Disease management programme for secondary prevention of coronary heart disease and heart failure in primary care: a cluster randomised controlled trial.

PubMed

Khunti, Kamlesh; Stone, Margaret; Paul, Sanjoy; Baines, Jan; Gisborne, Louise; Farooqi, Azhar; Luan, Xiujie; Squire, Iain

2007-11-01

To evaluate the effect of a disease management programme for patients with coronary heart disease (CHD) and chronic heart failure (CHF) in primary care. A cluster randomised controlled trial of 1316 patients with CHD and CHF from 20 primary care practices in the UK was carried out. Care in the intervention practices was delivered by specialist nurses trained in the management of patients with CHD and CHF. Usual care was delivered by the primary healthcare team in the control practices. At follow up, significantly more patients with a history of myocardial infarction in the intervention group were prescribed a beta-blocker compared to the control group (adjusted OR 1.43, 95% CI 1.19 to 1.99). Significantly more patients with CHD in the intervention group had adequate management of their blood pressure (<140/85 mm Hg) (OR 1.61, 95% CI 1.22 to 2.13) and their cholesterol (<5 mmol/l) (OR 1.58, 95% CI 1.05 to 2.37) compared to those in the control group. Significantly more patients with an unconfirmed diagnosis of CHF had a diagnosis of left ventricular systolic dysfunction confirmed (OR 4.69, 95% CI 1.88 to 11.66) or excluded (OR 3.80, 95% CI 1.50 to 9.64) in the intervention group compared to the control group. There were significant improvements in some quality-of-life measures in patients with CHD in the intervention group. Disease management programmes can lead to improvements in the care of patients with CHD and presumed CHF in primary care.

Automated outreach to increase primary adherence to cholesterol-lowering medications.

PubMed

Derose, Stephen F; Green, Kelley; Marrett, Elizabeth; Tunceli, Kaan; Cheetham, T Craig; Chiu, Vicki Y; Harrison, Teresa N; Reynolds, Kristi; Vansomphone, Southida S; Scott, Ronald D

2013-01-14

Primary nonadherence occurs when new prescriptions are not dispensed. Little is known about how to reduce primary nonadherence. We performed a randomized controlled trial to evaluate an automated system to decrease primary nonadherence to statins for lowering cholesterol. Adult members of Kaiser Permanente Southern California with no history of statin use within the past year who did not fill a statin prescription after 1 to 2 weeks were passively enrolled. The intervention group received automated telephone calls followed 1 week later by letters for continued nonadherence; the control group received no outreach. The primary outcome was a statin dispensed up to 2 weeks after delivery of the letter. Secondary outcomes included refills at intervals up to 1 year. Intervention effectiveness was determined by intent-to-treat analysis and Fisher exact test. Subgroups were examined using logistic regression. There were 2606 participants in the intervention group and 2610 in the control group. Statins were dispensed to 42.3% of intervention participants and 26.0% of control participants (absolute difference, 16.3%; P < .001). The relative risk for the intervention vs control group was 1.63 (95% CI, 1.50-1.76). Intervention effectiveness varied slightly by age (P = .045) but was effective across all age strata. Differences in the frequency of statin dispensations persisted up to 1 year (P < .001). The intervention was effective in reducing primary nonadherence to statin medications. Because of low marginal costs for outreach, this strategy appears feasible for reducing primary nonadherence. This approach may generalize well to other medications and chronic conditions.

[Reducing stress levels and anxiety in primary-care physicians through training and practice of a mindfulness meditation technique].

PubMed

Franco Justo, Clemente

2010-11-01

To check the effectiveness of a mindfulness development meditation technique on stress and anxiety in a group of primary-care physicians. Quasi-experimental with pretest/posttest/follow-up measurements in a control group and an experimental group. SITE: University of Almeria. 38 primary-care physicians enrolled in a Teaching Aptitude Course (CAP). An experimental group and a control group were formed with 19 participants in each. The experimental group took a psycho-educational meditation program for training and practice in mindfulness. The Perceived Stress Scale (PSS), the Strain Questionnaire and the State-Trait Anxiety Questionnaire were used to measure stress and anxiety levels. A comparative statistical analysis was performed using the Mann-Whitney non-parametric U test, finding a significant reduction in all the primary-care physician stress and anxiety variables in the experimental group compared to the control group in pretest-posttest and follow-up tests. The results of this study support the effectiveness of mindfulness development meditation techniques in decreasing stress and anxiety in primary-care physicians. Nevertheless, the study shows various limitations that would have to be corrected in successive studies to bring more validity to the results. Copyright © 2009 Elsevier España, S.L. All rights reserved.

Effects of allergen and trigger factor avoidance advice in primary care on asthma control: a randomized-controlled trial.

PubMed

Bobb, C; Ritz, T; Rowlands, G; Griffiths, C

2010-01-01

Allergy contributes significantly to asthma exacerbation, yet avoidance of triggers, in particular allergens, is rarely addressed in detail in regular asthma review in primary care. To determine whether structured, individually tailored allergen and trigger avoidance advice, given as part of a primary care asthma review, improves lung function and asthma control. In a randomized-controlled trial 214 adults with asthma in six general practices were either offered usual care during a primary care asthma review or usual care with additional allergen and trigger identification (by skin prick testing and structured allergy assessment) and avoidance advice according to a standardized protocol by trained practice nurses. Main outcome measures were lung function, asthma control, asthma self-efficacy. Both intervention groups were equivalent in demographic and asthma-related variables at baseline. At 3-6-month follow-up, patients receiving the allergen and trigger avoidance review showed significant improvements in lung function (assessed by blinded research nurses) compared with those receiving usual care. Significantly more patients in the intervention group than in the control group showed improvements in forced expiratory volume in 1 s > or =15%. No significant differences were found in self-report measures of asthma control. Asthma-specific self-efficacy improved in both groups but did not differ between groups. Allergen and trigger identification and avoidance advice, given as part of a structured asthma review delivered in primary care by nurses results in clinically important improvements in lung function but not self-report of asthma control. ISRCTN45684820.

Comparison of a Stratified Group Intervention (STarT Back) With Usual Group Care in Patients With Low Back Pain: A Nonrandomized Controlled Trial.

PubMed

Murphy, Susan E; Blake, Catherine; Power, Camillus K; Fullen, Brona M

2016-04-01

A nonrandomized controlled trial. This study aims to explore the effectiveness of group-based stratified care in primary care. Stratified care based on psychosocial screening (STarT Back) has demonstrated greater clinical and cost-effectiveness in patients with low back pain. However, low back pain interventions are often delivered in groups and evaluating this system of care in a group setting is important. Patients were recruited from 60 general practices and linked physiotherapy services. A new group stratified intervention was compared with a historical nonstratified control group. Patients stratified as low, medium and high risk were offered risk-matched group care. Consenting participants completed self-report measures of functional disability (primary outcome measure), pain, psychological distress, and beliefs. The historical control received a generic group intervention. Analysis was by intention to treat. In total, 251 patients in the new stratified intervention and 332 in the historical control were included in the primary analysis at 12 weeks. The mean age of patients was 43 ± 10.98 years. Overall adjusted mean changes in the RMDQ scores were higher in the stratified intervention than in the control arm at 12-week follow-up (P = 0.028). Exploring the risk groups, individually the high-risk stratified group, demonstrated better outcome over the controls (P = 0.031). The medium-risk stratified intervention demonstrated equally good outcomes (P = 0.125), and low-risk stratified patients, despite less intervention, did as well as the historical controls (P = 0.993). Stratified care delivered in a group setting demonstrated superior outcomes in the high-risk patients, and equally good outcomes for the medium and low-risk groups. This model, embedded in primary care, provides an early and effective model of chronic disease management and adds another dimension to the utility of the STarT Back system of care. 2.

Care of adults with developmental disabilities: Effects of a continuing education course for primary care providers.

PubMed

Balogh, Robert; Wood, Jessica; Lunsky, Yona; Isaacs, Barry; Ouellette-Kuntz, Hélène; Sullivan, William

2015-07-01

To evaluate the effects of an interdisciplinary, guideline-based continuing education course on measures related to the care of adults with developmental disabilities (DD). Before-and-after study with a control group. Ontario. Forty-seven primary care providers (physicians, registered nurses, and nurse practitioners). Participants either only received reference material about primary care of people with DD (control group) or participated in a continuing education course on primary care of people with DD in addition to receiving the reference material (intervention group). Participants reported on 5 key measures related to care of adults with DD: frequency of using guidelines, frequency of performing periodic health examinations, frequency of assessing patients who present with behaviour changes, level of comfort while caring for adults with DD, and knowledge of primary care related to adults with DD. Over time, the intervention group showed significant increases in 4 of the 5 key measures of care compared with the control group: the frequency of guideline use (P < .001), frequency of assessment of patients' behaviour change (P = .03), comfort level in caring for people with DD (P = .01), and knowledge of primary care related to adults with DD (P = .01). A continuing education course on primary care of adults with DD is a useful interdisciplinary model to train health professionals who provide primary care services to these patients.

Resting state functional connectivity in primary insomnia, generalized anxiety disorder and controls.

PubMed

Pace-Schott, Edward F; Zimmerman, Jared P; Bottary, Ryan M; Lee, Erik G; Milad, Mohammed R; Camprodon, Joan A

2017-07-30

Sleep abnormalities are extremely common in anxiety disorders and may contribute to their development and persistence. Their shared pathophysiological mechanisms could thus serve as biomarkers or targets for novel therapeutics. Individuals with Primary Insomnia were age- and sex-matched to controls and to persons with Generalized Anxiety Disorder. All underwent fMRI resting-state scans at 3-T. In Primary Insomnia and controls, sleep was recorded for 2 weeks using diaries and actigraphy. All participants completed state-anxiety and neuroticism inventories. Whole-brain connectivity of 6 fear- and extinction-related seeds were compared between the 3 groups using ANOVA. The only significant between-group main effect was seen for connectivity between the left amygdala seed and a bilateral cluster in the rostral anterior cingulate cortex. The latter is believed to exert top-down control over amygdala activity and their interaction may thus constitute an emotion regulatory circuit. This connectivity was significantly greatest in controls while Primary Insomnia was intermediate between that of controls and Generalized Anxiety Disorder. Across Primary Insomnia and control subjects, mean connectivity decreased with poorer sleep. Across all 3 groups, connectivity decreased with greater neuroticism and pre-scan anxiety. Decreased top-down control of the amygdala may increase risk of developing an anxiety disorder with preexisting Primary Insomnia. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Prospective case-control study of efficacy of bilateral selective neck dissection in primary surgical treatment of supraglottic laryngeal cancers with clinically negative cervical findings (N0).

PubMed

Djordjevic, V; Bukurov, B; Arsovic, N; Dimitrijevic, M; Jesic, S; Nesic, V; Petrovic, Z

2016-12-01

To evaluate the efficacy of bilateral selective neck dissection of levels II-IV in elective and therapeutic management of the neck as a part of primary surgical treatment of patients with supraglottic laryngeal cancer and clinically negative cervical findings (N0). Institutional, observational, case-control study with historic control of patients who underwent primary supraglottic tumour surgery, and a prospective cohort of patient, who underwent, besides the operation of primary tumour, bilateral selective neck dissection (level II-IV). University, tertiary level hospital, national referral centre. The study included 193 patients with supraglottic cancer and without palpable or ultrasound positive cervical findings who were surgically treated from 1988 to 2005. Besides the operation of primary tumour, all patients in the study group underwent bilateral selective neck dissection (level II-IV). Patients in the control group (N = 51) underwent primary tumour operation only and were followed up regularly. In cases with postoperative regional recurrences, the radical neck dissection was performed. All patients with histopathological confirmation of occult metastases were administered radiotherapy treatment (60 Gy) in the postoperative period. Five-year overall survival rate. Occult cervical metastases were found in 18% of patients. They were present in level II in 77.5%, in level III in 20% of cases and in one patient in level IV (2.5%); the extracapsular spread was observed in 20% of cases. Postoperative regional metastases were found in 4.15% of cases in the study group, and in 11.8% in the control group, which proved to be significantly higher. The five-year overall survival rate showed no significant difference between the study group and the control group. The incidence of postoperative regional recurrences could be reduced by performing bilateral selective neck dissection simultaneously with primary tumour operation, but with no influence on the survival rate. © 2015 John Wiley & Sons Ltd.

Body Image in Primary Schools: A pilot evaluation of a primary school intervention program designed by teachers to improve children's body satisfaction.

PubMed

Halliwell, Emma; Yager, Zali; Paraskeva, Nicole; Diedrichs, Phillippa C; Smith, Hilary; White, Paul

2016-12-01

Body Image in the Primary School (Hutchinson & Calland, 2011) is a body image curriculum that is widely available but has not yet been evaluated. This study evaluates a set of 6 of the 49 available lessons from this curriculum. Seventy-four girls and 70 boys aged 9-10 were recruited from four primary schools in the UK. Schools were randomly allocated into the intervention condition, where students received 6hours of body image lessons, or to lessons as normal. Body esteem was significantly higher among girls in the intervention group, compared to the control group, immediately post intervention, and at 3-month follow-up. Moreover, girls with lowest levels of body esteem at baseline reported the largest gains. Internalization was significantly lower among boys in the control group compared to the intervention group at 3-month follow-up. The pattern of results among the control group raises interesting issues for intervention evaluation. Copyright © 2016. Published by Elsevier Ltd.

Matched cohort study of topical tranexamic acid in cementless primary total hip replacement.

PubMed

Sanz-Reig, Javier; Mas Martinez, Jesus; Verdu Román, Carmen; Morales Santias, Manuel; Martínez Gimenez, Enrique; Bustamante Suarez de Puga, David

2018-03-29

Tranexamic acid has been shown to be effective in reducing blood loss after total hip replacement. The purpose of this study was to prospectively assess the effectiveness of topical TXA use to reduce blood loss after primary total hip replacement and to compare these outcomes with those of a matched control group from a similar cohort that did not have received tranexamic acid. This is a prospective matched control study to assess the effect of a 2 g topical tranexamic acid in 50 mL physiological saline solution in total hip replacement. Primary outcomes were hemoglobin and hematocrit drop, and total blood loss. Secondary outcomes were transfusion rates, length of hospital stay, deep vein thrombosis, and pulmonary embolism events. We could match 100 patients to a control group. There were no statistical significantly differences between the two groups. The hemoglobin and hematocrit postoperative values were significantly higher in topical tranexamic acid group than in control group (P < 0.001). The mean total blood loss was 769 in topical tranexamic acid group and 1163 in control group with significant differences (P = 0.001), which meant 34% reduction in total blood loss. Length of stay was lower in topical tranexamic acid group. The risk of deep vein thrombosis and pulmonary events did not increase. A single dose of 2 g tranexamic acid in 50 mL physiological saline solution topical administration was effective and safe in reducing bleeding in patients undergoing unilateral primary non-cemented total hip replacement compared to a matched control group.

Feasibility and Preliminary Efficacy of the Fit4Fun Intervention for Improving Physical Fitness in a Sample of Primary School Children: A Pilot Study

ERIC Educational Resources Information Center

Eather, Narelle; Morgan, Philip J.; Lubans, David R.

2013-01-01

Objective: The primary objective of this study was to evaluate the feasibility and preliminary efficacy of a school-based physical fitness intervention (Fit4Fun) on the physical fitness and physical activity (PA) levels of primary school children. Methods: A group-randomized controlled trial with a 3-month wait-list control group was conducted in…

Group Patient Education: Effectiveness of a Brief Intervention in People with Type 2 Diabetes Mellitus in Primary Health Care in Greece: A Clinically Controlled Trial

ERIC Educational Resources Information Center

Merakou, K.; Knithaki, A.; Karageorgos, G.; Theodoridis, D.; Barbouni, A.

2015-01-01

This study aims to assess the impact of a brief patient group education intervention in people with type 2 diabetes mellitus. The sample, 193 people with type 2 diabetes mellitus who were patients at the diabetic clinic of a primary health care setting in Attica, was assigned to two groups, intervention (138 individuals) and control group (55…

Assessment of the influence of one's education on early diagnosis of multiple primary cancer in patients with uveal melanoma.

PubMed

Mierzwa-Dobranowska, Marzena; Romanowska-Dixon, Bozena

2012-01-01

This study will show a comparison of two groups of patients with uveal melanoma; one group with multiple primary cancer, and a second group with no identifiable second cancer, in terms of education and occupation. Study concerns 240 patients, who were isolated from patients being treated with uveal melanoma at the Department of Ophthalmology and Ocular Oncology Jagiellonian University Medical College in the period from 1998 to 2007. On the basis of medical history and medical records 97 patients were diagnosed with the one or more independent primary cancers. These patients were subjected to comparative analysis with a group of 143 patients with uveal melanoma as a control group. Analyzing the impact of education on the recognition of multiple primary cancer, there were significantly more frequent diagnoses of second primary cancers among patients with secondary and higher education than among those who had primary and vocational education. Among the obtained data on patients in the study group, the largest occupational group (according to the ISCO-88 (COM)) constituted "professionals". In the control group prevailed "craft and related trades workers". The results suggest the great importance of knowledge about risk factors for the development of cancer among patients with uveal melanoma and the ensuing more scrupulous search for succesive primary neoplasm and indicate the neccesity of organizing broad prophylactic actions. uveal melanoma, multiple primary cancer.

Effects of thyroid cystectomy for primary hyperparathyroidism on immune function.

PubMed

Yin, Xiangdang; Hu, Liang; Wang, Xiaochun

2016-01-01

To evaluate the effects of thyroid cystectomy for primary hyperparathyroidism on immune function. Ninety-two patients with parathyroid cysts complicated with primary hyperparathyroidism were randomly divided into a treatment group and a control group (n=46). The treatment group received endoscopic thyroidectomy through the anterior chest wall via the areolar approach, and the control group was treated with conventional open thyroidectomy. The two groups had similar immune function indices as well as thyroid hormone, serum calcium and phosphorus levels before surgery (P>0.05). After surgery, FT3 and FT4 levels significantly increased in both groups, whereas that of TSH significantly decreased (P<0.05). The levels of the two groups differed significantly on the postoperative 5th day (P<0.05). NK%, CD3+%, CD4+% and CD8+%, which significantly fluctuated on the postoperative 1st day in both groups (P<0.05), were basically recovered on the postoperative 5th day in the treatment group that had significantly different outcomes from those of the control group (P<0.05). On the postoperative 1st and 5th days, the treatment group had significantly lower serum calcium level and significantly higher serum phosphorus level than those of the control group (P<0.05). The surgeries were successfully performed for all patients. During three months of follow-up, the treatment group was significantly less prone to complications such as surgical site infection, recurrent laryngeal nerve injury, parathyroid crisis and hoarseness than the control group (P<0.05). For treatment of primary hyperparathyroidism, endoscopic thyroidectomy through the anterior chest wall via the areolar approach decreased the incidence rate of complications, as well as promoted the recovery of serum calcium and phosphorous levels, probably by only mildly affecting immune function and thyroid hormone levels.

The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial.

PubMed

Moini, Ashraf; Ebrahimi, Tabandeh; Shirzad, Nooshin; Hosseini, Reihaneh; Radfar, Mania; Bandarian, Fatemeh; Jafari-Adli, Shahrzad; Qorbani, Mostafa; Hemmatabadi, Mahboobeh

2016-06-01

Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p < 0.001). Pain severity decreased significantly in treatment group after eight weeks of treatment. There was a significant difference in pain intensity between the two groups after eight weeks of treatment and one month after the end of treatment (p < 0.001 for both). A weekly high dose (50 000 IU) oral vit D supplementation for eight weeks in patients with primary dysmenorrhea and vit D deficiency could improve pain intensity.

Histopathological effects of fibrin glue on penile fracture in a rat model.

PubMed

Tasdemir, Cemal; Samdanci, Emine T; Turtay, Muhammet G; Firat, Cemal; Oguzturk, Hakan; Ozdemir, Hulya

2011-12-01

To evaluate both histopathological effects and potential clinical application of fibrin glue on the penile cavernosal tissue. Experimental penile fracture was formed by incising from the proximal dorsal side of the penis in 32 Wistar Albino rats. The rats were randomly assigned to four main groups of eight animals each. In the control group, the incision was not repaired and it was left to secondary healing. In the primary repair group, the incision was primarily repaired. In the fibrin glue group, glue was applied only to the incision. In the final group, fibrin glue was applied to the incision following primary repair. Three weeks later, penectomy tissue was examined histopathologically. When the control group was compared with primary repair+fibrin glue group, the differences in cavernous tissue healing with fibrosis and inflammation were statistically significant (p = 0.04 and 0.01, respectively). The primary repair+fibrin glue group, showed the best cavernous healing with fibrosis observed in only one rat. . There was no significant difference between the control group and the other groups according to cavernous tissue healing with fibrosis and inflammation (p = 0.11 and 0.12). Hyperemia was observed in the all groups of rats. Fibrin glue can be used in cavernoseal surgeries due to its adhesive and potentially anti-inflammatory features.

Patient-specific computer-based decision support in primary healthcare--a randomized trial.

PubMed

Kortteisto, Tiina; Raitanen, Jani; Komulainen, Jorma; Kunnamo, Ilkka; Mäkelä, Marjukka; Rissanen, Pekka; Kaila, Minna

2014-01-20

Computer-based decision support systems are a promising method for incorporating research evidence into clinical practice. However, evidence is still scant on how such information technology solutions work in primary healthcare when support is provided across many health problems. In Finland, we designed a trial where a set of evidence-based, patient-specific reminders was introduced into the local Electronic Patient Record (EPR) system. The aim was to measure the effects of such reminders on patient care. The hypothesis was that the total number of triggered reminders would decrease in the intervention group compared with the control group, indicating an improvement in patient care. From July 2009 to October 2010 all the patients of one health center were randomized to an intervention or a control group. The intervention consisted of patient-specific reminders concerning 59 different health conditions triggered when the healthcare professional (HCP) opened and used the EPR. In the intervention group, the triggered reminders were shown to the HCP; in the control group, the triggered reminders were not shown. The primary outcome measure was the change in the number of reminders triggered over 12 months. We developed a unique data gathering method, the Repeated Study Virtual Health Check (RSVHC), and used Generalized Estimation Equations (GEE) for analysing the incidence rate ratio, which is a measure of the relative difference in percentage change in the numbers of reminders triggered in the intervention group and the control group. In total, 13,588 participants were randomized and included. Contrary to our expectation, the total number of reminders triggered increased in both the intervention and the control groups. The primary outcome measure did not show a significant difference between the groups. However, with the inclusion of patients followed up over only six months, the total number of reminders increased significantly less in the intervention group than in the control group when the confounding factors (age, gender, number of diagnoses and medications) were controlled for. Computerized, tailored reminders in primary care did not decrease during the 12 months of follow-up time after the introduction of a patient-specific decision support system. ClinicalTrial.gov NCT00915304.

Alerts in electronic medical records to promote a colorectal cancer screening programme: a cluster randomised controlled trial in primary care.

PubMed

Guiriguet, Carolina; Muñoz-Ortiz, Laura; Burón, Andrea; Rivero, Irene; Grau, Jaume; Vela-Vallespín, Carmen; Vilarrubí, Mercedes; Torres, Miquel; Hernández, Cristina; Méndez-Boo, Leonardo; Toràn, Pere; Caballeria, Llorenç; Macià, Francesc; Castells, Antoni

2016-07-01

Participation rates in colorectal cancer screening are below recommended European targets. To evaluate the effectiveness of an alert in primary care electronic medical records (EMRs) to increase individuals' participation in an organised, population-based colorectal cancer screening programme when compared with usual care. Cluster randomised controlled trial in primary care centres of Barcelona, Spain. Participants were males and females aged 50-69 years, who were invited to the first round of a screening programme based on the faecal immunochemical test (FIT) (n = 41 042), and their primary care professional. The randomisation unit was the physician cluster (n = 130) and patients were blinded to the study group. The control group followed usual care as per the colorectal cancer screening programme. In the intervention group, as well as usual care, an alert to health professionals (cluster level) to promote screening was introduced in the individual's primary care EMR for 1 year. The main outcome was colorectal cancer screening participation at individual participant level. In total, 67 physicians and 21 619 patients (intervention group) and 63 physicians and 19 423 patients (control group) were randomised. In the intention-to-treat analysis screening participation was 44.1% and 42.2% respectively (odds ratio 1.08, 95% confidence interval [CI] = 0.97 to 1.20, P = 0.146). However, in the per-protocol analysis screening uptake in the intervention group showed a statistically significant increase, after adjusting for potential confounders (OR, 1.11; 95% CI = 1.02 to 1.22; P = 0.018). The use of an alert in an individual's primary care EMR is associated with a statistically significant increased uptake of an organised, FIT-based colorectal cancer screening programme in patients attending primary care centres. © British Journal of General Practice 2016.

A randomised controlled trial of self‐help interventions in patients with a primary care diagnosis of irritable bowel syndrome

PubMed Central

Robinson, A; Lee, V; Kennedy, A; Middleton, L; Rogers, A; Thompson, D G; Reeves, D

2006-01-01

Introduction Functional abdominal symptoms are very common and account for nearly two million primary care consultations in Britain every year and produce significant morbidity. The aims of this study were to evaluate the impact of two self‐help interventions on consultation rates and symptom severity in patients with a primary care diagnosis of irritable bowel syndrome. Methods A total of 420 patients from 54 primary care centres were randomised either to receive self‐help information in the form of a guidebook or the guidebook plus a “self‐help” group meeting or to be in a control group receiving neither intervention. Data were collected using questionnaires and primary care records. Results At one year, patients in the guidebook group had a 60% reduction in primary care consultations (p<0.001) and a reduction in perceived symptom severity (p<0.001) compared with controls. Allocation to the self‐help group conferred no additional benefit. Actual symptom scores did not change significantly in any group. Costs per patient were reduced by £73 (confidence interval £43, £103) or 40% per year. Conclusion Introduction of a self‐help guidebook results in a reduction in primary care consultations, a perceived reduction in symptoms, and significant health service savings. This suggests that patients attending their primary care physician with functional abdominal symptoms should be offered self‐help information as part of their management. PMID:16099784

Posttraumatic stress disorder symptom severity and control beliefs as the predictors of academic burnout amongst adolescents following the Wenchuan Earthquake.

PubMed

Zhou, Xiao; Zhen, Rui; Wu, Xinchun

2017-01-01

Background : Previous studies indicate that posttraumatic stress disorder (PTSD) and control beliefs can affect burnout and their unique role in this situation has been examined, but fewer studies have examined their combined role in adolescent's academic burnout following traumatic events. Objective : This study examined the combined effect of PTSD symptom severity and control beliefs on academic burnout among adolescents, and assessed the moderating role of primary and secondary control beliefs in the relation between PTSD symptom severity and academic burnout. Methods : Seven hundred and forty-five adolescents were investigated using self-report questionnaires, and a series of regression equations examined the impact of PTSD severity and control beliefs on academic burnout. Results : PTSD symptom severity is associated positively with academic burnout, while primary and secondary control beliefs have a negative relation with academic burnout. In addition, primary control beliefs buffer the positive effects of PTSD symptom severity on academic burnout. We found that the positive relation between PTSD symptom severity and academic burnout in the low primary control beliefs group is more intense than that found in the high primary control beliefs group. Conclusions : PTSD symptom severity is a risk factor, whereas primary and secondary control beliefs are protective factors in academic burnout. In addition, PTSD symptom severity and primary control beliefs have a combined effect on academic burnout in adolescents following natural disasters.

Controlled five-year follow-up study of laser trabeculoplasty as primary therapy for open-angle glaucoma

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tuulonen, A.; Niva, A.K.; Alanko, H.I.

1987-10-15

We followed up 32 eyes of 32 patients with early glaucoma (22 with capsular glaucoma and ten with simple glaucoma) who received laser trabeculoplasty as a primary therapy. These eyes were compared with a matched control group of 32 eyes treated with medication initially. The success rate (intraocular pressure below 22 mm Hg with laser alone or medication alone) at five years was 50% (16 of 32 eyes) in the laser-treated group and 22% (seven of 32 eyes) in the control group (P less than .02). The control group required more modifications of their therapy to control intraocular pressure. Themore » neuroretinal rim area in the control eyes decreased 2.5 times as much as in the laser group (P = .017). Changes in the Friedmann visual fields did not differ significantly between the two groups.« less

Microtensile Bond Strength of Polyacid-modified Composite Resin to Irradiated Primary Molars.

PubMed

Keles, Sultan; Yilmaz, Yucel; Sezen, Orhan

2018-02-01

This study evaluated the influence of various doses of radiotherapy on the microtensile bond strength (pTBS) of compomer resin to dentin and enamel in primary molars. Thirty-five intact primary molars were collected and divided into seven groups. Teeth were irradiated with doses from 10 to 60 Gy, except for the control group. Compomer restorations were performed, and enamel-compomer resin beams and dentin-compomer resin beams were tested at a crosshead speed of 1 mm/min. No statistically significant difference was found between the irradiated tooth enamel and the control group (F = 1.1468; p = 0.194). However, statistically significant differences were evident among the dentin groups (F = 11.050; p < 0.001). Radiation may not cause a significant difference in the pTBS of compomer resin to primary tooth enamel, but appears to dose dependently decrease its bond strength to primary tooth dentin. Radiotherapy may affect the success rate of compomer fillings in primary teeth, especially in deeper cavities with exposed dentin.

The effect of using Indonesian realistic mathematics education (PMRI) approach on the mathematics achievement amongst primary school students

NASA Astrophysics Data System (ADS)

Zubainur, Cut Morina; Veloo, Arsaythamby; Khalid, Rozalina

2015-05-01

This study aims to determine the effects of the Indonesian Realistic Mathematics Education (PMRI) in Aceh primary schools, Indonesia. Although a plethora of research evidence highlights significant outcomes of the incorporation PMRI in mathematics, its use in the teaching and learning process is limited. Total of 50 standard five students from public primary school participated in this study; 25 students in the experimental group and 25 in the control group. The teaching approaches varied between the groups. While the experimental group experienced the PMRI approach, the control group encountered the conventional teaching approach of chalk and talk. Data was collected at two points namely the pre-test and post-test that lasted for five weeks. The results showed significant differences in mathematics achievement among primary students. In addition, PMRI also creates an active learning environment in solving exercises, and discussions among students and teachers. This study provides evidence that learning mathematics with PMRI benefits primary school students.

Association between ascites and primary hyperfibrinolysis: A cohort study in 210 dogs.

PubMed

Zoia, Andrea; Drigo, Michele; Simioni, Paolo; Caldin, Marco; Piek, Christine J

2017-05-01

Coagulation profiles were determined in 70 dogs with ascites, 70 healthy control dogs and 70 sick control dogs without ascites. Dogs with ascites were divided into four sub-groups based on the pathophysiology of fluid formation. Coagulation profile, serum C-reactive protein and frequency of discordant plasma fibrin-fibrinogen degradation products and D-dimer assay results, suggesting primary hyperfibrinolysis, were compared between groups. Within the ascites group, 10 samples of ascitic fluid were transudates due to decreased osmotic pressure, 18 were transudates due to increased hydrostatic pressure, 13 were exudates and 29 were haemorrhagic. Plasma fibrinogen concentrations were significantly lower in dogs with ascites compared to sick dogs without ascites. Activated partial thromboplastin time, prothrombin time, plasma concentrations of fibrin-fibrinogen degradation products and D-dimers, and frequency of primary hyperfibrinolysis, were significantly higher for dogs with ascites compared to both control groups. There was no significant difference in platelet count between groups. The frequency of primary hyperfibrinolysis was highest in dogs with transudative ascites due to increased hydrostatic pressure. Serum C-reactive protein was significantly higher in dogs with ascites compared to both control groups, and significantly and positively correlated with plasma D-dimers. In conclusion, dogs with ascites have an increased frequency of primary hyperfibrinolysis, especially with ascites secondary to increased hydrostatic pressure. The increased inflammation present in these dogs may have activated haemostasis in some cases, explaining the higher plasma D-dimers. Copyright © 2017 Elsevier Ltd. All rights reserved.

Implementing Google Apps for Education as Learning Management System in Math Education

NASA Astrophysics Data System (ADS)

Widodo, S.

2017-09-01

This study aims to find the effectiveness of math education using Google Apps for Education (GAFE) as learning management system to improve mathematical communication skill primary school preservice teacher. This research used quasi-experimental approach, utilizing the control group pre-test - post-test design of two group of primary school preservice teachers at UPI Kampus Purwakarta. The result of this study showed that mathematical communication skill of primary school preservice teacher in the experiment group is better than the control group. This is because the primary school preservice teacher in the experiment group used GAFE as a tool to communicate their idea. The students can communicate their idea because they have read the learning material on the learning management system using GAFE. All in all, it can be concluded that the communication tool is very important, beside the learning material, and also the options to choose the learning model to achieve the better result.

Schistosoma japonicum infection in the pig: the effect of a patent primary infection on a challenge infection.

PubMed

Willingham, A L; Bøgh, H O; Johansen, M V; Christensen, N O; Nansen, P

1997-06-24

The response of pigs to a challenge infection of Schistosoma japonicum following a primary infection was assessed using parasitological parameters and eosinophil counts. Twenty-five Danish Landrace/Yorkshire/Duroc crossbred pigs were divided into four groups. Group A (n = 10) received a primary infection, group B (n = 5) received both a primary and challenge infection, group C (n = 5) received a challenge control infection and group D (n = 5) received no infection serving as helminth-free controls. A dose of 850 cercariae was administered by intramuscular injection at the primary infection (week 0) and challenge infection (week 12). The pigs were perfused at week 21, except for half of the group A pigs which were slaughtered at week 12. Challenge infection did not result in higher worm burdens or tissue egg counts in group B than group A at week 21 and mature/immature worm ratios were similar for the two groups. In addition, no increases in faecal egg counts or eosinophil counts were observed in group B after challenge infection. The results indicate that pigs are able to mount a very rapid and effective response to reinfection with S. japonicum following a patent primary infection resulting in prevention of establishment of challenge infection schistosomes. An anti-worm effect appears to be the main feature of this regulatory host response.

Extensive Surgical Wound Lavage Reduces the Incidence and Severity of Heterotopic Ossification in Primary Total Hip Replacement: A Study of 175 Hip Replacements.

PubMed

Kantak, Avadhoot P; Shah, Nirav N

2017-12-01

One of the local factors contributing to the formation of heterotopic ossification includes bone debris generated during the surgery. This risk can be partially nullified by use of saline wash. Our research aim was to ascertain if extensive intraoperative lavage can reduce the incidence and severity of heterotopic ossification in primary total hip arthroplasty. A retrospective case control radiological study of 145 patients (175 hip replacements). The control group received minimal intra-operative lavage (<1,000 mL); consisted of 90 primary hip replacements. The index group received extensive saline lavage (>3,000 mL), and included 85 primary hip replacements. Brooker classification was used to grade radiographs at one year for development of heterotopic ossification. Sixty-six patients in control group had heterotopic ossification, with six showing a significant grade (grade 3 or 4). Thirty-five patients in the index group had heterotopic ossification with no incidence of severe grade. Majority patients in the index group showed a predominantly grade 1 heterotopic ossification; 28 out of 35, as compared to 37 out of 66 in control group. There was a statistically significant difference in the incidence ( P <0.05) as well as severity of heterotopic ossification between the groups ( P <0.05). We conclude that use of extensive lavage during total hip replacement reduces the incidence as well as severity of heterotopic ossification.

Pre-hospital ticagrelor in patients with ST-segment elevation myocardial infarction with long transport time to primary PCI facility.

PubMed

Lupi, Alessandro; Schaffer, Alon; Lazzero, Maurizio; Tessitori, Massimo; De Martino, Leonardo; Rognoni, Andrea; Bongo, Angelo S; Porto, Italo

2016-12-01

Pre-hospital ticagrelor, given less than 1h before coronary intervention (PCI), failed to improve coronary reperfusion in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. It is unknown whether a longer interval from ticagrelor administration to primary PCI might reveal any improvement of coronary reperfusion. We retrospectively compared 143 patients, pre-treated in spoke centers or ambulance with ticagrelor at least 1.5h before PCI (Pre-treatment Group), with 143 propensity score-matched controls treated with ticagrelor in the hub before primary PCI (Control Group) extracted from RENOVAMI, a large observational Italian registry of more than 1400 STEMI patients enrolled from Jan. 2012 to Oct. 2015 (ClinicalTrials.gov id: NCT01347580). The median time from ticagrelor administration and PCI was 2.08h (95% CI 1.66-2.84) in the Pre-treatment Group and 0.56h (95% CI 0.33-0.76) in the Control Group. TIMI flow grade before primary PCI in the infarct related artery was the primary endpoint. The primary endpoint, baseline TIMI flow grade, was significantly higher in Pre-treatment Group (0.88±1.14 vs 0.53±0.86, P=0.02). However in-hospital mortality, in-hospital stent thrombosis, bleeding rates and other clinical and angiographic outcomes were similar in the two groups. In a real world STEMI network, pre-treatment with ticagrelor in spoke hospitals or in ambulance loading at least 1.5h before primary PCI is safe and might improve pre-PCI coronary reperfusion, in comparison with ticagrelor administration immediately before PCI. Copyright © 2016 Elsevier Inc. All rights reserved.

Improving Primary Care Residents' Proficiency in the Diagnosis of Skin Cancer

PubMed Central

Gerbert, Barbara; Bronstone, Amy; Wolff, Mimi; Maurer, Toby; Berger, Timothy; Pantilat, Steven; McPhee, Stephen J

1998-01-01

OBJECTIVE To determine whether a brief, multicomponent intervention could improve the skin cancer diagnosis and evaluation planning performance of primary care residents to a level equivalent to that of dermatologists. PARTICIPANTS Fifty-two primary care residents (26 in the control group and 26 in the intervention group) and 13 dermatologists completed a pretest and posttest. DESIGN A randomized, controlled trial with pretest and posttest measurements of residents' ability to diagnose and make evaluation plans for lesions indicative of skin cancer. INTERVENTION The intervention included face-to-face feedback sessions focusing on residents' performance deficiencies; an interactive seminar including slide presentations, case examples, and live demonstrations; and the Melanoma Prevention Kit including a booklet, magnifying tool, measuring tool, and skin color guide. MEASUREMENTS AND MAIN RESULTS We compared the abilities of a control and an intervention group of primary care residents, and a group of dermatologists to diagnose and make evaluation plans for six categories of skin lesions including three types of skin cancer—malignant melanoma, squamous cell carcinoma, and basal cell carcinoma. At posttest, both the intervention and control group demonstrated improved performance, with the intervention group revealing significantly larger gains. The intervention group showed greater improvement than the control group across all six diagnostic categories (a gain of 13 percentage points vs 5, p < .05), and in evaluation planning for malignant melanoma (a gain of 46 percentage points vs 36, p < .05) and squamous cell carcinoma (a gain of 42 percentage points vs 21, p < .01). The intervention group performed as well as the dermatologists on five of the six skin cancer diagnosis and evaluation planning scores with the exception of the diagnosis of basal cell carcinoma. CONCLUSIONS Primary care residents can diagnose and make evaluation plans for cancerous skin lesions, including malignant melanoma, at a level equivalent to that of dermatologists if they receive relevant, targeted education. PMID:9502368

Perspectives and concerns of clients at primary health care facilities involved in evaluation of a national mental health training programme for primary care in Kenya

PubMed Central

2013-01-01

Background A cluster randomised controlled trial (RCT) of a national Kenyan mental health primary care training programme demonstrated a significant impact on the health, disability and quality of life of clients, despite a severe shortage of medicines in the clinics (Jenkins et al. Submitted 2012). As focus group methodology has been found to be a useful method of obtaining a detailed understanding of client and health worker perspectives within health systems (Sharfritz and Roberts. Health Transit Rev 4:81–85, 1994), the experiences of the participating clients were explored through qualitative focus group discussions in order to better understand the potential reasons for the improved outcomes in the intervention group. Methods Two ninety minute focus groups were conducted in Nyanza province, a poor agricultural region of Kenya, with 10 clients from the intervention group clinics where staff had received the training programme, and 10 clients from the control group where staff had not received the training during the earlier randomised controlled trial. Results These focus group discussions suggest that the clients in the intervention group noticed and appreciated enhanced communication, diagnostic and counselling skills in their respective health workers, whereas clients in the control group were aware of the lack of these skills. Confidentiality emerged from the discussions as a significant client concern in relation to the volunteer cadre of community health workers, whose only training comes from their respective primary care health workers. Conclusion Enhanced health worker skills conferred by the mental health training programme may be responsible for the significant improvement in outcomes for clients in the intervention clinics found in the randomised controlled trial, despite the general shortage of medicines and other health system weaknesses. These findings suggest that strengthening mental health training for primary care staff is worthwhile even where health systems are not strong and where the medicine supply cannot be guaranteed. Trial registration ISRCTN 53515024. PMID:23343127

Age Effects on Cerebral Oxygenation and Behavior in Children with Sleep-disordered Breathing.

PubMed

Tamanyan, Knarik; Walter, Lisa M; Weichard, Aidan; Davey, Margot J; Nixon, Gillian M; Biggs, Sarah N; Horne, Rosemary S C

2018-06-01

Childhood sleep-disordered breathing ranges in severity from primary snoring to obstructive sleep apnea and is associated with behavioral and neurocognitive deficits. It remains unknown why children with primary snoring, who do not experience peripheral oxygen desaturation or sleep fragmentation, experience similar daytime deficits as those with obstructive sleep apnea or why effects are age-dependent. To examine cerebral tissue oxygenation and oxygen extraction as an explanation for daytime deficits in children with primary snoring. Children referred for suspected sleep-disordered breathing and nonsnoring control subjects underwent overnight polysomnography with near-infrared spectroscopy. Children were categorized into 3- to 6-year (n = 87) and 7- to 12-year (n = 72) old groups, and according to the obstructive apnea-hypopnea index into primary snoring (≤1 event/h), mild (>1-5 events/h), and moderate/severe obstructive sleep apnea (>5 events/h). Cognitive and behavioral performance were assessed. In the 3- to 6-year group, there were no differences in cerebral oxygenation or oxygen extraction between severity groups. In the 7- to 12-year group, cerebral oxygenation was significantly lower, although these differences were small, in control subjects versus primary snoring during quiet wakefulness before sleep onset, N1, and REM. Oxygen extraction was significantly higher in control subjects versus primary snoring during N1 sleep, with no differences between primary snoring and obstructive sleep apnea groups. Cerebral oxygenation was not associated with cognitive performance in either age group or behavior in the 3- to 6-year group; however, it was associated with behavior in the school-aged children. Children with sleep-disordered breathing are able to maintain cerebral oxygenation, and the small changes observed are not related to cognitive deficits. However, in older children these differences were related to behavioral measures.

Small Cash Incentives Can Encourage Primary Care Visits By Low-Income People With New Health Care Coverage.

PubMed

Bradley, Cathy J; Neumark, David

2017-08-01

In a randomized controlled trial, we studied low-income adults newly covered by a primary care program to determine whether a cash incentive could encourage them to make an initial visit to a primary care provider. Subjects were randomly assigned to one of four groups: three groups whose members received $10 to complete a baseline survey during an interview and who were randomized to incentives of $50, $25, or $0 to visit their assigned primary care provider within six months after enrolling in the study; and a nonincentivized control group not contacted by the research team. Subjects in the $50 and $25 incentive groups were more likely to see a primary care provider (77 percent and 74 percent, respectively), compared to subjects in the $0 incentive group (68 percent). The effects of the intervention were about twice as large when we compared the proportions of subjects in the $50 and $25 incentive groups who visited their providers and the proportion in the nonincentivized group (61 percent). Cash incentive programs may steer newly covered low-income patients toward primary care, which could result in improved health outcomes and lower costs. Project HOPE—The People-to-People Health Foundation, Inc.

Effects of communication training with the MAAS-Global-D instrument on the antibiotic prescribing for respiratory infections in primary care: study protocol of a randomised controlled trial.

PubMed

Hammersen, Friederike; Goetz, Katja; Soennichsen, Andreas; Emcke, Timo; Steinhaeuser, Jost

2016-04-02

Primary care physicians account for the majority of antibiotic prescribing in ambulatory care in Germany. Respiratory diseases are, regardless of effectiveness, often treated with antibiotics. Research has found this use without indication to be caused largely by communication problems (e.g. expectations on the patient's part or false assumptions about them by the physician). The present randomised controlled trial (RCT) study evaluates whether communication training for primary care physicians can reduce the antibiotic prescribing rate for respiratory tract infections. The study consists of three groups: group A will receive communication training; group B will be given the same, plus additional, access to an evidence-based point-of-care tool; and group C will function as the control group. The primary endpoint is the difference between intervention and control groups regarding the antibiotic prescribing rate before and after the intervention assessed through routine data. The communication skills are captured with the help of the communication instrument MAAS-Global-D, as well as individual videos of physician-patient consultations recorded by the primary care physicians. These skills will also be regarded with respect to the antibiotic prescribing rate. A process evaluation using qualitative as well as quantitative methods should provide information about barriers and enablers to implementing the communication training. The trial contributes to an insight into the effectiveness of the different components to reduce antibiotic prescribing, which will also be supported by an extensive evaluation. Communication training could be an effective method of reducing antibiotic prescribing in primary care. DRKS00009566 DATE REGISTRATION: 5 November 2015.

Comparison of Antimicrobial Efficacy of Diode Laser, Triphala, and Sodium Hypochlorite in Primary Root Canals: A Randomized Controlled Trial

PubMed Central

Asokan, Sharath; John, Baby; Priya, Geetha; Kumar, S

2017-01-01

Aim To evaluate the antimicrobial efficacy of diode laser, triphala, and sodium hypochlorite (NaOCl) against Enterococc-cus faecalis contaminated primary root canals. Materials and methods Forty-nine single-rooted human primary teeth were reduced up to cemento-enamel junction and biomechanically prepared. After sterilization, five teeth were selected as negative controls and remaining teeth were inoculated with E. faecalis. The teeth were then randomly divided into four groups. The first group was irradiated with diode laser, the second group was irrigated with sodium hypochlorite, and the third group with triphala solution. The fourth group served as the positive control. The antimicrobial efficacy was tested by collecting transfer fluid saline from the canals and counting the colony forming units (CFUs) of viable E. faecalis on agar plates. The Mann-Whitney test was used to analyze the results, using Statistical Package for the Social Sciences software version 19. Results The results showed that mean bacterial CFU were 8.00 ± 7.87 for laser, 58.60 ± 16.63 for triphala, and 69.80 ± 19.57 for NaOCl. Laser group showed significant reduction in the colony count compared to the other groups. Triphala group showed better antibacterial activity than NaOCl, but the difference was not statistically significant. Conclusion Laser was most effective against E. faecalis and triphala can be used as an alternative disinfectant to NaOCl in primary root canals. How to cite this article Thomas S, Asokan S, John B, Priya G, Kumar S. Comparison of Antimicrobial Efficacy of Diode Laser, Triphala, and Sodium Hypochlorite in Primary Root Canals: A Randomized Controlled Trial. Int J Clin Pediatr Dent 2017;10(1):14-17. PMID:28377648

Posttraumatic stress disorder symptom severity and control beliefs as the predictors of academic burnout amongst adolescents following the Wenchuan Earthquake

PubMed Central

Zhou, Xiao; Zhen, Rui; Wu, Xinchun

2017-01-01

ABSTRACT Background: Previous studies indicate that posttraumatic stress disorder (PTSD) and control beliefs can affect burnout and their unique role in this situation has been examined, but fewer studies have examined their combined role in adolescent’s academic burnout following traumatic events. Objective: This study examined the combined effect of PTSD symptom severity and control beliefs on academic burnout among adolescents, and assessed the moderating role of primary and secondary control beliefs in the relation between PTSD symptom severity and academic burnout. Methods: Seven hundred and forty-five adolescents were investigated using self-report questionnaires, and a series of regression equations examined the impact of PTSD severity and control beliefs on academic burnout. Results: PTSD symptom severity is associated positively with academic burnout, while primary and secondary control beliefs have a negative relation with academic burnout. In addition, primary control beliefs buffer the positive effects of PTSD symptom severity on academic burnout. We found that the positive relation between PTSD symptom severity and academic burnout in the low primary control beliefs group is more intense than that found in the high primary control beliefs group. Conclusions: PTSD symptom severity is a risk factor, whereas primary and secondary control beliefs are protective factors in academic burnout. In addition, PTSD symptom severity and primary control beliefs have a combined effect on academic burnout in adolescents following natural disasters. PMID:29296242

Influence of Stepped Osteotomy on Primary Stability of Implants Inserted in Low-Density Bone Sites: An In Vitro Study.

PubMed

Degidi, Marco; Daprile, Giuseppe; Piattelli, Adriano

The aims of this study were to evaluate the ability of a stepped osteotomy to improve dental implant primary stability in low-density bone sites and to investigate possible correlations between primary stability parameters. The study was performed on fresh humid bovine bone classified as type III. The test group consisted of 30 Astra Tech EV implants inserted following the protocol provided by the manufacturer. The first control group consisted of 30 Astra Tech EV implants inserted in sites without the underpreparation of the apical portion. The second control group consisted of 30 Astra Tech TX implants inserted following the protocol provided by the manufacturer. Implant insertion was performed at the predetermined 30 rpm. The insertion torque data were recorded and exported as a curve; using a trapezoidal integration technique, the area underlying the curve was calculated: this area represents the variable torque work (VTW). Peak insertion torque (pIT) and resonance frequency analysis (RFA) were also recorded. A Mann-Whitney test showed that the mean VTW was significantly higher in the test group compared with the first control and second control groups; furthermore, statistical analysis showed that pIT also was significantly higher in the test group compared with the first and second control groups. Analyzing RFA values, only the difference between the test group and second control group showed statistical significance. Pearson correlation analysis showed a very strong positive correlation between pIT and VTW values in all groups; furthermore, it showed a positive correlation between pIT and RFA values and between VTW and RFA values only in the test group. Within the limitations of an in vitro study, the results show that stepped osteotomy can be a viable method to improve implant primary stability in low-density bone sites, and that, when a traditional osteotomy method is performed, RFA presents no correlation with pIT and VTW.

Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial.

PubMed

Hermans, Michel P; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank; Vandenberghe, Hans; Brotons, Carlos

2013-11-01

To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. Primary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P < 0.001); 54.3 vs. 49.7% met the LDL cholesterol target (P = 0.006). Percentages of patients meeting all three targets increased during the study in both groups, with a statistically significant increase observed in the benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P < 0.001). In this prospective, randomized, controlled study, benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile.

Direct versus indirect and individual versus group modes of language therapy for children with primary language impairment: principal outcomes from a randomized controlled trial and economic evaluation.

PubMed

Boyle, James M; McCartney, Elspeth; O'Hare, Anne; Forbes, John

2009-01-01

Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and each delivery mode offered to children individually or in groups. To investigate the relative effectiveness of indirect and direct intervention therapy modes delivered individually or in groups for children with primary language impairment. A multi-centre randomized controlled trial investigated 161 children with primary language impairment aged 6-11 years randomized to a usual-therapy control group or to direct individual, indirect individual, direct group or indirect group therapy modes. Intervention was delivered three times a week for 30-40-min sessions in mainstream schools over 15 weeks. Language performance was assessed at baseline, post-therapy and at 12 months. Cost analysis was based on salary and travel costs for intervention modes and usual therapy. Compared with controls, children receiving project therapy made short-term improvements in expressive (p = 0.031), but not receptive, language immediately following intervention. Children with specific expressive language delay were more likely to show improvement than those with mixed receptive-expressive difficulties. The four project therapy modes did not differ on primary language outcomes (all p-values>0.392) and there were no further improvements evident at follow-up. Indirect group therapy was the least costly mode, with direct individual therapy the most costly. Intervention in this age group can be effective for expressive language and can be delivered equally effectively though speech and language therapy assistants and to children in groups.

GSTM1 null polymorphism at the glutathione S-transferase M1 locus: phenotype and genotype studies in patients with primary biliary cirrhosis.

PubMed Central

Davies, M H; Elias, E; Acharya, S; Cotton, W; Faulder, G C; Fryer, A A; Strange, R C

1993-01-01

Studies were carried out to test the hypothesis that the GSTM1 null phenotype at the mu (mu) class glutathione S-transferase 1 locus is associated with an increased predisposition to primary biliary cirrhosis. Starch gel electrophoresis was used to compare the prevalence of GSTM1 null phenotype 0 in patients with end stage primary biliary cirrhosis and a group of controls without evidence of liver disease. The prevalence of GSTM1 null phenotype in the primary biliary cirrhosis and control groups was similar; 39% and 45% respectively. In the primary biliary cirrhosis group all subjects were of the common GSTM1 0, GSTM1 A, GSTM1 B or GSTM1 A, B phenotypes while in the controls, one subject showed an isoform with an anodal mobility compatible with it being a product of the putative GSTM1*3 allele. As the GSTM1 phenotype might be changed by the disease process, the polymerase chain reaction was used to amplify the exon 4-exon 5 region of GSTM1 and show that in 13 control subjects and 11 patients with primary biliary cirrhosis, GSTM1 positive and negative genotypes were associated with corresponding GSTM1 expressing and non-expressing phenotypes respectively. The control subject with GSTM1 3 phenotype showed a positive genotype. Images Figure 1 Figure 2 PMID:8491405

Decreasing Inappropriate Use of Antibiotics in Primary Care in Four Countries in South America—Cluster Randomized Controlled Trial

PubMed Central

Urbiztondo, Inés; Caballero, Lidia; Suarez, Miguel Angel; Olinisky, Monica

2017-01-01

High antibiotic prescribing and antimicrobial resistance in patients attending primary care have been reported in South America. Very few interventions targeting general practitioners (GPs) to decrease inappropriate antibiotic prescribing have been investigated in this region. This study assessed the effectiveness of online feedback on reducing antibiotic prescribing in patients with suspected respiratory tract infections (RTIs) attending primary care. The aim was to reduce antibiotic prescribing in patients with acute bronchitis and acute otitis media. Both are RTIs for which antibiotics have a very limited effect. A cluster randomized two-arm control trial was implemented. Healthcare centres from Bolivia, Argentina, Paraguay and Uruguay participating in the quality improvement program HAPPY AUDIT were randomly allocated to either intervention or control group. During ten consecutive weeks, GPs in the intervention group received evidence-based online feedback on the management of suspected RTIs. In patients with acute bronchitis, the intervention reduced the antibiotic prescribing rate from 71.6% to 56% (control group from 61.2% to 52%). In patients with acute otitis media, the intervention reduced the antibiotic prescribing from 94.8% to 86.2% (no change in the control group). In all RTIs, the intervention reduced antibiotic prescribing rate from 37.4% to 28.1% (control group from 29% to 27.2%). Online evidence-based feedback is effective for reducing antibiotic prescribing in patients with RTIs attending primary care in South America. PMID:29240687

Activity of [des-Aspartyl1]-Angiotensin II in Primary Aldosteronism

PubMed Central

Carey, Robert M.; Ayers, Carlos R.; Vaughan, E. Darracott; Peach, Michael J.; Herf, Steven M.

1979-01-01

This study describes the effects of [des-Aspartyl1]-angiotensin II ([des-Asp]-AII) on blood pressure and aldosterone production in patients with primary aldosteronism due to aldosterone-producing adrenal adenoma (APA) and idiopathic adrenal hyperplasia (IHA), and in normotensive control subjects. 10 patients with primary aldosteronism, 7 with APA and 3 with IHA, and 6 normotensive control subjects were placed on a constant 150-meq sodium diet for 4 days. [des-Asp]-AII was infused for 30 min at 6, 12, and 18 pmol/kg per min. Three groups of patients were identified on the basis of aldosterone response to [des-Asp]-AII. Group I, composed of normotensive control subjects, showed incremental increases in plasma aldosterone concentration from 6±1 to 14±3 ng/100 ml (P < 0.01) with [des-Asp]-AII infusion. Group II, composed of patients with primary aldosteronism, showed incremental increases in plasma aldosterone concentration from 33±8 to 65±13 ng/100 ml (P < 0.05) with 12 pmol/kg per min of [des-Asp]-AII. Group III, also composed of patients with primary aldosteronism, showed no increase of plasma aldosterone concentration with [des-Asp]-AII. Groups I and II showed similar percentage increases in plasma aldosterone concentration (P = NS). Group III showed significantly lower aldosterone responses than group I (P < 0.01). Group II included all patients with IHA and two patients with APA. Group III included only patients with APA. The blood pressure responses to [des-Asp]-AII of subjects in group I did not differ significantly from those of groups II or III. Thus, patients with IHA and a subgroup of patients with APA showed responsiveness to [des-Asp]-AII which was limited to adrenal cortical stimulation of aldosterone biosynthesis. This suggests that adrenal responsiveness to angiotensin is a major control mechanism in some forms of primary aldosteronism. The differential adrenal responsiveness to [des-Asp]-AII in patients with APA indicates either that there are two distinct subpopulations of APA, or that alteration in tumor response to angiotensin occurs during the natural progression of the disease history. PMID:438332

Primary controls on species richness in higher taxa.

PubMed

Rabosky, Daniel L

2010-12-01

The disparity in species richness across the tree of life is one of the most striking and pervasive features of biological diversity. Some groups are exceptionally diverse, whereas many other groups are species poor. Differences in diversity among groups are frequently assumed to result from primary control by differential rates of net diversification. However, a major alternative explanation is that ecological and other factors exert primary control on clade diversity, such that apparent variation in net diversification rates is a secondary consequence of ecological limits on clade growth. Here, I consider a likelihood framework for distinguishing between these competing hypotheses. I incorporate hierarchical modeling to explicitly relax assumptions about the constancy of diversification rates across clades, and I propose several statistics for a posteriori evaluation of model adequacy. I apply the framework to a recent dated phylogeny of ants. My results reject the hypothesis that net diversification rates exert primary control on species richness in this group and demonstrate that clade diversity is better explained by total time-integrated speciation. These results further suggest that it may not possible to estimate meaningful speciation and extinction rates from higher-level phylogenies of extant taxa only.

Temperament and character properties of primary focal hyperhidrosis patients

PubMed Central

2013-01-01

Background Primary focal hyperhidrosis is a health problem, which has negative effects on the patient's quality of life and significantly affects the patients’ daily activities, social and business life. The aim of this study is to evaluate temperament and character properties of patients diagnosed with primary focal hyperhidrosis. Methods Fifty-six primary focal hyperhidrosis (22.42 ± 7.80) and 49 control subjects (24.48 ± 5.17) participated in the study. Patients who met the diagnostic criteria for PFH were referred to psychiatry clinic where the subjects were evaluated through Structured Clinical Interview for DSM Disorders-I and Temperament and Character Inventory. Results In order to examine the difference between the PFH and control group in terms of temperament and character properties, one-way Multivariate Analysis of Variance (MANOVA) was conducted. In terms of temperament properties, PFH group took significantly higher scores than control group in Fatigability and asthenia dimension. In terms of character properties, PFH group scored significantly lower than control group in Purposefulness , Resourcefulness , Self-Directedness and scored significantly higher than control group in Self-forgetfulness and Self-Transcendence. Conclusion Temperament and character features of PFH patients were different from healthy group and it was considered that these features were affected by many factors including genetic, biological, environmental, socio-cultural elements. During the follow-up of PFH cases, psychiatric evaluation is important and interventions, especially psychotherapeutic interventions can increase the chances of success of the dermatological treatments and can have a positive impact on the quality of life and social cohesion of chronic cases. PMID:23311945

Alerts in electronic medical records to promote a colorectal cancer screening programme: a cluster randomised controlled trial in primary care

PubMed Central

Guiriguet, Carolina; Muñoz-Ortiz, Laura; Burón, Andrea; Rivero, Irene; Grau, Jaume; Vela-Vallespín, Carmen; Vilarrubí, Mercedes; Torres, Miquel; Hernández, Cristina; Méndez-Boo, Leonardo; Toràn, Pere; Caballeria, Llorenç; Macià, Francesc; Castells, Antoni

2016-01-01

Background Participation rates in colorectal cancer screening are below recommended European targets. Aim To evaluate the effectiveness of an alert in primary care electronic medical records (EMRs) to increase individuals’ participation in an organised, population-based colorectal cancer screening programme when compared with usual care. Design and setting Cluster randomised controlled trial in primary care centres of Barcelona, Spain. Method Participants were males and females aged 50–69 years, who were invited to the first round of a screening programme based on the faecal immunochemical test (FIT) (n = 41 042), and their primary care professional. The randomisation unit was the physician cluster (n = 130) and patients were blinded to the study group. The control group followed usual care as per the colorectal cancer screening programme. In the intervention group, as well as usual care, an alert to health professionals (cluster level) to promote screening was introduced in the individual’s primary care EMR for 1 year. The main outcome was colorectal cancer screening participation at individual participant level. Results In total, 67 physicians and 21 619 patients (intervention group) and 63 physicians and 19 423 patients (control group) were randomised. In the intention-to-treat analysis screening participation was 44.1% and 42.2% respectively (odds ratio 1.08, 95% confidence interval [CI] = 0.97 to 1.20, P = 0.146). However, in the per-protocol analysis screening uptake in the intervention group showed a statistically significant increase, after adjusting for potential confounders (OR, 1.11; 95% CI = 1.02 to 1.22; P = 0.018). Conclusion The use of an alert in an individual’s primary care EMR is associated with a statistically significant increased uptake of an organised, FIT-based colorectal cancer screening programme in patients attending primary care centres. PMID:27266861

Pegfilgrastim in primary prophylaxis of febrile neutropenia following frontline bendamustine plus rituximab treatment in patients with indolent non-Hodgkin lymphoma: a single center, real-life experience.

PubMed

Cerchione, Claudio; De Renzo, Amalia; Di Perna, Maria; Della Pepa, Roberta; Pugliese, Novella; Catalano, Lucio; Pane, Fabrizio; Picardi, Marco

2017-03-01

In this prospective study, the impact of granulocyte colony-stimulating factors (G-2 CSF) administered during induction treatment with bendamustine plus rituximab for indolent non- Hodgkin Llymphoma (NHL) was evaluated by comparing patients who received secondary prophylaxis with filgrastim (control group) versus. patients who received pegfilgrastim as primary prophylaxis (peg-group). The primary endpoint was the incidence rate of febrile neutropenia (FN)- related chemotherapy disruptions (regarding dose-dense and/or dose-intensity of schedule). The Ssecondary endpoint included days of hospitalization due to FN, and G-CSF-related side effects (grade ≥3 WHO toxicity criteria) in each group. One hundred twenty-two: 122 consecutive patients, with untreated indolent NHL, were referred to our outpatient unit for remission induction immuno-chemotherapy with bendamustine-rituximab. During the first period, 61 patients received secondary prophylaxis with filgrastim, given "on demand" if ANC was <1000/mm3. During the second period, 61 patients received primary prophylaxis with pegfilgrastim in a single administration. Pegfilgrastim was significantly associated with fewer incidence rate of FN-related chemotherapy disruptions (11.4% in the control group vs. 1.6% in the peg-group, p = 0.04) and fewer days of hospitalization due to FN (median number 18 days in the control group vs. 6 in the peg-group, p = 0.04). In terms of G-CSF-related extra-hematological grade III side effects, no significant difference has been found in the two groups (9.8% in the control group vs. 11.5% in the peg-group, p = 0.77). Only one patient stopped the treatment in the peg-group due to intolerance. In patients with indolent NHL, in front-line treatment with bendamustine plus rituximab, primary prophylaxis with pegfilgrastim seems to reduce the incidence of chemotherapy disruptions due to FN, and the days of hospitalization. Moreover, it is well- tolerated and may increase the opportunity to maintain the planned schedule of treatment. These results make pegfilgrastim an advantageous option in most cases both in terms of cost-effectiveness and quality of life. These preliminary observations need to be validated by controlled clinical trials.

[Effects of Feiji decoction for soothing the liver combined with psychotherapy on quality of life in primary lung cancer patients].

PubMed

Yao, Yilin

2012-01-01

Primary lung cancer is one of the most common malignant tumors. It causes great pain and mood disorders to patients, and significantly reduces their quality of life. The aim of the current study is to evaluate the effect of Feiji Decoction for soothing the liver combined with psychotherapy on quality of life (QoL) and physical status of patients with primary lung cancer. A total of 118 patients with primary non-small cell lung cancer were randomly divided into two groups. The 57 patients in the combined therapy group were treated with Feiji Decoction for soothing the liver and psychotherapy combined with chemotherapy, whereas the 61 patients in the control group were treated with chemotherapy only. Both groups were observed for the two treatment courses. The European Organization for Research and Treatment of Cancer QoL Questionnaire LC-43 (EORTC QLQ-LC43) was used to assess the QoL of every patient in both groups before and after treatment scales. At the same time, physical status was assessed using the Karnofsky performance status (KPS) and East Cooperative Oncology Group performance status (ECOG). The scores of physiology function, role function, emotion function, cognize function, society function, and general health in the therapy group were higher than that of the control group. The therapy group also showed better QoL results than the contol group. Significant differences were observed between the two groups (P<0.01). Meanwhile, the scores of fatigue, vomit, pain, polypnea, insomnia, anorexia, constipation, and specific manifestation of lung cancer in the therapy group were obviously lower than that of the control group; more patients were observed to be relieved. Significant differences between the two groups were observed (P<0.01). The KPS and ECOG scores of the patients were observed to have improved and stabilized in the therapy group than that of the control group; the differences were statistically significant (P<0.01). Feiji Decoction for soothing the liver combined with psychotherapy can alleviate the clinical symptoms, elevate the physical status, and improve the QOL of patients with primary lung cancer. Thus, this therapy has a good clinical therapeutic effect.

Laparoscopy to Predict the Result of Primary Cytoreductive Surgery in Patients With Advanced Ovarian Cancer: A Randomized Controlled Trial.

PubMed

Rutten, Marianne J; van Meurs, Hannah S; van de Vrie, Roelien; Gaarenstroom, Katja N; Naaktgeboren, Christiana A; van Gorp, Toon; Ter Brugge, Henk G; Hofhuis, Ward; Schreuder, Henk W R; Arts, Henriette J G; Zusterzeel, Petra L M; Pijnenborg, Johanna M A; van Haaften, Maarten; Fons, Guus; Engelen, Mirjam J A; Boss, Erik A; Vos, M Caroline; Gerestein, Kees G; Schutter, Eltjo M J; Opmeer, Brent C; Spijkerboer, Anje M; Bossuyt, Patrick M M; Mol, Ben Willem; Kenter, Gemma G; Buist, Marrije R

2017-02-20

Purpose To investigate whether initial diagnostic laparoscopy can prevent futile primary cytoreductive surgery (PCS) by identifying patients with advanced-stage ovarian cancer in whom > 1 cm of residual disease will be left after PCS. Patients and Methods This multicenter, randomized controlled trial was undertaken within eight gynecologic cancer centers in the Netherlands. Patients with suspected advanced-stage ovarian cancer who qualified for PCS were eligible. Participating patients were randomly assigned to either laparoscopy or PCS. Laparoscopy was used to guide selection of primary treatment: either primary surgery or neoadjuvant chemotherapy followed by interval surgery. The primary outcome was futile laparotomy, defined as a PCS with residual disease of > 1 cm. Primary analyses were performed according to the intention-to-treat principle. Results Between May 2011 and February 2015, 201 participants were included, of whom 102 were assigned to diagnostic laparoscopy and 99 to primary surgery. In the laparoscopy group, 63 (62%) of 102 patients underwent PCS versus 93 (94%) of 99 patients in the primary surgery group. Futile laparotomy occurred in 10 (10%) of 102 patients in the laparoscopy group versus 39 (39%) of 99 patients in the primary surgery group (relative risk, 0.25; 95% CI, 0.13 to 0.47; P < .001). In the laparoscopy group, three (3%) of 102 patients underwent both primary and interval surgery compared with 28 (28%) of 99 patients in the primary surgery group ( P < .001). Conclusion Diagnostic laparoscopy reduced the number of futile laparotomies in patients with suspected advanced-stage ovarian cancer. In women with a plan for PCS, these data suggest that performance of diagnostic laparoscopy first is reasonable and that if cytoreduction to < 1 cm of residual disease seems feasible, to proceed with PCS.

ABO blood groups, Rhesus negativity, and primary biliary cirrhosis

PubMed Central

Hamlyn, A. N.; Morris, J. S.; Sherlock, S.

1974-01-01

The distribution of blood groups and Rhesus negativity in 91 British patients with primary biliary cirrhosis was compared with a sample of registered blood donors. There were no significant differences from the expected proportions calculated from the control groups. Although the number of cases studied is small the analysis does not confirm previous reports of an excess of A group in the disease. If a genetic basis exists for primary biliary cirrhosis alternative markers must be found. PMID:4211827

Primary Prevention of Parent-Child Conflict and Abuse in Iranian Mothers: A Randomized-Controlled Trial

ERIC Educational Resources Information Center

Oveisi, Sonia; Ardabili, Hassan Eftekhare; Dadds, Mark R.; Majdzadeh, Reza; Mohammadkhani, Parvaneh; Rad, Javad Alaqband; Shahrivar, Zahra

2010-01-01

Objective: The aim of this study was to assess whether primary health care settings can be used to engage and provide a preventive intervention to mothers of young children. Methods: Two hundred and twenty-four mothers who had come to the health centers were randomly assigned to either control group (CG: n=116) or intervention group (IG: n = 108).…

Factors Influencing Medical School Graduates Toward a Career in Psychiatry: Analysis from the 2011-2013 Association of American Medical Colleges Graduation Questionnaire.

PubMed

Wilbanks, Lindsey; Spollen, John; Messias, Erick

2016-04-01

Various factors influence choice of medical specialty. Previous research grouped specialties into controllable lifestyle, primary care, and surgical. This study compared factors influencing individuals to choose psychiatry versus other specialties. Data came from the 2011-2013 Association of American Medical Colleges Graduation Questionnaire. The authors grouped responses, ranging from no influence to minor, moderate, and strong influence, into psychiatry and controllable lifestyle, primary care, and surgical specialties and analyzed the data using one-way analysis of variance. The analyses included 29,227 students, of which 1329 (4.5%) elected psychiatry; 10,998 (37.6%), controllable lifestyle specialties; 12,320 (42.2%), primary care specialties; and 4580 (15.7%), surgical specialties. Students choosing psychiatry reported less influence of competitiveness, student debt, and salary expectations than those choosing controllable lifestyle and surgical specialties (p < 0.0001) and more influence of work/life balance than those choosing primary care and surgical specialties (p < 0.0001). They reported less influence of family expectations than those choosing controllable lifestyle specialties (p < 0.0001). They reported more influence of fit with personality than controllable lifestyle, primary care, and surgical specialties (p < 0.004). Students entering psychiatry do not fit the traditional categories of controllable lifestyle, primary care, and surgical profiles, but fall between controllable lifestyle and primary care specialties. Recruitment efforts may need to address this different pattern of influences.

Increasing older adults’ walking through primary care: results of a pilot randomized controlled trial

PubMed Central

Mutrie, Nanette

2012-01-01

Background. Physical activity can positively influence health for older adults. Primary care is a good setting for physical activity promotion. Objective. To assess the feasibility of a pedometer-based walking programme in combination with physical activity consultations. Methods. Design: Two-arm (intervention/control) 12-week randomized controlled trial with a 12-week follow-up for the intervention group. Setting: One general practice in Glasgow, UK. Participants: Participants were aged ≥65 years. The intervention group received two 30-minute physical activity consultations from a trained practice nurse, a pedometer and a walking programme. The control group continued as normal for 12 weeks and then received the intervention. Both groups were followed up at 12 and 24 weeks. Outcome measures: Step counts were measured by sealed pedometers and an activPALTM monitor. Psychosocial variables were assessed and focus groups conducted. Results. The response rate was 66% (187/284), and 90% of those randomized (37/41) completed the study. Qualitative data suggested that the pedometer and nurse were helpful to the intervention. Step counts (activPAL) showed a significant increase from baseline to week 12 for the intervention group, while the control group showed no change. Between weeks 12 and 24, step counts were maintained in the intervention group, and increased for the control group after receiving the intervention. The intervention was associated with improved quality of life and reduced sedentary time. Conclusions. It is feasible to recruit and retain older adults from primary care and help them increase walking. A larger trial is necessary to confirm findings and consider cost-effectiveness. PMID:22843637

Primary Care Strategies for Promoting Parent-Child Interactions and School Readiness in At-Risk Families

PubMed Central

Mendelsohn, Alan L.; Huberman, Harris S.; Berkule, Samantha B.; Brockmeyer, Carolyn A.; Morrow, Lesley M.; Dreyer, Benard P.

2011-01-01

Objective To determine the effects of pediatric primary care interventions on parent-child interactions in families with low socioeconomic status. Design In this randomized controlled trial, participants were randomized to 1 of 2 interventions (Video Interaction Project [VIP] or Building Blocks [BB]) or the control group. Setting Urban public hospital pediatric primary care clinic. Participants Mother-newborn dyads enrolled post partum from November 1, 2005, through October 31, 2008. Interventions In the VIP group, mothers and newborns participated in 1-on-1 sessions with a child development specialist who facilitated interactions in play and shared reading by reviewing videos made of the parent and child on primary care visit days; learning materials and parenting pamphlets were also provided. In the BB group, parenting materials, including age-specific newsletters suggesting interactive activities, learning materials, and parent-completed developmental questionnaires, were mailed to the mothers. Main Outcome Measures Parent-child interactions were assessed at 6 months with the StimQ-Infant and a 24-hour shared reading recall diary. Results A total of 410 families were assessed. The VIP group had a higher increased StimQ score (mean difference, 3.6 points; 95% confidence interval, 1.5 to 5.6 points; Cohen d, 0.51; 0.22 to 0.81) and more reading activities compared to the control group. The BB group also had an increased overall StimQ score compared with the control group (Cohen d, 0.31; 95% confidence interval, 0.03 to 0.60). The greatest effects for the VIP group were found for mothers with a ninth-grade or higher reading level (Cohen d, 0.68; 95% confidence interval, 0.33 to 1.03). Conclusions The VIP and BB groups each led to increased parent-child interactions. Pediatric primary care represents a significant opportunity for enhancing developmental trajectories in at-risk children. Trial Registration clinicaltrials.gov Identifier: NCT00212576 PMID:21199978

Evaluation of primary tooth enamel surface morphology and microhardness after Nd:YAG laser irradiation and APF gel treatment--an in vitro study.

PubMed

Banda, Naveen Reddy; Vanaja Reddy, G; Shashikiran, N D

2011-01-01

Laser irradiation and fluoride has been used as a preventive tool to combat dental caries in permanent teeth, but little has been done for primary teeth which are more prone to caries. The purpose of this study was to evaluate microhardness alterations in the primary tooth enamel after Nd-YAG laser irradiation alone and combined with topical fluoride treatment either before or after Nd-YAG laser irradiation. Ten primary molars were sectioned and assigned randomly to: control group, Nd-YAG laser irradiation, Nd-YAG lasing before APF and APF followed by Nd-YAG lasing. The groups were evaluated for microhardness. Surface morphological changes were observed using SEM. Statistical comparisons were performed. The control group's SEM showed a relatively smooth enamel surface and lasing group had fine cracks and porosities. In the lasing + fluoride group a homogenous confluent surface was seen. In the fluoride + lasing group an irregular contour with marked crack propagation was noted. There was a significant increase in the microhardness of the treatment groups. Nd-YAG laser irradiation and combined APF treatment of the primary tooth enamel gave morphologically hardened enamel surface which can be a protective barrier against a cariogenic attack.

Primary repair of colon injuries: clinical study of nonselective approach.

PubMed

Lazovic, Ranko G; Barisic, Goran I; Krivokapic, Zoran V

2010-12-02

This study was designed to determine the role of primary repair and to investigate the possibility of expanding indications for primary repair of colon injuries using nonselective approach. Two groups of patients were analyzed. Retrospective (RS) group included 30 patients managed by primary repair or two stage surgical procedure according to criteria published by Stone (S/F) and Flint (Fl). In this group 18 patients were managed by primary repair. Prospective (PR) group included 33 patients with primary repair as a first choice procedure. In this group, primary repair was performed in 30 cases. Groups were comparable regarding age, sex, and indexes of trauma severity. Time between injury and surgery was shorter in PR group, (1.3 vs. 3.1 hours). Stab wounds were more frequent in PR group (9:2), and iatrogenic lesions in RS group (6:2). Associated injuries were similar, as well as segmental distribution of colon injuries. S/F criteria and Flint grading were similar.In RS group 15 primary repairs were successful, while in two cases relaparotomy and colostomy was performed due to anastomotic leakage. One patient died. In PR group, 25 primary repairs were successful, with 2 immediate and 3 postoperative (7-10 days) deaths, with no evidence of anastomotic leakage. Results of this study justify more liberal use of primary repair in early management of colon injuries. Current Controlled Trials ISRCTN94682396.

Effectiveness of a parental training programme in enhancing the parent–child relationship and reducing harsh parenting practices and parental stress in preparing children for their transition to primary school: a randomised controlled trial

PubMed Central

2013-01-01

Background Entering primary school is an important childhood milestone, marking the beginning of a child’s formal education. Yet the change creates a time of vulnerability for the child, the parents and the parent–child relationship. Failure to adjust to the transition may place the family in a psychologically devastating position. The aims of this study were to test the effectiveness of a parental training programme in enhancing the parent–child relationship and decreasing parental stress by reducing harsh parenting in preparing children for the transition to primary school. Methods A randomised controlled trial incorporating a two-group pre-test and repeated post-test was conducted in one of the largest public housing estates in Hong Kong. A total of 142 parents were recruited, with 72 parents randomly assigned to the experimental group and 70 to the control group. Harsh parenting practices, parent–child relationships and parental stress were assessed. Results In comparison to parents in the control group, those in the experimental group engaged in less harsh parenting practices and reported better parent–child relationships. However, parental stress scores did not differ significantly between the two groups. Conclusion This study addressed a gap in the literature by examining the effectiveness of the training programme for enhancing parent–child relationship and decreasing parental stress at the time of a child’s transition to primary school. The findings from this study provide empirical evidence of the effectiveness of the parental training programme and highlight the significance of parenting in promoting a smooth transition for children from kindergarten to primary 1. Trial registration ClinicalTrials.gov: NCT01845948. PMID:24237718

Effectiveness of a parental training programme in enhancing the parent-child relationship and reducing harsh parenting practices and parental stress in preparing children for their transition to primary school: a randomised controlled trial.

PubMed

Li, Ho Cheung William; Chan, Sophia S C; Mak, Yim Wah; Lam, Tai Hing

2013-11-16

Entering primary school is an important childhood milestone, marking the beginning of a child's formal education. Yet the change creates a time of vulnerability for the child, the parents and the parent-child relationship. Failure to adjust to the transition may place the family in a psychologically devastating position. The aims of this study were to test the effectiveness of a parental training programme in enhancing the parent-child relationship and decreasing parental stress by reducing harsh parenting in preparing children for the transition to primary school. A randomised controlled trial incorporating a two-group pre-test and repeated post-test was conducted in one of the largest public housing estates in Hong Kong. A total of 142 parents were recruited, with 72 parents randomly assigned to the experimental group and 70 to the control group. Harsh parenting practices, parent-child relationships and parental stress were assessed. In comparison to parents in the control group, those in the experimental group engaged in less harsh parenting practices and reported better parent-child relationships. However, parental stress scores did not differ significantly between the two groups. This study addressed a gap in the literature by examining the effectiveness of the training programme for enhancing parent-child relationship and decreasing parental stress at the time of a child's transition to primary school. The findings from this study provide empirical evidence of the effectiveness of the parental training programme and highlight the significance of parenting in promoting a smooth transition for children from kindergarten to primary 1. ClinicalTrials.gov: NCT01845948.

Reducing disability in community-dwelling frail older people: cost-effectiveness study alongside a cluster randomised controlled trial.

PubMed

Metzelthin, Silke F; van Rossum, Erik; Hendriks, Marike R C; De Witte, Luc P; Hobma, Sjoerd O; Sipers, Walther; Kempen, Gertrudis I J M

2015-05-01

although proactive primary care, including early detection and treatment of community-dwelling frail older people, is a part of the national healthcare policy in several countries, little is known about its cost-effectiveness. to evaluate the cost-effectiveness of a proactive primary care approach in community-dwelling frail older people. embedded in a cluster randomised trial among 12 Dutch general practitioner practices, an economic evaluation was performed from a societal perspective with a time horizon of 24 months. frail older people in the intervention group received an in-home assessment and interdisciplinary care based on a tailor-made treatment plan and regular evaluation and follow-up. Practices in the control group delivered usual care. The primary outcome for the cost-effectiveness and cost-utility analysis was disability and health-related quality of life, respectively. multilevel analyses among 346 frail older people showed no significant differences between the groups regarding disability and health-related quality of life at 24 months. People in the intervention group used, as expected, more primary care services, but there was no decline in more expensive hospital and long-term care. Total costs over 24 months tended to be higher in the intervention group than in the control group (€26,503 versus €20,550, P = 0.08). the intervention under study led to an increase in healthcare utilisation and related costs without providing any beneficial effects. This study adds to the scarce amount of evidence of the cost-effectiveness of proactive primary care in community-dwelling frail older people. Current Controlled Trials, ISRCTN 31954692. © The Author 2015. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study).

PubMed

Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos

2011-09-01

To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Benchmarking Is Associated With Improved Quality of Care in Type 2 Diabetes

PubMed Central

Hermans, Michel P.; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank; Vandenberghe, Hans; Brotons, Carlos

2013-01-01

OBJECTIVE To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. RESEARCH DESIGN AND METHODS Primary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. RESULTS Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P < 0.001); 54.3 vs. 49.7% met the LDL cholesterol target (P = 0.006). Percentages of patients meeting all three targets increased during the study in both groups, with a statistically significant increase observed in the benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P < 0.001). CONCLUSIONS In this prospective, randomized, controlled study, benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile. PMID:23846810

CO2 Laser and Topical Fluoride Therapy in the Control of Caries Lesions on Demineralized Primary Enamel

PubMed Central

Valério, R. A.; Saraiva, M. C. P.; Corona, S. A. M.

2015-01-01

This study evaluated the effect of CO2 laser irradiation and topical fluoride therapy in the control of caries progression on primary teeth enamel. 30 fragments (3 × 3 × 2 mm) from primary canines were submitted to an initial cariogenic challenge that consisted of immersion on demineralizing solution for 3 hours and remineralizing solution for 21 hours for 5 days. Fragments were randomly assigned into three groups (n = 10): L: CO2 laser (λ = 10.6 μm), APF: 1.23% acidulated phosphate fluoride, and C: no treatment (control). CO2 laser was applied with 0.5 W power and 0.44 J/cm2 energy density. Fluoride application was performed with 0.1 g for 1 minute. Cariogenic challenge was conducted for 5 days following protocol previously described. Subsurface Knoop microhardness was measured at 30 μm from the edge. Obtained data were subjected to analysis the variance (ANOVA) and Duncan test with significance of 5%. It was found that the L group showed greater control of deciduous enamel demineralization and were similar to those of APF group, while being statistically different from C group (P ≤ 0.05) that showed the lowest microhardness values. It was concluded that CO2 laser can be an additional resource in caries control progression on primary teeth enamel. PMID:25874248

A smart rotary technique versus conventional pulpectomy for primary teeth: A randomized controlled clinical study

PubMed Central

Mokhtari, Negar; Shirazi, Alireza-Sarraf

2017-01-01

Background Techniques with adequate accuracy of working length determination along with shorter duration of treatment in pulpectomy procedure seems to be essential in pediatric dentistry. The aim of the present study was to evaluate the accuracy of root canal length measurement with Root ZX II apex locator and rotary system in pulpectomy of primary teeth. Material and Methods In this randomized control clinical trial complete pulpectomy was performed on 80 mandibular primary molars in 80, 4-6-year-old children. The study population was randomly divided into case and control groups. In control group conventional pulpectomy was performed and in the case group working length was determined by electronic apex locator Root ZXII and instrumented with Mtwo rotary files. Statistical evaluation was performed using Mann-Whitney and Chi-Square tests (P<0.05). Results There were no significant differences between electronic apex locator Root ZXII and conventional method in accuracy of root canal length determination. However significantly less time was needed for instrumenting with rotary files (P=0.000). Conclusions Considering the comparable results in accuracy of root canal length determination and the considerably shorter instrumentation time in Root ZXII apex locator and rotary system, it may be suggested for pulpectomy in primary molar teeth. Key words:Rotary technique, conventional technique, pulpectomy, primary teeth. PMID:29302280

A smart rotary technique versus conventional pulpectomy for primary teeth: A randomized controlled clinical study.

PubMed

Mokhtari, Negar; Shirazi, Alireza-Sarraf; Ebrahimi, Masoumeh

2017-11-01

Techniques with adequate accuracy of working length determination along with shorter duration of treatment in pulpectomy procedure seems to be essential in pediatric dentistry. The aim of the present study was to evaluate the accuracy of root canal length measurement with Root ZX II apex locator and rotary system in pulpectomy of primary teeth. In this randomized control clinical trial complete pulpectomy was performed on 80 mandibular primary molars in 80, 4-6-year-old children. The study population was randomly divided into case and control groups. In control group conventional pulpectomy was performed and in the case group working length was determined by electronic apex locator Root ZXII and instrumented with Mtwo rotary files. Statistical evaluation was performed using Mann-Whitney and Chi-Square tests ( P <0.05). There were no significant differences between electronic apex locator Root ZXII and conventional method in accuracy of root canal length determination. However significantly less time was needed for instrumenting with rotary files ( P =0.000). Considering the comparable results in accuracy of root canal length determination and the considerably shorter instrumentation time in Root ZXII apex locator and rotary system, it may be suggested for pulpectomy in primary molar teeth. Key words: Rotary technique, conventional technique, pulpectomy, primary teeth.

Ambulatory sleep-wake patterns and variability in young people with emerging mental disorders.

PubMed

Robillard, Rébecca; Hermens, Daniel F; Naismith, Sharon L; White, Django; Rogers, Naomi L; Ip, Tony K C; Mullin, Sharon J; Alvares, Gail A; Guastella, Adam J; Smith, Kristie Leigh; Rong, Ye; Whitwell, Bradley; Southan, James; Glozier, Nick; Scott, Elizabeth M; Hickie, Ian B

2015-01-01

The nature of sleep-wake abnormalities in individuals with mental disorders remains unclear. The present study aimed to examine the differences in objective ambulatory measures of the sleep-wake and activity cycles across young people with anxiety, mood or psychotic disorders. Participants underwent several days of actigraphy monitoring. We divided participants into 5 groups (control, anxiety disorder, unipolar depression, bipolar disorder, psychotic disorder) according to primary diagnosis. We enrolled 342 participants aged 12-35 years in our study: 41 healthy controls, 56 with anxiety disorder, 135 with unipolar depression, 80 with bipolar disorder and 30 with psychotic disorders. Compared with the control group, sleep onset tended to occur later in the anxiety, depression and bipolar groups; sleep offset occurred later in all primary diagnosis groups; the sleep period was longer in the anxiety, bipolar and psychosis groups; total sleep time was longer in the psychosis group; and sleep efficiency was lower in the depression group, with a similar tendency for the anxiety and bipolar groups. Sleep parameters were significantly more variable in patient subgroups than in controls. Cosinor analysis revealed delayed circadian activity profiles in the anxiety and bipolar groups and abnormal circadian curve in the psychosis group. Although statistical analyses controlled for age, the sample included individuals from preadolescence to adulthood. Most participants from the primary diagnosis subgroups were taking psychotropic medications, and a large proportion had other comorbid mental disorders. Our findings suggest that delayed and disorganized sleep offset times are common in young patients with various mental disorders. However, other sleep-wake cycle disturbances appear to be more prominent in broad diagnostic categories.

