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Sample records for quasi-factorial randomised controlled

  1. The ANU WellBeing study: a protocol for a quasi-factorial randomised controlled trial of the effectiveness of an Internet support group and an automated Internet intervention for depression

    Directory of Open Access Journals (Sweden)

    Mackinnon Andrew J

    2010-03-01

    Full Text Available Abstract Background Recent projections suggest that by the year 2030 depression will be the primary cause of disease burden among developed countries. Delivery of accessible consumer-focused evidenced-based services may be an important element in reducing this burden. Many consumers report a preference for self-help modes of delivery. The Internet offers a promising modality for delivering such services and there is now evidence that automated professionally developed self-help psychological interventions can be effective. By contrast, despite their popularity, there is little evidence as to the effectiveness of Internet support groups which provide peer-to-peer mutual support. Methods/Design Members of the community with elevated psychological distress were randomised to receive one of the following: (1 Internet Support Group (ISG intervention, (2 a multi-module automated psychoeducational and skills Internet Training Program (ITP, (3 a combination of the ISG and ITP, or (4 an Internet Attention Control website (IAC comprising health and wellbeing information and question and answer modules. Each intervention was 12 weeks long. Assessments were conducted at baseline, post-intervention, 6 and 12 months to examine depressive symptoms, social support, self-esteem, quality of life, depression literacy, stigma and help-seeking for depression. Participants were recruited through a screening postal survey sent to 70,000 Australians aged 18 to 65 years randomly selected from four rural and four metropolitan regions in Australia. Discussion To our knowledge this study is the first randomised controlled trial of the effectiveness of a depression ISG. Trial registration Current Controlled Trials ISRCTN65657330.

  2. Supported employment: randomised controlled trial*

    Science.gov (United States)

    Howard, Louise M.; Heslin, Margaret; Leese, Morven; McCrone, Paul; Rice, Christopher; Jarrett, Manuela; Spokes, Terry; Huxley, Peter; Thornicroft, Graham

    2010-01-01

    Background There is evidence from North American trials that supported employment using the individual placement and support (IPS) model is effective in helping individuals with severe mental illness gain competitive employment. There have been few trials in other parts of the world. Aims To investigate the effectiveness and cost-effectiveness of IPS in the UK. Method Individuals with severe mental illness in South London were randomised to IPS or local traditional vocational services (treatment as usual) (ISRCTN96677673). Results Two hundred and nineteen participants were randomised, and 90% assessed 1 year later. There were no significant differences between the treatment as usual and intervention groups in obtaining competitive employment (13% in the intervention group and 7% in controls; risk ratio 1.35, 95% CI 0.95–1.93, P = 0.15), nor in secondary outcomes. Conclusions There was no evidence that IPS was of significant benefit in achieving competitive employment for individuals in South London at 1-year follow-up, which may reflect suboptimal implementation. Implementation of IPS can be challenging in the UK context where IPS is not structurally integrated with mental health services, and economic disincentives may lead to lower levels of motivation in individuals with severe mental illness and psychiatric professionals. PMID:20435968

  3. Razors versus clippers. A randomised controlled trial.

    Science.gov (United States)

    Taylor, Tracy; Tanner, Judith

    2005-12-01

    The purpose of this randomised controlled trial was to determine if patients showed a preference for preoperative hair removal with razors or clippers and to identify if one method was associated with more trauma or postoperative infections. The trial took place in a day surgery unit with patients who were having a range of surgical procedures including hernias and varicose veins. This study was sponsored by an award from the NATN/3M Clinical Fellowship.

  4. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  5. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  6. Increasing recruitment to randomised trials: a review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Torgerson David J

    2006-07-01

    Full Text Available Abstract Background Poor recruitment to randomised controlled trials (RCTs is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective. Methods We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors. Results We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive. Conclusion Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.

  7. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    is taken out of the analysis, or to the exaggeration of effect; in a large study, for ... randomisation was 64 years; yet most often hormone replacement therapy (HRT) is ... in labour, and not the aggressive syntocinon augmentation, in the highly ...

  8. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  9. Yoga in schizophrenia : a systematic review of randomised controlled trials

    NARCIS (Netherlands)

    Vancampfort, D.; Vansteelandt, K.; Scheewe, T.; Probst, M.; Knapen, J.; De Herdt, A.; De Hert, M.

    2012-01-01

    Vancampfort D, Vansteelandt K, Scheewe T, Probst M, Knapen J, De Herdt A, De Hert M. Yoga in schizophrenia: a systematic review of randomised controlled trials. Objective: The objective of this systematic review was to assess the effectiveness of yoga as a complementary treatment on general psychopa

  10. Yoga in schizophrenia : a systematic review of randomised controlled trials

    NARCIS (Netherlands)

    Vancampfort, D.; Vansteelandt, K.; Scheewe, T.; Probst, M.; Knapen, J.; De Herdt, A.; De Hert, M.

    2012-01-01

    Vancampfort D, Vansteelandt K, Scheewe T, Probst M, Knapen J, De Herdt A, De Hert M. Yoga in schizophrenia: a systematic review of randomised controlled trials. Objective: The objective of this systematic review was to assess the effectiveness of yoga as a complementary treatment on general psychopa

  11. The effect of orthodontic referral guidelines: A randomised controlled trial

    OpenAIRE

    Conboy, Frances; O'Brien, K.

    2000-01-01

    Objective To develop and evaluate the effectiveness of referral guidelines for the referral of orthodontic patients to consultant and specialist practijioner orthodontists. Design Single centre randomised controlled trial with random allocation of referral guidelines for orthodontic treatment to general dental practitioners. Setting Hospital orthodontic departments and specialist orthodontic practices in Manchester and Stockport. Subjects General dental practitioners and the patients they ref...

  12. Structured risk assessment and violence in acute psychiatric wards: randomised controlled trial

    National Research Council Canada - National Science Library

    Abderhalden, Christoph; Needham, Ian; Dassen, Theo; Halfens, Ruud; Haug, Hans-Joachim; Fischer, Joachim E

    2008-01-01

    .... To assess whether such risk assessments decrease the incidence of violence and coercion. A cluster randomised controlled trial was conducted with 14 acute psychiatric admission wards as the units of randomisation, including a preference arm...

  13. Probiotics in the prevention of eczema: a randomised controlled trial

    OpenAIRE

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Catherine A Thornton; Gravenor, Michael B.; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 a...

  14. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p silicone impressions were preferred by patients. Clinical significance Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  16. Financial incentives for smoking cessation in pregnancy: randomised controlled trial.

    Science.gov (United States)

    Tappin, David; Bauld, Linda; Purves, David; Boyd, Kathleen; Sinclair, Lesley; MacAskill, Susan; McKell, Jennifer; Friel, Brenda; McConnachie, Alex; de Caestecker, Linda; Tannahill, Carol; Radley, Andrew; Coleman, Tim

    2015-01-27

    To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit. Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. 612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking, at least 16 years of age, less than 24 weeks pregnant, and had an exhaled carbon monoxide breath test result of 7 ppm or more. 306 women were randomised to incentives and 306 to control. The control group received routine care, which was the offer of a face to face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services, and four, weekly support phone calls. The intervention group received routine care plus the offer of up to £400 of shopping vouchers: £50 for attending a face to face appointment and setting a quit date; then another £50 if at four weeks' post-quit date exhaled carbon monoxide confirmed quitting; a further £100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks; a final £200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks' gestation. The primary outcome was cotinine verified cessation at 34-38 weeks' gestation through saliva (incentives were documented. Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) Pincentives need to be offered to achieve one extra quitter in late pregnancy) was 7.2 (95% confidence interval 5.1 to 12.2). The mean birth weight was 3140 g (SD 600 g) in the incentives group

  17. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  18. Pneumatic retinopexy versus scleral buckling: a randomised controlled trial.

