscopic rotator cuff repair is being performed by an increasing number of orthopaedic surgeons. The principles, techniques, and instrumentation have evolved to the extent that all patterns and sizes of rotator cuff tear, including massive tears, can now be repaired arthroscopically. Achieving a biomechanically stable construct is critical to biologic healing. The ideal repair construct must optimize suture-to-bone fixation, suture-to-tendon fixation, abrasion resistance of suture, suture strength, knot security, loop security, and restoration of the anatomic rotator cuff footprint (the surface area of bone to which the cuff tendons attach). By achieving optimized repair constructs, experienced arthroscopic surgeons are reporting results equal to those of open rotator cuff repair. As surgeons' arthroscopic skill levels increase through attendance at surgical skills courses and greater experience gained in the operating room, there will be an increasing trend toward arthroscopic repair of most rotator cuff pathology. PMID:16757673

  3. Heart disease prevention project: a randomised controlled trial in industry.

    PubMed

    Rose, G; Heller, R F; Pedoe, H T; Christie, D G

    1980-03-15

    Twenty-four factories or other occupational groups, employing 18 210 men aged 40 to 59, were formed into matched pairs. One of each pair was allocated randomly to receive a five to six year programme of medical examinations and intervention to reduce the levels of the main coronary risk factors. Men at factories in the intervention group were given advice on dietary reduction of plasma cholesterol concentrations, stopping or reducing cigarette smoking, regular exercies for the sedentary and reduced energy intake for the overweight, and hypertension was treated. The programme was delivered mainly through existing occupational medical services, helped by a small central staff. Personal consultations were largely confined to men with a high risk of developing coronary heart disease. Changes in risk factors were assessed by regular standardised examinations of random samples of men. The spread of information by general propaganda proved easy, but a change in habits seemed to require personal contact. Small but significant reductions occurred, mainly in the high-risk group, but these were not sustained when pressure was relaxed. PMID:6989437

  4. Rotator cuff problems

    MedlinePlus

    ... tear occurs when one of the tendons is torn from the bone from overuse or injury. Causes ... surgery with a larger incision) to repair the torn tendon. Outlook (Prognosis) With rotator cuff tendinitis, rest, ...

  5. Rotator cuff repair

    MedlinePlus

    ... already torn from chronic rotator cuff problems. A partial tear may not require surgery. Instead, rest and ... Follow any discharge and self-care instructions you are given. You will be wearing a sling when you leave the hospital. ...

  6. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    PubMed Central

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  7. Mendelian Randomisation study of the influence of eGFR on coronary heart disease

    PubMed Central

    Charoen, Pimphen; Nitsch, Dorothea; Engmann, Jorgen; Shah, Tina; White, Jonathan; Zabaneh, Delilah; Jefferis, Barbara; Wannamethee, Goya; Whincup, Peter; Mulick Cassidy, Amy; Gaunt, Tom; Day, Ian; McLachlan, Stela; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Brunner, Eric; Langenberg, Claudia; Ben-Shlomo, Yoav; Hingorani, Aroon; Whittaker, John; Pablo Casas, Juan; Dudbridge, Frank; Dale, Caroline; Finan, Chris; Wong, Andrew; Ong, Ken; Drenos, Fotios; Cooper, Jackie; Sofat, Reecha; Schmidt, Floriaan; Lawlor, Debbie A.; Talmud, Philippa J.; Humphries, Steve E.; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Morris, Richard; Plagno, Vincent

    2016-01-01

    Impaired kidney function, as measured by reduced estimated glomerular filtration rate (eGFR), has been associated with increased risk of coronary heart disease (CHD) in observational studies, but it is unclear whether this association is causal or the result of confounding or reverse causation. In this study we applied Mendelian randomisation analysis using 17 genetic variants previously associated with eGFR to investigate the causal role of kidney function on CHD. We used 13,145 participants from the UCL-LSHTM-Edinburgh-Bristol (UCLEB) Consortium and 194,427 participants from the Coronary ARtery DIsease Genome-wide Replication and Meta-analysis plus Coronary Artery Disease (CARDIoGRAMplusC4D) consortium. We observed significant association of an unweighted gene score with CHD risk (odds ratio = 0.983 per additional eGFR-increasing allele, 95% CI = 0.970–0.996, p = 0.008). However, using weights calculated from UCLEB, the gene score was not associated with disease risk (p = 0.11). These conflicting results could be explained by a single SNP, rs653178, which was not associated with eGFR in the UCLEB sample, but has known pleiotropic effects that prevent us from drawing a causal conclusion. The observational association between low eGFR and increased CHD risk was not explained by potential confounders, and there was no evidence of reverse causation, therefore leaving the remaining unexplained association as an open question. PMID:27338949

  8. Mendelian Randomisation study of the influence of eGFR on coronary heart disease.

    PubMed

    Charoen, Pimphen; Nitsch, Dorothea; Engmann, Jorgen; Shah, Tina; White, Jonathan; Zabaneh, Delilah; Jefferis, Barbara; Wannamethee, Goya; Whincup, Peter; Mulick Cassidy, Amy; Gaunt, Tom; Day, Ian; McLachlan, Stela; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Brunner, Eric; Langenberg, Claudia; Ben-Shlomo, Yoav; Hingorani, Aroon; Whittaker, John; Pablo Casas, Juan; Dudbridge, Frank

    2016-01-01

    Impaired kidney function, as measured by reduced estimated glomerular filtration rate (eGFR), has been associated with increased risk of coronary heart disease (CHD) in observational studies, but it is unclear whether this association is causal or the result of confounding or reverse causation. In this study we applied Mendelian randomisation analysis using 17 genetic variants previously associated with eGFR to investigate the causal role of kidney function on CHD. We used 13,145 participants from the UCL-LSHTM-Edinburgh-Bristol (UCLEB) Consortium and 194,427 participants from the Coronary ARtery DIsease Genome-wide Replication and Meta-analysis plus Coronary Artery Disease (CARDIoGRAMplusC4D) consortium. We observed significant association of an unweighted gene score with CHD risk (odds ratio = 0.983 per additional eGFR-increasing allele, 95% CI = 0.970-0.996, p = 0.008). However, using weights calculated from UCLEB, the gene score was not associated with disease risk (p = 0.11). These conflicting results could be explained by a single SNP, rs653178, which was not associated with eGFR in the UCLEB sample, but has known pleiotropic effects that prevent us from drawing a causal conclusion. The observational association between low eGFR and increased CHD risk was not explained by potential confounders, and there was no evidence of reverse causation, therefore leaving the remaining unexplained association as an open question. PMID:27338949

  9. Metformin in severe exacerbations of chronic obstructive pulmonary disease: a randomised controlled trial

    PubMed Central

    Hitchings, Andrew W; Lai, Dilys; Jones, Paul W; Baker, Emma H

    2016-01-01

    Background Severe exacerbations of COPD are commonly associated with hyperglycaemia, which predicts adverse outcomes. Metformin is a well-established anti-hyperglycaemic agent in diabetes mellitus, possibly augmented with anti-inflammatory effects, but its effects in COPD are unknown. We investigated accelerated metformin therapy in severe COPD exacerbations, primarily to confirm or refute an anti-hyperglycaemic effect, and secondarily to explore its effects on inflammation and clinical outcome. Methods This was a multicentre, randomised, double-blind, placebo-controlled trial testing accelerated metformin therapy in non-diabetic patients, aged ≥35 years, hospitalised for COPD exacerbations. Participants were assigned in a 2:1 ratio to 1 month of metformin therapy, escalated rapidly to 2 g/day, or matched placebo. The primary end point was mean in-hospital blood glucose concentration. Secondary end points included the concentrations of fructosamine and C reactive protein (CRP), and scores on the COPD Assessment Test and Exacerbations of Chronic Pulmonary Disease Tool. Results 52 participants (mean (±SD) age 67±9 years) were randomised (34 to metformin, 18 to placebo). All were included in the primary end point analysis. The mean blood glucose concentrations in the metformin and placebo groups were 7.1±0.9 and 8.0±3.3 mmol/L, respectively (difference −0.9 mmol/L, 95% CI −2.1 to +0.3; p=0.273). No significant between-group differences were observed on any of the secondary end points. Adverse reactions, particularly gastrointestinal effects, were more common in metformin-treated participants. Conclusion Metformin did not ameliorate elevations in blood glucose concentration among non-diabetic patients admitted to hospital for COPD exacerbations, and had no detectable effect on CRP or clinical outcomes. Trial registration number ISRCTN66148745 and NCT01247870. PMID:26917577

  10. Rotator Cuff Injuries.

    ERIC Educational Resources Information Center

    Connors, G. Patrick

    Many baseball players suffer from shoulder injuries related to the rotator cuff muscles. These injuries may be classified as muscular strain, tendonitis or tenosynovitis, and impingement syndrome. Treatment varies from simple rest to surgery, so it is important to be seen by a physician as soon as possible. In order to prevent these injuries, the…

  11. Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial

    PubMed Central

    O’Cathain, Alicia; Thomas, Clare; Edwards, Louisa; Gaunt, Daisy; Dixon, Padraig; Hollinghurst, Sandra; Nicholl, Jon; Large, Shirley; Yardley, Lucy; Fahey, Tom; Foster, Alexis; Garner, Katy; Horspool, Kimberley; Man, Mei-See; Rogers, Anne; Pope, Catherine; Montgomery, Alan A

    2016-01-01

    Objective To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design Pragmatic, multicentre, randomised controlled trial. Setting 42 general practices in three areas of England. Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. Interventions Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. Main outcome measures The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. Results 50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic −2.7 mm Hg (95% confidence interval −4.7 to −0.6 mm Hg

  12. Biologics in rotator cuff surgery

    PubMed Central

    Schär, Michael O; Rodeo, Scott A

    2014-01-01

    Pathologies of the rotator cuff are by far the most common cause of shoulder dysfunction and pain. Even though reconstruction of the rotator cuff results in improved clinical outcome scores, including decreased pain, several studies report high failure rates. Orthopaedic research has therefore focused on biologically augmenting the rotator cuff reconstruction and improving tendon–bone healing of the rotator cuff. This biological augmentation has included the application of different platelet concentrates containing growth factors, mesenchymal stem cells, scaffolds and a combination of the above. The present review provides an overview over the biological augmentation options based upon current evidence.

  13. Association between alcohol and cardiovascular disease: Mendelian randomisation analysis based on individual participant data

    PubMed Central

    Holmes, Michael V; Dale, Caroline E; Zuccolo, Luisa; Silverwood, Richard J; Guo, Yiran; Ye, Zheng; Prieto-Merino, David; Dehghan, Abbas; Trompet, Stella; Wong, Andrew; Cavadino, Alana; Drogan, Dagmar; Padmanabhan, Sandosh; Yesupriya, Ajay; Leusink, Maarten; Sundstrom, Johan; Hubacek, Jaroslav A; Pikhart, Hynek; Swerdlow, Daniel I; Panayiotou, Andrie G; Borinskaya, Svetlana A; Finan, Chris; Shah, Sonia; Kuchenbaecker, Karoline B; Shah, Tina; Engmann, Jorgen; Folkersen, Lasse; Eriksson, Per; Ricceri, Fulvio; Melander, Olle; Sacerdote, Carlotta; Gamble, Dale M; Rayaprolu, Sruti; Ross, Owen A; McLachlan, Stela; Vikhireva, Olga; Sluijs, Ivonne; Scott, Robert A; Adamkova, Vera; Flicker, Leon; van Bockxmeer, Frank M; Power, Christine; Marques-Vidal, Pedro; Meade, Tom; Marmot, Michael G; Ferro, Jose M; Paulos-Pinheiro, Sofia; Humphries, Steve E; Talmud, Philippa J; Leach, Irene Mateo; Verweij, Niek; Linneberg, Allan; Skaaby, Tea; Doevendans, Pieter A; Cramer, Maarten J; van der Harst, Pim; Klungel, Olaf H; Dowling, Nicole F; Dominiczak, Anna F; Kumari, Meena; Nicolaides, Andrew N; Weikert, Cornelia; Boeing, Heiner; Ebrahim, Shah; Gaunt, Tom R; Price, Jackie F; Lannfelt, Lars; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Malyutina, Sofia; Voevoda, Mikhail I; Tamosiunas, Abdonas; Maitland-van der Zee, Anke H; Norman, Paul E; Hankey, Graeme J; Bergmann, Manuela M; Hofman, Albert; Franco, Oscar H; Cooper, Jackie; Palmen, Jutta; Spiering, Wilko; de Jong, Pim A; Kuh, Diana; Hardy, Rebecca; Uitterlinden, Andre G; Ikram, M Arfan; Ford, Ian; Hyppönen, Elina; Almeida, Osvaldo P; Wareham, Nicholas J; Khaw, Kay-Tee; Hamsten, Anders; Husemoen, Lise Lotte N; Tjønneland, Anne; Tolstrup, Janne S; Rimm, Eric; Beulens, Joline W J; Verschuren, W M Monique; Onland-Moret, N Charlotte; Hofker, Marten H; Wannamethee, S Goya; Whincup, Peter H; Morris, Richard; Vicente, Astrid M; Watkins, Hugh; Farrall, Martin; Jukema, J Wouter; Meschia, James; Cupples, L Adrienne; Sharp, Stephen J; Fornage, Myriam; Kooperberg, Charles; LaCroix, Andrea Z; Dai, James Y; Lanktree, Matthew B; Siscovick, David S; Jorgenson, Eric; Spring, Bonnie; Coresh, Josef; Buxbaum, Sarah G; Schreiner, Pamela J; Ellison, R Curtis; Tsai, Michael Y; Patel, Sanjay R; Redline, Susan; Johnson, Andrew D; Hoogeveen, Ron C; Hakonarson, Hakon; Rotter, Jerome I; Boerwinkle, Eric; de Bakker, Paul I W; Kivimaki, Mika; Asselbergs, Folkert W; Sattar, Naveed; Lawlor, Debbie A; Whittaker, John; Davey Smith, George; Mukamal, Kenneth; Psaty, Bruce M; Wilson, James G; Lange, Leslie A; Hamidovic, Ajna; Hingorani, Aroon D; Nordestgaard, Børge G; Bobak, Martin; Leon, David A; Langenberg, Claudia; Palmer, Tom M; Reiner, Alex P; Keating, Brendan J; Dudbridge, Frank

    2014-01-01

    Objective To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease. Design Mendelian randomisation meta-analysis of 56 epidemiological studies. Participants 261 991 individuals of European descent, including 20 259 coronary heart disease cases and 10 164 stroke events. Data were available on ADH1B rs1229984 variant, alcohol phenotypes, and cardiovascular biomarkers. Main outcome measures Odds ratio for coronary heart disease and stroke associated with the ADH1B variant in all individuals and by categories of alcohol consumption. Results Carriers of the A-allele of ADH1B rs1229984 consumed 17.2% fewer units of alcohol per week (95% confidence interval 15.6% to 18.9%), had a lower prevalence of binge drinking (odds ratio 0.78 (95% CI 0.73 to 0.84)), and had higher abstention (odds ratio 1.27 (1.21 to 1.34)) than non-carriers. Rs1229984 A-allele carriers had lower systolic blood pressure (−0.88 (−1.19 to −0.56) mm Hg), interleukin-6 levels (−5.2% (−7.8 to −2.4%)), waist circumference (−0.3 (−0.6 to −0.1) cm), and body mass index (−0.17 (−0.24 to −0.10) kg/m2). Rs1229984 A-allele carriers had lower odds of coronary heart disease (odds ratio 0.90 (0.84 to 0.96)). The protective association of the ADH1B rs1229984 A-allele variant remained the same across all categories of alcohol consumption (P=0.83 for heterogeneity). Although no association of rs1229984 was identified with the combined subtypes of stroke, carriers of the A-allele had lower odds of ischaemic stroke (odds ratio 0.83 (0.72 to 0.95)). Conclusions Individuals with a genetic variant associated with non-drinking and lower alcohol consumption had a more favourable cardiovascular profile and a reduced risk of coronary heart disease than those without the genetic variant. This suggests that reduction of alcohol consumption, even for light to moderate drinkers, is beneficial for

  14. Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease

    PubMed Central

    Noble, B A; Loh, R S K; MacLennan, S; Pesudovs, K; Reynolds, A; Bridges, L R; Burr, J; Stewart, O; Quereshi, S

    2004-01-01

    Aims: To evaluate the efficacy of 50% autologous serum drops against conventional treatment in ocular surface disorders refractory to normal treatments in a prospective randomised crossover trial. Method: Patients fulfilling ophthalmological and haematological entry criteria were randomised to either 3 months of autologous serum 50% followed by 3 months of their conventional treatment, or 3 months of conventional treatment, followed by 3 months of autologous serum. Clinical assessments, including Schirmer’s test, rose Bengal, and fluorescein staining, were carried out on entry and at monthly intervals. Impression cytology was performed at entry, 3 and 6 months. Grading was carried out on degrees of squamous metaplasia and goblet cell density. Subjective comfort was recorded daily using the “faces” scale. These categorical scores were converted to linear measurement using Rasch analysis. Statistical analysis was carried out using Wilcoxon’s signed rank test and ANOVA. Results: 16 patients were recruited with 31 eyes studied. The ocular surface diseases chiefly included Sjögren’s syndrome (n = 6) and keratoconjunctivitis sicca (n = 5). Impression cytology available in 25 of 31 eyes showed significant improvement on serum treatment, p<0.02. Rasch weighted faces scores were statistically significantly better with serum, p<0.01. Conclusion: The results of this randomised study provide further evidence of the beneficial effects of autologous serum in severe ocular surface disorders. For most of these patients, autologous serum was superior to conventional treatment for improving ocular surface health and subjective comfort. PMID:15090417

  15. Special report: Occlusive cuff controller

    NASA Technical Reports Server (NTRS)

    Baker, J. T.

    1975-01-01

    A mechanical occlusive cuff controller suitable for blood flow experiments in space shuttle flights is described. The device requires 115 volt ac power and a pressurized gas source. Two occluding cuff pressures (30 and 50 mmHg) are selectable by a switch on the front panel. A screw driver adjustment allows accurate cuff pressurization levels for under or oversized limbs. Two pressurization cycles (20 second and 2 minutes) can be selected by a front panel switch. Adjustment of the timing cycles is also available through the front panel. A pushbutton hand switch allows remote start of the cuff inflation cycle. A stop/reset switch permits early termination of the cycle and disabling of the controller to prevent inadvertent reactivation. Pressure in the cuff is monitored by a differential aneroid barometer. In addition, an electrocardiogram trigger circuit permits the initiation of the pressurization cycle by an externally supplied ECG cycle.

  16. Factors affecting rotator cuff healing.

    PubMed

    Mall, Nathan A; Tanaka, Miho J; Choi, Luke S; Paletta, George A

    2014-05-01

    Several studies have noted that increasing age is a significant factor for diminished rotator cuff healing, while biomechanical studies have suggested the reason for this may be an inferior healing environment in older patients. Larger tears and fatty infiltration or atrophy negatively affect rotator cuff healing. Arthroscopic rotator cuff repair, double-row repairs, performing a concomitant acromioplasty, and the use of platelet-rich plasma (PRP) do not demonstrate an improvement in structural healing over mini-open rotator cuff repairs, single-row repairs, not performing an acromioplasty, or not using PRP. There is conflicting evidence to support postoperative rehabilitation protocols using early motion over immobilization following rotator cuff repair. PMID:24806015

  17. Home screening for sexually transmitted diseases in high‐risk young women: randomised controlled trial

    PubMed Central

    Cook, Robert L; Østergaard, Lars; Hillier, Sharon L; Murray, Pamela J; Chang, Chung‐Chou H; Comer, Diane M; Ness, Roberta B

    2007-01-01

    Objective Home screening tests could eliminate several barriers to testing sexually transmitted diseases (STDs). Aim To determine whether offering repeated home screening tests would increase the rate of testing for chlamydia and gonorrhoea in a high‐risk sample of young women. Methods In this randomised controlled trial, 403 young women (mean age 18.9 years, 70% black) with a recent STD or with STD‐related risk factors were enrolled. Participants were recruited from clinics and high‐prevalence neighbourhoods and then randomly assigned to receive either a home testing kit or an invitation to attend a medical clinic for testing at 6, 12 and 18 months after enrollment. Over 80% of women were followed for 2 years. The trial is registered with ClinicalTrials.gov, number NCT 00177437. Results Of 197 women in the intervention group, 140 (71%) returned at least one home test and 25 of 249 (10%) home tests were positive. Women who received home screening tests completed significantly more STD tests overall (1.94 vs 1.41 tests per woman‐year, p<0.001) and more STD tests in the absence of symptoms (1.18 vs 0.75 tests per woman‐year, p<0.001). More women in the intervention group completed at least one test when asymptomatic (162 (82.2%) vs 117 (61.3%), p<0.001). The intervention was most effective among women recruited outside medical clinics. There was no significant difference in the overall rate of STDs detected. Conclusions Home screening significantly increased the utilisation of chlamydia and gonorrhoea testing in this sample of high‐risk young women, and thus represents a feasible strategy to facilitate STD testing in young women. PMID:17301105

  18. Rolling cuff flexible bellows

    DOEpatents

    Lambert, Donald R.

    1985-01-01

    A flexible connector apparatus used to join two stiff non-deformable members, such as piping. The apparatus is provided with one or more flexible sections or assemblies each utilizing a bellows of a rolling cuff type connected between two ridge members, with the bellows being supported by a back-up ring, such that only the curved end sections of the bellows are unsupported. Thus, the bellows can be considered as being of a tube-shaped configuration and thus have high pressure resistance. The components of the flexible apparatus are sealed or welded one to another such that it is fluid tight.

  19. Rolling cuff flexible bellows

    SciTech Connect

    Lambert, D. R.

    1985-09-10

    A flexible connector apparatus used to join two stiff non-deformable members, such as piping. The apparatus is provided with one or more flexible sections or assemblies each utilizing a bellows of a rolling cuff type connected between two ridge members, with the bellows being supported by a back-up ring, such that only the curved end sections of the bellows are unsupported. Thus, the bellows can be considered as being of a tube-shaped configuration and thus have high pressure resistance. The components of the flexible apparatus are sealed or welded one to another such that it is fluid tight.

  20. Systematic review of randomised controlled trials of multiple risk factor interventions for preventing coronary heart disease.

    PubMed Central

    Ebrahim, S.; Smith, G. D.

    1997-01-01

    OBJECTIVE: To assess the effectiveness of multiple risk factor intervention in reducing cardiovascular risk factors, total mortality, and mortality from coronary heart disease among adults. DESIGN: Systematic review and meta-analysis of randomised controlled trials in workforces and in primary care in which subjects were randomly allocated to more than one of six interventions (stopping smoking, exercise, dietary advice, weight control, antihypertensive drugs, and cholesterol lowering drugs) and followed up for at least six months. SUBJECTS: Adults aged 17-73 years, 903000 person years of observation were included in nine trials with clinical event outcomes and 303000 person years in five trials with risk factor outcomes alone. MAIN OUTCOME MEASURES: Changes in systolic and diastolic blood pressure, smoking rates, blood cholesterol concentrations, total mortality, and mortality from coronary heart disease. RESULTS: Net decreases in systolic and diastolic blood pressure, smoking prevalence, and blood cholesterol were 4.2 mm Hg (SE 0.19 mm Hg), 2.7 mm Hg (0.09 mm Hg), 4.2% (0.3%), and 0.14 mmol/l (0.01 mmol/l) respectively. In the nine trials with clinical event end points the pooled odds ratios for total and coronary heart disease mortality were 0.97 (95% confidence interval 0.92 to 1.02) and 0.96 (0.88 to 1.04) respectively. Statistical heterogeneity between the studies with respect to changes in mortality and risk factors was due to trials focusing on hypertensive participants and those using considerable amounts of drug treatment, with only these trials showing significant reductions in mortality. CONCLUSIONS: The pooled effects of multiple risk factor intervention on mortality were insignificant and a small, but potentially important, benefit of treatment (about a 10% reduction in mortality) may have been missed. Changes in risk factors were modest, were related to the amount of pharmacological treatment used, and in some cases may have been overestimated

  1. Suprascapular Nerve: Is It Important in Cuff Pathology?

    PubMed Central

    Shi, Lewis L.; Freehill, Michael T.; Yannopoulos, Paul; Warner, Jon J. P.

    2012-01-01

    Suprascapular nerve and rotator cuff function are intimately connected. The incidence of suprascapular neuropathy has been increasing due to improved understanding of the disease entity and detection methods. The nerve dysfunction often results from a traction injury or compression, and a common cause is increased tension on the nerve from retracted rotator cuff tears. Suprascapular neuropathy should be considered as a diagnosis if patients exhibit posterosuperior shoulder pain, atrophy or weakness of supraspinatus and infraspinatus without rotator cuff tear, or massive rotator cuff with retraction. Magnetic resonance imaging and electromyography studies are indicated to evaluate the rotator cuff and function of the nerve. Fluoroscopically guided injections to the suprascapular notch can also be considered as a diagnostic option. Nonoperative treatment of suprascapular neuropathy can be successful, but in the recent decade there is increasing evidence espousing the success of surgical treatment, in particular arthroscopic suprascapular nerve decompression. There is often reliable improvement in shoulder pain, but muscle atrophy recovery is less predictable. More clinical data are needed to determine the role of rotator cuff repair and nerve decompression in the same setting. PMID:23193484

  2. Pioglitazone in early Parkinson's disease: a phase 2, multicentre, double-blind, randomised trial

    PubMed Central

    2015-01-01

    Summary Background A systematic assessment of potential disease-modifying compounds for Parkinson's disease concluded that pioglitazone could hold promise for the treatment of patients with this disease. We assessed the effect of pioglitazone on the progression of Parkinson's disease in a multicentre, double-blind, placebo-controlled, futility clinical trial. Methods Participants with the diagnosis of early Parkinson's disease on a stable regimen of 1 mg/day rasagiline or 10 mg/day selegiline were randomly assigned (1:1:1) to 15 mg/day pioglitazone, 45 mg/day pioglitazone, or placebo. Investigators were masked to the treatment assignment. Only the statistical centre and the central pharmacy knew the treatment name associated with the randomisation number. The primary outcome was the change in the total Unified Parkinson's Disease Rating Scale (UPDRS) score between the baseline and 44 weeks, analysed by intention to treat. The primary null hypothesis for each dose group was that the mean change in UPDRS was 3 points less than the mean change in the placebo group. The alternative hypothesis (of futility) was that pioglitazone is not meaningfully different from placebo. We rejected the null if there was significant evidence of futility at the one-sided alpha level of 0.10. The study is registered at ClinicalTrials.gov, number NCT01280123. Findings 210 patients from 35 sites in the USA were enrolled between May 10, 2011, and July 31, 2013. The primary analysis included 72 patients in the 15 mg group, 67 in the 45 mg group, and 71 in the placebo group. The mean total UPDRS change at 44 weeks was 4.42 (95% CI 2.55–6.28) for 15 mg pioglitazone, 5.13 (95% CI 3.17–7.08) for 45 mg pioglitazone, and 6.25 (95% CI 4.35–8.15) for placebo (higher change scores are worse). The mean difference between the 15 mg and placebo groups was −1.83 (80% CI −3.56 to −0.10) and the null hypothesis could not be rejected (p=0.19). The mean difference between the 45 mg and placebo

  3. 21 CFR 868.5760 - Cuff spreader.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cuff spreader. 868.5760 Section 868.5760 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5760 Cuff spreader. (a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes. (b) Classification. Class...

  4. 21 CFR 868.5760 - Cuff spreader.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cuff spreader. 868.5760 Section 868.5760 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5760 Cuff spreader. (a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes. (b) Classification. Class...

  5. 21 CFR 868.5760 - Cuff spreader.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cuff spreader. 868.5760 Section 868.5760 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5760 Cuff spreader. (a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes. (b) Classification. Class...

  6. 21 CFR 868.5760 - Cuff spreader.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cuff spreader. 868.5760 Section 868.5760 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5760 Cuff spreader. (a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes. (b) Classification. Class...

  7. 21 CFR 868.5760 - Cuff spreader.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cuff spreader. 868.5760 Section 868.5760 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5760 Cuff spreader. (a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes. (b) Classification. Class...

  8. Effect of screening and lifestyle counselling on incidence of ischaemic heart disease in general population: Inter99 randomised trial

    PubMed Central

    Jacobsen, Rikke Kart; Toft, Ulla; Aadahl, Mette; Glümer, Charlotte; Pisinger, Charlotta

    2014-01-01

    Objective To investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level. Design Randomised controlled community based trial. Setting Suburbs of Copenhagen, Denmark Participants 59 616 people aged 30-60 years randomised with different age and sex randomisation ratios to an intervention group (n=11 629) and a control group (n=47 987). Intervention The intervention group was invited for screening, risk assessment, and lifestyle counselling up to four times over a five year period. All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits (at baseline and after one and three years); those at high risk of ischaemic heart disease, according to predefined criteria, were furthermore offered six sessions of group based lifestyle counselling on smoking cessation, diet, and physical activity. After five years all were invited for a final counselling session. Participants were referred to their general practitioner for medical treatment, if relevant. The control group was not invited for screening. Main outcome measures The primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group. Secondary outcome measures were stroke, combined events (ischaemic heart disease, stroke, or both), and mortality. Results 6091 (52.4%) people in the intervention group participated at baseline. Among 5978 people eligible at five year follow-up (59 died and 54 emigrated), 4028 (67.4%) attended. A total of 3163 people died in the 10 year follow-up period. Among 58 308 without a history of ischaemic heart disease at baseline, 2782 developed ischaemic heart disease. Among 58 940 without a history of stroke at baseline, 1726 developed stroke. No significant difference was seen between the intervention and control groups in the

  9. Dietary Advanced Glycation End Products and Risk Factors for Chronic Disease: A Systematic Review of Randomised Controlled Trials

    PubMed Central

    Clarke, Rachel E.; Dordevic, Aimee L.; Tan, Sih Min; Ryan, Lisa; Coughlan, Melinda T.

    2016-01-01

    Dietary advanced glycation end-products (AGEs) form during heating and processing of food products and are widely prevalent in the modern Western diet. Recent systematic reviews indicate that consumption of dietary AGEs may promote inflammation, oxidative stress and insulin resistance. Experimental evidence indicates that dietary AGEs may also induce renal damage, however, this outcome has not been considered in previous systematic reviews. The purpose of this review was to examine the effect of consumption of a high AGE diet on biomarkers of chronic disease, including chronic kidney disease (CKD), in human randomized controlled trials (RCTs). Six databases (SCOPUS, CINHAL, EMBASE, Medline, Biological abstracts and Web of Science) were searched for randomised controlled dietary trials that compared high AGE intake to low AGE intake in adults with and without obesity, diabetes or CKD. Twelve dietary AGE interventions were identified with a total of 293 participants. A high AGE diet increased circulating tumour necrosis factor-alpha and AGEs in all populations. A high AGE diet increased 8-isoprostanes in healthy adults, and vascular cell adhesion molecule-1 (VCAM-1) in patients with diabetes. Markers of CKD were not widely assessed. The evidence presented indicates that a high AGE diet may contribute to risk factors associated with chronic disease, such as inflammation and oxidative stress, however, due to a lack of high quality randomised trials, more research is required. PMID:26938557

  10. Does objective measurement of tracheal tube cuff pressures minimise adverse effects and maintain accurate cuff pressures? A systematic review and meta-analysis.

    PubMed

    Ca, Hockey; Aaj, van Zundert; Jd, Paratz

    2016-09-01

    Correct inflation pressures of the tracheal cuff are recommended to ensure adequate ventilation and prevent aspiration and adverse events. However there are conflicting views on which measurement to employ. The aim of this review was to examine whether adjustment of cuff pressure guided by objective measurement, compared with subjective measurement or observation of the pressure value alone, was able to prevent patient-related adverse effects and maintain accurate cuff pressures. A search of PubMed, Web of Science, Embase, CINAHL and ScienceDirect was conducted using keywords 'cuff pressure' and 'measure*' and related synonyms. Included studies were randomised or pseudo-randomised controlled trials investigating mechanically ventilated patients both in the intensive care unit and during surgery. Outcomes included adverse effects and the comparison of pressure measurements. Pooled analyses were performed to calculate risk ratios, effect sizes and 95% confidence intervals. Meta-analysis found preliminary evidence that adjustment of cuff pressure guided by objective measurement as compared with subjective measurement or observation of the pressure value alone, has benefit in preventing adverse effects. These included cough at two hours (odds ratio [OR] 0.42, confidence interval [CI] 0.23 to 0.79, P=0.007), hoarseness at 24 hours (OR 0.49, CI 0.31 to 0.76, P <0.002), sore throat (OR 0.73, CI 0.54 to 0.97, P <0.03), lesions of the trachea and incidences of silent aspiration (P=0.001), as well as maintaining accurate cuff pressures (Hedges' g 1.61, CI 2.69 to 0.53, P=0.003). Subjective measurement to guide adjustment or observation of the pressure value alone may lead to patient-related adverse effects and inaccuracies. It is recommended that an objective form of measurement be used. PMID:27608338

  11. The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease

    PubMed Central

    Tew, Garry A.; Brabyn, Sally; Cook, Liz; Peckham, Emily

    2016-01-01

    Research supports the use of supervised exercise training as a primary therapy for improving the functional status of people with peripheral arterial disease (PAD). Several reviews have focused on reporting the outcomes of exercise interventions, but none have critically examined the quality of intervention reporting. Adequate reporting of the exercise protocols used in randomised controlled trials (RCTs) is central to interpreting study findings and translating effective interventions into practice. The purpose of this review was to evaluate the completeness of intervention descriptions in RCTs of supervised exercise training in people with PAD. A systematic search strategy was used to identify relevant trials published until June 2015. Intervention description completeness in the main trial publication was assessed using the Template for Intervention Description and Replication checklist. Missing intervention details were then sought from additional published material and by emailing authors. Fifty-eight trials were included, reporting on 76 interventions. Within publications, none of the interventions were sufficiently described for all of the items required for replication; this increased to 24 (32%) after contacting authors. Although programme duration, and session frequency and duration were well-reported in publications, complete descriptions of the equipment used, intervention provider, and number of participants per session were missing for three quarters or more of interventions (missing for 75%, 93% and 80% of interventions, respectively). Furthermore, 20%, 24% and 26% of interventions were not sufficiently described for the mode of exercise, intensity of exercise, and tailoring/progression, respectively. Information on intervention adherence/fidelity was also frequently missing: attendance rates were adequately described for 29 (38%) interventions, whereas sufficient detail about the intensity of exercise performed was presented for only 8 (11

  12. The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease.

    PubMed

    Tew, Garry A; Brabyn, Sally; Cook, Liz; Peckham, Emily

    2016-01-01

    Research supports the use of supervised exercise training as a primary therapy for improving the functional status of people with peripheral arterial disease (PAD). Several reviews have focused on reporting the outcomes of exercise interventions, but none have critically examined the quality of intervention reporting. Adequate reporting of the exercise protocols used in randomised controlled trials (RCTs) is central to interpreting study findings and translating effective interventions into practice. The purpose of this review was to evaluate the completeness of intervention descriptions in RCTs of supervised exercise training in people with PAD. A systematic search strategy was used to identify relevant trials published until June 2015. Intervention description completeness in the main trial publication was assessed using the Template for Intervention Description and Replication checklist. Missing intervention details were then sought from additional published material and by emailing authors. Fifty-eight trials were included, reporting on 76 interventions. Within publications, none of the interventions were sufficiently described for all of the items required for replication; this increased to 24 (32%) after contacting authors. Although programme duration, and session frequency and duration were well-reported in publications, complete descriptions of the equipment used, intervention provider, and number of participants per session were missing for three quarters or more of interventions (missing for 75%, 93% and 80% of interventions, respectively). Furthermore, 20%, 24% and 26% of interventions were not sufficiently described for the mode of exercise, intensity of exercise, and tailoring/progression, respectively. Information on intervention adherence/fidelity was also frequently missing: attendance rates were adequately described for 29 (38%) interventions, whereas sufficient detail about the intensity of exercise performed was presented for only 8 (11

  13. A Randomised Controlled Trial of Intravenous Zoledronic Acid in Malignant Pleural Disease: A Proof of Principle Pilot Study

    PubMed Central

    Clive, Amelia O.; Hooper, Clare E.; Edey, Anthony J.; Morley, Anna J.; Zahan-Evans, Natalie; Hall, David; Lyburn, Iain; White, Paul; Braybrooke, Jeremy P.; Sequeiros, Iara; Lyen, Stephen M.; Milton, Tim; Kahan, Brennan C.; Maskell, Nick A.