40 CFR 86.085-2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... designed for rebuild. Rated horsepower generally ranges from 170 to 250. Vehicle body types in this group... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTROL OF... area. Primary intended service class means: (a) The primary service application group for which a heavy...

40 CFR 86.085-2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... designed for rebuild. Rated horsepower generally ranges from 170 to 250. Vehicle body types in this group... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTROL OF... area. Primary intended service class means: (a) The primary service application group for which a heavy...

40 CFR 86.085-2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... designed for rebuild. Rated horsepower generally ranges from 170 to 250. Vehicle body types in this group... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTROL OF... area. Primary intended service class means: (a) The primary service application group for which a heavy...

[Withdrawal of a specialised diabetes education program in primary care: long term impact on the metabolic control outcomes].

PubMed

Jurado Campos, Jerónimo; Caula Ros, Jacint A; Hernández Anguera, Josep M; Juvinyà Canal, Dolors; Pou Torelló, José M

2009-12-01

To evaluate the possible relationships between a health policy decision, in relation to the diabetes education strategies and the metabolic control outcomes. Longitudinal prospective cohort study. A random cohort sample of 276 type II diabetes mellitus subjects. All primary care centres in three regions of Catalonia. Patients were classified as specialised (n=59) or non-specialised (n=217) groups, as regards whether having received previous diabetes education before the start of the study. HbA1c values were evaluated in all subjects at baseline and after 5 years after receiving only conventional education. Baseline evaluation showed a better metabolic control in the specialised group (P=0.009). The final evaluation showed no significant differences in outcomes between the two groups (P=0.679). When baseline and outcomes values were compared, significant differences were observed in all subjects (P=0.001), the specialised group showed significantly poorer metabolic control (P<0.001), but in the group with previous conventional education no significant differences were observed (P=0.058). Our results suggest that the withdrawal of higher levels of diabetes education may play a major role in poor metabolic control, and that conventional diabetes education does not improve outcomes. Health policy in Primary Care should consider improving the level of diabetes education.

The impact of dermatology consultation on diagnostic accuracy and antibiotic use among patients with suspected cellulitis seen at outpatient internal medicine offices: a randomized clinical trial.

PubMed

Arakaki, Ryan Y; Strazzula, Lauren; Woo, Elaine; Kroshinsky, Daniela

2014-10-01

Cellulitis is a common and costly problem, often diagnosed in the outpatient setting. Many cutaneous conditions may clinically mimic cellulitis, but little research has been done to assess the magnitude of the problem. To determine if obtaining dermatology consultations in the outpatient primary care setting could assist in the diagnosis of pseudocellulitic conditions and reduce the rate of unnecessary antibiotic use. Nonblinded randomized clinical trial of competent adults who were diagnosed as having cellulitis by their primary care physicians (PCPs), conducted at outpatient internal medical primary care offices affiliated with a large academic medical center. Outpatient dermatology consultation. Primary outcomes were final diagnosis, antibiotic use, and need for hospitalization. A total of 29 patients (12 male and 17 female) were enrolled for participation in this trial. Nine patients were randomized to continue with PCP management (control group), and 20 patients were randomized to receive a dermatology consultation (treatment group). Of the 20 patients in the dermatology consultation group, 2 (10%) were diagnosed as having cellulitis. In the control group, all 9 patients were diagnosed as having cellulitis by PCPs, but dermatologist evaluation determined that 6 (67%) of these patients had a psuedocellulitis rather than true infection. All 9 patients (100%) in the control group were treated for cellulitis with antibiotics vs 2 patients (10%) in the treatment group (P < .001). One patient in the control group was hospitalized. All patients in the treatment group reported improvement of their cutaneous condition at the 1-week follow-up examination. Dermatology consultation in the primary care setting improves the diagnostic accuracy of suspected cellulitis and decreases unnecessary antibiotic use in patients with pseudocellulitic conditions. Obtaining an outpatient dermatology consultation may be a cost-effective strategy that improves quality of care. clinicaltrials.gov Identifier:NCT01795092.

Gender roles, physical and sexual violence prevention in primary extend to secondary school in Samutsakorn Province, Thailand.

PubMed

Chamroonsawasdi, Kanittha; Suparp, Jarueyporn; Kittipichai, Wirin; Khajornchaikul, Piyathida

2010-03-01

To enhance positive attitude and life skills on gender roles to prevent physical and sexual violence. A whole school-based participatory learning program using a quasi-experimental study with pre and post test design was conducted among 2 schools during June-September, 2005. The experimental group, were 134 students in a primary school and 179 students in a secondary school. While the control group, were 122 students in a primary school and 95 students in a secondary school. Means score of attitude toward gender roles before implementation in the experimental group was significantly lower than the control group (p < 0.05). After implementation, the means score in the experimental group was not significantly different from the control group (p > 0.05). Means paired different score (after-before) between the two groups was significantly different (p = 0.002). A whole school-based program on gender roles and violence prevention is suitable for youths and should be merged as school curricula and expanded as a nationwide program at all level of education. Gender equity should be taught at an early childhood. Parental involvement in school-based activities should be negotiated.

Incontinence after primary repair of obstetric anal sphincter tears is related to relative length of reconstructed external sphincter: a case-control study.

PubMed

Norderval, S; Røssaak, K; Markskog, A; Vonen, B

2012-08-01

To determine if anatomic primary repair with end-to-end reconstruction of the external anal sphincter (EAS) in its full length combined with separate repair of coexisting internal anal sphincter (IAS) tear, when present, results in less incontinence and better anal sphincter integrity compared with conventional primary end-to-end repair in which the IAS is not actively reconstructed. Women who sustained third- or fourth-degree obstetric tears were included prospectively in the study following anatomic primary repair. Women treated with conventional primary repair prior to the study period comprised the control group. Three-dimensional endoanal ultrasonography (3D-EAUS) images were classified according to the EAUS defect score, and incontinence according to St Mark's score. Sixty-three women were included in the study group and 61 in the control group, with mean follow-up times of 11 and 21 months, respectively. Among women who had not delivered vaginally prior to the tear, St Mark's score ≥ 3 was reported by 9.6% (5/52) in the study group and 37.5% (15/40) in the control group at follow-up (P = 0.002). The corresponding numbers among women who had previously delivered vaginally were 36.4% (4/11) and 42.9% (9/21), respectively (non-significant). St Mark's score correlated with the EAUS defect score (P = 0.017). An EAS defect exceeding 50% of the sphincter length was significantly less common in the study group, and in a multivariable logistic regression model, mode of repair (anatomic vs conventional) was the only factor explaining the difference in EAS sphincter length between the two groups (P = 0.007). Improved continence status after anatomic primary repair was associated with a better longitudinal reconstruction of the EAS, while the integrity of the IAS did not differ between the groups. Women with a history of vaginal delivery prior to the sphincter tear had an inferior outcome regardless of mode of repair. Copyright © 2012 ISUOG. Published by John Wiley & Sons, Ltd.

40 CFR 63.845 - Incorporation of new source performance standards for potroom groups.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the effective date of this subpart, the existing potroom group was designed to accommodate that.../ton) from sampling secondary emissions and the primary control system for potroom groups or sections... by the regulatory authority; and that the potroom group and associated air pollution control...

[Community nursing intervention in population with high-risk coronary heart disease in Hengyang].

PubMed

Huang, Yanjin; Chen, Jia; Zeng, Ying; Liu, Dan; He, Guoping

2014-10-01

To explore the effect of community nursing intervention on awareness regarding primary prevention knowledge, self-management, and risk factors for coronary heart disease (CHD) in Hengyang City, Hunan Province. A total of 120 individuals at high risk of CHD were recruited and divided into a control group and an intervention group. The intervention group was given the health knowledge lecture and individual community nursing intervention. The control group was given the routine management. Before and after the intervention, all of the recruiters were evaluated by the awareness on primary prevention knowledge, self-management and risk factors for CHD. Before the intervention, there was no significant difference in the demographic data, the cognitive levels regarding primary prevention knowledge, the self-management and the risk factors for CHD between the 2 groups (P>0.05). After the intervention, the cognitive levels regarding primary prevention knowledge, the self-management and the risk factors for CHD between the 2 groups changed. In the intervention group, the cognitive level was significantly increased (P<0.05); the self management score was improved; the systolic blood pressure, BMI, and the levels of fasting glucose, TC and low density lipoprotein-cholesterol were significantly decreased and the level of high density lipoprotein-cholesterol was significantly increased (P<0.05). There was no significant difference in the above-mentioned parameters between before and after intervention in the control group (P>0.05). The cognitive levels regarding primary prevention knowledge and self-management for CHD can be improved effectively by community nursing intervention in high-risk population of CHD, and the risk factors for CHD can also be reduced.

EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children

PubMed Central

Llauradó, Elisabet; Tarro, Lucia; Moriña, David; Queral, Rosa; Giralt, Montse; Solà, Rosa

2014-01-01

Objectives To assess the reproducibility of an educational intervention EdAl-2 (Educació en Alimentació) programme in ‘Terres de l'Ebre’ (Spain), over 22 months, to improve lifestyles, including diet and physical activity (PA). Design Reproduction of a cluster randomised controlled trial. Setting Two semi-rural town-group primary-school clusters were randomly assigned to the intervention or control group. Participants Pupils (n=690) of whom 320 constituted the intervention group (1 cluster) and 370 constituted the control group (1 cluster). Ethnicity was 78% Western European. The mean age (±SD) was 8.04±0.6 years (47.7% females) at baseline. Inclusion criteria for clusters were towns from the southern part of Catalonia having a minimum of 500 children aged 7–8 year; complete data for participants, including name, gender, date and place of birth, and written informed consent from parents or guardians. Intervention The intervention focused on eight lifestyle topics covered in 12 activities (1 h/activity/session) implemented by health promoting agents in the primary school over three academic years. Primary and secondary outcomes The primary outcome was obesity (OB) prevalence and the secondary outcomes were body mass index (BMI) collected every year and dietary habits and lifestyles collected by questionnaires filled in by parents at baseline and end-of-study. Results At 22 months, the OB prevalence and BMI values were similar in intervention and control groups. Relative to children in control schools, the percentage of boys in the intervention group who performed ≥4 after-school PA h/week was 15% higher (p=0.027), whereas the percentage of girls in both groups remained similar. Also, 16.6% more boys in the intervention group watched ≤2 television (TV) h/day (p=0.009), compared to controls; and no changes were observed in girls in both groups. Conclusions Our school-based intervention is feasible and reproducible by increasing after-school PA (to ≥4 h/week) in boys. Despite this improvement, there was no change in BMI and prevalence of OB. Trial registration number: Clinical Trials NCT01362023. PMID:25412862

Preoperative MRI and surgical management in patients with nonpalpable breast cancer: the MONET - randomised controlled trial.

PubMed

Peters, N H G M; van Esser, S; van den Bosch, M A A J; Storm, R K; Plaisier, P W; van Dalen, T; Diepstraten, S C E; Weits, T; Westenend, P J; Stapper, G; Fernandez-Gallardo, M A; Borel Rinkes, I H M; van Hillegersberg, R; Mali, W P Th M; Peeters, P H M

2011-04-01

We evaluated whether performing contrast-enhanced breast MRI in addition to mammography and/or ultrasound in patients with nonpalpable suspicious breast lesions improves breast cancer management. The MONET - study (MR mammography of nonpalpable breast tumours) is a randomised controlled trial in patients with a nonpalpable BIRADS 3-5 lesion. Patients were randomly assigned to receive routine medical care, including mammography, ultrasound and lesion sampling by large core needle biopsy or additional MRI preceding biopsy. Patients with cancer were referred for surgery. Primary end-point was the rate of additional surgical procedures (re-excisions and conversion to mastectomy) in patients with a nonpalpable breast cancer. Four hundred and eighteen patients were randomised, 207 patients were allocated to MRI, and 211 patients to the control group. In the MRI group 74 patients had 83 malignant lesions, compared to 75 patients with 80 malignant lesions in the control group. The primary breast conserving surgery (BCS) rate was similar in both groups; 68% in the MRI group versus 66% in the control group. The number of re-excisions performed because of positive resection margins after primary BCS was increased in the MRI group; 18/53 (34%) patients in the MRI group versus 6/50 (12%) in the control group (p=0.008). The number of conversions to mastectomy did not differ significantly between groups. Overall, the rate of an additional surgical intervention (BCS and mastectomy combined) after initial breast conserving surgery was 24/53 (45%) in the MRI group versus 14/50 (28%) in the control group (p=0.069). Addition of MRI to routine clinical care in patients with nonpalpable breast cancer was paradoxically associated with an increased re-excision rate. Breast MRI should not be used routinely for preoperative work-up of patients with nonpalpable breast cancer. Copyright © 2010 Elsevier Ltd. All rights reserved.

The dental health of children subject to a child protection plan.

PubMed

Keene, Emily J; Skelton, Ruth; Day, Peter F; Munyombwe, Theresa; Balmer, Richard C

2015-11-01

In the United Kingdom, child maltreatment is an area of increased awareness and concern. To compare the dental health of children subject to child protection plans with controls. Children had to be aged between two and 11 years, medically healthy, and subject either to a child protection plan or attending the paediatric outpatient orthopaedic or general surgery clinics (control group). All children had a standardized oral examination. Seventy-nine children were examined in each group. Children with child protection plans had statistically higher levels of primary tooth decay than controls (mean dmft 3.82 and 2.03, Mann-Whitney U test P = 0.002). After adjusting for socioeconomic status, the incidence rate ratios for the occurrence of dental caries in the primary dentition in children with a child protection plan was 1.76 (95% CI: 1.44-2.15) relative to the controls. There was no statistical difference in the levels of permanent tooth decay between the study and control groups (mean DMFT 0.71 and 0.30, respectively). The care index was significantly lower (P = 0.008, Mann-Whitney U test) in the study group (1.69%) compared to the control group (6.02%). Children subject to child protection plans had significantly higher levels of dental caries in the primary dentition. © 2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT.

PubMed

Voigt-Radloff, Sebastian; Graff, Maud; Leonhart, Rainer; Hüll, Michael; Rikkert, Marcel Olde; Vernooij-Dassen, Myrra

2011-08-09

Background The positive effects of the Dutch Community Occupational Therapy in Dementia programme on patients' daily functioning were not found in a multicentre randomised controlled trial (RCT) in Germany. Objectives To evaluate possible effect modification on the primary outcome within the German RCT with regard to (1) participant characteristics, (2) treatment performance and (3) healthcare service utilisation; and (4) to compare the design and primary outcome between the German and the original Dutch study. Methods (1) The impact of participant baseline data on the primary outcome was analysed in exploratory ANCOVA and regression analyses. (2) Therapists completed questionnaires on context and performance problems. The main problems were identified by a qualitative content analysis and focus-group discussion. Associations of the primary outcome with scores of participant adherence and treatment performance were evaluated by regression analysis. (3) Utilisation rates of healthcare services were controlled for significant group differences. (4) Differences in the Dutch and German study design were identified, and the primary outcome was contrasted at the item level. Results (1) Participant characteristics could not explain more than 5% of outcome variance. (2) The treatment performance of some active intervention components was poor but not significantly associated with the primary outcome. (3) There were no significant group differences in the utilisation of healthcare resources. (4) In contrast to the Dutch waiting-control group, the active intervention in the German control group may have reduced group differences in the current RCT. The German patients demonstrated a higher independence at baseline and less improvement in instrumental activities of daily living. Conclusion The differences in outcome may be explained by a more active control treatment, partially poor experimental treatment and less room for improvement in the German sample. Future cross-national transfers should be prepared by pilot studies assessing the applicability of the intervention and patient needs specific to the target country. Trial registration International Clinical Trials Registry Platform, DRKS00000053.

[Effects of autologous blood injection at Zusanli (ST 36) on ovarian function in patients with primary ovarian insufficiency].

PubMed

Jiang, Renjian; Zou, Yu

2017-11-12

To observe the effects of autologous blood injection and 0.9% NaCl at Zusanli (ST 36) on ovarian function in patients with primary ovarian insufficiency. Sixty patients with primary ovarian insufficiency were randomly divided into an observation group and a control group, 30 cases in each one. The patients in the observation group were treated with injection of autologous blood at Zusanli (ST 36); the patients in the control group were treated with 0.9% NaCl with identical volume at Zusanli (ST 36). Both the treatments were given once a week for 3 months. The ovarian function, including follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E 2 ) were tested before treatment, 1 month, 2 months and 3 months after first acupoint injection; the endometrial thickness before and after treatment and clinical efficacy were compared in the two groups. Compared before treatment, FSH was lowered in the observation group after 1-month treatment ( P <0.05), while FSH and LH were lowered and E 2 was increased after 2-month treatment and 3-month treatment (all P <0.05). Compared with 1-month treatment, FSH and LH were lowered and E 2 was increased in the observation group after 2-month treatment and 3-month treatment (all P <0.05). Compared with 2-month treatment, FSH was lowered and E 2 was increased in the observation group after 3-month treatment (both P <0.05). The differences of all serum tests before and after treatment were insignificant in the control group (all P >0.05). The FSH after 1-month treatment, and FSH, LH and E 2 after 2-month treatment and 3-month treatment in the observation group were significantly different from those in the control group (all P <0.05). The endometrial thickness after treatment in the observation group was higher than that before treatment ( P <0.05), while the endometrial thickness after treatment in the control group was similar to that before treatment ( P >0.05); the difference of endometrial thickness before and after treatment in the observation group was higher than that in the control group ( P <0.05). The clinical effective rate was 83.3% (25/30) in the observation group, which was superior to 46.7% (14/30) in the control group ( P <0.05). The autologous blood injection at Zusanli (ST 36) can significantly improve ovarian function, promote endometrial growth in patients with primary ovarian insufficiency.

A prevention programme for somatoform disorders is effective for affective disorders.

PubMed

García-Campayo, Javier; Arevalo, Elisa; Claraco, Luis Manuel; Alda, Marta; Lopez del Hoyo, Yolanda

2010-04-01

To assess the effectiveness of a psycho-educational programme for the primary prevention of somatoform disorders in healthy primary care patients. Randomized, controlled trial. Participants (N=104) were randomly assigned to: (1) a psycho-educational intervention, or (2) no intervention at all. The primary outcome measure was somatoform disorder psychiatric diagnosis at 5-year follow-up. Secondary outcome measures were hypochondriasis, locus of control and attribution of symptoms and psychological distress. At 3 and 6 months, and 5 years, the intervention group significantly decreased hypochondriasis and somatic attributions; and increased psychological and normalizing attributions and internal locus of control. Five years after baseline, the prevalence of somatoform disorders showed no differences between both groups. Nevertheless, overall psychiatric morbidity was less prevalent in the intervention group (odds ratio: 2.72; 95%CI:1.10-6.72). In addition, a decrease in depression and anxiety subscales and in overall General Health Questionnaire scoring (p<.05) was found in the intervention group. A primary prevention programme for somatization seems to be useful, not to decrease somatoform disorders, but to prevent anxiety and depressive disorders. The effects of overlapping psychobiological mechanisms are discussed. Copyright 2009 Elsevier B.V. All rights reserved.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

PubMed

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. NCT02093520.

Animal Study on Primary Dysmenorrhoea Treatment at Different Administration Times

PubMed Central

Pu, Bao-Chan; Fang, Ling; Gao, Li-Na; Liu, Rui; Li, Ai-zhu

2015-01-01

The new methods of different administration times for the treatment of primary dysmenorrhea are more widely used clinically; however, no obvious mechanism has been reported. Therefore, an animal model which is closer to clinical evaluation is indispensable. A novel animal experiment with different administration times, based on the mice oestrous cycle, for primary dysmenorrhoea treatment was explored in this study. Mice were randomly divided into two parts (one-cycle and three-cycle part) and each part includes five groups (12 mice per group), namely, Jingqian Zhitong Fang (JQF) 6-day group, JQF last 3-day group, Yuanhu Zhitong tablet group, model control group, and normal control group. According to the one-way ANOVAs, results (writhing reaction, and PGF2α, PGE2, NO, and calcium ions analysis by ELISA) of the JQF cycle group were in accordance with those of JQF last 3-day group. Similarly, results of three-cycle continuous administration were consistent with those of one-cycle treatment. In conclusion, the consistency of the experimental results illustrated that the novel animal model based on mice oestrous cycle with different administration times is more reasonable and feasible and can be used to explore in-depth mechanism of drugs for the treatment of primary dysmenorrhoea in future. PMID:25705236

[Gene copy number, mRNA transcription and protein expression of PD-1 gene in primary hepatocarcinoma patients].

PubMed

Fan, Hui-Min; Wu, Ling-Jie; Hu, Feng-Yu; Yang, Zhan

2012-08-01

To study the gene copy number, mRNA transcription and protien expression of programmed cell death 1 (PD-1) gene in primary hepatocellular carcinoma (PHC) patients and normal control individuals (NC) who are anti-HBs positive, and to investigate the variations in PD-1 gene copy numbers and its relationship with PHC. Real-time PCR was adopted to detect the PD-1 gene copy numbers and their mRNA expressions in peripheral blood mononuclear cells (PBMCs) from 24 samples of PHC patients and 26 of NC. Protein expression level of PD-1 on CD8+ T was analyzed by flow cytometry. In terms of number of PD-1 gene copy numbers, the percentage of cases of haploid (single) was 34.62% and 4.17% in PHC group and control group respectively while the percentage of cases of diploid (double) was 61.54% and 95.83% respectively. The difference between the two was statistically significant (chi2 = 7.639, P = 0.006). The rate of cases with double PD-1 gene copy numbers was found to be higher in patients with PHC than in control group. It was also found that the average expression of PD-1 mRNA was 2.35E-03 in control group and 1.23E-03 in PHC group. The expression level was significant lower in PHC group than that in control group when compared by using Mann-whitey technic (U = 153, P = 0.009). Furthermore, the frequency of PD-1 protein expression on CD8+ T cells was 3.72 +/- 0.32 in control group and 16.13 +/- 1.68 in PHC group. The level of PD-1 mRNA expression was higher in PHC and significant differences was shown between two groups (t = -7.073, P = 0.000). Our study suggests that the variation in PD-1 gene copy number may trigger primary hepatocellular carcinoma to HBV carriers. The relationship between the variation of PD-1 gene copy numbers and its association with primary hepatocellular carcinoma is worth further focus.

Reduced coronary flow and resistance reserve in primary scleroderma myocardial disease

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nitenberg, A.; Foult, J.M.; Kahan, A.

1986-08-01

The maximum coronary vasodilator capacity after intravenous dipyridamole (0.14 mg X kg-1 X min-1 X 4 minutes) was studied in seven patients with primary scleroderma myocardial disease and compared to that of seven control subjects. Hemodynamic data and left ventricular angiographic data were not different in the two groups. The coronary flow reserve was evaluated by the dipyridamole/basal coronary sinus blood flow ratio (D/B CSBF) and the coronary resistance reserve by the dipyridamole/basal coronary resistance ratio (D/B CR). Coronary reserve was greatly impaired in the group with primary scleroderma myocardial disease: D/B CSBF was lower than in the control groupmore » (2.54 +/- 1.37 vs 4.01 +/- 0.56, respectively; p less than 0.05) and D/B CR was higher than in the control group (0.47 +/- 0.25 vs 0.23 +/- 0.04, respectively; p less than 0.05). Such a decreased coronary flow and resistance reserve in patients with primary scleroderma myocardial disease was not explained by an alteration of left ventricular function. It may be an important contributing factor in the pathogenesis of primary scleroderma myocardial disease.« less

Evaluation of a fissure sealant program as part of community-based teaching and training.

PubMed

van Wyk, Philippus J; Kroon, Jeroen; White, John G

2004-01-01

Since 1995 the Department of Community Dentistry of the University of Pretoria has been involved in the rendering of mobile primary oral health care services to children in the Hammanskraal area of Gauteng, South Africa, as part of their students' community-based training. Mokonyama Primary School was identified as the first school where a primary oral health care service could be rendered. The objective of this study was to evaluate the impact (outcomes) of a fissure sealant program on the dentition status of the school children. Seven years after the implementation of the program, the dentition status of children at Mokonyama was compared with that of a comparable group of children from the same area who were not exposed to the program. The results showed that the decayed, missing, and filled teeth in the primary dentition (dmft) in the six-year-old group in Mokonyama (1.74) did not differ significantly from the dmft (1.43) of the control group (p = 0.49). The decayed, missing, and filled teeth in the permanent dentition (DMFT) of 0.59 for the fifteen-year-old group in Mokonyama, however, differed significantly (p = 0.0001) from the DMFT of the control group (2.38). Fifteen-year-old children in Mokonyama had 75.2 percent fewer caries than their counterparts in the control group.

An electronic medical record-based intervention to improve quality of care for gastro-esophageal reflux disease (GERD) and atypical presentations of GERD.

PubMed

Player, Marty S; Gill, James M; Mainous, Arch G; Everett, Charles J; Koopman, Richelle J; Diamond, James J; Lieberman, Michael I; Chen, Ying Xia

2010-01-01

Gastro-esophageal reflux disease (GERD) is common in primary care but is often underdiagnosed and untreated. GERD can also present with atypical symptoms like chronic cough and asthma, and physicians may be unaware of this presentation. We aimed to implement and evaluate an intervention to improve diagnosis and treatment for GERD and atypical GERD in primary care. This was a randomised controlled trial in primary care office practice using a national network of US practices (the Medical Quality Improvement Consortium - MQIC) that share the same electronic medical record (EMR). Thirteen offices with 53 providers were randomised to the intervention of EMR-based prompts and education, and 14 offices with 66 providers were randomised to the control group totalling over 67 000 patients and examining outcomes of GERD diagnosis and appropriate treatment. Among patients who did not have GERD at baseline, new diagnoses of GERD increased significantly in the intervention group (3.1%) versus the control group (2.3%) (P<0.01). This remained significant after controlling for clustering with an odds of diagnosis of 1.33 (95% CI 1.13-1.56) for the intervention group. For patients with atypical symptoms, those in the intervention group had both higher odds of being diagnosed with GERD (OR 2.02, 95% CI 1.41-2.88) and of being treated for GERD (OR 1.40, 95% CI 1.08-1.83) than those in the control group. GERD diagnosis and treatment in primary care, particularly among patients with atypical symptoms, can be improved through the use of an EMR-based tool incorporating decision support and education. However, significant room for improvement exists in use of appropriate treatment.

Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial.

PubMed

O'Brien, Claire; Bray, Emma P; Bryan, Stirling; Greenfield, Sheila M; Haque, M Sayeed; Hobbs, F D Richard; Jones, Miren I; Jowett, Sue; Kaambwa, Billingsley; Little, Paul; Mant, Jonathan; Penaloza, Cristina; Schwartz, Claire; Shackleford, Helen; Varghese, Jinu; Williams, Bryan; McManus, Richard J

2013-03-23

Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care. The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes. The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond. ISRCTN87171227.

Prospective randomized controlled study of interferon-alpha in preventing hepatocellular carcinoma recurrence after medical ablation therapy for primary tumors.

PubMed

Lin, Shi-Ming; Lin, Chun-Jung; Hsu, Chao-Wei; Tai, Dar-In; Sheen, I-Shyan; Lin, Deng-Yn; Liaw, Yun-Fan

2004-01-15

Hepatocellular carcinoma (HCC) recurrence after ablation therapy for primary tumors is common. To evaluate the effectiveness of interferon-alpha (IFN-alpha) in preventing HCC recurrence, 30 eligible patients were randomized into three groups: 11 patients treated with three mega units (MU) of IFN-alpha three times weekly for 24 months (IFN-alpha-continuous group), 9 patients treated with 3 MU of IFN-alpha daily for 10 days every month for 6 months followed by 3 MU of IFN-alpha daily for 10 days every 3 months for a further 18 months (IFN-alpha-intermittent group), and 10 patients who received no IFN-alpha therapy (control group). The three groups were comparable in terms of etiology, demographics, and laboratory data at entry and HCC characteristics. After a median follow-up of 27 months (range 4-53 months), 9 patients (90%) in the control group and 9 patients (45%) in 2 treatment groups (6 patients in the IFN-alpha-continuous group and 3 patients in the IFN-alpha-intermittent group) developed an HCC recurrence (P = 0.021). Cumulative HCC recurrence rates in the IFN-alpha-intermittent, IFN-alpha-continuous, and control groups were 22.2%, 27.3%, and 40% at the end of 1 year and 33.3%, 54.6%, and 90% at the end of 4 years (P = 0.0375), respectively (control vs. IFN-alpha-intermittent group, P = 0.0123; vs. IFN-alpha-continuous group, P = 0.0822). If both IFN-alpha groups were combined, the cumulative HCC recurrence rate of the patients treated with IFN-alpha and the control group was 25% and 40% at the end of 1 year and 47% and 90% at the end of 4 years, respectively (P = 0.0135). The data suggested that IFN-alpha therapy may reduce HCC recurrence after medical ablation therapy for primary tumors. Copyright 2003 American Cancer Society.

A Retrospective Analysis of Dental Implants Replacing Failed Implants in Grafted Maxillary Sinus: A Case Series.

PubMed

Manor, Yifat; Chaushu, Gavriel; Lorean, Adi; Mijiritzky, Eithan

2015-01-01

To evaluate the survival rate of dental implants replacing failed implants in grafted maxillary sinuses using the lateral approach vs nongrafted posterior maxillae. A retrospective analysis was conducted to study the survival of secondary dental implants inserted in the posterior maxilla in previously failed implant sites between the years 2000 and 2010. The study group consisted of patients who had also undergone maxillary sinus augmentation, and the control group consisted of patients in whom implants in the posterior maxilla had failed. Clinical and demographic data were analyzed using a structured form. Seventy-five patients with a total of 75 replaced implants were included in the study. The study group comprised 40 patients and the control group, 35 patients. None of the replaced implants in the study group failed, resulting in an overall survival of 100%; three replaced implants in the control group failed (92% survival). The main reason for the primary implant removal was lack of osseointegration (35 [87.5%] of 40 study group implants and 23 [65.7%] of 35 control group implants [P = .027]). The difference between the groups with regard to the timing of primary implant failure was statistically significant. The study group had more early failures of the primary implant than did the control group (77% vs 62%; P = .038). Dental implants replaced in the posterior maxilla had a high survival rate. A higher rate of survival was found in augmented maxillary sinus sites. Within the limits of the present study, it can be concluded that previous implant failures in the grafted maxillary sinus should not discourage practitioners from a second attempt.

Group Medical Visits (GMVs) in primary care: an RCT of group-based versus individual appointments to reduce HbA1c in older people

PubMed Central

Khan, Karim M; Windt, Adriaan; Davis, Jennifer C; Dawes, Martin; Liu-Ambrose, Teresa; Madden, Ken; Marra, Carlo A; Housden, Laura; Hoppmann, Christiane; Adams, David J

2015-01-01

Introduction Type 2 diabetes mellitus (T2DM) affects more than 1.1 million Canadians aged ≥65 years. Group Medical Visits are an emerging health service delivery method. Recent systematic reviews show that they can significantly reduce glycated haemoglobin (HbA1c) levels, but Group Visits have not been evaluated within primary care. We intend to determine the clinical effectiveness, quality of life and economic implications of Group Medical Visits within a primary care setting for older people with T2DM. Methods and analysis A 2-year proof-of-concept, single-blinded (measurement team) randomised control trial to test the efficacy of Group Medical Visits in an urban Canadian primary care setting. Participants ≥65 years old with T2DM (N=128) will be equally randomised to either eight groups of eight patients each (Group Medical Visits; Intervention) or to Individual visits (Standard Care; Controls). Those administering cointerventions are not blinded to group assignment. Our sample size is based on estimates of variance (±1.4% for HbA1c) and effect size (0.9/1.4=0.6) from the literature and from our own preliminary data. Forty participants per group will provide a β likelihood of 0.80, assuming an α of 0.05. A conservative estimation of an effect size of 0.7/1.4 changes the N in the power calculation to 59 per group. Hence, we aim to enrol 64 participants in each study arm. We will use intention-to-treat analysis and compare mean HbA1c (% glycosylated HbA1c) (primary outcome) of Intervention/Control participants at 12 months, 24 months and 1 year postintervention on selected clinical, patient-rated and economic measures. Trial registration number NCT02002143. PMID:26169803

Ketamine Patient Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator Controlled, Blinded, Pilot Trial

DTIC Science & Technology

2017-01-11

patient- controlled analgesia per the primary treating team. Four subjects in the ketamine group and one subject in the hydromorphone group withdrew...occurred more frequently in the ketamine group , although this was not statistically significant (40% vs. 0%, P=0.090). Ketamine patient- controlled ...breakthrough IV morphine equivalents between groups . 4.0 RESULTS 4.1 Participants Due to unanticipated barriers to enrollment, including a

Effects of Auricular Acupressure Therapy on Primary Dysmenorrhea for Female High School Students in South Korea.

PubMed

Cha, Nam Hyun; Sok, Sohyune R

2016-09-01

To examine the effect of auricular acupressure therapy on primary dysmenorrhea among female high school students in South Korea. A randomized controlled trial was employed. The study sample consisted of 91 female high school students, with 45 participants in the experimental group and 46 in the control group in two regions of South Korea. The average age of the participants was 16.7 years, and the average age of menarche was 12.2 years. Auricular acupressure therapy including an auricular acupressure needle on skin paper tape was applied on an ear for 3 days during periods of extreme primary dysmenorrhea. The acupoint names were Jagung, Sinmun, Gyogam, and Naebunbi. For the placebo control group, only the skin paper tape without an auricular acupressure needle was applied on the same acupoints. Measures used were the Menstrual Distress Questionnaire to assess primary dysmenorrhea, and the visual analog scale to assess abdominal and back pain of participants. There were significant differences on abdominal pain (t = 24.594, p < .001), back pain (t = 22.661, p < .001), and primary dysmenorrhea (t = 32.187, p < .001) between the two groups. Auricular acupressure therapy decreased abdominal pain, back pain, and primary dysmenorrhea of female high school students in South Korea. Auricular acupressure therapy was an effective intervention for alleviating abdominal pain, back pain, and primary dysmenorrhea of female high school students in South Korea. For feasibility of the auricular acupressure therapy in practice, it is needed to train and learn the exact positions of acupoints in ear. Health providers should consider providing auricular acupressure therapy as an alternative method for reducing abdominal and back pain, and primary dysmenorrhea in female high school students in South Korea. © 2016 Sigma Theta Tau International.

A focus group study to understand biases and confounders in a cluster randomized controlled trial on low back pain in primary care in Norway.

PubMed

Werner, Erik L; Løchting, Ida; Storheim, Kjersti; Grotle, Margreth

2018-05-22

Cluster randomized controlled trials are often used in research in primary care but creates challenges regarding biases and confounders. We recently presented a study on low back pain from primary care in Norway with equal effects in the intervention and the control group. In order to understand the specific mechanisms that may produce biases in a cluster randomized trial we conducted a focus group study among the participating health care providers. The aim of this study was to understand how the participating providers themselves influenced on the study and thereby possibly on the results of the cluster randomized controlled trial. The providers were invited to share their experiences from their participation in the COPE study, from recruitment of patients to accomplishment of either the intervention or control consultations. Six clinicians from the intervention group and four from the control group took part in the focus group interviews. The group discussions focused on feasibility of the study in primary care and particularly on identifying potential biases and confounders in the study. The audio-recorded interviews were transcribed verbatim and analyzed according to a systematic text condensation. The themes for the analysis emerged from the group discussions. A personal interest for back pain, logistic factors at the clinics and an assessment of the patients' capacity to accomplish the study prior to their recruitment was reported. The providers were allowed to provide additional therapy to the intervention and it turned out that some of these could be regarded as opposed to the messages of the intervention. The providers seemed to select different items from the educational package according to personal beliefs and their perception of the patients' acceptance. The study disclosed several potential biases to the COPE study which may have impacted on the study results. Awareness of these is highly important when planning and conducting a cluster randomized controlled trial. Procedures in the recruitment of both providers and patients seem to be key factors and the providers should be aware of their role in a scientific study in order to standardize the provision of the intervention.

Effect of rhubarb (Rheum emodi) in primary dysmenorrhoea: a single-blind randomized controlled trial.

PubMed

Rehman, Hina; Begum, Wajeeha; Anjum, Farzana; Tabasum, Humyra; Zahid, Shabnam

2015-03-01

The aim of this study was to investigate and evaluate the efficacy of Rheum emodi in the management of primary dysmenorrhoea. A randomized, single-blind, standard controlled trial compared efficacy of R. emodi against mefenamic acid on diagnosed subjects of primary dysmenorrhoea for three consecutive cycles. Experimental group (n=30) received capsules of R. emodi powder two times a day, two days before the expected date of menstruation, and continued first three days of menstruation, while control group (n=15) participants received mefenamic acid capsules three times a day on the same protocol. The primary outcome measures were reduced in severity and duration of pain, assessed by visual analogue scale (VAS) and verbal multidimensional scoring system (VMSS), and secondary outcome measures were overall improvement of dysmenorrhoea and improved in quality of life (QOL). Statistical analysis was done by repeated measures analysis of variance and Chi-square/Fisher Exact test. The menstrual pain was significantly decreased in both groups after three-cycle intervention. Significant changes were observed in VAS (p<0.001) and VMSS (p<0.001) in the experimental group. There is a significant (p<0.001) reduction in duration of pain in both the groups. Associated symptoms and QOL were markedly improved after treatment (p<0.001). It has been clear from the above result that R. emodi is an effective herb in alleviating symptoms of primary dysmenorrhoea. It can serve as an alternative treatment without any apparent side effects. These results deserve further investigations.

Primary and submovement control of aiming in C6 tetraplegics following posterior deltoid transfer

PubMed Central

2014-01-01

Background Upper limb motor control in fast, goal-directed aiming is altered in tetraplegics following posterior-deltoid musculotendinous transfer. Specifically, movements have similar end-point accuracy but longer duration and lower peak velocity than those of age-matched, neurotypical controls. Here, we examine in detail the interplay between primary movement and submovement phases in five C6 tetraplegic and five control participants. Methods Aiming movements were performed in two directions (20 cm away or toward), with or without vision. Trials that contained a submovement phase (i.e., discontinuity in velocity, acceleration or jerk) were identified. Discrete kinematic variables were then extracted on the primary and submovements phases. Results The presence of submovements did not differ between the tetraplegic (68%) and control (57%) groups, and almost all submovements resulted from acceleration and jerk discontinuities. Tetraplegics tended to make a smaller amplitude primary movement, which had lower peak velocity and greater spatial variability at peak velocity. This was followed by a larger amplitude and longer duration secondary submovement. Peak velocity of primary movement was not related to submovement incidence. Together, the primary and submovement phases of both groups were equally effective in reducing end-point error. Conclusions C6 tetraplegic participants exhibit some subtle differences in measures of motor behaviour compared to control participants, but importantly feedforward and feedback processes work effectively in combination to achieve accurate goal-directed aiming. PMID:25055852

Postocclusive reactive hyperemia in hand-arm vibration syndrome.

PubMed

Stoyneva, Zlatka

2016-01-01

To assess laser Doppler-recorded postocclusive reactive hyperemic responses in vibration-induced Raynaud's phenomenon and compare it with primary and secondary to sclerodermy Raynaud's phenomenon. Thirty patients with vibration-induced Raynaud's phenomenon and 30 healthy controls and patients with primary and secondary to sclerodermy Raynaud's phenomenon were investigated. Fingerpulp skin blood flow was monitored by laser Doppler flowmetry during postocclusive reactive hyperemia test. Lower initial perfusion values were established in all the patients with Raynaud's phenomenon compared to the healthy controls (p < 0.0001). The postocclusive reactive hyperemic peak was lower in all the Raynaud's phenomenon groups compared to the controls (p < 0.0001). The postocclusive and basal perfusions were lower in the secondary Raynaud's phenomenon groups compared to the control and the primary Raynaud's phenomenon groups (p < 0.0001). The velocities to postocclusive hyperemic peak were lower in all the Raynaud's phenomenon patients (p < 0.0001), so were in the vibration-induced (p < 0.002) and the sclerodermy Raynaud's phenomenon (p < 0.004) groups in relation to the primary Raynaud's phenomenon group. The perfusion values and the velocities were significantly influenced by the initial superficial skin temperatures and perfusions, while the velocities were dependent also on gender, and the hyperemic peak on age. Postocclusive reactive hyperemia is abnormal in all Raynaud's phenomenon patients. Laser Doppler-recorded reactive hyperemia test contributes to diagnosing Raynaud's phenomenon and has proved to be valuable for group analysis. The applied method is not sensitive enough to discriminate adequately the type of Raynaud's phenomenon among individual cases. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

Parenting Stress and Emotional/Behavioral Problems in Adolescents with Primary Headache.

PubMed

Operto, Francesca Felicia; Craig, Francesco; Peschechera, Antonia; Mazza, Roberta; Lecce, Paola Alessandra; Margari, Lucia

2017-01-01

Primary headache is a frequent and disabling disorder, common among children and adolescents, and it is a painful syndrome often accompanied by functional impairment and associated with emotional and behavior problems. The aim of this study was to investigate parenting stress and emotional/behavioral problems in adolescents affected by primary headache compared with healthy adolescents. The study population consisted of 35 adolescents and a control group of 23 healthy subjects. The assessment included the administration of clinical standardized scales such as Parent Stress Index-Short Form, Pediatric Migraine Disability Assessment Score Questionnaire, and Child Behavior Checklist (CBCL). Headache group and control group did not differ in terms of parenting stress ( p  = 0.29). On the contrary, headache group showed more internalizing problems ( p  = 0.023), affective problems ( p  = 0.01), anxious ( p  = 0.001), and somatic complaints ( p  < 0.001) compared with control group. In addition, we found a significant correlation between PSI domains and specific CBCL subscales in the headache group. The findings emphasize the need for expanded intervention in the clinical treatment of pediatric headache, a treatment that may also include the family members. Further research is needed.

[The OPTIMISE study (Optimal Type 2 Diabetes Management Including Benchmarking and Standard Treatment]. Results for Luxembourg].

PubMed

Michel, G

2012-01-01

The OPTIMISE study (NCT00681850) has been run in six European countries, including Luxembourg, to prospectively assess the effect of benchmarking on the quality of primary care in patients with type 2 diabetes, using major modifiable vascular risk factors as critical quality indicators. Primary care centers treating type 2 diabetic patients were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). Primary endpoint was percentage of patients in the benchmarking group achieving pre-set targets of the critical quality indicators: glycated hemoglobin (HbAlc), systolic blood pressure (SBP) and low-density lipoprotein (LDL) cholesterol after 12 months follow-up. In Luxembourg, in the benchmarking group, more patients achieved target for SBP (40.2% vs. 20%) and for LDL-cholesterol (50.4% vs. 44.2%). 12.9% of patients in the benchmarking group met all three targets compared with patients in the control group (8.3%). In this randomized, controlled study, benchmarking was shown to be an effective tool for improving critical quality indicator targets, which are the principal modifiable vascular risk factors in diabetes type 2.

Effect on caries experience of a long-term preventive program for mothers and children starting during pregnancy.

PubMed

Günay, H; Dmoch-Bockhorn, K; Günay, Y; Geurtsen, W

1998-09-01

The aim of this three-phase prospective study was to determine the effects of a primary-primary prevention program on the oral health of children. Eighty-six pregnant women from various social backgrounds participated in the first phase of this study. In the second phase (at 3 years of age) 54 of the mother-child couples and in the third phase (at 4 years of age) 47 of the mother-child couples remained. Participants were recalled every 6 months and received individual prophylactic care. The following clinical parameters were assessed at each examination period for mother and child: DMF-S or dmf-s, proximal plaque index, and the salivary level of Streptococcus mutans (Dentocult SM). The control group consisted of 65 (at 3 years of age) and 45 (at 4 years of age) children from various kindergartens. All children in the second phase of the study group revealed a naturally healthy dentition with an API of 0-25% and a salivary S. mutans score of 0 (0-10(3) cfu/ml). In the third phase, only four of the 47 children of the study group showed caries, with a mean dmf-s of 1.5. No S. mutans could be detected in 20 (42.6%) children. Ten (21.3%) children of the study group showed a S. mutans score of > or = 2 (> 10(5) cfu/ml). In contrast, only 53 of the 65 children of the control group (second phase) and 26 of the 45 control children (third phase) revealed a naturally healthy dentition. The remaining 19 children of the control group revealed a mean dmf-s of 7.0 at 4 years of age. In the control group, no S. mutans could be detected in 25 (38.5%) children at 3 years of age whereas 21 (32.3%) children showed a S. mutans score of > or = 2. In the third phase, a salivary S. mutans score of > or = 2 was found in 27 (60%) children of the control group. The statistical comparison between the study and the control groups revealed significant differences for all results determined (P < 0.001). Additionally, all mothers revealed a significant improvement in oral health and a reduction of salivary S. mutans colonization. From our data we conclude that a pre- and postnatal prevention program (primary-primary vs primary prevention) may significantly improve the oral health of mother and child.

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol.

PubMed

Pérula-de-Torres, Luis Á; Martínez-Adell, Miguel Á; González-Blanco, Virginia; Baena-Díez, José M; Martín-Rioboó, Enrique; Parras-Rejano, Juan M; González-Lama, Jesús; Martín-Alvarez, Remedios; Ruiz-Moral, Roger; Fernández-García, José Á; Pérez-Díaz, Modesto; Ruiz-de-Castroviejo, Joaquin; Pérula-de-Torres, Carlos; Valero-Martín, Antonio; Roldán-Villalobos, Ana; Criado-Larumbe, Margarita; Burdoy-Joaquín, Emili; Coma-Solé, Montserrat; Cervera-León, Mercè; Cuixart-Costa, Lluís

2012-10-30

Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. The study is registered as NCT01291953 (ClinicalTrials.gob).

Heart failure and the discrepancy between trials of intensive blood pressure management: an analysis of individual patient data.

PubMed

Aggarwal, Rahul; Mirzan, Haares; Chiu, Nicholas; Steinkamp, Jackson

2018-02-26

ACCORD and SPRINT are the best randomized controlled trial data evaluating the effects of blood pressure targets below 140 mmHg. These trials had contradictory results regarding the benefits of intensive antihypertensive therapy. We investigate if this discordance was driven by SPRINT's inclusion of Heart Failure in its primary outcome, as this is a parameter not included in ACCORD's original primary outcome. This analysis helps to resolve a significant area of contention. Individual patient data from 4733 participants in ACCORD were analyzed from time of randomization. All participants were diabetic and at increased cardiovascular risk. Participants were assigned to their original intervention, a standard blood pressure target of less than 140 mmHg or an intensive target of less than 120 mmHg. Primary composite outcome was defined as in SPRINT: a composite of first occurrence of myocardial infarction, stroke, heart failure, death from cardiovascular causes, and other acute coronary syndromes. Primary outcome was not significantly different between standard and intensive groups [HR: 0.89; 95% CI: (0.76-1.03); p = 0.108]. The primary composite outcome occurred in 370 participants in the standard group (15.6%) and 324 participants in the intensive group (13.7%), with an event rate of 3.38% per year for the standard group and 3.01% per year for the intensive group. Differing results between ACCORD and SPRINT are not attributable to ACCORD's exclusion of Heart Failure from its original primary outcome measurement. No significant differences in primary outcome were observed between intensive and standard blood pressure groups in the ACCORD patients under the SPRINT primary outcome definition. Caution should be taken in extrapolating the intensive blood pressure control benefits of SPRINT to the diabetic population.

Healthcare utilization in women after abdominal surgery for ovarian cancer.

PubMed

McCorkle, Ruth; Jeon, Sangchoon; Ercolano, Elizabeth; Schwartz, Peter

2011-01-01

Women undergoing surgery for ovarian cancer are severely ill and are high users of health services. Contributing to these increased utilization rates are the multiple modalities used to treat ovarian cancer and the complications and side effects from those treatments. The purpose of this study was to evaluate the effectiveness of an intervention provided by advanced practice nurses and a psychiatric consultation-liaison nurse on patients' self-report of healthcare utilization compared with an attention control intervention in women undergoing surgery for a suspected diagnosis of ovarian cancer. A two-group, experimental, longitudinal design was used to compare women who were assigned randomly to the intervention group or to an attention control group at baseline within 48 hours after surgery and 1, 3, and 6 months after surgery. Healthcare utilization was measured as the number of self-reported inpatient admissions and outpatient visits, including emergency room visits, oncology outpatient visits, and primary care visits. Nurse interventions consisted of 16 contacts: symptom management, counseling, education, direct nursing care, coordination of resources, and referrals. The attention control interventions consisted of nine contacts that included instructions on use of a symptom management toolkit and strategies on how to manage symptoms. There were no differences in hospitalizations and oncology outpatient visits between the two groups. The main finding of this study was a significant difference in the number of primary care visits between the two groups. Women in the attention control group went to their primary care providers more often than the intervention group. The women who reported more visits also reported more depressive symptoms. In addition, a trend was found in the number of emergency room visits between the two groups. The intervention group visited the emergency room more often because the nurse instructed patients to go when they recognized symptoms that needed urgent care after hours. Women in the intervention group appropriately used the emergency room to manage their problems after hours, whereas more women in the attention control group reported significantly more primary care visits. These findings highlight the need for healthcare providers representing various disciplines to coordinate services across specialties, especially for women who have depressive symptoms.

Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

PubMed

Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

2015-09-01

To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

A randomized trial of a lay person-led self-management group intervention for back pain patients in primary care.

PubMed

Von Korff, M; Moore, J E; Lorig, K; Cherkin, D C; Saunders, K; González, V M; Laurent, D; Rutter, C; Comite, F

1998-12-01

Randomized, controlled trial. To evaluate a four-session self-management group intervention for patients with pain in primary care, led by trained lay persons with back pain. The intervention was designed to reduce patient worries, encourage self-care, and reduce activity limitations. Randomized trials of educational interventions suggest that activating interventions may improve back pain outcomes. Expert opinion increasingly regards effective self-management of back pain as important in achieving good outcomes. In this study, an educational intervention designed to activate patients and support effective self-management was evaluated. Six to 8 weeks after a primary care visit for back pain, patients were invited to participate in an educational program to improve back pain self-management. Those showing interest by returning a brief questionnaire became eligible for the study. Participants (n = 255) randomly were assigned to either a self-management group intervention or to a usual care control group. The effect of the intervention, relative to usual care, was assessed 3, 6, and 12 months after randomization, controlling for baseline values. The intervention consisted of a four-session group applying problem-solving techniques to back pain self-management, supplemented by educational materials (book and videos) supporting active management of back pain. The groups were led by lay persons trained to implement a fully structured group protocol. The control group received usual care, supplemented by a book on back pain care. Participants randomly assigned to the self-management groups reported significantly less worry about back pain and expressed more confidence in self-care. Roland Disability Questionnaire Scores were significantly lower among participants in the self-management groups relative to the usual care controls at 6 months (P = 0.007), and this difference was sustained at 12 months at borderline significance levels (P = 0.09). Among self-management group participants, 48% showed a 50% or greater reduction in Roland Disability Questionnaire Score at 6 months, compared with 33% among the usual care controls. Self-management groups led by trained lay persons following a structured protocol were more effective than usual care in reducing worries, producing positive attitudes toward self-care, and reducing activity limitations among patients with back pain in primary care.

EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children.

PubMed

Llauradó, Elisabet; Tarro, Lucia; Moriña, David; Queral, Rosa; Giralt, Montse; Solà, Rosa

2014-11-20

To assess the reproducibility of an educational intervention EdAl-2 (Educació en Alimentació) programme in 'Terres de l'Ebre' (Spain), over 22 months, to improve lifestyles, including diet and physical activity (PA). Reproduction of a cluster randomised controlled trial. Two semi-rural town-group primary-school clusters were randomly assigned to the intervention or control group. Pupils (n=690) of whom 320 constituted the intervention group (1 cluster) and 370 constituted the control group (1 cluster). Ethnicity was 78% Western European. The mean age (±SD) was 8.04±0.6 years (47.7% females) at baseline. Inclusion criteria for clusters were towns from the southern part of Catalonia having a minimum of 500 children aged 7-8 year; complete data for participants, including name, gender, date and place of birth, and written informed consent from parents or guardians. The intervention focused on eight lifestyle topics covered in 12 activities (1 h/activity/session) implemented by health promoting agents in the primary school over three academic years. The primary outcome was obesity (OB) prevalence and the secondary outcomes were body mass index (BMI) collected every year and dietary habits and lifestyles collected by questionnaires filled in by parents at baseline and end-of-study. At 22 months, the OB prevalence and BMI values were similar in intervention and control groups. Relative to children in control schools, the percentage of boys in the intervention group who performed ≥4 after-school PA h/week was 15% higher (p=0.027), whereas the percentage of girls in both groups remained similar. Also, 16.6% more boys in the intervention group watched ≤2 television (TV) h/day (p=0.009), compared to controls; and no changes were observed in girls in both groups. Our school-based intervention is feasible and reproducible by increasing after-school PA (to ≥4 h/week) in boys. Despite this improvement, there was no change in BMI and prevalence of OB. Clinical Trials NCT01362023. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The effectiveness of a primary care nursing-led dietary intervention for prediabetes: a mixed methods pilot study.

PubMed

Coppell, Kirsten J; Abel, Sally L; Freer, Trish; Gray, Andrew; Sharp, Kiri; Norton, Joanna K; Spedding, Terrie; Ward, Lillian; Whitehead, Lisa C

2017-12-21

Primary care nurse-led prediabetes interventions are seldom reported. We examined the implementation and feasibility of a 6-month multilevel primary care nurse-led prediabetes lifestyle intervention compared with current practice in patients with prediabetes, with weight and glycated haemoglobin (HbA1c) as outcomes. This study used a convergent mixed methods design involving a 6-month pragmatic non-randomised pilot study with a qualitative process evaluation, and was conducted in two neighbouring provincial cities in New Zealand, with indigenous Māori populations comprising 18.2% and 23.0%, respectively. Participants were non-pregnant adults aged ≤ 70 years with newly diagnosed prediabetes (HbA1c 41-49 mmol/mol), body mass index (BMI) ≥ 25 kg/m 2 and not prescribed Metformin. A structured dietary intervention tool delivered by primary care nurses with visits at baseline, 2-3 weeks, 3 months and 6 months was implemented in four intervention practices. Four control practices continued to provide usual care. Primary quantitative outcome measures were weight and HbA1c. Linear and quantile regression models were used to compare each outcome between the two groups at follow-up. Qualitative data included: observations of nurse training sessions and steering group meetings; document review; semi-structured interviews with a purposive sample of key informants (n = 17) and intervention patients (n = 20). Thematic analysis was used. One hundred fifty-seven patients with prediabetes enrolled (85 intervention, 72 control), 47.8% female and 31.2% Māori. Co-morbidities were common, particularly hypertension (49.7%), dyslipidaemia (40.1%) and gout (15.9%). Baseline and 6 month measures were available for 91% control and 79% intervention participants. After adjustment, the intervention group lost a mean 1.3 kg more than the control group (p < 0.001). Mean HbA1c, BMI and waist circumference decreased in the intervention group and increased in the control group, but differences were not statistically significant. Implementation fidelity was high, and it was feasible to implement the intervention in busy general practice settings. The intervention was highly acceptable to both patients and key stakeholders, especially primary care nurses. Study findings confirm the feasibility and acceptability of primary care nurses providing structured dietary advice to patients with prediabetes in busy general practice settings. The small but potentially beneficial mean weight loss among the intervention group supports further investigation. ANZCTR ACTRN12615000806561 . Registered 3 August 2015 (Retrospectively registered).

Improving healthy eating in families with a toddler at risk for overweight: A cluster randomized controlled trial

PubMed Central

Hammer, Lawrence D.; Huffman, Lynne C.; Mascola, Anthony; Bryson, Susan W.; Danaher, Carol

2012-01-01

Objective To ascertain whether a parent education program based on Satter’s division of responsibility in feeding children (DOR) is effective in enhancing parent/child feeding interactions for children with an overweight/obese parent. The primary hypothesis was that the intervention would decrease parental pressure to eat. Methods Sixty-two families with a child aged 2–4 years with at least one overweight/obese parent were randomly allocated using a cluster design to either the DOR intervention or a control group. The control group focused on increasing family consumption of healthy foods and activity levels, and enhancing child sleep duration. The primary outcome was parent pressure on their child to eat. Results The DOR intervention was superior to the control group in reducing pressure to eat. Two moderators of pressure to eat were found: disinhibition of eating and hunger. DOR group parents irrespective of disinhibition levels lowered pressure to eat whereas control group parents with low disinhibition increased pressure to eat. There were similar findings for hunger. Gender moderated restrictive feeding with DOR parents lowering restriction more than the control group in girls only. Conclusion The DOR intervention was more effective in reducing parent pressure to eat and food restriction (in girls only) than the control group. PMID:22947882

Impact of NGO run mid day meal program on nutrition status and growth of primary school children.

PubMed

Sharma, A K; Singh, Samiksha; Meena, Sonali; Kannan, A T

2010-07-01

To study the impact of wholesome mid day meal (MDM) program run by an NGO on the growth of the primary school students in rural area of Mathura district. This intervention study involved children enrolled in Government run rural primary schools in Mathura district in Uttar Pradesh from March 06 through August 07. A wholesome, nutritionally balanced MDM provided by an NGO for the students in the 6 primary schools was selected as intervention group. Control group consisted of children in 8 schools which received locally prepared MDM by village panchayats. Height, weight, change in height/month, change in weight/month, prevalence of protein-energy malnutrition and prevalence of signs of vitamin deficiencies, were measured. Food was provided for 221 days in one year. Within group and between groups repetitive measures were compared using generalized estimating equation (GEE). Within both intervention and control groups height and weight had significantly increased (p < 0.05), while there was no significant difference between the groups. There was no change in prevalence of malnutrition within either of the groups. Reduction in vitamin A deficiency signs was 38% more in intervention group (p < 0.001). Prevalence of Vitamin D deficiency reduced by 50% more in intervention group. No such differences between groups were observed for vitamin B complex and vitamin C. MDM provided by the NGO has no better impact on growth of the primary school children, however, it reduced prevalence of vitamin deficiency significantly in comparison to the MDM run by Village Panchayats.

Comparison of the Effect of Massage Therapy and Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial.

PubMed

Azima, Sara; Bakhshayesh, Hajar Rajaei; Kaviani, Maasumeh; Abbasnia, Keramatallah; Sayadi, Mehrab

2015-12-01

Dysmenorrhea is the most common cyclic pelvic pain, and it affects the quality of life of many women. We sought to compare the effects of massage and isometric exercises on primary dysmenorrhea. We conducted a randomized controlled trial at the dormitories of Shiraz University among 102 students with primary dysmenorrheal. The student groups were randomly divided into massage, isometric exercises, and control groups. The first group received 2 consecutive cycles of effleurage massage with lavender oil. The second group had 8 weeks of isometric exercises. No intervention was performed for the control group. Pain intensity was measured and recorded by using a visual analog scale. In addition, the duration of pain was measured in hours, and Spielberger's questionnaire was used to measure the anxiety level. Pain intensity had significantly reduced in the massage and exercises groups; the reduction was more significant in the massage group (P < .001). The results revealed a significant difference among the 3 groups in regard to the mean duration of pain after the third cycle (P = .006). However, no significant difference was found among the 3 groups concerning the mean level of anxiety. The results of intragroup comparisons only showed a significant reduction of anxiety level in the massage group after the third cycle (P = .017). Based on the present findings, it seems that massage therapy and isometric exercises were effective in reducing some symptoms of dysmenorrhea. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Tranexamic Acid as Antifibrinolytic Agent in Non Traumatic Intracerebral Hemorrhages

PubMed Central

ARUMUGAM, Ananda; A RAHMAN, Noor Azman; THEOPHILUS, Sharon Casilda; SHARIFFUDIN, Ashraf; ABDULLAH, Jafri Malin

2015-01-01

Background: Mortality and morbidity associated with intracerebral hemorrhage is still high. Up to now, there are no evidence-based effective treatments for acute ICH. This study is to assess the effect of tranexamic acid (TXA) on hematoma growth of patients with spontaneous ICH compared to a placebo. Methods: We performed a single-blinded, randomised placebo-controlled trial of TXA (intravenous 1g bolus, followed by infusion TXA 1 g/hour for 8 hours) in acute (< 8 hours) primary ICH. Strict blood pressure control (target SBP 140-160 mmHg). A repeat Computed Tomography brain was done after 24 hours to reassess hematoma growth. The primary objective is to test the effect of TXA on hematoma growth. Other objective was to test the feasibility, tolerability, and adverse events of TXA in primary ICH. Results: Statistical analysis showed significant hematoma growth in control group after 24 hours compared to baseline (14.3300 vs 17.9940, P = 0.001) whereas the treatment group there is no significant hematoma size expansion between baseline and after 24 hours (P = 0.313). Conclusions: This study showed a significant hematoma volume expansion in the control group compared to the treatment group. PMID:27006639

Tranexamic Acid as Antifibrinolytic Agent in Non Traumatic Intracerebral Hemorrhages.

PubMed

Arumugam, Ananda; A Rahman, Noor Azman; Theophilus, Sharon Casilda; Shariffudin, Ashraf; Abdullah, Jafri Malin

2015-12-01

Mortality and morbidity associated with intracerebral hemorrhage is still high. Up to now, there are no evidence-based effective treatments for acute ICH. This study is to assess the effect of tranexamic acid (TXA) on hematoma growth of patients with spontaneous ICH compared to a placebo. We performed a single-blinded, randomised placebo-controlled trial of TXA (intravenous 1g bolus, followed by infusion TXA 1 g/hour for 8 hours) in acute (< 8 hours) primary ICH. Strict blood pressure control (target SBP 140-160 mmHg). A repeat Computed Tomography brain was done after 24 hours to reassess hematoma growth. The primary objective is to test the effect of TXA on hematoma growth. Other objective was to test the feasibility, tolerability, and adverse events of TXA in primary ICH. Statistical analysis showed significant hematoma growth in control group after 24 hours compared to baseline (14.3300 vs 17.9940, P = 0.001) whereas the treatment group there is no significant hematoma size expansion between baseline and after 24 hours (P = 0.313). This study showed a significant hematoma volume expansion in the control group compared to the treatment group.

Using Aminocaproic Acid to Reduce Blood Loss After Primary Unilateral Total Knee Arthroplasty.

PubMed

Churchill, Jessica L; Toney, Victor A; Truchan, Susan; Anderson, Michael J

2016-01-01

xtensive blood loss after total knee arthroplasty (TKA) is common, and affected patients often require blood transfusions. Studies suggest that antifibrinolytic agents such as aminocaproic acid (ACA) reduce blood loss and blood transfusion rates in patients undergoing TKA. We conducted a study to evaluate whether a single intravenous 10-g dose of ACA given during primary unilateral TKA would decrease perioperative blood loss, raise postoperative hemoglobin levels, and reduce postoperative blood transfusion rates. We retrospectively reviewed the charts of 50 comparable cemented primary unilateral TKAs. Twenty-five patients had been given a single intraoperative 10-g dose of ACA (antifibrinolytic group), and the other 25 had not been given ACA (control group). Postoperative drain output was decreased significantly (P < .0001) in the antifibrinolytic group (155 mL) compared with the control group (410 mL), as was the number of units of blood transfused after surgery (antifibrinolytic group, 0 units; control group, 10 units; P < .002). There were no adverse events in the antifibrinolytic group. In TKA, perioperative blood loss and blood transfusion rates were reduced significantly in patients given a single intraoperative intravenous 10-g dose of ACA compared with patients not given antifibrinolytics. The positive effects of ACA were obtained without adverse events or complications.

Experience with the first 50 ex vivo lung perfusions in clinical transplantation.

PubMed

Cypel, Marcelo; Yeung, Jonathan C; Machuca, Tiago; Chen, Manyin; Singer, Lianne G; Yasufuku, Kazuhiro; de Perrot, Marc; Pierre, Andrew; Waddell, Thomas K; Keshavjee, Shaf

2012-11-01

Normothermic ex vivo lung perfusion is a novel method to evaluate and improve the function of injured donor lungs. We reviewed our experience with 50 consecutive transplants after ex vivo lung perfusion. A retrospective study using prospectively collected data was performed. High-risk brain death donor lungs (defined as Pao(2)/Fio(2) <300 mm Hg or lungs with radiographic or clinical findings of pulmonary edema) and lungs from cardiac death donors were subjected to 4 to 6 hours of ex vivo lung perfusion. Lungs that achieved stable airway and vascular pressures and Pao(2)/Fio(2) greater than 400 mm Hg during ex vivo lung perfusion were transplanted. The primary end point was the incidence of primary graft dysfunction grade 3 at 72 hours after transplantation. End points were compared with lung transplants not treated with ex vivo lung perfusion (controls). A total of 317 lung transplants were performed during the study period (39 months). Fifty-eight ex vivo lung perfusion procedures were performed, resulting in 50 transplants (86% use). Of these, 22 were from cardiac death donors and 28 were from brain death donors. The mean donor Pao(2)/Fio(2) was 334 mm Hg in the ex vivo lung perfusion group and 452 mm Hg in the control group (P = .0001). The incidence of primary graft dysfunction grade 3 at 72 hours was 2% in the ex vivo lung perfusion group and 8.5% in the control group (P = .14). One patient (2%) in the ex vivo lung perfusion group and 7 patients (2.7%) in the control group required extracorporeal lung support for primary graft dysfunction (P = 1.00). The median time to extubation, intensive care unit stay, and hospital length of stay were 2, 4, and 20 days, respectively, in the ex vivo lung perfusion group and 2, 4, and 23 days, respectively, in the control group (P > .05). Thirty-day mortality (4% in the ex vivo lung perfusion group and 3.5% in the control group, P = 1.00) and 1-year survival (87% in the ex vivo lung perfusion group and 86% in the control group, P = 1.00) were similar in both groups. Transplantation of high-risk donor lungs after 4 to 6 hours of ex vivo lung perfusion is safe, and outcomes are similar to those of conventional transplants. Ex vivo lung perfusion improved our center use of donor lungs, accounting for 20% of our current lung transplant activity. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

A cluster design controlled trial of arts-based observational skills training in primary care.

PubMed

Kirklin, Deborah; Duncan, Jane; McBride, Sandy; Hunt, Sam; Griffin, Mark

2007-04-01

To investigate whether the observational skills of doctors and nurses can be improved by arts-based observational skills training. We carried out a cluster design, controlled trial involving 42 general practitioners and 26 primary care nurses in 12 primary care practices in London. Six practices were allocated to the intervention arm and 6 to the control arm. The intervention group received 90 minutes of arts-based observational skills training. The control group received practical training in the management of psoriasis. Before and after this, control and intervention participants were asked to describe 3 dermatological photographs. Descriptions were scored blindly against a predetermined marking key. Participants completed a questionnaire about the intervention, and about their own confidence in diagnosing and referring suspicious pigmented skin lesions. Post-intervention scores were significantly higher in the intervention group compared with the control group (P < 0.001). The majority of participants judged the intervention relevant, enjoyable and valuable. A majority lacked confidence in their dermatological knowledge and skills. This study provides statistically significant evidence that arts-based observational skills training can improve the observational skills of doctors and nurses. It is important not to overstate the clinical significance of these findings, and to recognise that observational skills are just one of many complex and subtle factors affecting the quality of the clinical process. Further research is needed to assess the existence, nature and clinical significance of longer-term benefits, and to identify differences between professional groups.

Tablet vs. Paper: The Effect on Learners' Reading Performance

ERIC Educational Resources Information Center

Dundar, Hakan; Akcayir, Murat

2012-01-01

The purpose of this study is to compare primary school 5th-class students' electronic text reading performance, reading speed and reading comprehension with tablet PCs and printed books. This study examined a sample of 20 students. The students were randomly divided into two groups, a control group and a treatment group. The control group students…

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

PubMed

Obreli-Neto, Paulo Roque; Marusic, Srecko; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Renovato, Rogério Dias; Pilger, Diogo; Cuman, Roberto Kenji Nakamura; Pereira, Leonardo Régis Leira

2015-01-01

Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen. The mean ICER per QALY gained suggests a favorable cost-effectiveness.

Effects of problem-solving interventions on aggressive behaviours among primary school pupils in Ibadan, Nigeria.

PubMed

Abdulmalik, Jibril; Ani, Cornelius; Ajuwon, Ademola J; Omigbodun, Olayinka

2016-01-01

Aggressive patterns of behavior often start early in childhood, and tend to remain stable into adulthood. The negative consequences include poor academic performance, disciplinary problems and encounters with the juvenile justice system. Early school intervention programs can alter this trajectory for aggressive children. However, there are no studies evaluating the feasibility of such interventions in Africa. This study therefore, assessed the effect of group-based problem-solving interventions on aggressive behaviors among primary school pupils in Ibadan, Nigeria. This was an intervention study with treatment and wait-list control groups. Two public primary schools in Ibadan Nigeria were randomly allocated to an intervention group and a waiting list control group. Teachers rated male Primary five pupils in the two schools on aggressive behaviors and the top 20 highest scorers in each school were selected. Pupils in the intervention school received 6 twice-weekly sessions of group-based intervention, which included problem-solving skills, calming techniques and attribution retraining. Outcome measures were; teacher rated aggressive behaviour (TRAB), self-rated aggression scale (SRAS), strengths and difficulties questionnaire (SDQ), attitude towards aggression questionnaire (ATAQ), and social cognition and attribution scale (SCAS). The participants were aged 12 years (SD = 1.2, range 9-14 years). Both groups had similar socio-demographic backgrounds and baseline measures of aggressive behaviors. Controlling for baseline scores, the intervention group had significantly lower scores on TRAB and SRAS 1-week post intervention with large Cohen's effect sizes of 1.2 and 0.9 respectively. The other outcome measures were not significantly different between the groups post-intervention. Group-based problem solving intervention for aggressive behaviors among primary school students showed significant reductions in both teachers' and students' rated aggressive behaviours with large effect sizes. However, this was a small exploratory trial whose findings may not be generalizable, but it demonstrates that psychological interventions for children with high levels of aggressive behaviour are feasible and potentially effective in Nigeria.

Impact of yoga on blood pressure and quality of life in patients with hypertension – a controlled trial in primary care, matched for systolic blood pressure

PubMed Central

2013-01-01

Background Medical treatment of hypertension is not always sufficient to achieve blood pressure control. Despite this, previous studies on supplementary therapies, such as yoga, are relatively few. We investigated the effects of two yoga interventions on blood pressure and quality of life in patients in primary health care diagnosed with hypertension. Methods Adult patients (age 20–80 years) with diagnosed hypertension were identified by an electronic chart search at a primary health care center in southern Sweden. In total, 83 subjects with blood pressure values of 120–179/≤109 mmHg at baseline were enrolled. At baseline, the patients underwent standardized blood pressure measurement at the health care center and they completed a questionnaire on self-rated quality of life (WHOQOL-BREF). There were three groups: 1) yoga class with yoga instructor (n = 28); 2) yoga at home (n = 28); and 3) a control group (n = 27). The participants were matched at the group level for systolic blood pressure. After 12 weeks of intervention, the assessments were performed again. At baseline a majority of the patients (92%) were on antihypertensive medication, and the patients were requested not to change their medication during the study. Results The yoga class group showed no improvement in blood pressure or self-rated quality of life, while in the yoga at home group there was a decline in diastolic blood pressure of 4.4 mmHg (p < 0.05) compared to the control group. Moreover, the yoga at home group showed significant improvement in self-rated quality of life compared to the control group (p < 0.05). Conclusions A short yoga program for the patient to practice at home seems to have an antihypertensive effect, as well as a positive effect on self-rated quality of life compared to controls. This implies that simple yoga exercises may be useful as a supplementary blood pressure therapy in addition to medical treatment when prescribed by primary care physicians. Trial registration ClinicalTrials.gov (NCT01302535) PMID:24314119

Consequences of routine delivery at 38 weeks for A-2 gestational diabetes.

PubMed

Rayburn, William F; Sokkary, Nancy; Clokey, Diana E; Moore, Lisa E; Curet, Luis B

2005-11-01

To report our intrapartum experience with routine delivery at 38 weeks of gestation of A-2 diabetic pregnancies requiring primarily oral hypoglycemic therapy. This retrospective study consisted of 143 consecutive women with gestational diabetes not controlled with diet alone (A-2). Each underwent a routine trial of labor at 38 weeks of gestation. The preinduction condition of the cervix, need for oxytocin, and primary cesarean rates were primary endpoints. For comparison, a control group during that same period consisted of 137 consecutive diet-controlled diabetic (A-1) pregnancies with the same eligibility criteria who underwent expectant management at 38 weeks. The study group was more likely to have an unfavorable cervix (75% versus 45%; p < 0.001) and to require oxytocin (76% versus 56%; p < 0.001). Early onset meconium was less common in the study group (3.5% versus 13.1%; p < 0.01). Primary cesarean rates were low and not different between the study and control groups (12.7% versus 11.7%; p < 0.8). The only stillbirth was in the control group and was associated with a tight double nuchal cord encirclement. Mean birth weights and the frequency of birth weights > 4000 g were not different between groups. Shoulder dystocia, low Apgar scores, and admissions to the special care nursery were infrequent in either group. No respiratory difficulties requiring resuscitation or prolonged nursery care were encountered. Routine delivery at 38 weeks in an A-2 diabetic population is not associated with additional intrapartum morbidity or a greater need for cesarean delivery.

Effectiveness of a fluid chart in outpatient management of suspected dengue fever: A pilot study.

PubMed

Nasir, Nazrila Hairin; Mohamad, Mohazmi; Lum, Lucy Chai See; Ng, Chirk Jenn

2017-01-01

Dengue infection is the fastest spreading mosquito-borne viral disease in the world. One of the complications of dengue is dehydration which, if not carefully monitored and treated, may lead to shock, particularly in those with dengue haemorrhagic fever. WHO has recommended oral fluid intake of five glasses or more for adults who are suspected to have dengue fever. However, there have been no published studies looking at self-care intervention measures to improve oral fluid intake among patients suspected of dengue fever. To assess the feasibility and effectiveness of using a fluid chart to improve oral fluid intake in patients with suspected dengue fever in a primary care setting. This feasibility study used a randomized controlled study design. The data was collected over two months at a primary care clinic in a teaching hospital. The inclusion criteria were: age > 12 years, patients who were suspected to have dengue fever based on the assessment by the primary healthcare clinician, fever for > three days, and thrombocytopenia (platelets < 150 x 109/L). Both groups received a dengue home care card. The intervention group received the fluid chart and a cup (200ml). Baseline clinical and laboratory data, 24-hour fluid recall (control group), and fluid chart were collected. The main outcomes were: hospitalization rates, intravenous fluid requirement and total oral fluid intake. Among the 138 participants who were included in the final analysis, there were fewer hospital admissions in the intervention group (n = 7, 10.0%) than the control group (n = 12, 17.6%) (p = 0.192). Similarly, fewer patients (n = 9, 12.9%) in the intervention group required intravenous fluid compared to the control group (n = 15, 22.1%), (p = 0.154). There was an increase in the amount of daily oral fluid intake in the intervention group (about 3,000 ml) compared to the control group (about 2,500 ml, p = 0.521). However, these differences did not reach statistical significance. This is a feasible and acceptable study to perform in a primary care setting. The fluid chart is a simple, inexpensive tool that may reduce hospitalization and intravenous fluid requirement in suspected dengue patients. A randomized controlled trial with larger sample size is needed to determine this conclusively. International Standard Randomized Controlled Trial Number (ISRCTN) Registry ISRCTN25394628 http://www.isrctn.com/ISRCTN25394628.

The Primary Prevention of PTSD in Firefighters: Preliminary Results of an RCT with 12-Month Follow-Up.

PubMed

Skeffington, Petra M; Rees, Clare S; Mazzucchelli, Trevor G; Kane, Robert T

2016-01-01

To develop and evaluate an evidence-based and theory driven program for the primary prevention of Post-traumatic Stress Disorder (PTSD). A pre-intervention / post-intervention / follow up control group design with clustered random allocation of participants to groups was used. The "control" group received "Training as Usual" (TAU). Participants were 45 career recruits within the recruit school at the Department of Fire and Emergency Services (DFES) in Western Australia. The intervention group received a four-hour resilience training intervention (Mental Agility and Psychological Strength training) as part of their recruit training school curriculum. Data was collected at baseline and at 6- and 12-months post intervention. We found no evidence that the intervention was effective in the primary prevention of mental health issues, nor did we find any significant impact of MAPS training on social support or coping strategies. A significant difference across conditions in trauma knowledge is indicative of some impact of the MAPS program. While the key hypotheses were not supported, this study is the first randomised control trial investigating the primary prevention of PTSD. Practical barriers around the implementation of this program, including constraints within the recruit school, may inform the design and implementation of similar programs in the future. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12615001362583.

24-month intervention with a specific multinutrient in people with prodromal Alzheimer's disease (LipiDiDiet): a randomised, double-blind, controlled trial.

PubMed

Soininen, Hilkka; Solomon, Alina; Visser, Pieter Jelle; Hendrix, Suzanne B; Blennow, Kaj; Kivipelto, Miia; Hartmann, Tobias

2017-12-01

Nutrition is an important modifiable risk factor in Alzheimer's disease. Previous trials of the multinutrient Fortasyn Connect showed benefits in mild Alzheimer's disease dementia. LipiDiDiet investigated the effects of Fortasyn Connect on cognition and related measures in prodromal Alzheimer's disease. Here, we report the 24-month results of the trial. LipiDiDiet was a 24-month randomised, controlled, double-blind, parallel-group, multicentre trial (11 sites in Finland, Germany, the Netherlands, and Sweden), with optional 12-month double-blind extensions. The trial enrolled individuals with prodromal Alzheimer's disease, defined according to the International Working Group (IWG)-1 criteria. Participants were randomly assigned (1:1) to active product (125 mL once-a-day drink containing Fortasyn Connect) or control product. Randomisation was computer-generated centrally in blocks of four, stratified by site. All study personnel and participants were masked to treatment assignment. The primary endpoint was change in a neuropsychological test battery (NTB) score. Analysis was by modified intention to treat. Safety analyses included all participants who consumed at least one study product dose. This trial is registered with the Dutch Trial Register, number NTR1705. Between April 20, 2009, and July 3, 2013, 311 of 382 participants screened were randomly assigned to the active group (n=153) or control group (n=158). Mean change in NTB primary endpoint was -0·028 (SD 0·453) in the active group and -0·108 (0·528) in the control group; estimated mean treatment difference was 0·098 (95% CI -0·041 to 0·237; p=0·166). The decline in the control group was less than the prestudy estimate of -0·4 during 24 months. 66 (21%) participants dropped out of the study. Serious adverse events occurred in 34 (22%) participants in the active group and 30 (19%) in control group (p=0·487), none of which were regarded as related to the study intervention. The intervention had no significant effect on the NTB primary endpoint over 2 years in prodromal Alzheimer's disease. However, cognitive decline in this population was much lower than expected, rendering the primary endpoint inadequately powered. Group differences on secondary endpoints of disease progression measuring cognition and function and hippocampal atrophy were observed. Further study of nutritional approaches with larger sample sizes, longer duration, or a primary endpoint more sensitive in this pre-dementia population, is needed. European Commission 7th Framework Programme. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Micro-computed tomographic analysis of progression of artificial enamel lesions in primary and permanent teeth after resin infiltration.

PubMed

Ozgul, Betul Memis; Orhan, Kaan; Oz, Firdevs Tulga

2015-09-01

We investigated inhibition of lesion progression in artificial enamel lesions. Lesions were created on primary and permanent anterior teeth (n = 10 each) and were divided randomly into two groups with two windows: Group 1 (window A: resin infiltration; window B: negative control) and Group 2 (window A: resin infiltration + fluoride varnish; window B: fluoride varnish). After pH cycling, micro-computed tomography was used to analyze progression of lesion depth and changes in mineral density. Resin infiltration and resin infiltration + fluoride varnish significantly inhibited progression of lesion depth in primary teeth (P < 0.05). Inhibition of lesion depth progression in permanent teeth was significantly greater after treatment with resin infiltration + fluoride varnish than in the negative control (P < 0.05). Change in mineral density was smaller in the resin infiltration and resin infiltration + fluoride varnish groups; however, the difference was not significant for either group (P > 0.05). Resin infiltration is a promising method of inhibiting progression of caries lesions.

Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial.

PubMed

Gomez-Barrena, Enrique; Ortega-Andreu, Miguel; Padilla-Eguiluz, Norma G; Pérez-Chrzanowska, Hanna; Figueredo-Zalve, Reyes

2014-12-03

Abundant literature regarding the use of intravenous tranexamic acid (TXA) in primary total knee replacement is available. Randomized controlled trials have confirmed the efficacy of topical TXA compared with placebo, but the comparison between topical and intravenous TXA is unclear. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary total knee replacement with cemented implants. A Phase-III, single-center, double-blind, randomized, controlled clinical trial was performed to compare topical intra-articular TXA (3 g of TXA in 100 mL of physiological saline solution) with two intravenous doses of TXA (15 mg/kg in 100 mL of physiological saline solution, one dose before tourniquet release and another three hours after surgery) in a multimodal protocol for blood loss prevention. The primary outcome was the blood transfusion rate, and the secondary outcomes included visible blood loss (as measured in the drain) at twenty-four hours postoperatively and invisible blood loss (as estimated from the Nadler formula) at forty-eight hours postoperatively. The sample size of seventy-eight patients was calculated to give a statistical power of 99% for demonstrating noninferiority. Thirty-nine patients each were allocated to receive topical intra-articular TXA (the experimental group) and intravenous TXA (the control group); there were no significant differences in demographics or preoperative laboratory values between the groups. Noninferiority was estimated by comparing the confidence intervals with a delta of 10%. Student t and Mann-Whitney tests were used to assess the significance of any differences. The transfusion rate was zero in both groups; thus, noninferiority was demonstrated for the primary efficacy end point, suggesting equivalence. Noninferiority was also demonstrated for the secondary efficacy end points. Drain blood loss at twenty-four hours was 315.6 mL (95% confidence interval [CI], 248.5 to 382.7 mL) in the experimental group and 308.1 mL (95% CI, 247.6 to 368.5 mL) in the control group (p = 0.948, Mann-Whitney). Also, estimated blood loss at forty-eight hours was 1259.0 mL (95% CI, 1115.6 to 1402.3 mL) in the experimental group and 1317.9 mL (95% CI, 1175.4 to 1460.4 mL) in the control group (p = 0.837, Mann-Whitney). No significant safety differences were seen between groups. Topical administration of TXA according to the described protocol demonstrated noninferiority compared with intravenous TXA, with no safety concerns. This randomized controlled trial supports the topical intra-articular administration of TXA in primary total knee replacement with cemented implants. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.

The effect of an eye health promotion program on the health protective behaviors of primary school students

PubMed Central

Kirag, Nukhet; Temel, Ayla Bayik

2018-01-01

INTRODUCTION: Undiagnosed and uncorrected refractive errors in childhood can negatively affect the development of vision and cause students to have low academic success and even quit school before graduation. This study aims to determine the effects of an eye health promotion program on the health protective behaviors of primary school students. MATERIALS AND METHODS: This experimental study using a pretest-posttest design with a control group was conducted in three public primary schools in Aydın, a city in the Western Anatolia Region of Turkey, between April and November 2014. The eye health promotion program was provided by the researchers to the experimental Group 2 days in 4 weeks. The data were analyzed using the t-test, Chi-square analysis, the Mann–Whitney U-test, the Wilcoxon signed-rank test, and the McNemar test. RESULTS: The average age of the students was identified as 9.0 ± 3.64 years. The students wearing glasses all in the experimental group and 53.3% in the control group were found to always wear their glasses after the education program was completed (P < 0.05). These students, 97.9% in the experimental group and 58.1% in the control group underwent eye examinations from an ophthalmologist (P < 0.05). The eye health protective behaviors of the experimental group were found to have positively changed in the final follow-up, compared to the control group (P < 0.05). CONCLUSION: The eye health promotion program was found to be effective in improving eye health protective behaviors within the experimental group. PMID:29619388

Parenting Resilient Kids (PaRK), an online parenting program to prevent anxiety and depression problems in primary school-aged children: Study protocol for a randomised controlled trial.

PubMed

Fernando, Luwishennadige Madhawee N; Sim, Wan Hua; Jorm, Anthony F; Rapee, Ron; Lawrence, Katherine A; Yap, Marie B H

2018-04-19

Preventive efforts targeting childhood anxiety and depression symptoms have the potential to alter the developmental trajectory of depression and anxiety disorders across the lifespan. Substantial previous research suggests that modifiable parenting factors such as parental aversiveness and over-involvement are associated with childhood anxiety, depressive and internalising symptoms, indicating that parents can play a critical role in prevention. The Parenting Resilient Kids study is a new evidence-based online parenting program designed to prevent anxiety and depression problems in primary school-aged children by reducing family-based risk factors and enhancing protective factors through increased positive interactions between parent and child. The current study is a parallel group superiority randomised controlled trial with parent-child dyads randomised to the intervention or active-control group in a 1:1 ratio. The intervention group will receive the Parenting Resilient Kids program consisting of a feedback report on parenting behaviours and up to 12 interactive online modules personalised based on responses to the parent survey. The active-control group will receive a standardised package of online educational materials about child development and wellbeing. The trial website is programmed to run a stratified random allocation sequence (based on parent gender) to determine group membership. We aim to recruit 340 parent-child dyads (170 dyads per group). We hypothesise that the intervention group will show greater improvement in parenting risk and protective factors from baseline to 3-month follow-up (primary outcome), which will in turn mediate changes in child depressive and anxiety symptoms from baseline to 12 and 24 months (co-primary outcomes). We also hypothesise that the intervention group will show greater benefits from baseline to 3-, 12- and 24-month follow-up, with regard to: child depressive and anxiety symptoms (co-primary outcomes); and child and parent health-related quality of life, and overall family functioning (secondary outcomes). This randomised controlled trial will examine the efficacy of the Parenting Resilient Kids program as a preventive intervention for anxiety and depression symptoms in primary school-aged children, as well as changes in child and parent health-related quality of life. Findings from this study will examine design features that render web-based prevention programs effective and the extent to which parents can be engaged and motivated to change through a minimally guided parenting program. Australian New Zealand Clinical Trials Registry (ANZCTR): Trial ID ACTRN12616000621415 Registered on 13 May 2016. Updated on 3 March 2017.

Dental anomalies in primary dentition and their corresponding permanent teeth.

PubMed

Gomes, R R; Fonseca, J A C; Paula, L M; Acevedo, A C; Mestrinho, H D

2014-05-01

The objectives of this paper are to estimate the prevalence of dental anomalies in primary dentition in a sample of 2- to 5-year-old Brazilian preschool children, determine their distribution, and investigate their occurrence in the succedaneous teeth of the sample compared with a control group of children with no dental anomalies in the primary dentition. The one-stage sample comprised 1,718 two to five-year-old children with fully erupted primary dentition clinically examined for dental anomalies. All children presenting dental anomalies underwent panoramic radiographs. Descriptive statistics were performed for the studied variables. A control group matched by sex and age was studied to compare the prevalence ratio for dental anomalies in the permanent dentition. The prevalence of dental anomalies in the primary dentition was 1.8 %, with no significant statistical difference between sexes. Double teeth were the most frequently observed. Dental anomalies on the succedaneous permanent teeth were diagnosed in 54.8 % of the children with affected primary dentition. The prevalence ratio (PR) for dental anomalies in the succedaneous permanent teeth was 17.1 (confidence interval (CI) 5.33-54.12) higher compared with the control group, higher in children with bilateral anomalies (PR = 31.2, CI 10.18-94.36). An association between anomalies of the permanent dentition and the presence of dental anomalies in primary teeth was observed, especially when they occur bilaterally. The results in the present study have a clinical relevance in the diagnosis of children with dental anomalies in primary dentition. Early identification of these anomalies can aid the dentist in planning dental treatment at the appropriate time.