    Science.gov (United States)

    Mulvihill, A; Fulcher, T; Datta, V; Acheson, R

    1996-01-01

    Pneumatic retinopexy (PR) is a technique for repairing certain retinal detachments which is easier to perform than conventional sceral buckling (SB) surgery but has comparable results. We performed a prospective, randomised, controlled trial to determine for ourselves whether PR is a safe and acceptable procedure. Twenty patients presenting consecutively with retinal detachments which fulfilled the selection criteria were randomised to have their detachments repaired by either PR or SB, ten patients in each group. The suitable patients had a single retinal break or small group of breaks of not greater than one clock hour in size, situated within the superior eight clock hours of retina. Patients with significant proliferative vitreoretinopathy or other fundus disorders were excluded. All patients in the PR group had local anaesthesia while all those in the SB group had general anaesthesia. Successful reattachment of the retina was achieved with one or more procedures in 90 percent of the PR group and in 100 percent of the SB group. We feel that narrowing the selection criteria for PR may further improve the success rate.

  19. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    , nursing research, nursing, research, challenges, barriers, nurse's role, nurse attitude, attitude of health personnel. Findings: The literature on reported challenges and barriers between 1999 and 2009 showed that the most often experienced problems were (i) sufficient patient recruitment, (ii......Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...

  20. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an interm

  1. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

    NARCIS (Netherlands)

    Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

    OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

  2. Statistical issues in randomised controlled trials: a narrative synthesis

    Directory of Open Access Journals (Sweden)

    Bolaji Emmanuel Egbewale

    2015-05-01

    Full Text Available Randomised controlled trials (RCT s are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCT s to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s and the outcome variable is more in tandem with statistical principle(s than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-to-treat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCT s are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

  3. Statistical issues in randomised controlled trials: a narrative synthesis

    Institute of Scientific and Technical Information of China (English)

    Bolaji; Emmanuel; Egbewale

    2015-01-01

    Randomised controlled trials(RCTs) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCTs to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-totreat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCTs are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

  4. Stress debriefing after childbirth: a randomised controlled trial.

    Science.gov (United States)

    Priest, Susan R; Henderson, Jenni; Evans, Sharon F; Hagan, Ronald

    2003-06-02

    To test whether critical incident stress debriefing after childbirth reduces the incidence of postnatal psychological disorders. Randomised single-blind controlled trial stratified for parity and delivery mode. Two large maternity hospitals in Perth. 1745 women who delivered healthy term infants between April 1996 and December 1997 (875 allocated to intervention and 870 to control group). An individual, standardised debriefing session based on the principles of critical incident stress debriefing carried out within 72 hours of delivery. Diagnosis of stress disorders or depression in the 12 months postpartum, using structured psychological interview and criteria of the Diagnostic and statistical manual of mental disorders, 4th edition. Follow-up information was available for 1730 women (99.1%), 482 of whom underwent psychological interview. There were no significant differences between control and intervention groups in scores on Impact of Events or Edinburgh Postnatal Depression Scales at 2, 6 or 12 months postpartum, or in proportions of women who met diagnostic criteria for a stress disorder (intervention, 0.6% v control, 0.8%; P = 0.58) or major or minor depression (intervention, 17.8% v control, 18.2%; relative risk [95% CI], 0.99 [0.87-1.11]) during the postpartum year. Nor were there differences in median time to onset of depression (intervention, 6 [interquartile range, 4-9] weeks v control, 4 [3-8] weeks; P = 0.84), or duration of depression (intervention, 24 [12-46] weeks v control, 22 [10-52] weeks; P = 0.98). There is a high prevalence of depression in women during the first year after childbirth. A session of midwife-led, critical incident stress debriefing was not effective in preventing postnatal psychological disorders, but had no adverse effects.

  5. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease : randomised controlled trial

    NARCIS (Netherlands)

    van Nimwegen, Marlies; Speelman, Arlene D.; Overeem, Sebastiaan; van de Warrenburg, Bart P.; Smulders, Katrijn; Dontje, Manon L.; Borm, George F.; Backx, Frank J. G.; Bloem, Bastiaan R.; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). Parti

  6. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease : randomised controlled trial

    NARCIS (Netherlands)

    van Nimwegen, Marlies; Speelman, Arlene D.; Overeem, Sebastiaan; van de Warrenburg, Bart P.; Smulders, Katrijn; Dontje, Manon L.; Borm, George F.; Backx, Frank J. G.; Bloem, Bastiaan R.; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). Parti

  7. [Effects of a stepwise approach to behavioural problems in dementia: a cluster randomised controlled trial

    NARCIS (Netherlands)

    Pieper, M.J.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    OBJECTIVE: To investigate whether implementation of a stepwise multidisciplinary intervention ('STA OP!' ['STAND UP!']) is effective in reducing behavioural problems and depressive symptoms in nursing home residents with advanced dementia. DESIGN: Cluster randomised controlled trial. METHOD: We

  8. Representation of people with intellectual disabilities in randomised controlled trials on antipsychotic treatment for behavioural problems

    NARCIS (Netherlands)

    Scheifes, A.; Stolker, J.J.; Nijman, H.L.I.; Egberts, A.C.G.; Heerdink, E.R.

    2011-01-01

    Background Behavioural problems are common in people with intellectual disability (ID) and are often treated with antipsychotics. Aim To establish the frequency and characteristics of people with ID included in randomised controlled trials (RCTs) on antipsychotic treatment for behavioural problems

  9. Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial

    OpenAIRE

    Misra, Usha Kant; Kalita, Jayantee; Yadav, Rama Kant

    2007-01-01

    The objective of this study was to compare the efficacy of rizatriptan and ibuprofen in migraine. The study was a randomised placebo-controlled trial in a tertiary care teaching hospital. Migraine patients with

  10. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

  11. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

  12. Impact of industry collaboration on randomised controlled trials in oncology.

    Science.gov (United States)

    Linker, Anne; Yang, Annie; Roper, Nitin; Whitaker, Evans; Korenstein, Deborah

    2017-02-01

    Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88-6·83], p industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. Wound healing with honey - a randomised controlled trial

    African Journals Online (AJOL)

    Gold Mining and Westonaria Gold Mining from September. 1995 to July 1996 ... glycol20%, starch copolymer 2% and water 78%. ... Table I. Wound types randomised by block for treatment with honey or IntraSite Gel (withdrawn from analysis)*.

  14. Should desperate volunteers be included in randomised controlled trials?

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  15. Is voice therapy an effective treatment for dysphonia? A randomised controlled trial

    OpenAIRE

    MacKenzie, K.; Millar, A; Wilson, J. A.; Sellars, C.; Deary, I. J.

    2001-01-01

    OBJECTIVES: To assess the overall efficacy of voice therapy for dysphonia. DESIGN: Single blind randomised controlled trial. SETTING: Outpatient clinic in a teaching hospital. Participants: 204 outpatients aged 17-87 with a primary symptom of persistent hoarseness for at least two months. INTERVENTIONS: After baseline assessments, patients were randomised to six weeks of either voice therapy or no treatment. Assessments were repeated at six weeks on the 145 (71%) patients who continued to thi...