    2015-01-01

    Introduction Animal studies have shown Zoledronic Acid (ZA) may diminish pleural fluid accumulation and tumour bulk in malignant pleural disease (MPD). We performed a pilot study to evaluate its effects in humans. Methods We undertook a single centre, double-blind, placebo-controlled trial in adults with MPD. Patients were randomised (1:1) to receive 2 doses of intravenous ZA or placebo, 3 weeks apart and were followed-up for 6 weeks. The co-primary outcomes were change in Visual Analogue Scale (VAS) score measured breathlessness during trial follow-up and change in the initial area under the curve (iAUC) on thoracic Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) from randomisation to week 5. Multiple secondary endpoints were also evaluated. Results Between January 2010 and May 2013, 30 patients were enrolled, 24 randomised and 4 withdrew after randomisation (1 withdrew consent; 3 had a clinical decline). At baseline, the ZA group were more breathless, had more advanced disease on radiology and worse quality of life than the placebo group. There was no significant difference between the groups with regards change in breathlessness (Adjusted mean difference (AMD) 4.16 (95%CI −4.7 to 13.0)) or change in DCE-MRI iAUC (AMD −15.4 (95%CI −58.1 to 27.3). Two of nine (22%) in the ZA arm had a >10% improvement by modified RECIST (vs 0/11 who received placebo). There was no significant difference in quality of life measured by the QLQ-C30 score (global QOL: AMD -4.1 (-13.0 to 4.9)), side effects or serious adverse event rates. Conclusions This is the first human study to evaluate ZA in MPD. The study is limited by small numbers and imbalanced baseline characteristics. Although no convincing treatment effect was identified, potential benefits for specific subgroups of patients cannot be excluded. This study provides important information regarding the feasibility of future trials to evaluate the effects of ZA further. Trial Registration UK Clinical

  14. Rotator cuff repair - series (image)

    MedlinePlus

    ... shoulder and arm bones. The tendons can be torn from overuse or injury. ... Surgery to repair a torn rotator cuff is usually very successful at relieving pain in the shoulder. The procedure is less predictable at returning strength ...

  15. Rotator cuff - self-care

    MedlinePlus

    ... tendons that attach to the bones of the shoulder joint, allowing the shoulder to move and remain stable. Common rotator cuff ... can help when you feel pain in your shoulder. An ice pack applied to the shoulder 20 ...

  16. Predicting Rotator Cuff Tears Using Data Mining and Bayesian Likelihood Ratios

    PubMed Central

    Lu, Hsueh-Yi; Huang, Chen-Yuan; Su, Chwen-Tzeng; Lin, Chen-Chiang

    2014-01-01

    Objectives Rotator cuff tear is a common cause of shoulder diseases. Correct diagnosis of rotator cuff tears can save patients from further invasive, costly and painful tests. This study used predictive data mining and Bayesian theory to improve the accuracy of diagnosing rotator cuff tears by clinical examination alone. Methods In this retrospective study, 169 patients who had a preliminary diagnosis of rotator cuff tear on the basis of clinical evaluation followed by confirmatory MRI between 2007 and 2011 were identified. MRI was used as a reference standard to classify rotator cuff tears. The predictor variable was the clinical assessment results, which consisted of 16 attributes. This study employed 2 data mining methods (ANN and the decision tree) and a statistical method (logistic regression) to classify the rotator cuff diagnosis into “tear” and “no tear” groups. Likelihood ratio and Bayesian theory were applied to estimate the probability of rotator cuff tears based on the results of the prediction models. Results Our proposed data mining procedures outperformed the classic statistical method. The correction rate, sensitivity, specificity and area under the ROC curve of predicting a rotator cuff tear were statistical better in the ANN and decision tree models compared to logistic regression. Based on likelihood ratios derived from our prediction models, Fagan's nomogram could be constructed to assess the probability of a patient who has a rotator cuff tear using a pretest probability and a prediction result (tear or no tear). Conclusions Our predictive data mining models, combined with likelihood ratios and Bayesian theory, appear to be good tools to classify rotator cuff tears as well as determine the probability of the presence of the disease to enhance diagnostic decision making for rotator cuff tears. PMID:24733553

  17. The interleukin-6 receptor as a target for prevention of coronary heart disease: a mendelian randomisation analysis

    PubMed Central

    2012-01-01

    Summary Background A high circulating concentration of interleukin 6 is associated with increased risk of coronary heart disease. Blockade of the interleukin-6 receptor (IL6R) with a monoclonal antibody (tocilizumab) licensed for treatment of rheumatoid arthritis reduces systemic and articular inflammation. However, whether IL6R blockade also reduces risk of coronary heart disease is unknown. Methods Applying the mendelian randomisation principle, we used single nucleotide polymorphisms (SNPs) in the gene IL6R to evaluate the likely efficacy and safety of IL6R inhibition for primary prevention of coronary heart disease. We compared genetic findings with the effects of tocilizumab reported in randomised trials in patients with rheumatoid arthritis. Findings In 40 studies including up to 133 449 individuals, an IL6R SNP (rs7529229) marking a non-synonymous IL6R variant (rs8192284; p.Asp358Ala) was associated with increased circulating log interleukin-6 concentration (increase per allele 9·45%, 95% CI 8·34–10·57) as well as reduced C-reactive protein (decrease per allele 8·35%, 95% CI 7·31–9·38) and fibrinogen concentrations (decrease per allele 0·85%, 95% CI 0·60–1·10). This pattern of effects was consistent with IL6R blockade from infusions of tocilizumab (4–8 mg/kg every 4 weeks) in patients with rheumatoid arthritis studied in randomised trials. In 25 458 coronary heart disease cases and 100 740 controls, the IL6R rs7529229 SNP was associated with a decreased odds of coronary heart disease events (per allele odds ratio 0·95, 95% CI 0·93–0·97, p=1·53×10−5). Interpretation On the basis of genetic evidence in human beings, IL6R signalling seems to have a causal role in development of coronary heart disease. IL6R blockade could provide a novel therapeutic approach to prevention of coronary heart disease that warrants testing in suitably powered randomised trials. Genetic studies in populations could be used more widely to help to

  18. Phase 2 Randomised Controlled Trial and Feasibility Study of Future Care Planning in Patients with Advanced Heart Disease.

    PubMed

    Denvir, Martin A; Cudmore, Sarah; Highet, Gill; Robertson, Shirley; Donald, Lisa; Stephen, Jacqueline; Haga, Kristin; Hogg, Karen; Weir, Christopher J; Murray, Scott A; Boyd, Kirsty

    2016-01-01

    Future Care Planning (FCP) rarely occurs in patients with heart disease until close to death by which time the potential benefits are lost. We assessed the feasibility, acceptability and tested a design of a randomised trial evaluating the impact of FCP in patients and carers. 50 patients hospitalised with acute heart failure or acute coronary syndrome and with predicted 12 month mortality risk of >20% were randomly allocated to FCP or usual care for 12 weeks upon discharge and then crossed-over for the next 12 weeks. Quality of life, symptoms and anxiety/distress were assessed by questionnaire. Hospitalisation and mortality events were documented for 6 months post-discharge. FCP increased implementation and documentation of key decisions linked to end-of-life care. FCP did not increase anxiety/distress (Kessler score -E 16.7 (7.0) vs D 16.8 (7.3), p = 0.94). Quality of life was unchanged (EQ5D: E 0.54(0.29) vs D 0.56(0.24), p = 0.86) while unadjusted hospitalised nights was lower (E 8.6 (15.3) vs D 11.8 (17.1), p = 0.01). Qualitative interviews indicated that FCP was highly valued by patients, carers and family physicians. FCP is feasible in a randomised clinical trial in patients with acute high risk cardiac conditions. A Phase 3 trial is needed urgently. PMID:27090299

  19. Phase 2 Randomised Controlled Trial and Feasibility Study of Future Care Planning in Patients with Advanced Heart Disease

    PubMed Central

    Denvir, Martin A.; Cudmore, Sarah; Highet, Gill; Robertson, Shirley; Donald, Lisa; Stephen, Jacqueline; Haga, Kristin; Hogg, Karen; Weir, Christopher J.; Murray, Scott A.; Boyd, Kirsty

    2016-01-01

    Future Care Planning (FCP) rarely occurs in patients with heart disease until close to death by which time the potential benefits are lost. We assessed the feasibility, acceptability and tested a design of a randomised trial evaluating the impact of FCP in patients and carers. 50 patients hospitalised with acute heart failure or acute coronary syndrome and with predicted 12 month mortality risk of >20% were randomly allocated to FCP or usual care for 12 weeks upon discharge and then crossed-over for the next 12 weeks. Quality of life, symptoms and anxiety/distress were assessed by questionnaire. Hospitalisation and mortality events were documented for 6 months post-discharge. FCP increased implementation and documentation of key decisions linked to end-of-life care. FCP did not increase anxiety/distress (Kessler score -E 16.7 (7.0) vs D 16.8 (7.3), p = 0.94). Quality of life was unchanged (EQ5D: E 0.54(0.29) vs D 0.56(0.24), p = 0.86) while unadjusted hospitalised nights was lower (E 8.6 (15.3) vs D 11.8 (17.1), p = 0.01). Qualitative interviews indicated that FCP was highly valued by patients, carers and family physicians. FCP is feasible in a randomised clinical trial in patients with acute high risk cardiac conditions. A Phase 3 trial is needed urgently. PMID:27090299

  20. Collaborative care for comorbid depression and coronary heart disease: a systematic review and meta-analysis of randomised controlled trials

    PubMed Central

    Tully, Phillip J; Baumeister, Harald

    2015-01-01

    Objectives To systematically review the efficacy of collaborative care (CC) for depression in adults with coronary heart disease (CHD) and depression. Design Systematic review and meta-analysis. Data sources Electronic databases (Cochrane Central Register of Controlled Trials MEDLINE, EMBASE, PsycINFO and CINAHL) were searched until April 2014. Inclusion criteria Population, depression comorbid with CHD; intervention, randomised controlled trial (RCT) of CC; comparison, either usual care, wait-list control group or no further treatment; and outcome, (primary) major adverse cardiac events (MACE), (secondary) standardised measure of depression, anxiety, quality of life (QOL) and cost-effectiveness. Data extraction and analysis RevMan V.5.3 was used to synthesise the data as risk ratios (RRs), ORs and standardised mean differences (SMD) with 95% CIs in random effect models. Results Six RCTs met the inclusion criteria and comprised 655 participants randomised to CC and 629 participants randomised to the control group (total 1284). Collaborative depression care led to a significant reduction in MACE in the short term (three trials, RR 0.54; 95% CI 0.31 to 0.95, p=0.03) that was not sustained in the longer term. Small reductions in depressive symptoms were evident in the short term (6 trials, pooled SMD −0.31; 95% CI −0.43 to −0.19, p<0.00001) and depression remission was more likely to be achieved with CC (5 trials, OR 1.77; 95% CI 1.28 to 2.44, p=0.0005). Likewise, a significant effect was observed for anxiety symptoms (SMD −0.36) and mental QOL (SMD 0.24). The timing of the intervention was a source of between-group heterogeneity for depression symptoms (between groups p=0.04, I2=76.5%). Conclusions Collaborative depression care did not lead to a sustained reduction in the primary MACE end point. Small effects were observed for depression, depression remission, anxiety and mental QOL. Trials registration number PROSPERO CRD42014013653. PMID:26692557

  1. Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial

    PubMed Central

    Blakeman, Tom; Blickem, Christian; Kennedy, Anne; Reeves, David; Bower, Peter; Gaffney, Hannah; Gardner, Caroline; Lee, Victoria; Jariwala, Praksha; Dawson, Shoba; Mossabir, Rahena; Brooks, Helen; Richardson, Gerry; Spackman, Eldon; Vassilev, Ivaylo; Chew-Graham, Carolyn; Rogers, Anne

    2014-01-01

    Background Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. Methods and Findings In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. Conclusions An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention. Trial Registration Controlled-Trials.com ISRCTN45433299 PMID:25330169

  2. Efficacy of Different Rotator Cuff Repair Techniques.

    PubMed

    Gurnani, Navin; van Deurzen, Derek Friedrich Petrus; Flipsen, Mark; Raven, Eric Ernest Joseph; van den Bekerom, Michel Pieter Jozef

    2015-05-01

    The purpose of this review article is to describe the currently used techniques for rotator cuff repair and after treatment. The literature was searched for the different surgical techniques and additional treatment including: [1] full arthroscopic and arthroscopic assisted rotator cuff repair, [2] acromioplasty as an additional treatment to rotator cuff repair, [3] the use of plasma rich platelets (PRP) after rotator cuff repair, [4] the single and double row fixation techniques, [5] long head of the biceps brachii tenotomy or tenodesis with rotator cuff repair, [6] scaffolds in rotator cuff surgery, and [7] early motion or immobilization after rotator cuff repair. The rationale, the results, and the scientific evidence were reported for the eligible procedures. PMID:26055023

  3. How reliable are randomised controlled trials for studying the relationship between diet and disease? A narrative review.

    PubMed

    Temple, Norman J

    2016-08-01

    Large numbers of randomised controlled trials (RCT) have been carried out in order to investigate diet-disease relationships. This article examines eight sets of studies and compares the findings with those from epidemiological studies (cohort studies in seven of the cases). The studies cover the role of dietary factors in blood pressure, body weight, cancer and heart disease. In some cases, the findings from the two types of study are consistent, whereas in other cases the findings appear to be in conflict. A critical evaluation of this evidence suggests factors that may account for conflicting findings. Very often RCT recruit subjects with a history of the disease under study (or at high risk of it) and have a follow-up of only a few weeks or months. Cohort studies, in contrast, typically recruit healthy subjects and have a follow-up of 5-15 years. Owing to these differences, findings from RCT are not necessarily more reliable than those from well-designed prospective cohort studies. We cannot assume that the results of RCT can be freely applied beyond the specific features of the studies. PMID:27267302

  4. Association of plasma uric acid with ischaemic heart disease and blood pressure: mendelian randomisation analysis of two large cohorts

    PubMed Central

    Palmer, Tom M; Nordestgaard, Børge G; Benn, Marianne; Tybjærg-Hansen, Anne; Davey Smith, George; Lawlor, Debbie A

    2013-01-01

    Objectives To assess the associations between both uric acid levels and hyperuricaemia, with ischaemic heart disease and blood pressure, and to explore the potentially confounding role of body mass index. Design Mendelian randomisation analysis, using variation at specific genes (SLC2A9 (rs7442295) as an instrument for uric acid; and FTO (rs9939609), MC4R (rs17782313), and TMEM18 (rs6548238) for body mass index). Setting Two large, prospective cohort studies in Denmark. Participants We measured levels of uric acid and related covariables in 58 072 participants from the Copenhagen General Population Study and 10 602 from the Copenhagen City Heart Study, comprising 4890 and 2282 cases of ischaemic heart disease, respectively. Main outcome Blood pressure and prospectively assessed ischaemic heart disease. Results Estimates confirmed known observational associations between plasma uric acid and hyperuricaemia with risk of ischaemic heart disease and diastolic and systolic blood pressure. However, when using genotypic instruments for uric acid and hyperuricaemia, we saw no evidence for causal associations between uric acid, ischaemic heart disease, and blood pressure. We used genetic instruments to investigate body mass index as a potentially confounding factor in observational associations, and saw a causal effect on uric acid levels. Every four unit increase of body mass index saw a rise in uric acid of 0.03 mmol/L (95% confidence interval 0.02 to 0.04), and an increase in risk of hyperuricaemia of 7.5% (3.9% to 11.1%). Conclusion By contrast with observational findings, there is no strong evidence for causal associations between uric acid and ischaemic heart disease or blood pressure. However, evidence supports a causal effect between body mass index and uric acid level and hyperuricaemia. This finding strongly suggests body mass index as a confounder in observational associations, and suggests a role for elevated body mass index or obesity in the development of

  5. Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial

    PubMed Central

    Svensson, Annemarie Lyng; Løgstrup, Brian Bridal; Giraldi, Annamaria; Graugaard, Christian; Blegvad, Jesper; Thygesen, Tina; Sheetal, Ekta; Svendsen, Lone; Emmertsen, Henrik

    2016-01-01

    Introduction Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria. Methods and analysis The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, blood pressure <140/90 mm  Hg for patients without diabetes and <130/80 mm Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30 mg/g) after 1 year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1 year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60 months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60 months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia

  6. Memantine for axial signs in Parkinson's disease: a randomised, double-blind, placebo-controlled pilot study

    PubMed Central

    Moreau, Caroline; Delval, Arnaud; Tiffreau, Vincent; Defebvre, Luc; Dujardin, Kathy; Duhamel, Alain; Petyt, Gregory; Hossein-Foucher, Claude; Blum, David; Sablonnière, Bernard; Schraen, Susanna; Allorge, Delphine; Destée, Alain; Bordet, Régis; Devos, David

    2013-01-01

    Background Given that memantine is thought to decrease N-methyl-D-aspartic-acid-related (NMDA) glutamatergic hyperactivity and improve locomotion in rats, we sought to assess the drug's impact on axial symptoms in advanced Parkinson's disease (PD). Methods We performed a 90-day, randomised, double-blind, study with two parallel arms: 20 mg/day memantine versus placebo (ClinicalTrials.gov:NCT01108029). The main inclusion criterion was the presence of a severe gait disorder and an abnormal, forward-leaning stance. The following parameters were analysed under standardised conditions before and after acute administration of L-dopa: gait (stride length as primary criterion), the United-Parkinson's-Disease-Rating-Scale (UPDRS) motor score and its axial subscore, the hypertonia and strength of the axial extensors and flexors (isokinetic dynamometer), the Dyskinesia Rating Scale score (DRS) and its axial subscore. Results Twenty-five patients were included. The memantine and placebo group did not differ significantly in terms of stride length. However, in the memantine group, we observed significantly better results (vs placebo) for the overall UPDRS score (F(1,21)=4.9; p=0.039(−1)) and its axial subscore (F(1,21)=7.2; p=0.014(−1.1)), axial hypertonia, the axial and overall DRS and axial strength. Conclusions Memantine treatment was associated with lower axial motor symptom and dyskinesia scores but did not improve gait. These benefits must be confirmed in a broader population of patients. PMID:23077087

  7. Ergocalciferol and Microcirculatory Function in Chronic Kidney Disease and Concomitant Vitamin D Deficiency: An Exploratory, Double Blind, Randomised Controlled Trial

    PubMed Central

    Dreyer, Gavin; Tucker, Arthur T.; Harwood, Steven M.; Pearse, Rupert M.; Raftery, Martin J.; Yaqoob, Muhammad M.

    2014-01-01

    Background and Objectives Vitamin D deficiency and endothelial dysfunction are non-traditional risk factors for cardiovascular events in chronic kidney disease. Previous studies in chronic kidney disease have failed to demonstrate a beneficial effect of vitamin D on arterial stiffness, left ventricular mass and inflammation but none have assessed the effect of vitamin D on microcirculatory endothelial function. Study Design We conducted a randomised controlled trial of 38 patients with non diabetic chronic kidney disease stage 3–4 and concomitant vitamin D deficiency (<16 ng/dl) who received oral ergocalciferol (50,000 IU weekly for one month followed by 50,000 IU monthly) or placebo over 6 months. The primary outcome was change in microcirculatory function measured by laser Doppler flowmetry after iontophoresis of acetylcholine. Secondary endpoints were tissue advanced glycation end products, sublingual functional capillary density and flow index as well as macrovascular parameters. Parallel in vitro experiments were conducted to determine the effect of ergocalciferol on cultured human endothelial cells. Results Twenty patients received ergocalciferol and 18 patients received placebo. After 6 months, there was a significant improvement in the ergocalciferol group in both endothelium dependent microcirculatory vasodilatation after iontophoresis of acetylcholine (p = 0.03) and a reduction in tissue advanced glycation end products (p = 0.03). There were no changes in sublingual microcirculatory parameters. Pulse pressure (p = 0.01) but not aortic pulse wave velocity was reduced. There were no significant changes in bone mineral parameters, blood pressure or left ventricular mass index suggesting that ergocalciferol improved endothelial function independently of these parameters. In parallel experiments, expression of endothelial nitric oxide synthase and activity were increased in human endothelial cells in a dose dependent manner. Conclusions

  8. A novel conceptual framework for balance training in Parkinson’s disease-study protocol for a randomised controlled trial

    PubMed Central

    2012-01-01

    Background There is increasing scientific knowledge about the interaction between physiological (musculoskeletal, neuromuscular, cognitive and sensory) systems and their influence on balance and walking impairments in Parkinson’s disease. We have developed a new conceptual framework for balance training, emphasising specific components of balance control related to Parkinson’s disease symptoms by using highly challenging, progressive and varying training conditions. The primary aim of this proposed randomised controlled trial will be to investigate the short-term and long-term effects of a 10-week balance training regime in elderly with Parkinson’s disease. Methods/Design Eighty participants with mild to moderate idiopathic Parkinson’s disease will be recruited and randomly allocated to an intervention group receiving balance training or a control group whose participants will continue to receive their usual care. The intervention will consist of a 10-week group training regime (1-hour training, three times per week), which will be led by two physiotherapists to ensure training progression and safety. The conceptual framework will be applied by addressing specific balance components (sensory integration, anticipatory postural adjustments, motor agility, stability limits) through varying training conditions and structured progression. Assessment will be conducted through a multi-dimensional battery of outcomes, prior to and immediately after the 10-week intervention, and at 9 and 15 months’ follow-up after entering the study. Primary outcome measures will be balance performance (assessed using the Mini Balance Evaluation Systems Test), change in gait velocity (m/s) between single and dual task walking, and fear of falling (evaluated using the Fall Efficacy Scale International). Discussion This study has the potential to provide new insight and knowledge of the effects of specific, varied and challenging balance training on a wide health spectrum in

  9. Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: a randomised placebo controlled trial

    PubMed Central

    Kesse-Guyot, Emmanuelle; Czernichow, Sébastien; Briancon, Serge; Blacher, Jacques; Hercberg, Serge

    2010-01-01

    Objective To investigate whether dietary supplementation with B vitamins or omega 3 fatty acids, or both, could prevent major cardiovascular events in patients with a history of ischaemic heart disease or stroke. Design Double blind, randomised, placebo controlled trial; factorial design. Setting Recruitment throughout France via a network of 417 cardiologists, neurologists, and other physicians. Participants 2501 patients with a history of myocardial infarction, unstable angina, or ischaemic stroke. Intervention Daily dietary supplement containing 5-methyltetrahydrofolate (560 μg), vitamin B-6 (3 mg), and vitamin B-12 (20 μg) or placebo; and containing omega 3 fatty acids (600 mg of eicosapentanoic acid and docosahexaenoic acid at a ratio of 2:1) or placebo. Median duration of supplementation was 4.7 years. Main outcome measures Major cardiovascular events, defined as a composite of non-fatal myocardial infarction, stroke, or death from cardiovascular disease. Results Allocation to B vitamins lowered plasma homocysteine concentrations by 19% compared with placebo, but had no significant effects on major vascular events (75 v 82 patients, hazard ratio, 0.90 (95% confidence interval 0.66 to 1.23, P=0.50)). Allocation to omega 3 fatty acids increased plasma concentrations of omega 3 fatty acids by 37% compared with placebo, but also had no significant effect on major vascular events (81 v 76 patients, hazard ratio 1.08 (0.79 to 1.47, P=0.64)). Conclusion This study does not support the routine use of dietary supplements containing B vitamins or omega 3 fatty acids for prevention of cardiovascular disease in people with a history of ischaemic heart disease or ischaemic stroke, at least when supplementation is introduced after the acute phase of the initial event. Trial registration Current Controlled Trials ISRCTN41926726. PMID:21115589

  10. Rotator Cuff Tear Shape Characterization

    PubMed Central

    Goodwin, David Steven; Kaplan, Daniel James; Fralinger, David; Gyftopoulos, Soterios; Meislin, Robert J.; Jazrawi, Laith M.

    2016-01-01

    Objectives: Proper surgical planning requires accurate and reliable pre-operative patient information. The more comprehensive the data, the more the surgeon can tailor a general surgical technique to an individual patient’s unique anatomy. A previous retrospective study demonstrated that three-dimensional magnetic resonance imaging more accurately characterized rotator cuff tears compared to two-dimensional images when checked against intra-operative pictures. The purpose of this study was to determine if three-dimensional MRI imaging would continue to be more accurate than two-dimensional imaging in a prospective study. Methods: Patients were prospectively included if they had a full-thickness primary rotator cuff tear on pre-operative MRI. Intra-op videos were taken from the posterior and lateral portals, with a grasper fully mobilizing the torn tendon in each view. 7 surgeons then reviewed the videos and independently characterized the shape of the tears into crescent, U-shaped tears, L-shaped tears, or massive tears. This was considered the gold-standard. Two musculoskeletal radiologists reviewed the corresponding MRI studies independently and blind to the arthroscopic findings and characterized the shape on the basis of the tear’s retraction and size 2D MRI. The 3D reconstructions of each cuff tear were reviewed by each radiologist to characterize the shape. Statistical analysis included 95% confidence intervals and fleiss’s kappa. Results: 37 patients were enrolled in the study. Among the 7 surgeons, agreement on cuff tear was 93% ( =.87). The accuracy for differentiating between crescent-shaped, longitudinal, and massive tears using measurements on 2D MRI was 73.4% for reader 1 and 71.2% for reader 2. The accuracy for tear shape characterization into crescent and longitudinal U- or L-shaped using 3D MRI was 92% for reader 1 and 94% for reader 2. When further characterizing the longitudinal tears as massive or not using 3D MRI, both readers had an

  11. A randomised trial of peer review: the UK National Chronic Obstructive Pulmonary Disease Resources and Outcomes Project.

    PubMed

    Roberts, C M; Stone, R A; Buckingham, R J; Pursey, N A; Harrison, B D W; Lowe, D; Potter, J M

    2010-06-01

    Peer review has been widely employed within the NHS to facilitate health quality improvement but has not been rigorously evaluated. This article reports the largest randomised trial of peer review ever conducted in the UK. The peer review intervention was a reciprocal supportive exercise that included clinicians, hospital management, commissioners and patients which focused on the quality of the provision of four specific evidence-based aspects of chronic obstructive pulmonary disease care. Follow up at 12 months demonstrated few quantitative differences in the number or quality of services offered in the two groups. Qualitative data in contrast suggested many benefits of peer review in most but not all intervention units and some control teams. Findings suggest peer review in this format is a positive experience for most participants but is ineffective in some situations. Its longer term benefits and cost effectiveness require further study. The generic findings of this study have potential implications for the application of peer review throughout the NHS. PMID:20726448

  12. Ultrasound determination of rotator cuff tear repairability

    PubMed Central

    Tse, Andrew K; Lam, Patrick H; Walton, Judie R; Hackett, Lisa

    2015-01-01

    Background Rotator cuff repair aims to reattach the torn tendon to the greater tuberosity footprint with suture anchors. The present study aimed to assess the diagnostic accuracy of ultrasound in predicting rotator cuff tear repairability and to assess which sonographic and pre-operative features are strongest in predicting repairability. Methods The study was a retrospective analysis of measurements made prospectively in a cohort of 373 patients who had ultrasounds of their shoulder and underwent rotator cuff repair. Measurements of rotator cuff tear size and muscle atrophy were made pre-operatively by ultrasound to enable prediction of rotator cuff repairability. Tears were classified following ultrasound as repairable or irreparable, and were correlated with intra-operative repairability. Results Ultrasound assessment of rotator cuff tear repairability has a sensitivity of 86% (p < 0.0001) and a specificity of 67% (p < 0.0001). The strongest predictors of rotator cuff repairability were tear size (p < 0.001) and age (p = 0.004). Sonographic assessments of tear size ≥4 cm2 or anteroposterior tear length ≥25 mm indicated an irreparable rotator cuff tear. Conclusions Ultrasound assessment is accurate in predicting rotator cuff tear repairability. Tear size or anteroposterior tear length and age were the best predictors of repairability. PMID:27582996

  13. Imaging of the Rotator Cuff With Optical Coherence Tomography.

    PubMed

    Hartshorn, Timothy; Ren, Jian; Vangsness, C Thomas

    2015-09-01

    This study evaluated the utility of optical coherence tomography (OCT) in imaging porcine and human rotator cuff (RTC) tissue, analyzed its effectiveness in identifying clinical pathology, and correlated these findings with histologic examination. Twelve human cadaveric and 6 porcine shoulders were evaluated. Six-millimeter-wide bone sections were harvested from the proximal humerus of each specimen, with each containing the entire enthesis of the respective RTC tendon, as well as 2 cm of tendon medial to the enthesis. Only the supraspinatus tendon was evaluated in the human specimens, whereas the enthesis of multiple RTC tendons were evaluated in the porcine model. All specimens were imaged using OCT and correlated with histologic evaluation. Optical coherence tomography evaluation of macroscopically healthy tissue consistently showed an easily identifiable banding pattern (birefringence) in contrast to a disorganized, homogeneous appearance in grossly diseased tissue. Optical coherence tomography was more effective for qualitative evaluation of RTC tissue, identification of bursal-sided RTC tears, and localization of calcific deposits, whereas intrasubstance tendon delaminations and partial articular-sided tendon avulsion lesions were relatively more difficult to identify. Optical coherence tomography correlated well with histologic evaluation in all specimens. Optical coherence tomography provides high-resolution, subsurface imaging of rotator cuff tissue in real-time to a depth of up to 4 mm with excellent correlation to histology in a cadaveric model. Optical coherence tomography could be an effective adjunctive tool for the identification and localization of rotator cuff pathology. The use of OCT in arthroscopic shoulder surgery potentially provides a minimally invasive modality for qualitative assessment of rotator cuff pathology. This may allow for a decrease in soft tissue dissection, improved qualitative assessment of cuff tissue, and improved patient

  14. Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial

    PubMed Central

    2011-01-01

    Introduction Neuroinflammation is thought to be important in Alzheimer's disease pathogenesis. Mast cells are a key component of the inflammatory network and participate in the regulation of the blood-brain barrier's permeability. Masitinib, a selective oral tyrosine kinase inhibitor, effectively inhibits the survival, migration and activity of mast cells. As the brain is rich in mast cells, the therapeutic potential of masitinib as an adjunct therapy to standard care was investigated. Methods A randomised, placebo-controlled, phase 2 study was performed in patients with mild-to-moderate Alzheimer's disease, receiving masitinib as an adjunct to cholinesterase inhibitor and/or memantine. Patients were randomly assigned to receive masitinib (n = 26) (starting dose of 3 or 6 mg/kg/day) or placebo (n = 8), administered twice daily for 24 weeks. The primary endpoint was change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog) to assess cognitive function and the related patient response rate. Results The rate of clinically relevant cognitive decline according to the ADAS-Cog response (increase >4 points) after 12 and 24 weeks was significantly lower with masitinib adjunctive treatment compared with placebo (6% vs. 50% for both time points; P = 0.040 and P = 0.046, respectively). Moreover, whilst the placebo treatment arm showed worsening mean ADAS-Cog, Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory, and Mini-Mental State Examination scores, the masitinib treatment arm reported improvements, with statistical significance between treatment arms at week 12 and/or week 24 (respectively, P = 0.016 and 0.030; P = 0.035 and 0.128; and P = 0.047 and 0.031). The mean treatment effect according to change in ADAS-Cog score relative to baseline at weeks 12 and 24 was 6.8 and 7.6, respectively. Adverse events occurred more frequently with masitinib treatment (65% vs. 38% of patients); however, the majority of events

  15. Effects of community based nurses specialising in Parkinson's disease on health outcome and costs: randomised controlled trial

    PubMed Central

    Jarman, Brian; Hurwitz, Brian; Cook, Adrian; Bajekal, Madhavi; Lee, Alison

    2002-01-01

    Objective To determine the effects of community based nurses specialising in Parkinson's disease on health outcomes and healthcare costs. Design Two year randomised controlled trial. Setting 438 general practices in nine randomly selected health authority areas of England. Participants 1859 patients with Parkinson's disease identified by the participating general practices. Main outcome measures Survival, stand-up test, dot in square test, bone fracture, global health question, PDQ-39, Euroqol, and healthcare costs. Results After two years 315 (17.3%) patients had died, although mortality did not differ between those who were attended by nurse specialists and those receiving standard care from their general practitioner (hazard ratio for nurse group v control group 0.91, 95% confidence interval 0.73 to 1.13). No significant differences were found between the two groups for the stand-up test (odds ratio 1.15, 0.93 to 1.42) and dot in square score (difference −0.7, −3.25 to 1.84). Scores on the global health question were significantly better in patients attended by nurse specialists than in controls (difference −0.23, −0.4 to −0.06), but no difference was observed in the results of the PDQ-39 or Euroqol questionnaires. Direct costs for patient health care increased by an average of £2658 during the study, although not differentially between groups: the average increase was £266 lower among patients attended by a nurse specialist (−£981 to £449). Conclusions Nurse specialists in Parkinson's disease had little effect on the clinical condition of patients, but they did improve their patients' sense of wellbeing, with no increase in patients' healthcare costs. What is already known on this topicMost patients with Parkinson's disease have no regular contact with consultants specialising in the conditionContact by nurse specialists of patients attending hospital increases provision of information and is subjectively valuedIt has not been shown whether

  16. A randomised controlled trial investigating the effect of nutritional supplementation on visual function in normal, and age-related macular disease affected eyes: design and methodology [ISRCTN78467674

    PubMed Central

    Bartlett, Hannah; Eperjesi, Frank

    2003-01-01

    Background Age-related macular disease is the leading cause of blind registration in the developed world. One aetiological hypothesis involves oxidation, and the intrinsic vulnerability of the retina to damage via this process. This has prompted interest in the role of antioxidants, particularly the carotenoids lutein and zeaxanthin, in the prevention and treatment of this eye disease. Methods The aim of this randomised controlled trial is to determine the effect of a nutritional supplement containing lutein, vitamins A, C and E, zinc, and copper on measures of visual function in people with and without age-related macular disease. Outcome measures are distance and near visual acuity, contrast sensitivity, colour vision, macular visual field, glare recovery, and fundus photography. Randomisation is achieved via a random number generator, and masking achieved by third party coding of the active and placebo containers. Data collection will take place at nine and 18 months, and statistical analysis will employ Student's t test. Discussion A paucity of treatment modalities for age-related macular disease has prompted research into the development of prevention strategies. A positive effect on normals may be indicative of a role of nutritional supplementation in preventing or delaying onset of the condition. An observed benefit in the age-related macular disease group may indicate a potential role of supplementation in prevention of progression, or even a degree reversal of the visual effects caused by this condition. PMID:14594455

  17. Cuff width alters the amplitude envelope of wrist cuff pressure pulse waveforms.

    PubMed

    Jilek, Jiri; Stork, Milan

    2010-07-01

    The accuracy of noninvasive blood pressure (BP) measurement with any method is affected by cuff width. Measurement with a too narrow cuff overestimates BP and measurement with a too wide cuff underestimates BP. Automatic wrist cuff BP monitors use permanently attached narrow cuffs with bladders about 6 cm wide. Such narrow cuffs should result in under-cuffing for wrist circumferences larger than 15 cm. The objective of this qualitative study was to show that a narrow wrist cuff results in increased BP values when a cuff pulse amplitude ratio algorithm is used. According to the algorithm used in this study, systolic pressure (SBP) corresponds to the point of 50% of maximal amplitude; for diastolic pressure (DBP) the ratio is 70%. Data were acquired from 12 volunteers in the sitting position. The mean wrist circumference was 18 cm. The acquired cuff pulse data were used to compute SBP, mean pressure (MAP) and DBP. The mean values for a 6 cm cuff were SBP = 144 mmHg, MAP = 104 mmHg and DBP = 88 mmHg. The values for a 10 cm cuff were SBP = 128 mmHg, MAP = 93 mmHg and DBP = 78 mmHg. The reference BP values were SBP = 132 mmHg, MAP = 96 mmHg and DBP = 80 mmHg. All narrow (6 cm) cuff BP values were higher than wide (10 cm) cuff or reference BP values. The results indicate that wider wrist cuffs may be desirable for more accurate and reliable BP measurement with wrist monitors. PMID:20505218

  18. Empowering employees with chronic diseases; development of an intervention aimed at job retention and design of a randomised controlled trial

    PubMed Central

    Varekamp, Inge; de Vries, Gabe; Heutink, Annelies; van Dijk, Frank JH

    2008-01-01

    Background Persons with a chronic disease are less often employed than healthy persons. If employed, many of them experience problems at work. Therefore, we developed a training programme aimed at job retention. The objective of this paper is to describe this intervention and to present the design of a study to evaluate its effectiveness. Development and description of intervention A systematic review, a needs assessment and discussions with Dutch experts led to a pilot group training, tested in a pilot study. The evaluation resulted in the development of a seven-session group training combined with three individual counselling sessions. The training is based on an empowerment perspective that aims to help individuals enhance knowledge, skills and self-awareness. These advances are deemed necessary for problem solving in three stages: exploration and clarification of work related problems, communication at the workplace, and development and implementation of solutions. Seven themes are discussed and practised in the group sessions: 1) Consequences of a chronic disease in the workplace, 2) Insight into feelings and thoughts about having a chronic disease, 3) Communication in daily work situations, 4) Facilities for disabled employees and work disability legislation, 5) How to stand up for oneself, 6) A plan to solve problems, 7) Follow-up. Methods Participants are recruited via occupational health services, patient organisations, employers, and a yearly national conference on chronic diseases. They are eligible when they have a chronic physical medical condition, have a paid job, and experience problems at work. Workers on long-term, 100% sick leave that is expected to continue during the training are excluded. After filling in the baseline questionnaire, the participants are randomised to either the control or the intervention group. The control group will receive no care or care as usual. Post-test mail questionnaires will be sent after 4, 8, 12 and 24 months

  19. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve...