Comparison of Cerebrospinal Fluid Opening Pressure in Children With Demyelinating Disease to Children With Primary Intracranial Hypertension.

PubMed

Morgan-Followell, Bethanie; Aylward, Shawn C

2017-03-01

The authors aimed to compare the opening pressures of children with demyelinating disease to children with primary intracranial hypertension. Medical records were reviewed for a primary diagnosis of demyelinating disease, or primary intracranial hypertension. Diagnosis of demyelinating disease was made according to either the 2007 or 2012 International Pediatric Multiple Sclerosis Study Group criteria. Primary intracranial hypertension diagnosis was confirmed by presence of elevated opening pressure, normal cerebrospinal fluid composition and neuroimaging. The authors compared 14 children with demyelinating disease to children with primary intracranial hypertension in 1:1 and 1:2 fashions. There was a statistically significant higher BMI in the primary intracranial hypertension group compared to the demyelinating group ( P = .0203). The mean cerebrospinal fluid white blood cell count was higher in the demyelinating disease group compared to primary intracranial hypertension ( P = .0002). Among both comparisons, the cerebrospinal fluid opening pressure, glucose, protein and red blood cell counts in children with demyelinating disease were comparable to age- and sex-matched controls with primary intracranial hypertension.

A brief intervention affects parents' attitudes toward using less physical punishment.

PubMed

Chavis, Antwon; Hudnut-Beumler, Julia; Webb, Margaret W; Neely, Jill A; Bickman, Len; Dietrich, Mary S; Scholer, Seth J

2013-12-01

Consecutive English and Spanish speaking caregivers of 6-24 month old children were randomly assigned to either a control or intervention group. Parents in the intervention group were instructed to view at least 4 options to discipline a child in an interactive multimedia program. The control group participants received routine primary care with their resident physician. After the clinic visit, all parents were invited to participate in a research study; the participation rate was 98% (258/263). The key measure was the Attitudes Toward Spanking (ATS) scale. The ATS is correlated with parents' actual use of physical punishment. Parents with higher scores are more likely to use physical punishment to discipline their children. Parents in the intervention group had an ATS score that was significantly lower than the ATS score of parents in the control group (median=24.0, vs. median=30; p=0.043). Parents in the control group were 2 times more likely to report that they would spank a child who was misbehaving compared with parents in the intervention group (16.9% vs. 7.0%, p=0.015). In the short-term, a brief intervention, integrated into the primary care visit, can affect parents' attitudes toward using less physical punishment. It may be feasible to teach parents to not use physical punishment using a population-based approach. The findings have implications for how to improve primary care services and the prevention of violence. Copyright © 2013 Elsevier Ltd. All rights reserved.

Systematic Review of Interventions to Improve the Provision of Information for Adults with Primary Brain Tumors and Their Caregivers

PubMed Central

Langbecker, Danette; Janda, Monika

2014-01-01

Background: Adults with primary brain tumors and their caregivers have significant information needs. This review assessed the effect of interventions to improve information provision for adult primary brain tumor patients and/or their caregivers. Methods: We included randomized or non-randomized trials testing educational interventions that had outcomes of information provision, knowledge, understanding, recall, or satisfaction with the intervention, for adults diagnosed with primary brain tumors and/or their family or caregivers. PubMed, MEDLINE, EMBASE, and Cochrane Reviews databases were searched for studies published between 1980 and June 2014. Results: Two randomized controlled, 1 non-randomized controlled, and 10 single group pre–post trials enrolled more than 411 participants. Five group, four practice/process change, and four individual interventions assessed satisfaction (12 studies), knowledge (4 studies), and information provision (2 studies). Nine studies reported high rates of satisfaction. Three studies showed statistically significant improvements over time in knowledge and two showed greater information was provided to intervention than control group participants, although statistical testing was not performed. Discussion: The trials assessed intermediate outcomes such as satisfaction, and only 4/13 reported on knowledge improvements. Few trials had a randomized controlled design and risk of bias was either evident or could not be assessed in most domains. PMID:25667919

The effect of self-aromatherapy massage of the abdomen on the primary dysmenorrhoea.

PubMed

Sadeghi Aval Shahr, H; Saadat, M; Kheirkhah, M; Saadat, E

2015-05-01

Primary dysmenorrhoea (PD) is the most common gynaecological complaint that occurs in women. This study was a randomised controlled trial. The subjects were 75 students whose severity of pain was measured by visual analogue scale (VAS). Subjects were randomly divided into three groups: massage group with rose oil (n = 25) who applied self-massage with Rose damascene; a placebo group (n = 25) who performed self-massage with unscented almond oil and a no treatment control group (n = 25) who applied just self-massage. All three groups received the intervention in the first day of menstruation in two subsequent cycles. The severity of pain was self-reported by the students before and after intervention. All three groups were matched in demographic characteristics. The baseline pain reduced in the first cycle but this reduction was not significant in the groups (p > 0.05). In the second cycle, the menstrual pain was significantly lower in the rose oil group than in the other two groups after intervention (between massage with rose oil, almond oil p = 0.003 and massage with rose oil and just massage p = 0.000). Massage with aromatherapy reduces the severity of primary dysmenorrhoea, in comparison with massage therapy alone.

Impact of a Healthy Nails Program on Nail-Biting in Turkish Schoolchildren: A Controlled Pretest-Posttest Study

ERIC Educational Resources Information Center

Ergun, Ayse; Toprak, Rumeysa; Sisman, Fatma Nevin

2013-01-01

This study was conducted to examine the effect of a healthy nails program on nail-biting in Turkish schoolchildren. This quasi-experimental study was of pretest-posttest control group design. A total of 50 students of a primary school formed the intervention group, while 53 students from the same school formed the control group. Data were…

Evaluation of a tailored, multi-component intervention for implementation of evidence-based clinical practice guidelines in primary care physical therapy: a non-randomized controlled trial.

PubMed

Bernhardsson, Susanne; Larsson, Maria E H; Eggertsen, Robert; Olsén, Monika Fagevik; Johansson, Kajsa; Nilsen, Per; Nordeman, Lena; van Tulder, Maurits; Öberg, Birgitta

2014-03-04

Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence-based practice (EBP). There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy. The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden. An implementation strategy based on theory and current evidence was developed. A tailored, multi-component implementation intervention, addressing earlier identified determinants, was carried out in three areas comprising 28 physical therapy practices including 277 physical therapists (PTs) (intervention group). In two adjacent areas, 171 PTs at 32 practices received no intervention (control group). The core component of the intervention was an implementation seminar with group discussions. Among other components were a website and email reminders. Data were collected at baseline and follow-up with a web-based questionnaire. Primary outcomes were the self-reported awareness of, knowledge of, access to, and use of guidelines. Secondary outcomes were self-reported attitudes toward EBP and guidelines. Analyses were performed using Pearson's χ2 test and approximative z-test. 168 PTs (60.6%) in the intervention group and 88 PTs (51.5%) in the control group responded to the follow-up questionnaire. 186/277 PTs (67.1%) participated in the implementation seminars, of which 97 (52.2%) responded. The proportions of PTs reporting awareness of (absolute difference in change 20.6%, p = 0.023), knowledge where to find (20.4%, p = 0.007), access to (21.7%, p < 0.001), and frequent use of (9.5%, NS) guidelines increased more in the intervention group than in the control group. The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2% (p = 0.043) higher than the proportion in the control group. A higher proportion considered EBP helpful in decision making (p = 0.018). There were no other significant differences in secondary outcomes. A tailored, theory- and evidence-informed, multi-component intervention for the implementation of clinical practice guidelines had a modest, positive effect on awareness of, knowledge of, access to, and use of guidelines, among PTs in primary care in western Sweden. In general, attitudes to EBP and guidelines were not affected.

Continued smoking abstinence in diabetic patients in primary care: a cluster randomized controlled multicenter study.

PubMed

Pérez-Tortosa, Santiago; Roig, Lydia; Manresa, Josep M; Martin-Cantera, Carlos; Puigdomènech, Elisa; Roura, Pilar; Armengol, Angelina; Advani, Mamta

2015-01-01

To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change (TTM) in diabetic smokers attending primary care. A cluster randomized controlled clinical trial was designed in which the unit of randomization (intervention vs. usual care) was the primary care team. An intensive, individualized intervention using motivational interview and therapies and medications adapted to the patient's stage of change was delivered. The duration of the study was 1 year. A total of 722 people with diabetes who were smokers (345 in the intervention group and 377 in the control group) completed the study. After 1 year, continued abstinence was recorded in 90 (26.1%) patients in the intervention group and in 67 (17.8%) controls (p=0.007). In patients with smoking abstinence, there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls (21.2% vs. 13.7%, p=0.024). When the precontemplation stage was taken as reference (OR=1.0), preparation/action stage at baseline showed a protective effect, decreasing 3.41 times odds of continuing smoking (OR=0.293 95% CI 0.179-0.479, p<0.001). Contemplation stage at baseline also showed a protective effect, decreasing the odds of continuing smoking (OR=0.518, 95% CI 0.318-0.845, p=0.008). An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective, with a smoking cessation rate of 26.1% after 1 year. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial

PubMed Central

Britten, Jane; Prescott, Gordon J; Tappin, David; Ludbrook, Anne; Godden, David J

2009-01-01

Objective To assess the clinical effectiveness and cost effectiveness of a policy to provide breastfeeding groups for pregnant and breastfeeding women. Design Cluster randomised controlled trial with prospective mixed method embedded case studies to evaluate implementation processes. Setting Primary care in Scotland. Participants Pregnant women, breastfeeding mothers, and babies registered with 14 of 66 eligible clusters of general practices (localities) in Scotland that routinely collect breastfeeding outcome data. Intervention Localities set up new breastfeeding groups to provide population coverage; control localities did not change group activity. Main outcome measures Primary outcome: any breast feeding at 6-8 weeks from routinely collected data for two pre-trial years and two trial years. Secondary outcomes: any breast feeding at birth, 5-7 days, and 8-9 months; maternal satisfaction. Results Between 1 February 2005 and 31 January 2007, 9747 birth records existed for intervention localities and 9111 for control localities. The number of breastfeeding groups increased from 10 to 27 in intervention localities, where 1310 women attended, and remained at 10 groups in control localities. No significant differences in breastfeeding outcomes were found. Any breast feeding at 6-8 weeks declined from 27% to 26% in intervention localities and increased from 29% to 30% in control localities (P=0.08, adjusted for pre-trial rate). Any breast feeding at 6-8 weeks increased from 38% to 39% in localities not participating in the trial. Women who attended breastfeeding groups were older (P<0.001) than women initiating breast feeding who did not attend and had higher income (P=0.02) than women in the control localities who attended postnatal groups. The locality cost was £13 400 (€14 410; $20 144) a year. Conclusion A policy for providing breastfeeding groups in relatively deprived areas of Scotland did not improve breastfeeding rates at 6-8 weeks. The costs of running groups would be similar to the costs of visiting women at home. Trial registration Current Controlled Trials ISRCTN44857041. PMID:19181729

Effects of hydration in contrast-induced acute kidney injury after primary angioplasty: a randomized, controlled trial.

PubMed

Maioli, Mauro; Toso, Anna; Leoncini, Mario; Micheletti, Carlo; Bellandi, Francesco

2011-10-01

Intravascular volume expansion represents a beneficial measure against contrast-induced acute kidney injury (CI-AKI) in patients undergoing elective angiographic procedures. However, the efficacy of this preventive strategy has not yet been established for patients with ST-elevation-myocardial infarction (STEMI), who are at higher risk of this complication after primary percutaneous coronary intervention (PCI). In this randomized study we investigated the possible beneficial role of periprocedural intravenous volume expansion and we compared the efficacy of 2 different hydration strategies in patients with STEMI undergoing primary PCI. We randomly assigned 450 STEMI patients to receive (1) preprocedure and postprocedure hydration of sodium bicarbonate (early hydration group), (2) postprocedure hydration of isotonic saline (late hydration group), or (3) no hydration (control group). The primary end point was the development of CI-AKI, defined as an increase in serum creatinine of ≥25% or 0.5 mg/dL over the baseline value within 3 days after administration of the contrast medium. Moreover, we evaluated a possible relationship between the occurrence of CI-AKI and total hydration volume administered. There were no significant differences in baseline clinical, biochemical, and procedural characteristics in the 3 groups. Overall, CI-AKI occurred in 93 patients (20.6%): the incidence was significantly lower in the early hydration group (12%) with respect to both the late hydration group (22.7%) and the control group (27.3%) (P for trend=0.001). In hydrated patients (early and late hydration groups), lower infused volumes were associated with a significant increase in CI-AKI incidence, and the optimal cutoff point of hydration volume that best discriminates patients at higher risk was ≤960 mL. Adequate intravenous volume expansion may prevent CI-AKI in patients undergoing primary PCI. A regimen of preprocedure and postprocedure hydration therapy with sodium bicarbonate appears to be more efficacious than postprocedure hydration only with isotonic saline.

Financial team incentives improved recording of diagnoses in primary care: a quasi-experimental longitudinal follow-up study with controls.

PubMed

Lehtovuori, Tuomo; Kauppila, Timo; Kallio, Jouko; Raina, Marko; Suominen, Lasse; Heikkinen, Anna Maria

2015-11-11

In primary care, financial incentives have usually been directed to physicians because they are thought to make the key decisions in order to change the functions of a medical organization. There are no studies regarding the impact that directing these incentives to all disciplines of the care team (e.g. group bonuses for both nurses and doctors) may have, despite the low frequency with which diagnoses were being recorded for primary care visits to doctors. This study tested the effect of offering group bonuses to the care teams. This was a retrospective quasi-experimental study with before-and-after settings and two control groups. In the intervention group, the mean percentage of visits to a doctor for which a diagnosis was recorded by each individual care team (mean team-based percentage of monthly visits to a doctor with recorded diagnoses) and simultaneously the same data was gathered from two different primary care settings where no team bonuses were applied. To study the sustainability of changes obtained with the group bonuses the respective data were derived from the electronic health record system for 2 years after the cessation of the intervention. The differences in the rate of marking diagnoses was analyzed with ANOVA and RM-ANOVA with appropriate post hoc tests, and the differences in the rate of change in marking diagnoses was analyzed with linear regression followed by t-test. The proportion of doctor visits having recorded diagnoses in the teams was about 55 % before starting to use group bonuses and 90 % after this intervention. There was no such increase in control units. The effect of the intervention weakened slightly after cessation of the group bonuses. Group bonuses may provide a method to alter clinical practices in primary care. However, sustainability of these interventions may diminish after ceasing this type of financial incentive.

[Evaluating the relation of premenstrual syndrome and primary dysmenorrhea in women diagnosed with fibromyalgia].

PubMed

Terzi, Rabia; Terzi, Hasan; Kale, Ahmet

2015-01-01

In this study, we aimed to investigate the presence of premenstrual syndrome (PMS), primary dysmenorrhea (PD) and depression among women with fibromyalgia (FM) and healthy females and to determine possible factors related with PMS and PD in FM. The present study was conducted on 98 female patients diagnosed with FM and 102 age and sex-matched healthy controls. All patients were evaluated for premenstrual syndrome (PMS) and primary dysmenorrhea (PD). Premenstrual syndrome was assessed among the patients for the presence of one or more affective or somatic symptoms within the five days preceding menses. The diagnosis of primary dysmenorrhea was defined as having abdominal pain or lower back pain lasting at least two days during a menstrual period. Dysmenorrhea was assessed via visual analog scale. Dysmenorrhea was rated via Multidimensional Scoring System. The Hamilton depression scale was applied to all patients. Primary dysmenorrhea was established in 41% of FM patients and 28% of the control group. A statistically significant difference was found in PD between the two groups (p=0.03). PMS was established in 42% of the FM patients and 25% of the control group. A statistically significant difference was found in PMS between the two groups (p=0.03). There is an increased frequency of premenstrual syndrome and dysmenorrhea in FM patients. The patients with high symptom severity scores and high depression scores among the FM patients are at risk of PMS and PD. Copyright © 2015 Elsevier Editora Ltda. All rights reserved.

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial.

PubMed

Peters-Klimm, Frank; Campbell, Stephen; Müller-Tasch, Thomas; Schellberg, Dieter; Gelbrich, Goetz; Herzog, Wolfgang; Szecsenyi, Joachim

2009-08-13

Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes. This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2-13; p = 0.02). The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care. ISRCTN08601529.

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial

PubMed Central

Peters-Klimm, Frank; Campbell, Stephen; Müller-Tasch, Thomas; Schellberg, Dieter; Gelbrich, Goetz; Herzog, Wolfgang; Szecsenyi, Joachim

2009-01-01

Background Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes. Methods This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. Results There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2–13; p = 0.02). Conclusion The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care. Trial registration ISRCTN08601529. PMID:19678944

Measuring primary care practice performance within an integrated delivery system: a case study.

PubMed

Stewart, Louis J; Greisler, David

2002-01-01

This article examines the use of an integrated performance measurement system to plan and control primary care service delivery within an integrated delivery system. We review a growing body of literature that focuses on the development and implementation of management reporting systems among healthcare providers. Our study extends the existing literature by examining the use of performance information generated by an integrated performance measurement system within a healthcare organization. We conduct our examination through a case study of the WMG Primary Care Medicine Group, the primary care medical group practice of WellSpan Health System. WellSpan Health System is an integrated delivery system that serves south central Pennsylvania and northern Maryland. Our study examines the linkage between WellSpan Health's strategic objectives and its primary care medicine group's integrated performance measurement system. The conceptual design of this integrated performance measurement system combines financial metrics with practice management and clinical operating metrics to provide a more complete picture of medical group performance. Our findings demonstrate that WellSpan Health was able to achieve superior financial results despite a weak linkage between its integrated performance measurement system and its strategic objectives. WellSpan Health achieved this objective for its primary care medicine group by linking clinical performance information to physician compensation and reporting practice management performance through the use of statistical process charts. They found that the combined mechanisms of integrated performance measurement and statistical process control charts improved organizational learning and communications between organizational stakeholders.

Insurance-related disparities in primary care quality among U.S. Type 2 diabetes patients.

PubMed

Lee, De-Chih; Liang, Hailun; Shi, Leiyu

2016-08-02

This study explored insurance-related disparities in primary care quality among Americans with type 2 diabetes. Data came from the household component of the 2012 Medical Expenditure Panel Survey (MEPS). Analysis focused on adult subjects with type 2 diabetes. Logistic regressions were performed to investigate the associations between insurance status and primary care attributes related to first contact, longitudinality, comprehensiveness, and coordination, while controlling for confounding factors. Preliminary findings revealed differences among three insurance groups in the first contact domain of primary care quality. After controlling for confounding factors, these differences were no longer apparent, with all insurance groups reporting similar primary care quality according to the four domains of interest in the study. There were significant differences in socioeconomic status among different insurance groups. This study reveals equitable primary care quality for diabetes patients despite their health insurance status. In addition to insurance-related differences, the other socioeconomic stratification factors are assumed to be the root cause of disparities in care. This research emphasizes the crucial role that primary care plays in the accessibility and quality of care for chronically ill patients. Policy makers should continue their commitment to reduce gaps in insurance coverage and improve access as well as quality of diabetic care.

Transcervical embryoscopic and cytogenetic findings reveal distinctive differences in primary and secondary recurrent pregnancy loss.

PubMed

Feichtinger, Michael; Wallner, Elisabeth; Hartmann, Beda; Reiner, Angelika; Philipp, Thomas

2017-01-01

To assess the cytogenetic and embryoscopic characteristics of primary and secondary recurrent pregnancy loss. Clinical prospective descriptive study. Tertiary care center. Nine hundred and eighty-four women affected by first-trimester pregnancy loss; 145 patients with recurrent pregnancy loss (RPL) and 839 patients with nonrecurrent pregnancy loss as controls. Transcervical embryoscopic examination of the embryo before uterine evacuation, and cytogenetic analysis of the chorionic villi by standard G-banding cytogenetic techniques. Aneuploidy frequency in the primary and secondary RPL group and the nonrecurrent pregnancy loss (non-RPL) control group. Patients with RPL showed statistically significantly fewer aneuploid pregnancy losses (odds ratio [OR] 0.596; 95% confidence interval [CI], 0.40-0.88). Primary RPL was associated with lower aneuploidy rates compared with the non-RPL group (OR 0.423; 95% CI, 0.27-0.66) while secondary RPL was not (OR 1.414; 95% CI, 0.67-2.99). Patients with primary RPL had statistically significantly more morphologically normal embryos compared with non-RPL and secondary RPL. Patients' embryos after primary and secondary RPL show distinctive differences in aneuploidy and morphologic defect rates. These findings suggest different treatment approaches for the patients with primary and secondary RPL. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Treatment of primary Sjögren syndrome: a systematic review.

PubMed

Ramos-Casals, Manuel; Tzioufas, Athanasios G; Stone, John H; Sisó, Antoni; Bosch, Xavier

2010-07-28

A variety of topical and systemic drugs are available to treat primary Sjögren syndrome, although no evidence-based therapeutic guidelines are currently available. To summarize evidence on primary Sjögren syndrome drug therapy from randomized controlled trials. We searched MEDLINE and EMBASE for articles on drug therapy for primary Sjögren syndrome published between January 1, 1986, and April 30, 2010. Controlled trials of topical and systemic drugs including adult patients with primary Sjögren syndrome were selected as the primary information source. The search strategy yielded 37 trials. A placebo-controlled trial found significant improvement in the Schirmer and corneal staining scores, blurred vision, and artificial tear use in patients treated with topical ocular 0.05% cyclosporine. Three placebo-controlled trials found that pilocarpine was associated with improvements in dry mouth (61%-70% vs 24%-31% in the placebo group) and dry eye (42%-53% vs 26%). Two placebo-controlled trials found that cevimeline was associated with improvement in dry mouth (66%-76% vs 35%-37% in the placebo group) and dry eye (39%-72% vs 24%-30%). Small trials (<20 patients) found no significant improvement in sicca outcomes for oral prednisone or hydroxychloroquine and limited benefits for immunosuppressive agents (azathioprine and cyclosporine). A large trial found limited benefits for oral interferon alfa-2a. Two placebo-controlled trials of infliximab and etanercept did not achieve the primary outcome (a composite visual analog scale measuring joint pain, fatigue, and dryness); neither did 2 small trials (<30 patients) testing rituximab, although significant results were observed in some secondary outcomes and improvement compared with baseline. In primary Sjögren syndrome, evidence from controlled trials suggests benefits for pilocarpine and cevimeline for sicca features and topical cyclosporine for moderate or severe dry eye. Anti-tumor necrosis factor agents have not shown clinical efficacy, and larger controlled trials are needed to establish the efficacy of rituximab.

Effects of induced social roles on the High School Personality Questionnaire.

PubMed

Merydith, S P; Wallbrown, F H

1995-08-01

A one-way multivariate analysis of variance design with a control group (regular directions) and three treatment groups using induced social roles (Faking Good, Teacher, and Ideal Teacher) as independent variables and the High School Personality Questionnaire primary scores as dependent variables was used. Subjects were 384 male high school students from Grades 9 through 12. Within each classroom, students were randomly assigned to the four groups noted above. A broad pattern of differences in scores on primary and secondary personality dimensions were obtained. Significant differences between the control (standard directions) and the Faking Good, Teacher, and Ideal Teacher roles were obtained on three secondary and most of the primary personality dimensions. In several cases the ideal social role and neutral social role showed distinct differences from the more pervasive favorable impression role.

Effect of Training in Math Metacognitive Strategy on Fractional Achievement of Nigerian Schoolchildren

ERIC Educational Resources Information Center

Onu, V. C.; Eskay, M.; Igbo, J. N.; Obiyo, N.; Agbo, O.

2012-01-01

This study examined the effect of training in math metacognition on fractional mathematics among primary school pupils, with a quasi-experimental design, specifically a post-test only control group design. Two intact classes were randomly selected and assigned to treatment and control conditions. Sixty primary six pupils constituted the sample…

Endovascular Treatment of Haemodialysis Arteriovenous Fistula with Drug-Coated Balloon Angioplasty: A Single-Centre Study.

PubMed

Lučev, Jernej; Breznik, Silva; Dinevski, Dejan; Ekart, Robert; Rupreht, Mitja

2018-06-01

To evaluate the effect of percutaneous transluminal angioplasty (PTA) on haemodialysis fistulas utilising drug-coated balloons with plain balloon vessel preparation (DCB). In the study group, 31 patients (16 men; mean age 62.8 ± 17.2 years) with failing arteriovenous fistulas were treated, with DCB, and compared with a control group (31 patients; 15 men; mean age 67.0 ± 8.44 years), in which only plain balloon PTA was performed. All stenoses were dilated with regular PTA balloons. After achieving haemodynamic success (< 30% residual stenosis), drug-coated balloons were used for drug administration in the study group. The follow-up intervals were 6, 12 and 24 months. Target lesion primary patency, primary assisted patency and secondary patency were compared. The statistical significance was set at 0.05. Target lesion primary patency was compared in both groups and was significantly higher in the study group (DCB) at 6 months (90.3 vs. 61.3%; p = 0.016), 12 months (77.4 vs. 29%; p = 0.0004) as well as 24 months (45.2 vs. 16.1%; p = 0.026). Kaplan-Meier survival curves also showed a significant difference for target lesion primary patency (534.2 vs. 315.7 days; p = 0.0004). There were no significant differences in target lesion primary assisted patency and in secondary patency. However, only 38.7% of patients in the study group were treated twice or more versus 80.6% in the control group (p = 0.002). DCB increases target lesion primary patency during the first 24 months and decreases the rate of reinterventions.

[Analysis of the influence of the process of care in primary health care on avoidable hospitalizations for heart failure].

PubMed

del Saz Moreno, Vicente; Alberquilla Menéndez-Asenjo, Ángel; Camacho Hernández, Ana M; Lora Pablos, David; Enríquez de Salamanca Lorente, Rafael; Magán Tapia, Purificación

2016-02-01

To determine if the process of care in primary health, affects the risk of avoidable hospitalizations for ambulatory care sensitive conditions (ACSH) for heart failure (HF). Case-control study analyzing the risk of hospitalization for HF. The exposure factor was the process of care for HF in primary health. Health area of the region of Madrid (n=466.901). There were included all adult patients (14 years or older) with a documented diagnosis of HF in the electronic medical record of primary health (n=3.277). The cases were patients who were hospitalized for HF while the controls did not require admission, during 2007. risk of ACSH for HF related to the process of care considered both overall and for each separate standard of appropiate care. Differences in clinical complexity of the groups were measured using the Adjusted Clinical Group (ACG) classification system. 227 cases and 3.050 controls. Clinical complexity was greater in cases. The standards of appropriate care were met to a greater degree in the control group, but none of the two groups met all the standards that would define a process of care as fully appropriate. A significantly lower risk of ACSH was seen for only two standards of appropriate care. For each additional standard of appropriate care not met, the probability of admission was significantly greater (OR: 1,33, 95% CI: 1,19-1,49). Higher quality in the process of care in primary health was associated with a lower risk of hospitalization for HF. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Individualized Risk Communication and Outreach for Primary Cardiovascular Disease Prevention in Community Health Centers: Randomized Trial.

PubMed

Persell, Stephen D; Brown, Tiffany; Lee, Ji Young; Shah, Shreya; Henley, Eric; Long, Timothy; Luther, Stephanie; Lloyd-Jones, Donald M; Jean-Jacques, Muriel; Kandula, Namratha R; Sanchez, Thomas; Baker, David W

2015-11-01

Many eligible primary cardiovascular disease prevention candidates are not treated with statins. Electronic health record data can identify patients with increased cardiovascular disease risk. We performed a pragmatic randomized controlled trial at community health centers in 2 states. Participants were men aged ≥35 years and women ≥45 years, without cardiovascular disease or diabetes mellitus, and with a 10-year risk of coronary heart disease of at least 10%. The intervention group received telephone and mailed outreach, individualized based on patients' cardiovascular disease risk and uncontrolled risk factors, provided by lay health workers. Main outcomes included: documented discussion of medication treatment for cholesterol with a primary care clinician, receipt of statin prescription within 6 months, and low-density lipoprotein (LDL)-cholesterol repeated and at least 30 mg/dL lower than baseline within 1 year. Six hundred forty-six participants (328 and 318 in the intervention and control groups, respectively) were included. At 6 months, 26.8% of intervention and 11.6% of control patients had discussed cholesterol treatment with a primary care clinician (odds ratio, 2.79; [95% confidence interval, 2.25-3.46]). Statin prescribing occurred for 10.1% in the intervention group and 6.0% in the control group (odds ratio, 1.76; [95% confidence interval, 0.90-3.45]). The cholesterol outcome did not differ, and the majority of patients did not repeat lipid levels during follow-up. Risk communication and lay outreach increased cholesterol treatment discussions with primary care clinicians. However, most discussions did not result in statin prescribing. For outreach to be successful, it should be combined with interventions to encourage clinicians to follow contemporary risk-based cholesterol treatment guidelines. URL: http://www.clincialtrials.gov. Unique identifier: NCT01610609. © 2015 American Heart Association, Inc.

A Youth-Led, Social Marketing Intervention Run by Adolescents to Encourage Healthy Lifestyles among Younger School Peers (EYTO-Kids Project): A Protocol for Pilot Cluster Randomized Controlled Trial (Spain)

PubMed Central

Aceves-Martins, Magaly; Papell-Garcia, Ignasi; Arola, Lluís; Giralt, Montse; Solà, Rosa

2017-01-01

Introduction: The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement. Methods: This study is a pilot school-based cluster randomized controlled 10-month intervention spanning two academic years (2015–2016 and 2016–2017), with eight primary schools and three high schools randomized into and designated the control group and eight primary schools and four high schools designated the intervention group in Reus, Spain. At least 301 younger school peers per group should be included. At the intervention high schools, the adolescent creators (ACs) receive an initial 16-h training session. In total, 26–32 high school ACs (12–14 years) from the four high schools will design and implement four health-promotion activities (1 h/each) for their younger (8–10 years), primary school peers. The control group will not receive any intervention. The outcomes (fruit, vegetable, fast food and sugary drink consumption; physical activity; and sedentary behaviors) of the control and intervention groups will be measured pre- and post-intervention. Conclusion: This study describes a protocol for pilot, peer-led, social marketing and youth-involved intervention, where adolescents design and implement activities for their younger peers to promote healthy lifestyles.

Recommending Oral Probiotics to Reduce Winter Antibiotic Prescriptions in People With Asthma: A Pragmatic Randomized Controlled Trial.

PubMed

Smith, Timothy D H; Watt, Hilary; Gunn, Laura; Car, Josip; Boyle, Robert J

2016-09-01

Evidence from studies mainly in children has shown that orally administered probiotics may prevent respiratory tract infections and associated antibiotic use. We evaluated whether advice to take daily probiotics can reduce antibiotic prescribing for winter respiratory tract infections in people with asthma. We conducted a randomized controlled, parallel-group pragmatic study for participants aged 5 years and older with asthma in a UK primary care setting. The intervention was a postal leaflet with advice to take daily probiotics from October 2013 to March 2014, compared with a standard winter advice leaflet. Primary outcome was the proportion of participants prescribed antibiotics for respiratory tract infections. There were 1,302 participants randomly assigned to a control group (n = 650) or intervention group (n = 652). There was no significant difference in the primary outcome measure, with 27.7% receiving antibiotics in the intervention group and 26.9% receiving antibiotics in the control group (odds ratio = 1.04; 95% CI, 0.82-1.34). Uptake of probiotics was low, but outcomes were similar in those who accessed probiotics (adjusted odds ratio = 1.08; 95% CI, 0.69-1.69, compared with controls). We also found no evidence of an effect on respiratory tract infections or asthma exacerbations. In this pragmatic community-based trial in people with asthma, we found no evidence that advising use of winter probiotics reduces antibiotic prescribing. © 2016 Annals of Family Medicine, Inc.

Effect and maintenance of the SLIMMER diabetes prevention lifestyle intervention in Dutch primary healthcare: a randomised controlled trial.

PubMed

Duijzer, G; Haveman-Nies, A; Jansen, S C; Beek, J Ter; van Bruggen, R; Willink, M G J; Hiddink, G J; Feskens, E J M

2017-05-08

To assess the effectiveness of the SLIMMER combined dietary and physical activity lifestyle intervention on clinical and metabolic risk factors, dietary intake, physical activity, and quality of life after 12 months, and to investigate whether effects sustained six months after the active intervention period ended. SLIMMER was a randomised controlled intervention, implemented in Dutch primary healthcare. In total, 316 subjects aged 40-70 years with increased risk of type 2 diabetes were randomly allocated to the intervention group (10-month dietary and physical activity programme) or the control group (usual healthcare). All subjects underwent an oral glucose tolerance test and physical examination, and filled in questionnaires. Identical examinations were performed at baseline and after 12 and 18 months. Primary outcome was fasting insulin. The intervention group showed significantly greater improvements in anthropometry and glucose metabolism. After 12 and 18 months, differences between intervention and control group were -2.7 kg (95% confidence interval (CI): -3.7; -1.7) and -2.5 kg (95% CI: -3.6; -1.4) for weight, and -12.1 pmol l -1 (95% CI: -19.6; -4.6) and -8.0 pmol l -1 (95% CI: -14.7; -0.53) for fasting insulin. Furthermore, dietary intake, physical activity, and quality of life improved significantly more in the intervention group than in the control group. The Dutch SLIMMER lifestyle intervention is effective in the short and long term in improving clinical and metabolic risk factors, dietary intake, physical activity, and quality of life in subjects at high risk of diabetes.

Long-term rifaximin therapy as a primary prevention of hepatorenal syndrome.

PubMed

Ibrahim, El-Sayed; Alsebaey, Ayman; Zaghla, Hassan; Moawad Abdelmageed, Sabry; Gameel, Khalid; Abdelsameea, Eman

2017-11-01

Hepatorenal syndrome (HRS) is a severe complication of liver cirrhosis, with poor survival. Rifaximin is a gut-selective broad-spectrum antibiotic. The aim of this study was to evaluate the role of rifaximin as a primary prevention of HRS. Eighty patients with liver cirrhosis and ascites were enrolled. They were randomized into two groups: control (n=40) and rifaximin group (n=40). Baseline liver function tests, renal function tests, complete blood count, international normalized ratio, urine analysis, and abdominal ultrasonography were carried out. Rifaximin 550 mg was administered twice daily for 12 weeks. Renal functions were measured every 4 weeks with monitoring of HRS occurrence and possible precipitating factor. Both groups were matched for age, sex, virology, serum bilirubin, serum albumin, aspartate aminotransferase, alanine aminotransferase, hemoglobin, white blood cells, platelets, international normalized ratio, potassium, and Child-Pugh score. In contrast to the rifaximin group, the control group showed statistically significant serial blood urea nitrogen (18.84±7.17, 19.85±6.10, 21.54±4.79, and 22.96±5.82 mg/dl; P=0.001) and serum creatinine (0.94±0.25, 1.02±0.24, 1.12±0.16, and 1.21±0.17 mg/dl; P=0.001) levels. The overall blood urea nitrogen and serum creatinine change was statistically higher in the control group than the rifaximin group (20.8 vs. 18.24 mg/dl and 1.07 vs. 0.99 mg/dl, respectively). HRS developed more in the control group than the rifaximin group [9 (22.5%) vs. 2 (5%); P=0.048]. In both groups, HRS was precipitated by spontaneous bacterial peritonitis mainly and large volume paracentesis. The Child-Pugh score, control group, baseline serum sodium, and creatinine were predictors of HRS. Rifaximin may be useful as a primary prevention of HRS.

Towards a more efficient diabetes control in primary care: six-monthly monitoring compared with three-monthly monitoring in type 2 diabetes - The EFFIMODI trial. Design of a randomised controlled patient-preference equivalence trial in primary care.

PubMed

Wermeling, Paulien R; van den Donk, Maureen; Gorter, Kees J; Ardine de Wit, G; van der Graaf, Yolanda; Rutten, Guy Ehm

2010-05-11

Scientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking. If three-monthly control in general practice could be reduced to six-monthly control in some patients, this would on the one hand reduce the use of medical services including involvement of practice nurses, and thus reduce costs, and on the other hand alleviate the burden of people with type 2 diabetes. The goal of this study is to make primary diabetes care as efficient as possible for patients and health care providers. Therefore, we want to determine whether six-monthly monitoring of well-controlled type 2 diabetes patients in primary care leads to equivalent cardiometabolic control compared to the generally recommended three-monthly monitoring. The study is a randomised controlled patient-preference equivalence trial. Participants are asked if they prefer three-monthly (usual care) or six-monthly diabetes monitoring. If they do not have a preference, they are randomised to a three-monthly or six-monthly monitoring group. Patients are eligible for the study if they are between 40 and 80 years old, diagnosed with type 2 diabetes more than one year ago, treated by a general practitioner, not on insulin treatment, and with HbA1c < or = 7.5%, systolic blood pressure < or = 145 mmHg and total cholesterol < or = 5.2 mmol/l. The intervention group (six-monthly monitoring) will receive the same treatment with the same treatment targets as the control group (three-monthly monitoring). The intervention period will last one and a half year. After the intervention, the three-monthly and six-monthly monitoring groups are compared on equivalence of cardiometabolic control. Secondary outcome measures are HbA1c, blood pressure, cholesterol level, Body Mass Index, smoking behaviour, physical activity, loss of work due to illness, health status, diabetes-specific distress, satisfaction with treatment and adherence to medications. We will use intention-to-treat analysis with repeated measures. For outcomes that have only baseline and final measurements, we will use ANCOVA. Depending on the results, a cost-minimisation analysis or an incremental cost-effectiveness analysis will be done. This study will provide valuable information on the most efficient control frequency of well-controlled type 2 diabetes patients in primary care.

Impact of a short home-based yoga programme on blood pressure in patients with hypertension: a randomized controlled trial in primary care.

PubMed

Wolff, M; Rogers, K; Erdal, B; Chalmers, J P; Sundquist, K; Midlöv, P

2016-10-01

The present study was designed to evaluate yoga's impact on blood pressure (BP) and quality of life (QOL) and on stress, depression and anxiety in patients with hypertension in a primary care setting. We conducted a multi-centre randomized controlled trial with follow-up after 12-week intervention completion. Adult primary care patients diagnosed with hypertension were randomly allocated to yoga or usual care. The intervention group performed a short home-based Kundalini yoga programme 15 min twice-daily during the 12-week intervention period. At baseline and follow-up, the participants underwent standardized BP measurements and completed questionnaires on QOL, stress, anxiety and depression. Data obtained from 191 patients (mean age 64.7 years, s.d. 8.4) allocated to yoga intervention (n=96) and control group (n=95), with a total proportion of 52% women, showed a significant reduction in systolic and diastolic BP for both groups (-3.8/-1.7 mm Hg for yoga and -4.5/-3.0 mm Hg for control groups, respectively). However, the BP reduction for the yoga group was not significantly different from control. There were small but significant improvements for the yoga group in some of the QOL and depression measures (P<0.05, Hospital Anxiety and Depression scale, HADS-D) compared with control. The findings of our study, which is the largest study from an OECD country (Organization for Economic Co-operation and Development) to date, do not support the suggestion from previous smaller studies that yoga lowers the BP. Further clinical trials are needed to confirm these findings. However, the yoga patients had other health benefits.

Influence of control group therapy on the benefit from dose-dense chemotherapy in early breast cancer: a systemic review and meta-analysis.

PubMed

Goldvaser, Hadar; Majeed, Habeeb; Ribnikar, Domen; Šeruga, Boštjan; Ocaña, Alberto; Cescon, David W; Amir, Eitan

2018-06-01

Results from clinical trials of adjuvant dose-dense chemotherapy in patients with breast cancer are inconsistent. A systematic search of MEDLINE identified studies comparing the efficacy of dose-dense adjuvant chemotherapy to a standard treatment. The primary analysis included studies that used identical regimens in the experimental and control groups, but varied only dose density. A secondary analysis included studies that used either different drugs or doses in the experimental and the control groups. Hazard ratios (HRs) and 95% confidence intervals were computed for disease-free survival (DFS) and overall survival (OS) and pooled in a meta-analysis. Subgroup analyses and meta-regression explored drug schedules utilized in control groups and the influence of clinicopathologic variables on benefit from dose-dense therapy. The primary analysis included 5 studies comprising 9819 patients while the secondary analysis included 6 studies comprising 9679 patients. Dose-dense treatment significantly improved DFS (HR 0.85, p < 0.001) and OS (HR 0.86, p = 0.008) in the primary analysis. Similar results were observed in the secondary analysis. Dose-dense schedule was important primarily in studies utilizing paclitaxel every 3 weeks as the control group (interaction p = 0.04 for DFS interaction p = 0.001 for OS). A significantly greater relative magnitude of benefit was observed in pre-menopausal women and those with nodal involvement, but there was no influence of hormone receptor status on results. Adjuvant dose-dense regimens improve breast cancer outcomes. It remains uncertain whether the observed benefit reflects the impact of dose density or the inferiority of paclitaxel every 3 weeks as a control group.

Combining Primary Prevention and Risk Reduction Approaches in Sexual Assault Protection Programming

ERIC Educational Resources Information Center

Menning, Chadwick; Holtzman, Mellisa

2015-01-01

Objective: The object of this study is to extend prior evaluations of Elemental, a sexual assault protection program that combines primary prevention and risk reduction strategies within a single program. Participants and Methods: During 2012 and 2013, program group and control group students completed pretest, posttest, and 6-week and 6-month…

[Auditory evoked potential and personality traits in chronic primary insomniacs].

PubMed

Shen, Jian; Shui, Ren-de; Feng, Lei; Liu, Yu-Hong; He, Wei; Huang, Jing-Yi; Wang, Wei

2009-05-01

To investigate the personality traits and intensity dependence of auditory evoked potentials (AEPs) in chronic primary insomnia. Thirty-seven patients with chronic primary insomnia (insomnia group) and 44 healthy subjects (control group) were enrolled in the study. The AEPs were examined in insomnia and control groups; the personality traits were studied by Zuckerman's Sensation Seeking Scales (SSS) and Zuckerman-Kuhlman's Personality Questionnaire (ZKPQ); and the mood states by Plutchik-van Praag's Depression Inventory (PVP). The scores of neuroticism-anxiety and depression in insomnia group were significantly higher than those in control group (P<0.01); and the scores of impulsivity and aggression-hostility were also higher than those in control group (P<0.05); N1-P2 amplitude of AEP increased with stimulus intensity, which were significantly different in 70, 80, 90,100 dB (P<0.01). There were significant correlations between activity and N1 latency at 80 dB, activity and P2 latency at 100 dB (r=0.270, r=0.276, P<0.05); and between total scores of sensation seeking scale and N1-P2 amplitude (r=0.3746, r=0.35329, P<0.01) at 70 and 90 dB stimulus intensity in insomnia group. There were significant correlations among experience seeking and N1-P2 amplitude, experience seeking and slope rate (P<0.01) at 70, 80, 90, 100 dB stimulus intensity in insomnia group (r=0.539, r=0.3439, r=0.439, r=0.3278). There were significant correlations between sensation seeking of boredom susceptibility and slope rate (r=-0.282998, P<0.05) in insomnia group. There were significant correlations between thrill and adventure seeking and N1-P2 amplitude(r=0.2789, P<0.05) at 90 dB stimulus intensity in insomnia group; there were significant correlations between PVP and N1-P2 amplitude (r=-0.3434, r=-0.3158, P<0.05) at 70 dB and N1 latency at 80 dB in insomnia group. Chronic primary insomnia sufferers have higher levels of neuroticism-anxiety, depression, aggression-hostility and impulsivity, and some are correlated with stimulus intensity dependence in AEP.

A clinical investigation of the efficacy of a dentifrice containing 1.5% arginine and 1450 ppm fluoride, as sodium monofluorophosphate in a calcium base, on primary root caries.

PubMed

Hu, D Y; Yin, W; Li, X; Feng, Y; Zhang, Y P; Cummins, D; Mateo, L R; Ellwood, R P

2013-01-01

The purpose of this six-month study was to assess the ability of a new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate, to arrest and reverse primary root caries lesions in adults. Three test groups used dentifrices which contained either: 1) 1.5% arginine and 1450 ppm fluoride as sodium monofluorophosphate in a calcium base (experimental); 2) 1450 ppm fluoride as sodium fluoride in a silica base (positive control); or 3) no fluoride in a calcium base (negative control). The study participants were residents of the city of Chengdu, Sichuan Province, China. In order to take part, subjects had to have at least one non-cavitated primary root caries lesion. A total of 412 subjects completed the study. They were aged from 50 to 70 years (mean age 64 +/- 4.1 years) and 53.6% were female. Efficacy for arresting and reversal of primary root caries was assessed by clinical hardness measures and through the use of the Electrical Caries Monitor. After three months of product use, clinical hardness measures showed that 27.7%, 24.6%, and 13.1% of lesions had improved in the experimental, positive, and negative control groups, respectively, and 0.7%, 4.5%, and 16.8% had become worse, respectively. The differences in the distribution of lesion change between the negative control group and both the experimental (p < 0.001) and positive control (p = 0.001) were statistically significant. The Electrical Caries Monitor was also used as an objective measure of lesion severity. The end values increased from baseline to the three-month examinations, but none of the differences between the groups attained statistical significance. After six months, clinical hardness measures showed that only one lesion (0.7%) was worse than at the baseline examination-in the experimental group compared to 9.0% and 18.2% in the positive and negative control groups, respectively. In addition, 61.7%, 56.0%, and 27.0%, respectively, showed improvement for the three groups. The differences in the distribution of lesion change scores between the negative control group and both the experimental (p < 0.001) and positive control (p < 0.001) were statistically significant, as was the difference between the experimental group and the positive control (p = 0.006). The Electrical Caries Monitor end values for the experimental, positive, and negative control groups at the six-month examination were 7.9, 1.9 mega omega(s), and 387 kilo omegas(s), respectively. The differences between the negative control group and both the experimental (p < 0.001) and positive control (p < 0.001) were statistically significant. The difference between the experimental and positive control groups was also statistically significant (p = 0.03). It is concluded that the new toothpaste containing 1.5% arginine and 1450 ppm fluoride, as sodium monofluorophosphate in a calcium base, provided greater anticaries benefits than a conventional toothpaste containing 1450 ppm fluoride. Both fluoride toothpastes demonstrated greater benefits than non-fluoride toothpaste.

Pyogenic liver abscess as a warning sign for primary liver cancer: a nationwide population-based study.

PubMed

Huang, Wen-Kuan; Lin, Yung-Chang; Chiou, Meng-Jiun; Yang, Tsai-Sheng; Chang, John Wen-Cheng; Yu, Kuang-Hui; Kuo, Chang-Fu; See, Lai-Chu

2013-01-01

There have been no large-scale population-based studies to estimate the subsequent risk of primary liver cancer (PLC) among patients with pyogenic liver abscess (PLA). This study aimed to provide relevant data. The Taiwan Longitudinal Health Insurance Database for the years 2000 and 2005 was used. The PLA group were adult inpatients who were newly diagnosed with PLA from 2000 to 2008. The control group was randomly selected and matched with the PLA group in terms of age, sex, and date in which medical treatment was sought other than for PLA. There were 1,987 patients each in the PLA and control groups. In total, 56 had PLC, 48 (2.4%, 601.5 per 100,000 person-years) from the PLA group, and 8 from the control group. After adjusting for potential covariates, the hazard ratio of PLC for the PLA group was 3.4 times that of the control group (95% confidence interval = 1.6-7.3, p <0.001). The PLC risk for the PLA group was significantly higher within the first year after PLA diagnosis (hazard ratio: 35.4) as compared with the control group and became insignificant (hazard ratio: 2.0, 95% confidence interval = 0.8-4.9) more than one year after PLA diagnosis. Patients with PLA have a higher rate of PLC than matched controls, especially within the first year after the diagnosis of PLA, suggesting PLA is a warning sign for PLC.

Ischemic preconditioning inhibits over-expression of arginyl-tRNA synthetase gene Rars in ischemia-injured neurons.

PubMed

Shen, Yin; Zhao, Hong-Yang; Wang, Hai-Jun; Wang, Wen-Liang; Zhang, Li-Zhi; Fu, Rong

2016-08-01

The expression changes of Rars gene in ischemia-injured neurons were investigated by detecting its translational product arginyl-tRNA synthetase (ArgRS), and the inhibitory effects of ischemic preconditioning (IPC) on Rars gene were explored. Both IPC model and prolonged ischemia (PI) model were established by using the classic oxygen glucose deprivation (OGD) method. The primary cultured neurons were assigned into the following groups: the experimental group (IPC+PI group), undergoing PI after a short period of IPC; the conditional control group (PI control group), subjected to PI without IPC; blank control group, the normally cultured neurons. The Rars transcriptional activities and ArgRS expression levels were measured at different time points after re-oxygenation (3 h/6 h/12 h/24 h). Data were collected and statistically analyzed. Compared to the blank control group, the Rars activities and ArgRS levels were significantly increased in PI control group, peaking at the time point of 6 h after re-oxygenation. Rars activities and ArgRS levels were significantly lower in the experimental group than in the PI control group at different time points after re-oxygenation. PI insult can induce an escalating activity of Rars and lead to ArgRS over-expression in primary cultured neurons. IPC can inhibit the increased Rars activity and down-regulate ArgRS expression of ischemia-insulted neurons. This mechanism may confer ischemic tolerance on neurons.

Physical activity improves symptoms in irritable bowel syndrome: a randomized controlled trial.

PubMed

Johannesson, Elisabet; Simrén, Magnus; Strid, Hans; Bajor, Antal; Sadik, Riadh

2011-05-01

Physical activity has been shown to be effective in the treatment of conditions, such as fibromyalgia and depression. Although these conditions are associated with irritable bowel syndrome (IBS), no study has assessed the effect of physical activity on gastrointestinal (GI) symptoms in IBS. The aim was to study the effect of physical activity on symptoms in IBS. We randomized 102 patients to a physical activity group and a control group. Patients of the physical activity group were instructed by a physiotherapist to increase their physical activity, and those of the control group were instructed to maintain their lifestyle. The primary end point was to assess the change in the IBS Severity Scoring System (IBS-SSS). A total of 38 (73.7% women, median age 38.5 (19-65) years) patients in the control group and 37 (75.7% women, median age 36 (18-65) years) patients in the physical activity group completed the study. There was a significant difference in the improvement in the IBS-SSS score between the physical activity group and the control group (-51 (-130 and 49) vs. -5 (-101 and 118), P=0.003). The proportion of patients with increased IBS symptom severity during the study was significantly larger in the control group than in the physical activity group. Increased physical activity improves GI symptoms in IBS. Physically active patients with IBS will face less symptom deterioration compared with physically inactive patients. Physical activity should be used as a primary treatment modality in IBS.

Epidural Electrical Stimulation for Stroke Rehabilitation: Results of the Prospective, Multicenter, Randomized, Single-Blinded Everest Trial.

PubMed

Levy, Robert M; Harvey, Richard L; Kissela, Brett M; Winstein, Carolee J; Lutsep, Helmi L; Parrish, Todd B; Cramer, Steven C; Venkatesan, Lalit

2016-02-01

This prospective, single-blinded, multicenter study assessed the safety and efficacy of electrical epidural motor cortex stimulation (EECS) in improving upper limb motor function of ischemic stroke patients with moderate to moderately severe hemiparesis. Patients ≥ 4 months poststroke were randomized 2:1 to an investigational (n = 104) or control (n = 60) group, respectively. Investigational patients were implanted (n = 94) with an epidural 6-contact lead perpendicular to the primary motor cortex and a pulse generator. Both groups underwent 6 weeks of rehabilitation, but EECS was delivered to investigational patients during rehabilitation. The primary efficacy endpoint (PE) was defined as attaining a minimum improvement of 4.5 points in the upper extremity Fugl-Meyer (UEFM) scale as well as 0.21 points in the Arm Motor Ability Test (AMAT) 4 weeks postrehabilitation. Follow-up assessments were performed 1, 4, 12, and 24 weeks postrehabilitation. Safety was evaluated by monitoring adverse events (AEs) that occurred between enrollment and the end of rehabilitation. Primary intent-to-treat analysis showed no group differences at 4 weeks, with PE being met by 32% and 29% of investigational and control patients, respectively (P = .36). Repeated-measures secondary analyses revealed no significant treatment group differences in mean UEFM or AMAT scores. However, post hoc comparisons showed that a greater proportion of investigational (39%) than control (15%) patients maintained or achieved PE (P = .003) at 24 weeks postrehabilitation. Investigational group mean AMAT scores also improved significantly (P < .05) when compared to the control group at 24 weeks postrehabilitation. Post hoc analyses also showed that 69% (n = 9/13) of the investigational patients who elicited movement thresholds during stimulation testing met PE at 4 weeks, and mean UEFM and AMAT scores was also significantly higher (P < .05) in this subgroup at the 4-, 12-, and 24-week assessments when compared to the control group. Headache (19%), pain (13%), swelling (7%), and infection (7%) were the most commonly observed implant procedure-related AEs. Overall, there were 11 serious AEs in 9 investigational group patients (7 procedure related, 4 anesthesia related). The primary analysis pertaining to efficacy of EECS during upper limb motor rehabilitation in chronic stroke patients was negative at 4 weeks postrehabilitation. A better treatment response was observed in a subset of patients eliciting stimulation induced upper limb movements during motor threshold assessments performed prior to each rehabilitation session. Post hoc comparisons indicated treatment effect differences at 24 weeks, with the control group showing significant decline in the combined primary outcome measure relative to the investigational group. These results have the potential to inform future chronic stroke rehabilitation trial design. © The Author(s) 2015.

Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose.

PubMed

Pascale, Melanie; Murray, Nikki; Bachmann, Max; Barton, Garry; Clark, Allan; Howe, Amanda; Greaves, Colin; Sampson, Mike

2017-01-06

This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm. The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered diabetes prevention intervention, supported by lay mentors with T2DM, with intervention in multiple at risk glycaemic categories, and that takes into account the realities of normal clinical practice. ISRCTN34805606 (Retrospectively registered 16.3.16).

Impact of rapid antigen detection testing on antibiotic prescription in acute pharyngitis in adults. FARINGOCAT STUDY: a multicentric randomized controlled trial

PubMed Central

2010-01-01

Background Acute pharyngitis is one of the most frequent consultations to the general practitioner and in most of the cases an antibiotic is prescribed in primary care in Spain. Bacterial etiology, mainly by group A beta-hemolytic streptococcus (GABHS), accounts for 10-20% of all these infections in adults. The purpose of this study is to assess the impact of rapid antigen detection testing (RADT) to identify GABHS in acute pharyngitis on the utilization of antibiotics in primary care. Methods/design Multicentric randomized controlled trial in which antibiotic prescription between two groups of patients with acute pharyngitis will be compared. The trial will include two arms, a control and an intervention group in which RADT will be performed. The primary outcome measure will be the proportion of inappropriate antibiotic prescription in each group. Two hundred seventy-six patients are required to detect a reduction in antibiotic prescription from 85% in the control group to 75% in the intervention group with a power of 90% and a level of significance of 5%. Secondary outcome measures will be specific antibiotic treatment, antibiotic resistance rates, secondary effects, days without working, medical visits during the first month and patient satisfaction. Discussion The implementation of RADT would allow a more rational use of antibiotics and would prevent adverse effects of antibiotics, emergence of antibiotic resistance and the growth of inefficient health expenses. Trial registration ISRCTN23587778 PMID:20331895

A comparison of the application of fibrin glue and adhesive film for repair of anastomotic leaks in the rat.

PubMed

Ayhan, Baris; Erikoglu, Mehmet; Tavli, Süleyman S; Toy, Hatice

2012-08-04

Anastomotic leaks constitute one of the most serious intraoperative complications and although many studies have been devoted to finding a solution for this problem, none of them has yet been able offer a decisive, successful method. In this study, the ability of fibrin glue and adhesive film to repair anastomotic leaks in an experimental model was compared. The sample comprised four groups of seven rats: Group 1 (Control): the distal colon was transected and anastomosis was performed. Group 2 (Primary repair): incomplete anastomosis produced a leak that was closed by primary repair on day 3. Group 3 (Fibrin glue): incomplete anastomosis produced a leak that was closed by primary repair and fibrin glue applied on day 3. Group 4 (Adhesive film): incomplete anastomosis produced a leak that was closed by primary repair and adhesive film was applied on day 3. The rats were sacrificed on day 6 following anastomosis. Anastomotic blast compressions were measured and fibroblast activation, inflammation, neovascularization and levels of collagen were evaluated. The results from Group 4 showed that blast compression values were high and statistically significantly increased over control values (p < 0.05). Inflammation in Group 2 was significantly higher than the other groups (p < 0.05). No significant differences were detected in the comparison of the groups regarding the other scoring criteria (p > 0.05). Adhesive film is more effective in reducing anastomotic leakage than fibrin glue.

Couples-Focused Prevention Program to Reduce HIV Risk Among Transgender Women and Their Primary Male Partners: Feasibility and Promise of the Couples HIV Intervention Program.

PubMed

Operario, Don; Gamarel, Kristi E; Iwamoto, Mariko; Suzuki, Sachico; Suico, Sabrina; Darbes, Lynae; Nemoto, Tooru

2017-08-01

HIV risk among transgender women has been attributed to condomless sex with primary male partners. This study pilot tested a couples-focused HIV intervention program for transgender women and their primary male partners. We analyzed data from 56 transgender women and their male partners (n = 112 participants) who were randomized as a couple to one of two groups. Participants in the intervention group (27 couples) received 3 counseling sessions: 2 couples-focused sessions, which discussed relationship dynamics, communication, and HIV risk, and 1 individual-focused session on HIV prevention concerns. Participants in the control group (29 couples) received 1 session on general HIV prevention information delivered to both partners together. At 3-month follow-up, participants in the intervention reported lower odds of condomless sex with primary partners (OR 0.5, 95 % CI 0.3-1.0), reduced odds of engaging in sex with a casual partner (OR 0.3, 95 % CI 0.1-1.0), and reduction in the number of casual partners (B = -1.45, SE = 0.4) compared with the control group. Findings provide support for the feasibility and promise of a couples-focused HIV prevention intervention for transgender women and their primary male partners.

Intraperitoneal Vancomycin Plus Either Oral Moxifloxacin or Intraperitoneal Ceftazidime for the Treatment of Peritoneal Dialysis-Related Peritonitis: A Randomized Controlled Pilot Study.

PubMed

Xu, Rong; Yang, Zhikai; Qu, Zhen; Wang, Huan; Tian, Xue; Johnson, David W; Dong, Jie

2017-07-01

Intraperitoneal administration of antibiotics is recommended as a first treatment for managing peritoneal dialysis (PD)-related peritonitis. However, the efficacy of oral administration of quinolones has not been well studied. Randomized controlled pilot study. 80 eligible patients with PD-related peritonitis from Peking University First Hospital (40 in each arm). Intraperitoneal vancomycin, 1g, every 5 days plus oral moxifloxacin, 400mg, every day (treatment group) versus intraperitoneal vancomycin, 1g, every 5 days plus intraperitoneal ceftazidime, 1g, every day (control group). The primary end point was complete resolution of peritonitis, and secondary end points were primary or secondary treatment failure. PD effluent white blood cell count. Baseline demographic and clinical characteristics of the 2 groups were comparable. There were 24 and 22 Gram-positive organisms, 6 and 7 Gram-negative organisms, 9 and 10 culture-negative samples, and 1 and 1 fungal sample in the treatment and control groups, respectively. Complete resolution of peritonitis was achieved in 78% and 80% of cases in the treatment and control groups, respectively (OR, 0.86; 95% CI, 0.30-2.52; P=0.8). There were 3 and 1 cases of relapse in the treatment and control groups, respectively. Primary and secondary treatment failure rates were not significantly different (33% vs 20% and 10% vs 13%, respectively). In each group, there was 1 peritonitis-related death and 6 transfers to hemodialysis therapy. During the 3-month follow-up period, 7 and 3 successive episodes of peritonitis occurred in the treatment and control groups, respectively. Only 2 adverse drug reactions (mild nausea and mild rash, respectively) were observed in the 2 groups. Sample size was relatively small and the eligibility ratio was low. Also, the number of peritonitis episodes was low, limiting the power to detect a difference between groups. This pilot study suggests that intraperitoneal vancomycin with oral moxifloxacin is a safe, well-tolerated, practical, and effective first-line treatment for PD-related peritonitis. Larger adequately powered clinical trials are warranted. Copyright © 2016 National Kidney Foundation, Inc. All rights reserved.

Using mHealth technologies to improve the identification of behavioral health problems in urban primary care settings.

PubMed

Staeheli, Martha; Aseltine, Robert H; Schilling, Elizabeth; Anderson, Daren; Gould, Bruce

2017-01-01

Behavioral health disorders remain under recognized and under diagnosed among urban primary care patients. Screening patients for such problems is widely recommended, yet is challenging to do in a brief primary care encounter, particularly for this socially and medically complex patient population. In 2013, intervention patients at an urban Connecticut primary clinic were screened for post-traumatic stress disorder, depression, and risky drinking (n = 146) using an electronic tablet-based screening tool. Screening data were compared to electronic health record data from control patients (n = 129) to assess differences in the prevalence of behavioral health problems, rates of follow-up care, and the rate of newly identified cases in the intervention group. Results from logistic regressions indicated that both groups had similar rates of disorder at baseline. Patients in the intervention group were five times more likely to be identified with depression (p < 0.05). Post-traumatic stress disorder was virtually unrecognized among controls but was observed in 23% of the intervention group (p < 0.001). The vast majority of behavioral health problems identified in the intervention group were new cases. Follow-up rates were significantly higher in the intervention group relative to controls, but were low overall. This tablet-based electronic screening tool identified significantly higher rates of behavioral health disorders than have been previously reported for this patient population. Electronic risk screening using patient-reported outcome measures offers an efficient approach to improving the identification of behavioral health problems and improving rates of follow-up care.

Physiological responses of men during sleep deprivation.

DOT National Transportation Integrated Search

1970-05-01

The effects of 84 hours of sleep deprivation were examined in a group of six young men and compared with a group of six controls. Subjects were studied in pairs, one sleep-deprived and one control. Primary attention was given to the responses to acut...

Comparison of range of commercial or primary care led weight reduction programmes with minimal intervention control for weight loss in obesity: lighten Up randomised controlled trial.

PubMed

Jolly, Kate; Lewis, Amanda; Beach, Jane; Denley, John; Adab, Peymane; Deeks, Jonathan J; Daley, Amanda; Aveyard, Paul

2011-11-03

To assess the effectiveness of a range of weight management programmes in terms of weight loss. Eight arm randomised controlled trial. Primary care trust in Birmingham, England. 740 obese or overweight men and women with a comorbid disorder identified from general practice records. Weight loss programmes of 12 weeks' duration: Weight Watchers; Slimming World; Rosemary Conley; group based, dietetics led programme; general practice one to one counselling; pharmacy led one to one counselling; choice of any of the six programmes. The comparator group was provided with 12 vouchers enabling free entrance to a local leisure (fitness) centre. The primary outcome was weight loss at programme end (12 weeks). Secondary outcomes were weight loss at one year, self reported physical activity, and percentage weight loss at programme end and one year. Follow-up data were available for 658 (88.9%) participants at programme end and 522 (70.5%) at one year. All programmes achieved significant weight loss from baseline to programme end (range 1.37 kg (general practice) to 4.43 kg (Weight Watchers)), and all except general practice and pharmacy provision resulted in significant weight loss at one year. At one year, only the Weight Watchers group had significantly greater weight loss than did the comparator group (2.5 (95% confidence interval 0.8 to 4.2) kg greater loss,). The commercial programmes achieved significantly greater weight loss than did the primary care programmes at programme end (mean difference 2.3 (1.3 to 3.4) kg). The primary care programmes were the most costly to provide. Participants allocated to the choice arm did not have better outcomes than those randomly allocated to a programme. Commercially provided weight management services are more effective and cheaper than primary care based services led by specially trained staff, which are ineffective. Trial registration Current Controlled Trials ISRCTN25072883.

Normothermic ex-vivo preservation with the portable Organ Care System Lung device for bilateral lung transplantation (INSPIRE): a randomised, open-label, non-inferiority, phase 3 study.

PubMed

Warnecke, Gregor; Van Raemdonck, Dirk; Smith, Michael A; Massard, Gilbert; Kukreja, Jasleen; Rea, Federico; Loor, Gabriel; De Robertis, Fabio; Nagendran, Jayan; Dhital, Kumud K; Moradiellos Díez, Francisco Javier; Knosalla, Christoph; Bermudez, Christian A; Tsui, Steven; McCurry, Kenneth; Wang, I-Wen; Deuse, Tobias; Lesèche, Guy; Thomas, Pascal; Tudorache, Igor; Kühn, Christian; Avsar, Murat; Wiegmann, Bettina; Sommer, Wiebke; Neyrinck, Arne; Schiavon, Marco; Calebrese, Fiorella; Santelmo, Nichola; Olland, Anne; Falcoz, Pierre-Emanuel; Simon, Andre R; Varela, Andres; Madsen, Joren C; Hertz, Marshall; Haverich, Axel; Ardehali, Abbas

2018-05-01

Severe primary graft dysfunction (PGD) of grade 3 (PGD3) is a common serious complication following lung transplantation. We aimed to assess physiological donor lung preservation using the Organ Care System (OCS) Lung device compared with cold static storage. In this non-inferiority, randomised, controlled, open-label, phase 3 trial (INSPIRE) recipients were aged 18 years or older and were registered as standard criteria primary double lung transplant candidates. Eligible donors were younger than 65 years old with a ratio of partial pressure of oxygen in arterial blood to the fraction of inspired oxygen of more than 300 mm Hg. Transplant recipients were randomly assigned (1:1) with permuted blocks, stratified by centre, to receive standard criteria donor lungs preserved in the OCS Lung device (OCS arm) or cold storage at 4°C (control arm). The composite primary effectiveness endpoint was absence of PGD3 within the first 72 h after transplant and 30-day survival in the per-protocol population, with a stringent 4% non-inferiority margin. Superiority was tested upon meeting non-inferiority. The primary safety endpoint was the mean number of lung graft-related serious adverse events within 30 days of transplant. We did analyses in the per-protocol and intention-to-treat populations. This trial is registered with ClinicalTrials.gov, number NCT01630434. Between Nov 17, 2011, and Nov 24, 2014, we randomly assigned 370 patients, and 320 (86%) underwent transplantation (n=151 OCS and n=169 control); follow-up was completed in Nov 24, 2016. The primary endpoint was met in 112 (79·4%) of 141 patients (95% CI 71·8 to 85·8) in the OCS group compared with 116 (70·3%) of 165 patients (62·7 to 77·2) in the control group (non-inferiority point estimate -9·1%; 95% CI -∞ to -1·0; p=0·0038; and superiority test p=0·068). Patient survival at day 30 post-transplant was 135 (95·7%) of 141 patients (95% CI 91·0-98·4) in the OCS group and 165 patients (100%; 97·8-100·0) in the control group (p=0·0090) and at 12 months was 126 (89·4%) of 141 patients (83·1-93·9) for the OCS group compared with 146 (88·1%) of 165 patients (81·8-92·8) for the control group. Incidence of PGD3 within 72 h was reported in 25 (17·7%) of 141 patients in the OCS group (95% CI 11·8 to 25·1) and 49 (29·7%) of 165 patients in the control group (22·8 to 37·3; superiority test p=0·015). The primary safety endpoint was met (0·23 lung graft-related serious adverse events in the OCS group compared with 0·28 events in the control group [point estimate -0·045%; 95% CI -∞ to 0·047; non-inferiority test p=0·020]). In the intention-to-treat population, causes of death at 30 days and in hospital were lung graft failure or lung infection (n=2 for OCS vs n=7 for control), cardiac causes (n=4 vs n=1), vascular or stroke (n=3 vs n=0), metabolic coma (n=0 vs n=2), and generalised sepsis (n=0 vs n=1). The INSPIRE trial met its primary effectiveness and safety endpoints. Although no short-term survival benefit was reported, further research is needed to see whether the reduced incidence of PGD3 within 72 h of a transplant might translate into earlier recovery and improved long-term outcomes after lung transplantation. TransMedics Inc. Copyright © 2018 Elsevier Ltd. All rights reserved.

Establishment of mouse neuron and microglial cell co-cultured models and its action mechanism.

PubMed

Zhang, Bo; Yang, Yunfeng; Tang, Jun; Tao, Yihao; Jiang, Bing; Chen, Zhi; Feng, Hua; Yang, Liming; Zhu, Gang

2017-06-27

The objective of this study is to establish a co-culture model of mouse neurons and microglial cells, and to analyze the mechanism of action of oxygen glucose deprivation (OGD) and transient oxygen glucose deprivation (tOGD) preconditioning cell models. Mouse primary neurons and BV2 microglial cells were successfully cultured, and the OGD and tOGD models were also established. In the co-culture of mouse primary neurons and microglial cells, the cell number of tOGD mouse neurons and microglial cells was larger than the OGD cell number, observed by a microscope. CCK-8 assay result showed that at 1h after treatment, the OD value in the control group is lower compared to all the other three groups (P < 0.05). The treatment group exhibited the highest OD value among the four groups. The results observed at 5h were consistent with the results at 1 h. Flow cytometry results showed that at 1h after treatment the apoptosis percentages is higher in the control group compared to other three groups (P < 0.05). Mouse brain tissues were collected and primary neurons cells were cultured. In the meantime mouse BV2 microglia cells were cultured. Two types of cells were co-cultured, and OGD and tOGD cell models were established. There were four groups in the experiment: control group (OGD), treatment group (tOGD+OGD), placebo group (tOGD+OGD+saline) and minocycline intervention group (tOGD+OGD+minocycline). CCK-8 kit was used to detect cell viability and flow cytometry was used to detect apoptosis. In this study, mouse primary neurons and microglial cells were co-cultured. The OGD and tOGD models were established successfully. tOGD was able to effectively protect neurons and microglial cells from damage, and inhibit the apoptosis caused by oxygen glucose deprivation.

Effect of short-term hazelnut consumption on DNA damage and oxidized LDL in children and adolescents with primary hyperlipidemia: a randomized controlled trial.

PubMed

Guaraldi, Federica; Deon, Valeria; Del Bo', Cristian; Vendrame, Stefano; Porrini, Marisa; Riso, Patrizia; Guardamagna, Ornella

2018-07-01

Children with primary hyperlipidemia are prone to develop premature atherosclerosis, possibly associated with increased oxidative stress. Nutritional therapy is the primary strategy in the treatment of hyperlipidemia and associated conditions. Dietary interventions with bioactive-rich foods, such as nuts, may contribute to the modulation of both lipid profile and the oxidative/antioxidant status. Our study aimed to assess the impact of a dietary intervention with hazelnuts on selected oxidative stress markers in children and adolescents with primary hyperlipidemia. A single-blind, 8-week, randomized, controlled, three-arm, parallel-group study was performed. Children and adolescents diagnosed with primary hyperlipidemia (n=60) received dietary guidelines and were randomized into three groups: group 1 received hazelnuts with skin (HZN+S), and group 2 hazelnuts without skin (HZN-S), at equivalent doses (15-30 g/day, based on body weight); group 3 (controls) received only dietary recommendations (no nuts). At baseline and after 8 weeks, plasma oxidized low-density lipoprotein (ox-LDL) concentrations, oxidative levels of DNA damage in PBMCs and potential correlation with changes in serum lipids were examined. A reduction of endogenous DNA damage by 18.9%±51.3% (P=.002) and 23.1%±47.9% (P=.007) was observed after HZN+S and HZN-S, respectively. Oxidatively induced DNA strand breaks decreased by 16.0%±38.2% (P=.02) following HZN+S treatment. Ox-LDL levels did not change after HZN+S intervention but positively correlated with total cholesterol and LDL cholesterol. A short-term hazelnut intervention improves cell DNA protection and resistance against oxidative stress but not ox-LDL in hyperlipidemic pediatric patients. The trial was registered at ISRCTN.com, ID no. ISRCTN12261900. Copyright © 2018 Elsevier Inc. All rights reserved.

Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.

PubMed

Von Korff, Michael; Vitiello, Michael V; McCurry, Susan M; Balderson, Benjamin H; Moore, Amy L; Baker, Laura D; Yarbro, Patricia; Saunders, Kathleen; Keefe, Francis J; Rybarczyk, Bruce D

2012-07-01

Six weekly sessions of group cognitive-behavioral therapy for insomnia and osteoarthritis pain (CBT-PI), and for osteoarthritis pain alone (CBT-P) were compared to an education only control (EOC). Basic education about pain and sleep was comparable, so EOC controlled for information and group participation. Active interventions differed from EOC in training pain coping skills (CBT-P and CBT-PI) and sleep enhancement techniques (CBT-PI). Persons with osteoarthritis age 60 or older were screened for osteoarthritis pain and insomnia severity via mailed survey. Primary outcomes were pain severity (pain intensity and interference ratings from the Graded Chronic Pain Scale) and insomnia severity (Insomnia Severity Index). Secondary outcomes were arthritis pain (AIMS-2 symptom scale) and sleep efficiency assessed by wrist actigraphy. Ancillary outcomes included: cognitive function, depression, and health care use. A clustered randomized design provided adequate power to identify moderate effects on primary outcomes (effect size>0.35). Modified intent to treat analyses, including all participants who attended the first session, assessed effects across CBT-PI, CBT-P, and EOC groups. Treatment effects were assessed post-intervention (2 months) and at 9 months, with durability of intervention effects evaluated at 18 months. The trial was executed in 6 primary clinics, randomizing 367 participants, with 93.2% of randomized patients attending at least 4 group sessions. Response rates for post-intervention and 9 month assessments were 96.7% and 92.9% respectively. This hybrid efficacy-effectiveness trial design evaluates whether interventions yield specific benefits for clinical and behavioral outcomes relative to an education only control when implemented in a primary care setting. Copyright © 2012 Elsevier Inc. All rights reserved.

Patients with musculoskeletal conditions do less vigorous physical activity and have poorer physical fitness than population controls: a cross-sectional study.

PubMed

Moseng, T; Tveter, A T; Holm, I; Dagfinrud, H

2014-12-01

To compare physical activity and physical fitness in patients with various musculoskeletal conditions receiving physiotherapy in primary care with population controls. Cross-sectional. One hundred and sixty-seven patients with musculoskeletal conditions receiving physiotherapy in primary care and 313 population controls from various settings and geographical areas. Physical activity was measured with the International Physical Activity Questionnaire short-form (IPAQ-sf) and reported in metabolic equivalents (METs). The 6-minute walk test and 30-second sit-to-stand test reflected cardiorespiratory endurance and muscular strength, respectively. Differences in physical activity between the groups were explored using the Mann-Whitney U-test. The patient group reported significantly less vigorous activity compared with the control group {median 0 [interquartile range (IQR) 0 to 960] vs median 240 [IQR 0 to 1440] MET minutes/week, respectively)} (P=0.001). A similar proportion of patients (68%) and controls (75%) reached the recommended level of health-enhancing physical activity (P=0.11). Linear regression analyses adjusted for age, body mass index and gender showed significantly poorer fitness in the patient group compared with the control group, reflected by the 6-minute walk test and the 30-second sit-to-stand test {mean difference 69m [95% confidence interval (CI) 52 to 85; P≤0.001] and six repetitions [95% CI 5 to 7; P≤0.001], respectively}. Patients with various long-term musculoskeletal conditions receiving physiotherapy in primary care had significantly poorer physical fitness and reported less vigorous physical activity compared with population controls. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Mild therapeutic hypothermia in patients after out-of-hospital cardiac arrest due to acute ST-segment elevation myocardial infarction undergoing immediate percutaneous coronary intervention.

PubMed

Wolfrum, Sebastian; Pierau, Christian; Radke, Peter W; Schunkert, Heribert; Kurowski, Volkhard

2008-06-01

Mild therapeutic hypothermia (MTH) has been integrated into international resuscitation guidelines. In the majority of patients, sudden cardiac arrest is caused by myocardial infarction. This study investigated whether a combination of MTH with primary percutaneous coronary intervention (PCI) is feasible, safe, and potentially beneficial in patients after cardiac arrest due to acute myocardial infarction. Single-center observational study with a historical control group. University clinic. Thirty-three patients after cardiac arrest with ventricular fibrillation as initial rhythm and restoration of spontaneous circulation who remained unconscious at admission and presented with acute ST elevation myocardial infarction (STEMI). In 16 consecutive patients (2005-2006), MTH was initiated immediately after admission and continued during primary PCI. Seventeen consecutive patients who were treated in a similar 2-yr observation interval before implementation of MTH (2003-2004) served as a control group. Feasibility, safety, mortality, and neurologic outcome were documented. Initiation of MTH did not result in longer door-to-balloon times compared with the control group (82 vs. 85 mins), indicating that implementation of MTH did not delay the onset of primary PCI. Target temperature (32-34 degrees C) in the MTH group was reached within 4 hrs, consistent with previous trials and suggesting that primary PCI did not affect the velocity of cooling. Despite a tendency to increased bleeding complications and infections, patients treated with MTH tended to have a lower mortality after 6 months (25% vs. 35%, p = .71) and an improved neurologic outcome as determined by a Glasgow-Pittsburgh Cerebral Performance Scale score of 1 or 2 (69% vs. 47% in the control group, p = .30). MTH in combination with primary PCI is feasible and safe in patients resuscitated after cardiac arrest due to acute myocardial infarction. A combination of these therapeutic procedures should be strongly considered as standard therapy in patients after out-of-hospital cardiac arrest due to STEMI.

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

In vitro study of transverse strength of fiber reinforced composites.

PubMed

Mosharraf, R; Hashemi, Z; Torkan, S

2011-01-01

Reinforcement with fiber is an effective method for considerable improvement in flexural properties of indirect composite resin restorations. The aim of this in-vitro study was to compare the transverse strength of composite resin bars reinforced with pre-impregnated and non-impregnated fibers. Thirty six bar type composite resin specimens (3×2×25 mm) were constructed in three groups. The first group was the control group (C) without any fiber reinforcement. The specimens in the second group (P) were reinforced with pre-impregnated fibers and the third group (N) with non-impregnated fibers. These specimens were tested by the three-point bending method to measure primary transverse strength. Data were statistically analyzed with one way ANOVA and Tukey's tests. There was a significant difference among the mean primary transverse strength in the three groups (P<0.001). The post-hoc (Tukey) test showed that there was a significant difference between the pre-impregnated and control groups in their primary transverse strength (P<0.001). Regarding deflection, there was also a significant difference among the three groups (P=0.001). There were significant differences among the mean deflection of the control group and two other groups (P(C&N)<.001 and P(C&P)=.004), but there was no significant difference between the non-and pre-impregnated groups (P(N&P)=.813). Within the limitations of this study, it was concluded that reinforcement with fiber considerably increased the transverse strength of composite resin specimens, but impregnation of the fiber used implemented no significant difference in the transverse strength of composite resin samples.

Migraine Nurses in Primary Care: Costs and Benefits.

PubMed

van den Berg, Jan S P; Steiner, Timothy J; Veenstra, Petra J L; Kollen, Boudewijn J

2017-09-01

We examined the costs and benefits of introducing migraine nurses into primary care. Migraine is one of the most costly neurological diseases. We analyzed data from our earlier nonrandomized cohort study comparing an intervention group of 141 patients, whose care was supported by nurses trained in migraine management, and a control group of 94 patients receiving usual care. Estimates of per-person direct costs were based on nurses' salaries and referrals to neurologists. Indirect costs were estimated as lost productivity, including numbers of days of absenteeism or with <50% productivity at work due to migraine, and notional costs related to lost days of household activities or days of <50% household productivity. Analysis was conducted from the payer's perspective. After 9 months the direct costs were €281.11 in the control group against €332.23 in the intervention group (mean difference -51.12; 95% CI: -113.20-15.56; P = .134); the indirect costs were €1985.51 in the control group against €1631.75 in the intervention group (mean difference 353.75; 95% CI: -355.53-1029.82; P = .334); and total costs were €2266.62 in the control group, against €1963.99 in the intervention group (mean difference 302.64; 95% CI: -433.46-1001.27; P = .438). When costs attributable to lost household productivity were included, total costs increased to €6076.62 in the control group and €5048.15 in the intervention group (mean difference 1028.47; 95% CI: -590.26-2603.67; P = .219). Migraine nurses in primary care seemed in this study to increase practice costs but decrease total societal costs. However, it was a nonrandomized study, and the differences did not reach significance. For policy-makers concerned with headache-service organization and delivery, the important messages are that we found no evidence that nurses increased overall costs, and investment in a definitive study would therefore be worthwhile. © 2017 American Headache Society.

A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study).

PubMed

Flik, Carla E; van Rood, Yanda R; Laan, Wijnand; Smout, André Jpm; Weusten, Bas Lam; Whorwell, Peter J; de Wit, Niek J

2011-12-20

Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65) with IBS (Rome-III criteria). Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo), with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. ISRCTN: ISRCTN22888906.

Efficacy of RADPAD protective drape during coronary angiography.

PubMed

Kherad, B; Jerichow, T; Blaschke, F; Noutsias, M; Pieske, B; Tschöpe, C; Krackhardt, F

2018-06-01

Ionizing radiation is an integral part of percutaneous coronary angiographies. Chronic exposure to low-dose radiation confers a risk for skin damage, eye lens opacities or cataracts, and malignant diseases to staff in the catheter laboratory. The RADPAD is a sterile surgical drape that reduces the effect of scatter radiation on the operator. We sought to assess the efficacy of RADPAD shields in reducing radiation dose experienced by operators during routine diagnostic coronary angiography. Sixty consecutive patients due to undergo elective coronary angiography were randomized in a 1:1 pattern to have their procedures performed with and without the RADPAD drape in situ. Dosimetry was performed on the left arm of the primary operator. There was no significant difference in the two main determents of radiation exposure in both groups: the screening times (102 ± 86 s for the RADPAD group vs. 105 ± 36 s for the control group, p = 0.9) and body mass index (BMI; 27.7 ± 4.2 kg/m 2 for the RADPAD group vs. 27.9 ± 5.5 kg/m 2 for the control group, p = 0.8). Moreover, there was no difference in the dose-area ratio (1337 ± 582 cGy/cm 2 for the RADPAD group vs. 1541 ± 804 cGy/cm 2 for the control group, p = 0.3) between the two patient groups. The primary operator radiation dose was significantly lower in the RADPAD group at 8.0 µSv (Q1: 3.2, Q3: 20.1) compared with 19.6 µSv (Q1: 7.1, Q3: 37.7) for the control group (p = 0.02). The RADPAD significantly reduces radiation exposure to primary operators during routine diagnostic coronary angiography in patients with a BMI > 25 kg/m 2 . It reduces total radiation exposure to primary operators by 59%, and the radiation exposure rate by 47%.

A prescription for health: a primary care based intervention to maintain the non-smoking status of young people

PubMed Central

Fidler, W.; Lambert, T.

2001-01-01

OBJECTIVES—To evaluate the effectiveness of primary health care teams in maintaining a group of young people aged 10-15 years as non-smokers.
DESIGN—Randomised controlled trial using postal questionnaires.
SETTING—Oxfordshire, UK.
SUBJECTS—2942 young people who were initially self declared non-smokers.
INTERVENTION—Information about smoking, sent under signature of the subject's general practitioner, certificates and posters intended to reinforce non-smoking behaviour.
MAIN OUTCOME MEASURES—Changes in smoking behaviour, attitudes measured after one year.
RESULTS—After a year, smoking uptake was 7.8% in the control group compared with 5.1% in the intervention group (odds ratio (OR) 1.6, 95% confidence interval (CI) 1.1 to 2.2). Among boys the corresponding results were 5.2% and 2.4% (OR 2.3, 95% CI 1.2 to 4.6), and among girls 10.0% and 7.5% (OR 1.4, 95% CI 0.9 to 2.1). Among boys aged 14-15 the uptake rate was 12.8% in the control group compared with 5.4% in the intervention group. However, among girls of the same age the intervention was less effective, with smoking uptake of 15.1% in the control group and 12.8% in the intervention group. The intervention was more effective among young people whose initial attitudes identified them as definite non-smokers than those who were potential smokers.
CONCLUSIONS—The intervention substantially reduced smoking uptake among the young people, particularly boys. Primary health care teams can play an important role in maintaining the non-smoking status of their young patients. Confidential postal contact from the doctor direct to the young person at home is influential and cost-effective.


Keywords: smoking initiation; smoking prevention; young people; primary care PMID:11226356

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

PubMed Central

2012-01-01

Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob) PMID:23130754

Walking Away from Type 2 diabetes: a cluster randomized controlled trial.

PubMed

Yates, T; Edwardson, C L; Henson, J; Gray, L J; Ashra, N B; Troughton, J; Khunti, K; Davies, M J

2017-05-01

This study aimed to investigate whether an established behavioural intervention, Walking Away from Type 2 Diabetes, is effective at promoting and sustaining increased walking activity when delivered within primary care. Cluster randomized controlled trial involving 10 general practices recruited from Leicestershire, UK, in 2009-2010. Eight hundred and eight (36% female) individuals with a high risk of Type 2 diabetes mellitus, identified through a validated risk score, were included. Participants in five practices were randomized to Walking Away from Type 2 Diabetes, a pragmatic 3-h group-based structured education programme incorporating pedometer use with annual follow-on refresher sessions. The primary outcome was accelerometer assessed ambulatory activity (steps/day) at 12 months. Longer term maintenance was assessed at 24 and 36 months. Results were analysed using generalized estimating equation models, accounting for clustering. Complete accelerometer data for the primary outcome were available for 571 (71%) participants. Increases in ambulatory activity of 411 steps/day [95% confidence interval (CI): 117, 704] and self-reported vigorous-intensity physical activity of 218 metabolic equivalent min/week (95% CI: 6, 425) at 12 months were observed in the intervention group compared with control; differences between groups were not sustained at 36 months. No differences between groups were observed for markers of cardiometabolic health. Replacing missing data with multiple imputation did not affect the results. A pragmatic low-resource group-based structured education programme with pedometer use resulted in modest increases in ambulatory activity compared with control conditions after 12 months when implemented within a primary care setting to those at high risk of Type 2 diabetes mellitus; however, the results were not maintained over 36 months. © 2016 Diabetes UK.

Reducing Physical Violence Toward Primary School Students With Disabilities.