  16. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  17. Acupuncture for dry eye: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kim Ae-Ran

    2009-12-01

    Full Text Available Abstract Background Dry eye is usually managed by conventional medical interventions such as artificial tears, anti-inflammatory drugs and surgical treatment. However, since dry eye is one of the most frequent ophthalmologic disorders, safer and more effective methods for its treatment are necessary, especially for vulnerable patients. Acupuncture has been widely used to treat patients with dry eye. Our aim is to evaluate the effectiveness and safety of acupuncture for this condition. Methods/Design A randomised, patient-assessor blinded, sham (non-acupuncture point, shallow acupuncture controlled study was established. Participants allocated to verum acupuncture and sham acupuncture groups will be treated three times weekly for three weeks for a total of nine sessions per participant. Seventeen points (GV23; bilateral BL2, GB4, TE23, Ex1 (Taiyang, ST1 and GB20; and left SP3, LU9, LU10 and HT8 for men, right for women have been selected for the verum acupuncture; for the sham acupuncture, points have been selected that do not coincide with a classical acupuncture point and that are located close to the verum points, except in the case of the rim of the eye. Ocular surface disease index, tear film breakup time, the Schirmer I test, medication quantification scale and general assessment of improvement will be used as outcome variables for evaluating the effectiveness of acupuncture. Safety will also be assessed at every visit. Primary and secondary outcomes will be assessed four weeks after screening. All statistical analyses will be performed using analysis of covariance. Discussion The results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye. Trial registration ClinicalTrials.gov NCT00969280.

  18. Radiotherapy for Graves' orbitopathy : randomised placebo-controlled study

    NARCIS (Netherlands)

    Mourits, MP; van Kempen-Harteveld, ML; Garcia, MBG; Koppeschaar, HPF; Tick, L; Terwee, CB

    2000-01-01

    Background The best treatment (steroids, irradiation, or both) for moderately severe Graves' orbitopathy, a self-limiting disease is not known. We tested the efficacy of external beam irradiation compared with sham-irradiation. Methods In a double-blind randomised clinical trial, 30 patients with

  19. Radiotherapy for Graves' orbitopathy : randomised placebo-controlled study

    NARCIS (Netherlands)

    Mourits, MP; van Kempen-Harteveld, ML; Garcia, MBG; Koppeschaar, HPF; Tick, L; Terwee, CB

    2000-01-01

    Background The best treatment (steroids, irradiation, or both) for moderately severe Graves' orbitopathy, a self-limiting disease is not known. We tested the efficacy of external beam irradiation compared with sham-irradiation. Methods In a double-blind randomised clinical trial, 30 patients with mo

  20. A prospective, randomised, controlled clinical trial to evaluate the ...

    African Journals Online (AJOL)

    ... reactivity to carbon dioxide and autoregulation.1,2 ... Capnography [end-tidal carbon dioxide (EtCO2)]. ... The patients were randomised into two groups using a random ... 67% N2O in oxygen in group A, and 33% oxygen in air in group B,.

  1. Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review.

    Science.gov (United States)

    Pibouleau, Leslie; Boutron, Isabelle; Reeves, Barnaby C; Nizard, Rémy; Ravaud, Philippe

    2009-11-17

    To compare the reporting of essential applicability data from randomised controlled trials and non-randomised studies evaluating four new orthopaedic surgical procedures. Medline and the Cochrane central register of controlled trials. All articles of comparative studies assessing total hip or knee arthroplasty carried out by a minimally invasive approach or computer assisted navigation system. Items judged to be essential for interpreting the applicability of findings about such procedures were identified by a survey of a sample of orthopaedic surgeons (77 of 512 completed the survey). Reports were evaluated for data describing these "essential" items and the number of centres and surgeons involved in the trials. When data on the number of centres and surgeons were not reported, the corresponding author of the selected trials was contacted. Results 84 articles were identified (38 randomised controlled trials, 46 non-randomised studies). The median percentage (interquartile range) of essential items reported for non-randomised studies compared with randomised controlled trials was 38% (25-63%) versus 44% (38-45%) for items about patients, 71% (43-86%) versus 71% (57-86%) for items considered essential for all interventions, and 38% (25-50%) versus 50% (25-50%) for items about the context of care. More than 80% of both study types were single centre studies, with one or two participating surgeons. The reporting of data related to the applicability of results was poor in published articles of both non-randomised studies and randomised controlled trials and did not differ by study design. The applicability of results from the trials and studies was similar in terms of number of centres and surgeons involved and the reproducibility of the intervention.

  2. Testing the activitystat hypothesis: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Gomersall Sjaan

    2012-10-01

    Full Text Available Abstract Background The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. Methods This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey aged 18–60 years old will be recruited for this study (n=146. Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water and physical activity (accelerometry. Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks, mid- and end-intervention (three and six weeks with three (12 weeks and six month (24 week follow-up. All assessors will be

  3. Does antenatal pelvic floor muscle training affect the outcome of labour? A randomised controlled trial.

    Science.gov (United States)

    Agur, Wael; Steggles, Pippin; Waterfield, Malcolm; Freeman, Robert

    2008-01-01

    It is thought that antenatal pelvic floor muscle training (PFMT) might produce a strong pelvic floor resulting in prolonged labour, whilst some believe it produces well-controlled muscles that facilitate rotation of the foetal head and shortens the duration of labour. This secondary analysis (of a previously published randomised controlled trial) assesses the labour and delivery details of 268 primigravidae who were originally randomised at approximately 20 weeks gestation to supervised PFMT or a control group. Between the two groups, there was no difference in the duration of the second stage of labour or in the need for instrumental delivery. PFMT does not appear to facilitate or obstruct labour.

  4. Probiotics in the prevention of eczema: a randomised controlled trial

    Science.gov (United States)

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Thornton, Catherine A; Gravenor, Michael B; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20; total of 1010 organisms/day) or matching placebo. Main outcome measure Diagnosed eczema at age 2 years. Infants were followed up by questionnaire. Clinical examination and skin prick tests to common allergens were done at 6 months and 2 years. Results The cumulative frequency of diagnosed eczema at 2 years was similar in the probiotic (73/214, 34.1%) and placebo arms (72/222, 32.4%; OR 1.07, 95% CI 0.72 to 1.6). Among the secondary outcomes, the cumulative frequency of skin prick sensitivity at 2 years was reduced in the probiotic (18/171; 10.5%) compared with the placebo arm (32/173; 18.5%; OR 0.52, 95% CI 0.28 to 0.98). The statistically significant differences between the arms were mainly in sensitisation to cow's milk and hen's egg proteins at 6 months. Atopic eczema occurred in 9/171 (5.3%) children in the probiotic arm and 21/173 (12.1%) in the placebo arm (OR 0.40, 95% CI 0.18 to 0.91). Conclusions The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity. However, the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood. Trial registration Number ISRCTN26287422. PMID:24947281

  5. Randomised controlled trial of magnetic-resonance pelvimetry in breech presentation at term

    NARCIS (Netherlands)

    van Loon, AJ; Mantingh, A; Serlier, EK; Kroon, G; Mooyaart, EL; Huisjes, HJ

    1997-01-01

    Background Pelvimetry is widely used in women with breech presentation at term to select those for whom planned vaginal delivery is appropriate. However, its clinical value has never been established, We evaluated pelvimetry in a randomised controlled trial. The main outcome measures were the electi

  6. Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST)

    DEFF Research Database (Denmark)

    F. Rasmussen, Jakob; Siersma, V.; H. Pedersen, J.

    2015-01-01

    on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking. Results: 4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from...

  7. Timing of insertion of levonorgestrel-releasing intrauterine system : a randomised controlled trial

    NARCIS (Netherlands)

    van der Heijden, Pahh; Geomini, Pmaj; Herman, M C; Veersema, S; Bongers, M Y

    OBJECTIVE: The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle. DESIGN: A stratified two-armed non-inferiority randomised controlled trial. SETTING: Large

  8. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full t

  9. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

  10. Melatonin for chronic whiplash syndrome with delayed melatonin onset randomised, placebo-controlled trial

    NARCIS (Netherlands)

    Wieringen, S. van; Jansen, T.; Smits, M.G.; Nagtegaal, J.E.; Coenen, A.M.L.