  20. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve...

  1. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve...

  2. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve...

  3. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve...

  4. Logic-controlled occlusive cuff system

    NASA Technical Reports Server (NTRS)

    Baker, J. T.; Hoffler, G. W. (Inventor); Hursta, W. N.

    1981-01-01

    An occlusive cuff system comprises a pressure cuff and a source of regulated compressed gas feeding the cuff through an electrically operated fill valve. An electrically operated vent valve vents the cuff to the ambient pressure. The fill valve is normally closed and the vent valve is normally open. In response to an external start signal, a logic network opens the fill valve and closes the vent valve, thereby starting the pressurization cycle and a timer. A pressure transducer continuously monitors the pressure in the cuff. When the transducer's output equals a selected reference voltage, a comparator causes the logic network to close the fill valve. The timer, after a selected time delay, opens the vent valve to the ambient pressure, thereby ending the pressurization cycle.

  5. Effects of Oral Lycopene Supplementation on Vascular Function in Patients with Cardiovascular Disease and Healthy Volunteers: A Randomised Controlled Trial

    PubMed Central

    Gajendragadkar, Parag R.; Hubsch, Annette; Mäki-Petäjä, Kaisa M.; Serg, Martin; Wilkinson, Ian B.; Cheriyan, Joseph

    2014-01-01

    Aims The mechanisms by which a ‘Mediterranean diet’ reduces cardiovascular disease (CVD) burden remain poorly understood. Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects. We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately, in healthy volunteers (HV). Methods and Results We randomised 36 statin treated CVD patients and 36 healthy volunteers in a 2∶1 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial. Forearm responses to intra-arterial infusions of acetylcholine (endothelium-dependent vasodilatation; EDV), sodium nitroprusside (endothelium-independent vasodilatation; EIDV), and NG-monomethyl-L-arginine (basal nitric oxide (NO) synthase activity) were measured using venous plethysmography. A range of vascular and biochemical secondary endpoints were also explored. EDV in CVD patients post-lycopene improved by 53% (95% CI: +9% to +93%, P = 0.03 vs. placebo) without changes to EIDV, or basal NO responses. HVs did not show changes in EDV after lycopene treatment. Blood pressure, arterial stiffness, lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm. At baseline, CVD patients had impaired EDV compared with HV (30% lower; 95% CI: −45% to −10%, P = 0.008), despite lower LDL cholesterol (1.2 mmol/L lower, 95% CI: −1.6 to −0.9 mmol/L, P<0.001). Post-therapy EDV responses for lycopene-treated CVD patients were similar to HVs at baseline (2% lower, 95% CI: −30% to +30%, P = 0.85), also suggesting lycopene improved endothelial function. Conclusions Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention, but not in HVs. Trial Registration ClinicalTrials.gov NCT01100385 PMID:24911964

  6. Effects of Anabolic Steroids on Chronic Obstructive Pulmonary Disease: A Meta-Analysis of Randomised Controlled Trials

    PubMed Central

    Guo, Yongzhong

    2014-01-01

    Background Anabolic steroids are known to improve body composition and muscle strength in healthy people. However, whether anabolic steroids improve the physical condition and function in patients with chronic obstructive pulmonary disease (COPD) remains undetermined. A meta-analysis was conducted to review the current evidence regarding the effects of anabolic steroids on COPD patients. Methods A comprehensive literature search of PubMed and EMBASE was performed to identify randomised controlled trials that examine the effects of anabolic steroids on COPD patients. Weighted mean differences (WMDs) with 95% confidence intervals were calculated to determine differences between anabolic steroid administration and control conditions. Results Eight eligible studies involving 273 COPD patients were identified in this meta-analysis. Significant improvements were found in body weight (0.956 kg), fat-free mass (1.606 kg), St. George's Respiratory Questionnaire total score (−6.336) and symptom score (−12.148). The apparent improvements in maximal inspiratory pressure (2.740 cmH2O) and maximal expiratory pressure (12.679 cmH2O) were not significant. The effects on handgrip strength, forced expiratory volume in one second (FEV1), predicted FEV1 percent, PaO2, PaCO2 and six-min walk distance were negative, with WMDs of −0.245 kg, −0.096 L/sec, −1.996% of predicted, −1.648 cmHg, −0.039 cmHg and −16.102 meters, respectively. Conclusions Limited evidence available from the published literature suggests that the benefit of anabolic steroids on COPD patients cannot be denied. However, further studies are needed to identify the specific benefits and adverse effects of anabolic steroids on COPD patients and to determine the optimal populations and regimes of anabolic steroids in COPD patients. PMID:24427297

  7. Rolling-cuff flexible bellows

    DOEpatents

    Lambert, D.R.

    1982-09-27

    A flexible connector apparatus used to join two stiff non-deformable members, such as piping, is described. The apparatus is provided with one or more flexible sections or assemblies each utilizing a bellows of a rolling cuff type connected between two ridge members, with the bellows being supported by a back-up ring, such that only the curved end sections of the bellows are unsupported. Thus, the bellows can be considered as being of a tube-shaped configuration and thus have high pressure resistance. The components of the flexible apparatus are sealed or welded one to another such that it is fluid tight.

  8. Management of disorders of the rotator cuff: proceedings of the ISAKOS upper extremity committee consensus meeting.

    PubMed

    Arce, Guillermo; Bak, Klaus; Bain, Gregory; Calvo, Emilio; Ejnisman, Benno; Di Giacomo, Giovanni; Gutierrez, Vicente; Guttmann, Dan; Itoi, Eiji; Ben Kibler, W; Ludvigsen, Tom; Mazzocca, Augustus; de Castro Pochini, Alberto; Savoie, Felix; Sugaya, Hiroyuki; Uribe, John; Vergara, Francisco; Willems, Jaap; Yoo, Yon Sik; McNeil, John W; Provencher, Matthew T

    2013-11-01

    The goal of this article is to consolidate the International Society of Arthroscopy, Knee Surgery & Orthopaedic Sports Medicine (ISAKOS) Upper Extremity Committee's (UEC's) current knowledge on rotator cuff disease and management, as well as highlight key unresolved issues. The rotator cuff is an anatomically complex structure important for providing glenohumeral function and stability as part of a closed chain system. Current consensus suggests rotator cuff injuries are most accurately diagnosed, at levels similar to diagnosis by magnetic resonance imaging, with a combination of cuff- and impingement-specific clinical tests. Updates in the understanding of acromion morphology, the insertional anatomy of the rotator cuff, and the role of suprascapular nerve release may require changes to current classification systems and surgical strategies. Although initial management focuses on nonoperative protocols, discussion continues on whether surgery for isolated impingement is clinically more beneficial than rehabilitation. However, clear indications have yet to be established for the use of single- versus double-row repair because evidence confirms neither is clinically efficacious than the other. Biceps tenodesis, however, in non-isolated cuff tears has proven more successful in addressing the etiology of shoulder pain and yields improved outcomes over tenotomy. Data reviewing the benefits of tendon transfers, shoulder prostheses, and mechanical scaffolds, as well as new research on the potential benefit of platelet-rich plasma, pluripotential stem cells, and gene therapies, will also be presented. PMID:24041864

  9. Fusion versus Bryan Cervical Disc in two-level cervical disc disease: a prospective, randomised study

    PubMed Central

    Nie, Lin; Zhang, Li; Hou, Yong

    2008-01-01

    In this prospective study, our aim was to compare the functional results and radiographic outcomes of fusion and Bryan Cervical Disc replacement in the treatment of two-level cervical disc disease. A total of 65 patients with two-level cervical disc disease were randomly assigned to two groups, those operated on with Bryan Cervical Disc replacement (31) and those operated on with anterior cervical fusion with an iliac crest autograft and plate (34). Clinical evaluation was carried out using the visual analogue scale (VAS), the Short Form 36 (SF-36) and the neck disability index (NDI) during a two year follow-up. Radiological evaluation sought evidence of range of motion, stability and subsidence of the prosthesis. Substantial reduction in NDI scores occurred in both groups, with greater percent improvement in the Bryan group (P = 0.023). The arm pain VAS score improvement was substantial in both groups. Bryan artificial cervical disc replacement seems reliable and safe in the treatment of patients with two-level cervical disc disease. PMID:18956190

  10. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate...

  11. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate...

  12. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate...

  13. The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial

    PubMed Central

    2010-01-01

    Background Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. Methods All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. Results 92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye

  14. Exacerbations in patients with chronic obstructive pulmonary disease receiving physical therapy: a cohort-nested randomised controlled trial

    PubMed Central

    2014-01-01

    Background Physical exercise training aims at reducing disease-specific impairments and improving quality of life in patients with chronic obstructive pulmonary disease (COPD). COPD exacerbations in particular negatively impact COPD progression. Physical therapy intervention seems indicated to influence exacerbations and their consequences. However, information on the effect of physical therapy on exacerbation occurrence is scarce. This study aims to investigate the potential of a protocol-directed physical therapy programme as a means to prevent or postpone exacerbations, to shorten the duration or to decrease the severity of exacerbations in patients with COPD who have recently experienced an exacerbation. Besides, this study focuses on the effect of protocol-directed physical therapy on health status and quality of life and on cost-effectiveness and cost-utility in patients with COPD who have recently experienced an exacerbation. Methods/Design A prospective cohort of 300 COPD patients in all GOLD stages will be constructed. Patients will receive usual multidisciplinary COPD care including guideline-directed physical therapy. Patients in this cohort who have GOLD stage 2 to 4 (post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80% of predicted), who receive reimbursement by health insurance companies for physical therapy (post-bronchodilator Tiffeneau-index < 0.6) and who experience a COPD exacerbation will be asked within 56 days to participate in a cohort-nested prospective randomised controlled trial (RCT). In this RCT, the intervention group will receive a strict physical therapy programme for patients with COPD. This protocol-directed physical therapy (pdPT) will be compared to a control group that will receive sham-treatment, meaning no or very low-intensity exercise training (ST). An economic evaluation will be embedded in the RCT. Anthropometric measurements, comorbidities, smoking, functional exercise capacity, peripheral muscle strength

  15. Current Biomechanical Concepts for Rotator Cuff Repair

    PubMed Central

    2013-01-01

    For the past few decades, the repair of rotator cuff tears has evolved significantly with advances in arthroscopy techniques, suture anchors and instrumentation. From the biomechanical perspective, the focus in arthroscopic repair has been on increasing fixation strength and restoration of the footprint contact characteristics to provide early rehabilitation and improve healing. To accomplish these objectives, various repair strategies and construct configurations have been developed for rotator cuff repair with the understanding that many factors contribute to the structural integrity of the repaired construct. These include repaired rotator cuff tendon-footprint motion, increased tendon-footprint contact area and pressure, and tissue quality of tendon and bone. In addition, the healing response may be compromised by intrinsic factors such as decreased vascularity, hypoxia, and fibrocartilaginous changes or aforementioned extrinsic compression factors. Furthermore, it is well documented that torn rotator cuff muscles have a tendency to atrophy and become subject to fatty infiltration which may affect the longevity of the repair. Despite all the aforementioned factors, initial fixation strength is an essential consideration in optimizing rotator cuff repair. Therefore, numerous biomechanical studies have focused on elucidating the strongest devices, knots, and repair configurations to improve contact characteristics for rotator cuff repair. In this review, the biomechanical concepts behind current rotator cuff repair techniques will be reviewed and discussed. PMID:23730471

  16. Results and lessons from the Spironolactone To Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (STOP-CKD) randomised controlled trial

    PubMed Central

    Ng, Khai P; Jain, Poorva; Gill, Paramjit S; Heer, Gurdip; Townend, Jonathan N; Freemantle, Nick; Greenfield, Sheila; Ferro, Charles J

    2016-01-01

    Objectives To determine whether low-dose spironolactone can safely lower arterial stiffness in patients with chronic kidney disease stage 3 in the primary care setting. Design A multicentre, prospective, randomised, placebo-controlled, double-blinded study. Setting 11 primary care centres in South Birmingham, England. Participants Adult patients with stage 3 chronic kidney disease. Main exclusion criteria were diagnosis of diabetes mellitus, chronic heart failure, atrial fibrillation, severe hypertension, systolic blood pressure <120 mm Hg or baseline serum potassium ≥5 mmol/L. Intervention Eligible participants were randomised to receive either spironolactone 25 mg once daily, or matching placebo for an intended period of 40 weeks. Outcome measures The primary end point was the change in arterial stiffness as measured by pulse wave velocity. Secondary outcome measures included the rate of hyperkalaemia, deterioration of renal function, barriers to participation and expected recruitment rates to a potential future hard end point study. Results From the 11 practices serving a population of 112 462, there were 1598 (1.4%) patients identified as being eligible and were invited to participate. Of these, 134 (8.4%) attended the screening visit of which only 16 (1.0%) were eligible for randomisation. The main reasons for exclusion were low systolic blood pressure (<120 mm Hg: 40 patients) and high estimated glomerular filtration rate (≥60 mL/min/1.73 m2: 38 patients). The trial was considered unfeasible and was terminated early. Conclusions We highlight some of the challenges in undertaking research in primary care including patient participation in trials. This study not only challenged our preconceptions, but also provided important learning for future research in this large and important group of patients. Trial registration number ISRCTN80658312. PMID:26916697

  17. Combination of intralesional verapamil and oral antioxidants for Peyronie's disease: a prospective, randomised controlled study.

    PubMed

    Favilla, V; Russo, G I; Privitera, S; Castelli, T; Madonia, M; La Vignera, S; Condorelli, R; Calogero, A E; Farina, F P; Cimino, S; Morgia, G

    2014-10-01

    The aim of this study was to evaluate the efficacy of the association of intralesional verapamil (ILV) injection with oral antioxidants compared with ILV monotherapy in patients with early onset of Peyronie's disease (PD) at 12-week follow-up. Group A (n = 52) received ILV 10 mg weekly for 12 weeks, while group B (n = 53) received ILV 10 mg weekly for 12 weeks + antioxidants orally one tablet once a day for 3 months. The main efficacy outcomes were the change in plaque size (PS), penile curvature (PC), visual analogue score (VAS), IIEF-15 and IIEF-15 subdomains. Both groups showed significant improvement from baseline to week 12 relative to PS and PC, while group B also in IIEF-15 score (mean difference: 5.51, P < 0.01) and VAS (mean difference: -2.71, P < 0.01). No significant differences were observed between both groups in PS and PC. Finally, both groups showed significant increase in orgasmic function (IIEF-OF) and overall satisfaction (IIEF-OS), while group B showed significant improvement also in intercourse satisfaction (IIEF-IS). Significant differences were found relative to IIEF-OF, IIEF-IS, IIEF-OS and VAS scores in the group B compared with group A. Patients affected by PD may benefit from combination treatment with ILV and oral antioxidants thanks to the improvement in IIEF-OF, IIEF-IS and IIEF-OS at 12 weeks. PMID:24124921

  18. Probiotics and the Microbiome in Celiac Disease: A Randomised Controlled Trial

    PubMed Central

    Myers, Stephen P.; Rolfe, Margaret

    2016-01-01

    Background. There is limited research investigating the composition of the gastrointestinal microbiota in individuals with celiac disease (CoeD) reporting only partial symptom improvement despite adherence to a strict gluten-free diet (GFD). The aim of this research was to determine if the gastrointestinal microbiota could be altered by probiotic bacteria and provide a potential new therapy for this subgroup. Methods. A multicentre RCT was conducted between January and August 2011 in Australia. Participants included 45 people with CoeD reporting only partial symptom improvement despite adherence to a strict GFD for a minimum of 12 months. Participants took 5 g of VSL#™ probiotic formulation (n = 23) or 5 g placebo (n = 22) orally twice daily for 12 weeks. The main outcome measured was the efficacy of the probiotic formula in altering faecal microbiota counts between baseline and week 12. Safety was determined by safety blood and monitoring adverse events. Results. SPSS™ multivariate repeated measures analysis (95th confidence level) revealed no statistically significant changes between the groups in the faecal microbiota counts or blood safety measures over the course of the study. Conclusion. The probiotic formula when taken orally over the 12-week period did not significantly alter the microbiota measured in this population. The trial was registered with Australian and New Zealand Clinical Trials Register ACTRN12610000630011. PMID:27525027

  19. Probiotics and the Microbiome in Celiac Disease: A Randomised Controlled Trial.

    PubMed

    Harnett, Joanna; Myers, Stephen P; Rolfe, Margaret

    2016-01-01

    Background. There is limited research investigating the composition of the gastrointestinal microbiota in individuals with celiac disease (CoeD) reporting only partial symptom improvement despite adherence to a strict gluten-free diet (GFD). The aim of this research was to determine if the gastrointestinal microbiota could be altered by probiotic bacteria and provide a potential new therapy for this subgroup. Methods. A multicentre RCT was conducted between January and August 2011 in Australia. Participants included 45 people with CoeD reporting only partial symptom improvement despite adherence to a strict GFD for a minimum of 12 months. Participants took 5 g of VSL#™ probiotic formulation (n = 23) or 5 g placebo (n = 22) orally twice daily for 12 weeks. The main outcome measured was the efficacy of the probiotic formula in altering faecal microbiota counts between baseline and week 12. Safety was determined by safety blood and monitoring adverse events. Results. SPSS™ multivariate repeated measures analysis (95th confidence level) revealed no statistically significant changes between the groups in the faecal microbiota counts or blood safety measures over the course of the study. Conclusion. The probiotic formula when taken orally over the 12-week period did not significantly alter the microbiota measured in this population. The trial was registered with Australian and New Zealand Clinical Trials Register ACTRN12610000630011. PMID:27525027

  20. Magnesium for acute exacerbation of chronic obstructive pulmonary disease: A systematic review of randomised trials.

    PubMed

    Shivanthan, Mitrakrishnan Chrishan; Rajapakse, Senaka

    2014-04-01

    The efficacy of magnesium sulphate in chronic obstructive pulmonary disease (COPD) was assessed by conducting a systematic review of published randomized clinical trials through extensive searches in MEDLINE and SCOPUS with no date limits, as well as manual review of journals. Outcome measures varied depending on route(s) of administration of magnesium sulphate and medications co-administered. Risk of bias was evaluated and quality of evidence was graded. Four (4) randomized trials were included. All trials had a moderate risk of bias and were of average methodological quality. Magnesium sulphate given intravenously did not seem to have an immediate bronchodilatory effect; however it appears to potentiate the bronchodilatory effect of inhaled beta-2 agonists. Increase in peak expiratory flow rate (PEFR) at 30 and 45 min was greater in those who received magnesium sulphate compared to placebo (P = 0.03), although the mean percentage change in PEFR was just 24%, without significant differences in dyspnoea scores, hospital admission rates, or emergency department readmission rates compared to placebo. Nebulized magnesium sulphate with salbutamol versus nebulized salbutamol with saline placebo showed no significant differences is forced expiratory volume in 1 s (FEV1) measured at 90 min after adjustment for baseline FEV1 (P = 0.34) or differences in the need for hospital admission. Combined inhalational and intravenous magnesium sulphate versus intravenous saline placebo and nebulized ipratropium bromide were comparable in terms of hospital admission, intubation and death, but the ipratropium bromide group showed better bronchodilator effect and improvement in arterial blood gas parameters. Overall, trial evidence for trial evidence for magnesium sulphate in acute exacerbation of COPD is poor, and further well-designed trials are needed. PMID:24791169

  1. Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial

    PubMed Central

    Dixon, Padraig; Edwards, Louisa; Thomas, Clare; Gaunt, Daisy; Foster, Alexis; Large, Shirley; Montgomery, Alan A

    2016-01-01

    Objectives To investigate the cost-effectiveness of a telehealth intervention for primary care patients with raised cardiovascular disease (CVD) risk. Design A prospective within-trial patient-level economic evaluation conducted alongside a randomised controlled trial. Setting Patients recruited through primary care, and intervention delivered via telehealth service. Participants Adults with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, with at least 1 modifiable risk factor. Intervention A series of up to 13 scripted, theory-led telehealth encounters with healthcare advisors, who supported participants to make behaviour change, use online resources, optimise medication and improve adherence. Participants in the control arm received usual care. Primary and secondary outcome measures Cost-effectiveness measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Productivity impacts, participant out-of-pocket expenditure and the clinical outcome were presented in a cost-consequences framework. Results 641 participants were randomised—325 to receive the telehealth intervention in addition to usual care and 316 to receive only usual care. 18% of participants had missing data on either costs, utilities or both. Multiple imputation was used for the base case results. The intervention was associated with incremental mean per-patient National Health Service (NHS) costs of £138 (95% CI 66 to 211) and an incremental QALY gain of 0.012 (95% CI −0.001 to 0.026). The incremental cost-effectiveness ratio was £10 859. Net monetary benefit at a cost-effectiveness threshold of £20 000 per QALY was £116 (95% CI −58 to 291), and the probability that the intervention was cost-effective at this threshold value was 0.77. Similar results were obtained from a complete case analysis. Conclusions There is evidence to suggest that the Healthlines telehealth

  2. A two year randomised controlled trial of intramuscular depot steroids in patients with established rheumatoid arthritis who have shown an incomplete response to disease modifying antirheumatic drugs

    PubMed Central

    Choy, E; Kingsley, G; Khoshaba, B; Pipitone, N; Scott, D; the, I

    2005-01-01

    Background: In rheumatoid arthritis (RA), intramuscular (IM) pulsed depomedrone expedites an immediate response to disease modifying antirheumatic drugs (DMARDs). Although IM depomedrone is also widely used to treat disease flares in patients treated with DMARDs, its effect on radiological progression has not been assessed. Objective: To evaluate the benefits of 120 mg IM depomedrone versus placebo in patients with established RA whose disease was inadequately controlled by existing DMARDs. Methods: In a 2 year prospective randomised controlled trial patients were assessed using the ILAR/WHO core dataset, disease activity score (DAS28), x ray examination of hands and feet scored by Larsen's method, and bone densitometry. Results: 291 patients with RA were screened, 166 were eligible, and 91 consented and were randomised. Disease activity improved more rapidly in the steroid treated patients than with placebo, but after 6 months no difference remained. A small but significant reduction in erosive damage in the steroid group compared with placebo was also found. More adverse reactions occurred in the steroid treated group than in the placebo patients (55 v 42), especially those reactions traditionally related to steroids (16 v 2), including vertebral fracture, diabetes, and myocardial infarction. Hip bone density fell significantly in steroid treated but not placebo patients. Conclusions: IM depomedrone improved disease activity in the short term and produced a small reduction in bone erosion at the cost of a significant increase in adverse events. Despite the initial benefit of IM depomedrone, when patients respond suboptimally to a DMARD they should not be given long term additional steroids but should be treated with alternative or additional DMARDs. PMID:15760929

  3. Rotator cuff tear measurement by arthropneumotomography

    SciTech Connect

    Kilcoyne, R.F.; Matsen, F.A. III

    1983-02-01

    Five years of experience with a method of shoulder arthrography using upright tomography in cases of suspected or known rotator cuff tears has demonstrated its effectiveness. The value of the procedure lies in its ability to demonstrate the size of the cuff tear and the thickness of the remaining cuff tissue. This information provides the surgeon with a preoperative estimate of the difficulty of the repair and the prognosis for a good functional recovery. In 33 cases, there was good correlation between the upright thin-section tomogram findings and the surgical results. The tomograms provided better information about the size of the tear and the quality of the remaining cuff than did plain arthrograms.

  4. Effects of vitamin D supplementation on intestinal permeability, cathelicidin and disease markers in Crohn’s disease: Results from a randomised double-blind placebo-controlled study

    PubMed Central

    Raftery, Tara; Martineau, Adrian R; Greiller, Claire L; Ghosh, Subrata; McNamara, Deirdre; Bennett, Kathleen; Meddings, Jon

    2015-01-01

    Background Vitamin D (vitD) supplementation may prolong remission in Crohn’s disease (CD); however, the clinical efficacy and mechanisms are unclear. Aim To determine changes in intestinal permeability (IP), antimicrobial peptide (AMP) concentrations and disease markers in CD, in response to vitD supplementation. Methods In a double-blind randomised placebo-controlled study, we assigned 27 CD patients in remission to 2000 IU/day vitD or placebo for 3 mos. We determined IP, plasma cathelicidin (LL-37 in ng/mL), human-beta-defensin-2 (hBD2 in pg/mL), disease activity (Crohn’s Disease Activity Index (CDAI)), C-reactive protein (CRP in mg/L), fecal calprotectin (µg/g), Quality of Life (QoL) and serum 25-hydroxyvitamin D (25(OH)D in nmol/L) at 0 and 3 mos. Results At 3 mos., 25(OH)D concentrations were significantly higher in those whom were treated (p < 0.001). Intra-group analysis showed increased LL-37 concentrations (p = 0.050) and maintenance of IP measures in the treated group. In contrast, in the placebo group, the small bowel (p = 0.018) and gastro-duodenal permeability (p = 0.030) increased from baseline. At 3 mos., patients with 25(OH)D ≥ 75 nmol/L had significantly lower CRP (p = 0.019), higher QoL (p = 0.037), higher LL-37 concentrations (p < 0.001) and non-significantly lower CDAI scores (p = 0.082), compared to those with levels <75 nmol/L. Conclusion Short-term treatment with 2000 IU/day vitD significantly increased 25(OH)D levels in CD patients in remission and it was associated with increased LL-37 concentrations and maintenance of IP. Achieving 25(OH)D ≥ 75 nmol/l was accompanied by higher circulating LL-37, higher QoL scores and reduced CRP. Registered at ClinicalTrials.gov (NCT01792388). PMID:26137304

  5. Rotator cuff injuries in adolescent athletes.

    PubMed

    Weiss, Jennifer M; Arkader, Alexandre; Wells, Lawrence M; Ganley, Theodore J

    2013-03-01

    The cause of rotator cuff injuries in the young athlete has been described as an overuse injury related to internal impingement. Abduction coupled with external rotation is believed to impinge on the rotator cuff, specifically the supraspinatus, and lead to undersurface tears that can progress to full-thickness tears. This impingement is believed to be worsened with increased range of motion and instability in overhead athletes. A retrospective review of seven patients diagnosed with rotator cuff injuries was performed to better understand this shoulder injury pattern. The type of sport played, a history of trauma, diagnosis, treatment method, and outcome were noted. Six patients were male and one was a female. Baseball was the primary sport for four patients, basketball for one, gymnastics for one, and wrestling for one. The following injury patterns were observed: two patients tore their subscapularis tendon, two sustained avulsion fractures of their lesser tuberosity, one tore his rotator interval, one tore his supraspinatus, and one avulsed his greater tuberosity. Only four patients recalled a specific traumatic event. Three patients were treated with arthroscopic rotator cuff repair, three with miniopen repair, and one was treated with rehabilitation. Six of the seven patients returned to their preinjury level of sport after treatment. Rotator cuff tears are rare in the adolescent age group. The injury patterns suggest that acute trauma likely accounts for many rotator cuff tears and their equivalents in the young patient. Adolescents with rotator cuff tears reliably return to sports after treatment. The possibility of rotator cuff tears in skeletally immature athletes should be considered. The prognosis is very good once this injury is identified and treated. PMID:22668571

  6. Clinical Examination of the Rotator Cuff

    PubMed Central

    Jain, Nitin B.; Wilcox, Reginald; Katz, Jeffrey N.; Higgins, Laurence D.

    2013-01-01

    Rotator cuff tears are the leading cause of shoulder pain and shoulder-related disability accounting for 4.5 million physician visits in the United States annually. A careful history and structured physical examination are often sufficient for diagnosing rotator cuff disorders. We are not aware of a clinical review article that presents a structured physical examination protocol of the rotator cuff for the interested clinician. To fill this void, we present a physical examination protocol developed on the basis of review of prior literature and our clinical experience from dedicated shoulder practices. Our protocol includes range of motion testing using a goniometer, strength testing using a dynamometer, and select special tests. Among the many tests for rotator cuff disorders that have been described, we chose ones that have been more thoroughly assessed for sensitivity and specificity. This protocol can be used to isolate the specific rotator cuff tendon involved. The protocol can be typically completed in 15 minutes. We also discuss the clinical implications and limitations of the physical examination maneuvers described in our protocol. This protocol is thorough yet time-efficient for a busy clinical practice. It is useful in diagnosis of rotator cuff tears, impingement syndrome, and biceps pathology. PMID:23332909

  7. β-Blockers for the prevention of acute exacerbations of chronic obstructive pulmonary disease (βLOCK COPD): a randomised controlled study protocol

    PubMed Central

    Bhatt, Surya P; Connett, John E; Voelker, Helen; Lindberg, Sarah M; Westfall, Elizabeth; Wells, J Michael; Lazarus, Stephen C; Criner, Gerard J; Dransfield, Mark T

    2016-01-01

    Introduction A substantial majority of chronic obstructive pulmonary disease (COPD)-related morbidity, mortality and healthcare costs are due to acute exacerbations, but existing medications have only a modest effect on reducing their frequency, even when used in combination. Observational studies suggest β-blockers may reduce the risk of COPD exacerbations; thus, we will conduct a randomised, placebo-controlled trial to definitively assess the impact of metoprolol succinate on the rate of COPD exacerbations. Methods and analyses This is a multicentre, placebo-controlled, double-blind, prospective randomised trial that will enrol 1028 patients with at least moderately severe COPD over a 3-year period. Participants with at least moderate COPD will be randomised in a 1:1 fashion to receive metoprolol or placebo; the cohort will be enriched for patients at high risk for exacerbations. Patients will be screened and then randomised over a 2-week period and will then undergo a dose titration period for the following 6 weeks. Thereafter, patients will be followed for 42 additional weeks on their target dose of metoprolol or placebo followed by a 4-week washout period. The primary end point is time to first occurrence of an acute exacerbation during the treatment period. Secondary end points include rates and severity of COPD exacerbations; rate of major cardiovascular events; all-cause mortality; lung function (forced expiratory volume in 1 s (FEV1)); dyspnoea; quality of life; exercise capacity; markers of cardiac stretch (pro-NT brain natriuretic peptide) and systemic inflammation (high-sensitivity C reactive protein and fibrinogen). Analyses will be performed on an intent-to-treat basis. Ethics and dissemination The study protocol has been approved by the Department of Defense Human Protection Research Office and will be approved by the institutional review board of all participating centres. Study findings will be disseminated through presentations at national

  8. Healthy Ageing Through Internet Counselling in the Elderly: the HATICE randomised controlled trial for the prevention of cardiovascular disease and cognitive impairment

    PubMed Central

    Richard, Edo; Jongstra, Susan; Soininen, Hilkka; Brayne, Carol; Moll van Charante, Eric P; Meiller, Yannick; van der Groep, Bram; Beishuizen, Cathrien R L; Mangialasche, Francesca; Barbera, Mariagnese; Ngandu, Tiia; Coley, Nicola; Guillemont, Juliette; Savy, Stéphanie; Dijkgraaf, Marcel G W; Peters, Ron J G; van Gool, Willem A; Kivipelto, Miia; Andrieu, Sandrine

    2016-01-01

    Introduction Cardiovascular disease and dementia share a number of risk factors including hypertension, hypercholesterolaemia, smoking, obesity, diabetes and physical inactivity. The rise of eHealth has led to increasing opportunities for large-scale delivery of prevention programmes encouraging self-management. The aim of this study is to investigate whether a multidomain intervention to optimise self-management of cardiovascular risk factors in older individuals, delivered through an coach-supported interactive internet platform, can improve the cardiovascular risk profile and reduce the risk of cardiovascular disease and cognitive decline. Methods and analysis HATICE is a multinational, multicentre, prospective, randomised, open-label blinded end point (PROBE) trial with 18 months intervention. Recruitment of 2600 older people (≥65 years) at increased risk of cardiovascular disease will take place in the Netherlands, Finland and France. Participants randomised to the intervention condition will have access to an interactive internet platform, stimulating self-management of vascular risk factors, with remote support by a coach. Participants in the control group will have access to a static internet platform with basic health information. The primary outcome is a composite score based on the average z-score of the difference between baseline and 18 months follow-up values of systolic blood pressure, low-density-lipoprotein and body mass index. Main secondary outcomes include the effect on the individual components of the primary outcome, the effect on lifestyle-related risk factors, incident cardiovascular disease, mortality, cognitive functioning, mood and cost-effectiveness. Ethics and dissemination The study was approved by the medical ethics committee of the Academic Medical Center in Amsterdam, the Comité de Protection des Personnes Sud Ouest et Outre Mer in France and the Northern Savo Hospital District Research Ethics Committee in Finland. We

  9. Effect of increased water intake on plasma copeptin in patients with chronic kidney disease: results from a pilot randomised controlled trial

    PubMed Central

    Sontrop, Jessica M; Huang, Shi-Han; Garg, Amit X; Moist, Louise; House, Andrew A; Gallo, Kerri; Clark, William F

    2015-01-01

    Objectives Increased water intake may have a beneficial effect on the kidney through suppression of plasma vasopressin. We examined the effect of increased water intake on plasma copeptin (a marker of vasopressin) over 6 weeks in patients with chronic kidney disease. Design Secondary analysis of a randomised controlled parallel-group pilot trial. Setting Canada, 2012–2013. Participants 28 patients with stage 3 chronic kidney disease randomised (2:1) to a hydration (n=17) or control group (n=11). Intervention The hydration group was coached to increase water intake by up to 1.5 L/day for 6 weeks. The control group was asked to maintain regular water intake. Measures and outcomes Participants provided blood and 24 h urine samples at baseline and 6 weeks. Change in plasma copeptin was compared within and between study groups. Results Participants were 64% male with a mean age of 62 years and an estimated glomerular filtration rate of 40 mL/min/1.73 m2. Between baseline and 6 weeks, 24 h urine volume increased by 0.7 L/day in the hydration group, rising from 2.3 to 3.0 L/day (p=0.01), while decreasing by 0.3 L/day among controls, from 2.0 to 1.7 L/day (p=0.07); between-group difference: 0.9 L/day (95% CI 0.37 to 1.46; p=0.002). In the hydration group, median copeptin decreased by 3.6 pmol/L, from 15.0 to 10.8 pmol/L (p=0.005), while remaining stable among controls at 19 pmol/L (p=0.76; p=0.19 for the between-group difference in median change); the between-group difference in mean change was 5.4 pmol/L (95% CI −1.2 to 12.0; p=0.11). Conclusions Adults with stage 3 chronic kidney disease can be successfully randomised to drink approximately 1 L more per day than controls. This increased water intake caused a significant decrease in plasma copeptin concentration. Our larger 12-month trial will examine whether increased water intake can slow renal decline in patients with chronic kidney disease. Trial registration number NCT

  10. Handcrafted cuff manometers do not accurately measure endotracheal tube cuff pressure

    PubMed Central

    Annoni, Raquel; de Almeida, Antonio Evanir

    2015-01-01

    Objective To test the agreement between two handcrafted devices and a cuff-specific manometer. Methods The agreement between two handcrafted devices adapted to measure tracheal tube cuff pressure and a cuff-specific manometer was tested on 79 subjects. The cuff pressure was measured with a commercial manometer and with two handcrafted devices (HD) assembled with aneroid sphygmomanometers (HD1 and HD2). The data were compared using Wilcoxon and Spearman tests, the intraclass correlation coefficient (ICC) and limit-of-agreement analysis. Results Cuff pressures assessed with handcrafted devices were significantly different from commercial device measurements (pressures were higher when measured with HD1 and lower with HD2). The ICCs between the commercial device and HD1 and HD2 were excellent (ICC = 0.8 p < 0.001) and good (ICC = 0.66, p < 0.001), respectively. However, the Bland- Altman plots showed wide limits of agreement between HD1 and HD2 and the commercial device. Conclusion The handcrafted manometers do not provide accurate cuff pressure measurements when compared to a cuff-specific device and should not be used to replace the commercial cuff manometers in mechanically ventilated patients. PMID:26376160

  11. Occult Interpositional Rotator Cuff - an Extremely Rare Case of Traumatic Rotator Cuff Tear

    PubMed Central

    Lin, Cheng-Li; Su, Wei-Ren; Jou, I-Ming

    2012-01-01

    Traumatic interposition of a rotator cuff tendon in the glenohumeral joint without recognizable glenohumeral dislocation is an unusual complication after shoulder trauma. Here we report the clinical and imaging presentations of a 17-year-old man with trapped rotator cuff tendons in the glenohumeral joint after a bicycle accident. The possible trauma mechanism is also discussed. PMID:22247643

  12. Tumour necrosis factor inhibitors versus combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis: TACIT non-inferiority randomised controlled trial

    PubMed Central

    Ibrahim, Fowzia; Farewell, Vern; O’Keeffe, Aidan G; Walker, David; Kelly, Clive; Birrell, Fraser; Chakravarty, Kuntal; Maddison, Peter; Heslin, Margaret; Patel, Anita; Kingsley, Gabrielle H

    2015-01-01

    Objective To determine whether intensive combinations of synthetic disease modifying drugs can achieve similar clinical benefits at lower costs to high cost biologics such as tumour necrosis factor inhibitors in patients with active rheumatoid arthritis resistant to initial methotrexate and other synthetic disease modifying drugs. Design Open label pragmatic randomised multicentre two arm non-inferiority trial over 12 months. Setting 24 rheumatology clinics in England. Participants Patients with rheumatoid arthritis who were eligible for treatment with tumour necrosis factor inhibitors according to current English guidance were randomised to either the tumour necrosis factor inhibitor strategy or the combined disease modifying drug strategy. Interventions Biologic strategy: start tumour necrosis factor inhibitor; second biologic in six month for non-responders. Alternative strategy: start combination of disease modifying drugs; start tumour necrosis factor inhibitors after six months in non-responders. Main outcome measure Primary outcome: reduction in disability at 12 months measured with patient recorded heath assessment questionnaire (range 0.00-3.00) with a 0.22 non-inferiority margin for combination treatment versus the biologic strategy. Secondary outcomes: quality of life, joint damage, disease activity, adverse events, and costs. Intention to treat analysis used multiple imputation methods for missing data. Results 432 patients were screened: 107 were randomised to tumour necrosis factor inhibitors and 101 started taking; 107 were randomised to the combined drug strategy and 104 started taking the drugs. Initial assessments were similar; 16 patients were lost to follow-up (seven with the tumour necrosis factor inhibitor strategy, nine with the combined drug strategy); 42 discontinued the intervention but were followed-up (19 and 23, respectively). The primary outcome showed mean falls in scores on the health assessment questionnaire of −0.30 with the

  13. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

    PubMed Central

    Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

    2013-01-01

    Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. Interventions Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George’s respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. Results Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person

  14. Rotator Cuff Tendinitis and Tear (Beyond the Basics)

    MedlinePlus

    ... is usually treated with ice, antiinflammatory drugs, and physical therapy. (See 'Rotator cuff injury treatment' below.) Rotator cuff ... small- to medium-size tears usually improve with physical therapy exercises, stopping painful activities, and, in some cases, ...