PubMed

Devries, Karen; Kuper, Hannah; Knight, Louise; Allen, Elizabeth; Kyegombe, Nambusi; Banks, Lena Morgon; Kelly, Susan; Naker, Dipak

2018-03-01

We tested whether the Good School Toolkit reduces physical violence from peers and school staff toward students with and without disabilities in Ugandan primary schools. We conducted a cluster randomized controlled trial, with data collected via cross-sectional surveys in 2012 and 2014. Forty-two primary schools in Luwero District, Uganda, were randomly assigned to receive the Good School Toolkit for 18 months, or to a waitlisted control group. The primary outcome was past week physical violence from school staff, measured by primary 5, 6, and 7 students' (aged 11-14 years) self-reports using the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool-Child Institutional. Disability was assessed through the six Short Set Washington Group questions on functioning. Analyses were by intention to treat. At endline, 53% of control group students with no functional difficulties reported violence from peers or school staff, versus 84% of students with a disability. Prevalence of past week physical violence from school staff was lower in intervention schools than in the control schools after the intervention, in students with no functional difficulties (adjusted odds ratio [aOR] = .41, 95% confidence interval [CI .26-.65]), students with some functional difficulties (aOR = .36, 95% CI .21-.63), and students with disabilities (aOR = .29, 95% CI .14-.59). The intervention also reduced violence from peers in young adolescents, with no evidence of a difference in effect by disability status. The Good School Toolkit is an effective intervention to reduce violence perpetrated by peers and school staff against young adolescents with disabilities in Ugandan primary schools. Copyright © 2017 The Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

ERIC Educational Resources Information Center

Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

2012-01-01

This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

Latino Families, Primary Care, and Childhood Obesity

PubMed Central

Arauz Boudreau, Alexy D.; Kurowski, Daniel S.; Gonzalez, Wanda I.; Dimond, Melissa A.; Oreskovic, Nicolas M.

2017-01-01

Background Few successful treatment modalities exist to address childhood obesity. Given Latinos’ strong identity with family, a family-focused intervention may be able to control Latino childhood obesity. Purpose To assess the feasibility and effectiveness of a family-centered, primary care–based approach to control childhood obesity through lifestyle choices. Design Randomized waitlist controlled trial in which control participants received the intervention 6 months after the intervention group. Setting/participants Forty-one Latino children with BMI >85%, aged 9–12 years, and their caregivers were recruited from an urban community health center located in a predominantly low-income community. Intervention Children and their caregivers received 6 weeks of interactive group classes followed by 6 months of culturally sensitive monthly in-person or phone coaching to empower families to incorporate learned lifestyles and to address both family and social barriers to making changes. Main outcomes measures Caregiver report on child and child self-reported health-related quality of life (HRQoL); metabolic markers of obesity; BMI; and accelerometer-based physical activity were measured July 2010–November 2011 and compared with post-intervention assessments conducted at 6 months and as a function of condition assignment. Data were analyzed in 2012. Results Average attendance rate to each group class was 79%. Socio-environmental and family factors, along with knowledge, were cited as barriers to changing lifestyles to control obesity. Caregiver-proxy and child-self-reported HRQoL improved for both groups with a larger but not nonsignificant difference among intervention vs control group children (p=0.33). No differences were found between intervention and control children for metabolic markers of obesity, BMI, or physical activity. Conclusions Latino families are willing to participate in group classes and health coaching to control childhood obesity. It may be necessary for primary care to partner with community initiatives to address childhood obesity in a more intense manner. Trial registration This study is registered at Clinicaltrials.partners.org 2009P001721. PMID:23415190

A randomised controlled trial of a self-management education program for osteoarthritis of the knee delivered by health care professionals.

PubMed

Coleman, Sophie; Briffa, N Kathryn; Carroll, Graeme; Inderjeeth, Charles; Cook, Nicola; McQuade, Jean

2012-01-27

Our aim in the present study was to determine whether a disease-specific self-management program for primary care patients with osteoarthritis (OA) of the knee (the Osteoarthritis of the Knee Self-Management Program (OAK)) implemented by health care professionals would achieve and maintain clinically meaningful improvements in health-related outcomes compared with a control group. Medical practitioners referred 146 primary care patients with OA of the knee. Volunteers with coexistent inflammatory joint disease or serious comorbidities were excluded. Randomisation was to either a control group or the OAK group. The OAK group completed a 6-week self-management program. The control group had a 6-month waiting period before entering the OAK program. Assessments were taken at baseline, 8 weeks and 6 months. The primary outcomes were the results measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain and Function subscales on the Short Form 36 version 1 questionnaire (SF-36) Secondary outcomes were Visual Analogue Scale (VAS) pain, Timed Up & Go Test (TUG), knee range of motion and quadriceps and hamstring strength-isometric contraction. Responses to treatment (responders) and minimal clinically important improvements (MCIIs) were determined. In the OAK group, VAS pain improved from baseline to week 8 from mean (SEM) 5.21 (0.30) to 3.65 (0.29) (P ≤ 0.001). During this period, improvements in the OAK group compared with the control group and responses to treatment were demonstrated according to the following outcomes: WOMAC Pain, Physical Function and Total dimensions, as well as SF-36 Physical Function, Role Physical, Body Pain, Vitality and Social Functioning domains. In addition, from baseline to week 8, the proportion of MCIIs was greater among the OAK group than the control group for all outcomes. For the period between baseline and month 6, WOMAC Pain, Physical Function and Total dimensions significantly improved in the OAK group compared to the control group, as did the SF-36 Physical Function, Role Physical, Body Pain, Vitality and Social Functioning domains, as well as hamstring strength in both legs. During the same period, the TUG Test, range of motion extension and left-knee flexion improved compared with the control group, although these improvements had little clinical relevance. We recorded statistically significant improvements compared with a control group with regard to pain, quality of life and function for participants in the OAK program on the basis of WOMAC and SF-36 measures taken 8 weeks and 6 months from baseline.

Reconfiguring redundancy management

NASA Technical Reports Server (NTRS)

Gelderloos, H. J. C. (Inventor)

1982-01-01

A redundancy management system is described wherein input signals from a sensor are provided redundantly in parallel so that a primary control signal may be selected. Median value signals for groups of three sensors are detected in median value selectors of selection filter. The detected median value signals are then also compared in a subtractor/comparator to determine whether any of them exceed the others by an amount greater than the signal level for a failed sensor. If so, the exceeding detected medium value signal is sent to a control computer as the primary control signal. If not, the lowest level detected medium value signal is sent as the primary control signal.

A cross-national trial of brief interventions with heavy drinkers. WHO Brief Intervention Study Group.

PubMed Central

1996-01-01

OBJECTIVES. The relative effects of simple advice and brief counseling were evaluated with heavy drinkers identified in primary care and other health settings in eight countries. METHODS. Subjects (1260 men, 299 women) with no prior history of alcohol dependence were selected if they consumed alcohol with sufficient frequency or intensity to be considered at risk of alcohol-related problems. Subjects were randomly assigned to a control group, a simple advice group, or a group receiving brief counseling. Seventy-five percent of subjects were evaluated 9 months later. RESULTS. Male patients exposed to the interventions reported approximately 17% lower average daily alcohol consumption than those in the control group. Reductions in the intensity of drinking were approximately 10%. For women, significant reductions were observed in both the control and the intervention groups. Five minutes of simple advice were as effective as 20 minutes of brief counseling. CONCLUSIONS. Brief interventions are consistently robust across health care settings and sociocultural groups and can make a significant contribution to the secondary prevention of alcohol-related problems if they are widely used in primary care. PMID:8669518

Comparative Analysis of Protaper and Waveone Systems to Reduce Enterococcus Faecalis from Root Canal System in Primary Molars--An in Vitro Study.

PubMed

Pinheiro, Sérgio Luiz; Pessoa, Carolina; da Silva, Josianne Neres; Gonçalves, Rafael Orro; Duarte, Danilo Antonio; da Silveira Bueno, Carlos Eduardo

2016-01-01

To assess, in vitro, the ability of the ProTaper(™) and WaveOne(™) systems to reduce Enterococcus faecalis contamination in primary molars. Sixty roots of primary molars were contaminated with E. faecalis. Roots were randomly allocated to one of four groups (n=20): ProTaper(™), WaveOne(™), control A, or control B. The files used were S1 and S2/F1 and F2 (ProTaper(™) system) and 25.08 (WaveOne(™) system). In control group A, the root canal was left uninstrumented, whereas in control group B, the root canal was irrigated with NaCl 0.9%. E. faecalis was sampled from the root canal system before and after instrumentation and the Wilcoxon test and Mann-Whitney U were used. There were no differences in E. faecalis counts between pre-instrumentation counts in the ProTaper™ and WaveOne(™) (p>0.05). The ProTaper(™) system led to an 89.36% reduction in E. faecalis burden, versus 78.10% with the WaveOne(™) system (p>0.05). Instrumentation time was shorter with WaveOne(™) (p<0.0001). The ProTaper(™) and WaveOne™ systems were equally effective in reducing Enterococcus faecalis in primary molars. The WaveOne(™) system was associated with shorter instrumentation time.

Medical yoga for patients with stress-related symptoms and diagnoses in primary health care: a randomized controlled trial.

PubMed

Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

2013-01-01

An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care.

Medical Yoga for Patients with Stress-Related Symptoms and Diagnoses in Primary Health Care: A Randomized Controlled Trial

PubMed Central

Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

2013-01-01

An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care. PMID:23533465

Developing primary care in Hong Kong: evidence into practice and the development of reference frameworks.

PubMed

Griffiths, Sian M; Lee, Jeff P M

2012-10-01

Enhancing primary care is one of the proposals put forward in the Healthcare Reform Consultation Document "Your Health, Your Life" issued in March 2008. In 2009, the Working Group on Primary Care, chaired by the Secretary for Food and Health, recommended the development of age-group and disease-specific primary care conceptual models and reference frameworks. Drawing on international experience and best evidence, the Task Force on Conceptual Model and Preventive Protocols of the Working Group on Primary Care has developed two reference frameworks for the management of two common chronic diseases in Hong Kong, namely diabetes and hypertension, in primary care settings. Adopting a population approach for the prevention and control of diabetes and hypertension across the life course, the reference frameworks aim to provide evidence-based and appropriate recommendations for the provision of continuing and comprehensive care for patients with chronic diseases in the community.

Clinical characteristics and penile afferent neuronal function in patients with primary delayed ejaculation.

PubMed

Xia, J-D; Han, Y-F; Pan, F; Zhou, L-H; Chen, Y; Dai, Y-T

2013-09-01

Primary delayed ejaculation (DE) is a relatively uncommon condition and has not been studied broadly. In this study, we aimed to investigate the clinical characteristics and penile afferent neuronal function using somatosensory evoked potentials in patients with primary DE. Twenty-four patients with primary DE and 24 age-matched normally potent men were enrolled in this study. Results indicated that patients with primary DE had remarkably higher frequency of masturbatory activity (especially, some with idiosyncratic styles), lower night emissions, longer intravaginal ejaculation latency time (IELT), higher anxiety and depression states (p = 0.010, p = 0.017, p < 0.001, p < 0.001, p < 0.001 respectively). In addition, the mean penile shaft sensory threshold values in the patients were considerably higher than those in the healthy men (p < 0.001). Mean latencies of dorsal nerve somatosensory evoked potential DNSEP were 4.32 ms longer in the DE group than those in the control group (p < 0.001). However, the latencies of glans penis somatosensory evoked potential (GPSEP) between the two group showed no significant difference (p = 0.985). At the same time, in comparison with the control group, the amplitudes of DNSEP were considerably lower in the DE group (p = 0.016), but not in the amplitudes of GPSEP (p = 0.934). This study indicates that the patients with primary DE appear to have penile shaft rather than glans hyposensitivity and hypoexcitability, and adaptation to a certain masturbatory technique (higher and idiosyncratic) may be related to the causes of primary DE, which is also associated with lower night emissions, longer IELT, higher anxiety and depression states. © 2013 American Society of Andrology and European Academy of Andrology.

Neural plasticity expressed in central auditory structures with and without tinnitus

PubMed Central

Roberts, Larry E.; Bosnyak, Daniel J.; Thompson, David C.

2012-01-01

Sensory training therapies for tinnitus are based on the assumption that, notwithstanding neural changes related to tinnitus, auditory training can alter the response properties of neurons in auditory pathways. To assess this assumption, we investigated whether brain changes induced by sensory training in tinnitus sufferers and measured by electroencephalography (EEG) are similar to those induced in age and hearing loss matched individuals without tinnitus trained on the same auditory task. Auditory training was given using a 5 kHz 40-Hz amplitude-modulated (AM) sound that was in the tinnitus frequency region of the tinnitus subjects and enabled extraction of the 40-Hz auditory steady-state response (ASSR) and P2 transient response known to localize to primary and non-primary auditory cortex, respectively. P2 amplitude increased over training sessions equally in participants with tinnitus and in control subjects, suggesting normal remodeling of non-primary auditory regions in tinnitus. However, training-induced changes in the ASSR differed between the tinnitus and control groups. In controls the phase delay between the 40-Hz response and stimulus waveforms reduced by about 10° over training, in agreement with previous results obtained in young normal hearing individuals. However, ASSR phase did not change significantly with training in the tinnitus group, although some participants showed phase shifts resembling controls. On the other hand, ASSR amplitude increased with training in the tinnitus group, whereas in controls this response (which is difficult to remodel in young normal hearing subjects) did not change with training. These results suggest that neural changes related to tinnitus altered how neural plasticity was expressed in the region of primary but not non-primary auditory cortex. Auditory training did not reduce tinnitus loudness although a small effect on the tinnitus spectrum was detected. PMID:22654738

Sonographic Alteration of Basal Ganglia in Different Forms of Primary Focal Dystonia: A Cross-sectional Study

PubMed Central

Zhang, Ying; Zhang, Ying-Chun; Sheng, Yu-Jing; Chen, Xiao-Fang; Wang, Cai-Shan; Ma, Qi; Chen, Han-Bing; Yu, Li-Fang; Mao, Cheng-Jie; Xiong, Kang-Ping; Luo, Wei-Feng; Liu, Chun-Feng

2016-01-01

Background: Few studies have addressed whether abnormalities in the lenticular nucleus (LN) are characteristic transcranial sonography (TCS) echo features in patients with primary dystonia. This study aimed to explore alterations in the basal ganglia in different forms of primary focal dystonia. Methods: cross-sectional observational study was performed between December 2013 and December 2014 in 80 patients with different forms of primary focal dystonia and 55 neurologically normal control subjects. TCS was performed in patients and control subjects. Multiple comparisons of multiple rates were used to compare LN hyperechogenicity ratios between control and patient groups. Results: Thirteen individuals were excluded due to poor temporal bone windows, and two subjects were excluded due to disagreement in evaluation by sonologists. Totally, 70 patients (cervical dystonia, n = 30; blepharospasm, n = 30; oromandibular dystonia, n = 10) and 50 normal controls were included in the final analysis. LN hyperechogenicity was observed in 51% (36/70) of patients with primary focal dystonia, compared with 12% (6/50) of controls (P < 0.001). Substantia nigra hyperechogenicity did not differ between the two groups. LN hyperechogenicity was observed in 73% (22/30) of patients with cervical dystonia, a greater prevalence than in patients with blepharospasm (33%, 10/30, P = 0.002) and oromandibular dystonia (40%, 4/10, P = 0.126). LN hyperechogenicity was more frequently observed in patients with cervical dystonia compared with controls (73% vs. 12%, P < 0.001); however, no significant difference was detected in patients with blepharospasm (33% vs. 12%, P = 0.021) or oromandibular dystonia (40% vs. 12%, P = 0.088). Conclusions: LN hyperechogenicity is more frequently observed in patients with primary focal dystonia than in controls. It does not appear to be a characteristic TCS echo feature in patients with blepharospasm or oromandibular dystonia. PMID:27064039

Assessment of the Effectiveness of the Educational Environment Supported by Computer Aided Presentations at Primary School Level

ERIC Educational Resources Information Center

Kose, Erdogan

2009-01-01

The objective of this study is to assess the effectiveness of the educational environment supported by computer aided presentations at primary school. The effectiveness of the environment has been evaluated in terms of students' learning and remembering what they have learnt. In the study, we have compared experimental group and control group in…

The Use of Interactive Computer Animations Based on POE as a Presentation Tool in Primary Science Teaching

ERIC Educational Resources Information Center

Akpinar, Ercan

2014-01-01

This study investigates the effects of using interactive computer animations based on predict-observe-explain (POE) as a presentation tool on primary school students' understanding of the static electricity concepts. A quasi-experimental pre-test/post-test control group design was utilized in this study. The experiment group consisted of 30…

QT dispersion and ventricular arrhythmias in children with primary mitral valve prolapse

PubMed Central

İmamoğlu, Ebru Yalın; Eroğlu, Ayşe Güler

2016-01-01

Aim: To investigate ventricular arrhythmias in children with primary mitral valve prolapse and to evaluate its relation with QT length, QT dispersion, autonomic function tests and heart rate variability measurements. Material and Methods: Fourty two children with mitral valve prolapse and 32 healthy children were enrolled into the study. Twelve-lead electrocardiograms, autonomic function tests, echocardiography and 24-hour rhythm Holter tests were performed. Electrocardiograms were magnified digitally. The QT length was corrected according to heart rate. The patients were grouped according to the number of premature ventricular contractions and presence of complex ventricular arhythmia in the 24-hour rhythm Holter monitor test. Heart rate variability measurements were calculated automatically from the 24-hour rhythm Holter monitor test. Orthostatic hypotension and resting heart rate were used as autonomic function tests. Results: The mean age was 13.9±3.3 years in the patient group and 14.6±3.1 years in the control group (p>0.05). Thirty four of the patients (81%) were female and eight (19%) were male. Twenty five of the control subjects (78%) were female and seven (22%) were male. The QT dispersion and heart rate corrected QT interval were found to be significantly increased in the children with primary mitral valve prolapse when compared with the control group (56±16 ms vs. 43±11 ms, p=0.001; 426±25 ms vs. 407±26 ms, p=0.002, respectively). In 24-hour rhythm Holter monitor tests, ventricular arrhythmias were found in 21 out of 42 patients (50%) and 6 out of 32 control subjects (18.8%) (p=0.006). QT dispersion was found to be significantly increased in patients with premature ventricular contractions ≥ 10/day and/or complex ventricular arrhythmias compared to the control group without ventricular premature beats (p=0.002). There was no significant difference in autonomic function tests and heart rate variability measurements between the patient and control groups. Conclusions: The noted increase in QT dispersion may be a useful indicator for the clinician in the evaluation of impending ventricular arrhythmias in children with primary mitral valve prolapse. PMID:27738397

Effect of reciprocating file motion on microcrack formation in root canals: an SEM study.

PubMed

Ashwinkumar, V; Krithikadatta, J; Surendran, S; Velmurugan, N

2014-07-01

To compare dentinal microcrack formation whilst using Ni-Ti hand K-files, ProTaper hand and rotary files and the WaveOne reciprocating file. One hundred and fifty mandibular first molars were selected. Thirty teeth were left unprepared and served as controls, and the remaining 120 teeth were divided into four groups. Ni-Ti hand K-files, ProTaper hand files, ProTaper rotary files and WaveOne Primary reciprocating files were used to prepare the mesial canals. Roots were then sectioned 3, 6 and 9 mm from the apex, and the cut surface was observed under scanning electron microscope (SEM) and checked for the presence of dentinal microcracks. The control and Ni-Ti hand K-files groups were not associated with microcracks. In roots prepared with ProTaper hand files, ProTaper rotary files and WaveOne Primary reciprocating files, dentinal microcracks were present. There was a significant difference between control/Ni-Ti hand K-files group and ProTaper hand files/ProTaper rotary files/WaveOne Primary reciprocating file group (P < 0.001) with ProTaper rotary files producing the most microcracks. No significant difference was observed between teeth prepared with ProTaper hand files and WaveOne Primary reciprocating files. ProTaper rotary files were associated with significantly more microcracks than ProTaper hand files and WaveOne Primary reciprocating files. Ni-Ti hand K-files did not produce microcracks at any levels inside the root canals. © 2013 International Endodontic Journal. Published by John Wiley & Sons Ltd.

Web-based proactive system to improve breast cancer screening: a randomized controlled trial.

PubMed

Chaudhry, Rajeev; Scheitel, Sidna M; McMurtry, Erin K; Leutink, Dorinda J; Cabanela, Rosa L; Naessens, James M; Rahman, Ahmed S; Davis, Lynn A; Stroebel, Robert J

2007-03-26

Screening mammography is recommended for early detection of breast cancer but screening rates remain suboptimal. A primary care portal for a large academic primary practice was developed for all preventive services. Another Web-based system (PRECARES [PREventive CAre REminder System]) was developed for appointment secretaries to manage proactive breast cancer screening. Female patients aged 40 to 75 years were randomly assigned to a control group (usual care) and an intervention group. For the intervention group, 2 monthly letters inviting patients to undergo mammography were sent starting 3 months before they were due for annual screening, followed by a telephone call to nonresponding patients. A subgroup of women employees was further randomized to receive a reminder by either US mail or e-mail. Of the total eligible population of 6665 women identified as having consented to participate in research, 3339 were randomly assigned to the control group and 3326 to the intervention group. The screening rate for annual mammography was 64.3% for the intervention group and 55.3% for the control group (P <.001). There were no significant differences between the 2 groups for any of the other adult preventive services. For the employee subgroup, the screening rate was 57.5% for the control group, 68.1% for the US mail group, and 72.2% for the e-mail group (intervention vs control, P <.001; e-mail vs US mail; P = .24). The breast cancer screening rate improved significantly with the practice redesign of having appointment secretaries proactively manage breast cancer screening needs.

Lung Parenchymal Assessment in Primary and Secondary Pneumothorax.

PubMed

Bintcliffe, Oliver J; Edey, Anthony J; Armstrong, Lynne; Negus, Ian S; Maskell, Nick A

2016-03-01

The definition of primary spontaneous pneumothorax excludes patients with known lung disease; however, the assumption that the underlying lung is normal in these patients is increasingly contentious. The purpose of this study was to assess lung structure and compare the extent of emphysema in patients with primary versus secondary spontaneous pneumothorax and to patients with no pneumothorax in an otherwise comparable control group. We identified patients treated for pneumothorax by screening inpatient and outpatient medical records at one medical center in the United Kingdom. From this group, 20 patients had no clinically apparent underlying lung disease and were classified as having a primary spontaneous pneumothorax, and 20 patients were classified as having a secondary spontaneous pneumothorax. We assembled a control group composed of 40 subjects matched for age and smoking history who had a unilateral pleural effusion or were suspected to have a thoracic malignancy and had a chest computed tomography scan suitable for quantitative analysis. Demographics and smoking histories were collected. Quantitative evaluation of low-attenuation areas of the lung on computed tomography imaging was performed using semiautomated software, and the extent of emphysema-like destruction was assessed visually. The extent of emphysema and percentage of low-attenuation areas was greater for patients with primary spontaneous pneumothorax than for control subjects matched for age and smoking history (median, 0.25 vs. 0.00%; P = 0.019) and was also higher for patients with secondary pneumothorax than those with primary spontaneous pneumothorax (16.15 vs. 0.25%, P < 0.001). Patients with primary pneumothorax who smoked had significantly greater low-attenuation area than patients with primary pneumothorax who were nonsmokers (0.7 vs. 0.1%, P = 0.034). The majority of patients with primary spontaneous pneumothorax had quantifiable evidence of parenchymal destruction and emphysema. The exclusion of patients with underlying lung disease from the definition of primary spontaneous pneumothorax should be reappraised.

Effect of whitening toothpastes on bonding of restorative materials to enamel of primary teeth.

PubMed

Abdelmegid, F Y

2016-01-01

The aim of this in vitro investigation was to measure shear bond strength (SBS) of a resin composite and a resin-modified glass ionomer to enamel of primary teeth after application of different whitening toothpastes (WTs). Eighty labial enamel surfaces of primary incisors were randomly distributed into 8 groups of 10 each according to the surface treatment and bonding material. G1 and G2, control (brushed with water without WT); G3 and G4, (brushed with Colgate Optic White WT [Colgate-Palmolive Company, New York, NY, USA]), G5 and G6, (brushed with Crest Pro-Health Whitening WT [Procter and Gamble, Cincinnati, OH, USA]) and G7 and G8, (brushed with Arm and Hammer Advance White Extreme Whitening with Stain Defense WT [Church and Dwight Co., Princeton, NJ, USA]). SBS was measured at a crosshead speed of 0.5 mm/min and the type of bond failure was assessed using a stereomicroscope. There was significant difference between SBS of composite resin in groups 1, 3, 5, and 7 (P < 0.001), but no difference between resin-modified glass ionomer in groups 2, 4, 6, and 8 (P < 0.056). SBS of group 1 (control) was greater than groups 3, 5, and 7. There was a significant difference between group 1 and group 2 as well as group 7 and group 8 (P < 0.001). WTs affect SBS of resin composite, but not resin-modified glass ionomer to enamel of primary teeth. No difference of failure modes between different groups of tested materials.

Nurture Groups: A Large-Scale, Controlled Study of Effects on Development and Academic Attainment

ERIC Educational Resources Information Center

Reynolds, Sue; MacKay, Tommy; Kearney, Maura

2009-01-01

Nurture groups have contributed to inclusive practices in primary schools in the UK for some time now and have frequently been the subject of articles in this journal. This large-scale, controlled study of nurture groups across 32 schools in the City of Glasgow provides further evidence for their effectiveness in addressing the emotional…

Porous titanium construct cup compared to porous coated titanium cup in total hip arthroplasty. A randomised controlled trial.

PubMed

Salemyr, Mats; Muren, Olle; Eisler, Thomas; Bodén, Henrik; Chammout, Ghazi; Stark, André; Sköldenberg, Olof

2015-05-01

The purpose of this study was to determine if a new titanium cup with increased porosity resulted in different periacetabular bone loss and migration compared to a porous coated cup. Fifty-one patients with primary hip osteoarthritis were randomized to either a cup with porous titanium construct backside (porous titanium group, n = 25) or a conventional porous coated titanium cup (control group, n = 26). The primary outcome variable was change in periacetabular bone mineral density two years after surgery measured with dual energy X-ray absorptiometry (DXA). Secondary outcomes were implant fixation measured with radiostereometry (RSA) and clinical outcome scores. The pattern of bone remodelling was similar in the two groups with almost complete restoration to baseline values. BMD diminished in the two proximal zones and increased in the two distal zones. After minimal migration up to six months all implants in both groups became stable. We found no difference between the two groups in clinical outcome scores. In this prospective, randomized, controlled trial on a new porous titanium cup we found, compared to the control group, no clinically relevant differences regarding periacetabular bone preservation, implant fixation or clinical outcome up to two years postoperatively.

A nurse-delivered advice intervention can reduce chronic non-steroidal anti-inflammatory drug use in general practice: a randomized controlled trial.

PubMed

Jones, A C; Coulson, L; Muir, K; Tolley, K; Lophatananon, A; Everitt, L; Pringle, M; Doherty, M

2002-01-01

To find out whether a nurse-delivered educational package can reduce chronic oral non-steroidal anti-inflammatory drug (NSAID) usage in general practice. A prospective randomized controlled trial with assessment of economic cost/benefits was carried out in five general practices in Nottinghamshire with computerized prescribing systems, representing a mix of rural/urban and fundholding/non-fundholding practices. Patients suffering from non-malignant, non-inflammatory musculoskeletal pain received repeat prescriptions for oral NSAIDs. Two hundred and twenty-two patients were randomized to a control group (simple advice regarding NSAID use) or an intervention group (asked to withdraw their NSAIDs and employ appropriate alternative drug and non-drug therapies). All advice was supported by patient literature and delivered by a nurse practitioner trained in musculoskeletal assessment. The primary outcome measure was change in NSAID use 6 months after the intervention. Secondary outcome measures were changes in health and quality of life (SF-36 and EQ-5D questionnaires) and drug, health service and patient costs. An extra 28% of patients in the intervention group either stopped taking oral NSAIDs or reduced dosage by > or =50% at 6 months compared with controls. There was no detrimental effect on health and well-being. Oral NSAID prescription costs were significantly lowered in the intervention group but not in the control group. A non-significant increase in total drug prescription costs occurred in both groups. Nurse-based intervention can reduce chronic NSAID usage and costs in primary care and would be cost-effective if maintained in the long term. This intervention package would be readily applicable in primary care.

Can granisetron injection used as primary prophylaxis improve the control of nausea and vomiting with low- emetogenic chemotherapy?

PubMed

Keat, Chan Huan; Phua, Gillian; Abdul Kassim, Mohd Shainol; Poh, Wong Kar; Sriraman, Malathi

2013-01-01

The purpose of this study is to examine the risk of uncontrolled chemotherapy-induced nausea and vomiting (CINV) among patients receiving low emetogenic chemotherapy (LEC) with and without granisetron injection as the primary prophylaxis in addition to dexamethasone and metochlopramide. This was a single-centre, prospective cohort study. A total of 96 patients receiving LEC (52 with and 42 without granisetron) were randomly selected from the full patient list generated using the e-Hospital Information System (e-His). The rates of complete control (no CINV from days 1 to 5) and complete response (no nausea or vomiting in both acute and delayed phases) were identified through patient diaries which were adapted from the MASCC Antiemesis Tool (MAT). Selected covariates including gender, age, active alcohol consumption, morning sickness and previous chemotherapy history were controlled using the multiple logistic regression analyses. Both groups showed significant difference with LEC regimens (p<0.001). No differences were found in age, gender, ethnic group and other baseline characteristics. The granisetron group indicated a higher complete response rate in acute emesis (adjusted OR: 0.1; 95%CI 0.02-0.85; p=0.034) than did the non-granisetron group. Both groups showed similar complete control and complete response rates for acute nausea, delayed nausea and delayed emesis. Granisetron injection used as the primary prophylaxis in LEC demonstrated limited roles in CINV control. Optimization of the guideline-recommended antiemetic regimens may serve as a less costly alternative to protect patients from uncontrolled acute emesis.

[Symptoms related to the use of agricultural pesticides. The perspective from the primary care service].

PubMed

Subías Lorén, P J; Salvador Milian, M A; Moragues Farràs, C; Casanova Sandoval, J M; Marina Ortega, V

1995-12-01

To find whether agricultural workers seen in the general medical clinic attend due to symptoms connected with the use of pesticides. A crossover descriptive study comparing agricultural workers with a control group. Primary care. The clinical histories of 40 agricultural workers and a control group (sample of 58 paired for age and gender) who had been seen over the previous year. Age, gender, frequency of attendance, motives for consultation, risk factors and the number of consultations for symptoms possibly due to exposure to pesticides--in line with a previously composed list. There were no differences in frequency of attendance, overall reasons for consultation or risk factors. It was seen that agricultural workers consulted 4 times more than the control group for suspected pesticide poisoning (p = 0.0015). In our health area agricultural workers present symptoms which should probably be attributed to insufficient protection against pesticides. The primary care doctor working in rural zones where these products are heavily used must be able to identify these symptoms and take appropriate measures.

Evaluation of a tailored, multi-component intervention for implementation of evidence-based clinical practice guidelines in primary care physical therapy: a non-randomized controlled trial

PubMed Central

2014-01-01

Background Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence-based practice (EBP). There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy. The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden. Methods An implementation strategy based on theory and current evidence was developed. A tailored, multi-component implementation intervention, addressing earlier identified determinants, was carried out in three areas comprising 28 physical therapy practices including 277 physical therapists (PTs) (intervention group). In two adjacent areas, 171 PTs at 32 practices received no intervention (control group). The core component of the intervention was an implementation seminar with group discussions. Among other components were a website and email reminders. Data were collected at baseline and follow-up with a web-based questionnaire. Primary outcomes were the self-reported awareness of, knowledge of, access to, and use of guidelines. Secondary outcomes were self-reported attitudes toward EBP and guidelines. Analyses were performed using Pearson’s χ2 test and approximative z-test. Results 168 PTs (60.6%) in the intervention group and 88 PTs (51.5%) in the control group responded to the follow-up questionnaire. 186/277 PTs (67.1%) participated in the implementation seminars, of which 97 (52.2%) responded. The proportions of PTs reporting awareness of (absolute difference in change 20.6%, p = 0.023), knowledge where to find (20.4%, p = 0.007), access to (21.7%, p < 0.001), and frequent use of (9.5%, NS) guidelines increased more in the intervention group than in the control group. The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2% (p = 0.043) higher than the proportion in the control group. A higher proportion considered EBP helpful in decision making (p = 0.018). There were no other significant differences in secondary outcomes. Conclusions A tailored, theory- and evidence-informed, multi-component intervention for the implementation of clinical practice guidelines had a modest, positive effect on awareness of, knowledge of, access to, and use of guidelines, among PTs in primary care in western Sweden. In general, attitudes to EBP and guidelines were not affected. PMID:24589291

An embedded randomised controlled trial of a Teaser Campaign to optimise recruitment in primary care.

PubMed

Lee, Hopin; Hübscher, Markus; Moseley, G Lorimer; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; Williams, Christopher M; McAuley, James H

2017-04-01

Marketing communication and brand identity is a fundamental principle of advertising and end-user engagement. Health researchers have begun to apply this principle to trial recruitment in primary care. The aim of this study was to evaluate whether a Teaser Campaign using a series of postcards in advance of a conventional mail-out increases the number of primary care clinics that engage with a clinical trial. Embedded randomised recruitment trial across primary care clinics (general practitioners and physiotherapists) in the Sydney metropolitan area. Clinics in the Teaser Campaign group received a series of branded promotional postcards in advance of a standard letter inviting them to participate in a clinical trial. Clinics in the Standard Mail group did not receive the postcards. From a total of 744 clinics that were sent an invitation letter, 46 clinics in the Teaser Campaign group and 40 clinics in the Standard Mail group responded (11.6% total response rate). There was no between-group difference in the odds of responding to the invitation letter (odds ratio = 1.18, 95% confidence interval = 0.75-1.85, p = 0.49). For physiotherapy clinics and general practice clinics, the odds ratios were 1.43 (confidence interval = 0.82-2.48, p = 0.21) and 0.77 (confidence interval = 0.34-1.75, p  = 0.54), respectively. A Teaser Campaign using a series of branded promotional postcards did not improve clinic engagement for a randomised controlled trial in primary care.

Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy.

PubMed

Finkel, Richard S; Mercuri, Eugenio; Darras, Basil T; Connolly, Anne M; Kuntz, Nancy L; Kirschner, Janbernd; Chiriboga, Claudia A; Saito, Kayoko; Servais, Laurent; Tizzano, Eduardo; Topaloglu, Haluk; Tulinius, Már; Montes, Jacqueline; Glanzman, Allan M; Bishop, Kathie; Zhong, Z John; Gheuens, Sarah; Bennett, C Frank; Schneider, Eugene; Farwell, Wildon; De Vivo, Darryl C

2017-11-02

Spinal muscular atrophy is an autosomal recessive neuromuscular disorder that is caused by an insufficient level of survival motor neuron (SMN) protein. Nusinersen is an antisense oligonucleotide drug that modifies pre-messenger RNA splicing of the SMN2 gene and thus promotes increased production of full-length SMN protein. We conducted a randomized, double-blind, sham-controlled, phase 3 efficacy and safety trial of nusinersen in infants with spinal muscular atrophy. The primary end points were a motor-milestone response (defined according to results on the Hammersmith Infant Neurological Examination) and event-free survival (time to death or the use of permanent assisted ventilation). Secondary end points included overall survival and subgroup analyses of event-free survival according to disease duration at screening. Only the first primary end point was tested in a prespecified interim analysis. To control the overall type I error rate at 0.05, a hierarchical testing strategy was used for the second primary end point and the secondary end points in the final analysis. In the interim analysis, a significantly higher percentage of infants in the nusinersen group than in the control group had a motor-milestone response (21 of 51 infants [41%] vs. 0 of 27 [0%], P<0.001), and this result prompted early termination of the trial. In the final analysis, a significantly higher percentage of infants in the nusinersen group than in the control group had a motor-milestone response (37 of 73 infants [51%] vs. 0 of 37 [0%]), and the likelihood of event-free survival was higher in the nusinersen group than in the control group (hazard ratio for death or the use of permanent assisted ventilation, 0.53; P=0.005). The likelihood of overall survival was higher in the nusinersen group than in the control group (hazard ratio for death, 0.37; P=0.004), and infants with a shorter disease duration at screening were more likely than those with a longer disease duration to benefit from nusinersen. The incidence and severity of adverse events were similar in the two groups. Among infants with spinal muscular atrophy, those who received nusinersen were more likely to be alive and have improvements in motor function than those in the control group. Early treatment may be necessary to maximize the benefit of the drug. (Funded by Biogen and Ionis Pharmaceuticals; ENDEAR ClinicalTrials.gov number, NCT02193074 .).

Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer.

PubMed

Björneklett, Helena Granstam; Rosenblad, Andreas; Lindemalm, Christina; Ojutkangas, Marja-Leena; Letocha, Henry; Strang, Peter; Bergkvist, Leif

2013-04-01

Despite a fairly good prognosis, many breast-cancer patients suffer from symptoms such as anxiety, depression and fatigue, which may affect health-related quality of life and may persist for several years. The aim of the present study was to perform a long-term follow-up of a randomized study of support group intervention in women after primary breast cancer treatment. Three hundred and eighty two women with primary breast cancer were randomized to support group intervention or control group, 181 in each group. Women in the intervention group participated in 1 week of intervention followed by 4 days of follow-up 2 months later. This is a long-term follow-up undertaken, in average, 6.5 years after randomization. Patients answered the questionnaires the European Organisation for Research and Treatment of Cancer, quality of life questionnaire (EORTC QLQ-C30) and the breast cancer module questionnaire (BR 23), the hospital anxiety and depression scale (HAD) and the Norwegian version of the fatigue scale (FQ). After adjusting for treatment with chemotherapy, age, marriage, education and children at home, there was a significant improvement in physical, mental and total fatigue (FQ), cognitive function, body image and future perspective (EORTC QLQ C30 and BR23) in the intervention group compared with controls. The proportion of women affected by high anxiety and depression scores were not significantly different between the groups. Support intervention significantly improved cognitive function, body image, future perspective and fatigue, compared with to the findings in the control group. Copyright © 2012 Elsevier Inc. All rights reserved.

Primary Definitive Procedure versus Conventional Three-staged Procedure for the Management of Low-type Anorectal Malformation in Females: A Randomized Controlled Trial.

PubMed

Gupta, Alisha; Agarwala, Sandeep; Sreenivas, Vishnubhatla; Srinivas, Madhur; Bhatnagar, Veereshwar

2017-01-01

Females with Krickenbeck low-type anorectal malformations - vestibular fistula (VF) and perineal fistula (PF) - are managed either by a primary definitive or conventional three-staged approach. Ultimate outcome in these children may be affected by wound dehiscence leading to healing by fibrosis. Most of the literature favors one approach over other based on retrospective analysis of their outcomes. Whether a statistically significant difference in wound dehiscence rates between these approaches exists needed to be seen. A randomized controlled trial for girls <14 years with VF or PF was done. Random tables were used to randomize 33 children to Group I (primary procedure) and 31 to Group II (three-staged procedure). Statistical analysis was done for significance of difference ( P < 0.05) in the primary outcome (wound dehiscence) and secondary outcomes (immediate and early postoperative complications). Of the 64 children randomized, 54 (84%) had VF. Both groups were comparable in demography, clinical profile and age at surgery. The incidence of wound dehiscence (39.4% vs. 18.2%; P = 0.04), immediate postoperative complications (51.5% vs. 12.9%; P = 0.001), and early postoperative complications (42.4% vs. 12.9%; P = 0.01) was significantly higher in Group I as compared to Group II. Six of 13 children (46.2%) with dehiscence in Group I required a diverting colostomy to be made. Females with VF or PF undergoing primary definitive procedure have a significantly higher incidence of wound dehiscence ( P = 0.04), immediate ( P = 0.001) and early postoperative complications ( P = 0.01).

West End Walkers 65+: a randomised controlled trial of a primary care-based walking intervention for older adults: study rationale and design.

PubMed

Macmillan, Freya; Fitzsimons, Claire; Black, Karen; Granat, Malcolm H; Grant, Margaret P; Grealy, Madeleine; Macdonald, Hazel; McConnachie, Alex; Rowe, David A; Shaw, Rebecca; Skelton, Dawn A; Mutrie, Nanette

2011-02-19

In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged 65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group) or a 12-week waiting list control group (delayed group) who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor), mood (Positive and Negative Affect Schedule), functional ability (Perceived Motor-Efficacy Scale for Older Adults), quality of life (Short-Form (36) Health Survey version 2) and loneliness (UCLA Loneliness Scale) were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged 65 years. The study will also examine the effect of the intervention on the well-being of participants and gain an insight into both participant and research team member experiences of the intervention.

Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up

PubMed Central

Fea, Antonio Maria; Consolandi, Giulia; Zola, Marta; Pignata, Giulia; Cannizzo, Paola; Lavia, Carlo; Rolle, Teresa; Grignolo, Federico Maria

2015-01-01

Purpose. To report the long-term follow-up results in patients with cataract and primary open-angle glaucoma (POAG) randomly assigned to cataract surgery combined with micro-bypass stent implantation or phacoemulsification alone. Methods. 36 subjects with cataract and POAG were randomized in a 1 : 2 ratio to either iStent implantation and cataract surgery (combined group) or cataract surgery alone (control group). 24 subjects agreed to be evaluated again 48 months after surgery. Patients returned one month later for unmedicated washout assessment. Results. At the long-term follow-up visit we reported a mean IOP of 15,9 ± 2,3 mmHg in the iStent group and 17 ± 2,5 mmHg in the control group (p = NS). After washout, a 14,2% between group difference in favour of the combined group was statistically significant (p = 0,02) for mean IOP reduction. A significant reduction in the mean number of medications was observed in both groups compared to baseline values (p = 0,005 in the combined group and p = 0,01 in the control group). Conclusion. Patients in the combined group maintained low IOP levels after long-term follow-up. Cataract surgery alone showed a loss of efficacy in controlling IOP over time. Both treatments reduced the number of ocular hypotensive medications prescribed. This trial is registered with: NCT00847158. PMID:26587282

Mineral trioxide aggregate versus calcium hydroxide for pulpotomy in primary molars.

PubMed

Liu, He; Zhou, Qiong; Qin, Man

2011-01-01

To compare the effects of mineral trioxide aggregate (MTA) and calcium hydroxide (CH) for pulpotomy in primary molars. A randomised, bilateral self-controlled clinical trial was designed to compare the clinical effect of MTA and CH in pulpotomies in primary molars in 4- to 9-year-old children. Children with two similar-sized cavities on bilateral primary molar counterparts requiring pulpotomies were included. The two contralateral molars in each patient were randomly assigned to MTA or CH treatment. Clinical and radiographic examinations were performed to evaluate the treatment results at post-treatment recall. Seventeen pairs of self-controlled contralateral teeth were available for follow-up evaluations. The success rate of MTA was 94.1% (16/17), while the success rate of CH was 64.7% (11/17). Internal root resorption was the most frequent reason for failure in the CH group. Crown discolouration was common in the MTA-treated group. MTA was more successful than CH for pulpotomies in primary molar teeth, and may be a suitable replacement for CH in primary molar pulpotomies.

Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial

PubMed Central

2013-01-01

Background Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. Methods The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for cardiovascular disease. Participants were assigned to a control group or to one of two Mediterranean diets. The control group received education on following a low-fat diet, while the groups on Mediterranean diets received nutritional education and also free foods; either extra virgin olive oil, or nuts. Trained personnel measured participants’ BP at baseline and once yearly during a 4-year follow-up. We used generalized estimating equations to assess the differences between groups during the follow-up. Results The percentage of participants with controlled BP increased in all three intervention groups (P-value for within-group changes: P<0.001). Participants allocated to either of the two Mediterranean diet groups had significantly lower diastolic BP than the participants in the control group (−1.53 mmHg (95% confidence interval (CI) −2.01 to −1.04) for the Mediterranean diet supplemented with extra virgin olive oil, and −0.65 mmHg (95% CI -1.15 to −0.15) mmHg for the Mediterranean diet supplemented with nuts). No between-group differences in changes of systolic BP were seen. Conclusions Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP. However, we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group. Trial registration Current Controlled Trials ISRCTN35739639 PMID:24050803

Revision Ligament Reconstruction Tendon Interposition for Trapeziometacarpal Arthritis: A Case-Control Investigation

PubMed Central

Sadhu, Anita; Calfee, Ryan P.; Guthrie, Andre; Wall, Lindley B.

2016-01-01

Purpose To test the null hypothesis that there is no difference in patient-reported and objective outcomes of revision ligament reconstruction and tendon interposition (LRTI) compared to primary LRTI. Methods This case-control investigation enrolled 10 patients who had undergone revision LRTI at a tertiary care center. All patients had previously undergone primary trapeziectomy with LRTI. Patients with a minimum of two years of follow-up were eligible. All patients completed an in-office study evaluation. Controls (treated only with primary LRTI) were matched from our practice to reach a 1:2 case to control ratio. Outcome measures included Michigan Hand Questionnaire (primary outcome), Quick Disability of the Arm, Hand, and Shoulder (QuickDASH) Questionnaire, VAS for pain and improvement, and physical examination. Statistical analyses were conducted to compare the patient groups. Results Revision LRTI patients reported significantly worse outcomes on all measured standardized questionnaires compared with primary patients. The Michigan Hand Questionnaire indicated worse overall outcomes (54 versus 79) as well as worse pain, appearance, and ability to complete activities of daily living. Revision LRTI patients also reported more impairment (QuickDASH 47 versus 23), greater pain (VAS pain 6.3 versus 1), and less improvement after surgery (VAS improvement 2.7 versus 7.9). There was also a significantly higher rate of patient-reported depression in the revision LRTI group (50% versus 10% of primary LRTI patients). We did not find a significant difference in objective outcomes of pinch strength, grip strength, and thumb palmar abduction between the two groups. Conclusion Following revision LRTI patient-reported outcomes indicate worse perceived function and greater pain than expected following primary LRTI despite similar motion and strength. Revision surgery can be offered in the setting of persistent or recurrent symptoms, but patients should be counseled that improvement of symptoms is unpredictable. PMID:27751779

A randomized controlled trial of exercise therapy for dizziness and vertigo in primary care.

PubMed Central

Yardley, L; Beech, S; Zander, L; Evans, T; Weinman, J

1998-01-01

BACKGROUND: 'Vestibular rehabilitation' (VR) is an increasingly popular treatment option for patients with persistent dizziness. Previous clinical trials have only evaluated the effects of specialist therapy programmes in small, selective, or uncontrolled patient samples. AIM: To determine the benefits of VR compared with standard medical care, using a brief intervention for dizzy patients in primary care. METHOD: Adults consulting their general practitioner (GP) with dizziness or vertigo were randomly assigned to treatment or control groups. Patients in both groups received the same evaluation at baseline, six-week follow-up, and six-month follow-up, comprising examination of nystagmus, postural control, and movement-provoked dizziness, and a questionnaire assessment of subjective status, symptoms, handicap, anxiety, and depression. At baseline and six weeks later, the treatment group also received an individualized 30-minute therapy session, in which they were taught head, eye, and body exercises designed to promote vestibular compensation and enhance skill and confidence in balance. RESULTS: The treatment group (n = 67) improved on all measures, whereas the control group (n = 76) showed no improvement, resulting in a significant difference between the two groups on physical indices of balance and subjective indices of symptoms and distress. Odds ratios for improvement in treated patients relative to untreated patients were 3.1:1 at six weeks (95% CI = 1.4-6.8) and 3.8:1 at six months (95% CI = 1.6-8.7). CONCLUSION: VR is a simple, inexpensive, and beneficial treatment, and may be an appropriate first stage of management for many dizzy patients in primary care. PMID:9667087

Evaluation of a nurse-led dementia education and knowledge translation programme in primary care: A cluster randomized controlled trial.

PubMed

Wang, Yao; Xiao, Lily Dongxia; Ullah, Shahid; He, Guo-Ping; De Bellis, Anita

2017-02-01

The lack of dementia education programmes for health professionals in primary care is one of the major factors contributing to the unmet demand for dementia care services. To determine the effectiveness of a nurse-led dementia education and knowledge translation programme for health professionals in primary care; participants' satisfaction with the programme; and to understand participants' perceptions of and experiences in the programme. A cluster randomized controlled trial was used as the main methodology to evaluate health professionals' knowledge, attitudes and care approach. Focus groups were used at the end of the project to understand health professionals' perceptions of and experiences in the programme. Fourteen community health service centres in a province in China participated in the study. Seven centres were randomly assigned to the intervention or control group respectively and 85 health professionals in each group completed the programme. A train-the-trainer model was used to implement a dementia education and knowledge translation programme. Outcome variables were measured at baseline, on the completion of the programme and at 3-month follow-up. A mixed effect linear regression model was applied to compare the significant differences of outcome measures over time between the two groups. Focus groups were guided by four semi-structured questions and analysed using content analysis. Findings revealed significant effects of the education and knowledge translation programme on participants' knowledge, attitudes and a person-centred care approach. Focus groups confirmed that the programme had a positive impact on dementia care practice. A dementia education and knowledge translation programme for health professionals in primary care has positive effects on their knowledge, attitudes, care approach and care practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

A randomized controlled trial of a multilevel intervention to increase colorectal cancer screening among Latino immigrants in a primary care facility.

PubMed

Aragones, Abraham; Schwartz, Mark D; Shah, Nirav R; Gany, Francesca M

2010-06-01

Latino immigrants face a higher burden of colorectal cancer (CRC) and screening rates are low. To assess the effectiveness of a multilevel intervention in increasing the rate of CRC screening among Latino immigrants. A randomized controlled trial, with randomization at the physician level. Pairs of 65 primary care physicians and 65 Latino immigrant patients participated, 31 in the intervention and 34 in the control group. CRC educational video in Spanish on a portable personal digital video display device accompanied by a brochure with key information for the patient, and a patient-delivered paper-based reminder for their physician. Completed CRC screening, physician recommendation for CRC screening, and patient adherence to physician recommended CRC screening. The overall rate of completed screening for CRC was 55% for the intervention and 18% for the control group (p = 0.002). Physicians recommended CRC screening for 61% of patients in the intervention group versus 41% in the control group (p = 0.08). Of those that received a recommendation, 90% in the intervention group adhered to it versus 26% in the control group (p = 0.007). The intervention was successful in increasing rates of completed CRC screening primarily through increasing adherence after screening was recommended. Additional efforts should focus on developing new strategies to increase physician recommendation for CRC screening, while employing effective patient adherence interventions.

Poor glycemic control in younger women attending Malaysian public primary care clinics: findings from adults diabetes control and management registry.

PubMed

Cheong, Ai Theng; Lee, Ping Yein; Sazlina, Shariff-Ghazali; Mohamad Adam, Bujang; Chew, Boon How; Mastura, Ismail; Jamaiyah, Haniff; Syed Alwi, Syed-Abdul-Rahman; Sri Wahyu, Taher; Nafiza, Mat-Nasir

2013-12-10

Women of reproductive age are a group of particular concern as diabetes may affect their pregnancy outcome as well as long-term morbidity and mortality. This study aimed to compare the clinical profiles and glycemic control of reproductive and non-reproductive age women with type 2 diabetes (T2D) in primary care settings, and to determine the associated factors of poor glycemic control in the reproductive age group women. This was a cross-sectional study using cases reported by public primary care clinics to the Adult Diabetes Control and Management registry from 1st January to 31st December 2009. All Malaysian women aged 18 years old and above and diagnosed with T2D for at least 1 year were included in the analysis. The target for glycemic control (HbA1c < 6.5%) is in accordance to the recommended national guidelines. Both univariate and multivariate approaches of logistic regression were applied to determine whether reproductive age women have an association with poor glycemic control. Data from a total of 30,427 women were analyzed and 21.8% (6,622) were of reproductive age. There were 12.5% of reproductive age women and 18.0% of non-reproductive age women that achieved glycemic control. Reproductive age group women were associated with poorer glycemic control (OR = 1.5, 95% CI = 1.2-1.8). The risk factors associated with poor glycemic control in the reproductive age women were being of Malay and Indian race, longer duration of diabetes, patients on anti-diabetic agents, and those who had not achieved the target total cholesterol and triglycerides. Women with T2D have poor glycemic control, but being of reproductive age was associated with even poorer control. Health care providers need to pay more attention to this group of patients especially for those with risk factors. More aggressive therapeutic strategies to improve their cardiometabolic control and pregnancy outcome are warranted.

A randomized primary care trial of steroid titration against mannitol in persistent asthma: STAMINA trial.

PubMed

Lipworth, Brian J; Short, Philip M; Williamson, Peter A; Clearie, Karine L; Fardon, Thomas C; Jackson, Cathy M

2012-03-01

We compared titrating inhaled corticosteroid (ICS) against mannitol airway hyperresponsiveness (AHR) or a reference strategy (control) based on symptoms, reliever use, and lung function in primary care. One hundred sixty-four patients with persistent asthma were randomized in parallel group fashion following an initial ICS tapering. Subsequent ICS doses (as ciclesonide) were titrated against either the provocative dose of mannitol causing a 10% fall in FEV(1) (PD(10)) (AHR strategy) or a control group (reference strategy) over a 1-year period. One hundred nineteen participants (n = 61 AHR, n = 58 control) completed the study. Time to first mild exacerbation was not significantly different: hazard ratio, 1.29; 95% CI, 0.716-2.31; P = .40. Although there were 27% fewer total number of mild exacerbations over 12 months in AHR vs control groups (n = 84 vs n = 115, P = .03), there was no difference in severe exacerbations (n = 12 vs n = 13). No other significant differences were seen between groups with the exception of mannitol PD(10) and ICS dose. There was a 1.52 (95% CI, 0.61-2.42; P = .001) doubling dose difference in mannitol PD(10) between AHR vs control groups. The final mean daily ciclesonide dose was higher (P < .0001) in AHR vs control groups (514 μg vs 208 μg), with no associated significant suppression of overnight urinary cortisol/creatinine. Significant improvements were seen within the AHR group but not the control group for the provocative concentration of methacholine causing a 20% fall in FEV(1) (P < .05), salivary eosinophilic cationic protein (P < .05), exhaled nitric oxide (P < .05), symptoms (P < .005), and reliever use (P < .001). Mannitol challenge was well tolerated in a primary care setting. Using mannitol resulted in exposure to a higher dose of ciclesonide, which was associated with equivocal effects on exacerbations without associated adrenal suppression. Large-scale trials using mannitol in patients with more severe disease may now be warranted to further define its role. ClinicalTrials.gov; No.: NCT01216579; URL: www.clinicaltrials.gov.

Unilateral nasal obstruction affects motor representation development within the face primary motor cortex in growing rats.

PubMed

Abe, Yasunori; Kato, Chiho; Uchima Koecklin, Karin Harumi; Okihara, Hidemasa; Ishida, Takayoshi; Fujita, Koichi; Yabushita, Tadachika; Kokai, Satoshi; Ono, Takashi

2017-06-01

Postnatal growth is influenced by genetic and environmental factors. Nasal obstruction during growth alters the electromyographic activity of orofacial muscles. The facial primary motor area represents muscles of the tongue and jaw, which are essential in regulating orofacial motor functions, including chewing and jaw opening. This study aimed to evaluate the effect of chronic unilateral nasal obstruction during growth on the motor representations within the face primary motor cortex (M1). Seventy-two 6-day-old male Wistar rats were randomly divided into control ( n = 36) and experimental ( n = 36) groups. Rats in the experimental group underwent unilateral nasal obstruction after cauterization of the external nostril at 8 days of age. Intracortical microstimulation (ICMS) mapping was performed when the rats were 5, 7, 9, and 11 wk old in control and experimental groups ( n = 9 per group per time point). Repeated-measures multivariate ANOVA was used for intergroup and intragroup statistical comparisons. In the control and experimental groups, the total number of positive ICMS sites for the genioglossus and anterior digastric muscles was significantly higher at 5, 7, and 9 wk, but there was no significant difference between 9 and 11 wk of age. Moreover, the total number of positive ICMS sites was significantly smaller in the experimental group than in the control at each age. It is possible that nasal obstruction induced the initial changes in orofacial motor behavior in response to the altered respiratory pattern, which eventually contributed to face-M1 neuroplasticity. NEW & NOTEWORTHY Unilateral nasal obstruction in rats during growth periods induced changes in arterial oxygen saturation (SpO 2 ) and altered development of the motor representation within the face primary cortex. Unilateral nasal obstruction occurring during growth periods may greatly affect not only respiratory function but also craniofacial function in rats. Nasal obstruction should be treated as soon as possible to avoid adverse effects on normal growth, development, and physiological functions. Copyright © 2017 the American Physiological Society.

Effect of transcranial direct-current stimulation combined with treadmill training on balance and functional performance in children with cerebral palsy: a double-blind randomized controlled trial.

PubMed

Duarte, Natália de Almeida Carvalho; Grecco, Luanda André Collange; Galli, Manuela; Fregni, Felipe; Oliveira, Cláudia Santos

2014-01-01

Cerebral palsy refers to permanent, mutable motor development disorders stemming from a primary brain lesion, causing secondary musculoskeletal problems and limitations in activities of daily living. The aim of the present study was to determine the effects of gait training combined with transcranial direct-current stimulation over the primary motor cortex on balance and functional performance in children with cerebral palsy. A double-blind randomized controlled study was carried out with 24 children aged five to 12 years with cerebral palsy randomly allocated to two intervention groups (blocks of six and stratified based on GMFCS level (levels I-II or level III).The experimental group (12 children) was submitted to treadmill training and anodal stimulation of the primary motor cortex. The control group (12 children) was submitted to treadmill training and placebo transcranial direct-current stimulation. Training was performed in five weekly sessions for 2 weeks. Evaluations consisted of stabilometric analysis as well as the administration of the Pediatric Balance Scale and Pediatric Evaluation of Disability Inventory one week before the intervention, one week after the completion of the intervention and one month after the completion of the intervention. All patients and two examiners were blinded to the allocation of the children to the different groups. The experimental group exhibited better results in comparison to the control group with regard to anteroposterior sway (eyes open and closed; p<0.05), mediolateral sway (eyes closed; p<0.05) and the Pediatric Balance Scale both one week and one month after the completion of the protocol. Gait training on a treadmill combined with anodal stimulation of the primary motor cortex led to improvements in static balance and functional performance in children with cerebral palsy. Ensaiosclinicos.gov.br/RBR-9B5DH7.

Effect of vaginal spheres and pelvic floor muscle training in women with urinary incontinence: a randomized, controlled trial.

PubMed

Porta-Roda, Oriol; Vara-Paniagua, Jesús; Díaz-López, Miguel A; Sobrado-Lozano, Pilar; Simó-González, Marta; Díaz-Bellido, Paloma; Reula-Blasco, María C; Muñoz-Garrido, Francisco

2015-08-01

To compare the efficacy and safety of Kegel exercises performed with or without, vaginal spheres as treatment for women with urinary incontinence. Multicentre parallel-group, open, randomized controlled trial. Women were allocated to either a pelvic floor muscle-training program consisting of Kegel exercises performed twice daily, 5 days/week at home, over 6 months with vaginal spheres, or to the same program without spheres. The primary endpoint was women's report of urinary incontinence at 6 months using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF). Secondary outcome measures were the 1 hr pad-test, King's Health Questionnaire (KHQ) and a five-point Likert scale for subjective evaluation. Adherence was measured with the Morisky-Green test. Thirty-seven women were randomized to the spheres group and 33 to the control group. The primary endpoint was evaluated in 65 women (35 in the spheres group vs. 30 controls). ICIQ-UI-SF results improved significantly at 1-month follow-up in the spheres group (P < 0.01) and at 6 months in the controls. The 1 hr pad-test improved in the spheres group but not in the control group. No significant differences were found in the KHQ results or in the subjective evaluation of efficacy and safety. Adherence was higher in the spheres group but differences were not significant. Mild transient side effects were reported in four patients in the spheres group and one in the control group. Both treatments improved urinary incontinence but women who performed the exercises with vaginal spheres showed an earlier improvement. Vaginal spheres were well tolerated and safe. © 2014 Wiley Periodicals, Inc.

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 Patients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn. Trial registration National Medical Research Registration (NMRR) Number: NMRR-08-287-1442 Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370 PMID:23046818

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

Selvaraj, Francis Jude; Mohamed, Mafauzy; Omar, Khairani; Nanthan, Sudha; Kusiar, Zainab; Subramaniam, Selvaraj Y; Ali, Norsiah; Karanakaran, Kamalakaran; Ahmad, Fauziah; Low, Wilson H H

2012-10-10

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). 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. 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). Patients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn. National Medical Research Registration (NMRR) Number: NMRR-08-287-1442Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370.

Effects of platelet rich plasma on fascial healing in rats with fecal peritonitis

PubMed

Girgin, Mustafa; Binnetoglu, Kenan; Duman, Kazim; Kanat, Burhan Hakan; Cetinkaya, Ziya; Ayten, Refik; Ilhan, Yavuz Selim; Ilhan, Necip; Seker, Ibrahim; Timurkaan, Necati

2016-05-01

To evaluate the effects of platelet rich plasma (PRP) on the healing of fascia wherein peritonitis has been created. Twenty eight Wistar Albino rats were divided into four groups. Only a primary fascial repair following laparotomy was performed on Group 1, a primary fascial repair performed and PRP treatment applied following laparotomy on Group 2, and a fecal peritonitis created following laparotomy and a primary fascial repair carried out on Group 3. A fecal peritonitis was created following laparotomy and primary fascial repair and PRP treatment on the fascia was carried out on Group 4. TNF-α was found to be significantly lower in the control group (Group 1). It was detected at the highest level in the group in which fecal peritonitis was created and PRP applied (Group 4). TGF-β was determined as being significantly higher only in Group 4. Histopathologically, the differences between the groups in terms of cell infiltration and collagen deposition were not found to be significant. When platelet rich plasma was given histologically and biochemicaly as wound healing parameters cellular infiltration, collagen accumulation, and tissue hydroxyiproline levels were not increased but neovascularization, fibroblast activation and TNF Alfa levels were increased and PRP accelerated wound healing.

Effectiveness of Educational Poster on Knowledge of Emergency Management of Dental Trauma–Part 1. Cluster Randomised Controlled Trial for Primary and Secondary School Teachers

PubMed Central

Young, Cecilia; Wong, Kin Yau; Cheung, Lim K.

2013-01-01

Objective To investigate the effectiveness of educational posters in improving the knowledge level of primary and secondary school teachers regarding emergency management of dental trauma. Methods A cluster randomised controlled trial was conducted. 32 schools with a total of 515 teachers were randomised into intervention (poster) and control groups at the school level. Teachers’ baseline levels of knowledge about dental trauma were obtained by using a questionnaire. Posters containing information on dental trauma management were displayed in the school medical room, the common room used by staff, and on a notice board for 2 weeks in each school of the intervention group; in the control group, no posters were displayed. Teachers in both groups completed the questionnaire after 2 weeks. Results The teachers in the intervention schools (where posters were displayed for 2 weeks) showed statistically significant improvement in scores in cases where they had not previously learned about dental emergencies from sources other than first aid training, with an average score increase of 2.6656 (score range of questionnaire, −13 to 9; p-value <0.0001). Conclusion Educational posters on the management of dental trauma can significantly improve the level of knowledge of primary and secondary school teachers in Hong Kong. KClinicalTrials.com HKCTR-1307 ClinicalTrials.gov: NCT01707355 PMID:24147154

Patient Engagement Programs for Recognition and Initial Treatment of Depression in Primary Care: A Randomized Trial

PubMed Central

Kravitz, Richard L.; Franks, Peter; Feldman, Mitchell D.; Tancredi, Daniel J.; Slee, Christina A.; Epstein, Ronald M.; Duberstein, Paul R.; Bell, Robert A.; Jackson-Triche, Maga; Paterniti, Debora A.; Cipri, Camille; Iosif, Ana-Maria; Olson, Sarah; Kelly-Reif, Steven; Hudnut, Andrew; Dvorak, Simon; Turner, Charles; Jerant, Anthony

2015-01-01

Importance Interventions encouraging primary care patients’ engagement with their clinicians to address depression could improve outcomes but foster unnecessary treatment. Objective Determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care without increasing unnecessary anti-depressant prescribing. Design Randomized controlled trial comparing three interventions (DEV, IMCP, and control) conducted in two patients groups (depressed, defined by a Patient Health Questionnaire [PHQ]-9 score ≥5, and non-depressed [PHQ-9<5]) conducted between June 2010 and March 2012. Setting Primary care offices at 7 sites in 2 cities. Participants Depressed (N=559) and non-depressed (N=308) adult patients of 135 primary care clinicians. Intervention(s) DEV targeted to gender and income; IMCP tailored to individual patient characteristics; a sleep hygiene video (control). Main Outcome Measure(s) Depressed patients: composite measure of antidepressant recommendation and/or mental health referral (primary outcome); 12-week mental health, measured by the PHQ-8 (secondary outcome). Non- depressed patients: clinician-reported prescribing and patient-reported antidepressant recommendation (primary outcomes, pre-specified 3.5% non-inferiority margins). Results Depressed patients: composite care outcome rates were 18%, 26%, and 16% respectively in the DEV, IMCP, and control groups (cluster-adjusted DEV-control difference = 1.1% [95% CI −6.7 to 8.9, P=.79]; IMCP-control = 9.9% [95% CI 1.6 to 18.2, P=.02]). Twelve-week PHQ-8 effects were not significant: DEV- control = −0.2 points (95% CI −1.2 to 0.8); IMCP – control = 0.9 (95% CI −0.1 to 1.9). Non-depressed patients: clinician-reported antidepressant prescribing in the DEV and IMCP groups was non-inferior to control (DEV-control = −2.2%, 90% CI −8.0 to 3.498, non-inferiority (NI) P=.0499; IMCP-control = −3.3%, 90% CI −9.1 to 2.4, NI P=.02); patient-reported antidepressant recommendation did not achieve non-inferiority: DEV-control = 0.9% (90% CI −4.9 to 6.7; NI P=.23); IMCP-control = 0.3% (90% CI −5.1 to 5.7; NI P=.16). Conclusions and Relevance A tailored IMCP increased antidepressant recommendation and/or mental health referral among depressed patients but had no effect on 12-week mental health. The possibility that the IMCP and DEV increased patient-reported antidepressant recommendations among non-depressed patients could not be excluded. Further research is needed on the benefits and harms of these interventions. PMID:24193079

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

PubMed Central

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

2015-01-01

Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

Math Science Partnership of Southwest Pennsylvania: Measuring Progress Toward Goals

DTIC Science & Technology

2009-01-01

project design did not include a control group , the evaluation team used an alternative method to form comparison groups of school districts. The primary...providers. Additionally, educator networks bring together groups of teachers or coaches from across the region who are using common research -based curricula...goals. In addition, this study was not implemented as a randomized experiment with a control group , and this fact limits the ability to make

Local Control With Reduced-Dose Radiotherapy for Low-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group D9602 Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Breneman, John, E-mail: john.breneman@uchealth.com; Meza, Jane; Donaldson, Sarah S.

2012-06-01

Purpose: To analyze the effect of reduced-dose radiotherapy on local control in children with low-risk rhabdomyosarcoma (RMS) treated in the Children's Oncology Group D9602 study. Methods and Materials: Patients with low-risk RMS were nonrandomly assigned to receive radiotherapy doses dependent on the completeness of surgical resection of the primary tumor (clinical group) and the presence of involved regional lymph nodes. After resection, most patients with microscopic residual and uninvolved nodes received 36 Gy, those with involved nodes received 41.4 to 50.4 Gy, and those with orbital primary tumors received 45 Gy. All patients received vincristine and dactinomycin, with cyclophosphamide addedmore » for patient subsets with a higher risk of relapse in Intergroup Rhabdomyosarcoma Study Group III and IV studies. Results: Three hundred forty-two patients were eligible for analysis; 172 received radiotherapy as part of their treatment. The cumulative incidence of local/regional failure was 15% in patients with microscopic involved margins when cyclophosphamide was not part of the treatment regimen and 0% when cyclophosphamide was included. The cumulative incidence of local/regional failure was 14% in patients with orbital tumors. Protocol-specified omission of radiotherapy in girls with Group IIA vaginal tumors (n = 5) resulted in three failures for this group. Conclusions: In comparison with Intergroup Rhabdomyosarcoma Study Group III and IV results, reduced-dose radiotherapy does not compromise local control for patients with microscopic tumor after surgical resection or with orbital primary tumors when cyclophosphamide is added to the treatment program. Girls with unresected nonbladder genitourinary tumors require radiotherapy for postsurgical residual tumor for optimal local control to be achieved.« less

A prescription for health: a primary care based intervention to maintain the non-smoking status of young people.

PubMed

Fidler, W; Lambert, T W

2001-03-01

To evaluate the effectiveness of primary health care teams in maintaining a group of young people aged 10--15 years as non-smokers. Randomised controlled trial using postal questionnaires. Oxfordshire, UK. 2942 young people who were initially self declared non-smokers. Information about smoking, sent under signature of the subject's general practitioner, certificates and posters intended to reinforce non-smoking behaviour. Changes in smoking behaviour, attitudes measured after one year. After a year, smoking uptake was 7.8% in the control group compared with 5.1% in the intervention group (odds ratio (OR) 1.6, 95% confidence interval (CI) 1.1 to 2.2). Among boys the corresponding results were 5.2% and 2.4% (OR 2.3, 95% CI 1.2 to 4.6), and among girls 10.0% and 7.5% (OR 1.4, 95% CI 0.9 to 2.1). Among boys aged 14-15 the uptake rate was 12.8% in the control group compared with 5.4% in the intervention group. However, among girls of the same age the intervention was less effective, with smoking uptake of 15.1% in the control group and 12.8% in the intervention group. The intervention was more effective among young people whose initial attitudes identified them as definite non-smokers than those who were potential smokers. The intervention substantially reduced smoking uptake among the young people, particularly boys. Primary health care teams can play an important role in maintaining the non-smoking status of their young patients. Confidential postal contact from the doctor direct to the young person at home is influential and cost-effective.

Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial.

PubMed

Fioravanti, Antonella; Manica, Patrizia; Bortolotti, Roberto; Cevenini, Gabriele; Tenti, Sara; Paolazzi, Giuseppe

2018-05-05

The aim of this study was to assess the efficacy and tolerability of balneotherapy (BT) in patients with primary fibromyalgia syndrome (FS). In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 100 FS patients were randomized to receive a cycle of BT with highly mineralized sulfate water (BT group) or with tap water (control group). Clinical assessments were performed at screening visit, at basal time, and after treatment (2 weeks, 3 and 6 months). The primary outcome measures were the change of global pain on the Visual Analogue Scale (VAS) and Fibromyalgia Impact Questionnaire total score (FIQ-Total) from baseline to 15 days. Secondary outcomes included Widespread Pain Index, Symptom Severity Scale Score, Short Form Health Survey, State-Trait Anxiety Inventory (STAI), and Center for Epidemiologic Studies Depression Scale. We performed an intent-to-treat analysis. The Kolmogorov-Smirnov test was applied to verify the normality distribution of all quantitative variables and the Student's t test to compare sample data. In the BT group, we observed a significant improvement of VAS and FIQ-Total at the end of the treatment that persisted until 6 months, while no significant differences were found in the control group. The differences between groups were significant for primary parameters at each time point. Similar results were obtained for the other secondary outcomes except for the STAI outcome. Adverse events were reported by 10 patients in the BT group and by 22 patients in the control group. Our results support the short- and long-term therapeutic efficacy of BT in FS. NCT02548065.

Basic and clinical research on the therapeutic effect of intervention in primary liver cancer by targeted intra-arterial verapamil infusion.

PubMed

Pingsheng, Fan; Tengyue, Zhang; Qiang, Huang; Qiang, Wei; Xin, Sun; Liting, Qian

2012-01-01

The aim of this study was assess the therapeutic effect of targeted intra-arterial verapamil infusion in liver cancer patients and its side-effects in a dog model. The blood verapamil levels in dogs were determined after one-off intra-arterial infusion (0.7 mg/kg). Blood pressure, breathing state, and II-lead electrocardiogram were measured. Primary liver cancer patients (100) were randomly assigned into two groups. Controls (50) were treated with targeted intra-arterial infusion, and every patient received once-a-month interventional therapy, twice. Treatment group (50) received chemotherapeutics plus verapamil. Therapeutic and toxic side effects were evaluated. Control (41) and treatment group (45) patients were further treated with a second round of targeted intra-arterial infusion of chemotherapeutics plus verapamil, in 30 days after the 2-time interventional therapy. Every patient accepted interventional therapy 4-5 times during the 6 months after the first confirmed diagnosis. Following verapamil infusion, verapamil in dog liver was tenfold higher than in blood and was 4- to 20-fold higher than that needed for reversing carcinoma drug resistance. After interventional therapy, there were no significant changes in iconographic evaluation indices between the groups. Average activities of aminotransferases were 332 and 178 U/l in the treatment and control groups (P < 0.05). The imaging parameters of the treatment group were significantly better than those of control group. No side effects were found among the 91 patients who accepted verapamil infusion. After verapamil infusion, verapamil levels in dog hepatic tissue exceeded the effective concentration that reverses carcinoma multidrug resistance without any visible changes in the vital signs. Targeted intra-arterial verapamil infusion could improve the chemotherapy for the primary liver cancer patients without any side effects.

Effect of a training and educational intervention for physicians and caregivers on antibiotic prescribing for upper respiratory tract infections in children at primary care facilities in rural China: a cluster-randomised controlled trial.

PubMed

Wei, Xiaolin; Zhang, Zhitong; Walley, John D; Hicks, Joseph P; Zeng, Jun; Deng, Simin; Zhou, Yu; Yin, Jia; Newell, James N; Sun, Qiang; Zou, Guanyang; Guo, Yan; Upshur, Ross E G; Lin, Mei

2017-12-01

Inappropriate antibiotic prescribing contributes to the generation of drug resistance worldwide, and is particularly common in China. We assessed the effectiveness of an antimicrobial stewardship programme aiming to reduce inappropriate antibiotic prescribing in paediatric outpatients by targeting providers and caregivers in primary care hospitals in rural China. We did a pragmatic, cluster-randomised controlled trial with a 6-month intervention period. Clusters were primary care township hospitals in two counties of Guangxi province in China, which were randomly allocated to the intervention group or the control group (in a 1:1 ratio in Rong county and in a 5:6 ratio in Liujiang county). Randomisation was stratified by county. Eligible participants were children aged 2-14 years who attended a township hospital as an outpatient and were given a prescription following a primary diagnosis of an upper respiratory tract infection. The intervention included clinician guidelines and training on appropriate prescribing, monthly prescribing peer-review meetings, and brief caregiver education. In hospitals allocated to the control group, usual care was provided, with antibiotics prescribed at the individual clinician's discretion. Patients were masked to their allocated treatment group but doctors were not. The primary outcome was the antibiotic prescription rate in children attending the hospitals, defined as the cluster-level proportion of prescriptions for upper respiratory tract infections in 2-14-year-old outpatients, issued during the final 3 months of the 6-month intervention period (endline), that included one or more antibiotics. The outcome was based on prescription records and analysed by modified intention-to-treat. This study is registered with the ISRCTN registry, number ISRCTN14340536. We recruited all 25 eligible township hospitals in the two counties (14 hospitals in Rong county and 11 in Liujiang county), and randomly allocated 12 to the intervention group and 13 to the control group. We implemented the intervention in three internal pilot clusters between July 1, 2015, and Dec 31, 2015, and in the remaining nine intervention clusters between Oct 1, 2016 and March 31, 2016. Between baseline (the 3 months before implementation of the intervention) and endline (the final 3 months of the 6-month intervention period) the antibiotic prescription rate at the individual level decreased from 82% (1936/2349) to 40% (943/2351) in the intervention group, and from 75% (1922/2548) to 70% (1782/2552) in the control group. After adjusting for the baseline antibiotic prescription rate, stratum (county), and potentially confounding patient and prescribing doctor covariates, this endline difference between the groups represented an intervention effect (absolute risk reduction in antibiotic prescribing) of -29% (95% CI -42 to -16; p=0·0002). In China's primary care setting, pragmatic interventions on antimicrobial stewardship targeting providers and caregivers substantially reduced prescribing of antibiotics for childhood upper respiratory tract infections. Department of International Development (UKAID) through Communicable Diseases Health Service Delivery. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Basal insulin initiation in primary vs. specialist care: similar glycaemic control in two different patient populations.

PubMed

Orozco-Beltran, D; Pan, C; Svendsen, A L; Faerch, L; Caputo, S

2016-03-01

To investigate the effect of healthcare provider (HCP) type (primary vs. specialist) on glycaemic control and other treatment parameters. Study of Once-Daily Levemir (SOLVE(™) ) is an international, 24-week, observational study of insulin initiation in people with type 2 diabetes. A total of 17,374 subjects were included, comprising 4144 (23.9%) primary care subjects. Glycaemic control improved in both HCP groups from baseline to final visit [glycated haemoglobin (HbA1c) -1.2 ± 1.4% (-13.1 ± 15.3 mmol/mol) and -1.3 ± 1.6% (-14.2 ± 17.5 mmol/mol), respectively]. After adjustment for known confounders, there was no statistically significant effect of HCP group on final HbA1c [-0.04%, 95% confidence interval (CI) -0.09 to -0.01 (-0.4 mmol/mol, 95% CI -1.0-0.1 mmol/mol), p = 0.1590]. However, insulin doses at the final visit were higher in primary care patients (+0.06, 95% CI 0.06-0.07 U/kg, p < 0.0001). Logistic regression demonstrated a significant effect of HCP type (primary vs. specialist care) on hypoglycaemia risk [odds ratio (OR) 0.75, 95% CI 0.64-0.87, p = 0.0002]. Primary care physicians took more time to train patients and had more frequent contact with patients than specialists (both p < 0.0001). Primary care physicians and specialists achieved comparable improvements in glycaemic control following insulin initiation. © 2016 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Improving Quality of Care in Primary Health-Care Facilities in Rural Nigeria

PubMed Central

Ugo, Okoli; Ezinne, Eze-Ajoku; Modupe, Oludipe; Nicole, Spieker; Kelechi, Ohiri

2016-01-01

Background: Nigeria has a high population density but a weak health-care system. To improve the quality of care, 3 organizations carried out a quality improvement pilot intervention at the primary health-care level in selected rural areas. Objective: To assess the change in quality of care in primary health-care facilities in rural Nigeria following the provision of technical governance support and to document the successes and challenges encountered. Method: A total of 6 states were selected across the 6 geopolitical zones of the country. However, assessments were carried out in 40 facilities in only 5 states. Selection was based on location, coverage, and minimum services offered. The facilities were divided randomly into 2 groups. The treatment group received quality-of-care assessment, continuous feedback, and improvement support, whereas the control group received quality assessment and no other support. Data were collected using the SafeCare Healthcare Standards and managed on the SafeCare Data Management System—AfriDB. Eight core areas were assessed at baseline and end line, and compliance to quality health-care standards was compared. Result: Outcomes from 40 facilities were accepted and analyzed. Overall scores increased in the treatment facilities compared to the control facilities, with strong evidence of improvement (t = 5.28, P = .0004) and 11% average improvement, but no clear pattern of improvement emerged in the control group. Conclusion: The study demonstrated governance support and active community involvement offered potential for quality improvement in primary health-care facilities. PMID:28462280

Improving Quality of Care in Primary Health-Care Facilities in Rural Nigeria: Successes and Challenges.

PubMed

Ugo, Okoli; Ezinne, Eze-Ajoku; Modupe, Oludipe; Nicole, Spieker; Winifred, Ekezie; Kelechi, Ohiri

2016-01-01

Nigeria has a high population density but a weak health-care system. To improve the quality of care, 3 organizations carried out a quality improvement pilot intervention at the primary health-care level in selected rural areas. To assess the change in quality of care in primary health-care facilities in rural Nigeria following the provision of technical governance support and to document the successes and challenges encountered. A total of 6 states were selected across the 6 geopolitical zones of the country. However, assessments were carried out in 40 facilities in only 5 states. Selection was based on location, coverage, and minimum services offered. The facilities were divided randomly into 2 groups. The treatment group received quality-of-care assessment, continuous feedback, and improvement support, whereas the control group received quality assessment and no other support. Data were collected using the SafeCare Healthcare Standards and managed on the SafeCare Data Management System-AfriDB. Eight core areas were assessed at baseline and end line, and compliance to quality health-care standards was compared. Outcomes from 40 facilities were accepted and analyzed. Overall scores increased in the treatment facilities compared to the control facilities, with strong evidence of improvement ( t = 5.28, P = .0004) and 11% average improvement, but no clear pattern of improvement emerged in the control group. The study demonstrated governance support and active community involvement offered potential for quality improvement in primary health-care facilities.

Remineralization of primary tooth enamel from individuals with Down syndrome.

PubMed

Okamoto, Takuma; Shibata, Munenori; Tsuboi, Shinji; Nakagaki, Haruo; Fukuta, Osamu; Kusabe, Yoshitaka; Inukai, Junko

2011-01-01

The purpose of this study was to clarify the characteristics of primary tooth enamel of Down syndrome patients (DSPs). We examined 9 primary teeth of Down syndrome children and 11 primary teeth of normally developed children to investigate the remineralization processes of enamel by transverse microradiography and X ray micro analyzer (XMA). Mineral loss, lesion depth, maximum mineral value, minimum mineral value, depth of maximum mineral value, and depth of minimum mineral value were used to analyze transverse microradiography (TMR). In addition, we calculated the percentage of enamel remineralization. All the parameters in the 2 groups showed marked recovery. The results indicated that the Down syndrome group was significantly remineralized the same way as the control group. According to the comparison of mineral content distribution by XMA, the content distribution of magnesium was different between the 2 groups. While recovery through remineralization of primary teeth was similar between Down syndrome children and normally developed children, the mechanism of remineralization process may be different between the 2 groups; consequently, magnesium may be considered as one of the factors affecting recovery.

[Appraisal of occupational stress and strain in primary and secondary school teachers].

PubMed

Wang, Z; Lan, Y; Li, J; Wang, M

2001-09-01

This study was conducted to assess occupational stress and strain in primary and secondary school teachers. A test of occupational stress and strain was carried out by using Occupational Stress Inventory Revised Edition (OSI-R) in 1460 primary and secondary school teachers (teacher group) and 319 mental workers in non-educational area (non-teacher group as control). The results showed the level of occupational stress in role overload and physical environment in the teacher group was significantly higher than that in the non-teacher group (P < 0.05). In teacher group the level of occupational stress and strain increased with age; the occupational stress and strain in male teachers were significantly higher than those in female teachers (P < 0.01); the occupational stress and strain in secondary school teachers were significantly higher than those in primary school teachers. These results indicate: to protect and promote primary and secondary school teacher's health, particularly male teachers' health, to mitigate their work pressure and to raise the quality of education are important tasks in the area of occupational health.

Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

PubMed

Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

2014-05-01

Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work. Copyright 2014, SLACK Incorporated.

Discrete memory impairments in largely pure chronic users of MDMA.

PubMed

Wunderli, Michael D; Vonmoos, Matthias; Fürst, Marina; Schädelin, Katrin; Kraemer, Thomas; Baumgartner, Markus R; Seifritz, Erich; Quednow, Boris B

2017-10-01

Chronic use of 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") has repeatedly been associated with deficits in working memory, declarative memory, and executive functions. However, previous findings regarding working memory and executive function are inconclusive yet, as in most studies concomitant stimulant use, which is known to affect these functions, was not adequately controlled for. Therefore, we compared the cognitive performance of 26 stimulant-free and largely pure (primary) MDMA users, 25 stimulant-using polydrug MDMA users, and 56 MDMA/stimulant-naïve controls by applying a comprehensive neuropsychological test battery. Neuropsychological tests were grouped into four cognitive domains. Recent drug use was objectively quantified by 6-month hair analyses on 17 substances and metabolites. Considerably lower mean hair concentrations of stimulants (amphetamine, methamphetamine, methylphenidate, cocaine), opioids (morphine, methadone, codeine), and hallucinogens (ketamine, 2C-B) were detected in primary compared to polydrug users, while both user groups did not differ in their MDMA hair concentration. Cohen's d effect sizes for both comparisons, i.e., primary MDMA users vs. controls and polydrug MDMA users vs. controls, were highest for declarative memory (d primary =.90, d polydrug =1.21), followed by working memory (d primary =.52, d polydrug =.96), executive functions (d primary =.46, d polydrug =.86), and attention (d primary =.23, d polydrug =.70). Thus, primary MDMA users showed strong and relatively discrete declarative memory impairments, whereas MDMA polydrug users displayed broad and unspecific cognitive impairments. Consequently, even largely pure chronic MDMA use is associated with decreased performance in declarative memory, while additional deficits in working memory and executive functions displayed by polydrug MDMA users are likely driven by stimulant co-use. Copyright © 2017 Elsevier B.V. and ECNP. All rights reserved.

Creating SunSmart Schools

ERIC Educational Resources Information Center

Giles-Corti, B.; English, D. R.; Costa, C.; Milne, E.; Cross, D.; Johnston, R.

2004-01-01

Kidskin was a sun-protection intervention study involving 1776 children attending 33 primary schools in Perth, Western Australia. There were three study groups: a control group, a moderate intervention group and a high intervention group. In addition to receiving a specially designed curricular intervention (1995-1998), the moderate and high…

[Differentiation of coding quality in orthopaedics by special, illustration-oriented case group analysis in the G-DRG System 2005].

PubMed

Schütz, U; Reichel, H; Dreinhöfer, K

2007-01-01

We introduce a grouping system for clinical practice which allows the separation of DRG coding in specific orthopaedic groups based on anatomic regions, operative procedures, therapeutic interventions and morbidity equivalent diagnosis groups. With this, a differentiated aim-oriented analysis of illustrated internal DRG data becomes possible. The group-specific difference of the coding quality between the DRG groups following primary coding by the orthopaedic surgeon and final coding by the medical controlling is analysed. In a consecutive series of 1600 patients parallel documentation and group-specific comparison of the relevant DRG parameters were carried out in every case after primary and final coding. Analysing the group-specific share in the additional CaseMix coding, the group "spine surgery" dominated, closely followed by the groups "arthroplasty" and "surgery due to infection, tumours, diabetes". Altogether, additional cost-weight-relevant coding was necessary most frequently in the latter group (84%), followed by group "spine surgery" (65%). In DRGs representing conservative orthopaedic treatment documented procedures had nearly no influence on the cost weight. The introduced system of case group analysis in internal DRG documentation can lead to the detection of specific problems in primary coding and cost-weight relevant changes of the case mix. As an instrument for internal process control in the orthopaedic field, it can serve as a communicative interface between an economically oriented classification of the hospital performance and a specific problem solution of the medical staff involved in the department management.

Glucose control and vascular complications in veterans with type 2 diabetes.

PubMed

Duckworth, William; Abraira, Carlos; Moritz, Thomas; Reda, Domenic; Emanuele, Nicholas; Reaven, Peter D; Zieve, Franklin J; Marks, Jennifer; Davis, Stephen N; Hayward, Rodney; Warren, Stuart R; Goldman, Steven; McCarren, Madeline; Vitek, Mary Ellen; Henderson, William G; Huang, Grant D

2009-01-08

The effects of intensive glucose control on cardiovascular events in patients with long-standing type 2 diabetes mellitus remain uncertain. We randomly assigned 1791 military veterans (mean age, 60.4 years) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or standard glucose control. Other cardiovascular risk factors were treated uniformly. The mean number of years since the diagnosis of diabetes was 11.5, and 40% of the patients had already had a cardiovascular event. The goal in the intensive-therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level, as compared with the standard-therapy group. The primary outcome was the time from randomization to the first occurrence of a major cardiovascular event, a composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene. The median follow-up was 5.6 years. Median glycated hemoglobin levels were 8.4% in the standard-therapy group and 6.9% in the intensive-therapy group. The primary outcome occurred in 264 patients in the standard-therapy group and 235 patients in the intensive-therapy group (hazard ratio in the intensive-therapy group, 0.88; 95% confidence interval [CI], 0.74 to 1.05; P=0.14). There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause (hazard ratio, 1.07; 95% CI, 0.81 to 1.42; P=0.62). No differences between the two groups were observed for microvascular complications. The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard-therapy group and 24.1% in the intensive-therapy group. Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications with the exception of progression of albuminuria (P = 0.01) [added]. (ClinicalTrials.gov number, NCT00032487.) 2009 Massachusetts Medical Society

Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial.