    2001-01-01

    Objective: To assess the influence of melatonin in patients with chronic whiplash syndrome and delayed melatonin onset. Design: Randomised, double-blind, placebo-controlled, parallel-group trial. One-week baseline was followed by a 4-week treatment period with either melatonin or placebo. In the ba

  11. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-da

  12. Stress in Fathers of Moderately and Late Preterm Infants: A Randomised Controlled Trial

    Science.gov (United States)

    Ravn, Ingrid Helen; Lindemann, Rolf; Smeby, Nina Aarhus; Bunch, Eli Haugen; Sandvik, Leiv; Smith, Lars

    2012-01-01

    The atypical behaviour of preterm infants can elicit stress in fathers and influence their ability to perceive and interpret infants' cues. This study investigated whether fathers of moderately and late preterm infants were more stressed than fathers of term infants. In a randomised controlled trial, we also studied the effect of the Mother-Infant…

  13. Comparison of Bobath based and movement science based treatment for stroke: a randomised controlled trial

    OpenAIRE

    van Vliet, P. M.; Lincoln, N; Foxall, A

    2005-01-01

    Objectives: Bobath based (BB) and movement science based (MSB) physiotherapy interventions are widely used for patients after stroke. There is little evidence to suggest which is most effective. This single-blind randomised controlled trial evaluated the effect of these treatments on movement abilities and functional independence.

  14. Hysteroscopy before in-vitro fertilisation (inSIGHT) : A multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Smit, Janine G.; Kasius, Jenneke C.; Eijkemans, Marinus J C; Koks, Carolien A M; van Golde, Ronald; Nap, Annemiek W.; Scheffer, Gabrielle J.; Manger, Petra A P; Hoek, Annemieke; Schoot, Benedictus C.; van Heusden, Arne M.; Kuchenbecker, Walter K H; Perquin, Denise A M; Fleischer, Kathrin; Kaaijk, Eugenie M.; Sluijmer, Alexander; Friederich, Jaap; Dykgraaf, Ramon H M; van Hooff, Marcel; Louwe, Leonie A.; Kwee, Janet; de Koning, Corry H.; Janssen, Ineke C A H; Mol, Femke; Mol, Ben W J; Broekmans, Frank J M; Torrance, Helen L.

    2016-01-01

    BACKGROUND: Hysteroscopy is often done in infertile women starting in-vitro fertilisation (IVF) to improve their chance of having a baby. However, no data are available from randomised controlled trials to support this practice. We aimed to assess whether routine hysteroscopy before the first IVF tr

  15. Hysteroscopy before in-vitro fertilisation (inSIGHT) : a multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Smit, Janine G.; Kasius, Jenneke C.; Eijkemans, Marinus J. C.; Koks, Carolien A. M.; van Golde, Ronald; Nap, Annemiek W.; Scheffer, Gabrielle J.; Manger, Petra A. P.; Hoek, Annemieke; Schoot, Benedictus C.; van Heusden, Arne M.; Kuchenbecker, Walter K. H.; Perquin, Denise A. M.; Fleischer, Kathrin; Kaaijk, Eugenie M.; Sluijmer, Alexander; Friederich, Jaap; Dykgraaf, Ramon H. M.; van Hooff, Marcel; Louwe, Leonie A.; Kwee, Janet; de Koning, Corry H.; Janssen, Ineke C. A. H.; Mol, Femke; Mol, Ben W. J.; Broekmans, Frank J. M.; Torrance, Helen L.

    2016-01-01

    Background Hysteroscopy is often done in infertile women starting in-vitro fertilisation (IVF) to improve their chance of having a baby. However, no data are available from randomised controlled trials to support this practice. We aimed to assess whether routine hysteroscopy before the first IVF tre

  16. Skills Training to Avoid Inadvertent Plagiarism: Results from a Randomised Control Study

    Science.gov (United States)

    Newton, Fiona J.; Wright, Jill D.; Newton, Joshua D.

    2014-01-01

    Plagiarism continues to be a concern within academic institutions. The current study utilised a randomised control trial of 137 new entry tertiary students to assess the efficacy of a scalable short training session on paraphrasing, patch writing and plagiarism. The results indicate that the training significantly enhanced students' overall…

  17. The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study

    DEFF Research Database (Denmark)

    Jensen, Morten Lind; Lippert, Freddy; Hesselfeldt, Rasmus

    2009-01-01

    and retention of learning. Materials and methods: This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS...... a small but statistically significant impact on the retention of learning, but not on the immediate learning outcome....

  18. Initiation of home mechanical ventilation at home : A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    Introduction: Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is

  19. Initiation of home mechanical ventilation at home: A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A.; Kerstjens, H.A.M.; Prins, S.C.L.; Vermeulen, K.M.; Wijkstra, P.J.

    2014-01-01

    Introduction Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is

  20. Initiation of home mechanical ventilation at home : A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    2014-01-01

    Introduction: Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-in

  1. Delayed cord clamping in South African neonates with expected low birthweight : a randomised controlled trial

    NARCIS (Netherlands)

    Tiemersma, Sybrich; Heistein, Julia; Ruijne, Roos; Lopez, Gustavo; van Lobenstein, Jeroen; van Rheenen, Patrick

    OBJECTIVE: To evaluate safety and haematological effects of delayed cord clamping (DCC) in infants with expected low birthweight born in a resource-poor setting. METHODS: Randomised controlled trial involving pregnant women in early labour ≥18 years with intrapartum symphysal-fundal height ≤32 cm.

  2. Helmet therapy in infants with positional skull deformation: randomised controlled trial

    NARCIS (Netherlands)

    Wijk, R.M. van; Vlimmeren, L.A. van; Groothuis-Oudshoorn, C.G.M.; Ploeg, C.P.B. van der; Ijzerman, M.J.; Boere-Boonekamp, M.M.

    2014-01-01

    Objective To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months.Design Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a pro

  3. The gait and balance of patients with diabetes can be improved: a randomised controlled trial.

    NARCIS (Netherlands)

    Allet, L.; Armand, S.; Bie, R.A. de; Golay, A.; Monnin, D.; Aminian, K.; Staal, J.B.; Bruin, E.D. de

    2010-01-01

    AIMS/HYPOTHESIS: Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. METHODS: This was a randomised controlled trial (n=71) w

  4. Implementing Randomised Control Trials in Open and Distance Learning: A Feasibility Study

    Science.gov (United States)

    Herodotou, Christothea; Heiser, Sarah; Rienties, Bart

    2017-01-01

    Randomised control trials (RCTs) are an evidence-based research approach which has not yet been adopted and widely used in open and distance education to inform educational policy and practice. Despite the challenges entailed in their application, RCTs hold the power to robustly evaluate the effects of educational interventions in distance…

  5. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

    OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and character of adverse drug reactions. To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs

  6. Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial.

    NARCIS (Netherlands)

    R. van Linschoten (Robbart); M. van Middelkoop (Marienke); M.Y. Berger (Marjolein); E.M. Heintjes (Edith); J.A.N. Verhaar (Jan); S.P. Willemsen (Sten); B.W. Koes (Bart); S.M. Bierma-Zeinstra (Sita)

    2009-01-01

    textabstractOBJECTIVE: To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. DESIGN: Open label randomised controlled trial. SETTING: General practice and sport physician practic

  7. Helmet therapy in infants with positional skull deformation: randomised controlled trial

    NARCIS (Netherlands)

    Wijk, R.M. van; Vlimmeren, L.A. van; Groothuis-Oudshoorn, C.G.; Ploeg, C.P. van der; IJzerman, M.J.; Boere-Boonekamp, M.M.