  15. Rehabilitation following rotator cuff repair: a systematic review

    PubMed Central

    Bateman, Marcus; Clark, David; Selfe, James; Watkinson, Duncan; Walton, Mike; Funk, Lennard

    2015-01-01

    Background The aim of this systematic review was to evaluate the effectiveness of rehabilitation programmes following surgical repair of the rotator cuff with emphasis upon length of immobilisation and timing of introduction of load. Methods An electronic search of CENTRAL, MEDLINE and PEDro was undertaken to August 2014 and supplemented by hand searching. Randomised controlled trials were included, quality appraised using the PEDro scale and synthesised via meta-analysis or narrative synthesis, based upon levels of evidence, where appropriate. Results Twelve studies were included. There is strong evidence that early initiation of rehabilitation does not adversely affect clinical outcome but there is a marginally higher, statistically non-significant, incidence of tendon re-tear (OR 1.3; 95% CI 0.72 to 2.2). There is strong evidence that initiation of functional loading early in the rehabilitation programme does not adversely affect clinical outcome. Discussion Concern about early initiation of rehabilitation and introduction of gradual functional load does not appear warranted but this should be considered in a context of potential for Type II error. There is further need to evaluate approaches that foster early initiation of rehabilitation and gradual introduction of functional load as well as considering key outcomes such as return to work.

  16. HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD): mixed-method feasibility pilot randomised controlled trial of a novel intervention

    PubMed Central

    Buckingham, Susan; Kendall, Marilyn; Ferguson, Susie; MacNee, William; Sheikh, Aziz; White, Patrick; Worth, Allison; Boyd, Kirsty; Murray, Scott A; Pinnock, Hilary

    2015-01-01

    Background: Extending palliative care to those with advanced non-malignant disease is advocated, but the implications in specific conditions are poorly understood. AIMs: We piloted a novel nurse-led intervention, HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD), undertaken 4 weeks after discharge from hospital, which sought to identify and address the holistic care needs of people with severe COPD. Methods: This 6-month mixed-method feasibility pilot trial randomised (ratio 3:1) patients to HELP-COPD or usual care. We assessed the feasibility of using validated questionnaires as outcome measures and analysed the needs/actions recorded in the HELP-COPD records. Semi-structured interviews with a purposive sample of patients, carers and professionals explored the perceptions of HELP-COPD. Verbatim transcriptions and field notes were analysed using Normalisation Process Theory as a framework. Results: We randomised 32 patients (24 to HELP-COPD); 19 completed the study (death=3, ill-health=4, declined=6). The HELP-COPD record noted a mean of 1.6 actions/assessment, mostly provision of information or self-help actions: only five referrals were made. Most patients were positive about HELP-COPD, discussing their concerns and coping strategies in all domains, but the questionnaires were burdensome for some patients. Adaptation to their slowly progressive disability and a strong preference to rely on family support was reflected in limited acceptance of formal services. Professionals perceived HELP-COPD as addressing an important aspect of care, although timing overlapped with discharge planning. Conclusions: The HELP-COPD intervention was well received by patients and the concept resonated with professionals, although delivery post discharge overlapped with existing services. Integration of brief holistic care assessments in the routine primary care management of COPD may be more appropriate. PMID:26028347

  17. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into...

  18. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  19. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Inflatable tracheal tube cuff. 868.5750 Section 868.5750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  20. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  1. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  2. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  3. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  4. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Inflatable tracheal tube cuff. 868.5750 Section 868.5750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  5. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Inflatable tracheal tube cuff. 868.5750 Section 868.5750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  6. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Inflatable tracheal tube cuff. 868.5750 Section 868.5750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  7. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Inflatable tracheal tube cuff. 868.5750 Section 868.5750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  8. MAGnesium-oral supplementation to reduce PAin in patients with severe PERipheral arterial occlusive disease: the MAG-PAPER randomised clinical trial protocol

    PubMed Central

    Venturini, Monica Aida; Zappa, Sergio; Minelli, Cosetta; Bonardelli, Stefano; Lamberti, Laura; Bisighini, Luca; Zangrandi, Marta; Turin, Maddalena; Rizzo, Francesco; Rizzolo, Andrea; Latronico, Nicola

    2015-01-01

    Introduction Magnesium exerts analgaesic effects in several animal pain models, as well as in patients affected by acute postoperative pain and neuropathic chronic pain. There is no evidence that magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD). We describe the protocol of a single-centre randomised double-blind clinical trial aimed at assessing the efficacy of oral magnesium supplementation in controlling severe pain in patients with advanced PAOD. Methods and analysis Adult patients affected by PAOD at stages III and IV of Lèriche-Fontaine classification, who are opioid-naïve, and who have been admitted to our Acute Pain Service for intractable pain, will be eligible. Patients will be randomised to the control group, treated with standard therapy (oxycodone and pregabalin) plus placebo for 2 weeks, or to the experimental group (standard therapy plus magnesium oxide). Patients will be evaluated on days 0, 2, 4, 6, 8, 12 and 14; the following information will being collected: daily oxycodone dose; average and maximum pain (Numerical Rating Scale); pain relief (Pain Relief Scale); characteristics of the pain (Neuropathic Pain Scale); impact of pain on the patient's daily activities (Brief Pain Inventory). The primary outcome will be oxycodone dosage needed to achieve satisfactory analgaesia on day 14. Secondary outcomes will be pain relief on day 2, time needed to achieve satisfactory analgaesia and time needed to achieve a pain reduction of 50%. A sample size calculation was performed for the primary outcome, which estimated a required sample size of 150 patients (75 per group). Ethics and dissemination Ethical approval of the study protocol has been obtained from Comitato Etico Provinciale di Brescia, Brescia, Italy. Trial results will be disseminated through scientific journal manuscripts and scientific conference presentations. Trial registration number NCT02455726. PMID:26674497

  9. Randomised trial of pivampicillin plus pivmecillinam vs. pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae.

    PubMed

    Johansen, H K; Børch, K; Espersen, F; Koch, C; Høiby, N

    1999-01-01

    A prospective, randomised, single-blind comparative trial was carried out to determine whether double beta-lactam treatment with pivampicillin plus pivmecillinam is more effective than pivampicillin alone in the treatment of recurrent and chronic lung infections with Haemophilus influenzae in patients with chronic obstructive pulmonary disease (COPD) or cystic fibrosis (CF). Fifty-six children and young adults with COPD or CF were randomised to the clinical study. The patients were allocated at random to receive perorally either pivmecillinam, 40 mg/kg/day, combined with pivampicillin, 50 mg/kg/day, or pivampicillin 50 mg/kg/day alone for 14 days. A cross-over pharmacokinetic study using the same drugs was carried out in 10 CF patients to determine the antibiotic concentrations in serum and sputum after a single dose of each drug. The clinical study showed no significant differences in clinical scoring, lung function tests or adverse events after treatment with pivampicillin plus pivmecillinam or pivampicillin alone. Follow-up microbiological evaluation 2 and 6 weeks after the end of treatment showed that the offending pathogen was eradicated in 68% of the patients treated with pivampicillin plus pivmecillinam and in 67% of the patients treated with pivampicillin alone. Reinfection with another biotype was more common in the combination group (50% vs. 21%) than in the pivampicillin group. In the pharmacokinetic study the median peak serum concentration occurred two hours after intake of tablets. The efficacy of double beta lactam treatment in lung infections with H. influenzae appears to be equivalent to that of ampicillin on clinical lung symptoms, lung function tests, adverse effects and bacteriology. PMID:10640263

  10. Clinical effectiveness and cost-effectiveness of physiotherapy and occupational therapy versus no therapy in mild to moderate Parkinson's disease: a large pragmatic randomised controlled trial (PD REHAB).

    PubMed Central

    Clarke, Carl E; Patel, Smitaa; Ives, Natalie; Rick, Caroline E; Woolley, Rebecca; Wheatley, Keith; Walker, Marion F; Zhu, Shihua; Kandiyali, Rebecca; Yao, Guiqing; Sackley, Catherine M

    2016-01-01

    BACKGROUND Cochrane reviews of physiotherapy (PT) and occupational therapy (OT) for Parkinson's disease found insufficient evidence of effectiveness, but previous trials were methodologically flawed with small sample size and short-term follow-up. OBJECTIVES To evaluate the clinical effectiveness and cost-effectiveness of individualised PT and OT in Parkinson's disease. DESIGN Large pragmatic randomised controlled trial. SETTING Thirty-eight neurology and geriatric medicine outpatient clinics in the UK. PARTICIPANTS Seven hundred and sixty-two patients with mild to moderate Parkinson's disease reporting limitations in activities of daily living (ADL). INTERVENTION Patients were randomised online to either both PT and OT NHS services (n = 381) or no therapy (n = 381). Therapy incorporated a patient-centred approach with individual assessment and goal setting. MAIN OUTCOME MEASURES The primary outcome was instrumental ADL measured by the patient-completed Nottingham Extended Activities of Daily Living (NEADL) scale at 3 months after randomisation. Secondary outcomes were health-related quality of life [Parkinson's Disease Questionnaire-39 (PDQ-39); European Quality of Life-5 Dimensions (EQ-5D)], adverse events, resource use and carer quality of life (Short Form questionnaire-12 items). Outcomes were assessed before randomisation and at 3, 9 and 15 months after randomisation. RESULTS Data from 92% of the participants in each group were available at the primary time point of 3 months, but there was no difference in NEADL total score [difference 0.5 points, 95% confidence interval (CI) -0.7 to 1.7; p = 0.4] or PDQ-39 summary index (0.007 points, 95% CI -1.5 to 1.5; p = 1.0) between groups. The EQ-5D quotient was of borderline significance in favour of therapy (-0.03, 95% CI -0.07 to -0.002; p = 0.04). Contact time with therapists was for a median of four visits of 58 minutes each over 8 weeks (mean dose 232 minutes). Repeated measures analysis

  11. Free biceps tendon autograft to augment arthroscopic rotator cuff repair.

    PubMed

    Obma, Padraic R

    2013-01-01

    Arthroscopic rotator cuff repairs have become the standard of treatment for all sizes of tears over the past several years. Current healing rates reported in the literature are quite good, but improving the healing potential of rotator cuff repairs remains a challenging problem. There has been an increase recently in the use of augmentation of rotator cuff repairs with xenografts or synthetics for large and massive tears. Biceps tenodesis is often indicated as part of the treatment plan while one is performing rotator cuff surgery. A subpectoral biceps tenodesis provides a source of autograft to augment rotator cuff repairs of all sizes. Two techniques are presented to augment rotator cuff repairs with a free biceps tendon autograft. This is a novel idea in an attempt to improve healing rates and long-term results of rotator cuff repairs of all sizes. PMID:24400197

  12. Effectiveness of disease-specific cognitive–behavioural therapy on depression, anxiety, quality of life and the clinical course of disease in adolescents with inflammatory bowel disease: study protocol of a multicentre randomised controlled trial (HAPPY-IBD)

    PubMed Central

    van den Brink, Gertrude; Stapersma, Luuk; El Marroun, Hanan; Henrichs, Jens; Szigethy, Eva M; Utens, Elisabeth MWJ; Escher, Johanna C

    2016-01-01

    Introduction Adolescents with inflammatory bowel disease (IBD) show a higher prevalence of depression and anxiety, compared to youth with other chronic diseases. The inflammation-depression hypothesis might explain this association, and implies that treating depression can decrease intestinal inflammation and improve disease course. The present multicentre randomised controlled trial aims to test the effectiveness of an IBD-specific cognitive–behavioural therapy (CBT) protocol in reducing symptoms of subclinical depression and anxiety, while improving quality of life and disease course in adolescents with IBD. Methods and analysis Adolescents with IBD (10–20 years) from 7 hospitals undergo screening (online questionnaires) for symptoms of depression and anxiety. Those with elevated scores of depression (Child Depression Inventory (CDI) ≥13 or Beck Depression Inventory (BDI) II ≥14) and/or anxiety (Screen for Child Anxiety Related Disorders: boys ≥26, girls ≥30) receive a psychiatric interview. Patients meeting criteria for depressive/anxiety disorders are referred for psychotherapy outside the trial. Patients with elevated (subclinical) symptoms are randomly assigned to medical care-as-usual (CAU; n=50) or CAU plus IBD-specific CBT (n=50). Main outcomes: (1) reduction in depressive and/or anxiety symptoms after 3 months and (2) sustained remission for 12 months. Secondary outcomes: quality of life, psychosocial functioning, treatment adherence. In addition, we will assess inflammatory cytokines in peripheral blood mononuclear cells and whole blood RNA expression profiles. For analysis, multilevel linear models and generalised estimating equations will be used. Ethics and dissemination The Medical Ethics Committee of the Erasmus MC approved this study. If we prove that this CBT improves emotional well-being as well as disease course, implementation is recommended. Trial registration number NCT02265588. PMID:26966551

  13. The minimal leak test technique for endotracheal cuff maintenance.

    PubMed

    DA, Harvie; Jn, Darvall; M, Dodd; A, De La Cruz; M, Tacey; Rl, D'Costa; D, Ward

    2016-09-01

    Endotracheal tube (ETT) cuff pressure management is an essential part of airway management in intubated and mechanically ventilated patients. Both under- and over-inflation of the ETT cuff can lead to patient complications, with an ideal pressure range of 20-30 cmH2O defined. A range of techniques are employed to ensure adequate ETT cuff inflation, with little comparative data. We performed an observational cross-sectional study in a tertiary metropolitan ICU, assessing the relationship between the minimal leak test and cuff manometry. Forty-five mechanically ventilated patients, over a three-month period, had ETT cuff manometry performed at the same time as their routine cuff maintenance (minimal leak test). Bedside nurse measurements were compared with investigator measurements. At the endpoint of cuff inflation, 20 of 45 patients (44%) had cuff pressures between 20 and 30 cmH2O; 11 of 45 patients (24%) had cuff pressures <20 cmH2O; 14 of 45 patients (31%) had cuff pressures ≥30 cmH2O. Univariate analysis demonstrated an association between both patient obesity and female gender requiring less ETT cuff volume (P=0.008 and P <0.001 respectively), though this association was lost on multivariate analysis. No association was demonstrated between any measured variables and cuff pressures. Inter-operator reliability in performing the minimal leak test showed no evidence of bias between nurse and investigators (Pearson coefficient = 0.897). We conclude the minimal leak test for maintenance of ETT cuffs leads to both over- and under-inflation, and alternative techniques, such as cuff manometry, should be employed. PMID:27608343

  14. Biological aspects of rotator cuff healing

    PubMed Central

    Wildemann, Britt; Klatte, Franka

    2011-01-01

    Summary Tendon tears of the rotator cuff show a high prevalence in today’s population. Patients suffer from permanent pain and disability, and surgical reconstruction may be the only possibility for abatement. The complex process of tendon-bone healing leads to mechanically inferior scar-tissue, which often results in retears or non-healing. In the current literature, factors such as patients age, sex and fatty muscle infiltration are highly correlated to the presence of rotator cuff tears and the incidence of retears. To improve the tendon tissue quality after surgical reconstructions biologically based strategies with use of growth factors arouse more and more interest in the last years. However, to optimize the treatment of rotator cuff tears the biological background of tears and retears must be investigated in more detail. This article will elucidate different aspects that have an impact on rotator cuff healing and give a brief insight in tendon/ligament cell culture and animal studies focusing on growth factor treatments. PMID:23738265

  15. Control device for prosthetic urinary sphincter cuff

    NASA Technical Reports Server (NTRS)

    Reinicke, Robert H. (Inventor)

    1983-01-01

    A device for controlling flow of fluid to and from a resilient inflatable cuff implanted about the urethra to control flow of urine therethrough. The device comprises a flexible bulb reservoir and a control unit that includes a manually operated valve that opens automatically when the bulb is squeezed to force fluid into the cuff for closing the urethra. The control unit also includes a movable valve seat member having a relatively large area exposed to pressure of fluid in a chamber that is connected to the cuff and which moves to a position in which the valve member is unseated by an abutment when fluid pressure in the chamber exceeds a predetermined value to thereby relieve excess fluid pressure in the cuff. The arrangement is such that the valve element is held closed against the seat member by the full differential in fluid pressures acting on both sides of the valve element until the seat member is moved away from the valve element to thus insure positive closing of the valve element until the seat member is moved out of engagement with the valve element by excess pressure differential.

  16. Tissue discrimination in magnetic resonance imaging of the rotator cuff

    NASA Astrophysics Data System (ADS)

    Meschino, G. J.; Comas, D. S.; González, M. A.; Capiel, C.; Ballarin, V. L.

    2016-04-01

    Evaluation and diagnosis of diseases of the muscles within the rotator cuff can be done using different modalities, being the Magnetic Resonance the method more widely used. There are criteria to evaluate the degree of fat infiltration and muscle atrophy, but these have low accuracy and show great variability inter and intra observer. In this paper, an analysis of the texture features of the rotator cuff muscles is performed to classify them and other tissues. A general supervised classification approach was used, combining forward-search as feature selection method with kNN as classification rule. Sections of Magnetic Resonance Images of the tissues of interest were selected by specialist doctors and they were considered as Gold Standard. Accuracies obtained were of 93% for T1-weighted images and 92% for T2-weighted images. As an immediate future work, the combination of both sequences of images will be considered, expecting to improve the results, as well as the use of other sequences of Magnetic Resonance Images. This work represents an initial point for the classification and quantification of fat infiltration and muscle atrophy degree. From this initial point, it is expected to make an accurate and objective system which will result in benefits for future research and for patients’ health.

  17. Interrater reproducibility of clinical tests for rotator cuff lesions

    PubMed Central

    Ostor, A; Richards, C; Prevost, A; Hazleman, B; Speed, C

    2004-01-01

    Background: Rotator cuff lesions are common in the community but reproducibility of tests for shoulder assessment has not been adequately appraised and there is no uniform approach to their use. Objective: To study interrater reproducibility of standard tests for shoulder evaluation among a rheumatology specialist, rheumatology trainee, and research nurse. Methods: 136 patients were reviewed over 12 months at a major teaching hospital. The three assessors examined each patient in random order and were unaware of each other's evaluation. Each shoulder was examined in a standard manner by recognised tests for specific lesions and a diagnostic algorithm was used. Between-observer agreement was determined by calculating Cohen's κ coefficients (measuring agreement beyond that expected by chance). Results: Fair to substantial agreement was obtained for the observations of tenderness, painful arc, and external rotation. Tests for supraspinatus and subscapularis also showed at least fair agreement between observers. 40/55 (73%) κ coefficient assessments were rated at >0.2, indicating at least fair concordance between observers; 21/55 (38%) were rated at >0.4, indicating at least moderate concordance between observers. Conclusion: The reproducibility of certain tests, employed by observers of varying experience, in the assessment of the rotator cuff and general shoulder disease was determined. This has implications for delegation of shoulder assessment to nurse specialists, the development of a simplified evaluation schedule for general practitioners, and uniformity in epidemiological research studies. PMID:15361389

  18. Symptoms of Pain Do Not Correlate with Rotator Cuff Tear Severity

    PubMed Central

    Dunn, Warren R.; Kuhn, John E.; Sanders, Rosemary; An, Qi; Baumgarten, Keith M.; Bishop, Julie Y.; Brophy, Robert H.; Carey, James L.; Holloway, G. Brian; Jones, Grant L.; Ma, C. Benjamin; Marx, Robert G.; McCarty, Eric C.; Poddar, Sourav K.; Smith, Matthew V.; Spencer, Edwin E.; Vidal, Armando F.; Wolf, Brian R.; Wright, Rick W.

    2014-01-01

    Background: For many orthopaedic disorders, symptoms correlate with disease severity. The objective of this study was to determine if pain level is related to the severity of rotator cuff disorders. Methods: A cohort of 393 subjects with an atraumatic symptomatic full-thickness rotator-cuff tear treated with physical therapy was studied. Baseline pretreatment data were used to examine the relationship between the severity of rotator cuff disease and pain. Disease severity was determined by evaluating tear size, retraction, superior humeral head migration, and rotator cuff muscle atrophy. Pain was measured on the 10-point visual analog scale (VAS) in the patient-reported American Shoulder and Elbow Surgeons (ASES) score. A linear multiple regression model was constructed with use of the continuous VAS score as the dependent variable and measures of rotator cuff tear severity and other nonanatomic patient factors as the independent variables. Forty-eight percent of the patients were female, and the median age was sixty-one years. The dominant shoulder was involved in 69% of the patients. The duration of symptoms was less than one month for 8% of the patients, one to three months for 22%, four to six months for 20%, seven to twelve months for 15%, and more than a year for 36%. The tear involved only the supraspinatus in 72% of the patients; the supraspinatus and infraspinatus, with or without the teres minor, in 21%; and only the subscapularis in 7%. Humeral head migration was noted in 16%. Tendon retraction was minimal in 48%, midhumeral in 34%, glenohumeral in 13%, and to the glenoid in 5%. The median baseline VAS pain score was 4.4. Results: Multivariable modeling, controlling for other baseline factors, identified increased comorbidities (p = 0.002), lower education level (p = 0.004), and race (p = 0.041) as the only significant factors associated with pain on presentation. No measure of rotator cuff tear severity correlated with pain (p > 0.25). Conclusions

  19. Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: protocol for a randomised, double-blind, placebo controlled trial

    PubMed Central

    2011-01-01

    Background Depression, cardiovascular disease (CVD) risk factors and cognitive impairment are important causes of disability and poor health outcomes. In combination they lead to an even worse prognosis. Internet or web-based interventions have been shown to deliver efficacious psychological intervention programs for depression on a large scale, yet no published studies have evaluated their impact among patients with co-existing physical conditions. The aims of this randomised controlled trial are to determine the effects of an evidence-based internet intervention program for depression on depressive mood symptoms, cognitive function and treatment adherence in patients at risk of CVD. Methods/Design This study is an internet-based, double-blind, parallel group randomised controlled trial. The trial will compare the effectiveness of online cognitive behavioural therapy with an online attention control placebo. The trial will consist of a 12-week intervention phase with a 40-week follow-up. It will be conducted in urban and rural New South Wales, Australia and will recruit a community-based sample of adults aged 45 to 75 years. Recruitment, intervention, cognitive testing and follow-up data collection will all be internet-based and automated. The primary outcome is a change in severity of depressive symptoms from baseline to three-months. Secondary outcomes are changes in cognitive function and adherence to treatment for CVD from baseline to three, six and 12-months. Discussion Prior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression. The potential for intervening earlier in these disease states appears to have significant potential and has yet to be tested. Scalable psychological programs using web-based interventions could deliver care to large numbers in a cost effective way if efficacy were proved. This study will determine the effects of a web-based intervention on depressive symptoms and

  20. Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial

    PubMed Central

    Chiavaroli, Laura; Mirrahimi, Arash; Ireland, Christopher; Mitchell, Sandra; Sahye-Pudaruth, Sandhya; Coveney, Judy; Olowoyeye, Omodele; Maraj, Tishan; Patel, Darshna; de Souza, Russell J; Augustin, Livia S A; Bashyam, Balachandran; Blanco Mejia, Sonia; Nishi, Stephanie K; Leiter, Lawrence A; Josse, Robert G; McKeown-Eyssen, Gail; Moody, Alan R; Berger, Alan R; Kendall, Cyril W C; Sievenpiper, John L; Jenkins, David J A

    2016-01-01

    Introduction Type 2 diabetes (T2DM) produces macrovascular and microvascular damage, significantly increasing the risk of cardiovascular disease (CVD), renal failure and blindness. As rates of T2DM rise, the need for effective dietary and other lifestyle changes to improve diabetes management become more urgent. Low-glycaemic index (GI) diets may improve glycaemic control in diabetes in the short term; however, there is a lack of evidence on the long-term adherence to low-GI diets, as well as on the association with surrogate markers of CVD beyond traditional risk factors. Recently, advances have been made in measures of subclinical arterial disease through the use of MRI, which, along with standard measures from carotid ultrasound (CUS) scanning, have been associated with CVD events. We therefore designed a randomised, controlled, clinical trial to assess whether low-GI dietary advice can significantly improve surrogate markers of CVD and long-term glycaemic control in T2DM. Methods and analysis 169 otherwise healthy individuals with T2DM were recruited to receive intensive counselling on a low-GI or high-cereal fibre diet for 3 years. To assess macrovascular disease, MRI and CUS are used, and to assess microvascular disease, retinal photography and 24-hour urinary collections are taken at baseline and years 1 and 3. Risk factors for CVD are assessed every 3 months. Ethics and dissemination The study protocol and consent form have been approved by the research ethics board of St. Michael's Hospital. If the study shows a benefit, these data will support the use of low-GI and/or high-fibre foods in the management of T2DM and its complications. Trial Registration number NCT01063374; Pre-results. PMID:27388364

  1. Consistent Prebiotic Effect on Gut Microbiota With Altered FODMAP Intake in Patients with Crohn's Disease: A Randomised, Controlled Cross-Over Trial of Well-Defined Diets

    PubMed Central

    Halmos, Emma P; Christophersen, Claus T; Bird, Anthony R; Shepherd, Susan J; Muir, Jane G; Gibson, Peter R

    2016-01-01

    Objectives: Altering FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) intake has substantial effects on gut microbiota. This study aimed to investigate effects of altering FODMAP intake on markers of colonic health in patients with Crohn's disease. Methods: After evaluation of their habitual diet, 9 patients with clinically quiescent Crohn's disease were randomised to 21 days of provided low or typical (“Australian”) FODMAP diets with ≥21-day washout in between. Five-day fecal samples were collected at the end of each diet and analyzed for calprotectin, pH, short-chain fatty acids (SCFA) and bacterial abundance. Gastrointestinal symptoms were recorded daily. Results: Eight participants collected feces and were adherent to the diets. FODMAP intake differed across the three dietary periods with lowdisease, altering dietary FODMAP intake is associated with marked changes in fecal microbiota, most consistent with a prebiotic effect of increasing FODMAPs as shown in an irritable bowel/healthy cohort. This strategy might be favorable for gut health in Crohn's disease, but at the cost of inducing symptoms. PMID:27077959

  2. Treatment of lesions of the rotator cuff.

    PubMed

    Saggini, R; Cavezza, T; Di Pancrazio, L; Pisciella, V; Saladino, G; Zuccaro, M C; Bellomo, R G

    2010-01-01

    The impingement syndrome and tendinopathy of the rotator cuff are the most common causes (complaints) of pain and disability of the shoulder. The aim of this study is to evaluate the efficacy of a specific rehabilitative protocol, integrated with the administration of a nutritional supplement, in the conservative rehabilitative treatment, as well as in post-surgery, of patients with lesions of the rotator cuff. Two groups with syndrome of the rotator cuff were formed to follow different therapeutic courses, in relation to the choice of each subject to undergo the conservative treatment (Arm A) or the surgical one (Arm B). In Arm A the study included the association of therapy with ESWT (shock waves) with the proprioceptive Multi Joint System, for rehabilitating joint movement and muscle strength of the shoulder, and a specific nutritional supplement to reduce the pain and conserve the cartilage tissue. Between February 2009 and June 2009, we enrolled 30 subjects (randomized into three homogenous groups A1, A2, A3), average age 45±10 years, with rotator cuff syndrome with calcification of the shoulder, diagnosed through clinical examination and investigative instruments (X-ray, echography or NMR). In Arm B, from September 2009 to January 2010, we enrolled 50 patients (randomized into two groups, B1 and B2), 24 male (average age 58.4: min 28 and max 78) and 26 females (average age 59.5: min 30 and max 80), who had undergone rotator cuff operations and acromionplasty for non-massive lesions without important gleno-humeral instability, with either open or arthroscopic procedures. The analysis of the results of Arm A highlights that in terms of reducing pain the main benefits were found in Group A1 where the supplement was given. From the analysis of the data of Arm B, in both groups an improvement of the first 4 items evaluated was evident. In Group B1, 84 percent of the patients declared to be satisfied and improved and 16 percent were dissatisfied; in Group B2

  3. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial

    PubMed Central

    Williams, Adrian; Gill, Steven; Varma, Thelekat; Jenkinson, Crispin; Quinn, Niall; Mitchell, Rosalind; Scott, Richard; Ives, Natalie; Rick, Caroline; Daniels, Jane; Patel, Smitaa; Wheatley, Keith

    2010-01-01

    Summary Background Surgical intervention for advanced Parkinson's disease is an option if medical therapy fails to control symptoms adequately. We aimed to assess whether surgery and best medical therapy improved self-reported quality of life more than best medical therapy alone in patients with advanced Parkinson's disease. Methods The PD SURG trial is an ongoing randomised, open-label trial. At 13 neurosurgical centres in the UK, between November, 2000, and December, 2006, patients with Parkinson's disease that was not adequately controlled by medical therapy were randomly assigned by use of a computerised minimisation procedure to immediate surgery (lesioning or deep brain stimulation at the discretion of the local clinician) and best medical therapy or to best medical therapy alone. Patients were analysed in the treatment group to which they were randomised, irrespective of whether they received their allocated treatment. The primary endpoint was patient self-reported quality of life on the 39-item Parkinson's disease questionnaire (PDQ-39). Changes between baseline and 1 year were compared by use of t tests. This trial is registered with Current Controlled Trials, number ISRCTN34111222. Findings 366 patients were randomly assigned to receive immediate surgery and best medical therapy (183) or best medical therapy alone (183). All patients who had surgery had deep brain stimulation. At 1 year, the mean improvement in PDQ-39 summary index score compared with baseline was 5·0 points in the surgery group and 0·3 points in the medical therapy group (difference −4·7, 95% CI −7·6 to −1·8; p=0·001); the difference in mean change in PDQ-39 score in the mobility domain between the surgery group and the best medical therapy group was −8·9 (95% CI −13·8 to −4·0; p=0·0004), in the activities of daily living domain was −12·4 (−17·3 to −7·5; p<0·0001), and in the bodily discomfort domain was −7·5 (−12·6 to −2·4; p=0·004). Differences

  4. Therapeutic effect of mitoxantrone combined with methylprednisolone in multiple sclerosis: a randomised multicentre study of active disease using MRI and clinical criteria.

    PubMed Central

    Edan, G; Miller, D; Clanet, M; Confavreux, C; Lyon-Caen, O; Lubetzki, C; Brochet, B; Berry, I; Rolland, Y; Froment, J C; Cabanis, E; Iba-Zizen, M T; Gandon, J M; Lai, H M; Moseley, I; Sabouraud, O

    1997-01-01

    OBJECTIVE: To evaluate the efficiency of mitoxantrone in multiple sclerosis. METHODS: Forty two patients with confirmed multiple sclerosis, selected as having a very active disease on clinical and MRI criteria were randomised to receive either mitoxantrone (20 mg intravenously (IV) monthly) and methylprednisolone (1 g iv monthly) or methylprednisolone alone over six months. In the steroid alone group five patients dropped out due to severe exacerbation. RESULTS: Blinded analysis of MRI data showed significantly more patients with no new enhancing lesions in the mitoxantrone group compared with the steroid alone group, (90% v 31%, P < 0.001). In the mitoxantrone group there was a month by month decrease almost to zero in the number of new enhancing lesions, and in the total number of enhancing lesions, whereas both remained high in the steroid alone group. The differences were significant for both indices at all months from 1-6. Unblinded clinical assessments showed a significant improvement in change in EDSS at months 2-6 in the mitoxantrone group, with a final mean improvement of more than one point (-1.1 v + 0.3; P < 0.001). There was a significant reduction in the number of relapses (7 v 31; P < 0.01), and an increase in the number of patients free of exacerbation (14 v 7; P < 0.05). CONCLUSION: In this selected group of patients with multiple sclerosis with very active disease, mitoxantrone combined with methylprednisolone was effective in improving both clinical and MRI indices of disease activity over a period of six months whereas methylprednisolone alone was not. Further double blinded long term studies are needed to properly evaluate the effect of mitoxantrone on progression in disability. PMID:9048709

  5. Effect of a hospital outreach intervention programme on decreasing hospitalisations and medical costs in patients with chronic obstructive pulmonary disease in China: protocol of a randomised controlled trial

    PubMed Central

    Yan, Jin; Wang, Lianhong; Liu, Chun; Yuan, Hong; Wang, Xiaowan; Yu, Baorong; Luo, Qian

    2016-01-01

    Introduction Patients with chronic obstructive pulmonary disease (COPD) often have multiple hospitalisations because of exacerbation. Evidence shows disease management programmes are one of the most cost-effective measures to prevent re-hospitalisation for COPD exacerbation, but lack implementation and economic appraisal in China. The aims of the proposed study are to determine whether a hospital outreach invention programme for disease management can decrease hospitalisations and medical costs in patients with COPD in China. Economic appraisal of the programme will also be carried out. Methods and analysis A randomised single-blinded controlled trial will be conducted. 220 COPD patients with exacerbations will be recruited from the Third Xiangya Hospital, Central South University, China. After hospital discharge they will be randomly allocated into an intervention or a control group. Participants in the intervention group will attend a 3-month hospital-based pulmonary rehabilitation intervention and then receive a home-based programme. Both groups will receive identical usual discharge care before discharge from hospital. The primary outcomes will include rate of hospitalisation and medical cost, while secondary outcomes will include mortality, self-efficacy, self-management, health status, quality of life, exercise tolerance and pulmonary function, which will be evaluated at baseline and at 3, 12 and 24 months after the intervention. Cost-effectiveness analysis will be employed for economic appraisal. Ethics and dissemination The study has been approved by the institutional review board (IRB) of the Third Xiangya Hospital, Central South University (IRB2014-S159). Findings will be shared widely through conference presentations and peer-reviewed publications. Furthermore, the results of the programme will be submitted to health authorities and policy reform will be recommended. Trial registration number Chi CTR-TRC-14005108; Pre-results. PMID:27311900

  6. Observational data for comparative effectiveness research: an emulation of randomised trials to estimate the effect of statins on primary prevention of coronary heart disease

    PubMed Central

    Danaei, Goodarz; García Rodríguez, Luis A.; Cantero, Oscar Fernández; Logan, Roger; Hernán, Miguel A.