PubMed

Groeneweg, Ruud; van Assen, Luite; Kropman, Hans; Leopold, Huco; Mulder, Jan; Smits-Engelsman, Bouwien C M; Ostelo, Raymond W J G; Oostendorp, Rob A B; van Tulder, Maurits W

2017-01-01

Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. ClinicalTrials.gov Identifier: NCT00713843.

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

PubMed

Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

2015-07-01

Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

Traditional Indigenous Games promoting physical activity and cultural connectedness in primary schools--cluster randomised control trial.

PubMed

Kiran, Asha; Knights, Janice

2010-08-01

This study investigated the effectiveness of Traditional Indigenous Games (TIG) to improve physical activity and cultural connectedness among primary school students in the community renewal areas of Townsville in North Queensland. A cluster randomised control trial was conducted in four primary schools in 2007. Baseline and post implementation surveys were conducted in two intervention and two control schools and the results were compared. TIG delivered in primary schools every week over period of three months did not contribute to any statistically significant improvement in intervention and control groups in physical activity levels or cultural connectedness. Further research specifically in terms of intensity and duration of TIG may inform whether physical activity may be improved. Enhancing the Indigenous cultural features of the existing TIG kit might positively influence Indigenous cultural connectedness.

The Efficacy of Thai Herbal Prasaplai Formula for Treatment of Primary Dysmenorrhea: A Short-Term Randomized Controlled Trial

PubMed Central

Vannabhum, Manmas; Wongwananuruk, Thanyarat; Suwannatrai, Ueamphon; Dangrat, Chongdee; Apichartvorakit, Angkana; Booranasubkajorn, Suksalin; Laohapand, Tawee; Akaraserenont, Pravit

2016-01-01

This study aims to compare the efficacy of pain relief between a specific Thai herbal Prasaplai formula (PPF) and placebo in patients with primary dysmenorrhea. Forty women with primary dysmenorrhea symptoms were randomized into two groups. The experimental group received PPF capsules 1000 mg orally three times per day before meals for three days starting from the first day of menstruation. The placebo group received placebo as the same dose and time. Average pain intensity from the first day to the third day of cycle significantly decreased in both groups (p < 0.001), but with no statistically significant difference between groups. Using a pre- and posttreatment difference in NRS of at least 2, a greater proportion of patients in PPF group experienced pain relief compared to placebo during the first and second day of period. A greater proportion of PPF group also experienced no pain compared to the placebo group on day 1 and day 3 by using multidimensional scoring. The PPF demonstrates pain relief activity when used during menstruation in primary dysmenorrhea patients, with no adverse effects. However, further studies are needed in order to assess the value of PPF as a long-term prophylaxis for primary dysmenorrhea. PMID:27829860

[Evaluation of the effectiveness of a Mindfulness and Self-Compassion program to reduce stress and prevent burnout in Primary Care health professionals].

PubMed

Aranda Auserón, Gloria; Elcuaz Viscarret, M Rosario; Fuertes Goñi, Carmen; Güeto Rubio, Victoria; Pascual Pascual, Pablo; Sainz de Murieta García de Galdeano, Enrique

2018-03-01

To evaluate the effectiveness of a Mindfulness and Self-Compassion Program on the levels of stress and burnout in Primary Care health professionals. Randomised, controlled clinical trial. Training in Mindfulness was offered to 1,281 health professionals in Navarra (Spain) Primary Care, and 48 of them accepted. The participants were randomly assigned to groups: 25 to the intervention group, and the remaining 23 to the control group. The Mindfulness and Self-Compassion training program consisted of sessions of 2.5chours/week for 8 weeks. The participants had to attend at least 75% of the sessions and perform a daily practical of 45minutes. The levels of mindfulness, self-compassion, perceived stress, and burnout were measured using four questionnaires before and after the intervention. After the intervention, the scores of the intervention group improved significantly in mindfulness (P<.001); perceived stress (P<.001); self-compassion: self-kindness P<.001, shared humanity P=.004, mindfulness P=.001; and burnout: emotional fatigue (P=.046). The comparison with the control group showed significant differences in mindfulness (P<.001), perceived stress (P<.001), self-kindness (P<.001) and emotional fatigue (P=.032). This work suggests that it may be beneficial to encourage mindfulness and self-compassion practices in the health environment. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

A randomized trial of a primary care-based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes.

PubMed

Rothman, Russell L; Malone, Robb; Bryant, Betsy; Shintani, Ayumi K; Crigler, Britton; Dewalt, Darren A; Dittus, Robert S; Weinberger, Morris; Pignone, Michael P

2005-03-01

To assess the efficacy of a pharmacist-led, primary care-based, disease management program to improve cardiovascular risk factors and glycated hemoglobin (A(1C)) levels in vulnerable patients with poorly controlled diabetes. A randomized controlled trial of 217 patients with type 2 diabetes and poor glycemic control (A(1C) level >or=8.0%) was conducted at an academic general medicine practice from February 2001 to April 2003. Intervention patients received intensive management from clinical pharmacists, as well as from a diabetes care coordinator who provided diabetes education, applied algorithms for managing glucose control and decreasing cardiovascular risk factors, and addressed barriers to care. Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider. Outcomes were recorded at baseline and at 6 and 12 months. Primary outcomes included blood pressure, A(1C) level, cholesterol level, and aspirin use. Secondary outcomes included diabetes knowledge, satisfaction, use of clinical services, and adverse events. For the 194 patients (89%) with 12-month data, the intervention group had significantly greater improvement than did the control group for systolic blood pressure (-9 mm Hg; 95% confidence interval [CI]: -16 to -3 mm Hg) and A(1C) level (-0.8%; 95% CI: -1.7% to 0%). Change in total cholesterol level was not significant. At 12 months, aspirin use was 91% in the intervention group versus 58% among controls (P <0.0001). Intervention patients had greater improvements in diabetes knowledge and satisfaction than did control patients. There were no significant differences in use of clinical services or adverse events. Our comprehensive disease management program reduced cardiovascular risk factors and A(1C) levels among vulnerable patients with type 2 diabetes and poor glycemic control.

Does a socio-ecological school model promote resilience in primary schools?

PubMed

Lee, Patricia C; Stewart, Donald E

2013-11-01

This research investigates the extent to which the holistic, multistrategy "health-promoting school" (HPS) model using a resilience intervention can lead to improved resilience among students. A quasi-experimental design using a study cohort selected from 20 primary schools in Queensland, Australia was employed. Ten intervention schools using HPS protocols, with training support, were compared with 10 control schools in student resilience scores and protective factors. Baseline data explored the interactive effect of protective factors on overall resilience scores. Postintervention analysis compared changes in protective factors and resilience, after implementing the HPS project. Baseline data analysis indicated no significant differences in the mean scores of protective factors and resilience scores between intervention and control groups (except for school connection). After 18 months of implementation, a resurvey showed that the intervention group had significantly higher scores than the control group on students' family connection, community connection, peer support, and their overall resilience. Results showed that students in the HPS group had significantly higher scores on resilience than did students in the control group. A comprehensive, whole-school approach to building resilience that integrates students, staff, and community can strengthen important protective factors and build student resilience. © 2013, American School Health Association.

Community-based intervention for depression management at the primary care level in Ha Nam Province, Vietnam: a cluster-randomised controlled trial.

PubMed

Niemi, Maria; Kiel, Simone; Allebeck, Peter; Hoan, Le Thi

2016-05-01

To evaluate the effectiveness of an intervention including psychoeducation and yoga for depression management at the primary healthcare level in one district in the Hà Nam province, Vietnam. The Patient Health Questionnaire-9 (PHQ-9) was used for depression screening and follow-up. Screened patients were further diagnosed with the Mini-International Neuropsychiatric Diagnostic Interview, by a trained general doctor. A linear regression model, adjusted for age, gender and baseline PHQ-9 score was used to assess whether the intervention leads to decreased depression severity compared to standard care in the control communes. Both groups had similar PHQ-9 scores at baseline. The intervention group had on average significantly lower PHQ-9 scores after the intervention than the control group. Almost half of the patients in the intervention group recovered from depression, whereas nobody did in the control group. The results indicate that the intervention can be more effective than standard care in treating depression. The mean change of the PHQ-9 score after the intervention is deemed to be of clinical relevance. © 2016 John Wiley & Sons Ltd.

Family physician and endocrinologist coordination as the basis for diabetes care in clinical practice

PubMed Central

Duran, Alejandra; Runkle, Isabelle; Matía, Pilar; de Miguel, Maria P; Garrido, Sofia; Cervera, Emilio; Fernandez, Maria D; Torres, Pilar; Lillo, Tomas; Martin, Patricia; Cabrerizo, Lucio; de la Torre, Nuria Garcia; Calle, Jose R; Ibarra, Jose; Charro, Aniceto L; Calle-Pascual, Alfonso L

2008-01-01

Background To estimate the proportion of diabetic patients (DPts) with peripheral vascular disease treated at a primary health care site after an endocrinologist-based intervention, who meet ATP III and Steno targets of metabolic control, as well as to compare the outcome with the results of the patients treated by endocrinologists. Methods A controlled, prospective over 30-months period study was conducted in area 7 of Madrid. One hundred twenty six eligible diabetic patients diagnosed as having peripheral vascular disease between January 2003 and June 2004 were included in the study. After a treatment period of three months by the Diabetes team at St Carlos Hospital, 63 patients were randomly assigned to continue their follow up by diabetes team (Group A) and other 63 to be treated by the family physicians (FP) at primary care level with continuous diabetes team coordination (Group B). 57 DPts from Group A and 59 from Group B, completed the 30 months follow-up period. At baseline both groups were similar in age, weight, time from diagnosis and metabolic control. The main outcomes of this study were the proportion of patients meeting ATP III and Steno goals for HbA1c (%), Cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, blood pressure, albumine-to-creatinine excretion ratio (ACR), body mass index (BMI), waist circumference (WC), anti-aggregation treatment and smoking status. Results At the end of the follow up, no differences were found between the groups. More than 37% of diabetic patients assigned to be treated by FP achieved a HbA1c < 6.5%, more than 50% a ACR < 30 mg/g, and more than 80% reached low risk values for cholesterol, LDL cholesterol, triglycerides, diastolic blood pressure and were anti-aggregated, and 12% remained smokers. In contrast, less than 45% achieved a systolic blood pressure < 130 mm Hg, less than 12% had a BMI < 25 Kg.m-2 (versus 23% in group A; p < 0.05) and 49%/30% (men/women) had a waist circumference of low risk. Conclusion Improvements in metabolic control among diabetic patients with peripheral vascular disease treated at a primary health care setting is possible, reaching similar results to the patients treated at a specialized level. Despite such an improvement, body weight control remains more than poor in both levels, mainly at primary care level. General practitioner and endocrinologist coordination care may be important to enhance diabetes management in primary care settings. Trial registration Clinical Trial number ISRCTN75037597 PMID:18671870

Biomarkers of low-grade inflammation in primary varicose veins of the lower limbs.

PubMed

Flore, R; Ponziani, F R; Gerardino, L; Santoliquido, A; Di Giorgio, A; Lupascu, A; Nesci, A; Tondi, P

2015-02-01

To analyze serum biomarkers of CVD in selected patients with primary axial reflux of great saphenous vein in one or both lower limbs. Ninety-six patients affected by uncomplicated varicose veins, were enrolled in the study. A unilateral, primary axial reflux in great saphenous veins was detected in 54 patients (U-CVD group) and a bilateral one in 42 (B-CVD group). Sixty-five age and sex-matched subjects without venous reflux were enrolled as controls. Mean venous pressure of both lower limbs at the distal great saphenous vein (mGSVP) and venous reflux were measured by continuous-wave Doppler ultrasound and echoduplex scanning, respectively. Reactive Oxygen Species (ROS), tissue Plasminogen Activator (t-PA) and its Inhibitor 1 (PAI-1) activities, Hematocrit (HTC), White Blood Cells (WBC), Neutrophyls (NEU), Platelets (PLT), Fibrinogen (FIB) and Blood Viscosity (BV) were assessed in blood samples drawn from the antecubital vein. B-CVD group showed higher fibrinogen values (p < 0.005) and higher mean venous pressure (0 < 0.0001) in comparison to controls, while U-CVD did not. No difference was found between both groups and controls for all the other parameters. Increased fibrinogen levels in patients with bilateral varicose veins may represent an early warning signal, as it could be associated to the long-term progression of chronic venous disease.

Head posture and dental wear evaluation of bruxist children with primary teeth.

PubMed

Vélez, A L; Restrepo, C C; Peláez-Vargas, A; Gallego, G J; Alvarez, E; Tamayo, V; Tamayo, M

2007-09-01

The aim of the present study was to compare the head position and dental wear of bruxist and non-bruxist children with primary dentition. All the subjects had complete primary dentition, dental and skeletal class I occlusion and were classified as bruxist or non-bruxist according to their anxiety level, bruxism described by their parents and signs of temporomandibular disorders. The dental wear was drawn in dental casts and processed in digital format. Physiotherapeutic evaluation and a cephalometric radiograph with natural head position were also performed for each child to evaluate the cranio-cervical position for the bruxist group (n = 33) and the control group (n = 20). The variables of the two groups were compared, using the Student t-test and Mann-Whitney U-test. A more anterior and downward head tilt was found in the bruxist group, with statistically significant differences compared with the controls. More significant dental wear was observed in the bruxist children. Bruxism seems to be related to altered natural head posture and more intense dental wear. Further studies are necessary to explore bruxism mechanisms.

Evaluation of two educative models in a primary care hypertension programme.

PubMed

Martínez-Amenós, A; Fernández Ferré, M L; Mota Vidal, C; Alsina Rocasalbas, J

1990-08-01

This study was planned in the context of a regional high blood pressure programme, to compare the efficacy of two educative methods. The group of 722 hypertensive patients (58.8% women), mean age 61 years, was randomly selected from 19 primary care centres. Initial assessment was based on a patient interview including 22 questions on high blood pressure, its consequences and treatment. Patients agreeing to participate in an active education team programme were distributed into three groups: individual education, team education and a control group. Those who declined to participate formed two groups: individual education and controls. Team education consisted of two audiovisual sessions attended by groups of 8-12 patients and conducted by treating physicians and nurses. Individual education included comments related to the 22 questions. Follow-up assessment was made after two months. An increase in the level of hypertension control was observed only in the accepting group, in which educative action was followed by increased knowledge. Results were similarly favourable for both the individual and team education groups and suggested the need to consider educational factors together with those influencing patient attitude towards an active educational programme.

Comparison of quality of obturation and instrumentation time using hand files and two rotary file systems in primary molars: A single-blinded randomized controlled trial.

PubMed

Govindaraju, Lavanya; Jeevanandan, Ganesh; Subramanian, E M G

2017-01-01

In permanent dentition, different rotary systems are used for canal cleaning and shaping. Rotary instrumentation in pediatric dentistry is an emerging concept. A very few studies have compared the efficiency of rotary instrumentation for canal preparation in primary teeth. Hence, this study was performed to compare the obturation quality and instrumentation time of two rotary files systems - Protaper, Mtwo with hand files in primary molars. Forty-five primary mandibular molars were randomly allotted to one of the three groups. Instrumentation was done using K-files in Group 1; Protaper in Group 2; and Mtwo in Group 3. Instrumentation time was recorded. The canal filling quality was assessed as underfill, optimal fill, and overfill. Statistical analysis was done using Chi-square, ANOVA, and post hoc Tukey test. No significant difference was observed in the quality of obturation among three groups. Intergroup comparison of the instrumentation time showed a statistically significant difference between the three groups. The use of rotary instrumentation in primary teeth results in marked reduction in the instrumentation time and improves the quality of obturation.

Effect of an educational intervention on the clinical competence for primary healthcare of rheumatic diseases in Mexican physicians.

PubMed

Cabrera-Pivaral, Carlos E; Ramírez-García, Sergio A; Zavala-González, Marco A

2016-01-01

To measure the effect of an educational intervention on clinical competences for diagnosis and treatment of rheumatic diseases in primary healthcare physicians working in the Guadalajara Metropolitan Area, Jalisco, Mexico. Quasi-experimental study conducted in physicians from two primary health care units. The study was carried out in a 40 physicians sample, 21 in Group "A" (intervention) and 19 in Group "B" (control). The clinical competence for diagnosis and treatment of rheumatic diseases was measured in both groups by means of an instrument previously designed and validated (Kuder-Richardson reliability index =0,94). Clinical competence average score prior to intervention was 47 for Group "A" and 42 for Group "B", while after the intervention it was 72 and 47 respectively, which shows statistically significant differences (Wilcoxon test, p<0,05). Clinical competence for diagnosis and treatment of rheumatic diseases in primary healthcare physicians is low; however, it can be improved by implementing educational interventions based on a constructivist approach.

Expression of extracellular matrix metalloproteinase inducer (EMMPRIN) in the endometrium of patients with repeated implantation failure after in vitro fertilization.

PubMed

Turgut, A; Goruk, N Y; Tunc, S Y; Agaçayak, E; Alabalik, U; Yalinkaya, A; Gül, T

2014-01-01

To compare the immunohistochemical expression of extracellular matrix metalloproteinase inducer (EMMPRIN) in repeated implantation failure (RIF) patients with normal fertile controls. The study group consisted of primary infertile patients with RIF and normal fertile controls between January 2011 and February 2013. Endometrial samples received at the luteal phase were exposed to immunohistochemical staining for EMMPRIN antibodies. EMMPRIN expression of endometrial glandular epithelial cells, stromal cells and vascular endothelial cells were evaluated. The main outcome measure was defined as immunohistochemical score with regard to the severity and extent of staining. The study group consisted of 26 primary infertile patients, whereas the control group consisted of 40 normal fertile controls. The fertile group was found to have stronger expression of EMMPRIN than the study group when endometrial glandular epithelial cells, stromal cells and vascular endothelial cells were evaluated with regards to the severity of staining (p < 0.001), the extent of staining (p < 0.001) and total staining score (p < 0.001). This is the first study showing low expression of EMMPRIN in the endometrial cells of the patients with RIF compared with fertile healthy controls. We suggest that reduced EMMPRIN expression in the human endometrium may lead to poor endometrial receptivity.

Maternal serum amyloid A level as a novel marker of primary unexplained recurrent early pregnancy loss.

PubMed

Ibrahim, Moustafa I; Ramy, Ahmed R; Abdelhamid, Ahmed S; Ellaithy, Mohamed I; Omar, Amna; Harara, Rany M; Fathy, Hayam; Abolouz, Ashraf S

2017-03-01

To assess maternal serum amyloid A (SAA) levels among women with primary unexplained recurrent early pregnancy loss (REPL). A prospective study was conducted among women with missed spontaneous abortion in the first trimester at Ain Shams University Maternity Hospital, Cairo, Egypt, between January 21 and December 25, 2014. Women with at least two consecutive primary unexplained REPLs and no previous live births were enrolled. A control group was formed of women with no history of REPL who had at least one previous uneventful pregnancy with no adverse outcomes. Serum samples were collected to measure SAA levels. The main outcome was the association between SAA and primary unexplained REPL. Each group contained 96 participants. Median SAA level was significantly higher among women with REPL (50.0 μg/mL, interquartile range 26.0-69.0) than among women in the control group (11.6 μg/mL, interquartile range 6.2-15.5; P<0.001). The SAA level was an independent indicator of primary unexplained REPL, after adjusting for maternal age and gestational age (odds ratio 1.12, 95% confidence interval 1.06-1.19; P<0.001). Elevated SAA levels found among women with primary unexplained REPL could represent a novel biomarker for this complication of pregnancy. © 2016 International Federation of Gynecology and Obstetrics.

Methods to decrease blood loss and transfusion requirements for liver transplantation.

PubMed

Gurusamy, Kurinchi Selvan; Pissanou, Theodora; Pikhart, Hynek; Vaughan, Jessica; Burroughs, Andrew K; Davidson, Brian R

2011-12-07

Excessive blood loss and increased blood transfusion requirements may have significant impact on the short-term and long-term outcomes after liver transplantation. To compare the potential benefits and harms of different methods of decreasing blood loss and blood transfusion requirements during liver transplantation. We searched The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and metaRegister of Controlled Trials until September 2011. We included all randomised clinical trials that were performed to compare various methods of decreasing blood loss and blood transfusion requirements during liver transplantation. Two authors independently identified the trials and extracted the data. We analysed the data with both the fixed-effect and the random-effects model using RevMan Analysis. For each outcome we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI) based on available data analysis. We also conducted network meta-analysis. We included 33 trials involving 1913 patients. The sample size in the trials varied from 8 to 209 participants. The interventions included pharmacological interventions (aprotinin, tranexamic acid, epsilon amino caproic acid, antithrombin 3, recombinant factor (rFvIIa), oestrogen, prostaglandin, epinephrine), blood substitutes (blood components rather than whole blood, hydroxy-ethyl starch, thromboelastography), and cardiovascular interventions (low central venous pressure). All the trials were of high risk of bias. Primary outcomes were reported in at least two trials for the following comparisons: aprotinin versus control, tranexamic acid versus control, recombinant factor VIIa (rFVIIa) versus control, and tranexamic acid versus aprotinin. There were no significant differences in the 60-day mortality (3 trials; 6/161 (3.7%) in the aprotinin group versus 8/119 (6.7%) in the control group; RR 0.52; 95% CI 0.18 to 1.45), primary graft non-function (2 trials; 0/128 (0.0%) in the aprotinin group versus 4/89 (4.5%) in the control group; RR 0.15; 95% CI 0.02 to 1.25), retransplantation (3 trials; 2/256 (0.8%) in the aprotinin group versus 12/178 (6.7%) in the control group; RR 0.21; 95% CI 0.02 to 1.79), or thromboembolic episodes (3 trials; 4/161 (2.5%) in the aprotinin group versus 5/119 (4.2%) in the control group; RR 0.59; 95% CI 0.19 to 1.84) between the aprotinin and control groups. There were no significant differences in the 60-day mortality (3 trials; 4/83 (4.8%) in the tranexamic acid group versus 5/56 (8.9%) in the control group; RR 0.55; 95% CI 0.17 to 1.76), retransplantation (2 trials; 3/41 (7.3%) in the tranexamic acid group versus 3/36 (8.3%) in the control group; RR 0.79; 95% CI 0.18 to 3.48), or thromboembolic episodes (5 trials; 5/103 (4.9%) in the tranexamic acid group versus 1/76 (1.3%) in the control group; RR 2.20; 95% CI 0.38 to 12.64) between the tranexamic acid and control groups. There were no significant differences in the 60-day mortality (3 trials; 8/195 (4.1%) in the recombinant factor VIIa (rFVIIa) group versus 2/91 (2.2%) in the control group; RR 1.51; 95% CI 0.33 to 6.95), thromboembolic episodes (2 trials; 24/185 (13.0%) in the rFVIIa group versus 8/81 (9.9%) in the control group; RR 1.38; 95% CI 0.65 to 2.91), or serious adverse events (2 trials; 90/185 (48.6%) in the rFVIIa group versus 30/81 (37.0%) in the control group; RR 1.30; 95% CI 0.94 to 1.78) between the rFVIIa and control groups. There were no significant differences in the 60-day mortality (2 trials; 6/91 (6.6%) in the tranexamic acid group versus 1/87 (1.1%) in the aprotinin group; RR 4.12; 95% CI 0.71 to 23.76) or thromboembolic episodes (2 trials; 4/91 (4.4%) in the tranexamic acid group versus 2/87 (2.3%) in the aprotinin group; RR 1.97; 95% CI 0.37 to 10.37) between the tranexamic acid and aprotinin groups. The remaining outcomes in the above comparisons and the remaining comparisons included only only trial under the primary outcome or the outcome was not reported at all in the trials. There were no significant differences in the mortality, primary graft non-function, graft failure, retransplantation, thromboembolic episodes, or serious adverse events in any of these comparisons. However, the confidence intervals were wide, and it is not possible to reach any conclusion on the safety of the interventions. None of the trials reported the quality of life in patients.Secondary outcomes were reported in at least two trials for the following comparisons - aprotinin versus control, tranexamic acid versus control, rFVIIa versus control, thromboelastography versus control, and tranexamic acid versus aprotinin. There was significantly lower allogeneic blood transfusion requirements in the aprotinin group than the control group (8 trials; 185 patients in aprotinin group and 190 patients in control group; SMD -0.61; 95% CI -0.82 to -0.40). There were no significant differences in the allogeneic blood transfusion requirements between the tranexamic acid and control groups (4 trials; 93 patients in tranexamic acid group and 66 patients in control group; SMD -0.27; 95% CI -0.59 to 0.06); rFVIIa and control groups (2 trials; 141 patients in rFVIIa group and 80 patients in control group; SMD -0.05; 95% CI -0.32 to 0.23); thromboelastography and control groups (2 trials; 31 patients in thromboelastography group and 31 patients in control group; SMD -0.73; 95% CI -1.69 to 0.24); or between the tranexamic acid and aprotinin groups (3 trials; 101 patients in tranexamic acid group and 97 patients in aprotinin group; SMD -0.09; 95% CI -0.36 to 0.19). The remaining outcomes in the above comparisons and the remaining comparisons included only only trial under the primary outcome or the outcome was not reported at all in the trials. There were no significant differences in the blood loss, transfusion requirements, hospital stay, or intensive care unit stay in most of the comparisons. Aprotinin, recombinant factor VIIa, and thromboelastography groups may potentially reduce blood loss and transfusion requirements. However, risks of systematic errors (bias) and risks of random errors (play of chance) hamper the confidence in this conclusion. We need further well-designed randomised trials with low risk of systematic error and low risk of random errors before these interventions can be supported or refuted.

The Effect of Learning Geometry Topics of 7th Grade in Primary Education with Dynamic Geometer's Sketchpad Geometry Software to Success and Retention

ERIC Educational Resources Information Center

Kesan, Cenk; Caliskan, Sevdane

2013-01-01

The aim of this study is to investigate the effect of learning geometry topics of 7th grade in primary education with dynamic geometer's sketchpad geometry software to student's success and retention. The experimental research design with The Posttest-Only Control Group was used in this study. In the experimental group, dynamic geometer's…

An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial.

PubMed

Little, Paul; Stuart, Beth; Hobbs, Fd Richard; Kelly, Jo; Smith, Emily R; Bradbury, Katherine J; Hughes, Stephanie; Smith, Peter W F; Moore, Michael V; Lean, Mike E J; Margetts, Barrie M; Byrne, Chris D; Griffin, Simon; Davoudianfar, Mina; Hooper, Julie; Yao, Guiqing; Zhu, Shihua; Raftery, James; Yardley, Lucy

2016-10-01

The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care. We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703. Between Jan 30, 2013, and March 20, 2014, 818 participants were randomly assigned to the control group (n=279), the POWeR+F group (n=269), or the POWeR+R group (n=270). Weight loss averaged over 12 months was recorded in 666 (81%) participants. The control group lost almost 3 kg over 12 months (crude mean weight: baseline 104·38 kg [SD 21·11; n=279], 6 months 101·91 kg [19·35; n=136], 12 months 101·74 kg [19·57; n=227]). The primary imputed analysis showed that compared with the control group, patients in the POWeR+F group achieved an additional weight reduction of 1·5 kg (95% CI 0·6-2·4; p=0·001) averaged over 12 months, and patients in the POWeR+R group achieved an additional 1·3 kg (0·34-2·2; p=0·007). 21% of patients in the control group had maintained a clinically important 5% weight reduction at month 12, compared with 29% of patients in the POWeR+F group (risk ratio 1·56, 0·96-2·51; p=0·070) and 32% of patients in the POWeR+R group (1·82, 1·31-2·74; p=0·004). The incremental overall cost to the health service per kg weight lost with the POWeR+ interventions versus the control strategy was £18 (95% CI -129 to 195) for POWeR+F and -£25 (-268 to 157) for POWeR+R; the probability of being cost-effective at a threshold of £100 per kg lost was 88% and 98%, respectively. No adverse events were reported. Weight loss can be maintained in some individuals by use of novel written material with occasional brief nurse follow-up. However, more people can maintain clinically important weight reductions with a web-based behavioural program and brief remote follow-up, with no increase in health service costs. Future research should assess the extent to which clinically important weight loss can be maintained beyond 1 year. Health Technology Assessment Programme of the National Institute for Health Research. Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

Effectiveness of a Brief Psychosocial Intervention on Quality of Life of Primary Caregivers of Iranian Children With Cancer: A Randomized Controlled Trial.

PubMed

Safarabadi-Farahani, Atefeh; Maarefvand, Masoomeh; Biglarian, Akbar; Khubchandani, Jagdish

2016-01-01

Cancer in children has a great impact on primary caregiver quality of life (QOL). This study examined the effectiveness of a brief psychosocial intervention (BPI) on QOL of Primary Caregivers of Children with Cancer (PCCCs). Sixty-five PCCCs participated in a randomized controlled trial in Mahak Hospital and Rehabilitation Complex in Tehran, Iran. A 5-week long BPI (which comprised of counseling sessions and telephone follow-up) was delivered to the intervention group in addition to usual service, while the control group was provided with usual service. Data were collected using the Caregiver Quality of Life Index-Cancer-Persian version (CQOLC-P) prior to intervention, post-intervention, and at follow-up (i.e. 30days after the intervention). Repeated measures analysis of variance analysis (ANOVA) was used to evaluate outcomes. Majority of the participants were mothers (95%), between ages of 24-47 years (95%) with children between ages of 2-12 years. Most child cancer diagnoses were for brain tumors (n=31) and blood cancers (n=17). Significant improvement was found within the intervention group on QOL (p<0.001) including improvements on subscale measures of mental/emotional burden (p<0.001), disruption (p<0.001), and positive adaptation (p<0.001), compared with the control group over time. There was no difference between the intervention and control groups on the financial subscale measure after intervention (p>0.05). BPI was an effective strategy to improve the quality of life of PCCCs. Similar interventions can be planned by practitioners to reduce the burden of childhood cancer on PCCCs. Copyright © 2016 Elsevier Inc. All rights reserved.

Early ovarian follicular development in prepubertal Wistar rats acutely exposed to androgens.

PubMed

Paixão, L; Velez, L M; Santos, B R; Tusset, C; Lecke, S B; Motta, A B; Spritzer, P M

2016-08-01

Androgens may directly modulate early ovarian follicular development in preantral stages and androgen excess before puberty may disrupt this physiological process. Therefore, the aim of this study was to investigate the dynamics of follicular morphology and circulating androgen and estradiol levels in prepubertal Wistar rats acutely exposed to androgens. Prepubertal female Wistar rats were distributed into three groups: control, equine chorionic gonadotropin (eCG) intervention and eCG plus dehydroepiandrosterone (DHEA) intervention (eCG+DHEA). Serum DHEA, testosterone and estradiol levels were determined, and ovarian morphology and morphometry were assessed. The eCG+DHEA group presented increased serum estradiol and testosterone levels as compared with the control group (P<0.01), and higher serum DHEA concentration v. the eCG-only and control groups (P<0.01). In addition, the eCG+DHEA group had a higher number of, and larger-sized, primary and secondary follicles as compared with the control group (P<0.05). The eCG group presented intermediate values for number and size of primary and secondary follicles, without significant differences as compared with the other two groups. The number of antral follicles was higher in the eCG+DHEA and eCG groups v. controls (P<0.05). The number of primordial, atretic and cystic follicles were similar in all groups. In conclusion, the present experimental model using an acute eCG+DHEA intervention was useful to investigate events involved in initial follicular development under hyperandrogenic conditions, and could provide a reliable tool to study defective follicular development with possible deleterious reproductive consequences later in life.

Effectiveness of a school-based nutrition and food safety education program among primary and junior high school students in Chongqing, China.

PubMed

Zhou, Wen-Jie; Xu, Xiang-Long; Li, Ge; Sharma, Manoj; Qie, Ya-Ling; Zhao, Yong

2016-03-01

Health behavioral patterns, especially eating patterns, established in childhood often carry over into adulthood, and some of the unhealthy ones are later associated with adult morbidity and mortality. Recently, a few nutrition and food safety education programs have been implemented in primary and junior high schools in China. This study aims to examine the effectiveness of a school-based nutrition and food safety education program among primary and junior high school students in China. A mixed study design incorporating an intervention study and a quantitative survey was conducted for this research. With stratified cluster sampling, students from the 5(th) and 6(th) grade in one primary school and the 7(th) and 8(th) grade in one junior high school in Chongqing, China, were all selected and separated randomly into an intervention group (n = 501) and a control group (n = 522). Effectiveness evaluation investigations were performed at the initial time and nine-month follow-up (n = 472), respectively. Effectiveness of pre-/post-intervention and nine-month follow-up changes in scores of nutrition knowledge and food safety was assessed using a two-tailed t-test and analysis of variance. Nutrition knowledge scores for the intervention group were mean 9.03, SD±2.75 at the baseline, and 14.70±3.28 after intervention. There was a significant improvement (t = 29.78, p < 0.01). The nine-month follow-up knowledge scores of the intervention group were 12.35±2.89, which were lower than the immediately after the intervention group (t = 12.40, p<0.01), but higher than those of the baseline level (t = 18.04, p < 0.01). Food safety scores of the post-intervention were higher (p < 0.01) than that of the control group in both pre-intervention and nine-month follow-up. The control group had no significant change in the pre-post intervention. It is feasible and effective to improve nutrition and food safety knowledge among primary and junior high school students through school-based nutrition and food safety education programs. © The Author(s) 2014.

Animal source foods have a positive impact on the primary school test scores of Kenyan schoolchildren in a cluster-randomised, controlled feeding intervention trial.

PubMed

Hulett, Judie L; Weiss, Robert E; Bwibo, Nimrod O; Galal, Osman M; Drorbaugh, Natalie; Neumann, Charlotte G

2014-03-14

Micronutrient deficiencies and suboptimal energy intake are widespread in rural Kenya, with detrimental effects on child growth and development. Sporadic school feeding programmes rarely include animal source foods (ASF). In the present study, a cluster-randomised feeding trial was undertaken to determine the impact of snacks containing ASF on district-wide, end-term standardised school test scores and nutrient intake. A total of twelve primary schools were randomly assigned to one of three isoenergetic feeding groups (a local plant-based stew (githeri) with meat, githeri plus whole milk or githeri with added oil) or a control group receiving no intervention feeding. After the initial term that served as baseline, children were fed at school for five consecutive terms over two school years from 1999 to 2001. Longitudinal analysis was used controlling for average energy intake, school attendance, and baseline socio-economic status, age, sex and maternal literacy. Children in the Meat group showed significantly greater improvements in test scores than those in all the other groups, and the Milk group showed significantly greater improvements in test scores than the Plain Githeri (githeri+oil) and Control groups. Compared with the Control group, the Meat group showed significant improvements in test scores in Arithmetic, English, Kiembu, Kiswahili and Geography. The Milk group showed significant improvements compared with the Control group in test scores in English, Kiswahili, Geography and Science. Folate, Fe, available Fe, energy per body weight, vitamin B₁₂, Zn and riboflavin intake were significant contributors to the change in test scores. The greater improvements in test scores of children receiving ASF indicate improved academic performance, which can result in greater academic achievement.

Insulinlike growth factor I affects ocular development: a study of untreated and treated patients with Laron syndrome.

PubMed

Bourla, Dan Haim; Laron, Zvi; Snir, Moshe; Lilos, Pearl; Weinberger, Dov; Axer-Siegel, Ruth

2006-07-01

To evaluate the ocular dimensions in patients with primary growth hormone receptor insensitivity (Laron syndrome [LS]) and to study the effect of supplemental insulinlike growth factor I (IGF-I) on ocular growth. Retrospective case series. Twelve patients with LS, 8 untreated (LS group) and 4 treated (LS-T group) with supplemental IGF-I, and 30 healthy controls. Ocular dimensions and refraction were measured, and a full ophthalmologic examination was performed. Differences in the average ocular dimension data among IGF-I-treated patients, untreated ones, and controls. The average axial length of eyes in the LS group was 21.94 mm (standard deviation [SD], 0.81). Corresponding values for the LS-T and control group eyes were 22.53 mm (SD, 1.74) and 23.20 mm (SD, 1.35) respectively. The average anterior chamber depth of eyes in the LS group was 2.55 mm (SD, 0.26). Corresponding values for eyes in the LS-T and control groups were 3.48 mm (SD, 0.09) and 3.84 mm (SD, 0.16) respectively. The average lens thickness of eyes in the LS group was 4.56 mm (SD, 0.36). Corresponding values for the LS-T and control groups were 3.77 mm (SD, 0.23) and 3.51 mm (SD, 0.25), respectively. The average corneal curvature of eyes in the LS group was 46.9 diopters (D) (SD, 2.32). Corresponding values for the LS-T and control groups were 47.6 D (SD, 2.83) and 44.4 D (SD, 1.5), respectively. Insulinlike growth factor I seems to be an important regulator of ocular growth as documented in patients with primary growth hormone insensitivity. The mechanism of this observation should be investigated further.

Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study

PubMed Central

Wade, C; Wang, L; Zhao, W J; Cardini, F; Kronenberg, F; Gui, S Q; Ying, Z; Zhao, N Q; Chao, M T; Yu, J

2016-01-01

Objective To determine if injection of vitamin K3 in an acupuncture point is optimal for the treatment of primary dysmenorrhoea, when compared with 2 other injection treatments. Setting A Menstrual Disorder Centre at a public hospital in Shanghai, China. Participants Chinese women aged 14–25 years with severe primary dysmenorrhoea for at least 6 months not relieved by any other treatment were recruited. Exclusion criteria were the use of oral contraceptives, intrauterine devices or anticoagulant drugs, pregnancy, history of abdominal surgery, participation in other therapies for pain and diagnosis of secondary dysmenorrhoea. Eighty patients with primary dysmenorrhoea, as defined on a 4-grade scale, completed the study. Two patients withdrew after randomisation. Interventions A double-blind, double-dummy, randomised controlled trial compared vitamin K3 acupuncture point injection to saline acupuncture point injection and vitamin K3 deep muscle injection. Patients in each group received 3 injections at a single treatment visit. Primary and secondary outcome measures The primary outcome was the difference in subjective perception of pain as measured by an 11 unit Numeric Rating Scale (NRS). Secondary measurements were Cox Pain Intensity and Duration scales and the consumption of analgesic tablets before and after treatment and during 6 following cycles. Results Patients in all 3 groups experienced pain relief from the injection treatments. Differences in NRS measured mean pain scores between the 2 active control groups were less than 1 unit (−0.71, CI −1.37 to −0.05) and not significant, but the differences in average scores between the treatment hypothesised to be optimal and both active control groups (1.11, CI 0.45 to 1.78) and (1.82, CI 1.45 to 2.49) were statistically significant in adjusted mixed-effects models. Menstrual distress and use of analgesics were diminished for 6 months post-treatment. Conclusions Acupuncture point injection of vitamin K3 relieves menstrual pain rapidly and is a useful treatment in an urban outpatient clinic. Trial registration number NCT00104546; Results. PMID:26733563

[Intelligence level and intelligence structure of children with primary nocturnal enuresis].

PubMed

Dai, Xiao-Mei; Ma, Hong-Wei; Pan, Xue-Xia

2007-10-01

Some research has shown that there may be memory/caution (M/C) defects in children with primary nocturnal enuresis (PNE). This study aimed to investigate whether the defects affect the intelligence level and the intelligence structure in PNE children. Intelligence tests were performed by means of Wechsler Young Children Scales of Intelligence (C-WISC) in 40 children with PNE and 40 age-matched normal children. The full intelligence quotient (FIQ), verbal IQ (VIQ) and performances IQ (PIQ) in the PNE group were in a normal range and did not different from the control group. There were significant differences in the scores for digit extent, decipher, knowledge and arithmetics between the PNE and the control groups (P < 0.05). M/C factor in the PNE group was statistically lower than in the control group (93.44 +/-11.27 vs 100.03 +/-11.79; P < 0.05). The total intelligence level of children with PNE was normal, but the M/C factor in the intelligence structure had some defects, suggesting that PNE may be related to the abnormity of executive function in the frontal lobe.

Altered motor control patterns in whiplash and chronic neck pain.

PubMed

Woodhouse, Astrid; Vasseljen, Ottar

2008-06-20

Persistent whiplash associated disorders (WAD) have been associated with alterations in kinesthetic sense and motor control. The evidence is however inconclusive, particularly for differences between WAD patients and patients with chronic non-traumatic neck pain. The aim of this study was to investigate motor control deficits in WAD compared to chronic non-traumatic neck pain and healthy controls in relation to cervical range of motion (ROM), conjunct motion, joint position error and ROM-variability. Participants (n = 173) were recruited to three groups: 59 patients with persistent WAD, 57 patients with chronic non-traumatic neck pain and 57 asymptomatic volunteers. A 3D motion tracking system (Fastrak) was used to record maximal range of motion in the three cardinal planes of the cervical spine (sagittal, frontal and horizontal), and concurrent motion in the two associated cardinal planes relative to each primary plane were used to express conjunct motion. Joint position error was registered as the difference in head positions before and after cervical rotations. Reduced conjunct motion was found for WAD and chronic neck pain patients compared to asymptomatic subjects. This was most evident during cervical rotation. Reduced conjunct motion was not explained by current pain or by range of motion in the primary plane. Total conjunct motion during primary rotation was 13.9 degrees (95% CI; 12.2-15.6) for the WAD group, 17.9 degrees (95% CI; 16.1-19.6) for the chronic neck pain group and 25.9 degrees (95% CI; 23.7-28.1) for the asymptomatic group. As expected, maximal cervical range of motion was significantly reduced among the WAD patients compared to both control groups. No group differences were found in maximal ROM-variability or joint position error. Altered movement patterns in the cervical spine were found for both pain groups, indicating changes in motor control strategies. The changes were not related to a history of neck trauma, nor to current pain, but more likely due to long-lasting pain. No group differences were found for kinaesthetic sense.

Altered motor control patterns in whiplash and chronic neck pain

PubMed Central

Woodhouse, Astrid; Vasseljen, Ottar

2008-01-01

Background Persistent whiplash associated disorders (WAD) have been associated with alterations in kinesthetic sense and motor control. The evidence is however inconclusive, particularly for differences between WAD patients and patients with chronic non-traumatic neck pain. The aim of this study was to investigate motor control deficits in WAD compared to chronic non-traumatic neck pain and healthy controls in relation to cervical range of motion (ROM), conjunct motion, joint position error and ROM-variability. Methods Participants (n = 173) were recruited to three groups: 59 patients with persistent WAD, 57 patients with chronic non-traumatic neck pain and 57 asymptomatic volunteers. A 3D motion tracking system (Fastrak) was used to record maximal range of motion in the three cardinal planes of the cervical spine (sagittal, frontal and horizontal), and concurrent motion in the two associated cardinal planes relative to each primary plane were used to express conjunct motion. Joint position error was registered as the difference in head positions before and after cervical rotations. Results Reduced conjunct motion was found for WAD and chronic neck pain patients compared to asymptomatic subjects. This was most evident during cervical rotation. Reduced conjunct motion was not explained by current pain or by range of motion in the primary plane. Total conjunct motion during primary rotation was 13.9° (95% CI; 12.2–15.6) for the WAD group, 17.9° (95% CI; 16.1–19.6) for the chronic neck pain group and 25.9° (95% CI; 23.7–28.1) for the asymptomatic group. As expected, maximal cervical range of motion was significantly reduced among the WAD patients compared to both control groups. No group differences were found in maximal ROM-variability or joint position error. Conclusion Altered movement patterns in the cervical spine were found for both pain groups, indicating changes in motor control strategies. The changes were not related to a history of neck trauma, nor to current pain, but more likely due to long-lasting pain. No group differences were found for kinaesthetic sense. PMID:18570647

Leukocyte telomere length and depression, anxiety and stress and adjustment disorders in primary health care patients.

PubMed

Wang, Xiao; Sundquist, Kristina; Hedelius, Anna; Palmér, Karolina; Memon, Ashfaque A; Sundquist, Jan

2017-04-24

The primary aim was to examine possible differences in telomere length between primary health care patients, with depression, anxiety or stress and adjustment disorders, and healthy controls. The second aim was to examine the association between telomere length and baseline characteristics in the patients. The third aim was to examine the potential effects of the 8-week treatments (mindfulness-based group therapy or treatment as usual, i.e. mostly cognitive-based therapy) on telomere length, and to examine whether there was a difference in the potential effect on telomere length between the two groups. A total of 501 individuals including 181 patients (aged 20-64 years), with depression, anxiety and stress and adjustment disorders, and 320 healthy controls (aged 19-70 years) were recruited in the study. Patient data were collected from a randomized controlled trial comparing mindfulness-based group therapy with treatment as usual. We isolated genomic DNA from blood samples, collected at baseline and after the 8-week follow-up. Telomere length was measured by quantitative real-time (qRT)-PCR. Telomere length was significantly shorter in the patients (mean = 0.77 ± 0.12,), compared to the controls (mean = 0.81 ± 0.14) (p = 0.006). The difference in telomere length remained significant after controlling for age and sex. Old age, male sex and being overweight were associated with shorter telomere length. There was no significant difference in telomere length between baseline and at the 8-week follow-up in any of the treatment groups and no difference between the two groups. Our findings confirm that telomere length, as compared with healthy controls, is shortened in patients with depression, anxiety and stress and adjustment disorders. In both groups (mindfulness-based group therapy or treatment as usual), the telomere length remained unchanged after the 8-week treatment/follow-up and there was no difference between the two groups. (ClinicalTrials.gov ID: NCT01476371 ) Registered November 11, 2011.

Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study.

PubMed

Wade, C; Wang, L; Zhao, W J; Cardini, F; Kronenberg, F; Gui, S Q; Ying, Z; Zhao, N Q; Chao, M T; Yu, J

2016-01-05

To determine if injection of vitamin K3 in an acupuncture point is optimal for the treatment of primary dysmenorrhoea, when compared with 2 other injection treatments. A Menstrual Disorder Centre at a public hospital in Shanghai, China. Chinese women aged 14-25 years with severe primary dysmenorrhoea for at least 6 months not relieved by any other treatment were recruited. Exclusion criteria were the use of oral contraceptives, intrauterine devices or anticoagulant drugs, pregnancy, history of abdominal surgery, participation in other therapies for pain and diagnosis of secondary dysmenorrhoea. Eighty patients with primary dysmenorrhoea, as defined on a 4-grade scale, completed the study. Two patients withdrew after randomisation. A double-blind, double-dummy, randomised controlled trial compared vitamin K3 acupuncture point injection to saline acupuncture point injection and vitamin K3 deep muscle injection. Patients in each group received 3 injections at a single treatment visit. The primary outcome was the difference in subjective perception of pain as measured by an 11 unit Numeric Rating Scale (NRS). Secondary measurements were Cox Pain Intensity and Duration scales and the consumption of analgesic tablets before and after treatment and during 6 following cycles. Patients in all 3 groups experienced pain relief from the injection treatments. Differences in NRS measured mean pain scores between the 2 active control groups were less than 1 unit (-0.71, CI -1.37 to -0.05) and not significant, but the differences in average scores between the treatment hypothesised to be optimal and both active control groups (1.11, CI 0.45 to 1.78) and (1.82, CI 1.45 to 2.49) were statistically significant in adjusted mixed-effects models. Menstrual distress and use of analgesics were diminished for 6 months post-treatment. Acupuncture point injection of vitamin K3 relieves menstrual pain rapidly and is a useful treatment in an urban outpatient clinic. NCT00104546; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Southeastern Virtual Institute for Health Equity and Wellness (SEVIEW) Phase II

DTIC Science & Technology

2015-09-01

level intervention has been tested using community focus groups , following the CBPR approach • A Community Oral Health Promoter (COHP) has been hired...questionnaire immediately prior to their primary care visit and receive a summary printout for their physician; (B) The control group will take the...interactive tablet-based questionnaire, will show more improvement in the above outcomes than participants in the control group after 12 months of

Changes in Cognitive Function in Patients with Primary Insomnia.

PubMed

Guo, Hui; Wei, Meijie; Ding, Wantao

2017-06-25

Neuropsychological evidence is not sufficient concerning whether there is cognitive impairment in patients with primary insomnia. Further study is needed in this regard. To measure the changes in cognitive functioning in patients with primary insomnia. 40 patients with insomnia (insomnia group) and 48 normal sleepers (control group) were tested using the Pittsburgh Sleep Quality Index (PSQI), episodic memory test, and Montreal Cognitive Assessment (MoCA). The insomnia group had significantly lower scores than the control group in the naming ( t =3.17, p= 0.002), immediate memory ( t =3.33, p= 0.001), and delayed recall ( t =6.05, p= 0.001) sections of the MoCA, as well as a lower overall score on the MoCA ( t =3.24, p= 0.002). Participants with different degrees of insomnia also had significantly different scores in naming ( F =7.56, p= 0.001), language ( F =3.22, p= 0.045), total score ( F =6.72, p= 0.002), delayed memory ( F =8.41, p= 0.001), and delayed recall (F=22.67, p= 0.001) sections of the MoCA. The age of primary insomnia patients was correlated to MoCA total score, immediate memory, delayed recall, and delayed recognition function, also with statistical significance. The years of education of primary insomnia patients was also significantly correlated to overall MoCA score, as well as visuospatial and executive function, naming, attention, language, and abstraction sections of the MoCA. Primary insomnia patients have cognitive impairment. The more severe the insomnia is, the wider the range of and the more serious the degree of cognitive impairment is.

Biomechanical evaluation of macro and micro designed screw-type implants: an insertion torque and removal torque study in rabbits.

PubMed

Chowdhary, Ramesh; Jimbo, Ryo; Thomsen, Christian; Carlsson, Lennart; Wennerberg, Ann

2013-03-01

To investigate the combined effect of macro and pitch shortened threads on primary and secondary stability during healing, but before dynamic loading. Two sets of turned implants with different macro geometry were prepared. The test group possessed pitch shortened threads in between the large threads and the control group did not have thread alterations. The two implant groups were placed in both femur and tibiae of 10 lop-eared rabbits, and at the time of implant insertion, insertion torques were recorded. After 4 weeks, all implants were subjected to removal torque tests. The insertion torque values for the control and test groups for the tibia were 15.7 and 20.6 Ncm, respectively, and for the femur, 11.8, and 12.8 Ncm respectively. The removal torque values for the control and test groups in the tibia were 7.9 and 9.1 Ncm, respectively, and for the femur, 7.9 and 7.7 Ncm respectively. There was no statistically significant difference between the control and test groups. Under limited dynamic load, the addition of pitch shortened threads did not significantly improve either the primary or the secondary stability of the implants in bone. © 2011 John Wiley & Sons A/S.

Effects of online palliative care training on knowledge, attitude and satisfaction of primary care physicians.

PubMed

Pelayo, Marta; Cebrián, Diego; Areosa, Almudena; Agra, Yolanda; Izquierdo, Juan Vicente; Buendía, Félix

2011-05-23

The Spanish Palliative Care Strategy recommends an intermediate level of training for primary care physicians in order to provide them with knowledge and skills. Most of the training involves face-to-face courses but increasing pressures on physicians have resulted in fewer opportunities for provision of and attendance to this type of training. The effectiveness of on-line continuing medical education in terms of its impact on clinical practice has been scarcely studied. Its effect in relation to palliative care for primary care physicians is currently unknown, in terms of improvement in patient's quality of life and main caregiver's satisfaction. There is uncertainty too in terms of any potential benefits of asynchronous communication and interaction among on-line education participants, as well as of the effect of the learning process.The authors have developed an on-line educational model for palliative care which has been applied to primary care physicians in order to measure its effectiveness regarding knowledge, attitude towards palliative care, and physician's satisfaction in comparison with a control group.The effectiveness evaluation at 18 months and the impact on the quality of life of patients managed by the physicians, and the main caregiver's satisfaction will be addressed in a different paper. Randomized controlled educational trial to compared, on a first stage, the knowledge and attitude of primary care physicians regarding palliative care for advanced cancer patients, as well as satisfaction in those who followed an on-line palliative care training program with tutorship, using a Moodle Platform vs. traditional education. 169 physicians were included, 85 in the intervention group and 84 in the control group, of which five were excluded. Finally 82 participants per group were analyzed. There were significant differences in favor of the intervention group, in terms of knowledge (mean 4.6; CI 95%: 2.8 to 6.5 (p = 0.0001), scale range 0-33), confidence in symptom management (p = 0.02) and confidence in terms of communication (p = 0.038). Useful aspects were pointed out, as well as others to be improved in future applications. The satisfaction of the intervention group was high. The results of this study show that there was a significant increase of knowledge of 14%-20% and a significant increase in the perception of confidence in symptom management and communication in the intervention group in comparison with the control group that received traditional methods of education in palliative care or no educational activity at all. The overall satisfaction with the intervention was good-very good for most participants.This on-line educational model seems a useful tool for palliative care training in primary care physicians who have a high opinion about the integration of palliative care within primary care. The results of this study support the suggestion that learning effectiveness should be currently investigated comparing different Internet interventions, instead of Internet vs. no intervention.

Effects of online palliative care training on knowledge, attitude and satisfaction of primary care physicians

PubMed Central

2011-01-01

Background The Spanish Palliative Care Strategy recommends an intermediate level of training for primary care physicians in order to provide them with knowledge and skills. Most of the training involves face-to-face courses but increasing pressures on physicians have resulted in fewer opportunities for provision of and attendance to this type of training. The effectiveness of on-line continuing medical education in terms of its impact on clinical practice has been scarcely studied. Its effect in relation to palliative care for primary care physicians is currently unknown, in terms of improvement in patient's quality of life and main caregiver's satisfaction. There is uncertainty too in terms of any potential benefits of asynchronous communication and interaction among on-line education participants, as well as of the effect of the learning process. The authors have developed an on-line educational model for palliative care which has been applied to primary care physicians in order to measure its effectiveness regarding knowledge, attitude towards palliative care, and physician's satisfaction in comparison with a control group. The effectiveness evaluation at 18 months and the impact on the quality of life of patients managed by the physicians, and the main caregiver's satisfaction will be addressed in a different paper. Methods Randomized controlled educational trial to compared, on a first stage, the knowledge and attitude of primary care physicians regarding palliative care for advanced cancer patients, as well as satisfaction in those who followed an on-line palliative care training program with tutorship, using a Moodle Platform vs. traditional education. Results 169 physicians were included, 85 in the intervention group and 84 in the control group, of which five were excluded. Finally 82 participants per group were analyzed. There were significant differences in favor of the intervention group, in terms of knowledge (mean 4.6; CI 95%: 2.8 to 6.5 (p = 0.0001), scale range 0-33), confidence in symptom management (p = 0.02) and confidence in terms of communication (p = 0.038). Useful aspects were pointed out, as well as others to be improved in future applications. The satisfaction of the intervention group was high. Conclusions The results of this study show that there was a significant increase of knowledge of 14%-20% and a significant increase in the perception of confidence in symptom management and communication in the intervention group in comparison with the control group that received traditional methods of education in palliative care or no educational activity at all. The overall satisfaction with the intervention was good-very good for most participants. This on-line educational model seems a useful tool for palliative care training in primary care physicians who have a high opinion about the integration of palliative care within primary care. The results of this study support the suggestion that learning effectiveness should be currently investigated comparing different Internet interventions, instead of Internet vs. no intervention. Trial Registration German Clinical Trials Register DRKS00000694 PMID:21605381

Rates of Anovulation in Adolescents and Young Adults with Moderate to Severe Primary Dysmenorrhea and Those without Primary Dysmenorrhea.

PubMed

Seidman, Laura C; Brennan, Kathleen M; Rapkin, Andrea J; Payne, Laura A

2018-04-01

To evaluate rates of presumptive anovulation in eumenorrheic adolescents and young adults with moderate to severe primary dysmenorrhea and those without primary dysmenorrhea. Participants completed luteinizing hormone surge ovulation predictor test kits. Anovulatory cycles were defined by never receiving a positive result before the next menstrual period; participants were grouped as anovulatory if they experienced at least 1 anovulatory cycle during study participation. Participants rated daily level of menstrual pain on a 0-10 numeric rating scale. A university-based clinical research laboratory. Thirty-nine adolescents and young adults (ages 16-24) with primary dysmenorrhea and 52 age-matched control girls. Rates of presumptive anovulation. One hundred sixty-eight cycles were monitored, 29.8% (N = 50) of which were anovulatory (37.1% [39/105] vs 17.5% [11/63] of cycles in control and dysmenorrhea groups, respectively). During study participation, control girls were significantly more likely to have had at least 1 anovulatory cycle than were girls with primary dysmenorrhea (44.2% [23/52] vs 17.9% [7/39] of participants, respectively; P < .01). Cycle length and number of bleeding days between ovulatory and anovulatory cycles were similar. The primary dysmenorrhea group's maximum menstrual pain ratings did not differ between ovulatory and anovulatory cycles (4.77 and 4.36, respectively; P > .05). Our data support previous findings of increased rates of ovulation in primary dysmenorrhea. However, menstruation after anovulatory cycles can be as painful as menstruation after ovulatory cycles. These data support the idea that regular menses do not necessarily indicate that a normal ovulatory cycle has occurred. Previous implications that ovulation is necessary for the development of substantial menstrual pain are incomplete. Copyright © 2017 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Positive impact of child feeding training program for primary care health professionals: a cluster randomized field trial.

PubMed

Vitolo, Márcia Regina; Louzada, Maria Laura da Costa; Rauber, Fernanda

2014-12-01

To assess the impact of a child feeding training program for primary care health professionals about breastfeeding and complementary feeding practices. Cluster-randomized field trial conducted in the city of Porto Alegre, (RS), Brazil. Twenty primary health care centers (HCC) were randomized into intervention (n = 9) and control (n = 11) groups. The health professionals (n = 200) at the intervention group centers received training about healthy feeding practices. Pregnant women were enrolled at the study. Up to six months of child's age, home visits were made to obtain variables related to breastfeeding and introduction of foods. 619 children were evaluated: 318 from the intervention group and 301 from the control group. Exclusive breastfeeding prevalence in the first (72.3 versus 59.4%; RR = 1.21; 95%CI 1.08 - 1.38), second (62.6 versus 48.2%; RR = 1.29; 95%CI 1.10 - 1.53), and third months of life (44.0% versus 34.6%; RR = 1.27; 95%CI 1.04 - 1.56) was higher in the intervention group compared to the control group. The prevalence of children who consumed meat four or five times per week was higher in the intervention group than in the control group (36.8 versus 22.6%; RR = 1.62; 95%CI 1.32 - 2.03). The prevalence of children who had consumed soft drinks (34.9 versus 52.5%; RR = 0.66; 95%CI 0.54 - 0.80), chocolate (24.5 versus 36.7% RR = 0.66 95%CI 0.53 - 0.83), petit suisse (68.9 versus 79.7; 95%CI 0.75 - 0.98) and coffee (10.4 versus 20.1%; RR = 0.51; 95%CI 0.31 - 0.85) in their six first months of life was lower in the intervention group. The training of health professionals had a positive impact on infant feeding practices, contributing to the promotion of child health.

[Study of the intervention measures for the occupational stress to the teachers in the primary and secondary schools].

PubMed

Wu, Si-ying; Wang, Mian-zhen; Li, Jian; Zhang, Xue-feng

2006-03-01

To study the status of the occupational stress and the work ability of the teachers in the primary and secondary schools, then take some integrated intervention measures to reduce the occupational stress and improve their work ability, and evaluate the intervening efficacy. The levels of stressor and strain was measured with the occupation stress inventory revised edition (OSI-R) and the work ability was measured with the work ability index (WAI) for the teachers in nine primary and secondary schools in Sichuan Province, then health educations about occupational stress were taken to the teachers in the study group, the same test was carried out after one year for the teachers in the nine schools to evaluate the effect of intervention measures. (1) After intervening, among the six items of occupational role questionnaire, the scores of role overload, role boundary, responsibility and physical environment of the teachers in the study group significantly decreased, compared with the teachers in the control group, the scores of the role overload, role boundary and physical environment were significantly lower (P < 0.05). (2) Among the four items of personal strain questionnaire, only the scores of interpersonal strain of the teachers in the study group significantly decreased (P < 0.05), compared with the teachers in the control group, the scores of the vocational strain and interpersonal strain were significantly lower (P < 0.05). (3) Among the four items of personal resources questionnaire, the scores of the recreation, self-care and rational cognitive coping of the teachers in the study group significantly raised and were significantly higher than those of the teachers in the control group (P < 0.05). (4) The score of WAI of the teachers in the study group significantly raised and was significantly higher than that of the teachers in the control group (P < 0.05). The intervention measures are efficient to reduce the occupational stress of teachers, strengthen their coping resource and improve their work ability.

Impact of Skill-Based Approaches in Reducing Stigma in Primary Care Physicians: Results from a Double-Blind, Parallel-Cluster, Randomized Controlled Trial

PubMed Central

Patten, Scott; Knaak, Stephanie; Weinerman, Rivian; Campbell, Helen; Lauria-Horner, Bianca

2017-01-01

Objective: Most interventions to reduce stigma in health professionals emphasize education and social contact–based strategies. We sought to evaluate a novel skill-based approach: the British Columbia Adult Mental Health Practice Support Program. We sought to determine the program’s impact on primary care providers’ stigma and their perceived confidence and comfort in providing care for mentally ill patients. We hypothesized that enhanced skills and increased comfort and confidence on the part of practitioners would lead to diminished social distance and stigmatization. Subsequently, we explored the program’s impact on clinical outcomes and health care costs. These outcomes are reported separately, with reference to this article. Methods: In a double-blind, cluster randomized controlled trial, 111 primary care physicians were assigned to intervention or control groups. A validated stigma assessment tool, the Opening Minds Scale for Health Care Providers (OMS-HC), was administered to both groups before and after training. Confidence and comfort were assessed using scales constructed from ad hoc items. Results: In the primary analysis, no significant differences in stigma were found. However, a subscale assessing social distance showed significant improvement in the intervention group after adjustment for a variable (practice size) that was unequally distributed in the randomization. Significant increases in confidence and comfort in managing mental illness were observed among intervention group physicians. A positive correlation was found between increased levels of confidence/comfort and improvements in overall stigma, especially in men. Conclusions: This study provides some preliminary evidence of a positive impact on health care professionals’ stigma through a skill-building approach to management of mild to moderate depression and anxiety in primary care. The intervention can be used as a primary vehicle for enhancing comfort and skills in health care providers and, ultimately, reducing an important dimension of stigma: preference for social distance. PMID:28095259

Impact of Skill-Based Approaches in Reducing Stigma in Primary Care Physicians: Results from a Double-Blind, Parallel-Cluster, Randomized Controlled Trial.

PubMed

Beaulieu, Tara; Patten, Scott; Knaak, Stephanie; Weinerman, Rivian; Campbell, Helen; Lauria-Horner, Bianca

2017-05-01

Most interventions to reduce stigma in health professionals emphasize education and social contact-based strategies. We sought to evaluate a novel skill-based approach: the British Columbia Adult Mental Health Practice Support Program. We sought to determine the program's impact on primary care providers' stigma and their perceived confidence and comfort in providing care for mentally ill patients. We hypothesized that enhanced skills and increased comfort and confidence on the part of practitioners would lead to diminished social distance and stigmatization. Subsequently, we explored the program's impact on clinical outcomes and health care costs. These outcomes are reported separately, with reference to this article. In a double-blind, cluster randomized controlled trial, 111 primary care physicians were assigned to intervention or control groups. A validated stigma assessment tool, the Opening Minds Scale for Health Care Providers (OMS-HC), was administered to both groups before and after training. Confidence and comfort were assessed using scales constructed from ad hoc items. In the primary analysis, no significant differences in stigma were found. However, a subscale assessing social distance showed significant improvement in the intervention group after adjustment for a variable (practice size) that was unequally distributed in the randomization. Significant increases in confidence and comfort in managing mental illness were observed among intervention group physicians. A positive correlation was found between increased levels of confidence/comfort and improvements in overall stigma, especially in men. This study provides some preliminary evidence of a positive impact on health care professionals' stigma through a skill-building approach to management of mild to moderate depression and anxiety in primary care. The intervention can be used as a primary vehicle for enhancing comfort and skills in health care providers and, ultimately, reducing an important dimension of stigma: preference for social distance.

The effects of implementing a point-of-care electronic template to prompt routine anxiety and depression screening in patients consulting for osteoarthritis (the Primary Care Osteoarthritis Trial): A cluster randomised trial in primary care.

PubMed

Mallen, Christian D; Nicholl, Barbara I; Lewis, Martyn; Bartlam, Bernadette; Green, Daniel; Jowett, Sue; Kigozi, Jesse; Belcher, John; Clarkson, Kris; Lingard, Zoe; Pope, Christopher; Chew-Graham, Carolyn A; Croft, Peter; Hay, Elaine M; Peat, George

2017-04-01

This study aimed to evaluate whether prompting general practitioners (GPs) to routinely assess and manage anxiety and depression in patients consulting with osteoarthritis (OA) improves pain outcomes. We conducted a cluster randomised controlled trial involving 45 English general practices. In intervention practices, patients aged ≥45 y consulting with OA received point-of-care anxiety and depression screening by the GP, prompted by an automated electronic template comprising five questions (a two-item Patient Health Questionnaire-2 for depression, a two-item Generalized Anxiety Disorder-2 questionnaire for anxiety, and a question about current pain intensity [0-10 numerical rating scale]). The template signposted GPs to follow National Institute for Health and Care Excellence clinical guidelines for anxiety, depression, and OA and was supported by a brief training package. The template in control practices prompted GPs to ask the pain intensity question only. The primary outcome was patient-reported current pain intensity post-consultation and at 3-, 6-, and 12-mo follow-up. Secondary outcomes included pain-related disability, anxiety, depression, and general health. During the trial period, 7,279 patients aged ≥45 y consulted with a relevant OA-related code, and 4,240 patients were deemed potentially eligible by participating GPs. Templates were completed for 2,042 patients (1,339 [31.6%] in the control arm and 703 [23.1%] in the intervention arm). Of these 2,042 patients, 1,412 returned questionnaires (501 [71.3%] from 20 intervention practices, 911 [68.0%] from 24 control practices). Follow-up rates were similar in both arms, totalling 1,093 (77.4%) at 3 mo, 1,064 (75.4%) at 6 mo, and 1,017 (72.0%) at 12 mo. For the primary endpoint, multilevel modelling yielded significantly higher average pain intensity across follow-up to 12 mo in the intervention group than the control group (adjusted mean difference 0.31; 95% CI 0.04, 0.59). Secondary outcomes were consistent with the primary outcome measure in reflecting better outcomes as a whole for the control group than the intervention group. Anxiety and depression scores did not reduce following the intervention. The main limitations of this study are two potential sources of bias: an imbalance in cluster size (mean practice size 7,397 [intervention] versus 5,850 [control]) and a difference in the proportion of patients for whom the GP deactivated the template (33.6% [intervention] versus 27.8% [control]). In this study, we observed no beneficial effect on pain outcomes of prompting GPs to routinely screen for and manage comorbid anxiety and depression in patients presenting with symptoms due to OA, with those in the intervention group reporting statistically significantly higher average pain scores over the four follow-up time points than those in the control group. ISRCTN registry ISRCTN40721988.

Impaired endothelial function in patients with mild primary hyperparathyroidism improves after parathyroidectomy.

PubMed

Tuna, Mazhar M; Doğan, Berçem A; Arduç, Ayşe; Imga, Narin Nasiroğlu; Tütüncü, Yasemin; Berker, Dilek; Güler, Serdar

2015-12-01

Primary hyperparathyroidism (PHPT) is associated with cardiovascular morbidity; however, data on the reversibility of cardiovascular disease in mild primary hyperparathyroidism are conflicting. The aim of this study was to assess endothelial function in patients with mild PHPT before and after parathyroidectomy (Ptx). We prospectively evaluated 53 patients with mild PHPT (Group 1; 45 women, eight men; aged 52 ± 3·1 years) and 46 healthy control subjects (Group 2; 38 women, eight men; aged 46 ± 9·5 years). Endothelial function was measured as flow-mediated dilation (FMD) and carotid intima-media thickness (CIMT) using Doppler ultrasonography. Patients with diabetes mellitus, coronary heart disease, impaired renal function, hyperthyroidism, hypothyroidism and a history of smoking were excluded from the study. Patients were studied at baseline and 6-12 months after the first evaluation. There were no differences with respect to age, gender and BMI between the two groups. Hypertension prevalence was three times higher in group 1 than in controls. % FMD was lower in group 1 than in group 2 (2·6 ± 1·2 vs 14·8 ± 9·6, P < 0·001). CIMT was higher in patients with PHPT than controls (0·69 ± 0·18 vs 0·61 ± 0·12, P = 0·045). This significance remained when hypertensive patients were excluded from the analysis. While FMD and CIMT improved significantly after Ptx, there were no differences in mild PHPT patients who followed without parathyroidectomy. FMD and CIMT are impaired in patients with mild PHPT compared to controls and improved significantly after a successful Ptx. Ptx improves endothelial function in patients with mild PHPT that may lead to decreased cardiovascular morbidity and mortality. © 2014 John Wiley & Sons Ltd.

Effects of the Diabetes Manual 1:1 structured education in primary care.

PubMed

Sturt, J A; Whitlock, S; Fox, C; Hearnshaw, H; Farmer, A J; Wakelin, M; Eldridge, S; Griffiths, F; Dale, J

2008-06-01

To determine the effects of the Diabetes Manual on glycaemic control, diabetes-related distress and confidence to self-care of patients with Type 2 diabetes. A cluster randomized, controlled trial of an intervention group vs. a 6-month delayed-intervention control group with a nested qualitative study. Participants were 48 urban general practices in the West Midlands, UK, with high population deprivation levels and 245 adults with Type 2 diabetes with a mean age of 62 years recruited pre-randomization. The Diabetes Manual is 1:1 structured education designed for delivery by practice nurses. Measured outcomes were HbA(1c), cardiovascular risk factors, diabetes-related distress measured by the Problem Areas in Diabetes Scale and confidence to self-care measured by the Diabetes Management Self-Efficacy Scale. Outcomes were assessed at baseline and 26 weeks. There was no significant difference in HbA(1c) between the intervention group and the control group [difference -0.08%, 95% confidence interval (CI) -0.28, 0.11]. Diabetes-related distress scores were lower in the intervention group compared with the control group (difference -4.5, 95% CI -8.1, -1.0). Confidence to self-care Scores were 11.2 points higher (95% CI 4.4, 18.0) in the intervention group compared with the control group. The patient response rate was 18.5%. In this population, the Diabetes Manual achieved a small improvement in patient diabetes-related distress and confidence to self-care over 26 weeks, without a change in glycaemic control. Further study is needed to optimize the intervention and characterize those for whom it is more clinically and psychologically effective to support its use in primary care.

Comparison of the Effectiveness of Interactive Didactic Lecture Versus Online Simulation-Based CME Programs Directed at Improving the Diagnostic Capabilities of Primary Care Practitioners.

PubMed

McFadden, Pam; Crim, Andrew

2016-01-01

Diagnostic errors in primary care contribute to increased morbidity and mortality, and billions in costs each year. Improvements in the way practicing physicians are taught so as to optimally perform differential diagnosis can increase patient safety and lower the costs of care. This study represents a comparison of the effectiveness of two approaches to CME training directed at improving the primary care practitioner's diagnostic capabilities against seven common and important causes of joint pain. Using a convenience sampling methodology, one group of primary care practitioners was trained by a traditional live, expert-led, multimedia-based training activity supplemented with interactive practice opportunities and feedback (control group). The second group was trained online with a multimedia-based training activity supplemented with interactive practice opportunities and feedback delivered by an artificial intelligence-driven simulation/tutor (treatment group). Before their respective instructional intervention, there were no significant differences in the diagnostic performance of the two groups against a battery of case vignettes presenting with joint pain. Using the same battery of case vignettes to assess postintervention diagnostic performance, there was a slight but not statistically significant improvement in the control group's diagnostic accuracy (P = .13). The treatment group, however, demonstrated a significant improvement in accuracy (P < .02; Cohen d, effect size = 0.79). These data indicate that within the context of a CME activity, a significant improvement in diagnostic accuracy can be achieved by the use of a web-delivered, multimedia-based instructional activity supplemented by practice opportunities and feedback delivered by an artificial intelligence-driven simulation/tutor.

Physiotherapy in Primary Care Triage - the effects on utilization of medical services at primary health care clinics by patients and sub-groups of patients with musculoskeletal disorders: a case-control study.

PubMed

Bornhöft, Lena; Larsson, Maria E H; Thorn, Jörgen

2015-01-01

Primary Care Triage is a patient sorting system used in some primary health care clinics (PHCCs) in Sweden where patients with musculoskeletal disorders (MSD) are triaged directly to physiotherapists. The purpose of this study was to investigate whether sorting/triaging patients seeking a PHCC for MSD directly to physiotherapists affects their utilization of medical services at the clinic for the MSD and to determine whether the effects of the triaging system vary for different sub-groups of patients. A retrospective case-control study design was used at two PHCCs. At the intervention clinic, 656 patients with MSD were initially triaged to physiotherapists. At the control clinic, 1673 patients were initially assessed by general practitioners (GPs). The main outcome measures were the number of patients continuing to visit GPs after the initial assessment, the number of patients receiving referrals to specialists/external examinations, doctors' notes for sick-leave or prescriptions for analgesics during one year, all for the original MSD. Significantly fewer patients triaged to physiotherapists required multiple GP visits for the MSD or received MSD-related referrals to specialists/external examinations, sick-leave recommendations or prescriptions during the following year compared to the GP-assessed group. This applies to all sub-groups except for the group with lower extremity disorders, which did not reach significance for either multiple GP visits or sick-leave recommendations. The reduced utilization of medical services by patients with MSD who were triaged to physiotherapists at a PHCC is likely due to altered management of MSD with initial assessment by physiotherapists.

Effects of Training Program on Recognition and Management of Depression and Suicide Risk Evaluation for Slovenian Primary-care Physicians: Follow-up Study

PubMed Central

Roškar, Saška; Podlesek, Anja; Zorko, Maja; Tavčar, Rok; Dernovšek, Mojca Zvezdana; Groleger, Urban; Mirjanič, Milan; Konec, Nuša; Janet, Evgen; Marušič, Andrej

2010-01-01

Aim To implement and evaluate an educational program for primary care physicians on recognition and treatment of depression and suicide prevention. Method The study was conducted in 3 Slovenian neighboring regions (Celje, Ravne na Koroškem, and Podravska) with similar suicide rates and other health indicators. All primary care physicians from Celje (N = 155) and Ravne na Koroškem (N = 35) were invited to participate in the educational program on depression treatment and suicide risk recognition. From January to March 2003, approximately half of them (82 out of 190; educational group) attended the program, whereas the other half (108 out of 190; control group 1) and physicians from the Podravska region (N = 164; control group 2) did not attend the program. The prescription rates of antidepressants and anxiolytics before and after the intervention were compared between the studied regions. Also, suicide rates three-years before and after the intervention were compared. Results From 2002 to 2003, there was a 2.33-fold increase in the rate of antidepressant prescriptions in the educational group (P < 0.05) and only 1.28-fold (P < 0.05) and 1.34-fold (P < 0.05) increase in control groups 1 and 2, respectively. However, the 12% decrease in suicide rate in the intervention regions was not significantly greater than the 4% decrease in the non-intervention region (P > 0.05). Conclusion Our training program was beneficial for primary care physicians’ ability to recognize and manage depression. However, there was no significant decrease in local suicide rates. PMID:20564767

Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System.

PubMed

Li, Dianyou; Zhang, Chencheng; Gault, Judith; Wang, Wei; Liu, Jianmin; Shao, Ming; Zhao, Yanyan; Zeljic, Kristina; Gao, Guodong; Sun, Bomin

2017-01-01

Deep brain stimulation (DBS) is the most commonly performed surgery for the debilitating symptoms of Parkinson disease (PD). However, DBS systems remain largely unaffordable to patients in developing countries, warranting the development of a safe, economically viable, and functionally comparable alternative. To investigate the efficacy and safety of wirelessly programmed DBS of bilateral subthalamic nucleus (STN) in patients with primary PD. Sixty-four patients with primary PD were randomly divided into test and control groups (1:1), where DBS was initiated at either 1 month or 3 months, respectively, after surgery. Safety and efficacy of the treatment were compared between on- and off-medication states 3 months after surgery. Outcome measures included analysis of Unified Parkinson's Disease Rating Scale (UPDRS) scores, duration of "on" periods, and daily equivalent doses of levodopa. All patients were followed up both 6 and 12 months after surgery. Three months after surgery, significant decrease in the UPDRS motor scores were observed for the test group in the off-medication state (25.08 ± 1.00) versus the control group (4.20 ± 1.99). Bilateral wireless programming STN-DBS is safe and effective for patients with primary PD in whom medical management has failed to restore motor function. © 2017 S. Karger AG, Basel.

Pilot Test of an Innovative Interprofessional Education Assessment Strategy

ERIC Educational Resources Information Center

Emmert, Michelle Christine

2011-01-01

The primary goal of this study was to test an innovative way of assessing students' teamwork skills in a controlled environment. Twenty-four second year students from Western University of Health Sciences (WesternU) participated in the experimental group and 22 third year students from WesternU participated in the control group. Students in the…

A Randomized Controlled Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening among Latino Immigrants in a Primary Care Facility

PubMed Central

Schwartz, Mark D.; Shah, Nirav R.; Gany, Francesca M.

2010-01-01

BACKGROUND Latino immigrants face a higher burden of colorectal cancer (CRC) and screening rates are low. OBJECTIVE To assess the effectiveness of a multilevel intervention in increasing the rate of CRC screening among Latino immigrants. DESIGN A randomized controlled trial, with randomization at the physician level. PARTICIPANTS Pairs of 65 primary care physicians and 65 Latino immigrant patients participated, 31 in the intervention and 34 in the control group. INTERVENTION CRC educational video in Spanish on a portable personal digital video display device accompanied by a brochure with key information for the patient, and a patient-delivered paper-based reminder for their physician. MEASUREMENTS Completed CRC screening, physician recommendation for CRC screening, and patient adherence to physician recommended CRC screening. RESULTS The overall rate of completed screening for CRC was 55% for the intervention and 18% for the control group (p = 0.002). Physicians recommended CRC screening for 61% of patients in the intervention group versus 41% in the control group (p = 0.08). Of those that received a recommendation, 90% in the intervention group adhered to it versus 26% in the control group (p = 0.007). CONCLUSIONS The intervention was successful in increasing rates of completed CRC screening primarily through increasing adherence after screening was recommended. Additional efforts should focus on developing new strategies to increase physician recommendation for CRC screening, while employing effective patient adherence interventions. PMID:20213208

Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study).

PubMed

Nakamura, T; Fukunaga, M; Nakano, T; Kishimoto, H; Ito, M; Hagino, H; Sone, T; Taguchi, A; Tanaka, S; Ohashi, M; Ota, Y; Shiraki, M

2017-01-01

In a 2-year randomized, placebo-controlled study of 665 Japanese patients with primary osteoporosis, once-yearly administration of zoledronic acid (5 mg) reduced the risk of new morphometric vertebral fractures. The purpose of this study was to determine the efficacy and safety of once-yearly intravenous infusion of ZOL in Japanese patients with primary osteoporosis. This was a two-year multicenter, randomized, placebo-controlled, double-blind, parallel-group comparative study (ZONE Study). Subjects were 665 Japanese patients between the ages of 65 and 89 years who had prevalent vertebral fracture. Subjects were randomly assigned to receive once-yearly intravenous infusion of 5 mg of ZOL or placebo at baseline and 12 months. The 2-year incidence of new morphometric vertebral fracture was 3.0 % (10/330 subjects) in the ZOL group and 8.9 % (29/327) in the placebo group (p = 0.0016). The 24-month cumulative incidence of new morphometric vertebral fracture was 3.3 % in the ZOL group versus 9.7 % in the placebo group (log-rank test: p = 0.0029; hazard ratio: 0.35; 95 % confidence interval: 0.17-0.72). The cumulative incidence of any clinical fracture, clinical vertebral fracture, and non-vertebral fracture was significantly reduced in the ZOL group by 54, 70, and 45 %, respectively, compared to the placebo group. At 24 months, ZOL administration increased bone mineral density in the lumbar spine, femoral neck, and total hip (t test: p < 0.0001). No new adverse events or osteonecrosis of the jaw were observed in this study. Once-yearly administration of ZOL 5 mg to Japanese patients with primary osteoporosis reduced the risk of new morphometric vertebral fractures and was found to be safe.

Effect of Thunder-Fire Moxibustion on Pain, Quality of Life, and Tension of Multifidus in Patients with Primary Osteoporosis: A Randomized Controlled Trial.

PubMed

Xu, Dao-Ming; Xu, Huaning; Liu, Jing; Wang, Tong; Wu, Wenzhong; Liu, Lanying; Tian, Qianmo; Li, Hanjun; Zhang, Lili; Cao, Yana

2018-05-08

BACKGROUND Primary osteoporosis is a common disease among postmenopausal women and the elderly; low back pain is the most typical clinical manifestation an is the primary reason for a clinic visit, and directly affects patients' quality of life. Anti-osteoporosis medications have undesirable side effects, and many kinds of special traditional Chinese moxibustion methods have been widely used in the clinical treatment of osteoporosis low back pain. The purpose of this study was to observe whether thunder-fire moxibustion therapy, compared to calcium supplements alone, can ease osteoporosis low back pain, improve quality of life, and reduce tension of the multifidus. MATERIAL AND METHODS Sixty-three eligible patients were enrolled in the study (7 of these patients did not finish the study and are not included in analysis). Participants were randomly divided into 2 groups: a moxibustion group that received calcium carbonate D3 and thunder-fire moxibustion therapy, and a control group that received calcium carbonate D3 only. Level of pain experienced, assessed using the visual analogue scale (VAS), and quality of life (SF-36) were measured pre-treatment, at the end of 4 weeks of treatment, and at a 1-month post-treatment evaluation. Changes in values of Young's modulus of the multifidus were also collected before and after treatment. RESULTS After 4 weeks of treatment and at 1 month after treatment had ended, low back pain in both groups was reduced relative to pre-treatment levels. The moxibustion group was significantly improved at BP, GH, SF, and MH dimensions compared to pre-treatment levels. The control group improved in BP dimensions, but not to the same extent as the moxibustion group. Similarly, after treatment for 4 weeks with moxibustion, multifidus tension was significantly reduced. CONCLUSIONS Thunder-fire moxibustion is an effective method for treating low back pain due to primary osteoporosis.

Effect of Thunder-Fire Moxibustion on Pain, Quality of Life, and Tension of Multifidus in Patients with Primary Osteoporosis: A Randomized Controlled Trial

PubMed Central

Xu, Daoming; Xu, Huaning; Liu, Jing; Liu, Lanying; Tian, Qianmo; Li, Hanjun; Zhang, Lili; Cao, Yana

2018-01-01

Background Primary osteoporosis is a common disease among postmenopausal women and the elderly; low back pain is the most typical clinical manifestation an is the primary reason for a clinic visit, and directly affects patients’ quality of life. Anti-osteoporosis medications have undesirable side effects, and many kinds of special traditional Chinese moxibustion methods have been widely used in the clinical treatment of osteoporosis low back pain. The purpose of this study was to observe whether thunder-fire moxibustion therapy, compared to calcium supplements alone, can ease osteoporosis low back pain, improve quality of life, and reduce tension of the multifidus. Material/Methods Sixty-three eligible patients were enrolled in the study (7 of these patients did not finish the study and are not included in analysis). Participants were randomly divided into 2 groups: a moxibustion group that received calcium carbonate D3 and thunder-fire moxibustion therapy, and a control group that received calcium carbonate D3 only. Level of pain experienced, assessed using the visual analogue scale (VAS), and quality of life (SF-36) were measured pre-treatment, at the end of 4 weeks of treatment, and at a 1-month post-treatment evaluation. Changes in values of Young’s modulus of the multifidus were also collected before and after treatment. Results After 4 weeks of treatment and at 1 month after treatment had ended, low back pain in both groups was reduced relative to pre-treatment levels. The moxibustion group was significantly improved at BP, GH, SF, and MH dimensions compared to pre-treatment levels. The control group improved in BP dimensions, but not to the same extent as the moxibustion group. Similarly, after treatment for 4 weeks with moxibustion, multifidus tension was significantly reduced. Conclusions Thunder-fire moxibustion is an effective method for treating low back pain due to primary osteoporosis. PMID:29735964

Determination of asthma control using administrative data regarding short-acting beta-agonist inhaler purchase.

PubMed

Shlomi, Dekel; Katz, Irit; Segel, Michael J; Oberman, Bernice; Peled, Nir

2018-05-01

Symptom control is a primary goal in asthma. We hypothesized that administrative data regarding rescue inhaler purchases may correlate with asthma symptom control. We identified all patients who purchased short-acting beta-agonist (SABA) inhalers during the course of one year in the database of a Health Maintenance Organization (HMO). Primary physicians identified asthma patients and classified their asthma symptom control into three groups according to the Global Initiative for Asthma (GINA) guidelines. Asthma patients were asked to answer symptom questionnaires and grade their asthma control. SABA inhaler purchases were compared between asthma control groups as classified by the guidelines, the physicians and the patients. We also compared the agreement on asthma control between the three methods of classification. Of 241 asthma patients, 83 completed the questionnaires. Using the GINA guidelines criteria, 26 were symptom controlled, 46 were partially controlled and 11 were uncontrolled. SABA inhaler purchases were not significantly lower in the controlled group. Using patients' overall impression of their asthma control, the mean numbers of SABA inhalers purchased were 1.5, 4.4 and 6.4 per year in the controlled, partially controlled and uncontrolled groups, respectively (p = 0.03). Patients' classification of asthma control had better agreement (kappa = 0.34) with GINA guidelines than physician's' agreement (kappa = 0.05). When using administrative data for asthma patients, 2 or more SABA inhaler purchases in one year should alert the physician for the need for asthma control evaluation. Purchase of at least 4 SABA inhalers a year may be regarded as a marker for asthma that is not controlled.

Effects of a School-Based Instrumental Music Program on Verbal and Visual Memory in Primary School Children: A Longitudinal Study

PubMed Central

Roden, Ingo; Kreutz, Gunter; Bongard, Stephan

2012-01-01

This study examined the effects of a school-based instrumental training program on the development of verbal and visual memory skills in primary school children. Participants either took part in a music program with weekly 45 min sessions of instrumental lessons in small groups at school, or they received extended natural science training. A third group of children did not receive additional training. Each child completed verbal and visual memory tests three times over a period of 18 months. Significant Group by Time interactions were found in the measures of verbal memory. Children in the music group showed greater improvements than children in the control groups after controlling for children’s socio-economic background, age, and IQ. No differences between groups were found in the visual memory tests. These findings are consistent with and extend previous research by suggesting that children receiving music training may benefit from improvements in their verbal memory skills. PMID:23267341

Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial.