    2014-01-01

    OBJECTIVE: To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months. DESIGN: Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a

  8. Helmet therapy in infants with positional skull deformation: randomised controlled trial

    NARCIS (Netherlands)

    Wijk, van Renske M.; Vlimmeren, van Leo A.; Groothuis-Oudshoorn, Catharina G.M.; Ploeg, van der Catharina P.B.; IJzerman, Maarten J.; Boere-Boonekamp, Magda M.

    2014-01-01

    Objective To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months. Design Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a p

  9. Randomised controlled trial of topical kanuka honey for the treatment of rosacea

    NARCIS (Netherlands)

    Braithwaite, Irene; Hunt, Anna; Riley, Judith; Fingleton, James; Kocks, Janwillem; Corin, Andrew; Helm, Colin; Sheahan, Davitt; Tofield, Christopher; Montgomery, Barney; Holliday, Mark; Weatherall, Mark; Beasley, Richard

    2015-01-01

    OBJECTIVE: To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea. DESIGN: Randomised controlled trial with blinded assessment of primary outcome variable. SETTING: Outpatient primary healthcare population from 5 New Zealand sites.

  10. Skills Training to Avoid Inadvertent Plagiarism: Results from a Randomised Control Study

    Science.gov (United States)

    Newton, Fiona J.; Wright, Jill D.; Newton, Joshua D.

    2014-01-01

    Plagiarism continues to be a concern within academic institutions. The current study utilised a randomised control trial of 137 new entry tertiary students to assess the efficacy of a scalable short training session on paraphrasing, patch writing and plagiarism. The results indicate that the training significantly enhanced students' overall…

  11. A randomised controlled trial of Silirum vaccine for control of paratuberculosis in farmed red deer.

    Science.gov (United States)

    Stringer, L A; Wilson, P R; Heuer, C; Mackintosh, C G

    2013-12-07

    A randomised controlled trial to assess the efficacy of Silirum vaccine in control of paratuberculosis in young farmed deer was carried out in 2008-2009 in six New Zealand herds with a history of clinical disease. Vaccination with Silirum was carried out in four-month-old deer, and vaccinates (n=1671) and controls (n=1664) were weighed at vaccination and at 8 and 12 months old, when faecal samples were collected from 125 vaccinates and 123 controls on five farms. Deer were slaughtered between 11 and 20 months of age, and the incidence of gross visceral lymph node (VLN) pathology typical of paratuberculosis in deer, that is, enlarged and/or granulomatous VLN, was recorded. Clinical disease was confirmed in 18 controls and seven vaccinates, representing a vaccine efficacy estimate of 60 per cent (95% CI 3 per cent to 83 per cent, P=0.04). Forty-seven percent (95% CI 38 per cent to 56 per cent) of faecal samples from vaccinates and 55 per cent (95% CI 46 per cent to 64 per cent) from controls were Mycobacterium avium subspecies paratuberculosis positive (P=0.5). Average daily liveweight gain did not differ between the cohorts. At slaughter, 1.4 per cent of vaccinates and 4.5 per cent of controls had VLN pathology, RR=0.32 (95% CI 0.19 to 0.54, Pvaccination with Silirum may be useful as an aid to control losses associated with clinical paratuberculosis in young deer.

  12. Increasing participation of cancer patients in randomised controlled trials: a systematic review

    Directory of Open Access Journals (Sweden)

    Stirk Lisa

    2006-05-01

    Full Text Available Abstract Background There are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs of cancer treatments. Methods A systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted. Results Eight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work. Conclusion There is not a strong evidence-base for interventions that

  13. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study.

    Science.gov (United States)

    Lewin, Simon; Glenton, Claire; Oxman, Andrew D

    2009-09-10

    To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions. Review of randomised controlled trials of interventions to change professional practice or the organisation of care. Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group. Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done. 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable. Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.

  14. Conductive Education as a Method of Stroke Rehabilitation: A Single Blinded Randomised Controlled Feasibility Study

    Directory of Open Access Journals (Sweden)

    Judith Bek

    2016-01-01

    Full Text Available Background. Conductive Education for stroke survivors has shown promise but randomised evidence is unavailable. This study assessed the feasibility of a definitive randomised controlled trial to evaluate efficacy. Methods. Adult stroke survivors were recruited through local community notices. Those completing the baseline assessment were randomised using an online program and group allocation was independent. Intervention group participants received 10 weekly 1.5-hour sessions of Conductive Education at the National Institute of Conductive Education in Birmingham, UK. The control group participants attended two group meetings. The study evaluated the feasibility of recruitment procedures, delivery of the intervention, retention of participants, and appropriateness of outcome measures and data collection methods. Independent assessments included the Barthel Index, the Stroke Impact Scale, the Timed Up and Go test, and the Hospital Anxiety and Depression Scale. Results. Eighty-two patients were enrolled; 77 completed the baseline assessment (46 men, mean age 62.1 yrs. and were randomised. 70 commenced the intervention (n=37 or an equivalent waiting period (n=33. 32/37 completed the 10-week training and 32/33 the waiting period. There were no missing items from completed questionnaires and no adverse events. Discussion. Recruitment, intervention, and assessment methods worked well. Transport issues for intervention and assessment appointments require review. Conclusion. A definitive trial is feasible. This trial is registered with ISRCTN84064492.

  15. De Quervain's Tenosynovitis and Phonophoresis: A Randomised Controlled Trial in Pregnant Females

    OpenAIRE

    Tabinda Hasan; Mahmood Fauzi

    2015-01-01

    Background: De Quervain's tenosynovitis is a common cause of wrist pain in pregnant and postpartum females. This study provides objective evidence regarding the therapeutic efficacy of phonophoresis in treating de Quervain's disease during pregnancy. Methods: In a single blind, randomised, controlled trial (n = 50), ketoprofen phonophoresis was given to the intervention group and conventional ultrasound (US) was given to controls, coupled with thumb splint immobilisation, and supervised st...

  16. Dietary outcomes of a community based intervention for mothers of young children: a randomised controlled trial

    OpenAIRE

    Jancey, Jonine Maree; Dos Remedios Monteiro, Sarojini Maria; Dhaliwal, Satvinder S.; Howat, Peter A.; Burns, Sharyn; Andrew P. Hills; Anderson, Annie S.

    2014-01-01

    Background Unhealthy dietary behaviours are one of the key risk factors for many lifestyle-related diseases worldwide. This randomised controlled trial aimed to increase the level of fruit, vegetable and fibre intake and decrease the fat and sugar consumption of mothers with young children (0–5 years) via the playgroup setting. Methods Playgroups located in 60 neighbourhoods in Perth, Western Australia were randomly assigned to an intervention (n = 249) or control group (n = 272). Those in th...

  17. Effects of improved home heating on asthma in community dwelling children: randomised controlled trial

    OpenAIRE

    Howden-Chapman, Philippa; Pierse, Nevil; Nicholls, Sarah; Gillespie-Bennett, Julie; Viggers, Helen; Cunningham, Malcolm; Phipps, Robyn; Boulic, Mikael; Fjällström, Pär; Free, Sarah; Chapman, Ralph; Lloyd, Bob; Wickens, Kristin; Shields, David; Baker, Michael

    2008-01-01

    Objective To assess whether non-polluting, more effective home heating (heat pump, wood pellet burner, flued gas) has a positive effect on the health of children with asthma. Design Randomised controlled trial. Setting Households in five communities in New Zealand. Participants 409 children aged 6-12 years with doctor diagnosed asthma. Interventions Installation of a non-polluting, more effective home heater before winter. The control group received a replacement heater at the end of the tria...

