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METHODS | A random sample of pharmacies will send questionnaires 3 months after the first prescription . |
METHODS | This contains socio-demographic questions , a measure of beliefs about medicines ( BMQ ) , satisfaction with information received ( SIMS , abbreviated ) and frequency of pharmacy counselling ( Consumer Quality Index , CQI , abbreviated ) . |
METHODS | The primary outcome measure will be medication adherence calculated from dispensing records retrieved 12 months after the intervention . |
METHODS | Patients ' beliefs on medication , perception of the quality of information received and pharmacy counselling are secondary outcomes . |
CONCLUSIONS | The TelCIP study will determine the effectiveness of telephone counselling to improve adherence in patients initiating a new treatment . |
CONCLUSIONS | By measuring satisfaction with information and counselling and beliefs about medication the study will also give clues for the reason of a potential increase in adherence . |
CONCLUSIONS | Finally the study will provide information on which patients are most likely to benefit from this intervention . |
BACKGROUND | The trial is registered at http://www.trialregister.nl under the identifier NTR3237 . |
###25141094 | null |
OBJECTIVE | The purpose of this study was to examine the effects of including female athletes ' weights in athletic event programs on female spectators ' body image , eating disorder symptoms , self-esteem , and affective state and to investigate whether the magnitude of the athletes ' reported weights had differential effects on ... |
METHODS | We used an experimental design to examine hypotheses derived from competing theories to determine whether exposure to female athletes of varying weight would adversely or beneficially impact female undergraduates ( N = 152 ) who served as athletic event spectators . |
RESULTS | Analyses indicated that in this simulated study , female spectators ' body image , eating disorder symptoms , self-esteem , and affective states were not impacted by the presence or by the magnitude of female athletes ' weights in athletic event programs . |
CONCLUSIONS | The results imply that including athletes ' weights in game-day programs at women 's athletic events does not affect female spectators on an individual level . |
###24484541 | null |
BACKGROUND | Approximately 20 % of patients are not satisfied with the outcome of total knee replacement , great volumes of which are carried out yearly . |
BACKGROUND | Physiotherapy is often provided by the NHS to address dysfunction following knee replacement ; however the efficacy of this is unknown . |
BACKGROUND | Although clinically it is accepted that therapy is useful , provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year . |
BACKGROUND | No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improvin... |
BACKGROUND | We are also investigating whether the structure of the physiotherapy provision itself influences outcomes . |
METHODS | The study is a multi-centre prospective randomised controlled trial ( RCT ) of patients undergoing primary total knee replacement , with treatment targeted at those deemed most susceptible to gain from it . |
METHODS | Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review , and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy . |
METHODS | The intervention will be either ` intensive ' involving both hospital and home-based functional exercise rehabilitation , or ` standard of care ' consisting of home exercises . |
METHODS | Patients will be randomised to either group using a web-based system . |
METHODS | Both groups will receive pre and post-intervention physiotherapy review . |
METHODS | Patients will be followed-up to one year post-operation . |
METHODS | The primary outcome measure is the Oxford Knee Score . |
METHODS | Secondary outcomes are patient satisfaction , functional ability , pain scores and cost-effectiveness . |
BACKGROUND | Current Controlled Trials ISRCTN23357609 . |
BACKGROUND | ClinicalTrials.gov NCT01849445 . |
###26296950 | null |
BACKGROUND | In developing countries , mortality in children with very severe pneumonia is high , even with the provision of appropriate antibiotics , standard oxygen therapy , and other supportive care . |
BACKGROUND | We assessed whether oxygen therapy delivered by bubble continuous positive airway pressure ( CPAP ) improved outcomes compared with standard low-flow and high-flow oxygen therapies . |
METHODS | This open , randomised , controlled trial took place in Dhaka Hospital of the International Centre for Diarrhoeal Disease Research , Bangladesh . |