PubMed

Bleijenberg, Nienke; Drubbel, Irene; Schuurmans, Marieke J; Dam, Hester Ten; Zuithoff, Nicolaas P A; Numans, Mattijs E; de Wit, Niek J

2016-09-01

To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. Primary care setting, 39 general practices in the Netherlands. Community-dwelling people aged 60 and older (N = 3,092). A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care. Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living (ADLs), 8 instrumental activities of daily living (IADLs), one mobility item (range 0-15)); higher scores indicate greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality. The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval (CI) = 1.77-1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80-1.96; control group, 2.03, 95% CI = 1.92-2.13; P = .03). No differences in quality of life were observed. Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more-robust results. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Immobilization in External Rotation Versus Internal Rotation After Primary Anterior Shoulder Dislocation: A Meta-analysis of Randomized Controlled Trials.

PubMed

Whelan, Daniel B; Kletke, Stephanie N; Schemitsch, Geoffrey; Chahal, Jaskarndip

2016-02-01

The recurrence rate after primary anterior shoulder dislocation is high, especially in young, active individuals. Recent studies have suggested external rotation immobilization as a method to reduce the rate of recurrent shoulder dislocation in comparison to traditional sling immobilization. To assess and summarize evidence from randomized controlled trials on the effect of internal rotation versus external rotation immobilization on the rate of recurrence after primary anterior shoulder dislocation. Meta-analysis. PubMed, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and abstracts from recent proceedings were searched for eligible studies. Two reviewers selected studies for inclusion, assessed methodological quality, and extracted data. Six randomized controlled trials (632 patients) were included in this review. Demographic and prognostic variables measured at baseline were similar in the pooled groups. The average age was 30.1 years in the pooled external rotation group and 30.3 years in the pooled internal rotation group. Two studies found that external rotation immobilization reduced the rate of recurrence after initial anterior shoulder dislocation compared with conventional internal rotation immobilization, whereas 4 studies failed to find a significant difference between the 2 groups. This meta-analysis suggested no overall significant difference in the rate of recurrence among patients treated with internal rotation versus external rotation immobilization (risk ratio, 0.69; 95% CI, 0.42-1.14; P = .15). There was no significant difference in the rate of compliance between internal and external rotation immobilization (P = .43). The Western Ontario Shoulder Instability Index scores were pooled across 3 studies, and there was no significant difference between the 2 groups (P = .54). Immobilization in external rotation is not significantly more effective in reducing the recurrence rate after primary anterior shoulder dislocation than immobilization in internal rotation. Additionally, this review suggests that there is minimal difference in patients' perceptions of their health-related quality of life after immobilization in internal versus external rotation. © 2015 The Author(s).

[PERSONALIZED DISTAL FEMORAL VALGUS RESECTION ANGLE IN PRIMARY TOTAL KNEE ARTHROPLASTY].

PubMed

Wang, Xilong; Shang, Xifu; Ll, Guoyuan; He, Rui; Zheng, Jie

2015-01-01

To investigate the feasibility and effectiveness of a personalized distal femoral valgus resection angle for improving postoperative coronal alignment of lower limb in total knee arthroplasty (TKA). A retrospective analysis was made on the clinical data of 50 patients who received primary TKA between January 2013 and February 2013. There were 11 male and 39 female patients with degenerative knee osteoarthritis. The patients were divided into 2 groups. In test group (n=25), the resection angle was adjusted to the femoral mechanical anatomical angle (FMA); in control group (n=25), a fixed distal valgus resection angle of 5° was used. There was no significant difference in gender, age, body mass index, disease duration, sides, grade, preoperative FMA, mechanical femorotibial angle (MFT), and preoperative Knee Society Score (KSS) between 2 groups (P > 0.05). Whole long X-ray film was taken to measure FMA and MFT at 3 days after operation, postoperative KSS was used to evaluate the knee function after 6 and 15 months. MFT was (-0.20 ± 1.87)° in test group and was (1.71 ± 3.67)° in control group, showing significant difference between 2 groups (t = 2.32, P = 0.02). The ideal MFT angle (0 ± 3)° was achieved in 22 patients (88%) of test group and in 16 patients (64%) of control group, showing significant difference between 2 groups (χ2 = 2.32, P = 0.02). Primary healing of incision was obtained in all patients of 2 groups. No deep venous thrombosis occurred. The patients of 2 groups were followed up 15 months after operation. There was significant difference in KSS between test and control groups at 6 months (88.23 ± 2.57 vs. 82.92 ± 2.59) (t = 7.26, P = 0.00) and at 15 months (90.76 ± 2.77 vs. 88.65 ± 1.77) (t = 3.20, P = 0.02). No sign of prosthesis loosening was observed by X-ray examination. Compared with using of a fixed distal femoral resection angle, an individual FMA can significantly improve the postoperative MFT and promote early recovery of the knee function.

MILD® Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial.

PubMed

Benyamin, Ramsin M; Staats, Peter S; MiDAS Encore, Investigators

2016-05-01

Lumbar spinal stenosis (LSS) is a common degenerative condition of the spine, which is a major cause of pain and functional disability for the elderly. Neurogenic claudication symptoms are a hallmark of LSS, where patients develop low back or leg pain when walking or standing that is relieved by sitting or lumbar flexion. The treatment of LSS generally begins with conservative management such as physical therapy, home exercise programs, and oral analgesics. Once these therapies fail, patients commonly move forward with interventional pain treatment options such as epidural steroid injections (ESIs) or MILD® as the next step. To assess improvement of function and reduction in pain for Medicare beneficiaries following treatment with MILD (treatment group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy and to compare to a control group receiving ESIs. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. Patients in this trial were randomized one to one into 2 study arms. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Outcomes are assessed using the Oswestry Disability Index (ODI), Numeric Pain Rating Scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the ESI group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of = 10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy is the proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device- or procedure-related adverse events in each group. This report presents safety and efficacy results at 1-year follow-up. Outcomes at 2 years will be collected and reported for patients in the MILD group only. At 1-year follow-up, ODI, NPRS, and all 3 ZCQ domains (Symptom Severity, Physical Function and Patient Satisfaction) demonstrated statistically significant superiority of MILD versus the active control. For primary efficacy, the 58.0% ODI responder rate in the MILD group was higher than the 27.1% responder rate in the epidural steroid group (P < 0.001). The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). There was a lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to adjunctive pain therapy study restrictions. Study enrollment was not limited to patients that had never received ESI therapy. One-year results of this randomized controlled clinical trial demonstrate that MILD is statistically superior to ESIs in the treatment of LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. Primary and secondary efficacy outcome measures achieved statistical superiority in the MILD group compared to the control group. With 95% of patients in this study presenting with 5 or more LSS co-factors, it is important to note that patients with spinal co-morbidities also experienced statistically significant improved function that was durable through 1 year. MILD, minimally invasive lumbar decompression, interlaminar epidural steroid injections, ESI neurogenic claudication, ligamentum flavum, ENCORE, PILD, CED Study, LSS.

Programmed Approach vs. Conventional Approach Using highly Consistent Sound-Symbol System of Reading in Three Primary Grades.

ERIC Educational Resources Information Center

Shore, Robert Eugene

The effects of two primary reading programs using a programed format (with and without audio-supplement) and a conventional format (the program format deprogramed) in a highly consistent sound-symbol system of reading at three primary grade levels were compared, using a pretest, post-test control group design. The degree of suitability of…

The effects of a team-based continuous quality improvement intervention on the management of primary care: a randomised controlled trial

PubMed Central

Engels, Yvonne; van den Hombergh, Pieter; Mokkink, Henk; van den Hoogen, Henk; van den Bosch, Wil; Grol, Richard

2006-01-01

Aim To study the effects of a team-based model for continuous quality improvement (CQI) on primary care practice management. Design of study Randomised controlled trial. Setting Twenty-six intervention and 23 control primary care practices in the Netherlands. Method Practices interested in taking part in the CQI project were, after assessment of their practice organisation, randomly assigned to the intervention or control groups. During a total of five meetings, a facilitator helped the teams in the intervention group select suitable topics for quality improvement and follow a structured approach to achieve improvement objectives. Checklists completed by an outreach visitor, questionnaires for the GPs, staff and patients were used to assemble data on the number and quality of improvement activities undertaken and on practice management prior to the start of the intervention and 1 year later. Results Pre-test and post-test data were compared for the 26 intervention and 23 control practices. A significant intervention effect was found for the number of improvement objectives actually defined (93 versus 54, P<0.001) and successfully completed (80 versus 69% of the projects, P<0.001). The intervention group also improved on more aspects of practice management, as measured by our practice visit method, than the control group but none of these differences proved statistically significant. Conclusion The intervention exerted a significant effect on the number and quality of improvement projects undertaken and self-defined objectives met. Failure of the effects of the intervention on the other dimensions of practice management to achieve significance may be due to the topics selected for some of the improvement projects being only partly covered by the assessment instrument. PMID:17007709

Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial.

PubMed

Hoddinott, Pat; Britten, Jane; Prescott, Gordon J; Tappin, David; Ludbrook, Anne; Godden, David J

2009-01-30

To assess the clinical effectiveness and cost effectiveness of a policy to provide breastfeeding groups for pregnant and breastfeeding women. Cluster randomised controlled trial with prospective mixed method embedded case studies to evaluate implementation processes. Primary care in Scotland. Pregnant women, breastfeeding mothers, and babies registered with 14 of 66 eligible clusters of general practices (localities) in Scotland that routinely collect breastfeeding outcome data. Localities set up new breastfeeding groups to provide population coverage; control localities did not change group activity. any breast feeding at 6-8 weeks from routinely collected data for two pre-trial years and two trial years. any breast feeding at birth, 5-7 days, and 8-9 months; maternal satisfaction. Between 1 February 2005 and 31 January 2007, 9747 birth records existed for intervention localities and 9111 for control localities. The number of breastfeeding groups increased from 10 to 27 in intervention localities, where 1310 women attended, and remained at 10 groups in control localities. No significant differences in breastfeeding outcomes were found. Any breast feeding at 6-8 weeks declined from 27% to 26% in intervention localities and increased from 29% to 30% in control localities (P=0.08, adjusted for pre-trial rate). Any breast feeding at 6-8 weeks increased from 38% to 39% in localities not participating in the trial. Women who attended breastfeeding groups were older (P<0.001) than women initiating breast feeding who did not attend and had higher income (P=0.02) than women in the control localities who attended postnatal groups. The locality cost was pound13 400 (euro14 410; $20 144) a year. A policy for providing breastfeeding groups in relatively deprived areas of Scotland did not improve breastfeeding rates at 6-8 weeks. The costs of running groups would be similar to the costs of visiting women at home. Current Controlled Trials ISRCTN44857041.

Improving parent knowledge about antibiotics: a video intervention.

PubMed

Bauchner, H; Osganian, S; Smith, K; Triant, R

2001-10-01

To determine whether an educational video could improve parent knowledge, beliefs, and behaviors about the appropriate use of oral antibiotics. A randomized, controlled trial was conducted in an urban primary care clinic and a suburban pediatric practice. Parents were randomly assigned to the intervention or control groups. Parents in the intervention group were asked to view a 20-minute video, specifically developed for this project, over a 2-month period, and given a brochure about antibiotics. Parent knowledge, beliefs, and behaviors were assessed at the time of enrollment and then by telephone 2 months later. A total of 193 (94%) of 206 parents completed the study. The groups were equivalent with respect to all important baseline characteristics. No differences were found for adjusted posttest means between the intervention and control groups for knowledge, beliefs, or behavior. For example, the intervention group scored 8.04 on the knowledge questionnaire (11 true-false questions), compared with 7.82 for the control group. Subgroup analysis, based on site of enrollment, indicated that families in the intervention group from the primary care urban clinic improved their knowledge score (6.03 to 6.92) and were more likely to report that there were problems with children receiving too many antibiotics (intervention 67% vs control 34%). Overall, this video had only a modest effect on parent knowledge, beliefs, and self-reported behaviors regarding oral antibiotics. We believe that any campaign promoting the judicious use of oral antibiotics must use a multifaceted approach and target both parents and physicians.

Social Stories in mainstream schools for children with autism spectrum disorder: a feasibility randomised controlled trial.

PubMed

Marshall, David; Wright, Barry; Allgar, Victoria; Adamson, Joy; Williams, Christine; Ainsworth, Hannah; Cook, Liz; Varley, Danielle; Hackney, Lisa; Dempster, Paul; Ali, Shehzad; Trepel, Dominic; Collingridge Moore, Danielle; Littlewood, Elizabeth; McMillan, Dean

2016-08-11

To assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial. A single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control. 37 primary schools in York, UK. 50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27). Acceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial. An assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups. Results suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools. ISRCTN96286707; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Clinical Outcomes of Reoperation for Failed Antireflux Operations.

PubMed

Wilshire, Candice L; Louie, Brian E; Shultz, Dale; Jutric, Zeljka; Farivar, Alexander S; Aye, Ralph W

2016-04-01

Up to 18% of patients undergoing antireflux operations will require reoperation. Authors caution that with each additional reoperation, fewer patients achieve satisfaction. The quality of life in patients who underwent revision operations was compared with patients who underwent primary antireflux operations to determine the effectiveness of revision operations. We retrospectively reviewed patients who underwent revision after failed antireflux operations from 2004 to 2014. Patients were divided into two groups: first reoperation (Reop[1]) and more than one reoperation (Reop[>1]). For comparison, a control group of patients who underwent primary antireflux operations was included. Patients underwent quality of life assessment preoperatively and postoperatively. We identified 105 reoperative patients: 94 Reop(1), 11 Reop(>1), and 112 controls. The primary reason for failure was combined fundoplication herniation and slippage. Morbidity, mortality, and readmission rates were similar in all groups. Postoperative outcomes were improved in all groups but to a lesser degree in subsequent reoperations. Gastroesophageal Reflux Disease Health-Related Quality of Life: controls, 20.0 to 2.0; Reop(1), 26.5 to 4.0; and Reop(>1), 13.0 to 2.0. Quality of Life in Reflux and Dyspepsia: controls, 4.5 to 7.0; Reop(1), 3.7 to 6.7; and Reop(>1), 3.5 to 5.8. Dysphagia Severity Score: controls, 44.0 to 45.0; Reop(1), 36.0 to 45.0; and Reop(>1), 30.8 to 45.0. Patients undergoing revision antireflux operations have improved quality of life, relatively normal swallowing, and primary symptom resolution at a median of 20 months postoperatively. However, patients who undergo more than one reoperation have lower quality of life scores and less improvement in dysphagia, suggesting that other procedures such as Roux-en-Y or short colon interposition, should be considered after a failed initial reoperation. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Effects of Distant Reiki On Pain, Anxiety and Fatigue in Oncology Patients in Turkey: A Pilot Study.

PubMed

Demir, Melike; Can, Gulbeyaz; Kelam, Ayhan; Aydıner, Aydın

2015-01-01

Fatigue, stress and pain are common symptoms among cancer patients, affecting the quality of life. The purpose of the present study was to determine the effect of distant Reiki on pain, anxiety and fatigue in oncology patients. Participants in the control group received usual medical and nursing care during their stay. The intervention group received usual care plus five distant Reiki sessions, one each night for 30 min. A face to face interview was performed and patient personal and illness related characteristics were evaluated using the Patient Characteristics form. Pain, stress and fatigue were evaluated according to a numeric rating scale. The experimental group was predominantly composed of women (71.4%), married individuals (40%), and primary school graduates (40%). The control group was predominantly male (72.7%), married (60%), and primary school graduates (60%). The control group demonstrated greater levels of pain (p=0.002), stress (p=0.001) and fatigue (p=0.001). The Reiki group pain score (p<0.0001), stress score (p<0.001) and fatigue score were also significantly lower. The results of this study indicate that Reiki may decreasepain, anxiety and fatigue in oncology patients.

A randomised controlled trial of a lengthened and multi-disciplinary consultation model in a socially deprived community: a study protocol.

PubMed

Whitford, David L; Chan, Wai-Sun

2007-06-28

There has been little development of the general practice consultation over the years, and many aspects of the present consultation do not serve communities with multiple health and social problems well. Many of the problems presenting to general practitioners in socio-economically disadvantaged areas are not amenable to a purely medical solution, and would particularly benefit from a multidisciplinary approach. Socio-economic deprivation is also associated with those very factors (more psychosocial problems, greater need for health promotion, more chronic diseases, more need for patient enablement) that longer consultations have been shown to address. This paper describes our study protocol, which aims to evaluate whether a lengthened multidisciplinary primary care team consultation with families in a socially deprived area can improve the psychological health of mothers in the families. In a randomised controlled trial, families with a history of social problems, substance misuse or depression are randomly allocated to an intervention or control group. The study is based in three general practices in a highly deprived area of North Dublin. Primary health care teams will be trained in conducting a multidisciplinary lengthened consultation. Families in the intervention group will participate in the new style multidisciplinary consultation. Outcomes of families receiving the intervention will be compared to the control group who will receive only usual general practitioner care. The primary outcome is the psychological health of mothers of the families and secondary outcomes include general health status, quality of life measures and health service usage. The main aim of this study is to evaluate the effectiveness of a lengthened multidisciplinary team consultation in primary care. The embedded nature of this study in general practices in a highly deprived area ensures generalisability to other deprived communities, but more particularly it promises relevance to primary care. Current Controlled Trials ISRCTN70578736.

Some physiotherapy treatments may relieve menstrual pain in women with primary dysmenorrhea: a systematic review.

PubMed

Kannan, Priya; Claydon, Leica Sarah

2014-03-01

In women with primary dysmenorrhoea, what is the effect of physiotherapeutic interventions compared to control (either no treatment or placebo/sham) on pain and quality of life? Systematic review of randomised trials with meta-analysis. Women with primary dysmenorrhea. Any form of physiotherapy treatment. The primary outcome was menstrual pain intensity and the secondary outcome was quality of life. The search yielded 222 citations. Of these, 11 were eligible randomised trials and were included in the review. Meta-analysis revealed statistically significant reductions in pain severity on a 0-10 scale from acupuncture (weighted mean difference 2.3, 95% CI 1.6 to 2.9) and acupressure (weighted mean difference 1.4, 95% CI 0.8 to 1.9), when compared to a control group receiving no treatment. However, these are likely to be placebo effects because when the control groups in acupuncture/acupressure trials received a sham instead of no treatment, pain severity did not significantly differ between the groups. Significant reductions in pain intensity on a 0-10 scale were noted in individual trials of heat (by 1.8, 95% CI 0.9 to 2.7), transcutaneous electrical nerve stimulation (2.3, 95% CI 0.03 to 4.2), and yoga (3.2, 95% CI 2.2 to 4.2). Meta-analysis of two trials of spinal manipulation showed no significant reduction in pain. None of the included studies measured quality of life. Physiotherapists could consider using heat, transcutaneous electrical nerve stimulation, and yoga in the management of primary dysmenorrhea. While benefits were also identified for acupuncture and acupressure in no-treatment controlled trials, the absence of significant effects in sham-controlled trials suggests these effects are mainly attributable to placebo effects. Copyright © 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in Healthy Term Infants

PubMed Central

Billeaud, Claude; Puccio, Giuseppe; Saliba, Elie; Guillois, Bernard; Vaysse, Carole; Pecquet, Sophie; Steenhout, Philippe

2014-01-01

OBJECTIVE This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions. METHODS Healthy, full-term infants (n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: −3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated. RESULTS Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]). CONCLUSION Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group. PMID:25452707

Improved Clinical Efficacy with Wound Support Network Between Hospital and Home Care Service.

PubMed

Bergersen, Tone Kristin; Storheim, Elisabeth; Gundersen, Stina; Kleven, Linn; Johnson, Maria; Sandvik, Leiv; Kvaerner, Kari Jorunn; Ørjasæter, Nils-Otto

2016-11-01

The aim of this study was to test the efficacy of a wound support network model between the primary home care service and the hospital. The impact on wound healing rate, cost benefit, and transfer of knowledge was investigated. The intervention group was exposed to a wound support network (n = 32), and the control group continued standard organization of treatment (n = 21). Nonrandomized controlled study; observations were made before (baseline) and after the implementation of the intervention (12 weeks). Patients with chronic wounds (lasting >6 weeks and with wound area >1 cm) in Oslo, Norway. Closure of the observation wound; wound size; total number of wounds; presence of eczema, edema, and pain; number of dressings per week; time spent per dressing; and number of control appointments at the hospital. The economic impact is calculated for the hospital and for the community of Oslo, Norway. The number of control appointments (t = 3.80, P < .001) was significantly decreased, and the number of completed treatments (P = .02) was significantly increased after 12 weeks in the intervention group compared with the control group. A significant improvement was evident in the intervention group in terms of eczema (P = .02), edema (P = .03), and closing of the observational wound (46.7% cases in the intervention group versus 25.0% in the control group). A wound support network between the primary home care service and the hospital is cost-effective, improves clinical efficacy of the home care services' work, and reduces the need for consultations at the hospital.

The use of an intraarticular catheter on fast-track primary knee arthroplasty, is it a step forward?

PubMed

Cáceres-Sánchez, L; García-Benítez, J B; Coronado-Hijón, V; Montero-Pariente, M

This study compares the efficacy in post-operative pain control of the intraarticular catheter compared to the epidural catheter after primary total knee arthroplasty. Randomised clinical trial consisting of two groups of patients. A control group with intradural anaesthesia and an intraoperative epidural catheter (ropivacaine) and an intervention group using the same anaesthetic technique and an intraarticular catheter with an elastomeric pump (ropivacaine+dexketoprofen). Data such as demographic, anaesthetic and surgical variables, pain intensity according to Verbal Rating Scale, opioid use and complications, joint balance, onset of walking and hospital stay were recorded. A lower incidence and severity on Verbal Rating Scale and a better control of postoperative pain (p<.0014) were observed in the intervention group. Joint balance also presented significant results in flexion and 74% of these patients started walking before the first 36h and the control group had not yet done so. Regarding patient satisfaction, 54.1% of the patients were "very satisfied" with the use of the catheter (p>.001). Finally, the hospital stay decreased significantly, with 33.3% of intervention group patients discharged within the first 48h compared to none of the control group. The use of the intraarticular catheter as postoperative analgesia is a useful and safe alternative. It reduces the possibility of side effects. It helps in early improvement of joint balance, onset of walking and control of pain. All of which increase patient satisfaction and result in a shorter period of hospitalisation. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial.

PubMed

Epstein, Dana R; Sidani, Souraya; Bootzin, Richard R; Belyea, Michael J

2012-06-01

Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. A randomized, controlled study. Veterans Affairs medical center. 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1.

Macular Thickness Variability in Primary Open Angle Glaucoma Patients using Optical Coherence Tomography

PubMed Central

Agarwal, Prakashchand; Sathyan, P; Saini, VK

2014-01-01

ABSTRACT Aim: To compare the difference of retinal macular thickness and macular volume using optical coherence tomography (OCT) in primary open angle glaucoma (POAG) patients with the normal subjects. Materials and methods: This observational case control study included primary open angle glaucoma (POAG) patients (n = 124 eyes) and healthy subjects in the control group (n = 124 eyes). All subjects underwent detailed history, general and systemic exami -nation. Complete ocular examination included best corrected visual acuity (BCVA), slit lamp examination, intraocular pressure (IOP), central corneal thickness, gonioscopy, dilated fundus biomicroscopy. Field analysis was done by white on white Humphrey Field Analyzer (Carl Zeiss). Optical coherence tomography imaging of macular area was performed using Stratus OCT (OCT 3, Version 4, Carl Zeiss Inc, Dublin, California, USA). In both these groups, parameters analyzed were macular thickness, inner macular thicknesses (IMT), outer macular thicknesses (OMT), central macular thick ness (CMT) and total macular volume (TMV). Results: The POAG group had significantly decreased values of TMV, OMT and IMT, compared to control group, while there was no difference in CMT, presumably due to absence of ganglion cells in the central part. Thus, macular thickness and volume parameters may be used for making the diagnosis of glaucoma especially in patients with abnormalities of disc. Conclusion: Macular thickness parameters correlated well with the diagnosis of glaucoma. How to cite this article: Sharma A, Agarwal P, Sathyan P, Saini VK. Macular Thickness Variability in Primary Open Angle Glaucoma Patients using Optical Coherence Tomography. J Current Glau Prac 2014;8(1):10-14. PMID:26997801

[SEMITENDINOUS AND GRACILIS TRANSFER FOR TREATMENT OF MEDIAL COLLATERAL LIGAMENT INJURY CAUSED BY TOTAL KNEE ARTHROPLASTY].

PubMed

Cao Jiangang; Wang, Lei; Zhao, Huiwen; Liu, Jun

2016-02-01

To evaluate the effectiveness of semitendinous and gracilis transfer for the treatment of medial collateral ligament (MCL) injury caused by total knee arthroplasty (TKA). Between March 2009 and May 2014, 11 patients (11 knees) with MCL injuries caused by primary TKA were treated by semitendinous and gracilis transfer in primary TKA (injury group). Another 18 patients (21 knees) without MCL injury were included as the control group. There was no significant difference in gender, age, injury sides, disease duration, body mass index, knee varus deformity, and preoperative Knee Society Score (KSS) between 2 groups (P>0.05), with comparability. KSS score was used to evaluate the function after operation. Primary healing of incision was obtained in all patients, and no complications of joint instability and pain occurred. The follow-up time was-6-29 months in injury group and was 7-34 months in control group. At last follow-up, the KSS clinical score and ftinctional score were significantly increased to 89.82 +/- 3.76 and 89.54 +/- 3.50 in the injury group (P<0.05) and were significantly increased to 90.19 +/- 3.39 and 90.00 +/- 3.53 in the control group (P<0.05) respectively, but no significant difference was shown between 2 groups (t=0.158, P=0.877; t=0.820, P=0.432). X-ray films showed no prosthetic loosening or subsidence during follow-up. The semitendinous and gracilis transfer is reliable for the treatment of MCL injury caused by TKA. The insertions of semitendinous tendon and gracilis are close to that of the knee MCL, which can effectively improve knee function.

The primary prevention of asthma in children study: design of a multifaceted prevention program.

PubMed

Kuiper, Sandra; Maas, Tanja; van Schayck, Constant P; Muris, Jean W M; Schönberger, Huub J A M; Dompeling, Edward; Gijsbers, Barbara; van Weel, Chris; Knottnerus, J André

2005-06-01

The PREVASC study addresses the primary prevention of asthma in infants and small children. The objective of this study is to investigate whether a multifaceted prenatally started intervention strategy in high-risk infants leads to a decrease in the occurrence of (severe) asthma and whether a refinement of the prevention strategy leads to an increase in the adherence to the prevention program. The primary prevention program includes house dust mite impermeable bed coverings, education on breast feeding, hypoallergenic feeding, timing of introduction of solid food and smoking cessation. A total of 888 infants were prenatally included. By the time of inclusion the mothers were 3-7 months pregnant. About 27 infants were excluded from the study and 18 dropped out. Of the remaining 843 infants 535 had a first-degree familial predisposition of asthma (high-risk group), whereas a reference group of 308 (162 boys) infants was not predisposed for asthma in the first-degree (low-risk group). To evaluate the (cost-)effectiveness of the preventive intervention, 222 (118 boys) infants of the high-risk group allocated to the intervention group and 221 (112 boys) allocated to a control group are followed up. The low-risk infants served as controls to evaluate the predictive value of high risk (first-degree familial predisposition of asthma). The infants are followed from the prenatal stage until they reach the age of 6 yr. The remaining 92 high-risk infants were included in an optimized randomized-clinical adherence trial (RCAT). Of these 92 infants, 45 (20 boys) were allocated to an intervention group and 47 (24 boys) to a control group. Until now all infants have been followed for at least 1 yr.

The impacts of implementation of National Essential Medicines Policies on primary healthcare institutions: a cross-sectional study in China.

PubMed

Guo, Zhigang; Guan, Xiaodong; Shi, Luwen

2017-11-13

In 2009, China implemented the National Essential Medicines Policies (NEMPs) as part of a new round of medical system reforms. This study aims to evaluate the impacts of the NEMPs on primary healthcare institutions and discuss the roles of the policies in the new healthcare reforms of China. The study selected a total of six representative provinces of China, generating a sample of 261 primary healthcare institutions from August to December in 2010. A questionnaire survey developed by the study team was distributed to all of the primary healthcare institutions. Nine indicators from three dimensions as the outcome variables were used and calculated to evaluate the impacts of implementation of policies. All of the outcome variables were tested using independent-samples T test between the treatment group (with the NEMPs implemented) and the control group (without the NEMPs implemented). The ratio of drug sales and institution revenues at primary healthcare institutions was 42.99% in the treatment group, which was significantly lower than the control group (53.90%, p < 0.01), while the ratio of financial subsidies of the treatment group was shown to be higher (30.78% VS 20.82%, p < 0.01). The rate of healthcare workers income growth was greater in the treatment group (15.35% VS 5.79%, p = 0.006). The treatment group exhibited higher outpatient and emergency visits per month in urban areas (2720 VS 1763 visits per month) and rural areas (3830 VS 3633), and higher prescriptions per month in urban areas (2048 VS 1025, p = 0.005) and rural areas (3806 VS 3251). The treatment group used more essential medicines and received greater income from essential medicines while the drug price markup rate was lower. The NEMPs appear to affect the transformation of the operation mechanisms of primary healthcare institutions, the improvement of the mechanisms for government investment, and the healthcare pricing system. Meanwhile, the gaps between urban and rural areas need to be addressed. In conclusion, the NEMPs of China are instrumental to the aim of providing basic healthcare services to every citizen.

Effectiveness of a medical education intervention to treat hypertension in primary care.

PubMed

Martínez-Valverde, Silvia; Castro-Ríos, Angélica; Pérez-Cuevas, Ricardo; Klunder-Klunder, Miguel; Salinas-Escudero, Guillermo; Reyes-Morales, Hortensia

2012-04-01

In Mexico, hypertension is among the top five causes for visits to primary care clinics; its complications are among the main causes of emergency and hospital care. The present study reports the effectiveness of a continuing medical education (CME) intervention to improve appropriate care for hypertension, on blood pressure control of hypertensive patients in primary care clinics. A secondary data analysis was carried out using data of hypertensive patients treated by family doctors who participated in the CME intervention. The evaluation was designed as a pre-/post-intervention study with control group in six primary care clinics. The effect of the CME intervention was analysed using multiple logistic regression modelling in which the dependent variable was uncontrolled blood pressure in the post-intervention patient measurement. After the CME intervention, the net reduction of uncontrolled blood pressure between stages in the intervention group was 10.3%. The model results were that being treated by a family doctor who participated in the CME intervention reduced by 53% the probability of lack of control of blood pressure; receiving dietary recommendations reduced 57% the probability of uncontrolled blood pressure. Having uncontrolled blood pressure at the baseline stage increased the probability of lack of control in 166%, and per each unit of increase in body mass index the lack of control increased 7%. CME intervention improved the medical decision-making process to manage hypertension, thus increasing the probability of hypertensive patients to have blood pressure under control. © 2010 Blackwell Publishing Ltd.

Innovative approach to patient-centered care coordination in primary care practices.

PubMed

Clarke, Robin; Bharmal, Nazleen; Di Capua, Paul; Tseng, Chi-Hong; Mangione, Carol M; Mittman, Brian; Skootsky, Samuel A

2015-09-01

Although care coordination is an essential component of the patient-centered medical home structure, current case manager models have limited usefulness to population health because they typically serve a small group of patients defined based on disease or utilization. Our objective was to support our health system's population health by implementing and evaluating a program that embedded nonlicensed coordinators within our primary care practices to support physicians in executing care plans and communicating with patients. Matched case-control differences-in-differences. Comprehensive care coordinators (CCC) were introduced into 14 of the system's 28 practice sites in 2 waves. After a structured training program, CCCs identified, engaged, and intervened among patients within the practice in conjunction with practice primary care providers. We counted and broadly coded CCC activities that were documented in the intervention database. We examined the impact of CCC intervention on emergency department (ED) utilization at the practice level using a negative binomial multivariate regression model controlling for age, gender, and medical complexity. CCCs touched 10,500 unique patients over a 1-year period. CCC interventions included execution of care (38%), coordination of transitions (32%), self-management support/link to community resources (15%), monitor and follow-up (10%), and patient assessment (1%). The CCC intervention group had a 20% greater reduction in its prepost ED visit rate compared with the control group (P < .0001). Our CCC intervention demonstrated a significant reduction in ED visits by focusing on the centrality of the primary care provider and practice. Our model may serve as a cost-effective and scalable alternative for care coordination in primary care.

Reduced nasal growth after primary nasal repair combined with cleft lip surgery.

PubMed

Yoshimura, Y; Okumoto, T; Iijima, Y; Inoue, Y

2015-11-01

Nasal growth after cleft lip surgery with or without primary nasal repair was evaluated using lateral cephalograms. In 14 patients who underwent simultaneous nasal repair with primary cleft lip repair and 12 patients without simultaneous nasal repair, lateral cephalograms were obtained at 5 and 10 years of age. Lateral cephalograms of normal Japanese children were used as a control. At 5 years of age, there were significant differences in the nasal height and columellar angle among the three groups. Children without simultaneous nasal repair had shorter noses with more upward tilt of the columella compared with the controls, while children with simultaneous nasal repair had much shorter noses and more upward tilt than those without repair. At 10 years of age, the children without simultaneous nasal repair showed no differences from the control group, while those with simultaneous repair still had shorter noses and more upward tilt of the columella. These findings suggest that performing nasal repair at the same time as primary cleft lip surgery has an adverse influence on the subsequent growth of the nose. Copyright © 2015 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Intra-operative protective mechanical ventilation in lung transplantation: a randomised, controlled trial.

PubMed

Verbeek, G L; Myles, P S; Westall, G P; Lin, E; Hastings, S L; Marasco, S F; Jaffar, J; Meehan, A C

2017-08-01

Primary graft dysfunction occurs in up to 25% of patients after lung transplantation. Contributing factors include ventilator-induced lung injury, cardiopulmonary bypass, ischaemia-reperfusion injury and excessive fluid administration. We evaluated the feasibility, safety and efficacy of an open-lung protective ventilation strategy aimed at reducing ventilator-induced lung injury. We enrolled adult patients scheduled to undergo bilateral sequential lung transplantation, and randomly assigned them to either a control group (volume-controlled ventilation with 5 cmH 2 O, positive end-expiratory pressure, low tidal volumes (two-lung ventilation 6 ml.kg -1 , one-lung ventilation 4 ml.kg -1 )) or an alveolar recruitment group (regular step-wise positive end-expiratory pressure-based alveolar recruitment manoeuvres, pressure-controlled ventilation set at 16 cmH 2 O with 10 cmH 2 O positive end-expiratory pressure). Ventilation strategies were commenced from reperfusion of the first lung allograft and continued for the duration of surgery. Regular PaO 2 /F I O 2 ratios were calculated and venous blood samples collected for inflammatory marker evaluation during the procedure and for the first 24 h of intensive care stay. The primary end-point was the PaO 2 /F I O 2 ratio at 24 h after first lung reperfusion. Thirty adult patients were studied. The primary outcome was not different between groups (mean (SD) PaO 2 /F I O 2 ratio control group 340 (111) vs. alveolar recruitment group 404 (153); adjusted p = 0.26). Patients in the control group had poorer mean (SD) PaO 2 /F I O 2 ratios at the end of the surgical procedure and a longer median (IQR [range]) time to tracheal extubation compared with the alveolar recruitment group (308 (144) vs. 402 (154) (p = 0.03) and 18 (10-27 [5-468]) h vs. 15 (11-36 [5-115]) h (p = 0.01), respectively). An open-lung protective ventilation strategy during surgery for lung transplantation is feasible, safe and achieves favourable ventilation parameters. © 2017 The Association of Anaesthetists of Great Britain and Ireland.

Comparison of Implant Stability Using Resonance Frequency Analysis: Osteotome Versus Conventional Drilling

PubMed Central

Sadeghi, Rokhsareh; Miremadi, Asghar

2015-01-01

Objectives: Implant primary stability is one of the important factors in achieving implant success. The osteotome technique may improve primary stability in patients with poor bone quality. The aim of this study was to compare implant stability using two different techniques namely osteotome versus conventional drilling in the posterior maxilla. Materials and Methods: In this controlled randomized clinical trial, 54 dental implants were placed in 32 patients; 29 implants were placed in the osteotome group and 25 in the conventional drilling group. Implant stability was assessed at four time intervals namely at baseline, one, two and three months after implant placement using resonance frequency analysis (RFA). Results: Primary stability based on implant stability quotient (ISQ) units was 71.4±7 for the osteotome group and 67.4±10 for the control group. There was no statistically significant difference between the two groups in implant stability at any of the measurement times. In each group, changes in implant stability from baseline to one month and also from two months to three months post-operatively were not significant but from one month to two months after implant placement, implant stability showed a significant increase in both groups. Conclusion: The results of this study revealed that in both techniques, good implant stability was achieved and osteotome technique did not have any advantage compared to conventional drilling in this regard. PMID:27148375

Effects on readiness to change of an educational intervention on depressive disorders for general physicians in primary care based on a modified Prochaska model--a randomized controlled study.

PubMed

Shirazi, M; Zeinaloo, A A; Parikh, S V; Sadeghi, M; Taghva, A; Arbabi, M; Kashani, A Sabouri; Alaeddini, F; Lonka, K; Wahlström, R

2008-04-01

The Prochaska model of readiness to change has been proposed to be used in educational interventions to improve medical care. To evaluate the impact on readiness to change of an educational intervention on management of depressive disorders based on a modified version of the Prochaska model in comparison with a standard programme of continuing medical education (CME). This is a randomized controlled trial within primary care practices in southern Tehran, Iran. The participants included 192 general physicians working in primary care (GPs) were recruited after random selection and randomized to intervention (96) and control (96). Intervention consisted of interactive, learner-centred educational methods in large and small group settings depending on the GPs' stages of readiness to change. Change in stage of readiness to change measured by the modified version of the Prochaska questionnaire was the The final number of participants was 78 (81%) in the intervention arm and 81 (84%) in the control arm. Significantly (P < 0.01), more GPs (57/96 = 59% versus 12/96 = 12%) in the intervention group changed to higher stages of readiness to change. The intervention effect was 46% points (P < 0.001) and 50% points (P < 0.001) in the large and small group setting, respectively. Educational formats that suit different stages of learning can support primary care doctors to reach higher stages of behavioural change in the topic of depressive disorders. Our findings have practical implications for conducting CME programmes in Iran and are possibly also applicable in other parts of the world.

The impact of occupational therapy in Parkinson's disease: a randomized controlled feasibility study.

PubMed

Sturkenboom, Ingrid H; Graff, Maud J; Borm, George F; Veenhuizen, Yvonne; Bloem, Bastiaan R; Munneke, Marten; Nijhuis-van der Sanden, Maria W

2013-02-01

To evaluate the feasibility of a randomized controlled trial including process and potential impact of occupational therapy in Parkinson's disease. Process and outcome were quantitatively and qualitatively evaluated in an exploratory multicentre, two-armed randomized controlled trial at three months. Forty-three community-dwelling patients with Parkinson's disease and difficulties in daily activities, their primary caregivers and seven occupational therapists. Ten weeks of home-based occupational therapy according to the Dutch guidelines of occupational therapy in Parkinson's disease versus no occupational therapy in the control group. Process evaluation measured accrual, drop-out, intervention delivery and protocol adherence. Primary outcome measures of patients assessed daily functioning: Canadian Occupational Performance Measure (COPM) and Assessment of Motor and Process Skills. Primary outcome for caregivers was caregiver burden: Zarit Burden Inventory. Participants' perspectives of the intervention were explored using questionnaires and in-depth interviews. Inclusion was 23% (43/189), drop-out 7% (3/43) and unblinding of assessors 33% (13/40). Full intervention protocol adherence was 74% (20/27), but only 60% (71/119) of baseline Canadian Occupational Performance Measure priorities were addressed in the intervention. The outcome measures revealed negligible to small effects in favour of the intervention group. Almost all patients and caregivers of the intervention group were satisfied with the results. They perceived: 'more grip on the situation' and used 'practical advices that make life easier'. Therapists were satisfied, but wished for a longer intervention period. The positive perceived impact of occupational therapy warrants a large-scale trial. Adaptations in instructions and training are needed to use the Canadian Occupational Performance Measure as primary outcome measure.

Phonological short-term memory in logopenic variant primary progressive aphasia and mild Alzheimer's disease.

PubMed

Meyer, Aaron M; Snider, Sarah F; Campbell, Rachael E; Friedman, Rhonda B

2015-10-01

It has been argued that individuals with logopenic variant primary progressive aphasia (lvPPA) have an impairment of the phonological loop, which is a component of the short-term memory (STM) system. In contrast, this type of impairment is not thought to be present in mild typical Alzheimer's disease (AD). Thus, one would predict that people with lvPPA would score significantly lower than a matched AD group on tasks that require phonological STM. In the current study, an lvPPA group was compared with a mild AD group that was matched on age, education, and general cognitive functioning. For a subset of the tasks that involved pseudowords, the AD and lvPPA groups were compared to a healthy control group that was matched on age and education. The lvPPA group was more impaired than the AD group on all of the tasks that required phonological STM, including the pseudoword tasks, but there were no significant differences between these groups on tasks that required visuospatial STM. Compared to the healthy controls, the lvPPA group performed significantly worse on the repetition and reading of pseudowords, while the AD group did not differ significantly from the controls on these tasks. These findings are consistent with the hypothesis that phonological STM is impaired in lvPPA. Copyright © 2015 Elsevier Ltd. All rights reserved.

Up-front systemic chemotherapy is a feasible option compared to primary tumor resection followed by chemotherapy for colorectal cancer with unresectable synchronous metastases.

PubMed

Niitsu, Hiroaki; Hinoi, Takao; Shimomura, Manabu; Egi, Hiroyuki; Hattori, Minoru; Ishizaki, Yasuyo; Adachi, Tomohiro; Saito, Yasufumi; Miguchi, Masashi; Sawada, Hiroyuki; Kochi, Masatoshi; Mukai, Shoichiro; Ohdan, Hideki

2015-04-24

In stage IV colorectal cancer (CRC) with unresectable metastases, whether or not resection of the primary tumor should be indicated remains controversial. We aim to determine the impact of primary tumor resection on the survival of stage IV CRC patients with unresectable metastases. We retrospectively investigated 103 CRC patients with stage IV colorectal cancer with metastases, treated at Hiroshima University Hospital between 2007 and 2013. Of these, those who had resectable primary tumor but unresectable metastases and received any chemotherapy were included in the study. We analyzed the overall survival (OS) and short-term outcomes between the patients who received up-front systemic chemotherapy (USC group) and those who received primary tumor resection followed by chemotherapy (PTR group). Of the 57 included patients, 15 underwent USC and 42 PTR. The median survival times were 13.4 and 23.9 months in the USC and PTR groups, respectively (P = 0.093), but multivariate analysis for the overall survival showed no significant difference between the two groups (hazard ratio, 1.30; 95% confidence interval (CI), 0.60 to 2.73, P = 0.495). In the USC group, the disease control rate of primary tumor was observed in 12 patients (80.0%), but emergency laparotomy was required for 1 patient. Morbidity in the PTR group was observed in 18 cases (42.9%). The overall survival did not differ significantly between the USC and PTR groups. USC may help avoid unnecessary resection and consequently the high morbidity rate associated with primary tumor resection for stage IV CRC with unresectable metastases.

Impact of an academic-community partnership in medical education on community health: evaluation of a novel student-based home visitation program.

PubMed

Rock, John A; Acuña, Juan M; Lozano, Juan Manuel; Martinez, Iveris L; Greer, Pedro J; Brown, David R; Brewster, Luther; Simpson, Joe L

2014-04-01

Current US healthcare delivery systems do not adequately address healthcare demands. Physicians are integral but rarely emphasize prevention as a primary tool to change health outcomes. Home visitation is an effective method for changing health outcomes in some populations. The Florida International University Herbert Wertheim College of Medicine Green Family Foundation NeighborhoodHELP service-learning program assigns medical students to be members of interprofessional teams that conduct household visits to determine their healthcare needs. We performed a prospective evaluation of 330 households randomly assigned to one of two groups: visitation from a student team (intervention group) or limited intervention (control group). The program design allowed randomly selected control households to replace intervention-group households that left the program of their own volition. All of the households were surveyed at baseline and after 1 year of participation in the study. After 1 year in the program and after adjustment for confounders, intervention group households proved more likely (P ≤ 0.05) than control households to have undergone physical examinations, blood pressure monitoring, and cervical cytology screenings. Cholesterol screenings and mammograms were borderline significant (P = 0.05 and P = 0.06, respectively). This study supports the value of home visitation by interprofessional student teams as an effective way to increase the use of preventive health measures. The study underscores the important role interprofessional student teams may play in improving the health of US communities, while students concurrently learn about primary prevention and primary care.

Comparison of CPP-ACP, Tri-Calcium Phosphate and Hydroxyapatite on Remineralization of Artificial Caries Like Lesions on Primary Enamel -An in vitro Study.

PubMed

Bajaj, Meghna; Poornima, P; Praveen, S; Nagaveni, N B; Roopa, K B; Neena, I E; Bharath, K P

To compare CPP-ACP, Tri-calcium phosphate and Hydroxyapatite on remineralization of artificial caries like lesions on primary enamel. Ten extracted Primary molars coated with nail varnish, leaving a window of 2×4 mm on buccal and lingual surface were immersed in demineralizing solution for 96 hours and sectioned longitudinally to obtain 40 sections (4 sections per tooth) and were randomly divided into 4 groups (A to D) n=10; Group A: negative control, Group B: CPP-ACP, Group C: Tri-calcium phosphate, Group D: Hydroxyapatite. Sections were subjected to pH cycling for 10 days and were evaluated by polarized light microscope before and after treatment. Intra group comparison of demineralization and remineralization was done by paired t-test. One way ANOVA was used for multiple group comparisons followed by post HOC TUKEY'S Test for group wise comparisons. Remineralization was found more with Group D followed by Group B, C and A. Hydroxyapatite showed better remineralization when compared to CPP-ACP and Tri-calcium phosphate.

COMPARING PERIPHERAL VITRECTOMY UNDER AIR AND FLUID INFUSION FOR PRIMARY RHEGMATOGENOUS RETINAL DETACHMENT.

PubMed

Erdogan, Gurkan; Unlu, Cihan; Karasu, Bugra; Kardes, Esra; Ergin, Ahmet

2016-07-01

To evaluate the efficacy and safety of peripheral vitrectomy under air infusion in comparison with fluid infusion in patients undergoing 23-gauge pars plana vitrectomy for primary rhegmatogenous retinal detachment. A total of 80 eyes of 80 patients with primary rhegmatogenous retinal detachment were enrolled into the study. Forty cases underwent peripheral vitrectomy under air infusion (air group), and a control group of equal number underwent peripheral vitrectomy under fluid infusion (fluid group). Peripheral iatrogenic retinal breaks during peripheral vitrectomy, postoperative visual acuities, and retinal redetachment rates were compared. The number of eyes with peripheral iatrogenic retinal breaks in air group during peripheral vitrectomy was statistically comparable with that in fluid group (1/40 and 4/40, 2.5% and 10%, respectively; P = 0.16). Scleral depression was necessitated in 7 of 40 cases (17.5%) during the operation in the air group. There were no statistically significant differences between the groups in means of postoperative visual acuity and retinal redetachment (P = 0.18 and P = 1.0, respectively). Peripheral vitrectomy under air infusion for primary rhegmatogenous retinal detachment revealed comparable results with fluid infusion in terms of intraoperative and postoperative complications and surgical outcomes.

SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Sedentary lifestyles are now becoming a major concern for governments of developed and developing countries with physical inactivity related to increased all-cause mortality, lower quality of life, and increased risk of obesity, diabetes, hypertension and many other chronic diseases. The powerful onboard computing capacity of smartphones, along with the unique relationship individuals have with their mobile phones, suggests that mobile devices have the potential to influence behavior. However, no previous trials have been conducted using smartphone technology to promote physical activity. This project has the potential to provide robust evidence in this area of innovation. The aim of this study is to evaluate the effectiveness of a smartphone application as an intervention to promote physical activity in primary care. Methods/design A two-group, parallel randomized controlled trial (RCT) with a main outcome measure of mean difference in daily step count between baseline and follow up over eight weeks. A minimum of 80 active android smartphone users over 16 years of age who are able to undertake moderate physical activity are randomly assigned to the intervention group (n = 40) or to a control group (n = 40) for an eight week period. After randomization, all participants will complete a baseline period of one week during which a baseline mean daily step count will be established. The intervention group will be instructed in the usability features of the smartphone application, will be encouraged to try to achieve 10,000 steps per day as an exercise goal and will be given an exercise promotion leaflet. The control group will be encouraged to try to walk an additional 30 minutes per day along with their normal activity (the equivalent of 10,000 steps) as an exercise goal and will be given an exercise promotion leaflet. The primary outcome is mean difference in daily step count between baseline and follow-up. Secondary outcomes are systolic and diastolic blood pressure, resting heart rate, mental health score using HADS and quality of life score using Euroqol. Randomization and allocation to the intervention and groups will be carried out by an independent researcher, ensuring the allocation sequence is concealed from the study researchers until the interventions are assigned. The primary analysis is based on mean daily step count, comparing the mean difference in daily step count between the baseline and the trial periods in the intervention and control groups at follow up. Trial registration Current Controlled Trials ISRCTN99944116 PMID:23714362

A randomized controlled trial of single point acupuncture in primary dysmenorrhea.

PubMed

Liu, Cun-Zhi; Xie, Jie-Ping; Wang, Lin-Peng; Liu, Yu-Qi; Song, Jia-Shan; Chen, Yin-Ying; Shi, Guang-Xia; Zhou, Wei; Gao, Shu-Zhong; Li, Shi-Liang; Xing, Jian-Min; Ma, Liang-Xiao; Wang, Yan-Xia; Zhu, Jiang; Liu, Jian-Ping

2014-06-01

Acupuncture is often used for primary dysmenorrhea. But there is no convincing evidence due to low methodological quality. We aim to assess immediate effect of acupuncture at specific acupoint compared with unrelated acupoint and nonacupoint on primary dysmenorrhea. The Acupuncture Analgesia Effect in Primary Dysmenorrhoea-II is a multicenter controlled trial conducted in six large hospitals of China. Patients who met inclusion criteria were randomly assigned to classic acupoint (N = 167), unrelated acupoint (N = 167), or non-acupoint (N = 167) group on a 1:1:1 basis. They received three sessions with electro-acupuncture at a classic acupoint (Sanyinjiao, SP6), or an unrelated acupoint (Xuanzhong, GB39), or nonacupoint location, respectively. The primary outcome was subjective pain as measured by a 100-mm visual analog scale (VAS). Measurements were obtained at 0, 5, 10, 30, and 60 minutes following the first intervention. In addition, patients scored changes of general complaints using Cox retrospective symptom scales (RSS-Cox) and 7-point verbal rating scale (VRS) during three menstrual cycles. Secondary outcomes included VAS score for average pain, pain total time, additional in-bed time, and proportion of participants using analgesics during three menstrual cycles. Five hundred and one people underwent random assignment. The primary comparison of VAS scores following the first intervention demonstrated that classic acupoint group was more effective both than unrelated acupoint (-4.0 mm, 95% CI -7.1 to -0.9, P = 0.010) and nonacupoint (-4.0 mm, 95% CI -7.0 to -0.9, P = 0.012) groups. However, no significant differences were detected among the three acupuncture groups for RSS-Cox or VRS outcomes. The per-protocol analysis showed similar pattern. No serious adverse events were noted. Specific acupoint acupuncture produced a statistically, but not clinically, significant effect compared with unrelated acupoint and nonacupoint acupuncture in primary dysmenorrhea patients. Future studies should focus on effects of multiple points acupuncture on primary dysmenorrhea. Wiley Periodicals, Inc.

Two-year controlled effectiveness trial of a school-based intervention to prevent obesity in Chilean children.

PubMed

Kain, Juliana; Leyton, Barbara; Cerda, Ricardo; Vio, Fernando; Uauy, Ricardo

2009-09-01

Obesity prevalence among Chilean children is 19.4%. The present study aimed to assess the effectiveness of a school-based obesity prevention programme. Non-randomized controlled study. The intervention included activities in nutrition and physical activity, fully applied the first year and partially in the second one. Primary outcomes were BMI Z-score (BMIZ) and obesity prevalence; secondary outcomes were waist circumference and triceps skinfold thickness. Time effects were assessed by changes in BMI-related variables by gender and period (ANOVA and Tukey test), while intervention effects were determined by comparing changes in (i) obesity prevalence by gender and period (PROC GENMOD) and (ii) BMIZ according gender, age and period (PROC MIXED). Primary schools in the Chilean cities of Casablanca (intervention group) and Quillota (control group). One thousand seven hundred and fifty-nine children from three schools (intervention group) and 671 from one school (control group). Over the two years, obesity prevalence and BMIZ declined significantly in the intervention group; from 17.0% to 12.3% and 14.1% to 10.3% in boys and girls, respectively, and from 0.62 to 0.53 and 0.64 to 0.58, respectively. In the control group, obesity remained stable at about 21% and 15%, while BMIZ increased significantly in the second year. BMIZ declined in both genders and all age categories in the intervention group during the first year (significant only in younger boys). No changes occurred during the summer, while during the second year, BMIZ increased in boys and girls from both groups (significant only in the younger control boys). Obesity declined significantly only in boys during the first year. Effectiveness was greater in the first school year and more evident in younger boys.

Parental qualities as perceived by borderline personality disorders.

PubMed

Goldberg, R L; Mann, L S; Wise, T N; Segall, E A

1985-01-01

This study explores the contribution of parental qualities to the borderline personality disorder. The Parental Bonding Inventory is used to compare four parental qualities (caring mother, caring father, overprotective father, and overprotective mother) across three groups (borderline personality disorders, assorted psychiatric controls and normal controls). The major finding was that the borderline patients perceived their parents to be significantly less caring and more overprotective than both the psychiatric control or nonclinical control groups. This study was verified previous reports that patients diagnosed with an affective illness (in either the borderline group or psychiatric control group) reported no significant differences on the inventory. Pinpointing parental characteristics which antecede mental disorders may be an important first step in devising primary preventive interventions for adult disorders.

Changes in implant stability using different site preparation techniques: twist drills versus piezosurgery. A single-blinded, randomized, controlled clinical trial.

PubMed

Stacchi, Claudio; Vercellotti, Tomaso; Torelli, Lucio; Furlan, Fabio; Di Lenarda, Roberto

2013-04-01

The objective of the present investigation was to longitudinally monitor stability changes of implants inserted using traditional rotary instruments or piezoelectric inserts, and to follow their variations during the first 90 days of healing. A randomized, controlled trial was conducted on 20 patients. Each patient received two identical, adjacent implants in the upper premolar area: the test site was prepared with piezosurgery, and the control site was prepared using twist drills. Resonance frequency analysis measurements were taken by a blinded operator on the day of surgery and after 7, 14, 21, 28, 42, 56, and 90 days. At 90 days, 39 out of 40 implants were osseointegrated (one failure in the control group). Both groups showed an initial decrease in mean implant stability quotient (ISQ) values: a shift in implant stability to increasing ISQ values occurred after 14 days in the test group and after 21 days in the control group. The lowest mean ISQ value was recorded at 14 days for test implants (97.3% of the primary stability) and at 21 days for the control implants (90.8% of the primary stability). ISQ variations with respect to primary stability differed significantly between the two groups during the entire period of observation: from day 14 to day 42, in particular, the differences were extremely significant (p < .0001). All 39 implants were in function successfully at the visit scheduled 1 year after insertion. The findings from this study suggest that ultrasonic implant site preparation results in a limited decrease of ISQ values and in an earlier shifting from a decreasing to an increasing stability pattern, when compared with the traditional drilling technique. From a clinical point of view, implants inserted with the piezoelectric technique demonstrated a short-term clinical success similar to those inserted using twist drills. © 2011 Wiley Periodicals, Inc.

Effect of Conceptual Change Texts for Overcoming Misconceptions in "People and Management" Unit

ERIC Educational Resources Information Center

Dagdelen, Orhan; Kosterelioglu, Ilker

2015-01-01

This study aimed to investigate the effects of conceptual change texts in teaching concepts in the "People and Management" Unit of a Social Studies Course. The working group of the study was composed of 4th graders in a primary school in Çorum, assigned as control (n = 23) and experimental (n = 23) groups. Non-equivalent control group…

Efficacy of cognitive-behavioural therapy by general practitioners for unexplained fatigue among employees: Randomised controlled trial.

PubMed

Huibers, Marcus J H; Beurskens, Anna J H M; Van Schayck, Constant P; Bazelmans, Ellen; Metsemakers, Job F M; Knottnerus, J Andre; Bleijenberg, Gijs

2004-03-01

Fatigue is a common complaint that may lead to long-term sick leave and work disability. To assess the efficacy of cognitive-behavioural therapy by general practitioners for unexplained, persistent fatigue among employees. A randomised controlled trial, using a pre-randomisation design in primary care, investigated 151 employees on sick leave with fatigue. Participants in the experimental group were offered five to seven 30 min sessions of cognitive-behavioural therapy by a general practitioner; those in the control group were offered no treatment. Main outcome measures (fatigue severity, self-reported absenteeism, registered absenteeism and clinical recovery) were assessed at 4 months, 8 months and 12 months. At baseline, 44% of the patients already met research criteria for chronic fatigue syndrome. There was no significant difference between the experimental group and the control group on primary or secondary outcomes at any point. Cognitive-behavioural therapy by general practitioners for unexplained, persistent fatigue did not prove to be an effective intervention. Since these doctors were unable to deliver this therapy effectively under ideal circumstances, it is unlikely that doctors in routine practice would be more successful in doing so.

[Obstacles for the use of early childhood prevention services : The role of expected ability to control sources].

PubMed

Neumann, Anna; Renner, Ilona

2016-10-01

It is well established that preventive measures for pregnant women and families with small children do not reach all families alike. Often enough, it is those families, who due to heightened stresses and strains might gain the most from these measures, who cannot be reached (dilemma of prevention). This investigation explores whether parents can be grouped according to their views on health, prevention and measures available to young families, and whether belonging to one of the identified groups explains differences in the use of (primary and secondary) preventive measures for pregnant women and young families. In the context of home visits, parents of children aged two to four years (N = 273) completed questionnaires. Additionally, 203 parents took part in qualitative interviews. Based on interview data, parents from different sociocultural backgrounds could be grouped along their expected ability to control sources for parental support (Steuerungskompetenz). Parents high and low in Steuerungskompetenz differ regarding their knowledge of, use of, and satisfaction with (primary) preventive measures. Steuerungskompetenz explains the use of primary preventive measures above and beyond socioeconomic control variables as well as family stresses and strains. The use of secondary preventive measures is better explained by family stresses and strains. Results are discussed in terms of untapped services, needs and possibilities of target group-oriented approach.

The pathological status of exercise dependence

PubMed Central

Bamber, D.; Cockerill, I.; Carroll, D.

2000-01-01

Objectives—This study was concerned with the concept of exercise dependence. Levels of psychological morbidity, personality profiles, and exercise beliefs were compared among subjects screened for exercise dependence and eating disorders. Method—Adult female exercisers were allocated on the basis of questionnaire screening to one of the following groups: primary exercise dependence (n = 43); secondary exercise dependence, where there was the coincidence of exercise dependence and an eating disorder (n = 27); eating disorder (n =14); control, where there was no evidence of either exercise dependence or eating disorder (n = 110). Questionnaire assessment was undertaken of psychological morbidity, self esteem, weight and body shape dissatisfaction, personality, and exercise beliefs. Results—Aside from a higher incidence of reported menstrual abnormalities, the primary exercise dependence group was largely indistinguishable from the controls. In stark contrast, the secondary exercise dependence group reported higher levels of psychological morbidity, neuroticism, dispositional addictiveness, and impulsiveness, lower self esteem, greater concern with body shape and weight, as well as with the social, psychological, and aesthetic costs of not exercising than the controls, but differed little from the eating disorder group. Conclusions—In the absence of an eating disorder, women identified as being exercise dependent do not exhibit the sorts of personality characteristics and levels of psychological distress that warrant the construction of primary exercise dependence as a widespread pathology. Key Words: exercise dependence; eating disorders; personality; self esteem; neuroticism; psychological morbidity PMID:10786869

Effects of Animal-Assisted Activities with Guinea Pigs in the Primary School Classroom

PubMed Central

O’Haire, Marguerite E.; McKenzie, Samantha J.; McCune, Sandra; Slaughter, Virginia

2013-01-01

This study investigated the effects of a classroom-based animal-assisted activities (AAA) program with guinea pigs on the social functioning of primary school children. We hypothesized that participants in the experimental condition (n = 64), compared with a waitlist control group (n = 64), would demonstrate improvements in social functioning following the program. Parents and teachers used the Social Skills Rating System (SSRS) to evaluate the social skills and problem behaviors of 128 participating children (age range = 4.8 to 12.7 years) before and after an 8-week period. Teachers also rated academic competence at both time points. Children who participated in the AAA program demonstrated significantly greater improvements in social functioning than their control group peers, as defined by greater increases in social skills (teacher SSRS) and decreases in problem behaviors (parent and teacher SSRS). There were no significant differences between the groups in academic competence. AAA participants demonstrated significant increases in social skills and decreases in problem behaviors from pre- to post-program on the teacher version of the SSRS. Control group participants did not show significant changes on these measures. These findings suggest that an AAA program with guinea pigs may be a feasible addition to the primary school classroom in order to improve social functioning. Further component analysis will be necessary to determine whether the animal is the active ingredient in AAA programs of this nature. PMID:24265514

Implementing Group Medical Visits for Older Adults at Group Health Cooperative

PubMed Central

Levine, Martin D.; Ross, Tyler R.; Balderson, Benjamin H.K.; Phelan, Elizabeth A.

2010-01-01

In a pair of randomized controlled trials in Kaiser Colorado in the 1990s, Group Visits for older adults (monthly non disease-specific group medical appointments for a cohort of patients led by primary care teams) were proven to reduce costs, decrease hospitalizations, and improve patient and provider satisfaction. As part of a translational effort, this Group Visit intervention was replicated in a delivery system in Seattle, WA, and the log of total health care costs measured in the first year of the intervention. Utilization and patient and physician satisfaction were secondary outcomes. For the cost and utilization analysis, a retrospective case-control design compared 221 case patients 65 years of age and older with high outpatient utilization in the previous 18 months with 1,015 control patient selected randomly from clinics not participating in the intervention. Controls were matched to cases on the number of primary care visits in the prior 18 months. Total costs were not statistically different for intervention patients compared to controls ($8,845 vs. $10,288, p=0.11), nor were there statistically significant differences in utilization, including hospital admissions and outpatient visits. However, patient and provider satisfaction was high. This translational effort did not demonstrate the cost savings of the original efficacy trials. Possible explanations for these divergent results may have to do with differences in those who participated and differences between the two delivery systems. PMID:20002506

Effect of Screening for Partner Violence on Women's Quality of Life

PubMed Central

Klevens, Joanne; Kee, Romina; Trick, William; Garcia, Diana; Angulo, Francisco R.; Jones, Robin; Sadowski, Laura S.

2015-01-01

Context Although partner violence screening has been endorsed by many health organizations, there is insufficient evidence that it has beneficial health outcomes. Objective To determine the effect of computerized screening for partner violence plus provision of a partner violence resource list vs provision of a partner violence list only on women's health in primary care settings, compared with a control group. Design, Setting, and Participants A 3-group blinded randomized controlled trial at 10 primary health care centers in Cook County, Illinois. Participants were enrolled from May 2009–April 2010 and reinterviewed 1 year (range, 48–56 weeks) later. Participants were English- or Spanish-speaking women meeting specific inclusion criteria and seeking clinical services at study sites. Of 3537 women approached, 2727 were eligible, 2708 were randomized (99%), and 2364 (87%) were recontacted 1 year later. Mean age of participants was 39 years. Participants were predominantly non-Latina African American (55%) or Latina (37%), had a high school education or less (57%), and were uninsured (57%). Intervention Randomization into 3 intervention groups: (1) partner violence screen (using the Partner Violence Screen instrument) plus a list of local partner violence resources if screening was positive (n=909); (2) partner violence resource list only without screen (n=893); and (3) no-screen, no-partner violence list control group (n=898). Main Outcome Measures Quality of life (QOL, physical and mental health components) was the primary outcome, measured on the 12-item Short Form (scale range 0–100, mean of 50 for US population). Results At 1-year follow-up, there were no significant differences in the QOL physical health component between the screen plus partner violence resource list group (n=801; mean score, 46.8; 95% CI, 46.1–47.4), the partner violence resource list only group (n=772; mean score, 46.4; 95% CI, 45.8–47.1), and the control group (n=791; mean score, 47.2; 95% CI, 46.5–47.8), or in the mental health component (screen plus partner violence resource list group [mean score, 48.3; 95% CI, 47.5–49.1], the partner violence resource list only group [mean score, 48.0; 95% CI, 47.2–48.9], and the control group [mean score, 47.8; 95% CI, 47.0–48.6]). There were also no differences between groups in days unable to work or complete housework; number of hospitalizations, emergency department, or ambulatory care visits; proportion who contacted a partner violence agency; or recurrence of partner violence. Conclusions Among women receiving care in primary care clinics, providing a partner violence resource list with or without screening did not result in improved health. Trial Registration clinicaltrials.gov Identifier: NCT00526994 PMID:22893165

Ridge preservation using a composite bone graft and a bioabsorbable membrane with and without primary wound closure: a comparative clinical trial.

PubMed

Engler-Hamm, Daniel; Cheung, Wai S; Yen, Alec; Stark, Paul C; Griffin, Terrence

2011-03-01

The aim of this single-masked, randomized controlled clinical trial is to compare hard and soft tissue changes after ridge preservation performed with (control, RPc) and without (test, RPe) primary soft tissue closure in a split-mouth design. Eleven patients completed this 6-month trial. Extraction and ridge preservation were performed using a composite bone graft of inorganic bovine-derived hydroxyapatite matrix and cell binding peptide P-15 (ABM/P-15), demineralized freeze-dried bone allograft, and a copolymer bioabsorbable membrane. Primary wound closure was achieved on the control sites (RPc), whereas test sites (RPe) left the membrane exposed. Pocket probing depth on adjacent teeth, repositioning of the mucogingival junction, bone width, bone fill, and postoperative discomfort were assessed. Bone cores were obtained for histological examination. Intragroup analyses for both groups demonstrated statistically significant mean reductions in probing depth (RPc: 0.42 mm, P = 0.012; RPe: 0.25 mm, P = 0.012) and bone width (RPc: 3 mm, P = 0.002; RPe: 3.42 mm, P <0.001). However, intergroup analysis did not find these parameters to be statistically different at 6 months. The test group showed statistically significant mean change in bone fill (7.21 mm; P <0.001). Compared to the control group, the test group showed statistically significant lower mean postoperative discomfort (RPc 4 versus RPe 2; P = 0.002). Histomorphometric analysis showed presence of 0% to 40% of ABM/P-15 and 5% to 20% of new bone formation in both groups. Comparison of clinical variables between the two groups at 6 months revealed that the mucogingival junction was statistically significantly more coronally displaced in the control group than in the test group, with a mean of 3.83 mm versus 1.21 mm (P = 0.002). Ridge preservation without flap advancement preserves more keratinized tissue and has less postoperative discomfort and swelling. Although ridge preservation is performed with either method, ≈27% to 30% of bone width is lost.

Pre-emptive ice cube cryotherapy for reducing pain from local anaesthetic injections for simple lacerations: a randomised controlled trial.

PubMed

Song, JaeWoo; Kim, HyukHoon; Park, EunJung; Ahn, Jung Hwan; Yoon, Eunhui; Lampotang, Samsun; Gravenstein, Nikolaus; Choi, SangChun

2018-02-01

Subcutaneous local anaesthetic injection can be painful to patients in the ED. We evaluated the effect of cryotherapy by application of an ice cube to the injection site prior to injection in patients with simple lacerations. We conducted a prospective, randomised, controlled trial in consented patients with simple lacerations needing primary repair at a single emergency centre from April to July 2016. We randomly assigned patients undergoing repair for simple lacerations to either the cryotherapy group or the control group (standard care; no cryotherapy or other pretreatment of the injection site). In cryotherapy group subjects, we applied an ice cube (size: 1.5×1.5×1.5 cm) placed inside a sterile glove on the wound at the anticipated subcutaneous lidocaine injection site for 2 min prior to injection. The primary outcome was a subjective numeric rating (0-10 scale) of the perceived pain from the subcutaneous local anaesthetic injections. Secondary outcomes were (a) perceived pain on a numeric scale for cryotherapy itself, that is, pain from contact of the ice cube/glove with the skin and (b) the rate of complications after primary laceration repair. Fifty patients were enrolled, consented and randomised, with 25 in the cryotherapy group and 25 in the control group. The numeric rating scale for subcutaneous anaesthetic injections was median, IQR, 95% CI 2.0 (1 to 3.5), 1.81 to 3.47, respectively, in the cryotherapy group and 5.0 (3 to 7), 3.91 to 6.05 in the control group (Mann-Whitney U=147.50, p=0.001). No wound complications occurred in either group. The numeric rating scale for cryotherapy itself was median, IQR, 95% CI: 2.0 (1 to 3.5), 1.90 to 3.70. Pre-emptive topical injection site cryotherapy lasting 2 min before subcutaneous local anaesthetic injections can significantly reduce perceived pain from subcutaneous local anaesthetic injections in patients presenting for simple laceration repair. KCT0001990. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effectiveness of a diabetes mellitus pictorial diary handbook program for middle-aged and elderly type 2 diabetes mellitus patients: a quasi-experimental study at Taladnoi Primary Care Unit, Saraburi, Thailand.

PubMed

Eknithiset, Rapat; Somrongthong, Ratana

2017-01-01

The research question is "How does a diabetes mellitus (DM) pictorial diary handbook (PDHB) affect the knowledge, practice, and HbA1c among patients with DM type 2?" The aim of this study was to evaluate the effect of a PDHB program among middle-aged and elderly patients with DM type 2 in primary care units in Thailand. A quasi-experimental study design was applied. DM type 2 patients were recruited in the PDHB program by a simple random sampling method. The 3-month program consisted of a weekly health education structured for ~20 minutes, a 15-minute group activity training, a 10-minute individual record of participants' knowledge and practice regarding diet control, exercise, oral hypoglycemic drug taking, diet, self-care, alcohol consumption, smoking, weight management, and HbA1c, and a 15- to 30-minute home visit as well as the PDHB for recording self-care behavior daily. The control group received only the usual diabetes care. The primary expected outcomes were changes in HbA1c from the baseline data to 3 months after the program compared between the intervention and control groups. The secondary expected outcomes were compared within the intervention group. The third expected outcomes were changes in the mean score of knowledge and practice from baseline to 3 months after the program within and between the intervention and control groups. Compared with the baseline data, there was no significant difference in HbA1c, knowledge, and practice mean score between the intervention and control groups. However, there was a significant difference in HbA1c, knowledge, and practice mean score in the intervention group after they received a 3-month PDHB program and within the intervention group ( p -value =0.00). The PDHB program was effective in lowering HbA1c while also improving the mean score of knowledge and practice among elderly patients with DM type 2. However, larger and longer trial studies will be needed to evaluate the sustainability of this program.

Unilateral versus bilateral neck exploration for primary hyperparathyroidism: a prospective randomized controlled trial.

PubMed

Bergenfelz, Anders; Lindblom, Pia; Tibblin, Sten; Westerdahl, Johan

2002-11-01

To compare unilateral and bilateral neck exploration for primary hyperparathyroidism in a prospective randomized controlled trial. Based on the assumption that unilateral neck exploration for a solitary parathyroid adenoma should reduce operating time and morbidity, a variety of minimally invasive procedures have challenged the idea that bilateral neck exploration is the gold standard for the surgical treatment of primary hyperparathyroidism. However, to date, no open prospective randomized trial has been published comparing unilateral and bilateral neck exploration. Ninety-one patients with the preoperative diagnosis of primary hyperparathyroidism were randomized to unilateral or bilateral neck exploration. Preoperative scintigraphy and intraoperative parathyroid hormone measurement guided the unilateral exploration. Gross morphology and frozen section determined the extent of parathyroid tissue resection in the bilateral group. The primary end-point was the use of postoperative medication for hypocalcemic symptoms. Eighty-eight patients (97%) were cured. Histology and cure rate did not differ between the two groups. Patients in the bilateral group consumed more oral calcium, had lower serum calcium values on postoperative days 1 to 4, and had a higher incidence of early severe symptomatic hypocalcemia compared with patients in the unilateral group. In addition, for patients undergoing surgery for a solitary parathyroid adenoma, unilateral exploration was associated with a shorter operative time. The cost for the two procedures did not differ. Patients undergoing a unilateral procedure had a lower incidence of biochemical and severe symptomatic hypocalcemia in the early postoperative period compared with patients undergoing bilateral exploration. Unilateral neck exploration with intraoperative parathyroid hormone assessment is a valid surgical strategy in patients with primary hyperparathyroidism with distinct advantages, especially for patients with solitary parathyroid adenoma.

Sleep variability in military-related PTSD: a comparison to primary insomnia and healthy controls.

PubMed

Straus, Laura D; Drummond, Sean P A; Nappi, Carla M; Jenkins, Melissa M; Norman, Sonya B

2015-02-01

Sleep disturbances are prevalent in posttraumatic stress disorder (PTSD) and are associated with a number of adverse health consequences. Few studies have used comprehensive assessment methods to characterize sleep in Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn (OEF/OIF/OND) veterans with PTSD. OEF/OIF/OND veterans with PTSD and sleep disturbance (n = 45) were compared to patients with primary insomnia (n = 25) and healthy control subjects (n = 27). Participants were assessed using questionnaire-based measures as well as daily subjective and objective measures of sleep. The 3 groups were compared with regard to (a) group means, (b) intraindividual (i.e., night-to-night) variability of sleep, and (c) interindividual (i.e., within-group) variability of sleep. In terms of group means, only objective sleep efficiency was significantly worse with PTSD than with primary insomnia (d = 0.54). Those with PTSD differed from those with primary insomnia on measures of intraindividual as well as interindividual variability (d = 0.48-0.73). These results suggested sleep symptoms in OEF/OIF/OND veterans with PTSD are more variable across nights and less consistent across patients relative to sleep symptoms in insomnia patients without PTSD. These findings have implications for research, as well as for personalizing treatment for individuals with PTSD. Published 2015. This article is a US Government work and is in the public domain in the USA.

The Primary Prevention of PTSD in Firefighters: Preliminary Results of an RCT with 12-Month Follow-Up

PubMed Central

Rees, Clare S.; Mazzucchelli, Trevor G.; Kane, Robert T.

2016-01-01

Aim To develop and evaluate an evidence-based and theory driven program for the primary prevention of Post-traumatic Stress Disorder (PTSD). Design A pre-intervention / post-intervention / follow up control group design with clustered random allocation of participants to groups was used. The “control” group received “Training as Usual” (TAU). Method Participants were 45 career recruits within the recruit school at the Department of Fire and Emergency Services (DFES) in Western Australia. The intervention group received a four-hour resilience training intervention (Mental Agility and Psychological Strength training) as part of their recruit training school curriculum. Data was collected at baseline and at 6- and 12-months post intervention. Results We found no evidence that the intervention was effective in the primary prevention of mental health issues, nor did we find any significant impact of MAPS training on social support or coping strategies. A significant difference across conditions in trauma knowledge is indicative of some impact of the MAPS program. Conclusion While the key hypotheses were not supported, this study is the first randomised control trial investigating the primary prevention of PTSD. Practical barriers around the implementation of this program, including constraints within the recruit school, may inform the design and implementation of similar programs in the future. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12615001362583 PMID:27382968

A simple provider-based educational intervention to boost infant immunization rates: a controlled trial.

PubMed

Stille, C J; Christison-Lagay, J; Bernstein, B A; Dworkin, P H

2001-07-01

We sought to determine if a simple educational intervention initiated at the first well-child care visit, with reinforcement at subsequent visits, can improve inner-city infant immunization rates. We conducted a controlled trial involving 315 newborn infants and their primary caregivers in 3 inner-city primary care centers. Child health care providers gave caregivers in the intervention group an interactive graphic card with verbal reinforcement. At later visits, stickers were applied to the card when immunizations were given. Routine information was given to controls. After the trial, age-appropriate immunization rates at 7 months were 58% in each group. Intervention infants had 50% fewer missed opportunities to immunize (p=0.01) but cancelled 77% more appointments (p=0.04) than controls. We conclude that a brief educational intervention at the first well-child care visit did not boost 7-month immunization rates, although it was associated with fewer missed opportunities to immunize.

MAXCOG-Maximizing Cognition: A Randomized Controlled Trial of the Efficacy of Goal-Oriented Cognitive Rehabilitation for People with Mild Cognitive Impairment and Early Alzheimer Disease.

PubMed

Regan, Bridget; Wells, Yvonne; Farrow, Maree; O'Halloran, Paul; Workman, Barbara

2017-03-01

To review the efficacy of a home-based four-session individualized face-to-face cognitive rehabilitation (MAXCOG) intervention for clients with mild cognitive impairment (MCI) or early dementia and their close supporters. Randomized controlled trial comparing the intervention group (MAXCOG) with treatment as usual (control). A total of 55 client-supporter dyads were enrolled in the study and 40 completed; 25 client-supporter dyads completed MAXCOG and 15 completed treatment as usual. Both MAXCOG and control groups included more MCI cases than dementia (22 versus 3 and 12 versus 3, respectively). Four weekly individual sessions of MAXCOG consisting of personalized interventions to address individually relevant goals, supported by the provision of the MAXCOG information resource. The primary outcomes were goal performance and satisfaction, assessed using the Canadian Occupational Performance Measure (COPM). Questionnaires assessing mood, illness adjustment, quality of life, and carer burden were also administered. The intervention group displayed significantly higher performance and satisfaction with primary goals on the COPM post-intervention than the control group, using a per-protocol analysis. The MAXCOG intervention is effective in improving goal performance and satisfaction in clients with MCI and early dementia. Copyright © 2017 American Association for Geriatric Psychiatry. All rights reserved.

Patient Navigation for Patients Frequently Visiting the Emergency Department: A Randomized, Controlled Trial.

PubMed

Seaberg, David; Elseroad, Stanton; Dumas, Michael; Mendiratta, Sudave; Whittle, Jessica; Hyatte, Cheryl; Keys, Jan

2017-11-01

Emergency department (ED) superutilizers (patients with five or more visits/year) comprise only 5% of the patients seen yet comprise 25% of total ED visits. Although the reasons for this are multifactorial, the cost to the patient and the community is exceedingly high. The cost is not just monetary; care of these patients is inappropriately fragmented and their presence in the ED may contribute to overcrowding affecting the community's emergency readiness. Previous studies using staff trained to help patients navigate their care options have had conflicting results. The objective was to determine whether a trained patient navigator (PN) can reduce ED use and costs in superutilizers over a 1-year period. Superutilizers were enrolled in a prospective randomized controlled clinical trial. Patients were randomized into the treatment arm and met with a PN who reviewed their diagnosis and associated care plan and identified proper primary care services and community resources for follow-up. The remaining control group was provided standard care. Both groups were given a follow-up call and survey by the PN within 7 days of their visit who assessed primary care follow-up and patient satisfaction using a 4-point Likert scale. After 12 months, the patients' return ED visits and ED costs were compared to the year prior and primary care compliance and satisfaction were measured using Student's t-tests with Bonferroni correction or Mann-Whitney U-tests. A total of 282 patients were enrolled (148 in navigation treatment group, 134 controls). Patients were similarly matched in age, race, sex, insurance, and chief complaints. Overall ED visits decreased during the 12-month study period, compared to the 12 months prior to enrollment (2,249 visits prior to 2,050 visits during study period, -8.8%). There was a greater decrease in ED visits from the preenrollment year to postenrollment year in the treatment group (1,148 visits to 996 visits, -13.2%) compared to the control group (1,101 visits to 1,054 visits, -4.3%; p < 0.05). Overall health care costs (ED and hospital) for all 282 patients decreased in the year after compared to the 12 months prior to enrollment ($3.9M to $3.1M) with a greater decrease in the navigation treatment group (-26.6%) compared to the control group (-17.5%). Patient surveys found no difference in patient satisfaction in the pre- and postenrollment periods but there was an increase in primary care physician (PCP) use over the 12-month follow-up period in the treatment group (6.42 visits/patient) compared to the control group (4.07 visits/patient; p < 0.05). Our data showed that the overall number of return ED visits and costs did decrease for both groups, potentially inferring a placebo effect for the use of a PN; however, the decrease in ED visits and costs were greater in the treatment group. One-year follow-up noted an increase in PCP visits in the navigation group. Use of a PN may be cost-effective. © 2017 by the Society for Academic Emergency Medicine.

Effect of nurse-directed hypertension treatment among First Nations people with existing hypertension and diabetes mellitus: the Diabetes Risk Evaluation and Microalbuminuria (DREAM 3) randomized controlled trial.

PubMed

Tobe, Sheldon W; Pylypchuk, George; Wentworth, Joan; Kiss, Alexander; Szalai, John Paul; Perkins, Nancy; Hartman, Susan; Ironstand, Laurie; Hoppe, Jacqueline

2006-04-25

First Nations people with diabetes mellitus and hypertension are at greater risk of renal and cardiovascular complications than are non-native patients because of barriers to health care services. We conducted this randomized controlled trial to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes. We compared 2 community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes. In the intervention group, a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. In the control group, treatment decisions were made by each subject's primary care physician. The primary outcome measure was the difference between the 2 groups in the change in systolic blood pressure after 12 months. Secondary outcome measures were the change in diastolic blood pressure over time, the change in urine albumin status and the incidence of adverse events. Both groups experienced a significant reduction in systolic blood pressure by the final visit (by 24.0 [standard deviation (SD) 13.5] mm Hg in the intervention group and by 17.0 [SD 18.6] mm Hg in the control group); p < 0.001 in each case). However, the difference between the 2 groups in this change was not significant. Patients in the intervention group had a larger decrease in diastolic blood pressure over time than did those in the control group (by 11.6 [SD 10.6] mm Hg v. 6.8 [SD 11.1] mm Hg respectively; p = 0.05). The groups did not differ significantly in terms of changes in urine albumin excretion or incidence of adverse events. High rates of blood pressure control in the community were achieved in both groups in the DREAM 3 study. The addition of a home care nurse to implement a treatment strategy for blood pressure control was more effective in lowering diastolic than systolic blood pressure compared with home care visits for blood pressure monitoring alone and follow-up treatment by a family physician.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Shuangbai San for Treating Primary Liver Cancer Patients With Cancer Pain.

PubMed

Ye, Xiaowei; Lu, Dongyan; Chen, Xinlin; Li, Suihui; Chen, Yao; Deng, Li

2016-06-01

Shuangbai San is a Chinese herb preparation used externally to treat pain. There have been few randomized controlled trials addressing the safety and usefulness of Shuangbai San, such as its effect on pain relief and quality of life (QOL) improvement. This study was conducted to evaluate the effect of Shuangbai San on relieving pain and improving QOL in primary liver cancer patients with cancer pain. A total of 134 primary liver cancer patients with mild pain (numerical rating scale [NRS] ≤ 3), either locally in the liver or in the upper abdomen, were enrolled and randomly allocated to the group receiving Shuangbai San or the control group (receiving placebo). The primary outcome measures were the NRS score and QOL scales, including the QOL scale for patients with liver cancer, version 2.0 and the European Organization for Research and Treatment of Cancer QOL Questionnaire-C30. The secondary outcome measures included the Karnofsky Performance Status score, blood indicators, and liver and kidney function before and after treatment. The NRS scores decreased more significantly in the Shuangbai San group than in the placebo group (P < 0.05) at the corresponding time points. The changes in the scores for the physical function, psychological function, and symptoms/adverse effects domains of the QOL scale for patients with liver cancer, version 2.0 and the physical, emotional, and cognitive domains of the European Organization for Research and Treatment of Cancer QOL Questionnaire-C30 were significantly greater in the Shuangbai San group than in the placebo group (P < 0.05). The changes in the scores for the other domains were not significantly different (P > 0.05). The use of Shuangbai San can relieve mild pain in liver cancer patients and improve their QOL. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Primary prevention of cardiovascular disease with a Mediterranean diet.

PubMed

Estruch, Ramón; Ros, Emilio; Salas-Salvadó, Jordi; Covas, Maria-Isabel; Corella, Dolores; Arós, Fernando; Gómez-Gracia, Enrique; Ruiz-Gutiérrez, Valentina; Fiol, Miquel; Lapetra, José; Lamuela-Raventos, Rosa Maria; Serra-Majem, Lluís; Pintó, Xavier; Basora, Josep; Muñoz, Miguel Angel; Sorlí, José V; Martínez, José Alfredo; Martínez-González, Miguel Angel

2013-04-04

Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events. In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years. A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported. Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. (Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com number, ISRCTN35739639.).

Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial

PubMed Central

Naumann, M; Lowe, N J

2001-01-01

Objectives To evaluate the safety and efficacy of botulinum toxin type A in the treatment of bilateral primary axillary hyperhidrosis. Design Multicentre, randomised, parallel group, placebo controlled trial. Setting 17 dermatology and neurology clinics in Belgium, Germany, Switzerland, and the United Kingdom. Participants Patients aged 18-75 years with bilateral primary axillary hyperhidrosis sufficient to interfere with daily living. 465 were screened, 320 randomised, and 307 completed the study. Interventions Patients received either botulinum toxin type A (Botox) 50 U per axilla or placebo by 10-15 intradermal injections evenly distributed within the hyperhidrotic area of each axilla, defined by Minor's iodine starch test. Main outcome measures Percentage of responders (patients with ⩾50% reduction from baseline of spontaneous axillary sweat production) at four weeks, patients' global assessment of treatment satisfaction score, and adverse events. Results At four weeks, 94% (227) of the botulinum toxin type A group had responded compared with 36% (28) of the placebo group. By week 16, response rates were 82% (198) and 21% (16), respectively. The results for all other measures of efficacy were significantly better in the botulinum toxin group than the placebo group. Significantly higher patient satisfaction was reported in the botulinum toxin type A group than the placebo group (3.3 v 0.8, P<0.001 at 4 weeks). Adverse events were reported by only 27 patients (11%) in the botulinum toxin group and four (5%) in the placebo group (P>0.05). Conclusion Botulinum toxin type A is a safe and effective treatment for primary axillary hyperhidrosis and produces high levels of patient satisfaction. What is already known on this topicPrimary hyperhidrosis is a chronic disorder that can affect any part of the body, especially the axillas, palms, feet, and faceCurrent treatments are often ineffective, short acting, or poorly toleratedWhat this study addsBotulinum toxin type A was significantly better than placebo on all measures of sweatingPatient satisfaction was high and few adverse events were reportedEffects of treatment remained apparent at 16 weeks PMID:11557704

Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial.