    2013-01-01

    This article reviews methods to estimate treatment effectiveness research using observational data. The basic idea is using an observational study to emulate a hypothetical randomised trial by comparing initiators vs. non-initiators of treatment. After adjustment for baseline confounders, one can estimate the analogue of the intention-to-treat effect. We also explain two approaches to adjust for imperfect adherence using the per-protocol and as-treated analyses after adjusting for measured time-varying confounding and selection bias using inverse probability weighting of marginal structural models. As an example, we implemented these methods to estimate the effect of statins for primary prevention of coronary heart disease (CHD) using data from electronic medical records in the United Kingdom. Despite strong confounding by indication, our approach detected a potential benefit of statin therapy. The analogue of the intention-to-treat hazard ratio of CHD was 0.89 (0.73, 1.09) for statin initiators vs. noninitiators. The hazard ratio of CHD was 0.84 (0.54, 1.30) in the per-protocol analysis and 0.79 (0.41, 1.41) in the as-treated analysis for 2-years of use vs. no use. In contrast, a conventional comparison of current users vs. never users of statin therapy resulted in a hazard ratio of 1.31 (1.04, 1.66). We provide a flexible and annotated SAS program to implement the proposed analyses. PMID:22016461

  7. Short- and long-term effects of tactile massage on salivary cortisol concentrations in Parkinson’s disease: a randomised controlled pilot study

    PubMed Central

    2013-01-01

    Background Parkinson’s disease (PD) is a chronic neurodegenerative disorder with limited knowledge about the normal function and effects of non-pharmacological therapies on the hypothalamic-pituitary-adrenal (HPA) axis. The aim of the study was to analyse the basal diurnal and total secretion of salivary cortisol in short- and long-term aspects of tactile massage (TM). Methods Design: Prospective, Controlled and Randomised Multicentre Trial. Setting and interventions: Forty-five women and men, aged 50–79 years, were recruited. Twenty-nine of them were blindly randomised to tactile massage (TM) and 16 of them to the control group, rest to music (RTM). Ten interventions were given during 8 weeks followed by a 26 weeks of follow up. Salivary cortisol was collected at 8 am, 1 pm, 8 pm, and 8 am the next day, on five occasions. With the first and eighth interventions, it was collected immediately before and after intervention. Main outcome measures: The primary aim was to assess and compare cortisol concentrations before and immediately after intervention and also during the follow-up period. The secondary aim was to assess the impact of age, gender, body mass index (BMI), duration and severity of PD, effects of interventional time-point of the day, and levodopa doses on cortisol concentration. Results The median cortisol concentrations for all participants were 16.0, 5.8, 2.8, and 14.0 nmol/L at baseline, later reproduced four times without significant differences. Cortisol concentrations decreased significantly after TM intervention but no change in diurnal salivary cortisol pattern was found. The findings of reduced salivary cortisol concentrations immediately after the interventions are in agreement with previous studies. However, there was no significant difference between the TM and control groups. There were no significant correlations between cortisol concentrations and age, gender, BMI, time-point for intervention, time interval between anti

  8. The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial

    PubMed Central

    2012-01-01

    Background The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established. The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD) compared with usual care. Methods A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71) or control group (n = 75) using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication. Results The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference). In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor. Conclusions Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive lifestyle intervention had a

  9. Anomalous biceps origin from the rotator cuff

    PubMed Central

    Banerjee, Samik; Patel, Vipul R

    2015-01-01

    Variations in the origin of the long head of biceps tendon (LHBT) have been described in literature; however, its clinical significance remains uncertain. We describe in this report, the history, physical examination and the arthroscopic findings in a patient who had an anomalous origin of the LHBT from the rotator cuff, resulting in restriction of range of motion. This anomalous origin of the long head of biceps tendon causing capsular contracture and restriction of movements leading to secondary internal impingement, has not been extensively reported in the literature. Shoulder arthroscopists should be aware that, although, an uncommon clinical condition, the aberrant congenital origin of the LHBT from the rotator cuff can rarely become pathologic in middle age and lead to shoulder dysfunction. In such cases, release of the anomalous band may be required, along with the treatment of other concomitant intraarticular pathologies in the glenohumeral joint. PMID:25593361

  10. Sphygmomanometer cuffs: a potential source of infection!

    PubMed

    Zargaran, David; Hardwick, Sarah; Adel, Reeja; Hill, George; Stubbins, Daniel; Salmasi, Abdul Majeed

    2015-02-01

    We evaluated the potential pathogenic hazard of sphygmomanometer blood pressure cuffs (BPCs) in a hospital setting. Prospectively, the presence of bacterial organisms on 120 BPCs in 14 medical wards and outpatient clinics in a district general hospital in London was assessed. Swabs taken from the inner aspect of the cuffs were cultured using standard microbiological techniques. Bacterial organisms were found in 85% (102) of the 120 BPCs assessed. The highest rates of contamination were found in the outpatients department (90%). There were differences in the most common bacterial species isolated between the samples obtained from the outpatient clinics and the wards, with coagulase-negative Staphylococcus and diphtheroids being the most prevalent species in the wards and outpatient clinics, respectively. These findings highlight the necessity to eliminate this potential risk of infection. PMID:24569512

  11. Cerebrovascular effects of the thigh cuff maneuver.

    PubMed

    Panerai, R B; Saeed, N P; Robinson, T G

    2015-04-01

    Arterial hypotension can be induced by sudden release of inflated thigh cuffs (THC), but its effects on the cerebral circulation have not been fully described. In nine healthy subjects [aged 59 (9) yr], bilateral cerebral blood flow velocity (CBFV) was recorded in the middle cerebral artery (MCA), noninvasive arterial blood pressure (BP) in the finger, and end-tidal CO2 (ETCO2) with nasal capnography. Three THC maneuvers were performed in each subject with cuff inflation 20 mmHg above systolic BP for 3 min before release. Beat-to-beat values were extracted for mean CBFV, BP, ETCO2 , critical closing pressure (CrCP), resistance-area product (RAP), and heart rate (HR). Time-varying estimates of the autoregulation index [ARI(t)] were also obtained using an autoregressive-moving average model. Coherent averages synchronized by the instant of cuff release showed significant drops in mean BP, CBFV, and RAP with rapid return of CBFV to baseline. HR, ETCO2 , and ARI(t) were transiently increased, but CrCP remained relatively constant. Mean values of ARI(t) for the 30 s following cuff release were not significantly different from the classical ARI [right MCA 5.9 (1.1) vs. 5.1 (1.6); left MCA 5.5 (1.4) vs. 4.9 (1.7)]. HR was strongly correlated with the ARI(t) peak after THC release (in 17/22 and 21/24 recordings), and ETCO2 was correlated with the subsequent drop in ARI(t) (19/22 and 20/24 recordings). These results suggest a complex cerebral autoregulatory response to the THC maneuver, dominated by myogenic mechanisms and influenced by concurrent changes in ETCO2 and possible involvement of the autonomic nervous system and baroreflex. PMID:25659488

  12. On cuff imbalance and tripolar ENG amplifier configurations.

    PubMed

    Triantis, Iasonas F; Demosthenous, Andreas; Donaldson, Nick

    2005-02-01

    Electroneurogram (ENG) recording techniques benefit from the use of tripolar cuffs because they assist in reducing interference from sources outside the cuff. However, in practice the performance of ENG amplifier configurations, such as the quasi-tripole and the true-tripole, has been widely reported to be degraded due to the departure of the tripolar cuff from ideal behavior. This paper establishes the presence of cuff imbalance and investigates its relationship to cuff asymmetry, cuff end-effects and interference source proximity. The paper also presents a comparison of the aforementioned amplifier configurations with a new alternative, termed the adaptive-tripole, developed to automatically compensate for cuff imbalance. The output signal-to-interference ratio of the three amplifier configurations were compared in vivo for two interference signals (stimulus artifact and M-wave) superimposed on compound action potentials. The experiments showed (for the first time) that the two interference signals result in different cuff imbalance values. Nevertheless, even with two distinct cuff imbalances present, the adaptive-tripole performed better than the other two systems in 61.9% of the trials. PMID:15709669

  13. Assessment and treatment strategies for rotator cuff tears

    PubMed Central

    Al-Hakim, Wisam; Noorani, Ali

    2014-01-01

    Tears of the rotator cuff are common and becoming an increasingly frequent problem. There is a vast amount of literature on the merits and limitations of the various methods of clinical and radiological assessment of rotator cuff tears. This is also the case with regard to treatment strategies. Certain popular beliefs and principles practiced widely and the basis upon which they are derived may be prone to inaccuracy. We provide an overview of the historical management of rotator cuff tears, as well as an explanation for how and why rotator cuff tears should be managed, and propose a structured methodology for their assessment and treatment.

  14. Trunk muscle exercises as a means of improving postural stability in people with Parkinson's disease: a protocol for a randomised controlled trial

    PubMed Central

    Hubble, Ryan P; Naughton, Geraldine A; Silburn, Peter A; Cole, Michael H

    2014-01-01

    Introduction Exercise has been shown to improve clinical measures of strength, balance and mobility, and in some cases, has improved symptoms of tremor and rigidity in people with Parkinson's disease (PD). However, to date, no research has examined whether improvements in trunk control can remedy deficits in dynamic postural stability in this population. The proposed randomised controlled trial aims to establish whether a 12-week exercise programme aimed at improving dynamic postural stability in people with PD; (1) is more effective than education; (2) is more effective when training frequency is increased; and (3) provides greater long-term benefits than education. Methods/design Forty-five community-dwelling individuals diagnosed with idiopathic PD with a falls history will be recruited. Participants will complete baseline assessments including tests of cognition, vision, disease severity, fear of falling, mobility and quality of life. Additionally, participants will complete a series of standing balance tasks to evaluate static postural stability, while dynamic postural control will be measured during walking using head and trunk-mounted three-dimensional accelerometers. Following baseline testing, participants will be randomly-assigned to one of three intervention groups, who will receive either exercise once per week, exercise 3 days/week, or education. Participants will repeat the same battery of tests conducted at baseline after the 12-week intervention and again following a further 12-week sustainability period. Discussion This study has the potential to show that low-intensity and progressive trunk exercises can provide a non-invasive and effective means for maintaining or improving postural stability for people with PD. Importantly, if the programme is noted to be effective, it could be easily performed by patients within their home environment or under the guidance of available allied health professionals. Trial registration number The protocol for

  15. Infliximab therapy increases body fat mass in early rheumatoid arthritis independently of changes in disease activity and levels of leptin and adiponectin: a randomised study over 21 months

    PubMed Central

    2010-01-01

    Introduction Rheumatoid arthritis (RA) is associated with changes in body composition and bone mineral density (BMD). The purpose of the present study was to evaluate whether anti-TNF treatment in early RA has an impact on body composition and BMD besides that which could be achieved by intensive disease-modifying anti-rheumatic drug (DMARD) combination therapy. Methods Forty patients with early RA who failed treatment with methotrexate up to 20 mg/week for 3 months were randomised to addition of sulphasalazine and hydroxychloroquine (treatment A) or addition of infliximab (treatment B). At 3, 12 and 24 months, body composition and BMD were assessed by total-body dual-energy X-ray absorptiometry. At the same time points, leptin, adiponectin, apolipoproteins, insulin-like growth factor-1 (IGF-1) and markers of bone remodelling were analysed. Compliance to treatment was considered in the analyses. Data were analysed with a mixed, linear model. Results Patients treated with anti-TNF had a significant increase in fat mass at 2 years, 3.8 (1.6 to 5.9) kg, in contrast to patients in treatment A, 0.4 (-1.5 to 2.2) kg (P = 0.040), despite similar reduction in disease activity. Both treatment strategies prevented loss of muscle mass and bone. Leptin concentrations increased significantly in both groups at 2 years and adiponectin increased significantly at 2 years in treatment A and at 1 year in treatment B. There were no significant changes in apolipoproteins or IGF-1. The markers of bone resorption decreased at 12 months in both treatment groups with no significant difference between the treatment groups. Conclusions Infliximab therapy increased body fat mass, an effect that was not achieved with the combination of DMARDs, despite a similar reduction in disease activity, and thus seemed to be drug specific. The increase of fat mass was not associated with an exacerbated atherogenic lipid profile. Leptin and adiponectin concentrations increased in both treatment groups. The

  16. Increased risks of endotracheal tube cuff colonization after prolonged intubation.

    PubMed

    Tsai, Wen-Hui; Hsu, Hui-Chi; Shih, Chung-Hung

    2014-06-30

    Mechanical ventilation using endotracheal tube (ETT) intubation is crucial in saving life but may also cause ventilator-associated pneumonia resulting in morbidity and mortality. The purpose of this study was to examine the effects of intubation duration on pathogen colonization rates of ETT cuff region, and its association with the subsequent re-intubation and tracheostomy. We enrolled 92 patients who were successfully weaned from ventilator and were extubated within 20 days of intubation duration. Patients were divided into Group I and II based on intubation for 1-9 days and 10-20 days, respectively. Pathogen colonization over ETT cuff region and extra-cuff region (including sputum and ETT aspirates) were assessed. As compared to Group I patients, Group II patients had a significant higher pathogen colonization rate (100% vs. 69.2%; P < 0.001) in the ETT cuff samples, but not in the extra-cuff samples (92.6% vs. 84.8%; P = 0.442). Further studies demonstrated that there was no difference between Group I and II patients in the percentages of patients with the same pathogen over both the cuff and extra-cuff samples (35.5% vs. 30.8%; P = 0.925), suggesting that the increased pathogen colonization rate over the ETT cuff region was least likely from the extra-cuff region. In addition, the results showed that longer intubation was also associated with increased tracheostomy rate from 9.3% to 28.9% for Group I and Group II respectively (P = 0.025). We conclude that longer intubation has a higher pathogen colonization rate over the ETT cuff region in patients receiving mechanical ventilation support; longer intubation also increases the trend of receiving re-intubation and tracheostomy. Our findings indicate that it is crucial to remove ETT as soon as possible and perform pathogen culture over the ETT cuff regions immediately after extubation. PMID:24826783

  17. IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care

    PubMed Central

    2013-01-01

    Background Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. Methods/Design This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0–3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI. Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the

  18. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section 868.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy...

  19. Rotator Cuff Damage: Reexamining the Causes and Treatments.

    ERIC Educational Resources Information Center

    Nash, Heyward L.

    1988-01-01

    Sports medicine specialists are beginning to reexamine the causes and treatments of rotator cuff problems, questioning the role of primary impingement in a deficient or torn cuff and trying new surgical procedures as alternatives to the traditional open acromioplasty. (Author/CB)

  20. Ibandronate to treat skeletal-related events and bone pain in metastatic bone disease or multiple myeloma: a meta-analysis of randomised clinical trials

    PubMed Central

    Geng, Chun-Jing; Liang, Qian; Zhong, Jian-Hong; Zhu, Min; Meng, Fan-Ying; Wu, Ning; Liang, Rui; Yuan, Bin-Yi

    2015-01-01

    Objective Randomised controlled trials (RCTs) have given contradictory results about the efficacy and safety of ibandronate in treating metastatic bone disease (MBD) or multiple myeloma. This review meta-analysed the literature to gain a more comprehensive picture. Design Systematic review and meta-analysis of ibandronate compared with placebo or zoledronate. Data sources PubMed, EMBASE and the Cochrane Library databases were systematically searched to identify RCTs published up to March 2015 evaluating ibandronate to treat MBD or multiple myeloma. Review method 10 RCTs involving 3474 patients were included. Six RCTs were placebo-controlled and four compared ibandronate with zoledronate. The studies included in this review were mainly from European countries. Results Intravenous ibandronate (6 mg) or oral drug (50 mg) decreased the risk of skeletal-related events compared to placebo (risk ratio (RR) 0.80, 95% CI 0.71 to 0.90, p=0.002). It also reduced the bone pain score below baseline significantly more than did placebo at 96 weeks (weighted mean difference −0.41, 95% CI −0.56 to −0.27, p<0.001). The incidence of diarrhoea, nausea and adverse renal events was similar between the ibandronate and placebo groups, but ibandronate was associated with greater risk of abdominal pain. Ibandronate was associated with similar risk of skeletal-related events as another bisphosphonate drug, zoledronate (RR 1.02, 95% CI 0.82 to 1.26, p=0.87). The incidence of nausea, jaw osteonecrosis and fatigue was similar for the two drugs, but the incidence of adverse renal events was significantly lower in the ibandronate group. Conclusions Ibandronate significantly reduces the incidence of skeletal-related events and bone pain in patients with MBD or multiple myeloma relative to placebo. It is associated with a similar incidence of skeletal-related events as zoledronate. PMID:26038356

  1. Study design for a randomised controlled trial to explore the modality and mechanism of Tai Chi in the pulmonary rehabilitation of chronic obstructive pulmonary disease

    PubMed Central

    Fu, Juan-Juan; Min, Jie; Yu, Peng-Ming; McDonald, Vanessa M; Mao, Bing

    2016-01-01

    Introduction Although pulmonary rehabilitation (PR) is associated with significant clinical benefits in chronic obstructive pulmonary disease (COPD) and has been recommended by guidelines, PR with conventional exercise training has not been widely applied in the clinic because of its inherent limitations. Alternative exercise such as Tai Chi has been investigated and the results are promising. However, the strengths and weaknesses of the exercise modality of Tai Chi, conventional PR and a combination of Tai Chi and conventional PR and the possible mechanisms underlying Tai Chi exercise remain unclear. This study aims to address the above research gaps in a well-designed clinical trial. Methods and analysis This study is a single-blind, randomised controlled trial. Participants with stable COPD will be recruited and randomly assigned to one of four groups receiving Tai Chi exercise, conventional PR using a total body recumbent stepper (TBRS), combined Tai Chi and TBRS, or usual care (control) in a 1:1:1:1 ratio. Participants will perform 30 min of supervised exercise three times a week for 8 weeks; they will receive sequential follow-ups until 12 months after recruitment. The primary outcome will be health-related quality of life as measured by the St George's Respiratory Questionnaire. Secondary outcomes will include 6 min walking distance, pulmonary function, the modified Medical Research Council Dyspnoea Scale, the COPD Assessment Test, the Hospital Anxiety and Depression Scale, the Berg Balance Scale, exacerbation frequency during the study period, and systemic inflammatory and immune markers. Ethics and dissemination Ethics approval has been granted by the Clinical Trial and Biomedical Ethics Committee of West China Hospital of Sichuan University (No TCM-2015-82). Written informed consent will be obtained from each participant before any procedures are performed. The study findings will be published in peer-reviewed journals and presented at national

  2. Effectiveness of a Peer Support Programme versus Usual Care in Disease Management of Diabetes Mellitus Type 2 regarding Improvement of Metabolic Control: A Cluster-Randomised Controlled Trial

    PubMed Central

    Johansson, Tim; Keller, Sophie; Winkler, Henrike; Weitgasser, Raimund; Sönnichsen, Andreas C.

    2016-01-01

    Aim. Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Methods. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n = 337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. Results. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI −0.08 to 0.36%, p = 0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p = 0.046) compared to the intervention group. Conclusion. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. Trial Registration. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077). PMID:26858958

  3. Effectiveness of the Assessment of Burden of Chronic Obstructive Pulmonary Disease (ABC) tool: study protocol of a cluster randomised trial in primary and secondary care

    PubMed Central

    2014-01-01

    Background Chronic Obstructive Pulmonary Disease (COPD) is a growing worldwide problem that imposes a great burden on the daily life of patients. Since there is no cure, the goal of treating COPD is to maintain or improve quality of life. We have developed a new tool, the Assessment of Burden of COPD (ABC) tool, to assess and visualize the integrated health status of patients with COPD, and to provide patients and healthcare providers with a treatment algorithm. This tool may be used during consultations to monitor the burden of COPD and to adjust treatment if necessary. The aim of the current study is to analyse the effectiveness of the ABC tool compared with usual care on health related quality of life among COPD patients over a period of 18 months. Methods/Design A cluster randomised controlled trial will be conducted in COPD patients in both primary and secondary care throughout the Netherlands. An intervention group, receiving care based on the ABC tool, will be compared with a control group receiving usual care. The primary outcome will be the change in score on a disease-specific-quality-of-life questionnaire, the Saint George Respiratory Questionnaire. Secondary outcomes will be a different questionnaire (the COPD Assessment Test), lung function and number of exacerbations. During the 18 months follow-up, seven measurements will be conducted, including a baseline and final measurement. Patients will receive questionnaires to be completed at home. Additional data, such as number of exacerbations, will be recorded by the patients’ healthcare providers. A total of 360 patients will be recruited by 40 general practitioners and 20 pulmonologists. Additionally, a process evaluation will be performed among patients and healthcare providers. Discussion The new ABC tool complies with the 2014 Global Initiative for Chronic Obstructive Lung Disease guidelines, which describe the necessity to classify patients on both their airway obstruction and a comprehensive

  4. Rotator Cuff Tear Consequent to Glenohumeral Dislocation.

    PubMed

    Gilotra, Mohit N; Christian, Matthew W; Lovering, Richard M

    2016-08-01

    The patient was a 21-year-old collegiate running back who was tackled during a football game and sustained a posterior glenohumeral dislocation. He was referred to an orthopaedist and presented 3 weeks after the injury, and, following examination, further imaging was ordered by the orthopaedist due to rotator cuff weakness. Magnetic resonance imaging showed a complete tear of the supraspinatus and infraspinatus, as well as a posterior Bankart lesion, a subscapularis tear, and a dislocation of the biceps long head tendon into the reverse Hill-Sachs lesion. J Orthop Sports Phys Ther 2016;46(8):708. doi:10.2519/jospt.2016.0413. PMID:27477475

  5. [Mendelian randomisation - a genetic approach to an epidemiological method].

    PubMed

    Stensrud, Mats Julius

    2016-06-01

    BACKGROUND Genetic information is becoming more easily available, and rapid progress is being made in developing methods of illuminating issues of interest. Mendelian randomisation makes it possible to study causes of disease using observational data. The name refers to the random distribution of gene variants in meiosis. The methodology makes use of genes that influence a risk factor for a disease, without influencing the disease itself. In this review article I explain the principles behind Mendelian randomisation and present the areas of application for this methodology.MATERIAL AND METHOD Methodology articles describing Mendelian randomisation were reviewed. The articles were found through a search in PubMed with the combination «mendelian randomization» OR «mendelian randomisation», and a search in McMaster Plus with the combination «mendelian randomization». A total of 15 methodology articles were read in full text. Methodology articles were supplemented by clinical studies found in the PubMed search.RESULTS In contrast to traditional observational studies, Mendelian randomisation studies are not affected by two important sources of error: conventional confounding variables and reverse causation. Mendelian randomisation is therefore a promising tool for studying causality. Mendelian randomisation studies have already provided valuable knowledge on the risk factors for a wide range of diseases. It is nevertheless important to be aware of the limitations of the methodology. As a result of the rapid developments in genetics research, Mendelian randomisation will probably be widely used in future years.INTERPRETATION If Mendelian randomisation studies are conducted correctly, they may help to reveal both modifiable and non-modifiable causes of disease. PMID:27325033

  6. Intravenous immunoglobulins for the treatment of mild to moderate Alzheimer’s disease: a phase II, randomised, double-blind, placebo-controlled dose-finding trial

    PubMed Central

    Dodel, Richard; Rominger, Axel; Bartenstein, Peter; Barkhof, Frederik; Blennow, Kai; Förster, Stefan; Winter, Yaroslav; Bach, Jan-Philipp; Popp, Julius; Alferink, Judith; Wiltfang, Jens; Buerger, Katharina; Otto, Markus; Antuono, Piero; Jacoby, Michael; Richter, Ralph; Stevens, James; Melamed, Isaac; Goldstein, Jerome; Haag, Stefan; Wietek, Stefan; Farlow, Martin; Jessen, Frank

    2016-01-01

    Background Three small trials have suggested effects of intravenous immunoglobulins (IVIG) on biomarkers and symptoms of mild-to-moderate Alzheimer’s disease (AD). We explored the safety, the effective dose, and the infusion interval for Octagam®10% in this patients’ group. Methods The study was a 24-week multicentre, double-blind, placebo-controlled phase II trial with 8 treatment arms at 7 sites in the USA and 5 sites in Germany. Participants aged 50–85 years were randomised (using a computer-generated randomisation sequence) to either 4 weekly infusions (n=22) (0.2 g/0.5 g/0.8 g/kg body weight), 2 weekly infusions (0.1g/0.25 g/0.4 g/kg) (n=21) or to placebo (n=7, 4-weekly, n=8, 2 weekly). The primary endpoint was the mean area under the curve (AUC) of plasma Aβ1–40 after the last infusion for one infusion interval. We considered the AUC of plasma Aβ1–40 being more representative of the potential effect of IVIG than a single time point measurement. Secondary outcomes included changes in (a) the concentrations of Aβ1–40, Aβ1–42, anti-Aβ autoantibodies in CSF/plasma and tau/ptau181 in CSF, (b) cognitive and functional scales, and (c) brain imaging (MRI/FDG-PET). Patients’ safety was assessed by recording of adverse events, clinical examinations, MRI investigations, electrocardiography and laboratory tests. The infusions were performed by site personnel who were otherwise not involved in any other assessments; therefore, the patients, caregivers, and investigators were blinded to the treatment allocations. The study medication was blinded by using intransparent overpouches and infusion lines. The trial is registered at ClinicalTrials.gov (NCT00812565) and controlled-trials.com (ISRCTN64846759). Findings Fifty-six patients were randomized. AUC of plasma Aβ1–40, was not significantly different from the placebo for five of the six IVIG arms (median with range: −18.00 [−1347.0; 1068.5] for 0.2 g/kg; 364.25 [−5834.5; 1953.5] for 0.5 g

  7. Are We Ready to Abandon Placebo in Randomised Clinical Trials for Inflammatory Bowel Disease? Pros and Cons.

    PubMed

    Danese, Silvio; Schabel, Elmer; Masure, Johan; Plevy, Scott; Schreiber, Stefan

    2016-09-01

    The role of placebo in clinical trials for drug development in inflammatory bowel disease [IBD] was the topic of a panel discussion held during the 10th Congress of the European Crohn's and Colitis Organisation [ECCO], in Barcelona, Spain, in 2015. Panellists discussed a number of issues around placebo-controlled trials in IBD, noting issues such as difficulties with recruitment, leading to less then representative patient populations in clinical studies. It was noted that, whereas the easiest answer may be to drop placebo, it is much more complicated than that. The relevance of placebo is affected by a number of factors, including the phase of the trial, as well as the nature of the drug. In most cases where placebo has been left out in drug development, it has been for trials involving a new formulation, a new dosing schedule, or a biosimilar, for example. The panel agreed that placebo-controlled trials are of particular importance early in the development programme, perhaps not so much in phase III, although placebo is important for monitoring safety. The current trial paradigm, in which patients remain on a plethora of, likely ineffective and toxic, background medication, was also questioned. The applicability of placebo in the paediatric population was also discussed. The overall consensus from this panel discussion was that placebo is still necessary in clinical trials in inflammatory bowel disease, but there remain questions as to how and when placebo should be used. PMID:27604979

  8. The cost-effectiveness of a structured education pulmonary rehabilitation programme for chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial

    PubMed Central

    Gillespie, Paddy; O'Shea, Eamon; Casey, Dympna; Murphy, Kathy; Devane, Declan; Cooney, Adeline; Mee, Lorraine; Kirwan, Collette; McCarthy, Bernard; Newell, John

    2013-01-01

    Objective To assess the cost-effectiveness of a structured education pulmonary rehabilitation programme (SEPRP) for chronic obstructive pulmonary disease (COPD) relative to usual practice in primary care. The programme consisted of group-based sessions delivered jointly by practice nurses and physiotherapists over 8 weeks. Design Cost-effectiveness and cost-utility analysis alongside a cluster randomised controlled trial. Setting 32 general practices in Ireland. Participants 350 adults with COPD, 69% of whom were moderately affected. Interventions Intervention arm (n=178) received a 2 h group-based SEPRP session per week over 8 weeks delivered jointly by a practice nurse and physiotherapist at the practice surgery or nearby venue. The control arm (n=172) received the usual practice in primary care. Main outcome measures Incremental costs, Chronic Respiratory Questionnaire (CRQ) scores, quality-adjusted life years (QALYs) gained estimated using the generic EQ5D instrument, and expected cost-effectiveness at 22 weeks trial follow-up. Results The intervention was associated with an increase of €944 (95% CIs 489 to 1400) in mean healthcare cost and €261 (95% CIs 226 to 296) in mean patient cost. The intervention was associated with a mean improvement of 1.11 (95% CIs 0.35 to 1.87) in CRQ Total score and 0.002 (95% CIs −0.006 to 0.011) in QALYs gained. These translated into incremental cost-effectiveness ratios of €850 per unit increase in CRQ Total score and €472 000 per additional QALY gained. The probability of the intervention being cost-effective at respective threshold values of €5000, €15 000, €25 000, €35 000 and €45 000 was 0.980, 0.992, 0.994, 0.994 and 0.994 in the CRQ Total score analysis compared to 0.000, 0.001, 0.001, 0.003 and 0.007 in the QALYs gained analysis. Conclusions While analysis suggests that SEPRP was cost-effective if society is willing to pay at least €850 per one-point increase in disease-specific CRQ

  9. Unsafe health and safety: sphygmomanometer cuffs are not interchangeable.

    PubMed

    Shaw, K C; McEniery, C M; Wilkinson, I B; Brown, M J

    2013-07-01

    Unknown to its hypertension specialists, a major teaching hospital changed the cuffs on its sphygmomanometers from manufacturer-validated to a uniform washable alternative, in line with 'Health and Safety' concerns surrounding potential cross-contamination between patients. When clinic doctors suspected serious under-reading with the new cuffs, a systematic comparison was undertaken in 54 patients (mean±s.d. age, 61±17 years), using two UM-101 sphygmomanometers, one using the original, manufacturer-supplied cuff and the other with the washable replacement. The study confirmed an average under-reading of 8±10/5±5 mm Hg using the washable cuff, and a third of patients with poorly controlled hypertension were considered normotensive, after using this cuff. The UM-101 sphygmomanometers have now been re-fitted with the original cuffs. Sphygmomanometer cuffs are not interchangeable between devices and a modicum of common sense should be shown to prevent changes made in the name of Health and Safety from having the opposite effect to that intended. PMID:23172028

  10. Management of Rotator Cuff and Impingement Injuries in the Athlete

    PubMed Central

    Williams, Gerald R.; Kelley, Martin

    2000-01-01

    Objective: To review current concepts of the pathophysiology, diagnosis, and treatment of rotator cuff and impingement injuries in the athlete. Data Sources: The information we present was compiled from a review of classic and recently published material regarding rotator cuff and impingement injuries. These materials were identified through a search of a personal literature database compiled by the authors, as well as by selective searching of the MEDLINE. In addition, much of the information presented represents observations and opinions of the authors developed over 8 to 10 years of treating shoulder injuries in athletes. Data Synthesis: Biomechanics of the normal shoulder and pathophysiology of rotator cuff injuries in the athletic population are discussed, followed by a summary of the important diagnostic features of rotator cuff and impingement injuries. The principles of rehabilitation are extensively presented, along with indications and important technical aspects of selected surgical procedures. General principles and specific protocols of postoperative rehabilitation are also summarized. Conclusions/Recommendations: Rotator cuff and impingement injuries in the athletic population are multifactorial in etiology, exhibiting significant overlap with glenohumeral instability. Nonoperative treatment is successful in most athletic patients with rotator cuff and impingement injuries. When nonoperative treatment fails, arthroscopic surgical techniques such as rotator cuff repair and subacromial decompression may be successful in returning the athlete to competition. ImagesFigure 2.Figure 3.Figure 4.Figure 5.Figure 6.Figure 7.Figure 8.Figure 9.Figure 10.Figure 11.Figure 12.Figure 13. PMID:16558644

  11. A Comparison of Rehabilitation Methods After Arthroscopic Rotator Cuff Repair

    PubMed Central

    Yi, Anthony; Villacis, Diego; Yalamanchili, Raj; Hatch, George F. Rick

    2015-01-01

    Context: Despite the significant attention directed toward optimizing arthroscopic rotator cuff repair, there has been less focus on rehabilitation after rotator cuff repair surgery. Objective: To determine the effect of different rehabilitation protocols on clinical outcomes by comparing early versus late mobilization approaches and continuous passive mobilization (CPM) versus manual therapy after arthroscopic rotator cuff repair. Data Sources: PubMed was searched for relevant articles using the keywords rotator cuff, rotator, cuff, tears, lacerations, and rehabilitation to identify articles published from January 1980 to March 2014. Study Selection: Inclusion criteria consisted of articles of level 1 or 2 evidence, written in the English language, and with reported outcomes for early versus late mobilization or rehabilitation with CPM versus manual therapy after primary arthroscopic rotator cuff repair. Exclusion criteria consisted of articles of level 3, 4, or 5 evidence, non-English language, and those with significantly different demographic variables between study groups. Included studies were evaluated with the Consolidated Standards of Reporting Trials criteria. Study Design: Systematic review. Level of Evidence: Level 2. Data Extraction: Level of evidence, study type, number of patients enrolled, number of patients at final follow-up, length of follow-up, age, sex, rotator cuff tear size, surgical technique, and concomitant operative procedures were extracted from included articles. Postoperative data included clinical outcome scores, visual analog score for pain, shoulder range of motion, strength, and rotator cuff retear rates. Results: A total of 7 studies met all criteria and were included in the final analysis. Five studies compared early and late mobilization. Two studies compared CPM and manual therapy. Conclusion: In general, current data do not definitively demonstrate a significant difference between postoperative rotator cuff rehabilitation

  12. Magnitude of Interfractional Vaginal Cuff Movement: Implications for External Irradiation

    SciTech Connect

    Ma, Daniel J.; Michaletz-Lorenz, Martha; Goddu, S. Murty; Grigsby, Perry W.

    2012-03-15

    Purpose: To quantify the extent of interfractional vaginal cuff movement in patients receiving postoperative irradiation for cervical or endometrial cancer in the absence of bowel/bladder instruction. Methods and Materials: Eleven consecutive patients with cervical or endometrial cancer underwent placement of three gold seed fiducial markers in the vaginal cuff apex as part of standard of care before simulation. Patients subsequently underwent external irradiation and brachytherapy treatment based on institutional guidelines. Daily megavoltage CT imaging was performed during each external radiation treatment fraction. The daily positions of the vaginal apex fiducial markers were subsequently compared with the original position of the fiducial markers on the simulation CT. Composite dose-volume histograms were also created by summing daily target positions. Results: The average ({+-} standard deviation) vaginal cuff movement throughout daily pelvic external radiotherapy when referenced to the simulation position was 16.2 {+-} 8.3 mm. The maximum vaginal cuff movement for any patient during treatment was 34.5 mm. In the axial plane the mean vaginal cuff movement was 12.9 {+-} 6.7 mm. The maximum vaginal cuff axial movement was 30.7 mm. In the craniocaudal axis the mean movement was 10.3 {+-} 7.6 mm, with a maximum movement of 27.0 mm. Probability of cuff excursion outside of the clinical target volume steadily dropped as margin size increased (53%, 26%, 4.2%, and 1.4% for 1.0, 1.5, 2.0, and 2.5 cm, respectively.) However, rectal and bladder doses steadily increased with larger margin sizes. Conclusions: The magnitude of vaginal cuff movement is highly patient specific and can impact target coverage in patients without bowel/bladder instructions at simulation. The use of vaginal cuff fiducials can help identify patients at risk for target volume excursion.