  18. Self Management Activation Randomised Trial for Prostatitis (SMART-P: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rochester Mark

    2011-09-01

    Full Text Available Abstract Background Chronic prostatitis otherwise known as chronic pelvic pain syndrome is a common urological diagnosis that causes many men significant morbidity and has a detrimental effect on their quality of life. Standard treatment with antibiotics and simple analgesia are often ineffective and many patients are managed by the chronic pain services. Cognitive behavioural therapy has been shown to be helpful in the management of many chronic diseases and has recently been proposed as an effective treatment for chronic prostatitis. Furthermore, a self management programme administered to groups of men with lower urinary tract symptoms has been shown to be more effective than standard treatments including surgery. Therefore, we have developed a cognitive behavioural therapy programme specifically for men with chronic prostatitis. This novel treatment approach will be compared to conventional therapy in the pain clinic such as atypical analgesia and local anaesthetic injections in the context of a randomised controlled trial. Methods/Design Men will be recruited from general urology outpatient clinics following the exclusion of other diagnoses that could be responsible for their symptoms. Men will be randomised to attend either a self management healthcare and education programme or to pain clinic referral alone. The self management programme will be administered by a clinical psychologist to small groups of men over six consecutive weekly sessions each lasting two hours. Patients will be taught techniques of problem-solving and goal-setting and will learn coping mechanisms and how to modify catastrophic cognition. The primary outcome will be change from baseline in the National Institute of Health Chronic Prostatitis Symptom Index, a validated instrument for the assessment of men with chronic prostatitis. Secondary outcomes include generic quality of life scores and analgesic and drug usage. Outcomes will be assessed at 2, 6 and 12 months

  19. Self Management Activation Randomised Trial for Prostatitis (SMART-P): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Rochester, Mark; Armitage, James; Sanders, Mark; Christmas, Paula

    2011-09-26

    Chronic prostatitis otherwise known as chronic pelvic pain syndrome is a common urological diagnosis that causes many men significant morbidity and has a detrimental effect on their quality of life. Standard treatment with antibiotics and simple analgesia are often ineffective and many patients are managed by the chronic pain services.Cognitive behavioural therapy has been shown to be helpful in the management of many chronic diseases and has recently been proposed as an effective treatment for chronic prostatitis. Furthermore, a self management programme administered to groups of men with lower urinary tract symptoms has been shown to be more effective than standard treatments including surgery.Therefore, we have developed a cognitive behavioural therapy programme specifically for men with chronic prostatitis. This novel treatment approach will be compared to conventional therapy in the pain clinic such as atypical analgesia and local anaesthetic injections in the context of a randomised controlled trial. Men will be recruited from general urology outpatient clinics following the exclusion of other diagnoses that could be responsible for their symptoms. Men will be randomised to attend either a self management healthcare and education programme or to pain clinic referral alone. The self management programme will be administered by a clinical psychologist to small groups of men over six consecutive weekly sessions each lasting two hours. Patients will be taught techniques of problem-solving and goal-setting and will learn coping mechanisms and how to modify catastrophic cognition.The primary outcome will be change from baseline in the National Institute of Health Chronic Prostatitis Symptom Index, a validated instrument for the assessment of men with chronic prostatitis. Secondary outcomes include generic quality of life scores and analgesic and drug usage. Outcomes will be assessed at 2, 6 and 12 months. If this group administered self management programme is

  20. Chinese Obstetrics & Gynecology journal club: a randomised controlled trial.

    Science.gov (United States)

    Tsui, Ilene K; Dodson, William C; Kunselman, Allen R; Kuang, Hongying; Han, Feng-Juan; Legro, Richard S; Wu, Xiao-Ke

    2016-01-28

    To assess whether a journal club model could improve comprehension and written and spoken medical English in a population of Chinese medical professionals. The study population consisted of 52 medical professionals who were residents or postgraduate master or PhD students in the Department of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine, China. After a three-part baseline examination to assess medical English comprehension, participants were randomised to either (1) an intensive journal club treatment arm or (2) a self-study group. At the conclusion of the 8-week intervention participants (n=52) were re-tested with new questions. The primary outcome was the change in score on a multiple choice examination. Secondary outcomes included change in scores on written and oral examinations which were modelled on the Test of English as a Foreign Language (TOEFL). Both groups had improved scores on the multiple choice examination without a statistically significant difference between them (90% power). However, there was a statistically significant difference between the groups in mean improvement in scores for both written (95% CI 1.1 to 5.0; p=0.003) and spoken English (95% CI 0.06 to 3.7; p=0.04) favouring the journal club intervention. Interacting with colleagues and an English-speaking facilitator in a journal club improved both written and spoken medical English in Chinese medical professionals. Journal clubs may be suitable for use as a self-sustainable teaching model to improve fluency in medical English in foreign medical professionals. NCT01844609. 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/

  1. Timing of birth for women with a twin pregnancy at term: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Haslam Ross R

    2010-10-01

    is a protocol for a randomised trial, the findings of which will contribute information about the optimal time of birth for women with an uncomplicated multiple pregnancy at and beyond 37 weeks gestation. Clinical Trial Registration Current Controlled Trials ISRCTN15761056

  2. Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial

    NARCIS (Netherlands)

    S. Koning (Sander); L.W.A. van Suijlekom-Smit (Lisette); J.L. Nouwen (Jan); C.M. Verduin (Cees); R.M.D. Bernsen (Roos); A.P. Oranje (Arnold); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2002-01-01

    textabstractOBJECTIVE: To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo. DESIGN: Randomised placebo controlled trial. SETTING: General practices in Greater Rotterdam. PARTICIPANTS:

  3. Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial

    NARCIS (Netherlands)

    S. Koning (Sander); L.W.A. van Suijlekom-Smit (Lisette); J.L. Nouwen (Jan); C.M. Verduin (Cees); R.M.D. Bernsen (Roos); A.P. Oranje (Arnold); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2002-01-01

    textabstractOBJECTIVE: To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo. DESIGN: Randomised placebo controlled trial. SETTING: General practices in Greater Rotterdam. PARTICIPANTS:

  4. [Probiotic prophylaxis in patients with predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Besselink, M.G.; Santvoort, H.C. van; Buskens, E.; Boermeester, M.A.; Goor, H. van; Timmerman, H.M.; Nieuwenhuijs, V.B.; Bollen, T.L.; Ramshorst, B. van; Witteman, B.J.M.; Rosman, C.; Ploeg, R.J.; Brink, M.; Schaapherder, A.F.; Dejong, C.H.; Wahab, P.J.; Laarhoven, C.J.H.M. van; Harst, E. van der; Eijck, C.H. van; Cuesta, M.A.; Akkermans, L.M.; Gooszen, H.G.

    2008-01-01

    OBJECTIVE: To evaluate whether enteral prophylaxis with probiotics in patients with predicted severe acute pancreatitis prevents infectious complications. DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial. METHOD: A total of 296 patients with predicted severe acute pancreatitis

  5. Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial

    National Research Council Canada - National Science Library

    Garg, Amit X; Vincent, Jessica; Cuerden, Meaghan; Parikh, Chirag; Devereaux, P J; Teoh, Kevin; Yusuf, Salim; Hildebrand, Ainslie; Lamy, Andre; Zuo, Yunxia; Sessler, Daniel I; Shah, Pallav; Abbasi, Seyed Hesameddin; Quantz, Mackenzie; Yared, Jean-Pierre; Noiseux, Nicolas; Tagarakis, Georgios; Rochon, Antoine; Pogue, Janice; Walsh, Michael; Chan, Matthew T V; Lamontagne, Francois; Salehiomran, Abbas; Whitlock, Richard

    2014-01-01

    Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump...