PubMed

Barfod, Kristoffer Weisskirchner; Hansen, Maria Swennergren; Holmich, Per; Troelsen, Anders; Kristensen, Morten Tange

2016-11-29

Early controlled ankle motion is widely used in the non-operative treatment of acute Achilles tendon rupture, though its safety and efficacy have never been investigated in a randomized setup. The objectives of this study are to investigate if early controlled motion of the ankle affects functional and patient-reported outcomes. The study is performed as a blinded, randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged from 18 to 70 years are eligible for inclusion. The intervention group performs early controlled motion of the ankle in weeks 3-8 after rupture. The control group is immobilized. In total, 130 patients will be included from one big orthopedic center over a period of 2½ years. The primary outcome is the patient-reported Achilles tendon Total Rupture Score evaluated at 12 months post-injury. Secondary outcome measures are the heel-rise work test, Achilles tendon elongation, and the rate of re-rupture. The primary analysis will be conducted as intention-to-treat analyses. This trial is the first to investigate the safety and efficacy of early controlled motion in the treatment of acute Achilles tendon rupture in a randomized setup. The study uses the patient-reported outcome measure, the Achilles tendon Total Rupture Score, as the primary endpoint, as it is believed to be the best surrogate measure for the tendon's actual capability to function in everyday life. ClinicalTrials.gov: NCT02015364 . Registered on 13 December 2013.

Effectiveness of a multicomponent intervention to enhance implementation of a healthy canteen policy in Australian primary schools: a randomised controlled trial.

PubMed

Nathan, Nicole; Yoong, Sze Lin; Sutherland, Rachel; Reilly, Kathryn; Delaney, Tessa; Janssen, Lisa; Robertson, Katie; Reynolds, Renee; Chai, Li Kheng; Lecathelinais, Christophe; Wiggers, John; Wolfenden, Luke

2016-10-07

The implementation of school nutrition policies, which govern the provision of food in schools, is recommended as a public health strategy to support the development of healthy dietary behaviours in school-aged children. Despite this, research internationally and in Australia indicates that few schools implement such policies. This study aims to examine whether a theoretically designed, multi-strategy intervention was effective in increasing the implementation of a healthy canteen policy in Australian primary schools. A parallel group randomised controlled trial was conducted with all government and Catholic primary schools within one region in New South Wales, Australia who had an operational canteen that provided food to primary school aged children (5-12 years) and were not currently receiving an intervention to change their canteen practices. Schools randomised to the intervention arm received a 9-month multicomponent intervention including ongoing support, provision of resources, performance monitoring and feedback, executive support and recognition. The primary outcomes were the proportion of the schools with a canteen menu that: i) did not include 'red' or 'banned' items according to the healthy canteen policy; and ii) had more than 50 % 'green' items. The primary outcome was assessed via menu audit at baseline and follow up by dietitians blinded to group allocation. Fifty-three eligible schools were randomised to either the intervention or control group (28 intervention; 25 control). Analyses with 51 schools who returned school menus found that intervention schools were significantly more likely relative to control schools to have a menu without 'red' or 'banned' items (RR = 5.78 (1.45-23.05); p = 0.002) and have at least 50 % of menu items classified as green (RR = 2.03 (1.01-4.08); p = 0.03). This study found that a multi-component intervention was effective in improving primary schools' compliance with a healthy canteen policy. Given the lack of evidence regarding how best to support schools with implementing evidence-based policies to improve child diet, this trial for the first time provides high quality evidence to practitioners and policy makers seeking to improve nutrition policy implementation in schools. This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12614001148662 ) 30th October 2014.

The role of treatment timing and mode of stimulation in the treatment of primary dysmenorrhea with acupuncture: An exploratory randomised controlled trial.

PubMed

Armour, Mike; Dahlen, Hannah G; Zhu, Xiaoshu; Farquhar, Cindy; Smith, Caroline A

2017-01-01

We examined the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea. A randomised controlled trial was performed with four arms, low frequency manual acupuncture (LF-MA), high frequency manual acupuncture (HF-MA), low frequency electro acupuncture (LF-EA) and high frequency electro acupuncture (HF-EA). A manualised trial protocol was used to allow differentiation and individualized treatment over three months. A total of 74 women were randomly assigned to one of the four groups (LF-MA n = 19, HF-MA n = 18, LF-EA n = 18, HF-EA n = 19). Twelve treatments were performed over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry. During the treatment period and nine month follow-up all groups showed statistically significant (p < .001) reductions in peak and average menstrual pain compared to baseline but there were no differences between groups (p > 0.05). Health related quality of life increased significantly in six domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups (p = 0.02). HF-MA was most effective in reducing secondary menstrual symptoms compared to both-EA groups (p<0.05). Acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.

The role of treatment timing and mode of stimulation in the treatment of primary dysmenorrhea with acupuncture: An exploratory randomised controlled trial

PubMed Central

Dahlen, Hannah G.; Zhu, Xiaoshu; Farquhar, Cindy; Smith, Caroline A.

2017-01-01

Objectives We examined the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea. Methods A randomised controlled trial was performed with four arms, low frequency manual acupuncture (LF-MA), high frequency manual acupuncture (HF-MA), low frequency electro acupuncture (LF-EA) and high frequency electro acupuncture (HF-EA). A manualised trial protocol was used to allow differentiation and individualized treatment over three months. A total of 74 women were randomly assigned to one of the four groups (LF-MA n = 19, HF-MA n = 18, LF-EA n = 18, HF-EA n = 19). Twelve treatments were performed over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry. Results During the treatment period and nine month follow-up all groups showed statistically significant (p < .001) reductions in peak and average menstrual pain compared to baseline but there were no differences between groups (p > 0.05). Health related quality of life increased significantly in six domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups (p = 0.02). HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups (p<0.05). Conclusion Acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials. PMID:28700680

No additional cholesterol-lowering effect observed in the combined treatment of red yeast rice and Lactobacillus casei in hyperlipidemic patients: A double-blind randomized controlled clinical trial.

PubMed

Lee, Chien-Ying; Yu, Min-Chien; Perng, Wu-Tsun; Lin, Chun-Che; Lee, Ming-Yung; Chang, Ya-Lan; Lai, Ya-Yun; Lee, Yi-Ching; Kuan, Yu-Hsiang; Wei, James Cheng-Chung; Shih, Hung-Che

2017-08-01

To observe the effect of combining red yeast rice and Lactobacillus casei (L. casei) in lowering cholesterol in patients with primary hyperlipidemia, the later has also been shown to remove cholesterol in in vitro studies. A double-blind clinical trial was conducted to evaluate the cholesterol-lowering effect of the combination of red yeast rice and L. casei. Sixty patients with primary hyperlipidemia were recruited and randomized equally to either the treatment group (red yeast rice + L. casei) or the control group (red yeast rice + placebo). One red yeast rice capsule and two L. casei capsules were taken twice a day. The treatment lasted for 8 weeks, with an extended follow-up period of 4 weeks. The primary endpoint was a difference of serum low-density lipoprotein cholesterol (LDL-C) level at week 8. At week 8, the LDL-C serum level in both groups was lower than that at baseline, with a decrease of 33.85±26.66 mg/dL in the treatment group and 38.11±30.90 mg/dL in the control group; however, there was no statistical difference between the two groups (P>0.05). The total cholesterol was also lower than the baseline in both groups, yet without a statistical difference between the two groups. The only statistically signifificant difference between the two groups was the average diastolic pressure at week 12, which dropped by 2.67 mm Hg in the treatment group and increased by 4.43 mm Hg in the placebo group (P<0.05). The antihypertensive activity may be associated with L. casei. Red yeast rice can signifificantly reduce LDL-C, total cholesterol and triglyceride. The combination of red yeast rice and L. casei did not have an additional effect on lipid profifiles.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Morris, M.A.; Moix, I.; Mermillod, B.

Up to 1 in 3 couples have a problem of infertility at some time in their lives. Sex chromosome anomalies are found in 5-10% of couples, with mosaic aneuploidy being a common finding in primary infertility. Recurrent spontaneous abortion (RSA), in contrast, is frequently associated with autosomal structural anomalies. We hypothesized that low-level mosaic X chromosome aneuploidy was associated with primary infertility but not with RSA. Three groups were studied: women from couples with primary infertillity (n=26); women with three or more spontaneous abortions (n=22); and age-matched normally fertile women (at least two pregnancies; n=28). Interphase fluorescent in situ hybridizationmore » (FISH) was used to determine X chromosome ploidy in 100 nuclei per patient, using a contig of three cosmids from MAO locus (kindly donated by W. Berger, Nijmegen). A control probe (chr. 15 centromere) was simultaneously hybridized, and only nuclei containing two control signals were scored for the X chromosome. The mean numbers of nuclei with two X chromosome signals were the same in all groups (Welch equality of means test: p>0.97). However, there is a significant difference between the variances of the primary infertile and RSA groups (Levene`s test: p=0.025 after Bonferrone correction for multiple testing). This provides preliminary support for the hypothesis of an association between primary infertility and low-level mosaic X chromosome aneuploidy.« less

Evaluation of salivary function in patients with burning mouth syndrome.

PubMed

Lee, Y C; Hong, I K; Na, S Y; Eun, Y G

2015-04-01

To investigate salivary function in patients with primary burning mouth syndrome (BMS) compared with control and to evaluate salivary hypofunction using salivary gland scintigraphy (SGS). A total of 33 patients with primary BMS and 30 control subjects were enrolled in our study. The severity of the pain and the burning sensation on a 10-cm visual analog scale (VAS) and the Oral Health Impact Profile-14 (OHIP-14) were assessed. Unstimulated and stimulated salivary flow rates (SFRs) were measured. (99m) Tc pertechnetate SGS was used to evaluate salivary gland function. Unstimulated SFR in patients with BMS was significantly lower than that in the control group (0.11 ± 0.15 vs 0.21 ± 0.16 ml min(-1) , P = 0.014). There was no significant difference in stimulated SFR between the two groups. The VAS scores for oral pain and burning sensation, the total OHIP-14 score, and salivary gland function by salivary scintigraphy were not significantly different between BMS patients with normal flow rate and hyposalivation. Patients with primary BMS exhibited a significant decrease in unstimulated SFR compared with control group. In addition, we could not find any difference in salivary gland function between BMS patients with or without hyposalivation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Association of Structured Virtual Visits for Hypertension Follow-Up in Primary Care with Blood Pressure Control and Use of Clinical Services.

PubMed

Levine, David Michael; Dixon, Ronald F; Linder, Jeffrey A

2018-04-23

Optimal management of hypertension requires frequent monitoring and follow-up. Novel, pragmatic interventions have the potential to engage patients, maintain blood pressure control, and enhance access to busy primary care practices. "Virtual visits" are structured asynchronous online interactions between a patient and a clinician to extend medical care beyond the initial office visit. To compare blood pressure control and healthcare utilization between patients who received virtual visits compared to usual hypertension care. Propensity score-matched, retrospective cohort study with adjustment by difference-in-differences. Primary care patients with hypertension. Patient participation in at least one virtual visit for hypertension. Usual care patients did not use a virtual visit but were seen in-person for hypertension. Adjusted difference in mean systolic blood pressure, primary care office visits, specialist office visits, emergency department visits, and inpatient admissions in the 180 days before and 180 days after the in-person visit. Of the 1051 virtual visit patients and 24,848 usual care patients, we propensity score-matched 893 patients from each group. Both groups were approximately 61 years old, 44% female, 85% White, had about five chronic conditions, and about 20% had a mean pre-visit systolic blood pressure of 140-160 mmHg. Compared to usual care, virtual visit patients had an adjusted 0.8 (95% CI, 0.3 to 1.2) fewer primary care office visits. There was no significant adjusted difference in systolic blood pressure control (0.6 mmHg [95% CI, - 2.0 to 3.1]), specialist visits (0.0 more visits [95% CI, - 0.3 to 0.3]), emergency department visits (0.0 more visits [95% CI, 0.0 to 0.01]), or inpatient admissions (0.0 more admissions [95% CI, 0.0 to 0.1]). Among patients with reasonably well-controlled hypertension, virtual visit participation was associated with equivalent blood pressure control and reduced in-office primary care utilization.

The prevalence and effects of Pectus Excavatum and Pectus Carinatum on the respiratory function in children between 7-14 years old.

PubMed

Coskun, Zafer Kutay; Turgut, Hasan Basri; Demirsoy, Sadik; Cansu, Ali

2010-09-01

The study involved 1342 primary school students aged 7-14 years who applied to Ankara, a primary care center for general health check-up between 2006 and 2007. Forty-three students, 35 of whom had PE and 8 of whom had PC, were subjected to thorax measurement. All 43 students underwent pulmonary function tests (PFT).The prevalence rate of PC was 0.6%, and of PE, 2.6%. The thorax widths of the groups were similar (P = 0.273). The thorax circumference and depth of PE group were lower than those of the controls (P < 0.05). The probability rate of abnormality in PFT scores of PE group was statistically significantly higher than that of the controls (P = 0.022) whereas absence of normal PFT scores the difference between PC group and the controls was not statistically significant (p = 0.095). The results indicate that more than half of the individuals with pectus deformity do not have any physical complaints and do not have statistically significant differences in their PFT parameters.

Primary repair of civilian colon injuries is safe in the damage control scenario.

PubMed

Kashuk, Jeffry L; Cothren, C Clay; Moore, Ernest E; Johnson, Jeffrey L; Biffl, Walter L; Barnett, Carlton C

2009-10-01

Although the safety of primary repair/anastomosis for civilian colon injuries after standard laparotomy (SL) has been established, recent civilian and military reports have questioned the advisability of this technique in the patient requiring damage control laparotomy (DL). We hypothesized that, even in the high-risk DL group, primary repair could be safely used after patient stabilization and that the open abdomen would facilitate the safety of this procedure. All patients admitted to our level 1 trauma center with a colon injury over a 7-year period were reviewed from a prospectively collected database. Patients were categorized as having undergone either SL or DL at initial operation. Primary variables of interest were as follows: injury patterns; method of primary repair (suture repair, resection and primary anastomosis, resection and delayed anastomosis); diversion techniques (planned diversion or diversion for anastomotic dehiscence); and colon-related morbidity and mortality. High-risk status in the DL group was identified by the following physiologic variables: mean injury severity score (ISS), red blood cell (RBC) transfusions, ventilator days, and intensive care unit (ICU) duration of stay. During the study period, 309 patients had colonic wounds identified at laparotomy. Of these 309 patients, 280 (91%) underwent SL, of which 277 (98.9%) had primary colonic repair/anastomosis. In the SL group, 1 (0.3%) patient required diversion for subsequent leak and 2 (0.6%) patients had planned diversion The remaining 29 hemodynamically unstable patients required DL. Mean +/- standard deviation indices of injury severity in this group included: ISS = 36.2 +/- 15.8, RBC = 28.7 +/- 25.4 units, ventilator days = 20.1 +/- 16.3, ICU duration of stay = 29.5 +/- 21.6 days. Of the 29 patients in the DL group, 21 (72%) had bowel continuity successfully reestablished in 2.6 +/- 2 days after initial attempts at primary suture repair or resection/anastomosis. A total of 4 (16.6%) patients in this group developed colon-related complications, 3 of whom were treated with subsequent diversion before definitive abdominal closure. One patient developed a late leak. (day 43). Another 4 (13.8%) patients had planned diversion for injuries that were considered to be high risk for leak at subsequent reexploration. There were no colon-related deaths in either group. Primary repair of colon injuries appears safe in the majority of patients after DL. Although it is associated with a higher leak rate than SL, the open abdomen affords careful inspection of abdominal contents at reexploration to identify patients who require subsequent diversion.

"Go! to Sleep": A Web-Based Therapy for Insomnia.

PubMed

Bernstein, Adam M; Allexandre, Didier; Bena, James; Doyle, Jonathan; Gendy, Gina; Wang, Lu; Fay, Susan; Mehra, Reena; Moul, Douglas; Foldvary-Schaefer, Nancy; Roizen, Michael F; Drerup, Michelle

2017-07-01

Insomnia is a common complaint of individuals presenting to healthcare providers and is associated with decreased quality of life and higher healthcare utilization. In-person cognitive behavioral therapy (CBT) is an effective treatment for insomnia but is hindered by cost and limited access to treatment. Initial research suggests that Web-based CBT may mitigate these obstacles. This study tests the effectiveness of a Web-based program for insomnia based on principles of CBT and stress management. We conducted a randomized trial with wait-list controls among adults with primary insomnia (n = 88). Two hundred sixty-three adults with comorbid insomnia were also included and analyzed separately. The intervention was a 6-week online program, and effectiveness was measured via the Insomnia Severity Index (ISI). Baseline ISI score for the intervention group (n = 43) was 17.0; 16.6 for the control group (n = 45). At first follow-up, the intervention group (n = 25) had a mean change from baseline of -7.3 (95% CI: -9.0, -5.6), sustained through second follow-up, while the control group (n = 35) had a change of -1.3 (-2.7, 0.1). The between-group difference was statistically significant (p < 0.001). Participants in the comorbid insomnia group had a baseline ISI score of 16.7 with improvement similar to the primary insomnia group (-6.9; -7.6, -6.2). We observed clinically meaningful improvements in insomnia severity in adults with primary or comorbid insomnia. Sustained improvement over 4 months underscores the effectiveness of a well-constructed online CBT for insomnia program. Go! to Sleep © offers a potentially effective treatment option for adults with insomnia by eliminating geographical barriers to care.

Melatonin for sedative withdrawal in older patients with primary insomnia: a randomized double-blind placebo-controlled trial

PubMed Central

Lähteenmäki, Ritva; Puustinen, Juha; Vahlberg, Tero; Lyles, Alan; Neuvonen, Pertti J; Partinen, Markku; Räihä, Ismo; Kivelä, Sirkka-Liisa

2014-01-01

Aim We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here ‘BZD’) use. Methods A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted. Results There were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups. Conclusions Gradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstinence. CRM showed no withdrawal benefit compared with placebo. PMID:24286360

Improving Primary Teachers' Attitudes toward Science by Attitude-Focused Professional Development

ERIC Educational Resources Information Center

van Aalderen-Smeets, Sandra I.; van der Molen, Juliette H. Walma

2015-01-01

This article provides a description of a novel, attitude-focused, professional development intervention, and presents the results of an experimental pretest-posttest control group study investigating the effects of this intervention on primary teachers' personal attitudes toward science, attitudes toward teaching science, and their science…

[Effect of a Physical activity program on self-esteem in subjects with chronic diseases. 'Pas a Pas' community intervention trial].

PubMed

Villalobos, Felipe; Vinuesa, Angels; Pedret, Roser; Reche, Alicia; Domínguez, Eva; Arija, Victoria

2018-05-01

To evaluate the effectiveness of a 9 months of supervised Physical Activity (PA) Program with sociocultural activities, on self-esteem and its association on the control of chronic diseases in adult primary care users. Multicenter, randomized, controlled community intervention. 4 Primary care centers in Reus-Tarragona, Spain. 364 subjects, randomized to the Control Group (CG=104) and Intervention Group (IG=260). Supervised walking program of 120min/week with sociocultural activities once a month. At baseline and at post-intervention we assessed: PA (IPAQ-S), self-esteem (Rosenberg scale) and cardiovascular indicators: smoking, systolic (SBP) and diastolic (DBP) blood pressure, serum LDL and HDL cholesterol, and serum glucose. Sociodemographic characteristics and diagnostic of chronic diseases are recorded. The Program increased the PA in the IG (P=.001), while it decreased in the CG (P=.002), and also the self-esteem in the group of participants (1.28 points, P=.006) and in the groups with diagnoses of hypertension (1.60 points, P=.005), dyslipidemia (1.62 points, P=.012), excess weight (1.24 points, P=.011) or anxiety/depression (1.53 points, P=.045), assessed by multivariate statistical models. The increase in self-esteem during the intervention decreased SBP -0.5mmHg (P=.030) in the hypertension group, regardless of baseline SBP and the effect of the intervention. The PA program increased the PA and self-esteem in adult primary care users. The increase of self-esteem improved the control of SBP in hypertensive patients. Copyright © 2018 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.

Differential responses of primary auditory cortex in autistic spectrum disorder with auditory hypersensitivity.

PubMed

Matsuzaki, Junko; Kagitani-Shimono, Kuriko; Goto, Tetsu; Sanefuji, Wakako; Yamamoto, Tomoka; Sakai, Saeko; Uchida, Hiroyuki; Hirata, Masayuki; Mohri, Ikuko; Yorifuji, Shiro; Taniike, Masako

2012-01-25

The aim of this study was to investigate the differential responses of the primary auditory cortex to auditory stimuli in autistic spectrum disorder with or without auditory hypersensitivity. Auditory-evoked field values were obtained from 18 boys (nine with and nine without auditory hypersensitivity) with autistic spectrum disorder and 12 age-matched controls. Autistic disorder with hypersensitivity showed significantly more delayed M50/M100 peak latencies than autistic disorder without hypersensitivity or the control. M50 dipole moments in the hypersensitivity group were larger than those in the other two groups [corrected]. M50/M100 peak latencies were correlated with the severity of auditory hypersensitivity; furthermore, severe hypersensitivity induced more behavioral problems. This study indicates auditory hypersensitivity in autistic spectrum disorder as a characteristic response of the primary auditory cortex, possibly resulting from neurological immaturity or functional abnormalities in it. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Self-management education for rehabilitation inpatients suffering from inflammatory bowel disease: a cluster-randomized controlled trial.

PubMed

Reusch, A; Weiland, R; Gerlich, C; Dreger, K; Derra, C; Mainos, D; Tuschhoff, T; Berding, A; Witte, C; Kaltz, B; Faller, H

2016-12-01

Although inflammatory bowel disease (IBD) affects patients' psychological well-being, previous educational programs have failed to demonstrate effects on psychosocial outcomes and quality of life. Therefore, we developed a group-based psychoeducational program that combined provision of both medical information and psychological self-management skills, delivered in an interactive manner, and evaluated it in a large, cluster-randomized trial. We assigned 540 rehabilitation inpatients suffering from IBD (mean age 43 years, 66% female) to either the new intervention or a control group comprising the same overall intensity and the same medical information, but only general psychosocial information. The primary outcome was patient-reported IBD-related concerns. Secondary outcomes included disease knowledge, coping, self-management skills, fear of progression, anxiety, depression and quality of life. Assessments took place at baseline, end of rehabilitation and after 3 and 12 months.The psychoeducational self-management program did not prove superior to the control group regarding primary and secondary outcomes. However, positive changes over time occurred in both groups regarding most outcomes. The superior effectiveness of the newly developed psychoeducational program could not be demonstrated. Since the intervention and control groups may have been too similar, this trial may have been too conservative to produce between-group effects. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Evaluation of Interventions to Improve Solar Protection in Primary Schools.

ERIC Educational Resources Information Center

Girgis, Afaf; And Others

1993-01-01

An intensive intervention group (n=247) of 9-11 year olds were exposed to SKIN SAFE, a curriculum about sun protection. A standard group (n=180) received a lecture about skin cancer; control group numbered 185. The intensive group were significantly more likely to use high levels of protection; no differences were apparent between the standard and…

Osteoporosis improvement: a large-scale randomized controlled trial of patient and primary care physician education.

PubMed

Solomon, Daniel H; Katz, Jeffrey N; Finkelstein, Joel S; Polinski, Jennifer M; Stedman, Margaret; Brookhart, M Alan; Arnold, Marilyn; Gauthier, Suzanne; Avorn, Jerry

2007-11-01

We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. There was no difference in the probability of the primary composite endpoint (BMD test or osteoporosis medication) or in either of its components comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). Fractures from osteoporosis are associated with substantial morbidity, mortality, and cost. However, only a minority of at-risk older adults receives screening and/or treatment for this condition. We evaluated the effect of educational interventions for osteoporosis targeting at-risk patients, primary care physicians, or both. We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. The at-risk patients were women >or=65 yr of age, men and women >or=65 yr of age with a prior fracture, and men and women >or=65 yr of age who used oral glucocorticoids. The primary outcome studied was a composite of either undergoing a BMD test or initiating a medication used for osteoporosis. The secondary outcome was a hip, humerus, spine, or wrist fracture. We randomized 828 primary care physicians and their 13,455 eligible at-risk patients into four study arms. Physician and patient characteristics were very similar across all four groups. Across all four groups, the rate of the composite outcome was 10.3 per 100 person-years and did not differ between the usual care and the combined intervention groups (p = 0.5). In adjusted Cox proportional hazards models, there was no difference in the probability of the primary composite endpoint comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). There was also no difference in either of the components of the composite endpoint. The probability of fracture during follow-up was 4.2 per 100 person-years and did not differ by treatment assignment (p = 0.9). In this trial, a relatively brief program of patient and/or physician education did not work to improve the management of osteoporosis. More intensive efforts should be considered for future quality improvement programs for osteoporosis.

Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial.

PubMed

Lindgren, Hans I V; Qvarfordt, Peter; Bergman, Stefan; Gottsäter, Anders

2018-06-01

Intermittent claudication (IC) is commonly caused by lesions in the superficial femoral artery (SFA), yet invasive treatment is still controversial and longer term patient-reported outcomes are lacking. This prospective randomized trial assessed the 24-month impact of primary stenting with nitinol self-expanding stents compared to best medical treatment (BMT) alone in patients with stable IC due to SFA disease on health-related quality of life (HRQoL). One hundred patients with stable IC due to SFA disease treated with BMT were randomized to either stent (n = 48) or control (n = 52) group. HRQoL assessed by Short Form 36 Health Survey (SF-36) and EuroQoL 5-dimensions (EQ5D) 24 months after treatment were primary outcome measures. Walking Impairment Questionnaire, ankle-brachial index (ABI), and walking distance were secondary outcomes. Significantly better SF-36 Physical Component Summary (P = 0.024) and physical domain scores such as Physical Function (P = 0.012), Bodily Pain (P = 0.002), General Health (P = 0.037), and EQ5D (P = 0.010) were reported in intergroup comparison between the stent and the control group. Both ABI (from 0.58 ± 0.11 to 0.85 ± 0.18; P < 0.001 in the stent group and from 0.63 ± 0.17 to 0.69 ± 0.18; P = 0.036 in the control group) and walking distance (from 170 ± 90 m to 616 ± 375 m; P < 0.001 in the stent group and from 209 ± 111 m to 331 ± 304 m; P = 0.006 in the control group) improved significantly in intragroup comparisons. In patients with IC caused by lesions in the SFA, primary stenting compared to BMT alone was associated with significant improvements in HRQoL, ABI, and walking distance durable up to 24 months of follow-up. Clinical Trial Registration http://www.clinicaltrials.gov . Unique Identifier: NCT01230229.

Group metacognitive therapy for repetitive negative thinking in primary and non-primary generalized anxiety disorder: an effectiveness trial.

PubMed

McEvoy, Peter M; Erceg-Hurn, David M; Anderson, Rebecca A; Campbell, Bruce N C; Swan, Amanda; Saulsman, Lisa M; Summers, Mark; Nathan, Paula R

2015-04-01

Generalized anxiety disorder (GAD) is a common and highly comorbid anxiety disorder characterized by repetitive negative thinking (RNT). Treatment trials tend to exclude individuals with non-primary GAD, despite this being a common presentation in real world clinics. RNT is also associated with multiple emotional disorders, suggesting that it should be targeted regardless of the primary disorder. This study evaluated the acceptability and effectiveness of brief group metacognitive therapy (MCT) for primary or non-primary GAD within a community clinic. Patients referred to a specialist community clinic attended six, two-hour weekly sessions plus a one-month follow-up (N=52). Measures of metacognitive beliefs, RNT, symptoms, positive and negative affect, and quality of life were completed at the first, last, and follow-up sessions. Attrition was low and large intent-to-treat effects were observed on most outcomes, particularly for negative metacognitive beliefs and RNT. Treatment gains increased further to follow-up. Benchmarking comparisons demonstrated that outcomes compared favorably to longer disorder-specific protocols for primary GAD. No control group or independent assessment of protocol adherence. Brief metacognitive therapy is an acceptable and powerful treatment for patients with primary or non-primary GAD. Copyright © 2014 Elsevier B.V. All rights reserved.

Efficacy and safety of etravirine (TMC125) in patients with highly resistant HIV-1: primary 24-week analysis.

PubMed

Nadler, Jeffrey P; Berger, Daniel S; Blick, Gary; Cimoch, Paul J; Cohen, Calvin J; Greenberg, Richard N; Hicks, Charles B; Hoetelmans, Richard M W; Iveson, Kathy J; Jayaweera, Dushyantha S; Mills, Anthony M; Peeters, Monika P; Ruane, Peter J; Shalit, Peter; Schrader, Shannon R; Smith, Stephen M; Steinhart, Corklin R; Thompson, Melanie; Vingerhoets, Johan H; Voorspoels, Ellen; Ward, Douglas; Woodfall, Brian

2007-03-30

TMC125-C223 is an open-label, partially blinded, randomized clinical trial to evaluate the efficacy and safety of two dosages of etravirine (TMC125), a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against wild-type and NNRTI-resistant HIV-1. A total of 199 patients were randomly assigned 2: 2: 1 to twice-daily etravirine 400 mg, 800 mg and control groups, respectively. The primary endpoint was a change in viral load from baseline at week 24 in the intention-to-treat population. Patients had HIV-1 with genotypic resistance to approved NNRTIs and at least three primary protease inhibitor (PI) mutations. Etravirine groups received an optimized background of at least two approved antiretroviral agents [nucleoside reverse transcriptase inhibitors (NRTI) and/or lopinavir/ritonavir and/or enfuvirtide]. Control patients received optimized regimens of at least three antiretroviral agents (NRTIs or PIs and/or enfuvirtide). The mean change from baseline in HIV-1 RNA at week 24 was -1.04, -1.18 and -0.19 log10 copies/ml for etravirine 400 mg twice a day, 800 mg twice a day and the control group, respectively (P < 0.05 for both etravirine groups versus control). Etravirine showed no dose-related effects on safety and tolerability. No consistent pattern of neuropsychiatric symptoms was observed. There were few hepatic adverse events, and rashes were predominantly early onset and mild to moderate in severity. Etravirine plus an optimized background significantly reduced HIV-1-RNA levels from baseline after 24 weeks in patients with substantial NNRTI and PI resistance, and demonstrated a favorable safety profile compared with control.

High-Intensity Telemedicine Decreases Emergency Department Use by Senior Living Community Residents.

PubMed

Shah, Manish N; Wasserman, Erin B; Wang, Hongyue; Gillespie, Suzanne M; Noyes, Katia; Wood, Nancy E; Nelson, Dallas; Dozier, Ann; McConnochie, Kenneth M

2016-03-01

The failure to provide timely acute illness care can lead to adverse consequences or emergency department (ED) use. We evaluated the effect on ED use of a high-intensity telemedicine program that provides acute illness care for senior living community (SLC) residents. We performed a prospective cohort study over 3.5 years. Six SLCs cared for by a primary care geriatrics practice were intervention facilities, with the remaining 16 being controls. Consenting patients at intervention facilities could access telemedicine for acute illness care. Patients were provided patient-to-provider, real-time, or store-and-forward high-intensity telemedicine (i.e., technician-assisted with resources beyond simple videoconferencing) to diagnose and treat acute illnesses. The primary outcome was the rate of ED use. We enrolled 494 of 705 (70.1%) subjects/proxies in the intervention group; 1,058 subjects served as controls. Control and intervention subjects visited the ED 2,238 and 725 times, respectively, with 47.3% of control and 43.4% of intervention group visits resulting in discharge home. Among intervention subjects, ED use decreased at an annualized rate of 18% (rate ratio [RR]=0.82; 95% confidence interval [CI], 0.70-0.95), whereas in the control group there was no statistically significant change in ED use (RR=1.01; 95% CI, 0.95-1.07; p=0.009 for group-by-time interaction). Primary care use and mortality were not significantly different. High-intensity telemedicine significantly reduced ED use among SLC residents without increasing other utilization or mortality. This alternative to traditional acute illness care can enhance access to acute illness care and should be integrated into population health programs.

The Use of Interactive Computer Animations Based on POE as a Presentation Tool in Primary Science Teaching

NASA Astrophysics Data System (ADS)

Akpınar, Ercan

2014-08-01

This study investigates the effects of using interactive computer animations based on predict-observe-explain (POE) as a presentation tool on primary school students' understanding of the static electricity concepts. A quasi-experimental pre-test/post-test control group design was utilized in this study. The experiment group consisted of 30 students, and the control group of 27 students. The control group received normal instruction in which the teacher provided instruction by means of lecture, discussion and homework. Whereas in the experiment group, dynamic and interactive animations based on POE were used as a presentation tool. Data collection tools used in the study were static electricity concept test and open-ended questions. The static electricity concept test was used as pre-test before the implementation, as post-test at the end of the implementation and as delay test approximately 6 weeks after the implementation. Open-ended questions were used at the end of the implementation and approximately 6 weeks after the implementation. Results indicated that the interactive animations used as presentation tools were more effective on the students' understanding of static electricity concepts compared to normal instruction.

Intervention based on Transtheoretical Model promotes anthropometric and nutritional improvements - a randomized controlled trial.

PubMed

Menezes, Mariana Carvalho de; Mingoti, Sueli Aparecida; Cardoso, Clareci Silva; Mendonça, Raquel de Deus; Lopes, Aline Cristine Souza

2015-04-01

To analyze the effects of an intervention based on the Transtheoretical Model on anthropometric and dietetic profile among women in the Primary Health Care in Brazil. Randomized controlled trial. The control group participated in physical activity and open group-education regarding nutrition of usual care. The intervention group participated in 10 workshops based on the Transtheoretical Model. Seventy-one women completed the study, with a mean age of 57.9±11.7years. Participants in the intervention group showed an improved body perception, reduced weight and body mass index post-intervention, and lower consumption of calories and foods high in fat. Significant weight reduction in the intervention group was associated with higher per capita income, reduced consumption of protein, reduced consumption of lipids, and the removal of visible fat from red meat and skin from chicken. An intervention based on the Transtheoretical Model promoted reduction in consumption of foods high in calories and fat, with positive effects on weight and body perception. These results provide evidence of the applicability and benefit of the Transtheoretical Model within primary care. Copyright © 2014 Elsevier Ltd. All rights reserved.

A randomized clinical trial of the effectiveness of an acupressure device (relief brief) for managing symptoms of dysmenorrhea.

PubMed

Taylor, Diana; Miaskowski, Christine; Kohn, Joel

2002-06-01

To develop and test the safety and effectiveness of an acupressure garment (the Relief Brief) in decreasing the pain and symptom distress associated with dysmenorrhea. A randomized clinical trial applied a 2 (Relief Brief use or control group) x 3 (baseline and two treatment measurement occasions) mixed factorial design. Sixty-one (61) women with moderately severe primary dysmenorrhea were randomly assigned to the standard treatment control group or the Relief Brief acupressure device group after one pretreatment menses, with 58 women reporting the effect on their pain during two post-treatment menstrual cycles. The acupressure garment: The Relief Brief is a cotton Lycra panty brief with a fixed number of lower abdominal and lower back latex foam acupads that provide pressure to dysmenorrhea-relieving Chinese acupressure points. Menstrual pain severity (worst pain and symptom intensity), pain medication use, and adverse effects were analyzed using between-groups and repeated measures analyses of treatment effects. Statistical and clinical significance criteria were applied a priori. For pain measures and pain medication use, the group main effect, time main effect and group x time interaction were statistically significant. Median pain medication use, the same for both groups at baseline (6 pills per day), dropped to 2 pills per day for the Relief Brief group but remained at 6 pills for the control group at the second treatment cycle. Predicted clinical significance criteria were surpassed: almost all (90%) women wearing the Relief Brief obtained at least a 25% reduction in menstrual pain severity (a 2-3 point drop) compared to only 8% of the control group (z = 6.07; p < 0.05). Relief Brief use was associated with at least a 50% decline in menstrual pain symptom intensity in more than two thirds of the women. An acupressure device is an effective and safe nonpharmacologic strategy for the treatment of primary dysmenorrhea. With design modifications, it could serve as a main treatment modality for women who suffer from primary dysmenorrhea and do not wish to or cannot use the conventional pharmacologic agents. In addition, this acupressure device may serve as an adjuvant therapy to medication in more severe cases of dysmenorrhea.

Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project).

PubMed

González-González, Ana Isabel; Orrego, Carola; Perestelo-Perez, Lilisbeth; Bermejo-Caja, Carlos Jesús; Mora, Nuria; Koatz, Débora; Ballester, Marta; Del Pino, Tasmania; Pérez-Ramos, Jeannet; Toledo-Chavarri, Ana; Robles, Noemí; Pérez-Rivas, Francisco Javier; Ramírez-Puerta, Ana Belén; Canellas-Criado, Yolanda; Del Rey-Granado, Yolanda; Muñoz-Balsa, Marcos José; Becerril-Rojas, Beatriz; Rodríguez-Morales, David; Sánchez-Perruca, Luis; Vázquez, José Ramón; Aguirre, Armando

2017-10-30

Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases. This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice. This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases. ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016.

Randomized clinical trial to assess the efficacy of a comprehensive programme of secondary prevention of cardiovascular disease in general practice: the PREseAP study.

PubMed

Brotons, Carlos; Soriano, Núria; Moral, Irene; Rodrigo, María P; Kloppe, Pilar; Rodríguez, Ana I; González, María L; Ariño, Dolores; Orozco, Domingo; Buitrago, Francisco; Pepió, Josep M; Borrás, Isabel

2011-01-01

To assess the efficacy of a comprehensive program of secondary prevention of cardiovascular disease in general practice. A cluster randomized clinical trial was carried out in a regular general practice setting. Male and female patients aged under 86 years with a diagnosis of ischemic heart disease, stroke or peripheral artery disease were recruited between January 2004 and May 2005. Study participants were seen at 42 health centers throughout the whole of Spain. The primary endpoint was the combination of all-cause mortality and hospital cardiovascular readmission at 3-year follow-up. In total, 1224 patients were recruited: 624 in the intervention group and 600 in the control group. The primary endpoint was observed in 29.9% (95% confidence interval [CI], 25.5-34.8%) in the intervention group and 25.6% (22.3-29.2%) in the control group (P=.15). At the end of follow-up, 8.5% (6.3-11.3%) in the intervention group and 11% (7.4-16%) in the control group were smokers (P=.07). The mean waist circumference of patients in the intervention and control groups was 100.44 cm (95% CI, 98.97-101.91 cm) and 102.58 cm (95% CI, 100.96-104.21 cm), respectively (P=.07). Overall, 20.9% (15.6-27.7%) of patients in the intervention group and 29.6% (23.9-36.1%) in the control group suffered from anxiety (P=.05), and 29.6% (22.4-37.9%) in the intervention group and 41.4% (35.8-47.3%) in the control group had depression (P=.02). A comprehensive program of secondary prevention of cardiovascular disease in general practice was not effective in reducing cardiovascular morbidity and mortality. However, some factors associated with a healthy lifestyle were improved and anxiety and depression were reduced. Copyright © 2010 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

A Preliminary Efficacy and Feasibility of an Obstructive Sleep Apnea Educational Intervention in Oman

NASA Astrophysics Data System (ADS)

Al Mezeini, Khamis Abdallah

Background: Obstructive sleep apnea (OSA) is chronic disorder that contributes to multiple physiological and psychological conditions. Obstructive sleep apnea contributes to high rates of morbidity and mortality and has substantial impacts on both health care costs and the quality of life for affected individuals and their families. Healthcare providers - particularly primary health care nurses - are ideally situated to interrupt the cascading consequences of OSA if they are equipped with evidence-based knowledge about the disease process and appropriate methods for screening, education, and preventive interventions. Purpose: The purpose of the study was to test the preliminary efficacy and feasibility of an online health educational intervention on the knowledge and attitudes of OSA among primary health care nurses in Oman. Methods: This study was designed to assess the preliminary efficacy and feasibility of an online educational program on OSA by randomly assigning subjects to either a treatment (OSA content) or attention control (diabetes content) group. At baseline, the OSA knowledge and attitudes of both groups were assessed by the Obstructive Sleep Apnea Knowledge and Attitudes (OSAKA) questionnaire; both groups also completed the Diabetes Basic Knowledge Test (DBKT) to use for control comparisons. Following randomization, the intervention group viewed a 15-minute narrated video on "Brief Introduction to OSA for Omani Nurses" and the control group viewed a similarly formatted 15-minute narrated video on diabetes. The intent was for the subjects in both groups to complete a posttest that included both the OSAKA and DBKT instruments; however, due to a programming error, the software did not present the DBKT to the intervention subjects and did not present the OSAKA instrument to the control subjects as intended. Therefore, the results describe the findings from a one-group, pretest-posttest intervention study to assess the preliminary efficacy and feasibility of the educational intervention. Feasibility data were also collected with face-to face interviews with a convenience sample of nurse administrators who oversee primary health care nurses in health centers in the Al-Batinah governorate in Oman. Results: Overall, the baseline OSA knowledge scores for the entire sample (N=156) were very low (M=8.87, SD=2.91; median=9, range 0-15 out of possible 18 points). There were no significant relationships between OSA knowledge and any of the demographic variables. There was no significant difference in the mean OSA knowledge scores (p=0.80, t =0.26) between the intervention group (M=8.90, SD=2.68, n=73) and the control group (M=8.84, SD=3.12, n=83) at baseline. Primary health care nurses in the intervention group (n = 73) had a significant improvement in posttest knowledge scores on the OSAKA as compared to pretest scores ( p = .037, t= -2.1). After the online OSA educational intervention, 91.8% (n=67) of participants (n=73) indicated they were "likely" or "very likely" to recommend the online video to other health professionals. Although posttest attitudes were higher than baseline for the intervention group, the difference did not reach statistical significance. Implications for Practice: The low levels of OSA knowledge in this sample of primary health care nurses may indicate that their ability to identify patients at risk for OSA, assess at-risk patients appropriately, or refer as needed to physicians is limited. Nursing educators may consider integrating content about sleep disorders - and OSA - into the baccalaureate nursing curricula. Continuing education programs might offer focused programs on sleep disorders and OSA to raise awareness among practicing nurses. Conclusion: Primary health care nurses in Oman are expected to assess patients, identify health risks, and refer as necessary to physicians or other practitioners. In this sample of primary health care nurses, knowledge about OSA was limited; low knowledge of risk factors, symptoms, and treatment options may undermine the nurses' ability to assure that patients who may have OSA are referred appropriately. Implications for basic nursing curricula and continuing education are offered.

Effect of self-efficacy and social support on adherence to antihypertensive drugs.

PubMed

Criswell, Thomas J; Weber, Cynthia A; Xu, Yinghui; Carter, Barry L

2010-05-01

To determine the relationship between poor adherence and self-efficacy or social support after a pharmacist intervention. Post-hoc analysis of data from two randomized controlled trials of physician-pharmacist collaborative interventions (6 and 9 mo, respectively) to improve blood pressure control. Eleven university-affiliated primary care clinics. Five hundred eighty-four patients (aged 21-85 yrs) with uncontrolled primary hypertension; 296 were in the intervention group and 288 were in the control group. Pharmacists provided intensified hypertension management and drug adherence counseling to patients in the intervention group. Social support and self-efficacy questionnaires were administered at baseline and end-of-study visits. Patient adherence was monitored by using the Morisky self-reported adherence questionnaire. Self-reported adherence scores improved significantly in the control group (p=0.0053) but not in the intervention group; however, adherence at baseline in both groups was high. There were small, but significant, improvements in self-efficacy (p<0.04) and social support (p<0.05) scores in the intervention group but not the control group at the end of the study. Social support and, to a lesser extent, self-efficacy improved as a function of duration of study participation (9-mo vs 6-mo intervention), regardless of whether the patient received the intervention. Blood pressure control in both groups improved significantly at the end of the study; however, mean blood pressure was significantly lower in the intervention group (129.7/76.6 mm Hg) compared with the control group (140.8/78.9 mm Hg; p<0.0001 for systolic, p=0.032 for diastolic). Social support and self-efficacy improved significantly in the intervention group at the end of the pharmacist intervention. Drug adherence was correlated with self-efficacy even though drug adherence did not improve significantly in the intervention group. The fact that social support and self-efficacy improved as a function of duration of study participation suggests that participation in a research study may have had a positive influence on these measures. Even though the changes in social support, self-efficacy, and drug adherence were modest, there was significantly better blood pressure control in the intervention group compared with the control group. These findings indicate that changes in drug adherence, self-efficacy, or social support probably played a minor role in the blood pressure outcomes in these studies.

No association between level of vitamin D and chronic low back pain in Swedish primary care: a cross-sectional case-control study.

PubMed

Thörneby, Andreas; Nordeman, Lena Margareta; Johanson, Else Hellebö

2016-06-01

Assessment of vitamin D levels and deficiency status in individuals with chronic low back pain (CLBP) in a Swedish general population, compared with controls matched for sex and age. Cross-sectional case-control study. Primary care, southern Sweden. Participants (n = 44) with self-reported low back pain for at least 3 months and individually sex- and age-matched controls without a chronic pain condition (n = 44), recruited from the general population by random letter of invitation. Association between vitamin D level and CLBP when adjusting for possible confounders in a multivariate forward conditional logistic regression model. Mean S-25-hydroxyvitamin D levels were 81 and 80 nmol/L in the CLBP and control group, respectively. The prevalence of vitamin D deficiency was low and similar in the CLBP group and the control group. Vitamin D level was not associated with CLBP when potential confounders were taken into account. No difference in vitamin D levels between participants with CLBP and matched controls could be demonstrated in the present sample. Assessment of vitamin D level and deficiency status may be of questionable value in the management of CLBP in primary care settings at similar latitudes, unless there are additional risk factors for deficiency or specific indicators of osteomalacia. Key points Vitamin D deficiency is common and reported in many chronic pain conditions, including chronic low back pain (CLBP), but evidence for an association and causality is insufficient. • The present study found no association between vitamin D levels and CLBP in a case-control sample of 44 + 44 individuals from the Swedish general population. • Prevalence of vitamin D deficiency was low and comparable in individuals with CLBP and controls without chronic pain, matched for sex and age. • Assessment of vitamin D status, for the purpose of finding and treating an underlying cause of pain, may be of limited value in the management of CLBP in primary care settings at similar latitudes.

Psychoeducative groups help control type 2 diabetes in a primary care setting.

PubMed

Cervantes Cuesta, Miguel Ángel; García-Talavera Espín, Noelia Victoria; Brotons Román, Josefa; Núñez Sánchez, M Ángeles; Brocal Ibáñez, Pedro; Villalba Martín, Pilar; Saura García, Carmen; Sánchez Esteban, Tomasa; Romero López-Reinoso, Helena; Delgado Aroca, Ma José; Sánchez Gil, Dolores; Meoro Avilés, Amparo; Soriano Palao, José

2013-01-01

The purpose of this study is to measure the impact of a psychoeducational group intervention in diabetes using glycosylated haemoglobin (HbA1c), the body mass index (BMI) and cardiovascular risk factors (CVRF) compared with conventional educational measures provided individually. A quasi-experimental study (pre/post-intervention) with a non-equivalent control group was conducted, including 72 type 2 individuals with diabetes (mean data: age 63.08 years, HbA1C 6.98%, BMI 30.48 kg/m2).The beneficial effect of psychoeducational group therapy in the study group (PGT) was compared with conventional diabetes education in the control group (CG). The PGT had a higher mean HbA1c reduction (-0.51 ± 1.7 vs. -0.06 ± 0.53%, p 0.003), met the objectives of optimal control of HbA1c to a higher degree (80% vs. 48%, p 0.005) and greater mean weight reduction (-1.93 ± 3.57 vs. 0.52 ± 1.73 kg, p 0002) than the CG.A significant improvement in total cholesterol, LDL cholesterol, triglycerides, systolic and diastolic blood pressure was achieved in PGT (all p < 0.05). PGT patients achieved a significant improvement in HbA1C, BMI and CVRF, and outperformed the conventional diabetes education group in achieving the optimal diabetes control objectives. Structural changes in the assistance programs should be considered to introduce these more efficient therapies for diabetes education in primary care. Copyright © AULA MEDICA EDICIONES 2013. Published by AULA MEDICA. All rights reserved.

Family psychoeducation for major depression: randomised controlled trial.

PubMed

Shimazu, Kae; Shimodera, Shinji; Mino, Yoshio; Nishida, Atsushi; Kamimura, Naoto; Sawada, Ken; Fujita, Hirokazu; Furukawa, Toshi A; Inoue, Shimpei

2011-05-01

The value of family psychoeducation for schizophrenia has been well established, and indications for its use have recently expanded to include bipolar affective disorder. However, no study to date has adequately examined its use in depression. To examine family psychoeducation in the maintenance treatment of depression and to investigate the influence of the family's expressed emotion (EE) on its effectiveness. Of 103 patients diagnosed with major depression and their primary family members, 57 pairs provided written informed consent. The pairs were randomly allocated to the intervention (n = 25) or control (n = 32). One family in the intervention group and two in the control group withdrew their consent after randomisation. The intervention group underwent four psychoeducation sessions consisting of didactic lectures about depression and group problem-solving focusing on how to cope in high-EE situations. Patients did not attend these sessions. Patients in both the intervention and control groups received treatment as usual. The families' EE levels were evaluated through Five-Minute Speech Samples. The primary outcome was relapse. Time to relapse was statistically significantly longer in the psychoeducation group than in the control group (Kaplan-Meier survival analysis, P = 0.002). The relapse rates up to the 9-month follow-up were 8% and 50% respectively (risk ratio 0.17, 95% CI 0.04-0.66; number needed to treat 2.4, 95% CI 1.6-4.9). In Cox proportional hazard analysis, baseline EE did not moderate the effectiveness of the intervention. Family psychoeducation is effective in the prevention of relapse in adult patients with major depression.

Evaluation of treatment outcome after impacted mandibular third molar surgery with the use of autologous platelet-rich fibrin: a randomized controlled clinical study.

PubMed

Kumar, Nilima; Prasad, Kavitha; Ramanujam, Laitha; K, Ranganath; Dexith, Jayashree; Chauhan, Abhishek

2015-06-01

To assess the effect of platelet-rich fibrin (PRF) on postoperative pain, swelling, trismus, periodontal healing on the distal aspect of the second molar, and progress of bone regeneration in mandibular third molar extraction sockets. Over a 2-year period, 31 patients (mean age, 26.1 yr) who required surgical extraction of a single impacted third molar and met the inclusion criteria were recruited. After surgical extraction of the third molar, only primary closure was performed in the control group, whereas PRF was placed in the socket followed by primary closure in the case group (16 patients). The outcome variables were pain, swelling, maximum mouth opening, periodontal pocket depth, and bone formation, with a follow-up period of 3 months. Quantitative data are presented as mean. Statistical significance was inferred at a P value less than .05. Pain (P = .017), swelling (P = .022), and interincisal distance (P = .040) were less in the case group compared with the control group on the first postoperative day. Periodontal pocket depth decreased at 3 months postoperatively in the case (P < .001) and control (P = .014) groups, and this decrease was statistically significant. Bone density scores at 3 months postoperatively were higher in the case group than in the control group, but this difference was not statistically important. The application of PRF lessens the severity of immediate postoperative sequelae, decreases preoperative pocket depth, and hastens bone formation. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

In-vitro comparison of instrumentation time and cleaning capacity between endodontic handpiece and manual preparation techniques in primary molar teeth.

PubMed

Seraj, B; Ramezani, G; Ghadimi, S; Mosharrafian, S H; Motahhary, P; Safari, M

2013-01-01

The aim of this study was to evaluate and compare the cleaning ability and instrumentation time of manual method and use of endodontic handpiece for preparation of primary molar teeth. Forty primary teeth canals were used in this experimental study. Access cavities were prepared and India ink was injected into the canals. The samples were divided into three groups according to the preparation technique. In the first group the root canals were manually instrumented by k_files. Endodontic handpiece (TEP-ER10, NSK, Japan) were used for canal preparation in the second group and the samples in the third group (control) were not instrumented. After preparing the canal, the teeth were cleared with methyl salicylate and the removal of India ink was measured in the cervical, middle and apical thirds. The instrumentation time was transcribed by chronometer. Statistical analysis was performed using Mann-Whitney and t-test. There was no significant difference in cleaning capacity between the two techniques, but results of the first and second group differ from those of the control group. In fact, time taken for preparation was significantly shorter with endodontic handpiece system. Seen the shorter working time of endodontic handpiece and the similar cleaning ability of the two techniques, the application of the endodontic handpiece is recommended for preparation of deciduous root canals during pulpectomy.

Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study.

PubMed

Iwata, Satoshi; Kawamura, Naohisa; Kuroki, Haruo; Tokoeda, Yasunobu; Miyazu, Mitsunobu; Iwai, Asayuki; Oishi, Tomohiro; Sato, Tomohide; Suyama, Akari; François, Nancy; Shafi, Fakrudeen; Ruiz-Guiñazú, Javier; Borys, Dorota

2015-01-01

This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3-4-5 months of age) and booster vaccination (17-19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 μg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children.

Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study

PubMed Central

Iwata, Satoshi; Kawamura, Naohisa; Kuroki, Haruo; Tokoeda, Yasunobu; Miyazu, Mitsunobu; Iwai, Asayuki; Oishi, Tomohiro; Sato, Tomohide; Suyama, Akari; François, Nancy; Shafi, Fakrudeen; Ruiz-Guiñazú, Javier; Borys, Dorota

2015-01-01

This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3–4–5 months of age) and booster vaccination (17–19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 μg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children. PMID:25830489

Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

PubMed Central

Jerosch-Herold, C.; Houghton, J.; Miller, L.; Shepstone, L.

2016-01-01

Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning (n = 52) or control (n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II PMID:27402282

The effect of primary hyperparathyroidism on pancreatic exocrine function.

PubMed

Sisman, P; Avci, M; Akkurt, A; Sahin, A B; Gul, O O; Ersoy, C; Erturk, E

2018-03-01

Elastase-1 is a proteolytic enzyme secreted by pancreatic acinar cells, and measurements of the concentration this enzyme are used to evaluate pancreatic exocrine function. We aimed to determine whether pancreatic exocrine function declines due to chronic hypercalcemia by measuring fecal elastase levels. 75 patients with primary hyperparathyroidism (18 men and 47 women) and 30 healthy subjects (11 men and 19 women) participated in this study. Renal function tests, lipid parameters, bone mineral density, and serum calcium, phosphorus, vitamin D, parathormone, glucose, and thyroid stimulating hormone levels as well as fecal elastase concentrations, were determined in these patients and controls. The mean fecal elastase level was 335.3 ± 181.4 μg/g in the PHPT group and 317.4 ± 157.3 μg/g in the control group. There was no significant difference in fecal elastase levels between the two groups (p = 0.5). Chronic hypercalcemia in primary hyperparathyroidism did not decrease the fecal elastase level, which is an indirect indicator of chronic pancreatitis; therefore, chronic hypercalcemia in PHPT may not cause chronic pancreatitis.

Evaluation of olfactory function in adults with primary hypothyroidism.

PubMed

Günbey, Emre; Karlı, Rıfat; Gökosmanoğlu, Feyzi; Düzgün, Berkan; Ayhan, Emre; Atmaca, Hulusi; Ünal, Recep

2015-10-01

Sufficient clinical data are not available on the effect of hypothyroidism on olfactory function in adults. In this study, we aimed to evaluate the olfactory function of adult patients diagnosed with primary hypothyroidism. Forty-five patients aged between 18 and 60 years who were diagnosed with clinical primary hypothyroidism and 45 healthy controls who had normal thyroid function tests were included in the study. Sniffin' Sticks olfactory test results of the 2 groups were compared. The relationships between thyroid function tests and olfactory parameters were evaluated. Odor threshold, identification, and discrimination scores of the hypothyroid group were significantly lower than those of the control group (p < 0.001). A significant positive correlation was detected between free triiodothyronine (FT3) levels and odor threshold, identification, and discrimination scores (p < 0.001). There was no significant relationship between thyroid-stimulating hormone (TSH) or free thyroxine (FT4) levels and olfactory parameters. Our study revealed diminished olfactory function in adults with hypothyroidism. FT3 levels were found to have a more significant relationship with olfactory parameters than TSH or FT4 levels. © 2015 ARS-AAOA, LLC.

A School Support Intervention and Educational Outcomes Among Orphaned Adolescents: Results of a Cluster Randomized Controlled Trial in Kenya.

PubMed

Cho, Hyunsan; Catherine Ryberg, Renee; Hwang, Karam; Pearce, Lisa D; Iritani, Bonita J

2017-11-01

Globally, significant progress has been made in primary school enrollment. However, there are millions of adolescents-including orphans in sub-Saharan Africa-who still experience barriers to remaining in school. We conducted a 4-year cluster randomized controlled trial (cRCT) (N = 835) in a high HIV prevalence area in western Kenya to test whether providing orphaned adolescents with a school support intervention improves their educational outcomes. The school support intervention consisted of directly paying tuition, exam fees, and uniform costs to primary and secondary schools for those students who remained enrolled. In addition, research staff monitored intervention participants' school attendance and helped to address barriers to staying in school. This school support intervention had significant positive impacts on educational outcomes for orphaned adolescents. Over the course of the study, school absence remained stable for intervention group participants but increased in frequency for control group participants. Intervention group participants were less likely to drop out of school compared to the control group. Furthermore, the intervention participants were more likely to make age-appropriate progression in grade, matriculate into secondary school, and achieve higher levels of education by the end of the study. The intervention also increased students' expectations of graduating from college in the future. However, we found no significant intervention impact on primary and secondary school test scores. Results from this cRCT suggest that directly covering school-related expenses for male and female orphaned adolescents in western Kenya can improve their educational outcomes.

Effect of low-level laser therapy (LLLT) and light-emitting diodes (LEDT) applied during combined training on performance and post-exercise recovery: protocol for a randomized placebo-controlled trial.

PubMed

Machado, Aryane Flauzino; Micheletti, Jéssica Kirsch; Vanderlei, Franciele Marques; Nakamura, Fabio Yuzo; Leal-Junior, Ernesto Cesar Pinto; Netto Junior, Jayme; Pastre, Carlos Marcelo

Previous studies have shown positive results of phototherapy for improving performance and accelerating recovery; however, the effects of phototherapy during training and after a primary adaptation remain unclear. The aim of this randomized controlled trial is to analyze the effects of phototherapy and combined training on clinical, functional, and psychological outcomes and on vascular endothelial growth factor. This randomized placebo-controlled trial by stratified sample will involve 45 healthy male participants. In phase 1, the participants will undergo six weeks of combined training (sprints and squats). In phase 2, participants will be allocated through stratified randomization (based on adaptation capacity) into three groups: active phototherapy group (AG), placebo group (PG), and non-treatment control group (CG). A new six-week training program will then start and the participants will receive the recovery strategy between sprints and squats. The primary outcome will be maximal isometric contraction. The secondary outcomes include strength and power testing, maximal incremental test, squat jump, sprint test, muscle soreness, pain threshold, perceptions of exertion and recovery, psychological questionnaire, and vascular endothelial growth factor. This will be the first trial to include phototherapy during training. We believe that this strategy will combine the ergogenic and prophylactic effects in the same session. Furthermore, an application protocol performed after primary adaptation may reflect the real effect of the technique. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Effects of a culturally adapted lifestyle intervention on cardio-metabolic outcomes: a randomized controlled trial in Iraqi immigrants to Sweden at high risk for Type 2 diabetes.

PubMed

Siddiqui, Faiza; Kurbasic, Azra; Lindblad, Ulf; Nilsson, Peter M; Bennet, Louise

2017-01-01

Middle-Eastern immigrants constitute a growing proportion of the Swedish population and are at high risk for Type 2 diabetes. This calls for a more proactive preventive approach for dealing with diabetes risk in this target group. The aim was to test the effect of a culturally adapted lifestyle intervention programme on changes in lifestyle habits and cardio-metabolic outcomes comparing an intervention group with a control group receiving usual care. Citizens of Malmö, Sweden born in Iraq and at high risk for Type 2 diabetes (n=636) were invited. Participation rate was 15.1%. In all, 96 participants were randomized to the intervention group (n=50) or to the control group (n=46). The intervention group was offered seven group sessions addressing healthy diet and physical activity including one cooking class. Changes in body weight, physical activity levels and cardio-metabolic outcomes were evaluated using linear mixed-effects models. The mean follow-up time was 3.9 and 3.5months in the intervention and control groups, respectively. The drop-out rate from baseline to the last visit was 30.0% in the intervention group (n=15) and 30.4% in the control group (n=14). The mean insulin sensitivity index increased significantly at follow-up in the intervention group compared to the control group (10.9% per month, p=0.005). The intervention group also reached a significant reduction in body weight (0.4% per month, p=0.004), body mass index (0.4% per month, p=0.004) and LDL-cholesterol (2.1% per month, p=0.036) compared to the control group. In total, 14.3% in the intervention group reached the goal to lose ≥5% of body weight versus none in the control group. This culturally adapted lifestyle intervention programme shows a beneficial effect on insulin action, body weight reduction, as well as LDL-cholesterol reduction, in Middle-Eastern immigrants. The programme adapted to resources in primary health care provides tools for improved primary prevention and reduced cardio-metabolic risk in this high-risk group for Type 2 diabetes. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

The relationship between distortion product otoacoustic emissions and extended high-frequency audiometry in tinnitus patients. Part 1: normally hearing patients with unilateral tinnitus.

PubMed

Fabijańska, Anna; Smurzyński, Jacek; Hatzopoulos, Stavros; Kochanek, Krzysztof; Bartnik, Grażyna; Raj-Koziak, Danuta; Mazzoli, Manuela; Skarżyński, Piotr H; Jędrzejczak, Wieslaw W; Szkiełkowska, Agata; Skarżyński, Henryk

2012-12-01

The aim of this study was to evaluate distortion product otoacoustic emissions (DPOAEs) and extended high-frequency (EHF) thresholds in a control group and in patients with normal hearing sensitivity in the conventional frequency range and reporting unilateral tinnitus. Seventy patients were enrolled in the study: 47 patients with tinnitus in the left ear (Group 1) and 23 patients with tinnitus in the right ear (Group 2). The control group included 60 otologically normal subjects with no history of pathological tinnitus. Pure-tone thresholds were measured at all standard frequencies from 0.25 to 8 kHz, and at 10, 12.5, 14, and 16 kHz. The DPOAEs were measured in the frequency range from approximately 0.5 to 9 kHz using the primary tones presented at 65/55 dB SPL. The left ears of patients in Group 1 had higher median hearing thresholds than those in the control subjects at all 4 EHFs, and lower mean DPOAE levels than those in the controls for almost all primary frequencies, but significantly lower only in the 2-kHz region. Median hearing thresholds in the right ears of patients in Group 2 were higher than those in the right ears of the control subjects in the EHF range at 12.5, 14, and 16 kHz. The mean DPOAE levels in the right ears were lower in patients from Group 2 than those in the controls for the majority of primary frequencies, but only reached statistical significance in the 8-kHz region. Hearing thresholds in tinnitus ears with normal hearing sensitivity in the conventional range were higher in the EHF region than those in non-tinnitus control subjects, implying that cochlear damage in the basal region may result in the perception of tinnitus. In general, DPOAE levels in tinnitus ears were lower than those in ears of non-tinnitus subjects, suggesting that subclinical cochlear impairment in limited areas, which can be revealed by DPOAEs but not by conventional audiometry, may exist in tinnitus ears. For patients with tinnitus, DPOAE measures combined with behavioral EHF hearing thresholds may provide additional clinical information about the status of the peripheral hearing.

Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol

PubMed Central

2014-01-01

Background Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver. Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. Methods/design Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs. Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. Intervention: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request. Data analysis Dependent variables: Caregiver burden (short-form Zarit test), caregivers’ social support (Medical Outcomes Study), and caregivers’ reported quality of life (SF-12) Independent variables: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test). Discussion If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice. Trial registration Clinical trials registrar: NCT02065427 PMID:24666438

Dismantling Multicomponent Behavioral Treatment for Insomnia in Older Adults: A Randomized Controlled Trial

PubMed Central

Epstein, Dana R.; Sidani, Souraya; Bootzin, Richard R.; Belyea, Michael J.

2012-01-01

Study Objective: Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. Design: A randomized, controlled study. Setting: Veterans Affairs medical center. Participants: 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Interventions: Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Measurements and Results: Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. Conclusions: For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Clinical Trial Information: Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1. Citation: Epstein DR; Sidani S; Bootzin RR; Belyea MJ. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial. SLEEP 2012;35(6):797-805. PMID:22654199

Can Physical Education and Physical Activity Outcomes Be Developed Simultaneously Using a Game-Centered Approach?

ERIC Educational Resources Information Center

Miller, Andrew; Christensen, Erin; Eather, Narelle; Gray, Shirley; Sproule, John; Keay, Jeanne; Lubans, David

2016-01-01

The primary objective of this study was to evaluate the efficacy of a pilot intervention using a game-centered approach for improvement of physical activity (PA) and physical education (PE) outcomes simultaneously, and if this had an impact on enjoyment of PE. A group-randomized controlled trial with a 7-week wait-list control group was conducted…

Lessons learned about primary weight maintenance and secondary weight maintenance: results from a qualitative study.

PubMed

Reilly, Ann; Mawn, Barbara; Susta, Davide; Staines, Anthony; Browne, Sarah; Sweeney, Mary Rose

2015-06-24

Obesity is now a worldwide problem and Ireland is no exception with approximately two thirds of the adult population now overweight or obese. A recent report has found that 53% of Irish adults aged 50 years and over are classified as centrally obese and at substantially increased risk of metabolic complications. While most studies investigating weight maintenance have been conducted on those who have managed to lose weight and/or achieved weight loss maintenance (secondary weight maintainers), few studies have been undertaken to understand the attitudes, behaviours, motivations and strategies of those who maintain their weight within normal weight ranges over their lifetime, so called primary weight maintainers. This study aims to explore this issue through qualitative exploration of primary weight maintainers in an Irish University. Seven focus groups were conducted (including three single interviews) with 17 participants in total across three different groups, 1) primary weight maintainers, 2) secondary weight maintainers, and 3) those unable to sustain or achieve weight loss. The interviews were transcribed and thematic analysis was applied to interpret the findings. After analyzing the participant's interviews, planning and organization or lack of, emerged as themes across the three groups in varying degrees. Strategizing, perseverance and willpower were seen as integral to weight maintenance and weight loss in groups one and two, these were lacking in group three. Prioritizing exercise and perseverance in maintaining a high level of activity was evident in groups one and two and was lacking in group three. Motivational influences were equal across the groups however, group three found it difficult to turn this into action. Group one had behavioural control of calorie intake maintaining a balance between week and weekend eating. Group three found it difficult to control calorie intake and portion size. Self-image differed across the three groups with cognitive dissonance evident amongst those in group three. This study showed that there are many factors that influence primary weight maintenance. Considering that we live in a society that is predominantly sedentary, predominantly overweight and with poor food choice options facing us every day, fighting our way through to ensure healthy weight maintenance requires active, conscious efforts. The factors identified in this study which are important in healthy weight maintenance are all potentially modifiable with life-coach, nutrition, exercise and cognitive interventions particularly if peer support and a whole family approach are incorporated.

Blood glucose control and quality of health care in non-insulin-treated patients with Type 2 diabetes in Spain: a retrospective and cross-sectional observational study

PubMed Central

Rodríguez, A; Calle, A; Vázquez, L; Chacón, F; Polavieja, P; Reviriego, J

2011-01-01

Aims To assess blood glucose control and quality of health care provided to non-insulin-treated patients with Type 2 diabetes mellitus in routine clinical practice in Spain. Methods In this observational, retrospective, cross-sectional study, patients were grouped as either having good or suboptimal blood glucose control according to International Diabetes Federation or American Diabetes Association HbA1c goals. Clinical and socio-demographic data and compliance with the main standard level of care recommendations of the International Diabetes Federation were recorded during a routine visit. Correlates of glucose control were analysed by logistic regression. Results Many patients were grouped as having suboptimal control under International Diabetes Federation (61.9%) or American Diabetes Association (45.0%) criteria. The mean number of accomplished International Diabetes Federation recommendations (7.3 out of 11) was higher for endocrinologists (than for internists or primary care physicians), and significantly more patients under their care were in the good glucose control group (than with primary care physicians). More recommendations were associated with blood glucose control using International Diabetes Federation than American Diabetes Association criteria, demanding higher quality of health care for achieving stricter goals. Some recommendations were poorly observed, particularly those concerning patients’ education on diabetes, the prompt prescription of effective treatments and monitoring of complications. Diabetes complications were associated with being in the suboptimal control group. Patients’ education on diabetes and HbA1c monitoring were associated with being in the good control group. Conclusions These results demonstrate the need for improvement in the management of patients with non-insulin-treated Type 2 diabetes in actual clinical practice in Spain. Such improvement would entail a stricter adherence to International Diabetes Federation recommendations. PMID:21294772

Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients.

PubMed

Rixen, Dieter; Steinhausen, Eva; Sauerland, Stefan; Lefering, Rolf; Maegele, Marc G; Bouillon, Bertil; Grass, Guido; Neugebauer, Edmund A M

2016-01-25

Long bone fractures, particularly of the femur, are common in multiple-trauma patients, but their optimal management has not yet been determined. Although a trend exists toward the concept of "damage control orthopedics" (DCO), current literature is inconclusive. Thus, a need exists for a more specific controlled clinical study. The primary objective of this study was to clarify whether a risk-adapted procedure for treating femoral fractures, as opposed to an early definitive treatment strategy, leads to an improved outcome (morbidity and mortality). The study was designed as a randomized controlled multicenter study. Multiple-trauma patients with femur shaft fractures and a calculated probability of death of 20 to 60 % were randomized to either temporary fracture fixation with external fixation and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective was to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score. Thirty-four patients were randomized to two groups of 17 patients each. Both groups were comparable regarding sex, age, injury severity score, Glasgow Coma Scale, prothrombin time, base excess, calculated probability of death, and other physiologic variables. The maximum SOFA score was comparable (nonsignificant) between the groups. Regarding the secondary endpoints, the patients with external fixation required a significantly longer ventilation period (p = 0.049) and stayed on the intensive care significantly longer (p = 0.037), whereas the in-hospital length of stay was balanced for both groups. Unfortunately, the study had to be terminated prior to reaching the anticipated sample size because of unexpected low patient recruitment. Thus, the results of this randomized study reflect the ambivalence in the literature. No advantage of the damage control concept could be detected in the treatment of femur fractures in multiple-trauma patients. The necessity for scientific evaluation of this clinically relevant question remains. Current Controlled Trials ISRCTN10321620 Date assigned: 9 February 2007.

Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care.

PubMed

Khunti, Kamlesh; Gray, Laura J; Skinner, Timothy; Carey, Marian E; Realf, Kathryn; Dallosso, Helen; Fisher, Harriet; Campbell, Michael; Heller, Simon; Davies, Melanie J

2012-04-26

To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years. Three year follow-up of a multicentre cluster randomised controlled trial in primary care, with randomisation at practice level. 207 general practices in 13 primary care sites in the United Kingdom. 731 of the 824 participants included in the original trial were eligible for follow-up. Biomedical data were collected on 604 (82.6%) and questionnaire data on 513 (70.1%) participants. A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care. The primary outcome was glycated haemoglobin (HbA(1c)) levels. The secondary outcomes were blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, emotional impact of diabetes, and drug use at three years. HbA(1c) levels at three years had decreased in both groups. After adjusting for baseline and cluster the difference was not significant (difference -0.02, 95% confidence interval -0.22 to 0.17). The groups did not differ for the other biomedical and lifestyle outcomes and drug use. The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years (P<0.01). Depression scores and quality of life did not differ at three years. A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs. Current Controlled Trials ISRCTN17844016.

The effectiveness of a nurse-led illness perception intervention in COPD patients: a cluster randomised trial in primary care

PubMed Central

Schuurmans, Marieke J.; Zanen, Pieter; Heijmans, Monique J.W.M.; Sachs, Alfred P.E.; Lammers, Jan-Willem J.

2017-01-01

The new COPD-GRIP (Chronic Obstructive Pulmonary Disease – Guidance, Research on Illness Perception) intervention translates evidence regarding illness perceptions and health-related quality of life (HRQoL) into a nurse intervention to guide COPD patients and to improve health outcomes. It describes how to assess and discuss illness perceptions in a structured way. This study aimed to assess the effectiveness of the intervention in primary care. A cluster randomised controlled trial was conducted within 30 general practices and five home-care centres, including 204 COPD patients. 103 patients were randomly assigned to the intervention group and 101 patients to the usual-care group. To assess differences, repeated multilevel linear mixed modelling analyses were used. Primary outcome was change in health status on the Clinical COPD Questionnaire (CCQ) at 9 months. Secondary outcomes were HRQoL, daily activities, health education impact and changes in illness perceptions. There was no significant difference between the groups in the CCQ at 9 months. We found a significant increase in health-directed behaviour at 6 weeks (p=0.024) and in personal control (p=0.005) at 9 months in favour of the intervention group. The COPD-GRIP intervention, practised by nurses, did not improve health status in COPD patients in primary care. However, the intervention has benefits in improving the ability to control the disease and health-related behaviours in the short term. Therefore, taking illness perceptions into account when stimulating healthy behaviours in COPD patients should be considered. Further study on influencing the health status and HRQoL is needed. PMID:29250529

A Qualitative Assessment of Weight Control among Rural Kansas Women

ERIC Educational Resources Information Center

Ely, Andrea C.; Befort, Christie; Banitt, Angela; Gibson, Cheryl; Sullivan, Debra

2009-01-01

Objective: To explore weight control beliefs, attitudes, knowledge, and practices among rural Kansas women, and to characterize the relationship of these women with their primary-care providers around weight control. Design: Qualitative research using focus groups. Setting: Three separate communities of rural Kansas. Participants: Six focus groups…

Primary teachers conducting inquiry projects: effects on attitudes towards teaching science and conducting inquiry

NASA Astrophysics Data System (ADS)

van Aalderen-Smeets, Sandra I.; Walma van der Molen, Juliette H.; van Hest, Erna G. W. C. M.; Poortman, Cindy

2017-01-01

This study used an experimental, pretest-posttest control group design to investigate whether participation in a large-scale inquiry project would improve primary teachers' attitudes towards teaching science and towards conducting inquiry. The inquiry project positively affected several elements of teachers' attitudes. Teachers felt less anxious about teaching science and felt less dependent on contextual factors compared to the control group. With regard to attitude towards conducting inquiry, teachers felt less anxious and more able to conduct an inquiry project. There were no effects on other attitude components, such as self-efficacy beliefs or relevance beliefs, or on self-reported science teaching behaviour. These results indicate that practitioner research may have a partially positive effect on teachers' attitudes, but that it may not be sufficient to fully change primary teachers' attitudes and their actual science teaching behaviour. In comparison, a previous study showed that attitude-focused professional development in science education has a more profound impact on primary teachers' attitudes and science teaching behaviour. In our view, future interventions aiming to stimulate science teaching should combine both approaches, an explicit focus on attitude change together with familiarisation with inquiry, in order to improve primary teachers' attitudes and classroom practices.

Coordination Program Reduced Acute Care Use And Increased Primary Care Visits Among Frequent Emergency Care Users.

PubMed

Capp, Roberta; Misky, Gregory J; Lindrooth, Richard C; Honigman, Benjamin; Logan, Heather; Hardy, Rose; Nguyen, Dong Q; Wiler, Jennifer L

2017-10-01

Many high utilizers of the emergency department (ED) have public insurance, especially through Medicaid. We evaluated how participation in Bridges to Care (B2C)-an ED-initiated, multidisciplinary, community-based program-affected subsequent ED use, hospital admissions, and primary care use among publicly insured or Medicaid-eligible high ED utilizers. During the six months after the B2C intervention was completed, participants had significantly fewer ED visits (a reduction of 27.9 percent) and significantly more primary care visits (an increase of 114.0 percent), compared to patients in the control group. In a subanalysis of patients with mental health comorbidities, we found that recipients of B2C services had significantly fewer ED visits (a reduction of 29.7 percent) and hospitalizations (30.0 percent), and significantly more primary care visits (an increase of 123.2 percent), again compared to patients in the control group. The B2C program reduced acute care use and increased the number of primary care visits among high ED utilizers, including those with mental health comorbidities. Project HOPE—The People-to-People Health Foundation, Inc.

Analysis of the serum reproductive system related autoantibodies of infertility patients in Tianjin region of China

PubMed Central

Huo, Yan; Xu, Yanying; Wang, Jianmei; Wang, Fang; Liu, Yu; Zhang, Yujuan; Zhang, Bumei

2015-01-01

Object: Reproductive system related autoantibodies have been proposed to be associated with natural infertility. However, large scale systematic analysis of these of antibodies has not been conducted. The aim of this study is to analyze the positive rate of antisperm antibody (ASAb), anti-endometrium antibody (EMAb), anti-ovary antibody (AOAb), anti-zona pellucida antibody (AZP) and anticardiolipin antibody (ACA) in infertility patients in Tianjin region of China. Methods: 1305 male and 1711 female primary infertility patients and 1100 female secondary infertility patients were included in this study, as well as 627 healthy female controls. The above autoantibodies were tested and the positive rates in each group were calculated. Results: the positive rate of ASAb were significantly higher in primary infertility female than that in male, further analysis revealed that primary infertility population all exhibit significant higher positive rate of EMAb, AOAb, AZP and ACA compared with control group. Furthermore, the positive rates of all the antibodies in primary infertility female were significantly higher than those in secondary infertility female. Conclusions: Our study thus indicates that these autoantibodies might be associated with immunological related primary infertility and may have clinical significance in its diagnosis and treatment. PMID:26550366

Emancipatory actions displayed by multi-ethnic women: "Regaining control of my health care".

PubMed

Alexander, Ivy M

2010-11-01

Despite the recognized importance of patient involvement in primary care interactions, little information describing women's needs and expectations for these interactions is available. This participatory action study was based in Critical Action Theory and designed to describe any emancipatory interests that surfaced when eight ethnically diverse women examined their interactions with primary care nurse practitioners (PCNPs) over the course of five successive focus group meetings. Focus group meeting transcripts, field notes, interaction notations, seating maps, and first impression summaries. Participants wanted to learn how to "stand up" for themselves in primary care interactions. They believed this could be accomplished by developing a positive sense of self-esteem. Ultimately, they identified the right way to "talk back" to clinicians and created a method for regaining control of their own health care and maintaining equality in interactions with primary care clinicians. Nurse practitioners working in the primary setting are especially well situated to support self-management and foster patient participation by women as they live with chronic disease, engage in health promotion activities, and deal with common symptomatic problems for themselves and their families. ©2010 The Author Journal compilation ©2010 American Academy of Nurse Practitioners.

T-tube drainage versus primary closure after open common bile duct exploration.

PubMed

Gurusamy, Kurinchi Selvan; Koti, Rahul; Davidson, Brian R

2013-06-21

Between 5% and 11% of people undergoing cholecystectomy have common bile duct stones. Stones may be removed at the time of cholecystectomy by opening and clearing the common bile duct. The optimal technique is unclear. The aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after open common bile duct exploration for common bile duct stones. We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until April 2013. We included all randomised clinical trials comparing T-tube drainage versus primary closure after open common bile duct exploration. Two of four authors independently identified the studies for inclusion and extracted data. We analysed the data with both the fixed-effect and the random-effects model using Review Manager (RevMan) analyses. For each outcome we calculated the risk ratio (RR), rate ratio (RaR), or mean difference (MD) with 95% confidence interval (CI) based on intention-to-treat analysis. We included six trials randomising 359 participants, 178 to T-tube drainage and 181 to primary closure. All trials were at high risk of bias. There was no significant difference in mortality between the two groups (4/178 (weighted percentage 1.2%) in the T-tube group versus 1/181 (0.6%) in the primary closure group; RR 2.25; 95% CI 0.55 to 9.25; six trials). There was no significant difference in the serious morbidity rate between the two groups (24/136 (weighted serious morbidity rate, 145 events per 1000 patients) in the T-tube group versus 9/136 (weighted serious morbidity rate, 66 events per 1000 patients) in the primary closure group; RaR 2.19; 95% CI 0.98 to 4.91; four trials). Quality of life and return to work were not reported in any of the trials. The operating time was significantly longer in the T-tube drainage group compared with the primary closure group (MD 28.90 minutes; 95% CI 17.18 to 40.62 minutes; one trial). The hospital stay was significantly longer in the T-tube drainage group compared with the primary closure group (MD 4.72 days; 95% CI 0.83 days to 8.60 days; five trials). T-tube drainage appeared to result in significantly longer operating time and hospital stay compared with primary closure without any apparent evidence of benefit on clinically important outcomes after open common bile duct exploration. Based on the currently available evidence, there is no justification for the routine use of T-tube drainage after open common bile duct exploration in patients with common bile duct stones. T-tube drainage should not be used outside well designed randomised clinical trials. More randomised trials comparing the effects of T-tube drainage versus primary closure after open common bile duct exploration may be needed. Such trials should be conducted with low risk of bias and assessing the long-term beneficial and harmful effects of T-tube drainage, including long-term complications such as bile stricture and recurrence of common bile duct stones.

Reducing menopausal symptoms for women during the menopause transition using group education in a primary health care setting-a randomized controlled trial.

PubMed

Rindner, Lena; Strömme, Gunilla; Nordeman, Lena; Hange, Dominique; Gunnarsson, Ronny; Rembeck, Gun

2017-04-01

Women's physical and mental ill-health shows a marked increase during menopause, which usually occurs between 45 and 55 years of age. Mental illness and somatic symptoms are common causes of long-term sick leave. Women suffer from a lack of knowledge about the menopause transition and its associated symptoms. The aim of the study was to investigate whether group education for women in primary health care (PHC) about the menopause transition can improve their physical and mental ill-health. This randomized controlled study was conducted in PHC and aimed to evaluate a group education programme for women aged 45-55 years, around the menopause transition. A total of 131 women were randomized to group education or no intervention. The group intervention included two education sessions with topics related to menopause. They answered two questionnaires at baseline and at four-month follow-up: the Menopause Rating Scale (MRS) and the Montgomery-Asberg Depression Rating Scale (MADRS). Change in MRS and MADRS scores over the four months. The intervention group experienced a slight reduction in symptoms while the control group mostly experienced the opposite. This study showed that it was feasible to implement group education on menopause for women aged 45-55 years. NTC02852811. Copyright © 2017 Elsevier B.V. All rights reserved.

Randomized Controlled Trial of Primary Care Pediatric Parenting Programs

PubMed Central

Mendelsohn, Alan L.; Dreyer, Benard P.; Brockmeyer, Carolyn A.; Berkule-Silberman, Samantha B.; Huberman, Harris S.; Tomopoulos, Suzy

2011-01-01

Objectives To determine whether pediatric primary care–based programs to enhance parenting and early child development reduce media exposure and whether enhanced parenting mediates the effects. Design Randomized controlled trial. Setting Urban public hospital pediatric primary care clinic. Participants A total of 410 mother-newborn dyads enrolled after childbirth. Interventions Patients were randomly assigned to 1 of 2 interventions, the Video Interaction Project (VIP) and Building Blocks (BB) interventions, or to a control group. The VIP intervention comprised 1-on-1 sessions with a child development specialist who facilitated interactions in play and shared reading through review of videotapes made of the parent and child on primary care visit days; learning materials and parenting pamphlets were also provided. The BB intervention mailed parenting materials, including age-specific newsletters suggesting activities to facilitate interactions, learning materials, and parent-completed developmental questionnaires (Ages and Stages questionnaires). Outcome Measures Electronic media exposure in the home using a 24-hour recall diary. Results The mean (SD) exposure at 6 months was 146.5 (125.0) min/d. Exposure to VIP was associated with reduced total duration of media exposure compared with the BB and control groups (mean [SD] min/d for VIP, 131.6 [118.7]; BB, 151.2 [116.7]; control, 155.4 [138.7]; P=.009). Enhanced parent-child interactions were found to partially mediate relations between VIP and media exposure for families with a ninth grade or higher literacy level (Sobel statistic=2.49; P=.01). Conclusion Pediatric primary care may represent an important venue for addressing the public health problem of media exposure in young children at a population level. Trial Registration clinicaltrials.gov Identifier: NCT00212576 PMID:21199979

Case Method in COPD education for primary care physicians: study protocol for a cluster randomised controlled trial.

PubMed

Sandelowsky, Hanna; Krakau, Ingvar; Modin, Sonja; Ställberg, Björn; Nager, Anna

2017-04-27

Chronic obstructive pulmonary disease (COPD) is a common cause of morbidity and mortality worldwide. It is often undiagnosed and insufficiently managed. Effective forms of continuing medical education (CME) for primary care physicians (PCPs) are necessary to ensure the implementation of guidelines in clinical practice and, thus, improve patients' health. In this study, we will measure the effects of CME by Case Method and compare them against those of traditional lectures and no CME at all through an unblinded, cluster randomised controlled trial (CRCT). Thirty-three primary health care centres (PHCCs) in Stockholm, Sweden, with a total of 180 PCPs will be involved. Twenty-two primary PHCCs, will be cluster-randomised into: an intervention group who will receive CME by Case Method (n = 11) and a control group who will receive traditional lectures (n = 11). The remaining PHCCs (n = 11) will be a reference group and will receive no CME. From the intervention and control groups, 460 randomly selected patients with COPD in GOLD stages 2 and 3 will participate, while no patients will be recruited from the reference group. For the patients, smoking status, actual treatment and urgent visits to a health provider due to airway problems will be registered. For the PCPs, professional competence (i.e. knowledge and management skills) in COPD, will be measured using a questionnaire based on current guidelines and guideline implementation problems in clinical practice which has previously been described by the authors. Data will be collected at baseline and at follow-up, which will be after 1.5 years for the patients, and 1 year for the PCPs. Statistical methods for individual-level and cluster-level analyses will be used. COPD is considered a particularly complex clinical challenge involving managing multimorbidity, symptom adaptation, and lifestyle problematisation. Case Method in CME for PCPs may contribute to a better understanding of the impact of COPD on patients' lives and, thus, improve their management of it. The present study is expected to contribute scientific knowledge about indicators for an effective CME in COPD that is tailor-made to primary care physicians. ClinicalTrials.gov, identifier: NCT02213809 . Registered on 10 August 2014. Protocol version: Issue date: May 2014.

Cost-utility of exercise therapy in patients with hip osteoarthritis in primary care.

PubMed

Tan, S S; Teirlinck, C H; Dekker, J; Goossens, L M A; Bohnen, A M; Verhaar, J A N; van Es, P P; Koes, B W; Bierma-Zeinstra, S M A; Luijsterburg, P A J; Koopmanschap, M A

2016-04-01

To determine the cost-effectiveness (CE) of exercise therapy (intervention group) compared to 'general practitioner (GP) care' (control group) in patients with hip osteoarthritis (OA) in primary care. This cost-utility analysis was conducted with 120 GPs in the Netherlands from the societal and healthcare perspective. Data on direct medical costs, productivity costs and quality of life (QoL) was collected using standardised questionnaires which were sent to the patients at baseline and at 6, 13, 26, 39 and 52 weeks follow-up. All costs were based on Euro 2011 cost data. A total of 203 patients were included. The annual direct medical costs per patient were significantly lower for the intervention group (€ 1233) compared to the control group (€ 1331). The average annual societal costs per patient were lower in the intervention group (€ 2634 vs € 3241). Productivity costs were higher than direct medical costs. There was a very small adjusted difference in QoL of 0.006 in favour of the control group (95% CI: -0.04 to +0.02). Our study revealed that exercise therapy is probably cost saving, without the risk of noteworthy negative health effects. NTR1462. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Difference of Success Rates of Mineral Trioxide Aggregate Pulpotomies Performed Both by Undergraduate Dental Students and by an Expert Operator: A Retrospective Study.