  13. Vaginal Cuff Dehiscence in Robotic-Assisted Total Hysterectomy

    PubMed Central

    Kashani, Shabnam; Gallo, Taryn; Sargent, Anita; ElSahwi, Karim; Silasi, Dan-Arin

    2012-01-01

    Study Objective: The aim of this study was to estimate the cumulative incidence of vaginal cuff dehiscence in robotic-assisted total hysterectomies in our patients and to provide recommendations to decrease the incidence of vaginal cuff dehiscence. Methods: This was an observational case series, Canadian Task Force Classification II-3 conducted at an academic and community teaching hospital. A total of 654 patients underwent robotic-assisted total laparoscopic hysterectomy for both malignant and benign reasons from September 1, 2006 to March 1, 2011 performed by a single surgeon. The da Vinci Surgical System was used for robotic-assisted total laparoscopic hysterectomy. Results: There were 3 cases of vaginal cuff dehiscence among 654 robotic-assisted total laparoscopic hysterectomies, making our cumulative incidence of vaginal cuff dehiscence 0.4%. The mean time between the procedures and vaginal cuff dehiscence was 44.3 d (6.3 wk). All patients were followed up twice after surgery, at 3 to 4 wk and 12 to 16 wk. Conclusion: In our study, the incidence of vaginal cuff dehiscence after robotic-assisted total laparoscopic hysterectomy compares favorably to that of total abdominal and vaginal hysterectomy. Our study suggests that the incidence of vaginal cuff dehiscence is more likely related to the technique of colpotomy and vaginal cuff suturing than to robotic-assisted total hysterectomy per se. With proper technique and patient education, our vaginal dehiscence rate has been 0.4%, which is 2.5 to 10 times less than the previously reported vaginal cuff dehiscence rate in the literature. PMID:23484559

  14. Tracheomegaly Secondary to Tracheotomy Tube Cuff in Amyotrophic Lateral Sclerosis

    PubMed Central

    Lee, Dong Hoon; Yoon, Tae Mi; Lee, Joon Kyoo; Lim, Sang Chul

    2015-01-01

    Abstract Tracheomegaly has not been reported in amyotrophic lateral sclerosis (ALS). Herein, the authors report a case of tracheomegaly secondary to tracheotomy tube cuff in a patient with ALS. To our knowledge, this is the first report of an ALS patient with tracheomegaly and of tracheomegaly being associated with tracheotomy tube cuff and home tracheotomy mechanical ventilator. The clinician should consider the possibility of tracheomegaly in the differential diagnosis, if a patient with ALS develops repeat air leakage around the tracheotomy tube or rupture of tracheotomy tube cuff. PMID:26496301

  15. Laparoscopic Transvesical Resection of an En Bloc Bladder Cuff and Distal Ureter during Nephroureterectomy

    PubMed Central

    Giannakopoulos, Stilianos; Toufas, George; Dimitriadis, Charalampos; Giannopoulos, Stavros; Kalaitzis, Christos; Bantis, Athanasios; Patris, Emmanuel; Touloupidis, Stavros

    2012-01-01

    Objective. The most appropriate technique for excising the distal ureter and bladder cuff during laparoscopic nephroureterectomy is still debated. We report our experience with a pure laparoscopic transvesical method that duplicates the long-standing open transvesical approach. Materials and Methods. Seven men and three women diagnosed with upper tract transitional cell carcinoma were treated with this procedure. Three intravesical ports were inserted, and pneumovesicum was established at 12 mmHg. Transvesical laparoscopic circumferential detachment of the bladder cuff and en bloc mobilization of the last centimeters of the distal ureter were performed, followed by the closure of the bladder defect. Subsequently, a nephrectomy was performed either laparoscopically or using an open flank approach. Results. The median age was 68.5 years. The procedure was completed uneventfully in all cases. The median operating time for distal ureter excision was 82.5 minutes (range 55–120). No complications directly related to the pneumovesicum method were recorded. The median follow-up period was 31 months (range 12–55). During the follow-up period, two patients (20%) died from the disease, and a bladder tumor developed in three cases (30%). Conclusion. The laparoscopic transvesical resection of the en bloc bladder cuff and distal ureter is a reliable, effective, and oncologically safe technique, at least in the midterm. PMID:23049475

  16. Feasibility of a structured group education session to improve self-management of blood pressure in people with chronic kidney disease: an open randomised pilot trial

    PubMed Central

    Khunti, Kamlesh; Stone, Margaret; Farooqi, Azhar; Carr, Sue

    2011-01-01

    Objectives We aimed to test, at pilot level, a structured group educational intervention to improve self-management of blood pressure in people with chronic kidney disease (CKD). The current paper explores patient acceptability of the intervention. Design This was an open randomised pilot trial. Participants were randomly assigned to either: A control group (n=41) receiving standard clinical management of hypertension. An intervention group (n=40) receiving standard clinical care plus the educational intervention. Setting Renal outpatient clinics at a single study centre. Participants Patients with early CKD and hypertension were identified and approached for recruitment. Intervention An evidence-based structured group educational intervention (CHEERS) using the principles of social cognitive theory to improve knowledge and self-management skills. Outcomes Recruitment, uptake of the intervention and patient satisfaction were evaluated to explore patient acceptability of the intervention and to determine any differences between patients regarding recruitment and retention. Measures Data on age, sex and ethnicity were collected for all patients approached to take part. For recruited patients, data were also collected on self-efficacy (ability to self-manage). Reasons given by patients declining to take part were recorded. Patients attending the educational session also completed an evaluation form to assess satisfaction. Results A total of 267 patients were approached, and 30% were randomly assigned. Lack of time (48%) and lack of interest (44%) were the main reasons cited for non-participation in the study. Men were significantly more likely to be recruited (p=0.048). The intervention was rated enjoyable and useful by 100% of participants. However, 37.5% of the intervention group failed to attend the educational session after recruitment. Participants failing to attend were significantly more likely to be older (p=0.039) and have lower self-efficacy (p=0

  17. Feasibility of a structured group education session to improve self-management of blood pressure in people with chronic kidney disease: an open randomised pilot trial.

    PubMed

    Byrne, Jo; Khunti, Kamlesh; Stone, Margaret; Farooqi, Azhar; Carr, Sue

    2011-01-01

    Objectives We aimed to test, at pilot level, a structured group educational intervention to improve self-management of blood pressure in people with chronic kidney disease (CKD). The current paper explores patient acceptability of the intervention. Design This was an open randomised pilot trial. Participants were randomly assigned to either: A control group (n=41) receiving standard clinical management of hypertension. An intervention group (n=40) receiving standard clinical care plus the educational intervention. Setting Renal outpatient clinics at a single study centre. Participants Patients with early CKD and hypertension were identified and approached for recruitment. Intervention An evidence-based structured group educational intervention (CHEERS) using the principles of social cognitive theory to improve knowledge and self-management skills. Outcomes Recruitment, uptake of the intervention and patient satisfaction were evaluated to explore patient acceptability of the intervention and to determine any differences between patients regarding recruitment and retention. Measures Data on age, sex and ethnicity were collected for all patients approached to take part. For recruited patients, data were also collected on self-efficacy (ability to self-manage). Reasons given by patients declining to take part were recorded. Patients attending the educational session also completed an evaluation form to assess satisfaction. Results A total of 267 patients were approached, and 30% were randomly assigned. Lack of time (48%) and lack of interest (44%) were the main reasons cited for non-participation in the study. Men were significantly more likely to be recruited (p=0.048). The intervention was rated enjoyable and useful by 100% of participants. However, 37.5% of the intervention group failed to attend the educational session after recruitment. Participants failing to attend were significantly more likely to be older (p=0.039) and have lower self-efficacy (p=0

  18. Rotator cuff tears: An evidence based approach

    PubMed Central

    Sambandam, Senthil Nathan; Khanna, Vishesh; Gul, Arif; Mounasamy, Varatharaj

    2015-01-01

    Lesions of the rotator cuff (RC) are a common occurrence affecting millions of people across all parts of the globe. RC tears are also rampantly prevalent with an age-dependent increase in numbers. Other associated factors include a history of trauma, limb dominance, contralateral shoulder, smoking-status, hypercholesterolemia, posture and occupational dispositions. The challenge lies in early diagnosis since a high proportion of patients are asymptomatic. Pain and decreasing shoulder power and function should alert the heedful practitioner in recognizing promptly the onset or aggravation of existing RC tears. Partial-thickness tears (PTT) can be bursal-sided or articular-sided tears. Over the course of time, PTT enlarge and propagate into full-thickness tears (FTT) and develop distinct chronic pathological changes due to muscle retraction, fatty infiltration and muscle atrophy. These lead to a reduction in tendon elasticity and viability. Eventually, the glenohumeral joint experiences a series of degenerative alterations - cuff tear arthropathy. To avert this, a vigilant clinician must utilize and corroborate clinical skill and radiological findings to identify tear progression. Modern radio-diagnostic means of ultrasonography and magnetic resonance imaging provide excellent visualization of structural details and are crucial in determining further course of action for these patients. Physical therapy along with activity modifications, anti-inflammatory and analgesic medications form the pillars of nonoperative treatment. Elderly patients with minimal functional demands can be managed conservatively and reassessed at frequent intervals. Regular monitoring helps in isolating patients who require surgical interventions. Early surgery should be considered in younger, active and symptomatic, healthy patients. In addition to being cost-effective, this helps in providing a functional shoulder with a stable cuff. An easily reproducible technique of maximal strength and

  19. Assessment and characterization of in situ rotator cuff biomechanics

    NASA Astrophysics Data System (ADS)

    Trent, Erika A.; Bailey, Lane; Mefleh, Fuad N.; Raikar, Vipul P.; Shanley, Ellen; Thigpen, Charles A.; Dean, Delphine; Kwartowitz, David M.

    2013-03-01

    Rotator cuff disease is a degenerative disorder that is a common, costly, and often debilitating, ranging in severity from partial thickness tear, which may cause pain, to total rupture, leading to loss in function. Currently, clinical diagnosis and determination of disease extent relies primarily on subjective assessment of pain, range of motion, and possibly X-ray or ultrasound images. The final treatment plan however is at the discretion of the clinician, who often bases their decision on personal experiences, and not quantitative standards. The use of ultrasound for the assessment of tissue biomechanics is established, such as in ultrasound elastography, where soft tissue biomechanics are measured. Few studies have investigated the use of ultrasound elastography in the characterization of musculoskeletal biomechanics. To assess tissue biomechanics we have developed a device, which measures the force applied to the underlying musculotendentious tissue while simultaneously obtaining the related ultrasound images. In this work, the musculotendinous region of the infraspinatus of twenty asymptomatic male organized baseball players was examined to access the variability in tissue properties within a single patient and across a normal population. Elastic moduli at percent strains less than 15 were significantly different than those above 15 percent strain within the normal population. No significant difference in tissue properties was demonstrated within a single patient. This analysis demonstrated elastic moduli are variable across individuals and incidence. Therefore threshold elastic moduli will likely be a function of variation in local-tissue moduli as opposed to a specific global value.

  20. Management of complications after rotator cuff surgery.

    PubMed

    Parada, Stephen A; Dilisio, Matthew F; Kennedy, Colin D

    2015-03-01

    Rotator cuff repair (RCR) is a common procedure performed by orthopedic surgeons via arthroscopic, open, or mini-open techniques. While this surgery is considered to be of low morbidity, several potential complications can arise either intraoperatively or during the postoperative time period. Some of these complications are related to the surgical approach (arthroscopic or open), while others are patient dependent. Many of these complications can be managed through nonoperative means; however, early recognition and timely treatment is essential in limiting the long-term sequela and improving patient outcome. There are several different ways to classify complications after RCR repair: timing, severity, preventability, whether or not the pathology is intra- or extra-articular, and the type of treatment necessary. It is essential that the surgeon is cognizant of the etiology contributing to the failed RCR surgery in order to provide timely and proper management. PMID:25532916

  1. Tendon graft substitutes-rotator cuff patches.

    PubMed

    Coons, David A; Alan Barber, F

    2006-09-01

    Over the past few years, many biologic patches have been developed to augment repairs of large or complex tendon tears. These patches include both allograft and xenografts. Regardless of their origins, these products are primarily composed of purified type I collagen. Many factors should be considered when choosing an augmentation patch including tissue origin, graft processing, cross-linking, clinical experience, and physical properties. The purpose of this article is to familiarize the sports medicine community with several tendon augmentation grafts: GraftJacket (Wright Medical Technology, Arlington, TN), CuffPatch (Organogenesis, Canton, MA, licensed to Arthrotek, Warsaw, IN), Restore (Depuy, Warsaw, IN), Zimmer Collagen Repair (Permacol) patch (Tissue Science Laboratories Covington, GA, licensed to Zimmer, Warsaw, IN), TissueMend (TEI Biosciences, Boston, MA, licensed to Stryker Howmedica Osteonics, Kalamazoo, MI), OrthoADAPT (Pegasus Biologics, Irvine, CA), and BioBlanket (Kensey Nash, Exton, PA). PMID:17135966

  2. Evidence for an Environmental and Inherited Predisposition Contributing to the Risk for Global Tendinopathies or Compression Neuropathies in Patients With Rotator Cuff Tears

    PubMed Central

    Tashjian, Robert Z.; Farnham, James M.; Granger, Erin K.; Teerlink, Craig C.; Cannon-Albright, Lisa A.

    2016-01-01

    Background: Rotator cuff tearing has been found to be clinically associated with other tendinopathies and compression neuropathies; a significant excess of these phenotypes has been seen in patients with rotator cuff tears. It is unclear if the association is secondary to environmental or genetic influences. Purpose: To examine population-based data for comorbid association of rotator cuff tearing and tendinopathies and compression neuropathies and to determine whether the association extends to relatives of patients with rotator cuff tears, which could suggest a genetic contribution. Study Design: Cross-sectional study; Level of evidence, 3. Methods: The Utah Population Database (UPDB) contains health and genealogical data on over 2 million Utah residents. Current Procedural Terminology, Fourth Revision, codes (CPT 4) and International Classification of Diseases, Ninth Revision, codes (ICD-9) entered in patient records were used to identify patients with rotator cuff tearing and with comorbid tendinopathies and compression neuropathies. We tested the hypothesis of excess familial clustering of these other phenotypes with rotator cuff tearing using a well-established method (estimation of relative risks) in the overall study group of rotator cuff patients (N = 1889). Results: Significantly elevated risk for elbow, hand/wrist, foot/ankle, knee, and hip tendinopathies, as well as for all tendinopathies and compression neuropathies, was observed in rotator cuff tear cases themselves (P < 2.8e–13), in their spouses (P < .02), and in their first-degree relatives (P < 5.5e–4). A significant excess of elbow (P = .01), foot/ankle (P = .04), and all tendinopathies (P = 3.1e–3) was also observed in second-degree relatives, and a significant excess of compression neuropathies (P = .03) was observed in third-degree relatives. Conclusion: The current study shows strong evidence of familial clustering of rotator cuff tearing with other tendinopathies and with compression

  3. Augmentation of Rotator Cuff Repair With Soft Tissue Scaffolds

    PubMed Central

    Thangarajah, Tanujan; Pendegrass, Catherine J.; Shahbazi, Shirin; Lambert, Simon; Alexander, Susan; Blunn, Gordon W.

    2015-01-01

    Background Tears of the rotator cuff are one of the most common tendon disorders. Treatment often includes surgical repair, but the rate of failure to gain or maintain healing has been reported to be as high as 94%. This has been substantially attributed to the inadequate capacity of tendon to heal once damaged, particularly to bone at the enthesis. A number of strategies have been developed to improve tendon-bone healing, tendon-tendon healing, and tendon regeneration. Scaffolds have received considerable attention for replacement, reconstruction, or reinforcement of tendon defects but may not possess situation-specific or durable mechanical and biological characteristics. Purpose To provide an overview of the biology of tendon-bone healing and the current scaffolds used to augment rotator cuff repairs. Study Design Systematic review; Level of evidence, 4. Methods A preliminary literature search of MEDLINE and Embase databases was performed using the terms rotator cuff scaffolds, rotator cuff augmentation, allografts for rotator cuff repair, xenografts for rotator cuff repair, and synthetic grafts for rotator cuff repair. Results The search identified 438 unique articles. Of these, 214 articles were irrelevant to the topic and were therefore excluded. This left a total of 224 studies that were suitable for analysis. Conclusion A number of novel biomaterials have been developed into biologically and mechanically favorable scaffolds. Few clinical trials have examined their effect on tendon-bone healing in well-designed, long-term follow-up studies with appropriate control groups. While there is still considerable work to be done before scaffolds are introduced into routine clinical practice, there does appear to be a clear indication for their use as an interpositional graft for large and massive retracted rotator cuff tears and when repairing a poor-quality degenerative tendon. PMID:26665095

  4. Physiotherapy assessment of patients with rotator cuff pathology

    PubMed Central

    2014-01-01

    Pathology of the rotator cuff and sub-acromial bursa are considered to be the main cause of shoulder pain and dysfunction. In the absence of trauma, conservative care, including physiotherapy is the primary treatment. This paper aims to present the key features of a physiotherapy assessment, excluding diagnostic tests for rotator cuff pathology. It describes and explores how assessment can be used to direct management options and develop a treatment plan.

  5. No prosthetic management of massive and irreparable rotator cuff tears

    PubMed Central

    Garofalo, Raffaele; Cesari, Eugenio

    2014-01-01

    A massive rotator cuff tear is not necessarily irreparable. Number of tendons involved, muscle-tendon unit quality, and decreased acromionhumeral distance (AHD) are as important as tear size in determining reparability of lesion. Massive and irreparable rotator cuff tears cannot be anatomically repaired to the bone and are a common source of pain and disability even in middle-aged patients. In these patients when conservative management has failed, it is possible to perform different surgical techniques. A functional repair can help to restore the horizontal force couple of the cuff on the humeral head and to increase the AHD. Debridement of irreparable tears and biceps tenotomy or tenodesis can have a role in low functional demand patients but results deteriorate over time. Recently, several commercially available tissue-engineered biological and synthetic scaffolds have been developed to augment rotator cuff repairs. The aim is to provide a mechanical improvement in case of poor quality tissue at time zero and give a support to have a better cuff healing. In selected cases, the scaffold can be used also to bridge tendon defect. Patients who not have pseudoparalysis, cuff tear arthropathy and with intact deltoid function can benefit from tendon transfers with satisfactory outcomes. These different procedures should be chosen for each patient with selected criteria and after a satisfactory explanation about the really possible expectation after surgery.

  6. The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) protocol: a randomised controlled study to evaluate treatment of asymptomatic coeliac disease in type 1 diabetes

    PubMed Central

    Mahmud, Farid H; De Melo, Emilia N; Noordin, Karima; Assor, Esther; Sahota, Kamaljeet; Davies-Shaw, Jolie; Cutz, Ernest; Somers, Gino; Lawson, Margaret; Mack, David R; Gallego, Patricia; McDonald, Charlotte; Beaton, Melanie D; Bax, Kevin; Saibil, Fred; Gilbert, Jeremy; Kirsch, Susan; Perkins, Bruce A; Cino, Maria; Szentgyorgyi, Eva; Koltin, Dror; Parikh, Amish; Mukerji, Geetha; Advani, Andrew; Lou, Olivia; Marcon, Margaret A

    2015-01-01

    Introduction Coeliac disease (CD) is an autoimmune condition characterised by gluten-induced intestinal inflammation, and observed at a 5–10 fold greater prevalence in type 1 diabetes. While universal screening for CD in patients with diabetes is frequently advocated, objective data is limited as to benefits on diabetes control, bone health or quality of life related to the adoption of a gluten-free diet (GFD) in the large proportion of patients with diabetes with asymptomatic CD. The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) study is a multicenter, randomised controlled trial to evaluate the efficacy and safety of a GFD in patients with type 1 diabetes with asymptomatic CD. Methods and analysis Children and adults (8–45 years) with type 1 diabetes will be screened for asymptomatic CD. Eligible patients with biopsy-proven CD will be randomly assigned in a 1:1 ratio to treatment with a GFD for 1 year, or continue with a gluten-containing diet. The primary outcome will evaluate the impact of the GFD on change in glycated haemoglobin. Secondary outcomes will evaluate changes in bone mineral density, blood glucose variability and health-related quality of life between GFD-treated and the regular diet group over a 1-year period. The study was initiated in 2012 and has subsequently expanded to multiple paediatric and adult centres in Ontario, Canada. Ethics and dissemination The findings from this study will provide high-quality evidence as to the impact of GFD treatment on glycaemic control and complications in asymptomatic children and adults with CD and type 1 diabetes. Trial registration number NCT01566110. PMID:25968008

  7. Correlations of survival with progression-free survival, response rate, and disease control rate in advanced biliary tract cancer: a meta-analysis of randomised trials of first-line chemotherapy

    PubMed Central

    Moriwaki, Toshikazu; Yamamoto, Yoshiyuki; Gosho, Masahiko; Kobayashi, Mariko; Sugaya, Akinori; Yamada, Takeshi; Endo, Shinji; Hyodo, Ichinosuke

    2016-01-01

    Background: The need to promote novel drug development for advanced biliary tract cancer (ABTC) has emphasised the importance of determining whether various efficacy end points can act as surrogates for overall survival (OS). Methods: We conducted a literature search of randomised trials of first-line chemotherapy for ABTC and investigated correlations between efficacy end points and OS using weighted linear regression analysis. The ratios of the median OS, median progression-free survival (PFS), response rate, and disease control rate in each trial were used to summarise treatment effects. The surrogate threshold effect (STE), which was the minimum treatment effect on PFS required to predict a non-zero treatment effect on OS, was calculated. Results: Seventeen randomised trials with 36 treatment arms were identified, and a sample size of 2148 patients with 19 paired arms was analysed. The strongest correlation between all evaluated efficacy end points was observed between median OS and median PFS ratios (r2=0.66). In trials with gemcitabine-containing therapies and targeted agents, the r2-values were 0.78. The STE was estimated at 0.83 for all trials and 0.81 for trials with gemcitabine-containing therapies, and was not calculated for trials with targeted agents. Conclusions: The median PFS ratio correlated well with the median OS ratio, and may be useful for planning a clinical trial for novel drug development. PMID:27031848

  8. Does a 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine prevent respiratory exacerbations in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Recurrent protracted bacterial bronchitis (PBB), chronic suppurative lung disease (CSLD) and bronchiectasis are characterised by a chronic wet cough and are important causes of childhood respiratory morbidity globally. Haemophilus influenzae and Streptococcus pneumoniae are the most commonly associated pathogens. As respiratory exacerbations impair quality of life and may be associated with disease progression, we will determine if the novel 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) reduces exacerbations in these children. Methods A multi-centre, parallel group, double-blind, randomised controlled trial in tertiary paediatric centres from three Australian cities is planned. Two hundred six children aged 18 months to 14 years with recurrent PBB, CSLD or bronchiectasis will be randomised to receive either two doses of PHiD-CV or control meningococcal (ACYW135) conjugate vaccine 2 months apart and followed for 12 months after the second vaccine dose. Randomisation will be stratified by site, age (<6 years and ≥6 years) and aetiology (recurrent PBB or CSLD/bronchiectasis). Clinical histories, respiratory status (including spirometry in children aged ≥6 years), nasopharyngeal and saliva swabs, and serum will be collected at baseline and at 2, 3, 8 and 14 months post-enrolment. Local and systemic reactions will be recorded on daily diaries for 7 and 30 days, respectively, following each vaccine dose and serious adverse events monitored throughout the trial. Fortnightly, parental contact will help record respiratory exacerbations. The primary outcome is the incidence of respiratory exacerbations in the 12 months following the second vaccine dose. Secondary outcomes include: nasopharyngeal carriage of H. influenzae and S. pneumoniae vaccine and vaccine- related serotypes; systemic and mucosal immune responses to H. influenzae proteins and S. pneumoniae vaccine and vaccine-related serotypes; impact upon lung function

  9. Arthroscopic Transosseous Rotator Cuff Repair: Technical Note, Outcomes, and Complications

    PubMed Central

    Black, Eric M.; Lin, Albert; Srikumaran, Uma; Jain, Nitin; Freehill, Michael T.

    2016-01-01

    The goal of this study was to review the authors’ initial experience with arthroscopic transosseous rotator cuff repair. Thirty-one patients with full-thickness rotator cuff tears underwent arthroscopic transosseous rotator cuff repair over a 15-month period. Preoperatively, demographics and subjective scores were recorded. Postoperatively, pain levels, subjective shoulder values, satisfaction scores, American Shoulder and Elbow Surgeons (ASES) scores, complications, and reoperations were noted with a minimum 2-year follow-up. The relationships between pre- and intraoperative variables and outcome scores were determined with univariate analysis. Average patient age was 56 years, and 23 patients (74%) were men. Twenty patients (65%) underwent primary rotator cuff repair, and 11 patients (35%) underwent revision repair. Average time to follow-up was 26 months. Average preoperative pain level and subjective shoulder value were 5.1 of 10 and 35%, respectively. Average postoperative scores included pain level of 0.9 of 10, subjective shoulder value of 84%, satisfaction score of 90.6 of 100, and ASES score of 86.3 of 100. There were 3 (9.7%) major and 2 (6%) minor complications. Patients undergoing revision rotator cuff repair had significantly worse outcomes (pain level, subjective shoulder value, ASES score; P<.05) compared with those undergoing primary repair, and cortical augmentation did not significantly affect outcome. Overall, outcomes after arthroscopic transosseous rotator cuff repair are good, although patients undergoing revision repair do not have the same outcomes as those undergoing primary cuff repair. The procedure is not without complications (9.7% major, 6% minor complications). Cortical augmentation may be used to supplement fixation, although it does not necessarily affect outcomes. Patients without such augmentation may be at increased risk for suture cutout through the bone. PMID:25970360

  10. Rotator Cuff Tears in the Elderly Patients

    PubMed Central

    Geary, Michael B.

    2015-01-01

    Rotator cuff tears (RCT) are a common clinical problem in the geriatric population, and debate exists over how to best provide pain relief and restore shoulder function. Treatment options can be broadly divided into nonsurgical and surgical, with the majority of patients initially placed on a trial of conservative therapy. For those with irreparable RCT, low functional demand, or interest in nonoperative management, there are a number of nonsurgical treatments to consider, including rehabilitation and injections of corticosteroids, hyaluronate, and platelet-rich plasma. Surgical treatment is increasingly common, as geriatric patients remain active with high functional demands. Studies in elderly populations have demonstrated satisfactory healing and clinical results following surgical repair. Predictors of poor outcome after repair are large tear size as well as higher stages of fatty infiltration. Decompression is a less invasive surgical option that has been shown to provide short-term pain relief, though the lasting effects may deteriorate over time. A number of factors must be weighed when considering which patients are likely to benefit from surgical intervention. PMID:26328240

  11. Acellular Dermal Matrix in Rotator Cuff Surgery.

    PubMed

    Cooper, Joseph; Mirzayan, Raffy

    2016-01-01

    The success of rotator cuff repair (RCR) surgery can be measured clinically (validated outcome scores, range of motion) as well as structurally (re-tear rates using imaging studies). Regardless of repair type or technique, most studies have shown that patients do well clinically. However, multiple studies have also shown that structurally, the failure rate can be very high. A variety of factors, including poor tendon quality, age over 63 years, smoking, advanced fatty infiltration into the muscle, and the inability of the tendon to heal to bone, have been implicated as the cause of the high re-tear rate in RCRs. The suture-tendon interface is felt to be the weakest link in the RCR construct, and suture pullout through the tendon is believed to be the most common method of failure. This review of the published literature seeks to determine if there is support for augmentation of RCR with acellular dermal matrices to strengthen the suture-tendon interface and reduce the re-tear rate. PMID:27552454

  12. The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial

    PubMed Central

    2012-01-01

    Background To evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm). Methods This was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Results Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended). Conclusion

  13. Glycosaminoglycans of human rotator cuff tendons: changes with age and in chronic rotator cuff tendinitis.

    PubMed Central

    Riley, G P; Harrall, R L; Constant, C R; Chard, M D; Cawston, T E; Hazleman, B L

    1994-01-01

    OBJECTIVES--To analyse the glycosaminoglycans of the adult human rotator cuff tendon matrix, to characterise changes in the glycosaminoglycan composition with age and in chronic rotator cuff tendinitis. METHODS--Rotator cuff (supraspinatus) tendons (n = 84) and common biceps tendons (n = 26) were obtained from cadavers with no history of tendon pathology (age range 11-95 years). Biopsies of rotator cuff tendons (supraspinatus and subscapularis tendons, n = 53) were obtained during open shoulder surgery to repair shoulder lesions (age range 38-80 years). Glycosaminoglycans were extracted by papain digestion and analysed by cellulose acetate electrophoresis, the carbazole assay for uronic acid and the dimethylmethylene blue dye-binding assay for sulphated glycosaminoglycans. Some digests were analysed for keratan sulphate by 5D4 monoclonal antibody ELISA. Soluble proteoglycans were extracted in 4M guanidine hydrochloride and analysed by 4-15% SDS PAGE. RESULTS--The mean (SD) sulphated glycosaminoglycan (GAG) content of the normal cadaver supraspinatus tendon was 12.3 (4.3) micrograms/mg dry weight, between three and ten times greater than in the common biceps tendon [1.2 (0.6) micrograms/mg dry weight]. The major GAG was chondroitin sulphate [6.9 (2.6) micrograms/mg dry weight], with a smaller proportion of dermatan sulphate [2.5 (1.2) micrograms/mg dry weight]. In contrast, the common biceps tendon contained predominantly dermatan sulphate [0.8 (0.2) microgram/mg dry weight] with less chondroitin sulphate [0.2 (0.2) microgram/mg dry weight]. There was no difference in the concentration of hyaluronan in these tendons [9.3 (2.8) micrograms/mg dry weight and 10.8 (4.3) micrograms/mg dry weight respectively] and there was no significant change of hyaluronan with age. Keratan sulphate was a small but significant component of the supraspinatus tendon [0.43 (0.33) microgram/mg dry weight, n = 25], whereas there was little or none in the common biceps tendon [0.04 (0

  14. A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial

    PubMed Central

    2013-01-01

    Background Blood Pressure related disease affected 118 million people in India in the year 2000; this figure will double by 2025. Around one in four adults in rural India have hypertension, and of those, only a minority are accessing appropriate care. Health systems in India face substantial challenges to meet these gaps in care, and innovative solutions are needed. Methods We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare. This intervention will be implemented as a stepped wedge, cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk (approximately 15,000 people). Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension’s region-specific risk charts. Cluster randomisation will occur at the level of the primary health centres. Outcome analyses will be conducted blinded to intervention allocation. Expected outcomes The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period. Secondary outcomes include mean reduction in blood pressure levels; change in other cardiovascular disease risk factors, including body mass index, current smoking, reported healthy eating habits, and reported physical activity levels; self-reported use of blood pressure and other cardiovascular medicines; quality of life (using the EQ-5D); and cardiovascular disease events (using hospitalisation data). Trial outcomes will be accompanied by detailed process and economic

  15. A Survey of Expert Opinion Regarding Rotator Cuff Repair.

    PubMed

    Acevedo, Daniel C; Paxton, E Scott; Williams, Gerald R; Abboud, Joseph A

    2014-07-16

    Many patients with rotator cuff tears have questions for their surgeons regarding the surgical procedure, perioperative management, restrictions, therapy, and ability to work after a rotator cuff repair. The purpose of our study was to determine common clinical practices among experts regarding rotator cuff repair and to assist them in counseling patients. We surveyed 372 members of the American Shoulder and Elbow Surgeons (ASES) and the Association of Clinical Elbow and Shoulder Surgeons (ACESS); 111 members (29.8%) completed all or part of the survey, and 92.8% of the respondents answered every question. A consensus response (>50% agreement) was achieved on 49% (24 of 49) of the questions. Variability in responses likely reflects the fact that clinical practices have evolved over time based on clinical experience. PMID:25031385

  16. Effects of Wing-Cuff on NACA 23015 Aerodynamic Performances

    NASA Astrophysics Data System (ADS)

    Meftah, S. M. A.; Belhenniche, M.; Madani Fouatih, O.; Imine, B.

    2014-03-01

    The main subject of this work is the numerical study control of flow separation on a NACA 23015 airfoil by using wing cuff. This last is a leading edge modification done to the wing. The modification consists of a slight extension of the chord on the outboard section of the wings. Different numerical cases are considered for the baseline and modified airfoil NACA 23015 according at different angle of incidence. The turbulence is modeled by two equations k-epsilon model. The results of this numerical investigation showed several benefits of the wing cuff compared with a conventional airfoil and an agreement is observed between the experimental data and the present study. The most intriguing result of this research is the capability for wing cuff to perform short take-offs and landings.

  17. Calcific tendinitis of the rotator cuff.

    PubMed

    ElShewy, Mohamed Taha

    2016-01-18

    Calcific tendinitis within the rotator cuff tendon is a common shoulder disorder that should be differentiated from dystrophic calcification as the pathogenesis and natural history of both is totally different. Calcific tendinitis usually occurs in the fifth and sixth decades of life among sedentary workers. It is classified into formative and resorptive phases. The chronic formative phase results from transient hypoxia that is commonly associated with repeated microtrauma causing calcium deposition into the matrix vesicles within the chondrocytes forming bone foci that later coalesce. This phase may extend from 1 to 6 years, and is usually asymptomatic. The resorptive phase extends from 3 wk up to 6 mo with vascularization at the periphery of the calcium deposits causing macrophage and mononuclear giant cell infiltration, together with fibroblast formation leading to an aggressive inflammatory reaction with inflammatory cell accumulation, excessive edema and rise of the intra-tendineous pressure. This results in a severely painful shoulder. Radiological investigations confirm the diagnosis and suggest the phase of the condition and are used to follow its progression. Although routine conventional X-ray allows detection of the deposits, magnetic resonance imaging studies allow better evaluation of any coexisting pathology. Various methods of treatment have been suggested. The appropriate method should be individualized for each patient. Conservative treatment includes pain killers and physiotherapy, or "minimally invasive" techniques as needling or puncture and aspiration. It is almost always successful since the natural history of the condition ends with resorption of the deposits and complete relief of pain. Due to the intolerable pain of the acute and severely painful resorptive stage, the patient often demands any sort of operative intervention. In such case arthroscopic removal is the best option as complete removal of the deposits is unnecessary. PMID

  18. Calcific tendinitis of the rotator cuff

    PubMed Central

    ElShewy, Mohamed Taha

    2016-01-01

    Calcific tendinitis within the rotator cuff tendon is a common shoulder disorder that should be differentiated from dystrophic calcification as the pathogenesis and natural history of both is totally different. Calcific tendinitis usually occurs in the fifth and sixth decades of life among sedentary workers. It is classified into formative and resorptive phases. The chronic formative phase results from transient hypoxia that is commonly associated with repeated microtrauma causing calcium deposition into the matrix vesicles within the chondrocytes forming bone foci that later coalesce. This phase may extend from 1 to 6 years, and is usually asymptomatic. The resorptive phase extends from 3 wk up to 6 mo with vascularization at the periphery of the calcium deposits causing macrophage and mononuclear giant cell infiltration, together with fibroblast formation leading to an aggressive inflammatory reaction with inflammatory cell accumulation, excessive edema and rise of the intra-tendineous pressure. This results in a severely painful shoulder. Radiological investigations confirm the diagnosis and suggest the phase of the condition and are used to follow its progression. Although routine conventional X-ray allows detection of the deposits, magnetic resonance imaging studies allow better evaluation of any coexisting pathology. Various methods of treatment have been suggested. The appropriate method should be individualized for each patient. Conservative treatment includes pain killers and physiotherapy, or “minimally invasive” techniques as needling or puncture and aspiration. It is almost always successful since the natural history of the condition ends with resorption of the deposits and complete relief of pain. Due to the intolerable pain of the acute and severely painful resorptive stage, the patient often demands any sort of operative intervention. In such case arthroscopic removal is the best option as complete removal of the deposits is unnecessary. PMID

  19. Biceps Lesion Associated With Rotator Cuff Tears

    PubMed Central

    Jeong, Ho Yeon; Kim, Jung Youn; Cho, Nam Su; Rhee, Yong Girl

    2016-01-01

    Background: Various tenodesis methods are being used for long head of the biceps tendon lesions. However, there is no consensus on the most appropriate surgical method. Hypothesis: There are significant differences in incidence of cosmetic deformity and persistent bicipital pain between open subpectoral and arthroscopic intracuff tenodesis groups. Study Design: Cohort study; Level of evidence, 3. Methods: This study included 72 patients who underwent biceps tenodesis and rotator cuff repair between January 2009 and May 2014 and who were followed for at least 1 year. Open subpectoral tenodesis was performed in 39 patients (group A), and arthroscopic intracuff tenodesis was performed in 33 patients (group B). Results: In group A, the mean visual analog scale (VAS) score for pain during motion and mean University of California, Los Angeles (UCLA) and Constant scores significantly improved from 4.6, 18.6, and 64.5 preoperatively to 1.9, 30.5, and 86.5 at last follow-up, respectively (P < .001 for all). In group B, these scores significantly improved from 5.1, 17.6, and 62.9 preoperatively to 1.8, 31.5, and 85.9 at last follow-up, respectively (P < .001 for all). Popeye deformity was noted in 2 (5.2%) patients from group A and 5 (15.6%) patients from group B (P = .231). Additionally, persistent bicipital tenderness was noted in 1 (2.6%) patient from group A and 8 (24.2%) patients from group B (P = .012). Conclusion: Both open subpectoral tenodesis and arthroscopic intracuff tenodesis show good clinical outcomes for long head of the biceps tendon lesions. However, open subpectoral tenodesis may be more appropriate, considering the low incidence of Popeye deformity and tenderness. PMID:27231699

  20. [Bony avulsions of the rotator cuff : Arthroscopic concepts].