METHODS | We randomly assigned children younger than 5 years with severe pneumonia and hypoxaemia to receive oxygen therapy by either bubble CPAP ( 5 L/min starting at a CPAP level of 5 cm H2O ) , standard low-flow nasal cannula ( 2 L/min ) , or high-flow nasal cannula ( 2 L/kg per min up to the maximum of 12 L/min ) . |
METHODS | Randomisation was done with use of the permuted block methods ( block size of 15 patients ) and Fisher and Yates tables of random permutations . |
METHODS | The primary outcome was treatment failure ( ie , clinical failure , intubation and mechanical ventilation , death , or termination of hospital stay against medical advice ) after more than 1 h of treatment . |
METHODS | Primary and safety analyses were by intention to treat . |
METHODS | We did two interim analyses and stopped the trial after the second interim analysis on Aug 3 , 2013 , as directed by the data safety and monitoring board . |
METHODS | This trial is registered at ClinicalTrials.gov , number NCT01396759 . |
RESULTS | Between Aug 4 , 2011 , and July 17 , 2013 , 225 eligible children were recruited . |
RESULTS | We randomly allocated 79 ( 35 % ) children to receive oxygen therapy by bubble CPAP , 67 ( 30 % ) to low-flow oxygen therapy , and 79 ( 35 % ) to high-flow oxygen therapy . |
RESULTS | Treatment failed for 31 ( 14 % ) children , of whom five ( 6 % ) had received bubble CPAP , 16 ( 24 % ) had received low-flow oxygen therapy , and ten ( 13 % ) had received high-flow oxygen therapy . |
RESULTS | Significantly fewer children in the bubble CPAP group had treatment failure than in the low-flow oxygen therapy group ( relative risk [ RR ] 027 , 997 % CI 007-099 ; p = 00026 ) . |
RESULTS | No difference in treatment failure was noted between patients in the bubble CPAP and those in the high-flow oxygen therapy group ( RR 050 , 997 % 011-229 ; p = 0175 ) . |
RESULTS | 23 ( 10 % ) children died . |
RESULTS | Three ( 4 % ) children died in the bubble CPAP group , ten ( 15 % ) children died in the low-flow oxygen therapy group , and ten ( 13 % ) children died in the high-flow oxygen therapy group . |
RESULTS | Children who received oxygen by bubble CPAP had significantly lower rates of death than the children who received oxygen by low-flow oxygen therapy ( RR 025 , 95 % CI 007-089 ; p = 0022 ) . |
CONCLUSIONS | Oxygen therapy delivered by bubble CPAP improved outcomes in Bangladeshi children with very severe pneumonia and hypoxaemia compared with standard low-flow oxygen therapy . |
CONCLUSIONS | Use of bubble CPAP oxygen therapy could have a large effect in hospitals in developing countries where the only respiratory support for severe childhood pneumonia and hypoxaemia is low-flow oxygen therapy . |
CONCLUSIONS | The trial was stopped early because of higher mortality in the low-flow oxygen group than in the bubble CPAP group , and we acknowledge that the early cessation of the trial reduces the certainty of the findings . |
CONCLUSIONS | Further research is needed to test the feasibility of scaling up bubble CPAP in district hospitals and to improve bubble CPAP delivery technology . |
BACKGROUND | International Centre for Diarrhoeal Disease Research , Bangladesh , and Centre for International Child Health , University of Melbourne . |
###24274431 | null |
BACKGROUND | Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 . |
BACKGROUND | Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care . |
BACKGROUND | Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed . |
METHODS | We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular diseas... |
METHODS | This intervention will be implemented as a stepped wedge , cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged 40 years at high cardiovascular disease event risk ( approximately 15,000 people ) . |
METHODS | Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension 's region-specific risk charts . |
METHODS | Cluster randomisation will occur at the level of the primary health centres . |
METHODS | Outcome analyses will be conducted blinded to intervention allocation . |
OBJECTIVE | The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period . |
OBJECTIVE | Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quali... |
OBJECTIVE | Trial outcomes will be accompanied by detailed process and economic evaluations . |
CONCLUSIONS | The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served populations in low and middle income country settings . |
BACKGROUND | Clinical Trial Registry India CTRI/2013/06 / 003753 . |
###25137845 | null |
OBJECTIVE | To observe the effect of external application of Zhuangshenling Recipe ( ZR ) combined with Western medicine ( WM ) on the heart function of chronic heart failure ( CHF ) patients of Xin-Shen yang deficiency , interior retention of water-fluid syndrome ( XSYDIRWFS ) . |