  6. Changing cluster composition in cluster randomised controlled trials: design and analysis considerations.

    Science.gov (United States)

    Corrigan, Neil; Bankart, Michael J G; Gray, Laura J; Smith, Karen L

    2014-05-24

    There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations include avoidance of cluster merges where

  7. Diamorphine for pain relief in labour : a randomised controlled trial comparing intramuscular injection and patient-controlled analgesia.

    Science.gov (United States)

    McInnes, Rhona J; Hillan, Edith; Clark, Diana; Gilmour, Harper

    2004-10-01

    To compare the efficacy of diamorphine administered by a patient-controlled pump (patient-controlled analgesia) with intramuscular administration for pain relief in labour. Randomised controlled trial. The South Glasgow University Hospitals NHS Trust. Primigravidae and multigravidae in labour at term (37-42 weeks). Women were randomised in labour to the study (patient-controlled analgesia) or control group (intramuscular). Randomisation was achieved through a random permuted block design stratified by parity. Study group women were given a loading dose of 1.2 mg diamorphine intravenously and then attached to the pump. Control group women received intramuscular diamorphine as per hospital protocol. Participants were also given 3 mg of buccal Stemetil. Data were collected throughout labour and at six postnatal weeks. Analgesia requirements during labour and women's satisfaction with the method of pain relief. Women in the study group (patient-controlled analgesia) used significantly less diamorphine than women in the control group (intramuscular) but were significantly more likely to state that they were very dissatisfied with their use of diamorphine and were significantly more likely to opt out of the trial before the birth of the baby. The majority of women in both groups used other analgesia concurrent with diamorphine such as Entonox, aromatherapy or TENS. Patient-controlled analgesia administration of diamorphine for the relief of pain in labour offers no significant advantages over intramuscular administration. The results also suggest that diamorphine is a poor analgesic for labour pain irrespective of the mode of administration.

  8. A randomised, controlled clinical study on total hip arthroplasty using 4 different bearings

    DEFF Research Database (Denmark)

    Borgwardt, Arne; Zerahn, Bo; Fabricius, Sandra D

    2017-01-01

    PURPOSE: To compare 4 different bearings in total hip arthroplasty (THA) in a randomised controlled clinical study on clinical performance. METHODS: 393 patients with osteoarthritis of the hip or avascular necrosis were included and allocated to 1 of the head-and-cup couples zirconia-on-polyethyl......PURPOSE: To compare 4 different bearings in total hip arthroplasty (THA) in a randomised controlled clinical study on clinical performance. METHODS: 393 patients with osteoarthritis of the hip or avascular necrosis were included and allocated to 1 of the head-and-cup couples zirconia...... cumulated prosthesis survival percentages and 95% confidence interval after 10 years were: group A 84.6 (75.8-93.4); group B 95.0 (89.5-100); group C 93.2 (86.7-99.7); group D 66.1 (54.5-77.7). The patients' physical function was significantly improved and remained equally good in all 4 groups, however...

  9. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol

    OpenAIRE

    Cox, Helen; Tilbrook, Helen; Aplin, John; Chuang, Ling-Hsiang; Hewitt, Catherine; Jayakody, Shalmini; Semlyen, Anna; Soares, Marta O; Torgerson, David; Trewhela, Alison; Watt, Ian; Worthy, Gill

    2010-01-01

    A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is...

  10. A low cost virtual reality system for home based rehabilitation of the arm following stroke: A randomised controlled feasibility trial

    OpenAIRE

    Standen, P.; Threapleton, K; Richardson, A; Connell, L; Brown, D.; Battersby, S; Platts, F; Burton, A

    2016-01-01

    Objective: To assess the feasibility of conducting a randomised controlled trial of a home-based virtual reality system for rehabilitation of the arm following stroke. Design: Two group feasibility randomised controlled trial of intervention versus usual care. Setting: Patients’ homes. Participants: Patients aged 18 or over, with residual arm dysfunction following stroke and, no longer receiving any other intensive rehabilitation. Interventions: Eight weeks’ use of a low cost home-based virtu...

  11. The haemodynamic effects of the perioperative terlipressin infusion in living donor liver transplantation: A randomised controlled study

    OpenAIRE

    Nagwa Ibrahim; Ashraf Hasanin; Sabry Abd Allah; Eman Sayed; Mohamed Afifi; Khaled Yassen; Wesam Saber; Magdy Khalil

    2015-01-01

    Background and Aims: Liver disease is usually accompanied with a decline in systemic vascular resistance (SVR). We decided to assess effects of the peri-operative terlipressin infusion on liver donor liver transplantation recipients with respect to haemodynamics and renal parameters. Methods: After Ethical Committee approval for this prospective randomised controlled study, 50 recipients were enrolled and allotted to control (n = 25) or terlipressin group (n = 25) with simple randomisation me...

  12. Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

    OpenAIRE

    Sierevelt Inger N; Krips Rover; Struijs Peter AA; Poolman Rudolf W; Lutz Kristina H; Bhandari Mohit

    2006-01-01

    Abstract Background The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals. Methods Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instr...

  13. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    Nichol, Alistair

    2015-02-08

    Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.

  14. Double blind randomised controlled trial of effect of metoprolol on myocardial ischaemia during endoscopic cholangiopancreatography.

    OpenAIRE

    Rosenberg, J.; Overgaard, H.; Andersen, M.; Rasmussen, V; Schulze, S.

    1996-01-01

    OBJECTIVE--To evaluate the effect of metoprolol, a beta adrenergic blocking drug, on the occurrence of myocardial ischaemia during endoscopic cholangiopancreatography. DESIGN--Double blind, randomised, controlled trial. SETTING--University Hospital. SUBJECTS--38 (two groups of 19) patients scheduled for endoscopic cholangiopancreatography. INTERVENTIONS--Metoprolol 100 mg or placebo as premedication two hours before endoscopy. MAIN OUTCOME MEASURES--Heart rate, arterial oxygen saturation by c...

  15. Surgery versus prolonged conservative treatment for sciatica: 5-year results of a randomised controlled trial

    OpenAIRE

    Lequin, Michiel B.; Verbaan, Dagmar; Jacobs, Wilco C. H.; Brand, Ronald; Gerrit J. Bouma; Vandertop, William P.; Peul, Wilco C; ,

    2013-01-01

    Objective This study describes the 5 years’ results of the Sciatica trial focused on pain, disability, (un)satisfactory recovery and predictors for unsatisfactory recovery. Design A randomised controlled trial. Setting Nine Dutch hospitals. Participants Five years’ follow-up data from 231 of 283 patients (82%) were collected. Intervention Early surgery or an intended 6 months of conservative treatment. Main outcome measures Scores from Roland disability questionnaire, visual analogue scale (V...

  16. Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study

    OpenAIRE

    Gill, Christopher J.; Phiri-Mazala, Grace; Guerina, Nicholas G.; Kasimba, Joshua; Mulenga, Charity; MacLeod, William B; Waitolo, Nelson; Knapp, Anna B; Mirochnick, Mark; Mazimba, Arthur; Matthew P Fox; Sabin, Lora; Seidenberg, Philip; SIMON, Jonathon L.; Hamer, Davidson H

    2011-01-01

    Objective To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a resource poor country with limited access to healthcare. Design Prospective, cluster randomised and controlled effectiveness study. Setting Lufwanyama, an agrarian, poorly developed district located in the Copperbelt province, Zambia. All births carried out by study birth attendants occurred at mothers’ homes, in rural village s...

  17. The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

    OpenAIRE

    Forster Anne; Young John; Barber Sally; Clegg Andrew; Iliffe Steve

    2011-01-01

    Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to a...

  18. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers.

    Science.gov (United States)

    O'Cathain, Alicia; Hoddinott, Pat; Lewin, Simon; Thomas, Kate J; Young, Bridget; Adamson, Joy; Jansen, Yvonne Jfm; Mills, Nicola; Moore, Graham; Donovan, Jenny L

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

  19. Calculating the probability of random sampling for continuous variables in submitted or published randomised controlled trials.