    PubMed

    Greiner, S; Scheibel, M

    2011-01-01

    Bony avulsions of the rotator cuff and isolated greater or lesser tuberosity fractures are rare injuries and a clear consensus regarding classification and therapy does not yet exist. Conservative therapy is limited, especially in injuries with displaced fragments and in these cases surgical treatment is frequently indicated. The ongoing development of arthroscopic techniques has led to quite a number of reports about arthroscopically assisted or total arthroscopic techniques in the treatment of these injuries. The advantages and disadvantages of arthroscopic concepts for the treatment of bony avulsions of the rotator cuff are presented with reference to the current literature. PMID:21153534

  1. Drinking Citrus Fruit Juice Inhibits Vascular Remodeling in Cuff-Induced Vascular Injury Mouse Model

    PubMed Central

    Ohnishi, Arika; Asayama, Rie; Mogi, Masaki; Nakaoka, Hirotomo; Kan-no, Harumi; Tsukuda, Kana; Chisaka, Toshiyuki; Wang, Xiao-Li; Bai, Hui-Yu; Shan, Bao-Shuai; Kukida, Masayoshi; Iwanami, Jun; Horiuchi, Masatsugu

    2015-01-01

    Citrus fruits are thought to have inhibitory effects on oxidative stress, thereby attenuating the onset and progression of cancer and cardiovascular disease; however, there are few reports assessing their effect on vascular remodeling. Here, we investigated the effect of drinking the juice of two different citrus fruits on vascular neointima formation using a cuff-induced vascular injury mouse model. Male C57BL6 mice were divided into five groups as follows: 1) Control (water) (C), 2) 10% Citrus unshiu (CU) juice (CU10), 3) 40% CU juice (CU40), 4) 10% Citrus iyo (CI) juice (CI10), and 5) 40% CI juice (CI40). After drinking them for 2 weeks from 8 weeks of age, cuff injury was induced by polyethylene cuff placement around the femoral artery. Neointima formation was significantly attenuated in CU40, CI10 and CI40 compared with C; however, no remarkable preventive effect was observed in CU10. The increases in levels of various inflammatory markers including cytokines such as monocyte chemotactic protein-1, interleukin-6 (IL-6), IL-1β, and tumor necrosis factor-α in response to vascular injury did not differ significantly between C, CU10 and CI10. The increases in cell proliferation and superoxide anion production were markedly attenuated in CI10, but not in CU10 compared with C. The increase in phosphorylated ERK expression was markedly attenuated both in CU10 and CI10 without significant difference between CU10 and CI10. Accumulation of immune cells did not differ between CU10 and CI10. These results indicate that drinking citrus fruit juice attenuates vascular remodeling partly via a reduction of oxidative stress. Interestingly, the preventive efficacy on neointima formation was stronger in CI than in CU at least in part due to more prominent inhibitory effects on oxidative stress by CI. PMID:25692290

  2. Drinking citrus fruit juice inhibits vascular remodeling in cuff-induced vascular injury mouse model.

    PubMed

    Ohnishi, Arika; Asayama, Rie; Mogi, Masaki; Nakaoka, Hirotomo; Kan-No, Harumi; Tsukuda, Kana; Chisaka, Toshiyuki; Wang, Xiao-Li; Bai, Hui-Yu; Shan, Bao-Shuai; Kukida, Masayoshi; Iwanami, Jun; Horiuchi, Masatsugu

    2015-01-01

    Citrus fruits are thought to have inhibitory effects on oxidative stress, thereby attenuating the onset and progression of cancer and cardiovascular disease; however, there are few reports assessing their effect on vascular remodeling. Here, we investigated the effect of drinking the juice of two different citrus fruits on vascular neointima formation using a cuff-induced vascular injury mouse model. Male C57BL6 mice were divided into five groups as follows: 1) Control (water) (C), 2) 10% Citrus unshiu (CU) juice (CU10), 3) 40% CU juice (CU40), 4) 10% Citrus iyo (CI) juice (CI10), and 5) 40% CI juice (CI40). After drinking them for 2 weeks from 8 weeks of age, cuff injury was induced by polyethylene cuff placement around the femoral artery. Neointima formation was significantly attenuated in CU40, CI10 and CI40 compared with C; however, no remarkable preventive effect was observed in CU10. The increases in levels of various inflammatory markers including cytokines such as monocyte chemotactic protein-1, interleukin-6 (IL-6), IL-1β, and tumor necrosis factor-α in response to vascular injury did not differ significantly between C, CU10 and CI10. The increases in cell proliferation and superoxide anion production were markedly attenuated in CI10, but not in CU10 compared with C. The increase in phosphorylated ERK expression was markedly attenuated both in CU10 and CI10 without significant difference between CU10 and CI10. Accumulation of immune cells did not differ between CU10 and CI10. These results indicate that drinking citrus fruit juice attenuates vascular remodeling partly via a reduction of oxidative stress. Interestingly, the preventive efficacy on neointima formation was stronger in CI than in CU at least in part due to more prominent inhibitory effects on oxidative stress by CI. PMID:25692290

  3. Study protocol for a phase III multicentre, randomised, open-label, blinded-end point trial to evaluate the efficacy and safety of immunoglobulin plus cyclosporin A in patients with severe Kawasaki disease (KAICA Trial)

    PubMed Central

    Aoyagi, Reiko; Hamada, Hiromichi; Sato, Yasunori; Suzuki, Hiroyuki; Onouchi, Yoshihiro; Ebata, Ryota; Terauchi, Moe; Terai, Masaru; Hanaoka, Hideki; Hata, Akira

    2015-01-01

    Introduction Kawasaki disease (KD) is an acute, self-limited vasculitis of unknown aetiology that predominantly affects infants and young children. We hypothesise that cyclosporin A (CsA) may be effective in treating KD by regulating the Ca2+/NFAT signalling pathway. This trial compares the current standard therapy of intravenous immunoglobulin (IVIG) and the combined IVIG+CsA therapy in paediatric patients with severe KD. Methods and analysis This trial is a phase III, multicentre, randomised, open-label, blinded-end point trial that evaluates the efficacy and safety of IVIG+CsA therapy. Patients with severe KD who satisfy the eligibility criteria are randomised (1:1) to receive either CsA (5 mg/kg/day for 5 days; Neoral) plus high-dose IVIG (2 g/kg for 24 h and aspirin 30 mg/kg/day), or high-dose IVIG alone (2 g/kg for 24 h and aspirin 30 mg/kg/day). The primary end point is the frequency of occurrence of coronary artery abnormalities during the trial period. An independent end point review committee will be in charge of the trial assessment. Ethics and dissemination The protocol was approved by the Institutional Review Board of each institution. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, in Japan. The trial is currently on-going and is scheduled to finish in April 2017. The findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number JMA-IIA00174; Pre-results. PMID:26628527

  4. Is There an Association Between the “Critical Shoulder Angle” and Clinical Outcome after Rotator Cuff Repair?

    PubMed Central

    Kirsch, Jacob Matthew; Nathani, Amit; Robbins, Christopher; Gagnier, Joel Joseph; Bedi, Asheesh; Miller, Bruce S.

    2016-01-01

    that a CSA less than 38 degrees was associated with better outcomes in patients following surgical repair of atraumatic full-thickness rotator cuff tears. This is the first study to examine the relationship between the CSA and outcomes following RCR. These findings suggest that individual scapular morphology may influence both disease development and surgical outcomes of rotator cuff tears. This association warrants further investigation.

  5. Complications Following Arthroscopic Rotator Cuff Tear Repair

    PubMed Central

    Audigé, Laurent; Blum, Raphael; Müller, Andreas M.; Flury, Matthias; Durchholz, Holger

    2015-01-01

    Background Valid comparison of outcomes after surgical procedures requires consensus on which instruments and parameters should be used, including the recording and evaluation of surgical complications. An international standard outlining the terminology and definitions of surgical complications in orthopaedics is lacking. Purpose This study systematically reviewed the literature for terms and definitions related to the occurrence of negative events or complications after arthroscopic rotator cuff repair (ARCR) with specific focus on shoulder stiffness. Study Design Systematic review; Level of evidence, 4. Methods PubMed, EMBASE, Cochrane Library, and Scopus databases were searched for reviews, clinical studies, and case reports of complications associated with ARCR. Reference lists of selected articles were also screened. The terminology of complications and their definitions were extracted from all relevant original articles by a single reviewer and verified by a second reviewer. Definitions of shoulder stiffness or equivalent terms were tabulated. Results Of 654 references published after 2007 and obtained from the search, 233 full-text papers (44 reviews, 155 studies, 31 case reports, and 3 surgical technique presentations) were reviewed. Twenty-two additional references cited for a definition were checked. One report defined the term surgical complication. There were 242 different terms used to describe local events and 64 to describe nonlocal events. Furthermore, 16 definitions of terms such as frozen shoulder, shoulder stiffness, or stiff painful shoulder were identified. Diagnosis criteria for shoulder stiffness differed widely; 12 various definitions for restriction in range of motion were noted. One definition included a gradation of stiffness severity, whereas another considered the patient’s subjective assessment of motion. Conclusion The literature does not consistently report on complications after ARCR, making valid comparison of the incidence of

  6. Endotracheal tube cuff pressure before, during, and after fixed-wing air medical retrieval.

    PubMed

    Brendt, Peter; Schnekenburger, Marc; Paxton, Karen; Brown, Anthony; Mendis, Kumara

    2013-01-01

    Abstract Background. Increased endotracheal tube (ETT) cuff pressure is associated with compromised tracheal mucosal perfusion and injuries. No published data are available for Australia on pressures in the fixed-wing air medical retrieval setting. Objective. After introduction of a cuff pressure manometer (Mallinckrodt, Hennef, Germany) at the Royal Flying Doctor Service (RFDS) Base in Dubbo, New South Wales (NSW), Australia, we assessed the prevalence of increased cuff pressures before, during, and after air medical retrieval. Methods. This was a retrospective audit in 35 ventilated patients during fixed-wing retrievals by the RFDS in NSW, Australia. Explicit chart review of ventilated patients was performed for cuff pressures and changes during medical retrievals with pressurized aircrafts. Pearson correlation was calculated to determine the relation of ascent and ETT cuff pressure change from ground to flight level. Results. The mean (± standard deviation) of the first ETT cuff pressure measurement on the ground was 44 ± 20 cmH2O. Prior to retrieval in 11 patients, the ETT cuff pressure was >30 cmH2O and in 11 patients >50 cmH2O. After ascent to cruising altitude, the cuff pressure was >30 cmH2O in 22 patients and >50 cmH2O in eight patients. The cuff pressure was reduced 1) in 72% of cases prior to take off and 2) in 85% of cases during flight, and 3) after landing, the cuff pressure increased in 85% of cases. The correlation between ascent in cabin altitude and ETT cuff pressure was r = 0.3901, p = 0.0205. Conclusions. The high prevalence of excessive cuff pressures during air medical retrieval can be avoided by the use of cuff pressure manometers. Key words: cuff pressure; air medical retrieval; prehospital. PMID:23252881

  7. Analysis of Direct Costs of Outpatient Arthroscopic Rotator Cuff Repair.

    PubMed

    Narvy, Steven J; Ahluwalia, Avtar; Vangsness, C Thomas

    2016-01-01

    Arthroscopic rotator cuff surgery is one of the most commonly performed orthopedic surgical procedures. We conducted a study to calculate the direct cost of arthroscopic repair of rotator cuff tears confirmed by magnetic resonance imaging. Twenty-eight shoulders in 26 patients (mean age, 54.5 years) underwent primary rotator cuff repair by a single fellowship-trained arthroscopic surgeon in the outpatient surgery center of a major academic medical center. All patients had interscalene blocks placed while in the preoperative holding area. Direct costs of this cycle of care were calculated using the time-driven activity-based costing algorithm. Mean time in operating room was 148 minutes; mean time in recovery was 105 minutes. Calculated surgical cost for this process cycle was $5904.21. Among material costs, suture anchor costs were the main cost driver. Preoperative bloodwork was obtained in 23 cases, adding a mean cost of $111.04. Our findings provide important preliminary information regarding the direct economic costs of rotator cuff surgery and may be useful to hospitals and surgery centers negotiating procedural reimbursement for the increased cost of repairing complex tears. PMID:26761928

  8. The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411

    PubMed Central

    Murphy, Andrew W; Cupples, Margaret E; Smith, Susan M; Byrne, Molly; Leathem, Claire; Byrne, Mary C

    2005-01-01

    Background The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. Methods SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to

  9. Dose-Response Evaluation of Braslet-M Occlusion Cuffs

    NASA Technical Reports Server (NTRS)

    Ebert, Douglas; Garcia, Kathleen; Sargsyan, Ashot E.; Ham, David; Hamilton, Douglas; Dulchavsky, Scott A.

    2010-01-01

    Introduction: Braslet-M is a set of special elasticized thigh cuffs used by the Russian space agency to reduce the effects of the head-ward fluid shift during early adaptation to microgravity by sequestering fluid in the lower extremities. Currently, no imaging modalities are used in the calibration of the device, and the pressure required to produce a predictable physiological response is unknown. This investigation intends to relate the pressure exerted by the cuffs to the extent of fluid redistribution and commensurate physiological effects. Materials and Methods: Ten healthy subjects with standardized fluid intake participated in the study. Data collection included femoral and internal jugular vein imaging in two orthogonal planes, pulsed Doppler of cervical and femoral vessels and middle cerebral artery, optic nerve imaging, and echocardiography. Braslet-M cuff pressure was monitored at the skin interface using pre-calibrated pressure sensors. Using 6 and 30 head-down tilt in two separate sessions, the effect of Braslet-M was assessed while incrementally tightening the cuffs. Cuffs were then simultaneously released to document the resulting hemodynamic change. Results: Preliminary analysis shows correlation between physical pressure exerted by the Braslet-M device and several parameters such as jugular and femoral vein cross-sections, resistivity of the lower extremity vascular bed, and others. A number of parameters reflect blood redistribution and will be used to determine the therapeutic range of the device and to prevent unsafe application. Conclusion: Braslet-M exerts a physical effect that can be measured and correlated with many changes in central and peripheral hemodynamics. Analysis of the full data set will be required to make definitive recommendations regarding the range of safe therapeutic application. Objective data and subjective responses suggest that a safer and equally effective use of Braslet can be achieved when compared with the current

  10. Retrospective study of sonographic findings in bone involvement associated with rotator cuff calcific tendinopathy: preliminary results of a case series*

    PubMed Central

    Nogueira-Barbosa, Marcello H.; Gregio-Junior, Everaldo; Lorenzato, Mario Muller

    2015-01-01

    Objective The present study was aimed at investigating bone involvement secondary to rotator cuff calcific tendonitis at ultrasonography. Materials and Methods Retrospective study of a case series. The authors reviewed shoulder ultrasonography reports of 141 patients diagnosed with rotator cuff calcific tendonitis, collected from the computer-based data records of their institution over a four-year period. Imaging findings were retrospectively and consensually analyzed by two experienced musculoskeletal radiologists looking for bone involvement associated with calcific tendonitis. Only the cases confirmed by computed tomography were considered for descriptive analysis. Results Sonographic findings of calcific tendinopathy with bone involvement were observed in 7/141 (~ 5%) patients (mean age, 50.9 years; age range, 42-58 years; 42% female). Cortical bone erosion adjacent to tendon calcification was the most common finding, observed in 7/7 cases. Signs of intraosseous migration were found in 3/7 cases, and subcortical cysts in 2/7 cases. The findings were confirmed by computed tomography. Calcifications associated with bone abnormalities showed no acoustic shadowing at ultrasonography, favoring the hypothesis of resorption phase of the disease. Conclusion Preliminary results of the present study suggest that ultrasonography can identify bone abnormalities secondary to rotator cuff calcific tendinopathy, particularly the presence of cortical bone erosion. PMID:26811551

  11. Efficacy and safety of betahistine treatment in patients with Meniere’s disease: primary results of a long term, multicentre, double blind, randomised, placebo controlled, dose defining trial (BEMED trial)

    PubMed Central

    Adrion, Christine; Fischer, Carolin Simone; Wagner, Judith; Gürkov, Robert; Mansmann, Ulrich

    2016-01-01

    Study question What is the long term efficacy of betahistine dihydrochloride on the incidence of vertigo attacks in patients with Meniere’s disease, compared with placebo? Methods The BEMED trial is a multicentre, double blind, randomised, placebo controlled, three arm, parallel group, phase III, dose defining superiority trial conducted in 14 German tertiary referral centres (for neurology or ear, nose, and throat). Adults aged 21-80 years (mean age 56 years) with definite unilateral or bilateral Meniere’s disease were recruited from March 2008 to November 2012. Participants received placebo (n=74), low dose betahistine (2×24 mg daily, (n=73)), or high dose betahistine (3×48 mg daily, (n=74)) over nine months. The primary outcome was the number of attacks per 30 days, based on patients’ diaries during a three month assessment period at months seven to nine. An internet based randomisation schedule performed a concealed 1:1:1 allocation, stratified by study site. Secondary outcomes included the duration and severity of attacks, change in quality of life scores, and several observer-reported parameters to assess changes in audiological and vestibular function. Study answer and limitations Incidence of attacks related to Meniere’s disease did not differ between the three treatment groups (P=0.759). Compared with placebo, attack rate ratios were 1.036 (95% confidence interval 0.942 to 1.140) and 1.012 (0.919 to 1.114) for low dose and high dose betahistine, respectively. The overall monthly attack rate fell significantly by the factor 0.758 (0.705 to 0.816; P<0.001). The population based, mean monthly incidence averaged over the assessment period was 2.722 (1.304 to 6.309), 3.204 (1.345 to 7.929), and 3.258 (1.685 to 7.266) for the placebo, low dose betahistine, and high dose betahistine groups, respectively. Results were consistent for all secondary outcomes. Treatment was well tolerated with no unexpected safety findings. Without a control group of

  12. Ultrasound for the detection of full-thickness rotator cuff tears: the learning curve for an orthopaedic surgeon using a novel training method

    PubMed Central

    Ibrahim, Edward F; Petrou, Charalambos

    2014-01-01

    Background The present study aims to add to the body of evidence delineating the learning curve for a shoulder surgeon to become proficient in focussed ultrasound for the detection of full-thickness rotator cuff tears, as well as to describe a learning method for this skill. Methods Consecutive patients who were scheduled to undergo an arthroscopy for rotator cuff disease were scanned immediately before surgery by a senior shoulder surgeon with limited previous experience of shoulder ultrasound. The presence or absence of a full-thickness rotator cuff tear on scan was compared with intra-operative findings as the gold standard. Results Two hundred and ten shoulders were scanned over three equal learning periods. Comparing predictive values from the first to the third training period, sensitivity improved from 0.86 to 0.95, specificity from 0.92 to 0.98, negative predictive value from 0.94 to 0.98, and positive predictive value from 0.82 to 0.95. Conclusions The high predictive values obtained in the present study for surgeon-led detection of cuff tears using ultrasound are comparable with those quoted for musculoskeletal radiologists in the literature. The present study adds evidence that a shoulder surgeon can achieve accelerated learning of this skill and offers some potentially time-saving and patient-friendly alternatives to existing guidelines.

  13. 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

  14. Arthroscopic Rotator Cuff Repair Using the Undersurface Technique

    PubMed Central

    Rubenis, Imants; Lam, Patrick H.; Murrell, George A.C.

    2015-01-01

    Background: Arthroscopic rotator cuff repair has traditionally been performed in the subacromial space from the bursal side of the tendon. The undersurface rotator cuff repair technique involves the arthroscope remaining in the glenohumeral joint, thus viewing the tendon from its undersurface during repair without a bursectomy or acromioplasty. Purpose: To compare the clinical and structural outcomes of undersurface rotator cuff repair with bursal-side repair. Study Design: Cohort study; Level of evidence, 3. Methods: A retrospective analysis of prospectively collected data was conducted on 2 cohorts of patients who had undergone arthroscopic rotator cuff repair with knotless suture anchors configured in a single-row formation using inverted mattress–style sutures from either the bursal side (n = 100) or undersurface (n = 165) of the supraspinatus tendon. Data were collected preoperatively, intraoperatively, and at 1 week, 6 weeks, 3 months, 6 months, and 2 years postoperatively. At each time point, patients completed a modified L’Insalata questionnaire to assess patient-ranked pain scores and were clinically examined using standardized tests. Ultrasound examination was performed at 6 months and 2 years to assess the integrity of the repair. Results: At 2 years postoperatively, patients in both cohorts had significantly less pain and less difficulty with overhead activities compared with preoperative levels (P < .001). The type of repair performed (bursal or undersurface) did not affect the ability to perform overhead activities at 2 years. At 2 years, both groups also had similar retear rates (21% for bursal side, 23% for undersurface). The mean operative time for the arthroscopic rotator cuff repair was 32 minutes when performed from the bursal side and 20 minutes when performed from the undersurface (P < .001). Conclusion: Arthroscopic rotator cuff repair, whether performed from the subacromial space or glenohumeral joint, resulted in decreased levels of

  15. Azithromycin and cough-specific health status in patients with chronic obstructive pulmonary disease and chronic cough: a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Macrolides reduce exacerbations in patients with COPD. Their effects on health status has not been assessed as primary outcome and is less clear. This study assessed the effects of prophylactic azithromycin on cough-specific health status in COPD-patients with chronic productive cough. Methods In this randomised controlled trial 84 patients met the eligibility criteria: age of ≥40 years, COPD GOLD stage ≥2 and chronic productive cough. The intervention-group (n = 42) received azithromycin 250 mg 3 times a week and the control-group (n = 42) received a placebo. Primary outcome was cough-specific health status at 12 weeks, measured with the Leicester Cough Questionnaire (LCQ). Secondary outcomes included generic and COPD-specific health status and exacerbations. Changes in adverse events and microbiology were monitored. Results Mean age of participants was 68 ± 10 years and mean FEV1 was 1.36 ± 0.47 L. The improvement in LCQ total score at 12 weeks was significantly greater with azithromycin (difference 1.3 ± 0.5, 95% CI 0.3;2.3, p = 0.01) and met the minimal clinically important difference. Similar results were found for the domain scores, and COPD-specific and generic health status questionnaires. Other secondary endpoints were non-significant. No imbalances in adverse events were found. Conclusions Prophylactic azithromycin improved cough-specific health status in COPD-patients with chronic productive cough to a clinically relevant degree. Trial registration ClinicalTrials.gov NCT01071161 PMID:24229360

  16. Comparison of prophylactic effects of polyurethane cylindrical or tapered cuff and polyvinyl chloride cuff endotracheal tubes on ventilator-associated pneumonia.

    PubMed

    Mahmoodpoor, Ata; Peyrovi-far, Ali; Hamishehkar, Hadi; Bakhtyiari, Zhaleh; Mirinezhad, Mir Mousa; Hamidi, Masoud; Golzari, Samad Eslam Jamal

    2013-01-01

    Because microaspiration of contaminated supraglottic secretions past the endotracheal tube cuff is considered to be central in the pathogenesis of pneumonia, improved design of tracheal tubes with new cuff material and shape have reduced the size and number of folds, which together with the addition of suction ports above the cuff to drain pooled subglottic secretions leads to reduced aspiration of oropharyngeal secretions. So we conducted a study to compare the prophylactic effects of polyurethane-cylindrical or tapered cuff and polyvinyl chloride cuff endotracheal tubes (ETT) on ventilator-associated pneumonia. This randomized clinical trial was carried out in a 12 bed surgical intensive care unit. 96 patients expected to require mechanical ventilation more than 96 hours were randomly allocated to one of three following groups: Polyvinyl chloride cuff (PCV) ETT, Polyurethane (PU) cylindrical Sealguard ETT and PU Taperguard ETT. Cuff pressure monitored every three hours 3 days in all patients. Mean cuff pressure didn't have significant difference between three groups during 72 hours. Pneumonia was seen in 11 patients (34%) in group PVC, 8 (25%) in Sealguard and 7 (21%) in Taperguard group. Changes in mean cuff pressure between Sealguard and PVC tubes and also between Taperguard and PVC tubes did not show any significant difference. There was no significant difference in overinflation between three groups. The use of ETT with PU material results in reducing ventilator-associated pneumonia compared to ETT with PVC cuff. In PU tubes Taperguard has less incidence of ventilator-associated pneumonia compared to Sealguard tubes. PMID:23945890

  17. Treatment options for irreparable postero-superior cuff tears in young patients

    PubMed Central

    Galasso, Olimpio; Familiari, Filippo; Gasparini, Giorgio

    2015-01-01

    Rotator cuff tears (RCTs) occur more commonly with advanced age, with most rotator cuff abnormalities in patients less than 30 years old being painful tendinoses or partial-thickness RCTs. Irreparable postero-superior cuff tears has been reported as frequent as 7% to 10% in the general population, and the incidence of irreparable RCTs in young patients is still unknown. Several surgical procedures have been proposed for young patients with irreparable postero-superior RCTs, such as rotator cuff debridement, partial rotator cuff repair, biceps tenotomy/tenodesis, rotator cuff grafting, latissimus dorsi tendon transfer, and reverse shoulder arthroplasty. After being thoroughly investigated in open surgery, arthroscopic techniques for latissimus dorsi tendon transfer have been recently described. They have been shown to be an adequate option to open surgery for managing irreparable postero-superior RCTs refractory to conservative management. PMID:26601058

  18. Treatment options for irreparable postero-superior cuff tears in young patients.

    PubMed

    Galasso, Olimpio; Familiari, Filippo; Gasparini, Giorgio

    2015-11-18

    Rotator cuff tears (RCTs) occur more commonly with advanced age, with most rotator cuff abnormalities in patients less than 30 years old being painful tendinoses or partial-thickness RCTs. Irreparable postero-superior cuff tears has been reported as frequent as 7% to 10% in the general population, and the incidence of irreparable RCTs in young patients is still unknown. Several surgical procedures have been proposed for young patients with irreparable postero-superior RCTs, such as rotator cuff debridement, partial rotator cuff repair, biceps tenotomy/tenodesis, rotator cuff grafting, latissimus dorsi tendon transfer, and reverse shoulder arthroplasty. After being thoroughly investigated in open surgery, arthroscopic techniques for latissimus dorsi tendon transfer have been recently described. They have been shown to be an adequate option to open surgery for managing irreparable postero-superior RCTs refractory to conservative management. PMID:26601058

  19. The effect of problem-based learning in patient education after an event of CORONARY heart disease – a randomised study in PRIMARY health care: design and methodology of the COR-PRIM study

    PubMed Central

    2012-01-01

    Background Even though there is convincing evidence that self-care, such as regular exercise and/or stopping smoking, alters the outcomes after an event of coronary heart disease (CHD), risk factors remain. Outcomes can improve if core components of secondary prevention programmes are structurally and pedagogically applied using adult learning principles e.g. problem-based learning (PBL). Until now, most education programs for patients with CHD have not been based on such principles. The basic aim is to discover whether PBL provided in primary health care (PHC) has long-term effects on empowerment and self-care after an event of CHD. Methods/Design A randomised controlled study is planned for patients with CHD. The primary outcome is empowerment to reach self-care goals. Data collection will be performed at baseline at hospital and after one, three and five years in PHC using quantitative and qualitative methodologies involving questionnaires, medical assessments, interviews, diaries and observations. Randomisation of 165 patients will take place when they are stable in their cardiac condition and have optimised cardiac medication that has not substantially changed during the last month. All patients will receive conventional care from their general practitioner and other care providers. The intervention consists of a patient education program in PHC by trained district nurses (tutors) who will apply PBL to groups of 6–9 patients meeting on 13 occasions for two hours over one year. Patients in the control group will not attend a PBL group but will receive home-sent patient information on 11 occasions during the year. Discussion We expect that the 1-year PBL-patient education will improve patients’ beliefs, self-efficacy and empowerment to achieve self-care goals significantly more than one year of standardised home-sent patient information. The assumption is that PBL will reduce cardiovascular events in the long-term and will also be cost-effective compared to

  20. Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial

    PubMed Central

    Farmer, Andrew; Toms, Christy; Hardinge, Maxine; Williams, Veronika; Rutter, Heather; Tarassenko, Lionel

    2014-01-01

    Introduction The potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education. Methods and analysis The EDGE (sElf management anD support proGrammE) for COPD is a multicentre, randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention (the EDGE platform) in improving quality of life in patients with moderate to very severe COPD compared with usual care. Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system. Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics. Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter. Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables. The primary outcome of quality of life is measured using the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) baseline, 6 and 12 months. Secondary outcome measures are recorded at these intervals in addition to 3 months. Ethics and dissemination The Research Ethics Committee for Berkshire—South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the

  1. I.S.Mu.L.T - Rotator Cuff Tears Guidelines.

    PubMed

    Oliva, Francesco; Piccirilli, Eleonora; Bossa, Michela; Via, Alessio Giai; Colombo, Alessandra; Chillemi, Claudio; Gasparre, Giuseppe; Pellicciari, Leonardo; Franceschetti, Edoardo; Rugiero, Clelia; Scialdoni, Alessandro; Vittadini, Filippo; Brancaccio, Paola; Creta, Domenico; Buono, Angelo Del; Garofalo, Raffaele; Franceschi, Francesco; Frizziero, Antonio; Mahmoud, Asmaa; Merolla, Giovanni; Nicoletti, Simone; Spoliti, Marco; Osti, Leonardo; Padulo, Johnny; Portinaro, Nicola; Tajana, Gianfranco; Castagna, Alex; Foti, Calogero; Masiero, Stefano; Porcellini, Giuseppe; Tarantino, Umberto; Maffulli, Nicola

    2015-01-01

    Despite the high level achieved in the field of shoulder surgery, a global consensus on rotator cuff tears management is lacking. This work is divided into two main sessions: in the first, we set questions about hot topics involved in the rotator cuff tears, from the etiopathogenesis to the surgical treatment. In the second, we answered these questions by mentioning Evidence Based Medicine. The aim of the present work is to provide easily accessible guidelines: they could be considered as recommendations for a good clinical practice developed through a process of systematic review of the literature and expert opinion, in order to improve the quality of care and rationalize the use of resources. PMID:26958532

  2. I.S.Mu.L.T - Rotator Cuff Tears Guidelines

    PubMed Central

    Oliva, Francesco; Piccirilli, Eleonora; Bossa, Michela; Via, Alessio Giai; Colombo, Alessandra; Chillemi, Claudio; Gasparre, Giuseppe; Pellicciari, Leonardo; Franceschetti, Edoardo; Rugiero, Clelia; Scialdoni, Alessandro; Vittadini, Filippo; Brancaccio, Paola; Creta, Domenico; Buono, Angelo Del; Garofalo, Raffaele; Franceschi, Francesco; Frizziero, Antonio; Mahmoud, Asmaa; Merolla, Giovanni; Nicoletti, Simone; Spoliti, Marco; Osti, Leonardo; Padulo, Johnny; Portinaro, Nicola; Tajana, Gianfranco; Castagna, Alex; Foti, Calogero; Masiero, Stefano; Porcellini, Giuseppe; Tarantino, Umberto; Maffulli, Nicola

    2015-01-01

    Despite the high level achieved in the field of shoulder surgery, a global consensus on rotator cuff tears management is lacking. This work is divided into two main sessions: in the first, we set questions about hot topics involved in the rotator cuff tears, from the etiopathogenesis to the surgical treatment. In the second, we answered these questions by mentioning Evidence Based Medicine. The aim of the present work is to provide easily accessible guidelines: they could be considered as recommendations for a good clinical practice developed through a process of systematic review of the literature and expert opinion, in order to improve the quality of care and rationalize the use of resources. PMID:26958532

  3. Gender Affects Early Postoperative Outcomes of Rotator Cuff Repair

    PubMed Central

    Ye, Hee-Uk; Jung, Jae-Won; Lee, Young-Kuk

    2015-01-01

    Background The literature does not provide consistent information on the impact of patients' gender on recovery after rotator cuff repair. The purpose of this study was to determine whether gender affects pain and functional recovery in the early postoperative period after rotator cuff repair. Methods Eighty patients (40 men and 40 women) were prospectively enrolled. Pain intensity and functional recovery were evaluated, using visual analog scale (VAS) pain score and range of motion on each of the first 5 postoperative days, at 2 and 6 weeks and at 3, 6, and 12 months after surgery. Perioperative medication-related adverse effects and postoperative complications were also assessed. Results The mean VAS pain score was significantly higher for women than men at 2 weeks after surgery (p = 0.035). For all other periods, there was no significant difference between men and women in VAS pain scores, although women had higher scores than men. Mean forward flexion in women was significantly lower than men at 6 weeks after surgery (p = 0.033) and the mean degree of external rotation in women was significantly lower than men at 6 weeks (p = 0.007) and at 3 months (p = 0.017) after surgery. There was no significant difference in medication-related adverse effects or postoperative complications. Conclusions Women had more pain and slower recovery of shoulder motion than men during the first 3 months after rotator cuff repair. These findings can serve as guidelines for pain management and rehabilitation after surgery and can help explain postoperative recovery patterns to patients with scheduled rotator cuff repair. PMID:26217471

  4. Evaluation of Internet Information About Rotator Cuff Repair.

    PubMed

    Lawson, Kevin A; Codella, Stephen; Ciccotti, Michael G; Kane, Patrick W; Duncan, Ian C; Cohen, Steven B

    2016-01-01

    The content and quality of Internet websites are not governed or regulated. Therefore, patients who consult the Internet may receive outdated or incorrect medical information. Researchers have analyzed the quality of web information about various orthopedic surgeries, but no such analysis has been performed on websites covering rotator cuff repair. We conducted a study to evaluate and analyze rotator cuff repair information available to the general public through the Internet; to assess changes in the quality of information over time; to determine if sites sponsored by academic institutions offered higher-quality information; and to assess whether the readability of the material varied according to DISCERN scores. Two Internet searches were conducted, in 2011 and 2014. The 3 most commonly used search engines were used to search for rotator cuff repair. The first 50 websites from each search engine were evaluated for authorship and content. The DISCERN instrument was used to analyze the quality of each website's health information. The 2011 search revealed 21% of websites were associated with an academic institution, 38% were authored by a hospital or physician group, and 11.5% were industry-sponsored. The 2014 search revealed a similar distribution of contributors. The highest DISCERN scores were given to academic institution websites (51.6) and public education websites (49). There was no correlation between readability and DISCERN scores. Websites associated with academic institutions produced the highest-quality medical information. Over the past few years, authorship and content have changed little with respect to Internet information about rotator cuff repair. PMID:26991581

  5. All-Arthroscopic Patch Augmentation of a Massive Rotator Cuff Tear: Surgical Technique

    PubMed Central

    Chalmers, Peter N.; Frank, Rachel M.; Gupta, Anil K.; Yanke, Adam B.; Trenhaile, Scott W.; Romeo, Anthony A.; Bach, Bernard R.; Verma, Nikhil N.