PubMed

Pasini, Marco; Giuca, Maria Rita; Gatto, Roberto; Caruso, Silvia

2017-01-01

The aim of this retrospective study was to evaluate the clinical and radiographic success of pulpotomy on primary molars performed by dental students compared to that performed by an expert operator. The study was conducted on 142 second primary molars in 102 children. The patients were randomly selected from the available records. The test group (treated by dental students) included 51 subjects (28 males and 23 females, mean age: 7.2 ± 1) and the control group included 51 children (29 males and 22 females, mean age: 7.4 ± 1.2 years). After pulpotomy, a clinical and radiographic evaluation after 12 months was performed. Chi-square test and odds ratio were calculated and significance level was set at p < 0.05. The success rate was significantly lower, 81.6% ( p < 0.05), in the test group than in the control group (93%). The test group showed less clinical and radiographic success (86% and 80%, resp.) compared to the control group (97.2% for clinical success and 93% for radiographic success). Pulpotomy with MTA is an effective method that ensures a good percentage of success. The clinical experience of the operator is a contributing factor.

On-demand tramadol hydrochloride use in premature ejaculation treatment.

PubMed

Kaynar, Mehmet; Kilic, Ozcan; Yurdakul, Talat

2012-01-01

To determine the efficacy of tramadol in premature ejaculation (PE) treatment compared with placebo. A single-blind, placebo-controlled, crossover study was conducted with 60 lifelong (primary) patients with PE. The patients were randomized into 2 groups, each consisting of 30 patients, who took tramadol or placebo on demand. PE was defined as an intravaginal ejaculation latency time of ≤60 seconds in 90% of intercourse episodes. The efficacy of the drugs was assessed using the intravaginal ejaculation latency time, ability of ejaculation control, and sexual satisfaction scores after an 8-week treatment period. All participants completed the study voluntarily. Two groups were similar in terms of the patient demographics. Increases in the intravaginal ejaculation latency time, ability of ejaculation control, and sexual satisfaction score between the placebo and tramadol groups were compared with the baseline values in both groups. At the end of study period, the tramadol group had significantly (P<.001) greater values for all 3 parameters compared with those in the placebo group. On-demand use of low-dose tramadol is effective for lifelong PE. Currently, selective seratonin reuptake inhibitors such as dapoxetine, are a more popular treatment option for PE. However, tramadol might be considered an alternative agent for primary PE treatment. Copyright © 2012 Elsevier Inc. All rights reserved.

Impact of a Preemptive Multimodal Analgesia plus Femoral Nerve Blockade Protocol on Rehabilitation, Hospital Length of Stay, and Postoperative Analgesia after Primary Total Knee Arthroplasty: A Controlled Clinical Pilot Study

PubMed Central

Beaupre, Lauren A.; Johnston, D. Bill C.; Dieleman, Sherry; Tsui, Ban

2012-01-01

Purpose. To compare preemptive multimodal analgesia (PMMA) without femoral nerve blocks (FNB) to PMMA including FNB following total knee arthroplasty (TKA). Methods. In a prospective, controlled pilot study, subjects with noninflammatory arthritis undergoing TKA and a short postoperative stay received either PMMA + FNB (FNB group; n = 19) or PMMA only (PMMA group; n = 20). No preoperative group differences were noted. Evaluations occurred in hospital and at 2, 6, and 12 weeks postoperatively. The primary outcome (knee flexion) was measured on day two postoperatively. Rehabilitation indices, pain, analgesic use, and length of stay (LOS) were also measured. Results. All subjects completed the study. The only significant group differences were quadriceps motor blocks in the FNB group (P < 0.001). No significant differences were noted in ROM, pain levels, analgesic use, or hospital LOS. Conclusion. Other than the quadriceps motor block, no group differences were noted; both achieved satisfactory analgesia. Best postoperative pain management strategies when following a short hospital stay program are still unclear. PMID:22666096

Impact of a preemptive multimodal analgesia plus femoral nerve blockade protocol on rehabilitation, hospital length of stay, and postoperative analgesia after primary total knee arthroplasty: a controlled clinical pilot study.

PubMed

Beaupre, Lauren A; Johnston, D Bill C; Dieleman, Sherry; Tsui, Ban

2012-01-01

To compare preemptive multimodal analgesia (PMMA) without femoral nerve blocks (FNB) to PMMA including FNB following total knee arthroplasty (TKA). In a prospective, controlled pilot study, subjects with noninflammatory arthritis undergoing TKA and a short postoperative stay received either PMMA + FNB (FNB group; n = 19) or PMMA only (PMMA group; n = 20). No preoperative group differences were noted. Evaluations occurred in hospital and at 2, 6, and 12 weeks postoperatively. The primary outcome (knee flexion) was measured on day two postoperatively. Rehabilitation indices, pain, analgesic use, and length of stay (LOS) were also measured. All subjects completed the study. The only significant group differences were quadriceps motor blocks in the FNB group (P < 0.001). No significant differences were noted in ROM, pain levels, analgesic use, or hospital LOS. Other than the quadriceps motor block, no group differences were noted; both achieved satisfactory analgesia. Best postoperative pain management strategies when following a short hospital stay program are still unclear.

Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care

PubMed Central

Slok, Annerika H M; Kotz, Daniel; van Breukelen, Gerard; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H; Kerstjens, Huib A M; van der Molen, Thys; Asijee, Guus M; Dekhuijzen, P N Richard; Holverda, Sebastiaan; Salomé, Philippe L; Goossens, Lucas M A; Twellaar, Mascha; in ‘t Veen, Johannes C C M; van Schayck, Onno C P

2016-01-01

Objective Assessing the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with chronic obstructive pulmonary disease (COPD) measured with the St. George's Respiratory Questionnaire (SGRQ), compared with usual care. Methods A pragmatic cluster randomised controlled trial, in 39 Dutch primary care practices and 17 hospitals, with 357 patients with COPD (postbronchodilator FEV1/FVC ratio <0.7) aged ≥40 years, who could understand and read the Dutch language. Healthcare providers were randomly assigned to the intervention or control group. The intervention group applied the ABC tool, which consists of a short validated questionnaire assessing the experienced burden of COPD, objective COPD parameter (eg, lung function) and a treatment algorithm including a visual display and treatment advice. The control group provided usual care. Researchers were blinded to group allocation during analyses. Primary outcome was the number of patients with a clinically relevant improvement in SGRQ score between baseline and 18-month follow-up. Secondary outcomes were the COPD Assessment Test (CAT) and the Patient Assessment of Chronic Illness Care (PACIC; a measurement of perceived quality of care). Results At 18-month follow-up, 34% of the 146 patients from 27 healthcare providers in the intervention group showed a clinically relevant improvement in the SGRQ, compared with 22% of the 148 patients from 29 healthcare providers in the control group (OR 1.85, 95% CI 1.08 to 3.16). No difference was found on the CAT (−0.26 points (scores ranging from 0 to 40); 95% CI −1.52 to 0.99). The PACIC showed a higher improvement in the intervention group (0.32 points (scores ranging from 1 to 5); 95% CI 0.14 to 0.50). Conclusions This study showed that use of the ABC tool may increase quality of life and perceived quality of care. Trial registration number NTR3788; Results. PMID:27401361

Different postconditioning cycles affect prognosis of aged patients undergoing primary percutaneous coronary intervention.

PubMed

Zhang, Jie; Zhang, Xin; Cui, Yuqi; Ferdous, Misbahul; Cui, Lianqun; Zhao, Peng

2017-07-17

Postconditioning can affect the infarct size in acute myocardial infarction (AMI). However, few studies show an effect of different postconditioning cycles on AMI aged patients. This study sought to assess the effect of different postconditioning cycles on prognosis in aged patients with AMI who underwent primary percutaneous coronary intervention (PCI). 74 aged patients were randomly assigned to three groups. Control group; PC-1 group accepted postconditioning 4 cycles of 30 s inflation and 30 s deflation; PC-2 group accepted postconditioning 4 cycles of 60 s. Creatine kinase MB (CK-MB), troponin I (cTnI), high-sensitive C-reactive protein (hs-CRP) and corrected Thrombolysis in Myocardial Infarction (TIMI) frame counts (CTFC) were analyzed before andafter treatment. All patients received an echocardiographic examination for whole heart function, wall motion score index (WMSI) and single-photon emission computed tomography (SPECT) examination at 7 days and 6 months after treatment. S: The peak of CK-MB, postoperative 72 h cTnI and CTFC were significantly attenuated by postconditioning when compared with the control group. The hs-CRP of the postconditioning group was lower than the control group 24 h postoperative. No difference was observed between PC-1 and PC-2 group about the effect described above. At 7 days, heart function in the postconditioning group was improved when compared with the control group. At 6 months, the WMSI and SPECT score significantly reduced in the PC-2 group compared with the control and PC-1 groups, but there was no difference among the three groups about echo data except the left ventricular end-systolic diameter. Postconditioning is significantly beneficial to prognosis in aged patients with AMI. The cardiac protective effect of 4 cycles of 60 s procedure was observed in WMSI and SPECT. It is favorable to implement this procedure in aged patients with AMI in clinic.

Auricular vagal nerve stimulation in peripheral arterial disease patients.

PubMed

Hackl, Gerald; Prenner, Andreas; Jud, Philipp; Hafner, Franz; Rief, Peter; Seinost, Gerald; Pilger, Ernst; Brodmann, Marianne

2017-10-01

Auricular nerve stimulation has been proven effective in different diseases. We investigated if a conservative therapeutic alternative for claudication in peripheral arterial occlusive disease (PAD) via electroacupuncture of the outer ear can be established. In this prospective, double-blinded trial an ear acupuncture using an electroacupuncture device was carried out in 40 PAD patients in Fontaine stage IIb. Twenty patients were randomized to the verum group using a fully functional electroacupuncture device, the other 20 patients received a sham device (control group). Per patient, eight cycles (1 cycle = 1 week) of electroacupuncture were performed. The primary endpoint was defined as a significantly more frequent doubling of the absolute walking distance after eight cycles in the verum group compared to controls in a standardized treadmill testing. Secondary endpoints were a significant improvement of the total score of the Walking Impairment Questionnaire (WIQ) as well as improvements in health related quality of life using the Short Form 36 Health Survey (SF-36). There were no differences in baseline characteristics between the two groups. The initial walking distance significantly increased in both groups (verum group [means]: 182 [95 % CI 128-236] meters to 345 [95 % CI 227-463] meters [+ 90 %], p < 0.01; control group [means]: 159 [95 % CI 109-210] meters to 268 [95 % CI 182-366] meters [+ 69 %], p = 0.01). Twelve patients (60 %) in the verum group and five patients (25 %) in controls reached the primary endpoint of doubling walking distance (p = 0.05). The total score of WIQ significantly improved in the verum group (+ 22 %, p = 0.01) but not in controls (+ 8 %, p = 0.56). SF-36 showed significantly improvements in six out of eight categories in the verum group and only in one of eight in controls. Electroacupuncture of the outer ear seems to be an easy-to-use therapeutic option in an age of increasingly invasive and mechanically complex treatments for PAD patients.

Group therapy for somatization disorders in primary care: maintenance of treatment goals of short cognitive-behavioural treatment one-and-a-half-year follow-up.

PubMed

Lidbeck, J

2003-06-01

The objective of this study was to evaluate the maintenance of treatment goals of a short cognitive-behavioural group treatment programme for the management of somatization disorders in primary care. In a previous controlled 6-month follow-up study, patients with somatization disorders (n=32) improved with respect to illness and somatic preoccupation, hypochondriasis, and medication usage. In the present report the same group of patients were also investigated one-and-a-half year after initial treatment. The long-term follow-up manifested maintained improvement with respect to hypochondriasis. There was additional reduction of anxiety and psychosocial preoccupation, whereas somatization and depression-anxiety scores improved progressively. A short cognitive-behavioural group treatment of psychosomatic patients can be useful in primary care and may manifest maintained or progressive beneficial outcome.

Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial.

PubMed

Gensichen, Jochen; Hiller, Thomas S; Breitbart, Jörg; Teismann, Tobias; Brettschneider, Christian; Schumacher, Ulrike; Piwtorak, Alexander; König, Hans-Helmut; Hoyer, Heike; Schneider, Nico; Schelle, Mercedes; Blank, Wolfgang; Thiel, Paul; Wensing, Michel; Margraf, Jürgen

2014-04-06

Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness. This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs. Current Controlled Trials [http://ISCRTN64669297].

Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial

PubMed Central

2014-01-01

Background Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness. Methods/Design This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs. Trial registration Current Controlled Trials [http://ISCRTN64669297] PMID:24708672

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

PubMed

Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Tong, Seng Fah; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H

2016-11-14

The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect. A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. -4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes. This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting. Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

Effectiveness of a new health care organization model in primary care for chronic cardiovascular disease patients based on a multifactorial intervention: the PROPRESE randomized controlled trial.

PubMed

Orozco-Beltran, Domingo; Ruescas-Escolano, Esther; Navarro-Palazón, Ana Isabel; Cordero, Alberto; Gaubert-Tortosa, María; Navarro-Perez, Jorge; Carratalá-Munuera, Concepción; Pertusa-Martínez, Salvador; Soler-Bahilo, Enrique; Brotons-Muntó, Francisco; Bort-Cubero, Jose; Nuñez-Martinez, Miguel Angel; Bertomeu-Martinez, Vicente; Gil-Guillen, Vicente Francisco

2013-08-02

To evaluate the effectiveness of a new multifactorial intervention to improve health care for chronic ischemic heart disease patients in primary care. The strategy has two components: a) organizational for the patient/professional relationship and b) training for professionals. Experimental study. Randomized clinical trial. Follow-up period: one year. primary care, multicenter (15 health centers). For the intervention group 15 health centers are selected from those participating in ESCARVAL study. Once the center agreed to participate patients are randomly selected from the total amount of patients with ischemic heart disease registered in the electronic health records. For the control group a random sample of patients with ischemic heart disease is selected from all 72 health centers electronic records. This study aims to evaluate the efficacy of a multifactorial intervention strategy involving patients with ischemic heart disease for the improvement of the degree of control of the cardiovascular risk factors and of the quality of life, number of visits, and number of hospitalizations. NCT01826929.

Myocardial infarction increases progressive visual field defects in well treated early primary open angle glaucoma--a prospective case control study.

PubMed

Mondal, Lakshmikanta; Baidya, Krishnapada; Choudhury, Himadri; Roy, Rupam

2013-06-01

The purpose of the study was to evaluate the progression of glaucomatous field damage in patients with stable primary open angle glaucoma after an attack of myocardial infarction. In this case control study, 62 open angle glaucoma patients were selected and regularly followed up. Among 62 patients, 9 had an attack of myocardial infarction. The intra-ocular pressure and visual field progression of both the groups (myocardial infarction versus no myocardial infarction) were analysed. Three (33.3%) out of 9 patients who had suffered from myocardial infarction showed progressive visual field loss whereas only 9 (16.9%) out of 53 patients who did not suffer from myocardial infarction, showed progressive field changes. Both the groups had stable target intra-ocular pressure between 14 and 16 mm Hg. Myocardial infarction may adversely influence the progression of primary open angle glaucoma which is suspected to result from ischaemia induced neuronal loss and only control of intraocular pressure is not the only solution. We have to look for other drugs that prevents ischaemia induced neuronal damage.

Primary venous insufficiency increases risk of deep vein thrombosis.

PubMed

Shaydakov, Maxim E; Comerota, Anthony J; Lurie, Fedor

2016-04-01

Varicose veins have been recognized as a risk factor for deep vein thrombosis (DVT). However, venous reflux has not carried the same correlation. This study evaluated the association between primary valvular reflux and DVT. We performed a nested case-control study with enrollment of outpatients presenting to the vascular laboratory with signs and symptoms of DVT. All patients had a complete bilateral venous duplex examination evaluating for DVT and superficial and deep venous valvular reflux. Eighty-seven patients with confirmed DVT on venous duplex were selected for the study group. The control group was randomly selected from the same cohort in a 4:1 ratio matched by age and gender (n = 348). Groups were compared for the prevalence of deep and superficial reflux. DVT outpatients were 4.7-times more likely to have primary valvular reflux than symptomatic controls (65.5% vs 29.0%; 95% confidence interval [CI], 2.8-7.7; P < .000001). Deep reflux was 2.1-times more prevalent (36.8% vs 21.6%; odds ratio, 2.12; 95% CI, 1.28-3.51; P = .005) and superficial reflux was 4.6-times more prevalent (43.7% vs 14.4%; odds ratio, 4.62; 95% CI, 2.75-7.77; P < .0000001) in DVT patients than in controls. DVT patients were also 2.1-times more likely to have combined deep and superficial reflux than non-DVT patients (13.8% vs 6.6%, 95% CI, 1.08-4.75; P = .044). The prevalence of primary valvular reflux in patients with DVT is significantly higher than expected. Reflux may be considered as a novel risk factor for DVT. Two-thirds of patients with DVT have pre-existent primary chronic venous disease, which is likely to contribute to post-thrombotic morbidity. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Active Care Management Supported by Home Telemonitoring in Veterans With Type 2 Diabetes

PubMed Central

Stone, Roslyn A.; Rao, R. Harsha; Sevick, Mary Ann; Cheng, Chunrong; Hough, Linda J.; Macpherson, David S.; Franko, Carol M.; Anglin, Rebecca A.; Obrosky, D. Scott; DeRubertis, Frederick R.

2010-01-01

OBJECTIVE We compared the short-term efficacy of home telemonitoring coupled with active medication management by a nurse practitioner with a monthly care coordination telephone call on glycemic control in veterans with type 2 diabetes and entry A1C ≥7.5%. RESEARCH DESIGN AND METHODS Veterans who received primary care at the VA Pittsburgh Healthcare System from June 2004 to December 2005, who were taking oral hypoglycemic agents and/or insulin for ≥1 year, and who had A1C ≥7.5% at enrollment were randomly assigned to either active care management with home telemonitoring (ACM+HT group, n = 73) or a monthly care coordination telephone call (CC group, n = 77). Both groups received monthly calls for diabetes education and self-management review. ACM+HT group participants transmitted blood glucose, blood pressure, and weight to a nurse practitioner using the Viterion 100 TeleHealth Monitor; the nurse practitioner adjusted medications for glucose, blood pressure, and lipid control based on established American Diabetes Association targets. Measures were obtained at baseline, 3-month, and 6-month visits. RESULTS Baseline characteristics were similar in both groups, with mean A1C of 9.4% (CC group) and 9.6% (ACM+HT group). Compared with the CC group, the ACM+HT group demonstrated significantly larger decreases in A1C at 3 months (1.7 vs. 0.7%) and 6 months (1.7 vs. 0.8%; P < 0.001 for each), with most improvement occurring by 3 months. CONCLUSIONS Compared with the CC group, the ACM+HT group demonstrated significantly greater reductions in A1C by 3 and 6 months. However, both interventions improved glycemic control in primary care patients with previously inadequate control. PMID:20009091

The correlation between NK cell and liver function in patients with primary hepatocellular carcinoma.

PubMed

Sha, Wei Hong; Zeng, Xiao Hui; Min, Lu

2014-05-01

This study aimed to detect the expression of natural killer (NK) cell receptor natural killer group 2D (NKG2D) in the peripheral blood of patients with primary hepatocellular carcinoma and to discuss the correlation between NK cell cytotoxicity and liver function. The number of NK cells and the expression of NK cell receptor NKG2D in peripheral blood were determined by flow cytometry in patients with primary hepatocellular carcinoma, hepatitis B cirrhosis, chronic hepatitis B, and healthy controls. When compared with patients in the healthy and the chronic hepatitis B groups, the primary hepatocellular carcinoma group showed significant decreases in all parameters, including the cytotoxicity of NK cells on K562 cells, expression rate of NKG2D in NK cells, number of NKG2D(+) NK cells, expression level of NKG2D, and number of NK cells (p<0.05). The activity of NK cells showed a positive correlation, whereas the Child-Pugh scores in the primary hepatocellular carcinoma and the hepatitis B cirrhosis groups showed a negative correlation with all parameters detected above. The decrease of NK cell activity in patients with primary hepatocellular carcinoma is closely related to their lower expression of NKG2D. Liver function affects the expression of NKG2D and the activity of NK cells.

Can supervised group exercises including ergonomic advice reduce the prevalence and severity of low back pain and pelvic girdle pain in pregnancy? A randomized controlled trial.

PubMed

Eggen, Marit Horst; Stuge, Britt; Mowinckel, Petter; Jensen, Kjersti Smee; Hagen, Kåre Birger

2012-06-01

Many women have low back pain (LBP) or pelvic girdle pain (PGP) during pregnancy, but there is limited evidence of effective primary and secondary preventive strategies. The purpose of this study was to investigate whether a group-based exercise program can reduce the prevalence and severity of LBP and PGP in pregnant women. An observer-blinded randomized controlled trial with equal assignments to a training group and a control group was conducted. The study was conducted in primary care maternity units in 2 suburban municipalities in the southeastern part of Norway. The participants were 257 pregnant women who were healthy and between 18 and 40 years of age before gestation week 20. The training group received supervised exercises in groups once a week, and the control group received standard care. The main outcome measures were self-reported LBP and self-reported PGP. Secondary outcome measures were pain intensity in the morning and evening, disability, and 8-Item Short-Form Health Survey (SF-8) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Follow-up measurements were performed at gestation weeks 24, 28, 32, and 36. Overall, there was no effect of the program on the prevalence of PGP (odds ratio = 1.03, 95% confidence interval [CI] = 0.66 to 1.59) or LBP (odds ratio = 0.77, 95% CI = 0.50 to 1.19). For the secondary outcomes, the estimated mean differences between the groups were -0.4 (95% CI = -0.8 to 0.1) for pain intensity in the morning, -0.4 (95% CI = -1.0 to 0.2) for pain intensity in the evening, -1.0 (95% CI = -2.2 to 0.0) for disability, 1.8 (95% CI = 0.0 to 3.7) for the SF-8 PCS, and -0.6 (95% CI = -2.2 to 1.4) for the SF-8 MCS. Due to low statistical power, the estimates for the primary outcomes are imprecise. Supervised group exercise did not reduce the prevalence of LBP or PGP in pregnancy.

Extrusion of Debris from Primary Molar Root Canals following Instrumentation with Traditional and New File Systems.

PubMed

Thakur, Bhagyashree; Pawar, Ajinkya M; Kfir, Anda; Neelakantan, Prasanna

2017-11-01

To assess the amount of debris extruded apically during instrumentation of distal canals of extracted primary molars by three instrument systems [ProTaper Universal (PTU), ProTaper NEXT (PTN), and self-adjusting file (SAF)] compared with conventional stainless steel hand K-files (HF, control). Primary mandibular molars (n = 120) with a single distal canal were selected and randomly divided into four groups (n = 30) for root canal instrumentation using group I, HF (to size 0.30/0.02 taper), group II, PTU (to size F3), group III, PTN (to size X3), and group IV, SAF. Debris extruded during instrumentation was collected in preweighed Eppendorf tubes, stored in an incubator at 70°C for 5 days and then weighed. Statistical analysis was performed by one-way analysis of variance (ANOVA), followed by Turkey's post hoc test (p = 0.05). All the groups resulted in extrusion of debris. There was statistically significant difference (p < 0.001) in the debris extrusion between the three groups: HF (0.00133 ± 0.00012), PTU (0.00109 ± 0.00005), PTN (0.00052 ± 0.00008), and SAF (0.00026 ± 0.00004). Instrumentation with SAF resulted in the least debris extrusion when used for shaping root canals of primary molar teeth. Debris extrusion in primary teeth poses an adverse effect on the stem cells and may also alter the permanent dental germ. Debris extrusion is rarely reported for primary teeth and it is important for the clinician to know which endodontic instrumentation leads to less extrusion of debris.

Pineal gland volume in primary insomnia and healthy controls: a magnetic resonance imaging study.

PubMed

Bumb, Jan M; Schilling, Claudia; Enning, Frank; Haddad, Leila; Paul, Franc; Lederbogen, Florian; Deuschle, Michael; Schredl, Michael; Nolte, Ingo

2014-06-01

Little is known about the relation between pineal volume and insomnia. Melatonin promotes sleep processes and, administered as a drug, it is suitable to improve primary and secondary sleep disorders in humans. Recent magnetic resonance imaging studies suggest that human plasma and saliva melatonin levels are partially determined by the pineal gland volume. This study compares the pineal volume in a group of patients with primary insomnia to a group of healthy people without sleep disturbance. Pineal gland volume (PGV) was measured on the basis of high-resolution 3 Tesla MRI (T1-magnetization prepared rapid gradient echo) in 23 patients and 27 controls, matched for age, gender and educational status. Volume measurements were performed conventionally by manual delineation of the pineal borders in multi-planar reconstructed images. Pineal gland volume was significantly smaller (P < 0.001) in patients (48.9 ± 26.6 mm(3) ) than in controls (79 ± 30.2 mm(3) ). In patients PGV correlated negatively with age (r = -0.532; P = 0.026). Adjusting for the effect of age, PGV and rapid eye movement (REM) latency showed a significant positive correlation (rS  = 0.711, P < 0.001) in patients. Pineal volume appears to be reduced in patients with primary insomnia compared to healthy controls. Further studies are needed to clarify whether low pineal volume is the basis or the consequence of functional sleep changes to elucidate the molecular pathology for the pineal volume loss in primary insomnia. © 2014 European Sleep Research Society.

Primary Teachers Conducting Inquiry Projects: Effects on Attitudes towards Teaching Science and Conducting Inquiry

ERIC Educational Resources Information Center

van Aalderen-Smeets, Sandra I.; Walma van der Molen, Juliette H.; van Hest, Erna G. W. C. M.; Poortman, Cindy

2017-01-01

This study used an experimental, pretest-posttest control group design to investigate whether participation in a large-scale inquiry project would improve primary teachers' attitudes towards teaching science and towards conducting inquiry. The inquiry project positively affected several elements of teachers' attitudes. Teachers felt less anxious…

Waste the waist: a pilot randomised controlled trial of a primary care based intervention to support lifestyle change in people with high cardiovascular risk.

PubMed

Greaves, Colin; Gillison, Fiona; Stathi, Afroditi; Bennett, Paul; Reddy, Prasuna; Dunbar, James; Perry, Rachel; Messom, Daniel; Chandler, Roger; Francis, Margaret; Davis, Mark; Green, Colin; Evans, Philip; Taylor, Gordon

2015-01-16

In the UK, thousands of people with high cardiovascular risk are being identified by a national risk-assessment programme (NHS Health Checks). Waste the Waist is an evidence-informed, theory-driven (modified Health Action Process Approach), group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk. This pilot randomised controlled trial aimed to assess the feasibility of delivering the Waste the Waist intervention in UK primary care and of conducting a full-scale randomised controlled trial. We also conducted exploratory analyses of changes in weight. Patients aged 40-74 with a Body Mass Index of 28 or more and high cardiovascular risk were identified from risk-assessment data or from practice database searches. Participants were randomised, using an online computerised randomisation algorithm, to receive usual care and standardised information on cardiovascular risk and lifestyle (Controls) or nine sessions of the Waste the Waist programme (Intervention). Group allocation was concealed until the point of randomisation. Thereafter, the statistician, but not participants or data collectors were blinded to group allocation. Weight, physical activity (accelerometry) and cardiovascular risk markers (blood tests) were measured at 0, 4 and 12 months. 108 participants (22% of those approached) were recruited (55 intervention, 53 controls) from 6 practices and 89% provided data at both 4 and 12 months. Participants had a mean age of 65 and 70% were male. Intervention participants attended 72% of group sessions. Based on last observations carried forward, the intervention group did not lose significantly more weight than controls at 12 months, although the difference was significant when co-interventions and co-morbidities that could affect weight were taken into account (Mean Diff 2.6Kg. 95%CI: -4.8 to -0.3, p = 0.025). No significant differences were found in physical activity. The Waste the Waist intervention is deliverable in UK primary care, has acceptable recruitment and retention rates and produces promising preliminary weight loss results. Subject to refinement of the physical activity component, it is now ready for evaluation in a full-scale trial. Current Controlled Trials ISRCTN10707899 .

Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion—Learning, Cognition and Motion – A Cluster Randomized Controlled Trial

PubMed Central

Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H.; Andersen, Lars Bo; Bugge, Anna

2016-01-01

Background Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12–14 years old adolescents. Methods A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. Results No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p’s>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4–38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39–0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0–9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p’s>0.05). Conclusions No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing executive functioning or mathematics skills compared to a control group, but low implementation fidelity precludes interpretation of the causal relationship. Trial Registration www.ClinicalTrials.gov NCT02012881 PMID:27341346

Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion-Learning, Cognition and Motion - A Cluster Randomized Controlled Trial.

PubMed

Tarp, Jakob; Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H; Andersen, Lars Bo; Bugge, Anna

2016-01-01

Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12-14 years old adolescents. A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p's>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4-38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39-0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0-9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p's>0.05). No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing executive functioning or mathematics skills compared to a control group, but low implementation fidelity precludes interpretation of the causal relationship. www.ClinicalTrials.gov NCT02012881.

Impact of Nano Hydroxyapatite, Nano Silver Fluoride and Sodium Fluoride Varnish on Primary Teeth Enamel Remineralization: An In Vitro Study

PubMed Central

Nozari, Ali; Ajami, Shabnam; Rafiei, Azade

2017-01-01

Introduction Dental caries is still prevailing worldwide, although different anti caries products have been introduced. Each remineralizing agent has its own shortcomings. Therefore, looking for new agents to have benefits of previous ones with lesser side effects is worthwhile. Aim To determine the remineralization ability of NaF varnish, nano-Hydroxyapatite Serum (n-HAP) and Nano Silver Fluoride (NSF) on enamel of primary anterior teeth. Materials and Methods Incipient caries were induced in primary sound anterior teeth by storing each specimen in demineralization solution for 72 hours. Then they were randomly divided into four groups of 15 samples each: (1) NaF varnish; (2) n-HAP repairing serum; (3) NSF and (4) no treatment (control). Surface Microhardness (SMH) was assessed with Vickers micro hardness tester before and after demineralization and after 10 days of pH-cycling. A total of 12 random specimens from groups 1 to 4 (3 random samples of each group) were examined by Atomic Force Microscopy (AFM). The SMH values were analysed with one-way and repeated measures ANOVA. Level of significance was set at p=0.05. Results Post lesion SMH values significantly decreased in all groups (p<0.001). Post treatment SMH values significantly increased in comparison to post lesion ones (p<0.001) except for control group which was not different statistically (p=0.86). The highest SMH values were observed in NSF group (mean 222.90 ± 28.79). Statistically significant differences were shown between all groups (p<0.05). However, NaF varnish and n-HAP groups were not statistically different (p=0.165). AFM images demonstrated protective layers in all treated groups. Conclusion The results of this in vitro study suggest that NSF could have the greatest remineralization efficacy. NaF varnish and n-HAP serum were similar in remineralizing initial caries. Future clinical studies are recommended for selection of the most appropriate remineralizing agent in primary teeth. PMID:29207844

Influence of de qi on the immediate analgesic effect of SP6 acupuncture in patients with primary dysmenorrhoea and cold and dampness stagnation: a multicentre randomised controlled trial.

PubMed

Zhao, Min-Yi; Zhang, Peng; Li, Jing; Wang, Lin-Peng; Zhou, Wei; Wang, Yan-Xia; She, Yan-Fen; Ma, Liang-Xiao; Wang, Pei; Hu, Ni-Juan; Lin, Chi; Hu, Shang-Qin; Wu, Gui-Wen; Wang, Ya-Feng; Sun, Jun-Jun; Jiang, Si-Zhu; Zhu, Jiang

2017-10-01

The aim of this multicentre randomised controlled trial was to investigate the contribution of de qi to the immediate analgesic effect of acupuncture in patients with primary dysmenorrhoea and the specific traditional Chinese medicine diagnosis cold and dampness stagnation . Eighty-eight patients with primary dysmenorrhoea and cold and dampness stagnation were randomly assigned to de qi (n=43) or no de qi (n=45) groups and underwent 30 min of SP6 acupuncture. The de qi group received deep needling at SP6 with manipulation using thick needles; the no de qi group received shallow needling with no manipulation using thin needles. In both groups the pain scores and actual de qi sensation were evaluated using a visual analogue scale for pain (VAS-P) and the acupuncture de qi clinical assessment scale (ADCAS), respectively. Both groups showed reductions in VAS-P, with no signficant differences between groups. ADCAS scores showed 43/43 and 25/45 patients in de qi and no de qi groups, respectively, actually experienced de qi sensation. Independent of original group allocation, VAS-P reductions associated with actual de qi (n=68) were greater than those without (28.4±18.19 mm vs 14.6±12.28 mm, p=0.008). This study showed no significant difference in VAS-P scores in patients with primary dysmenorrhoea and cold and dampness stagnation immediately after SP6 acupuncture designed to induce or avoid de qi sensation. Both treatments significantly reduced VAS-P relative to baseline. Irrespective of group allocation, patients experiencing actual de qi sensation demonstrated larger reductions in pain score relative to those without, suggesting greater analgesic effects. Chinese Clinical Trial Registry (ChiCTR-TRC-13003086); Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Feasibility of an obesity intervention for paediatric primary care targeting parenting and children: Helping HAND.

PubMed

O'Connor, T M; Hilmers, A; Watson, K; Baranowski, T; Giardino, A P

2013-01-01

  The primary care setting offers the opportunity to reach children and parents to encourage healthy lifestyle behaviours, and improve weight status among children.   Test the feasibility of Helping HAND (Healthy Activity and Nutrition Directions), an obesity intervention for 5- to 8-year-old children in primary care clinics.   A randomized controlled pilot study of Helping HAND, a 6-month intervention, targeted children with body mass index 85-99%tile and their parents. Intervention group attended monthly sessions and self-selected child behaviours and parenting practices to change. Control group received regular paediatric care and was wait-listed for Helping HAND. Session completion, participant satisfaction, child anthropometrics, dietary intake, physical activity, TV viewing and behaviour-specific parenting practices were measured pre and post intervention.   Forty parent-child dyads enrolled: 82.5% were Hispanic, 80% had a girl and 65% reported income ≤ $30, 000/year. There was 20% attrition from Helping HAND (attended <4/6 sessions). Families self-selected 4.35 (SD 1.75) behaviours to target during the 6-month programme and each of the seven behaviours was selected by 45-80% of the families. There were no between group differences in the child's body mass index z-score, dietary intake or physical activity post intervention. Intervention group viewed 14.9 (SE 2.3) h/week of TV post intervention versus control group 23.3 (SE 2.4) h/week (P < 0.05).   Helping HAND is feasible, due to low attrition, good programme attendance, and clinically relevant improvements in some child and parenting behaviours. © 2011 Blackwell Publishing Ltd.

A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study).

PubMed

Littlewood, Chris; Bateman, Marcus; Brown, Kim; Bury, Julie; Mawson, Sue; May, Stephen; Walters, Stephen J

2016-07-01

To evaluate the clinical effectiveness of a self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. Multi-centre pragmatic unblinded parallel group randomised controlled trial. UK National Health Service. Patients with a clinical diagnosis of rotator cuff tendinopathy. The intervention was a programme of self-managed exercise prescribed by a physiotherapist in relation to the most symptomatic shoulder movement. The control group received usual physiotherapy treatment. The primary outcome measure was the Shoulder Pain & Disability Index (SPADI) at three months. Secondary outcomes included the SPADI at six and twelve months. A total of 86 patients (self-managed loaded exercise n=42; usual physiotherapy n=44) were randomised. Twenty-six patients were excluded from the analysis because of lack of primary outcome data at the 3 months follow-up, leaving 60 (n=27; n=33) patients for intention to treat analysis. For the primary outcome, the mean SPADI score at three months was 32.4 (SD 20.2) for the self-managed group, and 30.7 (SD 19.7) for the usual physiotherapy treatment group; mean difference adjusted for baseline score: 3.2 (95% Confidence interval -6.0 to +12.4 P = 0.49).By six and twelve months there remained no significant difference between the groups. This study does not provide sufficient evidence of superiority of one intervention over the other in the short-, mid- or long-term and hence a self-management programme based around a single exercise appears comparable to usual physiotherapy treatment. © The Author(s) 2015.

SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial.

PubMed

Glynn, Liam G; Hayes, Patrick S; Casey, Monica; Glynn, Fergus; Alvarez-Iglesias, Alberto; Newell, John; Ólaighin, Gearóid; Heaney, David; Murphy, Andrew W

2013-05-29

Sedentary lifestyles are now becoming a major concern for governments of developed and developing countries with physical inactivity related to increased all-cause mortality, lower quality of life, and increased risk of obesity, diabetes, hypertension and many other chronic diseases. The powerful onboard computing capacity of smartphones, along with the unique relationship individuals have with their mobile phones, suggests that mobile devices have the potential to influence behavior. However, no previous trials have been conducted using smartphone technology to promote physical activity. This project has the potential to provide robust evidence in this area of innovation. The aim of this study is to evaluate the effectiveness of a smartphone application as an intervention to promote physical activity in primary care. A two-group, parallel randomized controlled trial (RCT) with a main outcome measure of mean difference in daily step count between baseline and follow up over eight weeks. A minimum of 80 active android smartphone users over 16 years of age who are able to undertake moderate physical activity are randomly assigned to the intervention group (n = 40) or to a control group (n = 40) for an eight week period. After randomization, all participants will complete a baseline period of one week during which a baseline mean daily step count will be established. The intervention group will be instructed in the usability features of the smartphone application, will be encouraged to try to achieve 10,000 steps per day as an exercise goal and will be given an exercise promotion leaflet. The control group will be encouraged to try to walk an additional 30 minutes per day along with their normal activity (the equivalent of 10,000 steps) as an exercise goal and will be given an exercise promotion leaflet. The primary outcome is mean difference in daily step count between baseline and follow-up. Secondary outcomes are systolic and diastolic blood pressure, resting heart rate, mental health score using HADS and quality of life score using Euroqol. Randomization and allocation to the intervention and groups will be carried out by an independent researcher, ensuring the allocation sequence is concealed from the study researchers until the interventions are assigned. The primary analysis is based on mean daily step count, comparing the mean difference in daily step count between the baseline and the trial periods in the intervention and control groups at follow up.

Cardioprotective Effects of Intracoronary Morphine in ST-Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Prospective, Randomized Trial.

PubMed

Gwag, Hye Bin; Kim, Eun Kyoung; Park, Taek Kyu; Lee, Joo Myung; Yang, Jeong Hoon; Song, Young Bin; Choi, Jin-Ho; Choi, Seung-Hyuk; Lee, Sang Hoon; Chang, Sung-A; Park, Sung-Ji; Lee, Sang-Chol; Park, Seung Woo; Jang, Woo Jin; Lee, Mirae; Chun, Woo Jung; Oh, Ju Hyeon; Park, Yong Hwan; Choe, Yeon Hyeon; Gwon, Hyeon-Cheol; Hahn, Joo-Yong

2017-04-03

A cardioprotective role of morphine acting via opioid receptors has been demonstrated, and previous preclinical studies have reported that morphine could reduce reperfusion injury and myocardial infarct size in a way similar to that of ischemic periconditioning. This study aimed to evaluate the effect of intracoronary morphine on myocardial infarct size in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. This study was designed as a 2-center, prospective, randomized, open-label, blinded end point trial. A total of 91 ST-elevation myocardial infarction patients with thrombolysis in myocardial infarction flow grade of 0 to 1 undergoing primary percutaneous coronary intervention were randomly assigned to a morphine or control group at a 1:1 ratio. The morphine group received 3 mg of morphine sulfate diluted with 3 mL of normal saline, and the control group received 3 mL of normal saline into a coronary artery immediately after restoration of coronary flow. The primary end point was myocardial infarct size assessed by cardiac magnetic resonance imaging The cardiac magnetic resonance images were evaluated for 42 and 38 patients in the morphine and control groups, respectively. Myocardial infarct size was not different between the 2 groups (25.6±11.2% versus 24.6±10.5%, P =0.77), nor was the extent of microvascular obstruction or myocardial salvage index (6.0±6.3% versus 5.1±4.6%, P =0.91; 31.1±15.2% versus 30.3±10.9%, P =0.75, respectively). There was no difference in peak creatine kinase-MB level, final thrombolysis in myocardial infarction flow, myocardial brush grade, or complete resolution of ST-segment. Intracoronary morphine administration could not reduce myocardial infarct size in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01738100. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Iron profile and dietary pattern of primary school obese Egyptian children.

PubMed

Abd-El Wahed, Mohamed A; Mohamed, Maha H; Ibrahim, Samia S; El-Naggar, Wafaa A

2014-08-01

Poor iron status affects billions of people worldwide. The prevalence of obesity continues to rise in both the developed and developing nations. An association between iron status and obesity has been described in children and adults. The aim of the study was to assess the iron profile and dietary pattern in primary school-aged obese Egyptian children. A case-control study was conducted on 120 children, both obese (n=60) and control group (n=60), recruited from three primary governmental schools located in Dokki Sector, El-Giza Governorate, Egypt. Their ages ranged from 6 to 12 years. All children were subjected to full medical and dietetic history, anthropometric measurements, thorough clinical examination, and determination of complete blood count, serum iron, total iron-binding capacity, transferrin saturation (TS), and ferritin. Despite similar dietary iron intake in the two groups, obese children showed highly significantly decreased hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, serum iron, and TS, and increased mean corpuscular hemoglobin concentration and total iron-binding capacity when compared with the nonobese group. The obese group showed a highly significant increased rate of iron deficiency (ID) (TS<15% or mean corpuscular volume<76 fl) when compared with the nonobese group. Obesity was a significant risk factor for the development of ID (odds ratio: 7.09, 95% confidence interval: 3.16-15.92). The association between ID and obesity may have important public health and clinical implications. For primary school children with elevated BMIs, screening for ID should be considered. Increasing awareness of the importance of physical activity and carrying out nutritional education programs are required.

Reducing the rate of early primary hip dislocation by combining a change in surgical technique and an increase in femoral head diameter to 36 mm.

PubMed

Ho, Ki Wai Kevin; Whitwell, George S; Young, Steve K

2012-07-01

We report how changes to our total hip arthroplasty (THA) surgical practise lead to a decrease in early hip dislocation rates. Group B consisted of 421 consecutive primary THA operations performed via a posterior approach. The operative technique included a meticulous repair of the posterior capsule, alignment of the acetabular cup with the transverse acetabular ligament (TAL) and a 36-mm-diameter femoral head. We compared the dislocation rates and cost implications of this technique to a historical control Group A consisting of 389 patients. The control group had their THA performed with no repair of the capsule, no identification of the TAL and all received a 28-mm-diameter head. Our primary outcome is the rate of early hip dislocation and we hypothesised that we can reduce the rate of early hip dislocation with this new regime. In Group B there were no early dislocations (within 6 months) and two (0.5 %) dislocations within 18 months; minimum follow-up time was 18 months with a range of (18-96 months). This compared to a 1.8 % early dislocation rate and a 2.6 % rate at 18 months in Group A; minimum follow-up time was 60 months with a range of (60-112 months). These results were statistically significant (p = 0.006). We suggest that when primary hip arthroplasty is performed through a posterior approach, a low early dislocation rate can be achieved using the described methods.

Impact of a multifaceted intervention to improve the clinical management of osteoporosis. The ESOSVAL-F study.

PubMed

Sanfélix-Genovés, José; Peiró, Salvador; Sanfélix-Gimeno, Gabriel; Hurtado, Isabel; Pascual de la Torre, Manuel; Trillo-Mata, José Luis; Giner-Ruiz, Vicente

2010-10-21

A study to evaluate the impact of a combined intervention (in-class and on-line training courses, a practicum and economic incentives) to improve anti-osteoporosis treatment and to improve recordkeeping for specific information about osteoporosis. A before/after study with a non-equivalent control group to evaluate the impact of the interventions associated with participation in the ESOSVAL-R cohort study (intervention group) compared to a group receiving no intervention (control group). The units of analysis are medical practices identified by a Healthcare Position Code (HPC) referring to a specific medical position in primary care general medicine in a Healthcare Department of the Region of Valencia, Spain. The subjects of the study are the 400 participating "practices" (population assigned to health care professionals, doctors and/or nurses) selected by the Healthcare Departments of the Valencia Healthcare Agency for participation as associate researchers in the ESOSVAL-R study (intervention group), compared to 400 participating "practices" assigned to primary care professionals NOT selected for participation as associate researchers in the ESOSVAL-R study, who are selected on the basis of their working in the same Healthcare Centers as the practices receiving the interventions (control group). The study's primary endpoint is the appropriateness of treatment according by the Spanish National Health System guide (2010) and the National Osteoporosis Foundation (NOF, 2008) and International Osteoporosis Foundation guidance (IOF, 2008).The study will also evaluate a series of secondary and tertiary endpoints. The former are the suitability of treatment and evaluation of the risk of fracture; and the latter are the volume of information registered in the electronic clinical records, and the evaluation of risks and the suitability of treatment.

Impact of a multifaceted intervention to improve the clinical management of osteoporosis. The ESOSVAL-F study

PubMed Central

2010-01-01

Background A study to evaluate the impact of a combined intervention (in-class and on-line training courses, a practicum and economic incentives) to improve anti-osteoporosis treatment and to improve recordkeeping for specific information about osteoporosis. Methods/design A before/after study with a non-equivalent control group to evaluate the impact of the interventions associated with participation in the ESOSVAL-R cohort study (intervention group) compared to a group receiving no intervention (control group). The units of analysis are medical practices identified by a Healthcare Position Code (HPC) referring to a specific medical position in primary care general medicine in a Healthcare Department of the Region of Valencia, Spain. The subjects of the study are the 400 participating "practices" (population assigned to health care professionals, doctors and/or nurses) selected by the Healthcare Departments of the Valencia Healthcare Agency for participation as associate researchers in the ESOSVAL-R study (intervention group), compared to 400 participating "practices" assigned to primary care professionals NOT selected for participation as associate researchers in the ESOSVAL-R study, who are selected on the basis of their working in the same Healthcare Centers as the practices receiving the interventions (control group). The study's primary endpoint is the appropriateness of treatment according by the Spanish National Health System guide (2010) and the National Osteoporosis Foundation (NOF, 2008) and International Osteoporosis Foundation guidance (IOF, 2008). The study will also evaluate a series of secondary and tertiary endpoints. The former are the suitability of treatment and evaluation of the risk of fracture; and the latter are the volume of information registered in the electronic clinical records, and the evaluation of risks and the suitability of treatment. PMID:20964817

Inhibition of duck hepatitis B virus replication by mimic peptides in vitro

PubMed Central

JIA, HONGYU; LIU, CHANGHONG; YANG, YING; ZHU, HAIHONG; CHEN, FENG; LIU, JIHONG; ZHOU, LINFU

2015-01-01

The aim of the present study was to investigate the inhibitory effect of specific mimic peptides targeting duck hepatitis B virus polymerase (DHBVP) on duck hepatitis B virus (DHBV) replication in primary duck hepatocytes. Phage display technology (PDT) was used to screen for mimic peptides specifically targeting DHBVP and the associated coding sequences were determined using DNA sequencing. The selected mimic peptides were then used to treat primary duck hepatocytes infected with DHBV in vitro. Infected hepatocytes expressing the mimic peptides intracellularly were also prepared. The cells were divided into mimic peptide groups (EXP groups), an entecavir-treated group (positive control) and a negative control group. The medium was changed every 48 h. Following a 10-day incubation, the cell supernatants were collected. DHBV-DNA in the cellular nucleus, cytoplasm and culture supernatant was analyzed by quantitative polymerase chain reaction (qPCR). Eight mimic peptides were selected following three PDT screening rounds for investigation in the DHBV-infected primary duck hepatocytes. The qPCR results showed that following direct treatment with mimic peptide 2 or 7, intracellular expression of mimic peptide 2 or 7, or treatment with entecavir, the DHBV-DNA levels in the culture supernatant and cytoplasm of duck hepatocytes were significantly lower than those in the negative control (P<0.05). The cytoplasmic DHBV-DNA content of the cells treated with mimic peptide 7 was lower than that in the other groups (P<0.05). In addition, the DHBV-DNA content of the nuclear fractions following the intracellular expression of mimic peptide 7 was significantly lower than that in the other groups (P<0.05). Mimic peptides specifically targeting DHBVP, administered directly or expressed intracellularly, can significantly inhibit DHBV replication in vitro. PMID:26640539

Inhibition of duck hepatitis B virus replication by mimic peptides in vitro.

PubMed

Jia, Hongyu; Liu, Changhong; Yang, Ying; Zhu, Haihong; Chen, Feng; Liu, Jihong; Zhou, Linfu

2015-11-01

The aim of the present study was to investigate the inhibitory effect of specific mimic peptides targeting duck hepatitis B virus polymerase (DHBVP) on duck hepatitis B virus (DHBV) replication in primary duck hepatocytes. Phage display technology (PDT) was used to screen for mimic peptides specifically targeting DHBVP and the associated coding sequences were determined using DNA sequencing. The selected mimic peptides were then used to treat primary duck hepatocytes infected with DHBV in vitro. Infected hepatocytes expressing the mimic peptides intracellularly were also prepared. The cells were divided into mimic peptide groups (EXP groups), an entecavir-treated group (positive control) and a negative control group. The medium was changed every 48 h. Following a 10-day incubation, the cell supernatants were collected. DHBV-DNA in the cellular nucleus, cytoplasm and culture supernatant was analyzed by quantitative polymerase chain reaction (qPCR). Eight mimic peptides were selected following three PDT screening rounds for investigation in the DHBV-infected primary duck hepatocytes. The qPCR results showed that following direct treatment with mimic peptide 2 or 7, intracellular expression of mimic peptide 2 or 7, or treatment with entecavir, the DHBV-DNA levels in the culture supernatant and cytoplasm of duck hepatocytes were significantly lower than those in the negative control (P<0.05). The cytoplasmic DHBV-DNA content of the cells treated with mimic peptide 7 was lower than that in the other groups (P<0.05). In addition, the DHBV-DNA content of the nuclear fractions following the intracellular expression of mimic peptide 7 was significantly lower than that in the other groups (P<0.05). Mimic peptides specifically targeting DHBVP, administered directly or expressed intracellularly, can significantly inhibit DHBV replication in vitro .

Short- and long-term effects of mud-bath treatment on hand osteoarthritis: a randomized clinical trial

NASA Astrophysics Data System (ADS)

Fioravanti, Antonella; Tenti, Sara; Giannitti, Chiara; Fortunati, Nicola Angelo; Galeazzi, Mauro

2014-01-01

The aim of this study was to evaluate both the short-term and the long-term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA). This was a prospective randomized, single blind controlled trial. Sixty outpatients with primary bilateral hand OA were included in the study and randomized to one of two groups. One group ( n = 30) was treated with 12 daily local mud packs and generalized thermal baths with a sulfate-calcium-magnesium-fluorides mineral water added to usual treatment. The control group ( n = 30) continued regular outpatient care routine (exercise, NSAIDs and/or analgesics). Each patient was examined at baseline, after 2 weeks, and after 3, 6, 9 and 12 months. Primary outcome measures were global spontaneous hand pain on a visual analogue scale (VAS) and the functional index for hand osteoarthritis (FIHOA) score; secondary outcomes were health assessment questionnaire (HAQ), duration of morning stiffness, medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption. Our results demonstrated that the efficacy of spa therapy was significant in all the assessed parameters, both at the end of therapy and after 3 months; the values of FIHOA, HAQ and drugs consumption continued to be significantly better after 6 months in comparison with baseline. There were no significant modifications of the parameters throughout the follow-up in the control group. Differences between the two groups were significant for all parameters at the 15th day and at 3 months follow-up; regarding FIHOA, HAQ, and symptomatic drugs consumption, the difference between the two groups persisted and was significant at 6month follow-up. Tolerability of spa therapy seemed to be good. In conclusion, our results confirm that the beneficial effects of spa therapy in patients with hand OA last over time.

How Caregivers and Workers Fared in Cash and Counseling

PubMed Central

Foster, Leslie; Dale, Stacy B; Brown, Randall

2007-01-01

Objectives To assess the effects of Cash and Counseling on Medicaid beneficiaries' primary informal caregivers and describe the experiences of their directly hired workers. Study Setting Beneficiaries in Arkansas, Florida, and New Jersey voluntarily enrolled in the demonstration and were randomly assigned to direct their own Medicaid supportive services as Cash and Counseling consumers (the treatment group) or to rely on Medicaid services as usual (the control group). Beneficiaries identified their primary informal caregiver during a baseline interview and their primary paid worker during a 9-month follow-up interview. Data Sources Data were collected through telephone interviews with caregivers and workers. These interviews were conducted about 10 months after beneficiaries' random assignment, between February 2000 and May 2003, depending on the state. Data Analysis Methods We estimated program effects with regression and logit models and compared the mean characteristics of directly hired workers and agency workers, by state. Principal Findings Compared with caregivers in the control group, those in the treatment group had modestly to substantially better outcomes for measures of satisfaction with care, worry, and physical and financial strain. For hours of care and emotional strain, outcomes in the treatment group were similar to or somewhat better than those in the control group. Directly hired workers reported greater satisfaction with wages, similar satisfaction with working conditions, and similar rates of injuries as agency workers. Workers who were related to the beneficiary reported more emotional strain than agency workers. Conclusions Cash and Counseling can lessen some of the burden associated with caring for a child or adult with disabilities. The experiences of hired workers suggest consumer direction is a sustainable option, but support networks for workers might be a welcome program improvement. PMID:17244295

The impact of a multidisciplinary information technology-supported program on blood pressure control in primary care.

PubMed

Rinfret, Stéphane; Lussier, Marie-Thérèse; Peirce, Anthony; Duhamel, Fabie; Cossette, Sylvie; Lalonde, Lyne; Tremblay, Chantal; Guertin, Marie-Claude; LeLorier, Jacques; Turgeon, Jacques; Hamet, Pavel

2009-05-01

Hypertension is a leading mortality risk factor yet inadequately controlled in most affected subjects. Effective programs to address this problem are lacking. We hypothesized that an information technology-supported management program could help improve blood pressure (BP) control. This randomized controlled trial included 223 primary care hypertensive subjects with mean 24-hour BP >130/80 and daytime BP >135/85 mm Hg measured with ambulatory monitoring (ABPM). Intervention subjects received a BP monitor and access to an information technology-supported adherence and BP monitoring system providing nurses, pharmacists, and physicians with monthly reports. Control subjects received usual care. The mean (+/-SD) follow-up was 348 (+/-78) and 349 (+/-84) days in the intervention and control group, respectively. The primary end point of the change in the mean 24-hour ambulatory BP was consistently greater in intervention subjects for both systolic (-11.9 versus -7.1 mm Hg; P<0.001) and diastolic BP (-6.6 versus -4.5 mm Hg; P=0.007). The proportion of subjects that achieved Canadian Guideline target BP (46.0% versus 28.6%) was also greater in the intervention group (P=0.006). We observed similar BP declines for ABPM and self-recorded home BP suggesting the latter could be an alternative for confirming BP control. The intervention was associated with more physician-driven antihypertensive dose adjustments or changes in agents (P=0.03), more antihypertensive classes at study end (P=0.007), and a trend toward improved adherence measured by prescription refills (P=0.07). This multidisciplinary information technology-supported program that provided feedback to patients and healthcare providers significantly improved blood pressure levels in a primary care setting.

[Protocol to evaluate the effectiveness of a consciousness-raising and training intervention for primary care professionals, in order to improve detection of domestic violence (ISFVIDAP)].

PubMed

Fernández Alonso, M Carmen; Herrero Velázquez, Sonia; Cordero Guevara, José Aurelio; Maderuelo Fernández, José Angel; Madereuelo Fernández, José Angel; González Castro, María Luisa

2006-01-01

To evaluate the effectiveness of an intervention aimed at primary care physicians and nurses to improve the detection of domestic violence. Community intervention study with control, randomized in clusters, pragmatic, open, and with parallel groups. Primary care centres in Spain. Primary care physicians and nurses from the entire country who agree to participate in the study. UNIT OF ANALYSIS: The basic care team (BCT) of doctor and nurse looking after a list is the unit of analysis for evaluating the number of cases detected; and their clinical records are the units of analysis for evaluating recorded cases (suspicion and/or confirmation of mistreatment). Sixty eight BCT in each group (136 in the 2 groups) and 1700 clinical records per group (25 per BCT). Altogether, they will cover some 130,000 women of 14 and over. A short training programme with homogeneous training contents, aimed at raising the awareness of health professionals and teaching them how to identify risk factors, situations of special vulnerability and alarm signals. The programme also aims to provide health professionals with tools to make the clinical interview easier, when they suspect mistreatment and how to tackle a case once it is detected. The main measurement will be the mean variation between intervention and control groups in the number of cases of domestic violence detected during the study, through specific recording and mean variation between the initial and final variations in each group. A weighted student's t test or, if covariates need to be adjusted, a regression analysis will be used for comparison. All analyses will be based on intention to treat.

Acceptance and practicability of a visual communication tool in smoking cessation counselling: a randomised controlled trial.

PubMed

Neuner-Jehle, Stefan; Knecht, Marianne I; Stey-Steurer, Claudia; Senn, Oliver

2013-12-01

Smoking cessation advice is important for reducing the worldwide burden of disease resulting from tobacco smoking. Appropriate risk communication formats improve the success of counselling interventions in primary care. To test the feasibility and acceptance of a smoking cessation counselling tool with different cardiovascular risk communication formats including graphs, in comparison with the International Primary Care Respiratory Group (IPCRG) 'quit smoking assistance' tool. GPs were randomised into an intervention group (using our communication tool in addition to the IPCRG sheet) and a control group (using the IPCRG sheet only). We asked participants for socioeconomic data, smoking patterns, understanding of information, motivation, acceptance and feasibility, and measured the duration and frequency of counselling sessions. Twenty-five GPs performed 2.8 counselling sessions per month in the intervention group and 1.7 in the control group (p=0.3) with 114 patients. The median duration of a session was 10 mins (control group 11 mins, p=0.09 for difference). Median patients' motivation for smoking cessation was 7 on a 10-point visual analogue scale with no significant difference before and after the intervention (p=0.2) or between groups (p=0.73 before and p=0.15 after the intervention). Median patients' ratings of motivation, selfconfidence, understanding of information, and satisfaction with the counselling were 3-5 on a 5-point Likert scale, similar to GPs' ratings of acceptance and feasibility, with no significant difference between groups. Among Swiss GPs and patients, both our innovative communication tool and the IPCRG tool were well accepted and both merit further dissemination and application in research.

Office managers' perception of stress, control, and satisfaction: a comparison between primary care and specialty practices.

PubMed

Chang, Jyh-Hann; Whittier, Nathan; DeFries, Erin; Garfinkle, Amanda

2006-01-01

Perception of stress, control, and satisfaction was measured by office managers in medical practices. Office managers spend enormous amounts of time each day handling difficult interpersonal issues among staff physicians, and patients. As a group, physician disruptions were the most prevalent per day. Other staff members were considered the most stressful by rank order. Significant differences were discovered between primary care practices versus specialty practices in the areas of interactions with physicians.

Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial.

PubMed

Lean, Michael Ej; Leslie, Wilma S; Barnes, Alison C; Brosnahan, Naomi; Thom, George; McCombie, Louise; Peters, Carl; Zhyzhneuskaya, Sviatlana; Al-Mrabeh, Ahmad; Hollingsworth, Kieren G; Rodrigues, Angela M; Rehackova, Lucia; Adamson, Ashley J; Sniehotta, Falko F; Mathers, John C; Ross, Hazel M; McIlvenna, Yvonne; Stefanetti, Renae; Trenell, Michael; Welsh, Paul; Kean, Sharon; Ford, Ian; McConnachie, Alex; Sattar, Naveed; Taylor, Roy

2018-02-10

Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes. We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20-65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27-45 kg/m 2 , and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal/day formula diet for 3-5 months), stepped food reintroduction (2-8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA 1c ) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836. Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n=23) and control (n=26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8-49·8; p<0·0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0-5 kg weight loss, 19 (34%) of 56 participants with 5-10 kg loss, 16 (57%) of 28 participants with 10-15 kg loss, and 31 (86%) of 36 participants who lost 15 kg or more. Mean bodyweight fell by 10·0 kg (SD 8·0) in the intervention group and 1·0 kg (3·7) in the control group (adjusted difference -8·8 kg, 95% CI -10·3 to -7·3; p<0·0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7·2 points (SD 21·3) in the intervention group, and decreased by 2·9 points (15·5) in the control group (adjusted difference 6·4 points, 95% CI 2·5-10·3; p=0·0012). Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study. Our findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care. Diabetes UK. Copyright © 2018 Elsevier Ltd. All rights reserved.

Comparison of the microhardness of primary and permanent teeth after immersion in two types of carbonated beverages.

PubMed

Haghgou, Hamid R; Haghgoo, Roza; Asdollah, Fatemah Molla

2016-01-01

The consumption of carbonated beverages is one of the etiological factors that cause dental erosion. The purpose of this research was to compare changes in the microhardness of permanent and primary teeth after immersion in two types of carbonated beverages. This investigation was done on 30 healthy permanent molars and 30 healthy primary canines. Each group of primary and permanent teeth was subdivided into three groups of 10 teeth. The teeth was immersed in 40 ml of each of the three beverages for 5 min. One subgroup was immersed in water (as a control). The next was immersed in Lemon Delster and the last subgroup was immersed in Coca-Cola. The microhardness of enamel was measured using the Vickers method before and after immersion. Finally, the data was analyzed by paired t-test, one-way analysis of variance, and t-test. Microhardness reduction in the primary teeth was significant in both the Lemon Delster and Coca-Cola groups (P < 0.05). This reduction was also statistically significant in the permanent teeth (P < 0.05). A comparison of the enamel changes in the primary teeth with permanent teeth after immersion in both beverages showed a greater microhardness reduction in the primary teeth in both the experimental groups. Coca-Cola and Lemon Delster caused a significant reduction of microhardness in tooth enamel. This reduction was greater in primary teeth than in permanent teeth, and was also greater after immersion in Coca-Cola than after immersion in Lemon Delster.

Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial.

PubMed

Yan, Shiyan; Zhang, Runshun; Zhou, Xuezhong; Li, Peng; He, Liyun; Liu, Baoyan

2013-02-28

Chinese herbal medicine is one of the most popular Chinese medicine (CM) therapies for primary insomnia. One of the important characteristics of CM is that different Chinese clinicians give different prescriptions even for the same patient. However, there must be some fixed drug patterns in every clinician's prescriptions. This study aims to screen the effective core drug patterns in primary insomnia treatment of three prestigious Chinese clinicians. A triple-blind, randomized, placebo-controlled, parallel-group clinical trial will be performed. Three clinicians will diagnose and treat every eligible patient individually and independently, producing three prescriptions from three clinicians for every patient. Patients will equally be randomized to one of four groups - medical group A, medical group B, medical group C, or placebo group - and observed for efficacy of treatment. The sample will include primary insomnia patients meeting DSM IV-TR criteria, Spiegel scale score >18, and age 18 to 65 years. A sequential design is employed. Interim analysis will be conducted when between 80 and 160 patients complete the study. The interim study could be stopped and treated as final if a statistically significant difference between treatment and placebo groups can be obtained and core effective drug patterns can be determined. Otherwise, the study continues until the maximum sample size reaches 300. Treatment of the CM group is one of three Chinese clinicians' prescriptions, who provide independently prescriptions based on their own CM theory and the patient's disease condition. Assessment will be by sleep diary and Pittsburgh sleep quality index, and CM symptoms and signs will be measured. Primary outcome is total sleep time. Assessment will be carried out at the washout period, weeks 1, 2, 3, and 4 and 4th week after the end of treatment. Effectiveness analysis will be per intent to treat. A multi-dimension association rule and scale-free networks method will be used to explore the effective core drug patterns. The effective core drug patterns will be found through analyzing several prestigious CM clinicians' treatment information. Screening the effective core drug patterns from prestigious clinicians can accelerate the development of new CM drugs. NCT01613183.

Effectiveness of dry needling of rectus abdominis trigger points for the treatment of primary dysmenorrhoea: a randomised parallel-group trial.

PubMed

Gaubeca-Gilarranz, Alberto; Fernández-de-Las-Peñas, César; Medina-Torres, José Raúl; Seoane-Ruiz, José M; Company-Palonés, Aurelio; Cleland, Joshua A; Arias-Buría, Jose L

2018-05-02

To compare the effectiveness of trigger point dry needling (TrP-DN) versus placebo needling, relative to an untreated control group, on pain and quality of life in primary dysmenorrhoea. In this randomised, single blind, parallel-group trial, 56 females with primary dysmenorrhoea were randomly allocated to TrP-DN (n=19), placebo needling (n=18) or no treatment (n=19). Patients in both groups were asked to undertake a stretching exercise of the rectus abdominis daily. The needling group received a single session of TrP-DN to trigger points (TrPs) in the rectus abdominis, and the placebo group received placebo needling. The primary outcome was pain intensity (visual analogue scale). Secondary outcomes were quality of life, use of non-steroidal anti-inflammatory drugs, the number of days with pain, and self-perceived improvement, measured using a Global Rate of Change. Outcomes were assessed at baseline, and 1 and 2 months after the treatment. Females receiving TrP-DN exhibited greater decreases (P<0.001) in pain than those receiving placebo (1 month: Δ-19.8 mm, 25.9 to -13.7; 2 months: Δ-26.0 mm, -33.1 to -18.9) or assigned to the untreated control group (1 month: Δ-26.0mm, -32.5 to -19.5; 2 months: Δ-20.1 mm, -26.4 to -13.8). Females in the TrP-DN group also exhibited a greater decrease in the amount of medications (P<0.001). No differences in the number of days with pain or quality of life were found (all P>0.1). This trial suggests that a single session of TrP-DN of the rectus abdominis combined with stretching was more effective than placebo needling and stretching alone at reducing pain and the amount of medication used in primary dysmenorrhoea. ACTRN12616000170426. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Educating resident physicians using virtual case-based simulation improves diabetes management: a randomized controlled trial.

PubMed

Sperl-Hillen, JoAnn; O'Connor, Patrick J; Ekstrom, Heidi L; Rush, William A; Asche, Stephen E; Fernandes, Omar D; Appana, Deepika; Amundson, Gerald H; Johnson, Paul E; Curran, Debra M

2014-12-01

To test a virtual case-based Simulated Diabetes Education intervention (SimDE) developed to teach primary care residents how to manage diabetes. Nineteen primary care residency programs, with 341 volunteer residents in all postgraduate years (PGY), were randomly assigned to a SimDE intervention group or control group (CG). The Web-based interactive educational intervention used computerized virtual patients who responded to provider actions through programmed simulation models. Eighteen distinct learning cases (L-cases) were assigned to SimDE residents over six months from 2010 to 2011. Impact was assessed using performance on four virtual assessment cases (A-cases), an objective knowledge test, and pre-post changes in self-assessed diabetes knowledge and confidence. Group comparisons were analyzed using generalized linear mixed models, controlling for clustering of residents within residency programs and differences in baseline knowledge. The percentages of residents appropriately achieving A-case composite clinical goals for glucose, blood pressure, and lipids were as follows: A-case 1: SimDE = 21.2%, CG = 1.8%, P = .002; A-case 2: SimDE = 15.7%, CG = 4.7%, P = .02; A-case 3: SimDE = 48.0%, CG = 10.4%, P < .001; and A-case 4: SimDE = 42.1%, CG = 18.7%, P = .004. The mean knowledge score and pre-post changes in self-assessed knowledge and confidence were significantly better for SimDE group than CG participants. A virtual case-based simulated diabetes education intervention improved diabetes management skills, knowledge, and confidence for primary care residents.

Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial.

PubMed

Schaefert, R; Kaufmann, C; Wild, B; Schellberg, D; Boelter, R; Faber, R; Szecsenyi, J; Sauer, N; Guthrie, E; Herzog, W

2013-01-01

Patients with medically unexplained symptoms (MUS) are frequent in primary care and substantially impaired in their quality of life (QoL). Specific training of general practitioners (GPs) alone did not demonstrate sustained improvement at later follow-up in current reviews. We evaluated a collaborative group intervention. We conducted a cluster randomized controlled trial. Thirty-five GPs recruited 304 MUS patients (intervention group: 170; control group: 134). All GPs were trained in diagnosis and management of MUS (control condition). Eighteen randomly selected intervention GPs participated in training for a specific collaborative group intervention. They conducted 10 weekly group sessions and 2 booster meetings in their practices, together with a psychosomatic specialist. Six and 12 months after baseline, QoL was assessed with the Short-Form 36. The primary outcome was the physical composite score (PCS), and the secondary outcome was the mental composite score (MCS). At 12 months, intention-to-treat analyses showed a significant between-group effect for the MCS (p = 0.023) but not for the PCS (p = 0.674). This effect was preceded by a significant reduction of somatic symptom severity (15-item somatic symptom severity scale of the Patient Health Questionnaire, PHQ-15) at 6 months (p = 0.008) that lacked significance at 12 months (p = 0.078). As additional between-group effects at 12 months, per-protocol analyses showed less health anxiety (Whiteley-7; p = 0.038) and less psychosocial distress (PHQ; p = 0.024); GP visits were significantly (p = 0.042) reduced in the intervention group. Compared to pure GP training, collaborative group intervention achieved a progressive, clinically meaningful improvement in mental but not physical QoL. It could bridge gaps between general practice and mental health care. Copyright © 2012 S. Karger AG, Basel.

Application of propensity scores to estimate the association between government subsidy and injection use in primary health care institutions in China.

PubMed

Tang, Yuqing; Zhang, Xiaopeng; Yang, Chunyan; Yang, Lianping; Wang, Hongtao; Zhang, Xinping

2013-05-21

The problem posed by therapeutic injection is a clinical practice issue that influences health care quality and patient safety. Although sufficient government subsidy was one of the 12 key interventions to promote rational drug use initiated by WHO (World Health Organization), limited information is available about the association between government subsidy and injection use in primary health care institutions. In 2009, National Essential Medicines System (NEMS) was implemented in China. The subsidy policy plays an important role in maintaining primary health care institutions. This study explores the impact of government subsidies on the injection use in primary health care institutions in China. 126 primary health institutions were included in this study. Institutions were divided into two groups (intervention and control groups) according to the median GS (General subsidy per personnel). Propensity score matching (PSM) was used to minimize the observed covariate differences in the characteristics of the primary institutions between the two groups. Kappa score was calculated to determine the consistency between the groups. Paired chi-square test and Relative Risk (RR) were calculated to compare the differences in injection use between the groups. Among all the investigated prescriptions, the overall percent of people who received an injection prescribed was 36.96% (n = 12600). PSM showed no significant covariate difference among the 34 groups obtained through this analysis. Kappa score (k = -0.082, p = 0.558) indicated an inconsistency between groups and paired chi-square test revealed a significant difference (p < 0.05) in injection use between the two groups. Relative Risk = 0.679 (95%CI [0.485, 0.950]) indicate that high General subsidy per personnel is a protective factor for primary health care institutions to prescribe injections properly. The intervention group obtained a higher possibility of using injection properly. The overall effect of government subsidy on the use of injection was positively significant. However, the mechanism by which government subsidy influence injection administration remains unclear, and thus requires further study.

A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis.

PubMed

Forster, Anne; Dickerson, Josie; Young, John; Patel, Anita; Kalra, Lalit; Nixon, Jane; Smithard, David; Knapp, Martin; Holloway, Ivana; Anwar, Shamaila; Farrin, Amanda

2013-12-21

Most patients who have had a stroke are dependent on informal caregivers for activities of daily living. The TRACS trial investigated a training programme for caregivers (the London Stroke Carers Training Course, LSCTC) on physical and psychological outcomes, including cost-effectiveness, for patients and caregivers after a disabling stroke. We undertook a pragmatic, multicentre, cluster randomised controlled trial with a parallel cost-effectiveness analysis. Stroke units were eligible if four of five criteria used to define a stroke unit were met, a substantial number of patients on the unit had a diagnosis of stroke, staff were able to deliver the LSCTC, and most patients were discharged to a permanent place of residence. Stroke units were randomly assigned to either LSCTC or usual care (control group), stratified by geographical region and quality of care, and using blocks of size 2. Patients with a diagnosis of stroke, likely to return home with residual disability and with a caregiver providing support were eligible. The primary outcome for patients was self-reported extended activities of daily living at 6 months, measured with the Nottingham Extended Activities of Daily Living (NEADL) scale. The primary outcome for caregivers was self-reported burden at 6 months, measured with the caregivers burden scale (CBS). We combined patient and caregiver costs with primary outcomes and quality-adjusted life-years (QALYs) to assess cost-effectiveness. This trial is registered with controlled-trials.com, number ISRCTN 49208824. We assessed 49 stroke units for eligibility, of which 36 were randomly assigned to either the intervention group or the control group. Between Feb 27, 2008, and Feb 9, 2010, 928 patient and caregiver dyads were registered, of which 450 were in the intervention group, and 478 in the control group. Patients' self-reported extended activities of daily living did not differ between groups at 6 months (adjusted mean NEADL score 27·4 in the intervention group versus 27·6 in the control group, difference -0·2 points [95% CI -3·0 to 2·5], p value=0·866, ICC=0·027). The caregiver burden scale did not differ between groups either (adjusted mean CBS 45·5 in the intervention group versus 45·0 in the control group, difference 0·5 points [95% CI -1·7 to 2·7], p value=0·660, ICC=0·013). Patient and caregiver costs were similar in both groups (length of the initial stroke admission and associated costs were £13,127 for the intervention group and £12,471 for the control group; adjusted mean difference £1243 [95% CI -1533 to 4019]; p value=0·380). Probabilities of cost-effectiveness based on QALYs were low. In a large scale, robust evaluation, results from this study have shown no differences between the LSCTC and usual care on any of the assessed outcomes. The immediate period after stroke might not be the ideal time to deliver structured caregiver training. Medical Research Council. Copyright © 2013 Elsevier Ltd. All rights reserved.

Abacus Training Affects Math and Task Switching Abilities and Modulates Their Relationships in Chinese Children

PubMed Central

Yao, Yuan; Weng, Jian; Hu, Yuzheng; Chen, Feiyan

2015-01-01

Our previous work demonstrated that abacus-based mental calculation (AMC), a traditional Chinese calculation method, could help children improve their math abilities (e.g. basic arithmetical ability) and executive function (e.g. working memory). This study further examined the effects of long-term AMC training on math ability in visual-spatial domain and the task switching component of executive function. More importantly, this study investigated whether AMC training modulated the relationship between math abilities and task switching. The participants were seventy 7-year-old children who were randomly assigned into AMC and control groups at primary school entry. Children in AMC group received 2-hour AMC training every week since primary school entry. On the contrary, children in the control group had never received any AMC training. Math and task switching abilities were measured one year and three years respectively after AMC training began. The results showed that AMC children performed better than their peers on math abilities in arithmetical and visual-spatial domains. In addition, AMC group responded faster than control group in the switching task, while no group difference was found in switch cost. Most interestingly, group difference was present in the relationships between math abilities and switch cost. These results implied the effect of AMC training on math abilities as well as its relationship with executive function. PMID:26444689

Abacus Training Affects Math and Task Switching Abilities and Modulates Their Relationships in Chinese Children.

PubMed

Wang, Chunjie; Geng, Fengji; Yao, Yuan; Weng, Jian; Hu, Yuzheng; Chen, Feiyan

2015-01-01

Our previous work demonstrated that abacus-based mental calculation (AMC), a traditional Chinese calculation method, could help children improve their math abilities (e.g. basic arithmetical ability) and executive function (e.g. working memory). This study further examined the effects of long-term AMC training on math ability in visual-spatial domain and the task switching component of executive function. More importantly, this study investigated whether AMC training modulated the relationship between math abilities and task switching. The participants were seventy 7-year-old children who were randomly assigned into AMC and control groups at primary school entry. Children in AMC group received 2-hour AMC training every week since primary school entry. On the contrary, children in the control group had never received any AMC training. Math and task switching abilities were measured one year and three years respectively after AMC training began. The results showed that AMC children performed better than their peers on math abilities in arithmetical and visual-spatial domains. In addition, AMC group responded faster than control group in the switching task, while no group difference was found in switch cost. Most interestingly, group difference was present in the relationships between math abilities and switch cost. These results implied the effect of AMC training on math abilities as well as its relationship with executive function.

The Effectiveness of the "Lions Quest Program: Skills for Growing" on School Climate, Students' Behaviors, Perceptions of School, and Conflict Resolution Skills

ERIC Educational Resources Information Center

Gol-Guven, Mine

2017-01-01

This study examines the effectiveness of the Lions Quest Program: Skills for Growing by employing a quasi-experimental design with a control group. The experimental and control group each comprises two primary schools--one public, one private. One classroom at each grade level, 1 through 4, in each school was selected by random sampling for a…

Urinary markers of renal damage in hypertensive children diagnosed with ambulatory blood pressure monitoring.

PubMed

Girişgen, İlknur; Sönmez, Ferah; Yenisey, Ciğdem; Kurt-Omurlu, İmran

2014-01-01

Primary hypertension is the most important risk factor for chronic kidney disease in adulthood. However, the role of hypertension in kidney damage in childhood is not known exactly. The aim of this study was to evaluate the ambulatory blood pressure measurements of healthy children diagnosed as hypertensive with routine office blood pressure monitoring and to investigate the effects of primary hypertension on the kidney. Fifty-six patients who had blood pressure higher than 90th percentile during their well-child follow-up and 27 healthy children with normal blood pressure were included in the study. Twenty-four hour blood pressure measurements were recorded for all the patients. Microalbumin and N-acetyl-β-D-glucosaminidase (NAG) levels in the 24-hour urine were determined in the study groups. According to the results of ambulatory blood pressure measurements, 52% of the patients were diagnosed as white coat hypertension. The patients and the white coat hypertensive group had higher levels of urinary NAG than the control group. No significant difference was found in the levels of urinary microalbumin excretion between the primary hypertension and control groups. It was thought that ambulatory blood pressure measurement was necessary for the true diagnosis of hypertension in children, and further, that primary and white coat hypertension had effects on kidney damage in childhood. It is suggested that urine NAG excretion might be used as an early sign of hypertension-induced renal damage.

Effectiveness of transcutaneous electrical nerve stimulation and interferential current in primary dysmenorrhea.

PubMed

Tugay, Nazan; Akbayrak, Türkan; Demirtürk, Funda; Karakaya, Ilkim Citak; Kocaacar, Ozge; Tugay, Umut; Karakaya, Mehmet Gürhan; Demirtürk, Fazli

2007-01-01

To compare the effectiveness of transcutaneous electrical nerve stimulation and interferential current in primary dysmenorrhea. A prospective, randomized, and controlled study. Hacettepe University School of Physical Therapy and Rehabilitation. Thirty-four volunteer subjects with primary dysmenorrhea (mean age: 21.35 +/- 1.70 years) were included. Statistical analyses were performed in 32 subjects who completed all measures. Fifteen subjects received interferential current application for 20 minutes and 17 subjects received transcutaneous electrical nerve stimulation for 20 minutes when they were experiencing dysmenorrhea. Physical characteristics, years since menarche, length of menstrual cycle (days), and duration of menstruation (days) were recorded. Visual analog scale ( VAS) intensities of menstrual pain, referred lower limb pain, and low back pain were recorded before treatment, and immediately, 8 hours, and 24 hours after treatment. Intensities of the evaluated parameters decreased beginning from just after the applications in both groups (P<0.05). Intensity of referring low back pain in first three measurement times was different between the groups (P<0.05), but this difference is thought to be due to the baseline values of the groups. So, it can be said that no superiority existed between the methods (P>0.05). Both transcutaneous electrical nerve stimulation and interferential current appear to be effective in primary dysmenorrhea. As they are free from the potentially adverse effects of analgesics, and no adverse effects are reported in the literature nor observed in this study, a clinical trial of their effectiveness in comparison with untreated and placebo-treated control groups is warranted.

Role of Uttara Vasti with Trivrit and Lasuna oil in the management of primary dysmenorrhea

PubMed Central

Jahan, Shabnam; Sujatha, N.; Neelam

2010-01-01

Dysmenorrhea is one of the most common clinical entities encountered in regular practice by the gynecologists. Dysmenorrhea means painful menstruation. Fifty percent of the women suffer from dysmenorrhea. Primary dysmenorrhea is correlated with Udavartini yonivyapad in Ayurveda. No successful advances have been made in the line of management till today by western medicine. Therefore, a complete, comprehensive and holistic approach toward its understanding and treatment is the need of the age. In this series, Uttar Vasti, a unique panchakarma procedure, is studied for its role in yonivyapads. A research study was conductedto evaluate the efficacy of Uttar Vasti with Trivrit and Lasuna oil in Primary dysmenorrhea. Thirty-six diagnosed cases of Udavartini Yonivyapad, viz., primary (spasmodic) dysmenorrhea, were selected and randomly allocated into two groups. The effect of Uttar Vasti was compared with the commonly used non steroidal anti inflammatory drug (control group). Uttar Vasti with Operculina turpethum (Trivrit) and Allium sativum (Lasuna) oil has shown encouraging results in Udavartini yonivyapad. Statistically significant relief was seen in the intensity of pain and the successive cycles were less painful in the treated group as compared to control group. The mode of action can be attributed to anti-inflammatory (vatahara), vasodilatory (ushna virya) antispasmodic and laxative (anulomana) properties of the trial drugs. The present study shows Uttar Vasti as a safe and easy technique to treat dysmenorrhea like conditions without any side effects. PMID:22131715

Sexual Abuse Prevention Mobile Application (SAP_MobAPP) for Primary School Children in Korea.

PubMed

Moon, Kyoung Ja; Park, Kyung Min; Sung, Yunsick

2017-07-01

This study aimed to develop and evaluate the effects of a sexual abuse prevention mobile application, SAP_MobAPP, for primary school children. Forty-five subjects were trained for 40 minutes once a week. The experimental group received education that utilized the SAP_MobAPP. Control group A received Web based sexual abuse prevention education, while control group B received textbook based sexual abuse prevention education. Effectiveness was verified through a survey on child sexual abuse recognition and avoidance skills administered before and after training. The SAP_MobAPP program improved recognition (awareness) and the child's skills to avoid child sexual abuse situations, and the effects were long-lasting. However, differences between groups were not statistically significant. This study developed a sexual abuse prevention application and verified its effectiveness. Awareness and skills to avoid child sexual abuse after app education increased immediately after training and four weeks later. The SAP_MobAPP could be used for sexual abuse prevention education in schools.

A feasibility randomised controlled trial of pre-operative occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis (PROOF-THR).

PubMed

Jepson, Paul; Sands, Gina; Beswick, Andrew D; Davis, Edward T; Blom, Ashley W; Sackley, Catherine M

2016-02-01

To assess the feasibility of a pre-operative occupational therapy intervention for patients undergoing primary total hip replacement. Single blinded feasibility randomised controlled trial, with data collection prior to the intervention, and at 4, 12, and 26 weeks following surgery. Recruitment from two NHS orthopaedic outpatient centres in the West Midlands, UK. Patients awaiting primary total hip replacement due to osteoarthritis were recruited. Following pre-operative assessment, patients were individually randomised to intervention or control by a computer-generated block randomisation algorithm stratified by age and centre. The intervention group received a pre-surgery home visit by an occupational therapist who discussed expectations, assessed home safety, and provided appropriate adaptive equipment. The control group received treatment as usual. The study assessed the feasibility of recruitment procedures, delivery of the intervention, appropriateness of outcome measures and data collection methods. Health related quality of life and resource use were recorded at 4, 12 and 26 weeks. Forty-four participants were recruited, 21 were randomised to the occupational therapy intervention and 23 to usual care. Analysis of 26 week data included 18 participants in the intervention group and 21 in the control. The intervention was delivered successfully with no withdrawals or crossovers; 5/44 were lost to follow-up with further missing data for participation and resource use. The feasibility study provided the information required to conduct a definitive trial. Burden of assessment would need to be addressed. A total of 219 patients would be required in an efficacy trial. © The Author(s) 2015.

Do motivational incentives reduce the inhibition deficit in ADHD?

PubMed

Shanahan, Michelle A; Pennington, Bruce F; Willcutt, Erik W

2008-01-01

The primary goal of this study was to test three competing theories of ADHD: the inhibition theory, the motivational theory, and a dual deficit theory. Previous studies have produced conflicting findings about the effects of incentives on executive processes in ADHD. In the present study of 25 children with ADHD and 30 typically developing controls, motivation was manipulated within the Stop Task. Stop signal reaction time was examined, as well as reaction time, its variability, and the number of errors in the primary choice reaction time task. Overall, the pattern of results supported the inhibition theory over the motivational or dual deficit hypotheses, as main effects of group were found for most key variables (ADHD group was worse), whereas the group by reward interaction predicted by the motivational and dual deficit accounts was not found. Hence, as predicted by the inhibition theory, children with ADHD performed worse than controls irrespective of incentives.

Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: cluster randomised controlled trial (WAVES study).

PubMed

Adab, Peymane; Pallan, Miranda J; Lancashire, Emma R; Hemming, Karla; Frew, Emma; Barrett, Tim; Bhopal, Raj; Cade, Janet E; Canaway, Alastair; Clarke, Joanne L; Daley, Amanda; Deeks, Jonathan J; Duda, Joan L; Ekelund, Ulf; Gill, Paramjit; Griffin, Tania; McGee, Eleanor; Hurley, Kiya; Martin, James; Parry, Jayne; Passmore, Sandra; Cheng, K K

2018-02-07

To assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity. Cluster randomised controlled trial. UK primary schools from the West Midlands. 200 schools were randomly selected from all state run primary schools within 35 miles of the study centre (n=980), oversampling those with high minority ethnic populations. These schools were randomly ordered and sequentially invited to participate. 144 eligible schools were approached to achieve the target recruitment of 54 schools. After baseline measurements 1467 year 1 pupils aged 5 and 6 years (control: 28 schools, 778 pupils) were randomised, using a blocked balancing algorithm. 53 schools remained in the trial and data on 1287 (87.7%) and 1169 (79.7%) pupils were available at first follow-up (15 month) and second follow-up (30 month), respectively. The 12 month intervention encouraged healthy eating and physical activity, including a daily additional 30 minute school time physical activity opportunity, a six week interactive skill based programme in conjunction with Aston Villa football club, signposting of local family physical activity opportunities through mail-outs every six months, and termly school led family workshops on healthy cooking skills. The protocol defined primary outcomes, assessed blind to allocation, were between arm difference in body mass index (BMI) z score at 15 and 30 months. Secondary outcomes were further anthropometric, dietary, physical activity, and psychological measurements, and difference in BMI z score at 39 months in a subset. Data for primary outcome analyses were: baseline, 54 schools: 1392 pupils (732 controls); first follow-up (15 months post-baseline), 53 schools: 1249 pupils (675 controls); second follow-up (30 months post-baseline), 53 schools: 1145 pupils (621 controls). The mean BMI z score was non-significantly lower in the intervention arm compared with the control arm at 15 months (mean difference -0.075 (95% confidence interval -0.183 to 0.033, P=0.18) in the baseline adjusted models. At 30 months the mean difference was -0.027 (-0.137 to 0.083, P=0.63). There was no statistically significant difference between groups for other anthropometric, dietary, physical activity, or psychological measurements (including assessment of harm). The primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity. Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments. Current Controlled Trials ISRCTN97000586. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.