METHODS | Totally 140 CHF patients of XSYDIRWFS were randomly assigned to two groups , the treatment group and the control group , 70 in each group . |
METHODS | All patients received WM therapy . |
METHODS | Those in the treatment group were applied with ZR at Xinshu ( BL15 ) and Shenshu ( BL23 ) , while those in the control group were applied with placebos at Xinshu ( BL15 ) and Shenshu ( BL23 ) . |
METHODS | The therapeutic course for all was 12 weeks . |
METHODS | The integrals of TCM syndrome , grading of cardiac function , brain natriuretic polypeptide ( BNP ) , and 6 min walking distance were observed before and after treatment . |
RESULTS | After twelve weeks of treatment , the effective rate of improved grading of cardiac function , the total effective rate of TCM syndrome efficacy , and the BNP level were obviously better in the treatment group ( P < 0.05 ) . |
RESULTS | There was no statistical difference in 6 min walking distance between the two groups ( P > 0.05 ) . |
CONCLUSIONS | External application of ZR combined with WM could improve the heart function of CHF patients of XSYDIRWFS . |
###24885942 | null |
BACKGROUND | High levels of circulating fibroblast growth factor 23 ( FGF23 ) are associated with chronic kidney disease ( CKD ) progression and high mortality . |
BACKGROUND | In the Phosphate Reduction Evaluation of FGF23 in Early CKD Treatment ( PREFECT ) study , we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF23 levels in normophosphatemic patients with CKD stage 3 . |
METHODS | Thirty-five individuals were randomized to lanthanum carbonate 3000 mg/day ( n = 23 ) or placebo ( n = 12 ) for 12 weeks . |
METHODS | Levels of intact FGF23 ( iFGF23 ) , C-terminal FGF23 , serum and urinary phosphate and calcium , intact parathyroid hormone and 1,25-dihydroxyvitamin D were assessed . |
RESULTS | The median age was 65 years in the lanthanum group and 73 years in the placebo group ; 58.8 % and 41.7 % were men , respectively . |
RESULTS | No significant difference was seen in mean iFGF23 between groups at week 12 . |
RESULTS | There was , however , a transient reduction from baseline in iFGF23 in the lanthanum group at week 1 , from 70.5 pg/ml to 51.9 pg/ml , which was not seen in the placebo group ; this between-group difference in percentage change from baseline was significant in post hoc analyses ( p = 0.0102 ) . |
RESULTS | Urinary phosphate decreased after 1 week of lanthanum treatment and remained low at week 12 . |
CONCLUSIONS | Reducing intestinal phosphate absorption with lanthanum carbonate did not lead to sustained reductions in iFGF23 in patients with CKD stage 3 , although phosphaturia decreased . |
CONCLUSIONS | This suggests that factors other than phosphate burden may be responsible for driving increases in circulating FGF23 in patients with CKD . |
BACKGROUND | ClinicalTrials.gov NCT01128179 , 20 May 2010 . |
###24412457 | null |
OBJECTIVE | This study sought to compare the efficacy of drug-eluting balloons ( DEB ) with that of everolimus-eluting stents ( EES ) in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) . |
BACKGROUND | Treatment of patients with ISR remains a challenge . |
METHODS | This was a prospective , multicenter , randomized trial comparing DEB with EES in patients with bare-metal stents ( BMS ) in-stent restenosis ( ISR ) . |
METHODS | The primary endpoint was the minimal lumen diameter at 9 months ' follow-up . |
RESULTS | A total of 189 patients with BMS-ISR from 25 Spanish sites were included ( 95 were allocated to DEB and 94 to EES ) . |
RESULTS | Procedural success was achieved in all patients . |
RESULTS | At late angiography ( median 249 days ; 92 % of eligible patients ) , patients in the EES arm had a significantly larger minimal lumen diameter ( 2.36 0.6 mm vs. 2.01 0.6 mm , p < 0.001 ; absolute mean difference : 0.35 mm ; 95 % confidence interval [ CI ] : 0.16 to 0.53 ) and a lower percent of diameter stenosis ( 13 ... |
RESULTS | However , late loss ( 0.04 0.5 mm vs. 0.14 0.5 mm , p = 0.14 ) and binary restenosis rate ( 4.7 % vs. 9.5 % , p = 0.22 ) were very low and similar in both groups . |
RESULTS | Clinical follow-up ( median 365 days ) was obtained in all ( 100 % ) patients . |
RESULTS | Occurrences of the combined clinical outcome measure ( cardiac death , myocardial infarction , and target vessel revascularization ; 6 % vs. 8 % ; hazard ratio [ HR ] : 0.76 ; 95 % CI : 0.26 to 2.18 , p = 0.6 ) and the need for target vessel revascularization ( 2 % vs. 6 % ; HR : 0.32 : 95 % CI : 0.07 to 1.59 , p = 0.1... |
CONCLUSIONS | In patients with BMS-ISR , both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences . |
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