    2013-01-01

    Surgical management of massive rotator cuff tears remains challenging, with failure rates ranging from 20% to 90%. Multiple different arthroscopic and open techniques have been described, but there is no current gold standard. Failure after rotator cuff repair is typically multifactorial; however, failure of tendon-footprint healing is often implicated. Patch augmentation has been described as a possible technique to augment the biology of rotator cuff repair in situations of compromised tendon quality and has shown promising short-term results. The purpose of this article is to describe our preferred surgical technique for arthroscopic rotator cuff repair with patch augmentation. PMID:24400198

  6. EXTENSIVE ROTATOR CUFF INJURIES: AN EVALUATION OF ARTHROSCOPIC REPAIR OUTCOMES

    PubMed Central

    Miyazaki, Alberto Naoki; Fregoneze, Marcelo; Santos, Pedro Doneux; Silva, Luciana Andrade; Eduardo, Cesar Moreira Mariz Pinto Rodrigo Tormin Ortiz; Checchia, Sergio Luiz

    2015-01-01

    To assess the outcomes of the surgical treatment of extensive rotator cuff injuries through arthroscopy. Methods: Between June 1998 and October 2006, 61 patients with extensive rotator cuff injuries and submitted to surgical arthroscopy technique by the Shoulder and Elbow Group of the Department of Orthopaedics and Traumatology, Santa Casa de Misericórdia Medical School were reassessed. The study included all patients with at least two tendons affected or with retraction at least on two tendons up to the glenoidal cavity edge and with at least 12 months of follow-up. Results: According to UCLA's evaluation criteria, 54 (89%) patients showed excellent or good outcomes; no fair outcome in none of the patients; and seven (11%) poor outcomes. A satisfaction rate of 92% was reported. Postoperative joint motion went from a mean lifting value of 93° to 141°, the mean lateral rotation went from 32° to 48° and the mean medial rotation went from L1 to T10. These differences were regarded as statistically significant. Conclusion: The arthroscopic repair of extensive rotator cuff injuries leads to satisfactory outcomes for most of the patients, with a high satisfaction degree. PMID:26998466

  7. Biologic and pharmacologic augmentation of rotator cuff repairs.

    PubMed

    Edwards, Sara L; Lynch, T Sean; Saltzman, Matthew D; Terry, Michael A; Nuber, Gordon W

    2011-10-01

    As rotator cuff repair techniques have improved, failure of the tendon to heal to the proximal humerus is less likely to occur from weak tendon-to-bone fixation. More likely causes of failure include biologic factors such as intrinsic tendon degeneration, fatty atrophy, fatty infiltration of muscle, and lack of vascularity of the tendons. High failure rates have led to the investigation of biologic augmentation to potentially enhance the healing response. Histologic studies have shown that restoration of the rotator cuff footprint during repair can help reestablish the enthesis. In animal models, growth factors and their delivery scaffolds as well as tissue engineering have shown promise in decreasing scar tissue while maintaining biomechanical strength. Platelet-rich plasma may be a safe adjuvant to rotator cuff repair, but it has not been shown to improve healing or function. Many of these strategies need to be further defined to permit understanding of, and to optimize, the biologic environment; in addition, techniques need to be refined for clinical use. PMID:21980023

  8. Management of failed rotator cuff repair: a systematic review

    PubMed Central

    Lädermann, Alexandre; Denard, Patrick J; Burkhart, Stephen S

    2016-01-01

    Importance Recurrent tear after rotator cuff repair (RCR) is common. Conservative, and open and arthroscopic revisions, have been advocated to treat these failures. Aim or objective The purpose of this systematic review was to evaluate the different options for managing recurrent rotator cuff tears. Evidence review A search was conducted of level I through 4 studies from January 2000 to October 2015, to identify studies reporting on failed RCR. 10 articles were identified. The overall quality of evidence was very low. Findings Mid-term to long-term follow-up of patients treated conservatively revealed acceptable results; a persistent defect is a well-tolerated condition that only occasionally requires subsequent surgery. Conservative treatment might be indicated in most patients, particularly in case of posterosuperior involvement and poor preoperative range of motion. Revision surgery might be indicated in a young patient with a repairable lesion, a 3 tendon tear, and in those with involvement of the subscapularis. Conclusions and relevance The current review indicates that arthroscopic revision RCR can lead to improvement in functional outcome despite a high retear rate. Further studies are needed to develop specific rehabilitation in the case of primary rotator cuff failure, to better understand the place of each treatment option, and, in case of repair, to optimise tendon healing. PMID:27134759

  9. Open Rotator Cuff Tear Repair Using Deltopectoral Approach

    PubMed Central

    Guity, Mohammad Reza; Eraghi, Amir Sobhani

    2015-01-01

    Background: The goal of this study was to evaluate the outcome of the open repair of rotator cuff tears via the deltopectoral approach in patients unable to afford arthroscopic repair costs. Methods: We evaluated 80 consecutive patients who were treated for full-thickness rotator cuff tears by open repair through the deltopectoral approach. There were 48 men and 32 women at a mean age of 60.1 years (range, 35-80 years). Preoperative and postoperative clinical assessments were performed with the Constant score, American Shoulder and Elbow Surgeons (ASES) score, modified University of California Los Angeles (UCLA) score, and pain visual analog scale. Results: The mean follow-up period was 30.6 months (range, 18-48 months). At final follow-up visits, the ASES, Constant score, and modified UCLA score were found to have improved significantly from 33.56, 39.24, and 13.0 to 85.64, 81.46, and 32.2, respectively (P <0.01). Pain, as measured on a visual analog scale, was improved significantly (P <0.01). The mean time for recovering the full range of motion was 2.5 months. Postoperative pain at 48 hours and at 6 weeks was relatively low. There were no cases of intractable stiffness. Conclusion: The deltopectoral approach for open rotator cuff repair produced satisfactory results and reduces rate of shoulder stiffness and postoperative pain. PMID:26622080

  10. Postanesthesia patients with large upper arm circumference: is use of an "extra-long" adult cuff or forearm cuff placement accurate?

    PubMed

    Watson, Sheri; Aguas, Marita; Bienapfl, Tracy; Colegrove, Pat; Foisy, Nancy; Jondahl, Bonnie; Yosses, Mary Beth; Yu, Larissa; Anastas, Zoe

    2011-06-01

    The purpose of this study was to determine if blood pressure (BP) measured in the forearm or with an extra-long BP cuff in the upper arm accurately reflects BP measured in the upper arm with an appropriately sized BP cuff in patients with large upper arm circumference. A method-comparison design was used with a convenience sample of 49 PACU patients. Noninvasive blood pressures were obtained in two different locations (forearm; upper arm) and in the upper arm with an extra-long adult and recommended large adult cuff sizes. Data were analyzed by calculating bias and precision for the BP cuff size and location and Student's t-tests, with P < .0125 considered significant. Significantly higher forearm systolic (P < .0001) and diastolic (P < .0002) BP measurements were found compared to BP obtained in the upper arm with the reference standard BP cuff. Significantly higher systolic (t(48df) = 5.38, P < .0001), but not diastolic (t(48df) = 4.11, P < .019), BP differences were found for BP measured with the extra-long cuff at the upper arm site compared to the upper arm, reference standard BP. Findings suggest that the clinical practice of using the forearm or an extra-long cuff in the upper arm for BP measurement in post anesthesia patients with large upper arm circumferences may result in inaccurate BP values. PMID:21641528

  11. Effect of tamoxifen on fatty degeneration and atrophy of rotator cuff muscles in chronic rotator cuff tear: An animal model study.

    PubMed

    Cho, Edward; Zhang, Yue; Pruznak, Anne; Kim, H Mike

    2015-12-01

    Fatty degeneration of the rotator cuff muscles is an irreversible change resulting from chronic rotator cuff tear and is associated with poor clinical outcomes following rotator cuff repair. We evaluated the effect of Tamoxifen, a competitive estrogen receptor inhibitor, on fatty degeneration using a mouse model for chronic rotator cuff tear. Sixteen adult mice were divided into two diet groups (Tamoxifen vs. Regular) and subjected to surgical creation of a large rotator cuff tear and suprascapular nerve transection in their left shoulder with the right shoulder serving as a control. The rotator cuff muscles were harvested at 16 weeks and subjected to histology and RT-PCR for adipogenic and myogenic markers. Histology showed substantially decreased atrophy and endomysial inflammation in Tamoxifen group, but no significant differences in the amount of intramuscular adipocytes and lipid droplets compared to the Regular group. With RT-PCR, the operated shoulders showed significant upregulation of myogenin and PPAR-γ, and downregulation of myostatin compared to the nonsurgical shoulder. No significant differences of gene expression were found between the two diet groups. Our study demonstrated that tamoxifen diet leads to decreased muscle atrophy and inflammatory changes following chronic rotator cuff tear, but has no apparent effect on adipogenesis. PMID:26121952

  12. Vitamin D and the immunomodulation of rotator cuff injury

    PubMed Central

    Dougherty, Kaitlin A; Dilisio, Matthew F; Agrawal, Devendra K

    2016-01-01

    Tendon-to-bone healing after rotator cuff repair surgery has a failure rate of 20%–94%. There has been a recent interest to determine the factors that act as determinants between successful and unsuccessful rotator cuff repair. Vitamin D level in patients is one of the factors that have been linked to bone and muscle proliferation and healing, and it may have an effect on tendon-to-bone healing. The purpose of this article is to critically review relevant published research that relates to the effect of vitamin D on rotator cuff tears and subsequent healing. A review of the literature was conducted to identify all studies that investigate the relationship between vitamin D and tendon healing, in addition to its mechanism of action. The data were then analyzed in order to summarize what is currently known about vitamin D, rotator cuff pathology, and tendon-to-bone healing. The activated metabolite of vitamin D, 1α,25-dihydroxyvitamin D3, affects osteoblast proliferation and differentiation. Likewise, vitamin D plays a significant role in the tendon-to-bone healing process by increasing the bone mineral density and strengthening the skeletal muscles. The 1α,25-dihydroxyvitamin D3 binds to vitamin D receptors on myocytes to stimulate growth and proliferation. The form of vitamin D produced by the liver, calcifediol, is a key initiator of the myocyte healing process by moving phosphate into myocytes, which improves function and metabolism. Investigation into the effect of vitamin D on tendons has been sparse, but limited studies have been promising. Matrix metalloproteinases play an active role in remodeling the extracellular matrix (ECM) of tendons, particularly deleterious remodeling of the collagen fibers. Also, the levels of transforming growth factor-β3 positively influence the success of the surgery for rotator cuff repair. In the tendon-to-bone healing process, vitamin D has been shown to successfully influence bone and muscle healing, but more research is

  13. Arthroscopic Superior Capsule Reconstruction for Irreparable Rotator Cuff Tears

    PubMed Central

    Mihata, Teruhisa; Lee, Thay Q.; Itami, Yasuo; HASEGAWA, Akihiko; Ohue, Mutsumi; Neo, Masashi

    2016-01-01

    Objectives: An arthroscopic superior capsule reconstruction, in which the fascia lata autograft attached medially to the superior glenoid and laterally to the greater tuberosity, restores shoulder stability and muscle balance in patients with irreparable rotator cuff tears; consequently, it improves shoulder function specifically deltoid muscle function and relieves pain. We assessed the clinical outcome of arthroscopic superior capsule reconstruction (Figure 1) in 100 consecutive patients with irreparable rotator cuff tears. Specifically, we focused on the rates of return to sport and work. Methods: From 2007 to 2014, we performed arthroscopic superior capsule reconstruction on 107 consecutive patients (mean 66.7 years; range, 43 to 82) with irreparable rotator cuff tears that had failed conservative treatment. Seven patients were lost to follow-up because of other medical problems or reasons. In the remaining 100 patients there were 56 supraspinatus and infraspinatus tears; 39 supraspinatus, infraspinatus, and subscapularis tears; 3 supraspinatus, infraspinatus, teres minor, and subscapularis tears; and 2 supraspinatus, infraspinatus, and teres minor tears. Physical examination, radiography, and MRI were performed before surgery; at 3, 6, and 12 months after surgery; and yearly thereafter. Rates of return to sport and work were also investigated in those patients who had been employed (34 patients: 21 manual workers, 10 farmers, 1 butcher, 1 cook, and 1 athletic trainer) or played sport (26 patients: 6 golf, 4 table tennis, 4 swimming, 3 martial arts, 2 baseball, 2 yoga, 1 tennis, 1 badminton, 1 skiing, 1 mountain-climbing, and 1 ground golf) before injury. Results: The average preoperative American Shoulder and Elbow Surgeons (ASES) score was 31.6 points (range, 3.3 to 63.3 points) and the average Japanese Orthopaedic Association (JOA) score was 51.6 points (26.5 to 68.5 points). Average postoperative clinical outcome scores all improved significantly at final

  14. Assessment of musculoskeletal pain sensitivity and temporal summation by cuff pressure algometry: a reliability study.

    PubMed

    Graven-Nielsen, Thomas; Vaegter, Henrik Bjarke; Finocchietti, Sara; Handberg, Gitte; Arendt-Nielsen, Lars

    2015-11-01

    Chronic musculoskeletal pain is linked with sensitization, and standardized methods for assessment are needed. This study investigated (1) the test-retest reliability of computer-controlled cuff-pressure algometry (pain thresholds and temporal pain summation) on the arm and leg and (2) conditioned pain modulation (CPM) assessed by cuff algometry. The influences of age and gender were evaluated. On 2 different days, cuff pain threshold (cPPT), cuff pain tolerance (cPTT), and temporal summation of pain (TSP) by visual analog scale scores to 10 repeated cuff stimulations at cPTT intensity, as well as pressure pain threshold with handheld pressure algometry, were assessed in 136 healthy subjects. In one session, cuff pain sensitivity was also assessed before and after cold pressor-induced CPM. Good-to-excellent intraclass correlations (0.60-0.90) were demonstrated for manual and cuff algometry, and no systematic bias between sessions was found for cPPT, cPTT, and TSP on the leg and for cPTT and TSP on the arm. Cuff pressure pain threshold and cPTT were higher in men compared with women (P < 0.05). Middle-aged subjects had higher pressure pain threshold, but lower cPPT and cPTT, compared with younger subjects (P < 0.05). Temporal summation of pain was increased in women compared with men (P < 0.05). Cuff algometry was sensitive to CPM demonstrated as increased cPPT and cPTT and reduced TSP (P < 0.05). Reliability and sensitivity of computer-controlled cuff algometry for pain assessment is comparable with manual pressure algometry and constitutes a user-independent method for assessment of pain. Difference in age-related pain sensitivity between manual and cuff algometry should be further investigated. PMID:26172551

  15. Evaluation of an Intervention to Maintain Endotracheal Tube Cuff Pressure Within Therapeutic Range

    PubMed Central

    Sole, Mary Lou; Su, Xiaogang; Talbert, Steve; Penoyer, Daleen Aragon; Kalita, Samar; Jimenez, Edgar; Ludy, Jeffery E.; Bennett, Melody

    2012-01-01

    Background Endotracheal tube cuff pressure must be kept within an optimal range that ensures ventilation and prevents aspiration while maintaining tracheal perfusion. Objectives To test the effect of an intervention (adding or removing air) on the proportion of time that cuff pressure was between 20 and 30 cm H2O and to evaluate changes in cuff pressure over time. Methods A repeated-measure crossover design was used to study 32 orally intubated patients receiving mechanical ventilation for two 12-hour shifts (randomized control and intervention conditions). Continuous cuff pressure monitoring was initiated, and the pressure was adjusted to a minimum of 22 cm H2O. Caregivers were blinded to cuff pressure data, and usual care was provided during the control condition. During the intervention condition, cuff pressure alarm or clinical triggers guided the intervention. Results Most patients were men (mean age, 61.6 years). During the control condition, 51.7% of cuff pressure values were out of range compared with 11.1% during the intervention condition (P < .001). During the intervention, a mean of 8 adjustments were required, mostly to add air to the endotracheal tube cuff (mean 0.28 [SD, 0.13] mL). During the control condition, cuff pressure decreased over time (P < .001). Conclusions The intervention was effective in maintaining cuff pressure within an optimal range, and cuff pressure decreased over time without intervention. The effect of the intervention on outcomes such as ventilator-associated pneumonia and tracheal damage requires further study. PMID:21362715

  16. 76 FR 10578 - Cuffs Run Pumped Storage, LLC; Notice of Preliminary Permit Application Accepted for Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-25

    ... Energy Regulatory Commission Cuffs Run Pumped Storage, LLC; Notice of Preliminary Permit Application... 18, 2010, Cuffs Run Pumped Storage, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Cuffs Run Pumped...

  17. REHABILITATION AFTER ARTHROSCOPIC ROTATOR CUFF REPAIR: CURRENT CONCEPTS REVIEW AND EVIDENCE-BASED GUIDELINES

    PubMed Central

    Westgard, Paul; Chandler, Zachary; Gaskill, Trevor R.; Kokmeyer, Dirk; Millett, Peter J.

    2012-01-01

    Purpose: To provide an overview of the characteristics and timing of rotator cuff healing and provide an update on treatments used in rehabilitation of rotator cuff repairs. The authors' protocol of choice, used within a large sports medicine rehabilitation center, is presented and the rationale behind its implementation is discussed. Background: If initial nonsurgical treatment of a rotator cuff tear fails, surgical repair is often the next line of treatment. It is evident that a successful outcome after surgical rotator cuff repair is as much dependent on surgical technique as it is on rehabilitation. To this end, rehabilitation protocols have proven challenging to both the orthopaedic surgeon and the involved physical therapist. Instead of being based on scientific rationale, traditionally most rehabilitation protocols are solely based on clinical experience and expert opinion. Methods: A review of currently available literature on rehabilitation after arthroscopic rotator cuff tear repair on PUBMED / MEDLINE and EMBASE databases was performed to illustrate the available evidence behind various postoperative treatment modalities. Results: There is little high-level scientific evidence available to support or contest current postoperative rotator cuff rehabilitation protocols. Most existing protocols are based on clinical experience with modest incorporation of scientific data. Conclusion: Little scientific evidence is available to guide the timing of postsurgical rotator cuff rehabilitation. To this end, expert opinion and clinical experience remains a large facet of rehabilitation protocols. This review describes a rotator cuff rehabilitation protocol that incorporates currently available scientific literature guiding rehabilitation. PMID:22530194

  18. Muscle atrophy and fatty infiltration after an acute rotator cuff repair in a sheep model

    PubMed Central

    Luan, Tammy; Liu, Xuhui; Easley, Jeremiah T.; Ravishankar, Bharat; Puttlitz, Christian; Feeley, Brian T.

    2015-01-01

    Summary Introduction rotator cuff tears (RCTs) are the most common tendon injury seen in orthopedic patients. Muscle atrophy and fatty infiltration of the muscle are crucial factors that dictate the outcome following rotator cuff surgery. Though less studied in humans, rotator cuff muscle fibrosis has been seen in animal models as well and may influence outcomes as well. The purpose of this study was to determine if the rotator cuff would develop muscle changes even in the setting of an acute repair in a sheep model. We hypothesized that fatty infiltration and fibrosis would be present even after an acute repair six months after initial surgery. Methods twelve female adult sheep underwent an acute rotator cuff tear and immediate repair on the right shoulder. The left shoulder served as a control and did not undergo a tear or a repair. Six months following acute rotator cuff repairs, sheep muscles were harvested to study atrophy, fatty infiltration, and fibrosis by histological analysis, western blotting, and reverse transcription polymerase chain reaction (RT-PCR). Results the repair group demonstrated an increase expression of muscle atrophy, fatty infiltration, and fibrosis related genes. Significantly increased adipocytes, muscle fatty infiltration, and collagen deposition was observed in rotator cuff muscles in the tendon repair group compared to the control group. Conclusions rotator cuff muscle undergoes degradation changes including fatty infiltration and fibrosis even after the tendons are repair immediately after rupture. Level of Evidence Basic Science Study. PMID:26261789

  19. Blood pressure measurement in pregnancy: the effect of arm circumference and sphygmomanometer cuff size

    PubMed Central

    Kho, Chye L; Brown, Mark A; Ong, Sharon L H; Mangos, George J

    2009-01-01

    This study aimed to assess the difference in blood pressure readings between the standard and large cuff and to determine if such a difference applies over a range of arm circumferences (ACs) in pregnancy. We measured blood pressure on 219 antenatal women. Six blood pressure readings were taken, three with a standard ‘adult’ and three with a ‘large’ cuff, in random order. A random zero sphygmomanometer was used by a trained observer. Women with an AC >33 cm were similar in age, gestational age and parity but were heavier and had more hypertension than those with AC ≤33 cm. There was a systematic difference between the standard and large cuff of 5–7 mmHg with little effect due to AC. We were unable to demonstrate an association between the standard and large cuff blood pressure difference and increasing blood pressure. Our study has shown that both systolic and diastolic blood pressure measurements are more dependent on the cuff size used than AC and for the individual it is difficult to predict the magnitude of effect the different cuff sizes will have on blood pressure measurements. This study has shown the presence of an average difference in blood pressure measurement between standard and large cuffs in pregnancy, and does not support the arbitrary 33 cm ‘cut-off’ recommended in guidelines for the use of a large cuff in pregnancy.

  20. Investigating the cellular origin of rotator cuff muscle fatty infiltration and fibrosis after injury

    PubMed Central

    Liu, Xuhui; Ning, Anne Y.; Chang, Nai Chen; Kim, Hubert; Nissenson, Robert; Wang, Liping; Feeley, Brian T.

    2016-01-01

    Summary Background rotator cuff muscle atrophy, fibrosis and fatty infiltration are common complications after large and massive rotator cuff tears. Currently, there are no effective treatments for these muscle pathologies after injury. Furthermore, the cellular source for fibrotic and adipose tissues in rotator cuff muscle after injury remains unknown. In this study, we proposed that two groups of muscle resident progenitors, Tie2+ muscle mesenchymal progenitors and PDGFRα+ fibro/adipogenic progenitor cells (FAPs), contribute significantly to rotator cuff muscle fibrosis and fatty infiltration. Methods we tested our hypothesis using reporter mice. Rotator cuff muscles from Tie2-GFP and PDGFRα-GFP reporter mice were harvested at 2 and 6 weeks after unilateral massive rotator cuff tear surgeries. Immunofluorescent staining for fibroblast and adipocyte markers was conducted. Results our results showed significant co-localization of Tie2+ cells with fibrotic markers vimentin and αSMA. In the PDGFRα-GFP reporter mice, GFP signal was seen in only a small fraction of cells staining positive for vimentin and αSMA. However, PDGFRα showed significant co-localization with adipocyte markers, including PPAR-γ, adiponectin, and perilipin A. Oil red O staining confirmed that the mature adipocytes appearing in rotator cuff muscles after injury are also PDGFRα+. Conclusion these data demonstrated that the Tie2+ muscle mesenchymal progenitors are the major source of fibroblasts while PDGFRα+ FAPs are the major source of adipocytes in rotator cuff muscle fatty infiltration. Basic Science Study. PMID:27331027

  1. The effectiveness of a structured education pulmonary rehabilitation programme for improving the health status of people with moderate and severe chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial

    PubMed Central

    Casey, Dympna; Murphy, Kathy; Devane, Declan; Cooney, Adeline; McCarthy, Bernard; Mee, Lorraine; Newell, John; O'Shea, Eamon; Scarrott, Carl; Gillespie, Paddy; Kirwan, Collette; Murphy, Andrew W

    2013-01-01

    Objective To evaluate the effectiveness of a structured education pulmonary rehabilitation programme on the health status of people with chronic obstructive pulmonary disease (COPD). Design Two-arm, cluster randomised controlled trial. Setting 32 general practices in the Republic of Ireland. Participants 350 participants with a diagnosis of moderate or severe COPD. Intervention Experimental group received a structured education pulmonary rehabilitation programme, delivered by the practice nurse and physiotherapist. Control group received usual care. Main outcome measure Health status as measured by the Chronic Respiratory Questionnaire (CRQ) at baseline and at 12–14 weeks postcompletion of the programme. Results Participants allocated to the intervention group had statistically significant higher mean change total CRQ scores (adjusted mean difference (MD) 1.11, 95% CI 0.35 to 1.87). However, the CI does not exclude a smaller difference than the one that was prespecified as clinically important. Participants allocated to the intervention group also had statistically significant higher mean CRQ Dyspnoea scores after intervention (adjusted MD 0.49, 95% CI 0.20 to 0.78) and CRQ Physical scores (adjusted MD 0.37, 95% CI 0.14 to 0.60). However, CIs for both the CRQ Dyspnoea and CRQ Physical subscales do not exclude smaller differences as prespecified as clinically important. No other statistically significant differences between groups were seen. Conclusions A primary care based structured education pulmonary rehabilitation programme is feasible and may increase local accessibility to people with moderate and severe COPD. Trial registration ISRCTN52403063. PMID:23736156

  2. Safety and efficacy of liraglutide in patients with type 2 diabetes and end-stage renal disease: protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded, parallel intervention study

    PubMed Central

    Idorn, Thomas; Knop, Filip K; Jørgensen, Morten; Jensen, Tonny; Resuli, Marsela; Hansen, Pernille M; Christensen, Karl B; Holst, Jens J; Hornum, Mads; Feldt-Rasmussen, Bo

    2013-01-01

    Introduction Diabetes is the leading cause of end-stage renal disease (ESRD). Owing to renal clearance, several antidiabetic agents cannot be used in patients with ESRD. The present protocol describes an investigator-initiated trial aiming to test safety and efficacy of treatment with the glucagon-like peptide-1 receptor agonist liraglutide in patients with type 2 diabetes and dialysis-dependent ESRD. Methods and analysis Twenty patients with type 2 diabetes and ESRD will be compared with 20 matched patients with type 2 diabetes and normal kidney function in a randomised, parallel, placebo-controlled (1 : 1), double-blinded setting. All participants will receive 12 weeks of daily treatment with liraglutide/placebo in an individually titrated dose of 0.6, 1.2 or 1.8 mg. Over nine visits, plasma liraglutide, glycaemic control, β-cell response, cardiovascular parameters, various biomarkers and adverse events will be assessed. The primary endpoint will be evaluated from dose-corrected plasma trough liraglutide concentration at the final trial visit to determine potential accumulation in the ESRD group. Ethics and dissemination The study has been approved by the Danish Medicines Agency, the Scientific-Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the study. The results of the study will be presented at national and international scientific meetings, and publications will be submitted to peer-reviewed journals. Trial registration ClinicalTrials.gov Identifier: NCT01394341 PMID:23624993

  3. Effect of traditional Chinese exercise on the quality of life and depression for chronic diseases: a meta-analysis of randomised trials

    PubMed Central

    Wang, Xueqiang; Pi, Yanling; Chen, Binglin; Chen, Peijie; Liu, Yu; Wang, Ru; Li, Xin; Zhu, Yi; Yang, Yujie; Niu, Zhanbin

    2015-01-01

    Traditional Chinese exercise (TCE) has many uses in the prevention and treatment of chronic diseases. However, there is no consensus regarding the benefit of TCE for chronic diseases. Our objective is to examine the effect of TCE on the quality of life and depression for chronic diseases by performing a meta-analysis of randomized controlled trials (RCTs). We only cover published RCTs. The outcome measures included quality of life and depression. Sixty articles with a total of 4311 patients were included. The pooling revealed that TCE could improve the SF-36 physical function subscale in the short term [SMD (95% CI) = 0.35 (0.13, 0.56), P = 0.002] and mid-term [SMD (95% CI) = 0.49 (0.12, 0.85), P = 0.009], GHQ [SMD (95% CI) = −0.68 (−1.26, −0.09), P = 0.02], the Center for Epidemiologic Studies depression scale in the short term [SMD (95% CI) = −0.86 (−1.42, −0.31), P = 0.002] and mid-term [SMD (95% CI) = −0.41 (−0.64, −0.18), P < 0.001]. The meta-analysis of RCT demonstrates that TCE can significantly improve the quality of life and depression of patients with chronic diseases. These findings provide useful information for patients with chronic diseases as well as for medical staff. PMID:26525282

  4. Korotkoff sound versus oscillometric cuff sphygmomanometers: comparison between auscultatory and DynaPulse blood pressure measurements.

    PubMed

    Chio, Shiu-Shin; Urbina, Elaine M; Lapointe, Jeffery; Tsai, Jeffrey; Berenson, Gerald S

    2011-01-01

    Listening to Korotkoff sounds (K-sounds) to determine systolic and diastolic blood pressure (BP) has been the standard for noninvasive BP measurement in medical practices for nearly 100 years. It is the essential tool used for evaluation and assessment of patients with hypertension and risks of cardiovascular diseases (CVD) by physicians and nurses despite limited understanding of the nature of K-sounds. Analyzing cuff oscillometric signals to obtain BP has been the foundation of most digital BP monitors available today. DynaPulse is an oscillometric digital BP monitor that records and analyzes subtle changes of pulse waveforms during the course of a BP measurement while cuff pressure slowly decreases from above systolic to below diastolic. This study compares systolic and diastolic readings obtained by K-sound method following the Bogalusa Heart Study protocol and BP measured by DynaPulse (DP2000A) monitor, in order to better understand the nature and difference between K-sound and oscillometric methods. Analysis of means and differences is applied to BP data collected from 803 subjects examined in the Bogalusa Heart Study. The results indicated: 1) DynaPulse systolic was 9 mm Hg higher (P < .0001) than Phase 1 (K1) systolic, 2) DynaPulse diastolic was 5 mm Hg lower (P < .0001) than Phase 4 (K4), and 3) is less than 1 mm Hg higher than Phase 5 (K5) diastolic (P < .0001), when compared with K-sound auscultatory measurement. Understanding the methods and differences of DynaPulse oscillometric and K-sound BP measurements is important for clinic BP screening and self-BP monitoring, as well as future research to improve hypertension and CVD managements. PMID:21269907

  5. The role of post-operative radiotherapy in non-small-cell lung cancer: a multicentre randomised trial in patients with pathologically staged T1-2, N1-2, M0 disease. Medical Research Council Lung Cancer Working Party.

    PubMed Central

    Stephens, R. J.; Girling, D. J.; Bleehen, N. M.; Moghissi, K.; Yosef, H. M.; Machin, D.

    1996-01-01

    The role of post-operative radiotherapy for patients with non-small-cell lung cancer (NSCLC) is unclear despite five previous randomised trials. One deficiency with these trials was that they did not include adequate TNM staging, and so the present randomised trial was designed to compare surgery alone (S) with surgery plus post-operative radiotherapy (SR) in patients with pathologically staged T1-2, N1-2. M0 NSCLC. Between July 1986 and October 1993, 308 patients (154 S, 154 SR) were entered from 16 centres in the UK. The median age of the patients was 62 years, 74% were male, > 85% had normal or near normal levels of general condition, activity and breathlessness, 68% had squamous carcinoma, 52% had had a pneumonectomy, 63% had N1 disease and 37% N2 disease. SR patients received 40 Gy in 15 fractions starting 4-6 weeks post-operatively. Overall there was no advantage to either group in terms of survival, although definite local recurrence and bony metastases appeared less frequently and later in the SR group. In a subgroup analysis, in the N1 group no differences between the treatment groups were seen, but in the N2 group SR patients appeared to gain a one month survival advantage, delayed time to local recurrence and time to appearance of the bone metastases. There is, therefore, no clear indication for post-operative radiotherapy in N1 disease, but the question remains unresolved in N2 disease. PMID:8761382

  6. Association between alcohol consumption and rotator cuff tear.

    PubMed

    Passaretti, Daniele; Candela, Vittorio; Venditto, Teresa; Giannicola, Giuseppe; Gumina, Stefano

    2016-04-01

    Background and purpose - Long-term alcohol intake is associated with various negative effects on capillary microcirculation and tissue perfusion. We hypothesized that alcohol consumption might be a risk factor for both the occurrence and the severity of rotator cuff tears (RCTs). Patients and methods - A case-control study was performed. We studied 249 consecutive patients (139 men and 110 women; mean age 64 (54-78) years) who underwent arthroscopic rotator cuff repair. Tear size was determined intraoperatively. The control group had 356 subjects (186 men and 170 women; mean age 66 (58-82) years) with no RCT. All participants were questioned about their alcohol intake. Participants were divided into: (1) non-drinkers if they consumed less than 0.01 g of ethanol per day, and (2) moderate drinkers and (3) excessive drinkers if women (men) consumed > 24 g (36 g) per day for at least 2 years. Results - Total alcohol consumption, wine consumption, and duration of alcohol intake were higher in both men and women with RCT than in both men and women in the control group. Excessive alcohol consumption was found to be a risk factor for the occurrence of RCT in both sexes (men: OR = 1.7, 95% CI: 1.2-3.9; women: OR = 1.9, 95% CI: 0.94-4.1). Massive tears were associated with a higher intake of alcohol (especially wine) than smaller lesions. Interpretation - Long-term alcohol intake is a significant risk factor for the occurrence and severity of rotator cuff tear in both sexes. PMID:26610042

  7. Association between alcohol consumption and rotator cuff tear

    PubMed Central

    Passaretti, Daniele; Candela, Vittorio; Venditto, Teresa; Giannicola, Giuseppe; Gumina, Stefano

    2016-01-01

    Background and purpose — Long-term alcohol intake is associated with various negative effects on capillary microcirculation and tissue perfusion. We hypothesized that alcohol consumption might be a risk factor for both the occurrence and the severity of rotator cuff tears (RCTs). Patients and methods — A case-control study was performed. We studied 249 consecutive patients (139 men and 110 women; mean age 64 (54–78) years) who underwent arthroscopic rotator cuff repair. Tear size was determined intraoperatively. The control group had 356 subjects (186 men and 170 women; mean age 66 (58–82) years) with no RCT. All participants were questioned about their alcohol intake. Participants were divided into: (1) non-drinkers if they consumed less than 0.01 g of ethanol per day, and (2) moderate drinkers and (3) excessive drinkers if women (men) consumed > 24 g (36 g) per day for at least 2 years. Results — Total alcohol consumption, wine consumption, and duration of alcohol intake were higher in both men and women with RCT than in both men and women in the control group. Excessive alcohol consumption was found to be a risk factor for the occurrence of RCT in both sexes (men: OR = 1.7, 95% CI: 1.2–3.9; women: OR = 1.9, 95% CI: 0.94–4.1). Massive tears were associated with a higher intake of alcohol (especially wine) than smaller lesions. Interpretation — Long-term alcohol intake is a significant risk factor for the occurrence and severity of rotator cuff tear in both sexes. PMID:26610042

  8. Endotracheal cuff pressure changes with change in position in neurosurgical patients

    PubMed Central

    Athiraman, UmeshKumar; Gupta, Rohit; Singh, Georgene

    2015-01-01

    Background: Placement of a cuffed endotracheal tube for the administration of general anesthesia is routine. The cuff of the endotracheal tube is inflated with air to achieve an adequate seal to prevent micro-aspiration. Over inflation of the cuff can decrease the mucosal perfusion, leading to pressure necrosis and nerve palsies. Inadequate seal can lead to micro aspiration. So the cuff pressure has to be monitored and kept within the prescribed limits of 20-30 cms of water. Aim of the Study: To observe the effect of different positions on the endotracheal cuff pressure in patients undergoing neurosurgical procedures. Materials and Methods: This is an observational study conducted on 70 patients undergoing neurosurgical procedures in various positions. After intubation, the cuff pressure was checked with a cuff pressure manometer, Endotest (Teleflex Medical, Rush) and adjusted to be within the allowable pressure limits as is the routine practice. The cuff pressure was checked again at three time points after achieving the final position with the head on pins, at the end of the procedure and before extubation. Various factors such as the age, position, duration of surgery were studied. There were no major complications like aspiration, stridor or hoarseness of voice post extubation in any of the patients. Results: A significant decline in the cuff pressures were noted from the initial supine position to extubation (P < .001) in the supine group. Also a significant decline in the cuff pressures were found in the prone group from their initial intubated supine position to all the other three corresponding time points namely after final positioning (P < .001), at the end of the procedure (P < .001) and before extubation (P < .001). Conclusion: Cuff pressure has to be checked after achieving the final positioning of the patient and adjusted to the prescribed limits to prevent micro aspiration. PMID:26807392

  9. Contractile dysfunction of the shoulder (rotator cuff tendinopathy): an overview

    PubMed Central

    Littlewood, Chris

    2012-01-01

    It is now over a decade since the features defining a contractile dysfunction of the shoulder were first reported. Since this time, some progress has been made to better understand this mechanical syndrome. In response to these developments, this narrative review will explore current understanding in relation to pathology, diagnosis, treatment, and prognosis of this syndrome with reference to literature specifically relating to contractile dysfunction but also literature relating to rotator cuff tendinopathy where necessary. The review not only identifies the strengths of the mechanical diagnosis and therapy approach with reference to a contractile dysfunction of the shoulder but also identifies where further progress needs to be made. PMID:24179329

  10. Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease

    PubMed Central

    2012-01-01

    Background We have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD) and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids. Results This clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA) in l'Hospitalet de Llobregat (Barcelona) and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl), cholesterol < 250 mg/dl, 218 of whom received a more intensive intervention consisting of advice on lifestyle and treatment. The follow-up frequency of the intervention group was every 2 months. The other 218 patients followed their standard care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed. The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index. Conclusion Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol. Trial Registration ClinicalTrials.gov: NCT01089530 PMID:22381072