    Science.gov (United States)

    Carlisle, J B; Dexter, F; Pandit, J J; Shafer, S L; Yentis, S M

    2015-07-01

    In a previous paper, one of the authors (JBC) used a chi-squared method to analyse the means (SD) of baseline variables, such as height or weight, from randomised controlled trials by Fujii et al., concluding that the probabilities that the reported distributions arose by chance were infinitesimally small. Subsequent testing of that chi-squared method, using simulation, suggested that the method was incorrect. This paper corrects the chi-squared method and tests its performance and the performance of Monte Carlo simulations and ANOVA to analyse the probability of random sampling. The corrected chi-squared method and ANOVA method became inaccurate when applied to means that were reported imprecisely. Monte Carlo simulations confirmed that baseline data from 158 randomised controlled trials by Fujii et al. were different to those from 329 trials published by other authors and that the distribution of Fujii et al.'s data were different to the expected distribution, both p non-random (i.e. unreliable) data in randomised controlled trials submitted to journals. © 2015 The Association of Anaesthetists of Great Britain and Ireland.

  20. REFINE (Reducing Falls in In-patient Elderly - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sach Tracey

    2009-09-01

    Full Text Available Abstract Background Falls in hospitals are common, resulting in injury and anxiety to patients, and large costs to NHS organisations. More than half of all in-patient falls in elderly people in acute care settings occur at the bedside, during transfers or whilst getting up to go to the toilet. In the majority of cases these falls are unwitnessed. There is insufficient evidence underpinning the effectiveness of interventions to guide clinical staff regarding the reduction of falls in the elderly inpatient. New patient monitoring technologies have the potential to offer advances in falls prevention. Bedside sensor equipment can alert staff, not in the immediate vicinity, to a potential problem and avert a fall. However no studies utilizing this assistive technology have demonstrated a significant reduction in falls rates in a randomised controlled trial setting. Methods/Design The research design is an individual patient randomised controlled trial of bedside chair and bed pressure sensors, incorporating a radio-paging alerting mode to alert staff to patients rising from their bed or chair, across five acute elderly care wards in Nottingham University Hospitals NHS Trust. Participants will be randomised to bedside chair and bed sensors or to usual care (without the use of sensors. The primary outcome is the number of bedside in-patient falls. Discussion The REFINE study is the first randomised controlled trial of bedside pressure sensors in elderly inpatients in an acute NHS Trust. We will assess whether falls can be successfully and cost effectively reduced using this technology, and report on its acceptability to both patients and staff. Trial Registration ISRCTN trial number: ISRCTN44972300.

  1. Homoeopathy for delayed onset muscle soreness: a randomised double blind placebo controlled trial.

    Science.gov (United States)

    Vickers, A J; Fisher, P; Smith, C; Wyllie, S E; Lewith, G T

    1997-01-01

    OBJECTIVE: To pilot a model for determining whether a homoeopathic medicine is superior to placebo for delayed onset muscle soreness (DOMS). DESIGN: Randomised double blind placebo controlled trial. SETTING: Physiotherapy department of a homoeopathic hospital. SUBJECTS: Sixty eight healthy volunteers (average age 30; 41% men) undertook a 10 minute period of bench stepping carrying a small weight and were randomised to a homoeopathic medicine or placebo. OUTCOME MEASURES: Mean muscle soreness in the five day period after the exercise test, symptom free days, maximum soreness score, days to no soreness, days on medication. RESULTS: The difference between group means was 0.17 in favour of placebo with 95% confidence intervals +/- 0.50. Similar results were found for other outcome measures. CONCLUSION: The study did not find benefit of the homoeopathic remedy in DOMS. Bench stepping may not be an appropriate model to evaluate the effects of a treatment on DOMS because of wide variation between subject soreness scores. PMID:9429007

  2. Evidence for non-random sampling in randomised, controlled trials by Yuhji Saitoh.

    Science.gov (United States)

    Carlisle, J B; Loadsman, J A

    2017-01-01

    A large number of randomised trials authored by Yoshitaka Fujii have been retracted, in part as a consequence of a previous analysis finding a very low probability of random sampling. Dr Yuhji Saitoh co-authored 34 of those trials and he was corresponding author for eight of them. We found a number of additional randomised, controlled trials that included baseline data, with Saitoh as corresponding author, that Fujii did not co-author. We used Monte Carlo simulations to analyse the baseline data from 32 relevant trials in total as well as an outcome (muscle twitch recovery ratios) reported in several. We also compared a series of muscle twitch recovery graphs appearing in a number of Saitoh's publications. The baseline data in 14/32 randomised, controlled trials had p sampling. Combining the continuous and categorical probabilities of the 32 included trials, we found a very low likelihood of random sampling: p = 1.27 × 10(-8) (1 in 100,000,000). The high probability of non-random sampling and the repetition of lines in multiple graphs suggest that further scrutiny of Saitoh's work is warranted. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

  3. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial

    DEFF Research Database (Denmark)

    2009-01-01

    OBJECTIVE: To assess the effect of virtual reality training on an actual laparoscopic operation. DESIGN: Prospective randomised controlled and blinded trial. SETTING: Seven gynaecological departments in the Zeeland region of Denmark. PARTICIPANTS: 24 first and second year registrars specialising...... in gynaecology and obstetrics. INTERVENTIONS: Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls). MAIN OUTCOME MEASURE: The main outcome measure was technical performance assessed by two independent observers blinded to trainee......-14 minutes) and in the control group was 24 (20-29) minutes (Pvirtual reality simulator training. The performance level of novices...

  4. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    Directory of Open Access Journals (Sweden)

    Clancy Richard

    2011-07-01

    Full Text Available Abstract Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic. Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT; referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide, will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration

  5. Inositol for the prevention of neural tube defects: a pilot randomised controlled trial.

    Science.gov (United States)

    Greene, Nicholas D E; Leung, Kit-Yi; Gay, Victoria; Burren, Katie; Mills, Kevin; Chitty, Lyn S; Copp, Andrew J

    2016-03-28

    Although peri-conceptional folic acid (FA) supplementation can prevent a proportion of neural tube defects (NTD), there is increasing evidence that many NTD are FA non-responsive. The vitamin-like molecule inositol may offer a novel approach to preventing FA-non-responsive NTD. Inositol prevented NTD in a genetic mouse model, and was well tolerated by women in a small study of NTD recurrence. In the present study, we report the Prevention of Neural Tube Defects by Inositol (PONTI) pilot study designed to gain further experience of inositol usage in human pregnancy as a preliminary trial to a future large-scale controlled trial to evaluate efficacy of inositol in NTD prevention. Study subjects were UK women with a previous NTD pregnancy who planned to become pregnant again. Of 117 women who made contact, ninety-nine proved eligible and forty-seven agreed to be randomised (double-blind) to peri-conceptional supplementation with inositol plus FA or placebo plus FA. In total, thirty-three randomised pregnancies produced one NTD recurrence in the placebo plus FA group (n 19) and no recurrences in the inositol plus FA group (n 14). Of fifty-two women who declined randomisation, the peri-conceptional supplementation regimen and outcomes of twenty-two further pregnancies were documented. Two NTD recurred, both in women who took only FA in their next pregnancy. No adverse pregnancy events were associated with inositol supplementation. The findings of the PONTI pilot study encourage a large-scale controlled trial of inositol for NTD prevention, but indicate the need for a careful study design in view of the unwillingness of many high-risk women to be randomised.

  6. Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial

    OpenAIRE

    Ly, Kien Hoa; Trüschel, Anna; Jarl, Linnea; Magnusson, Susanna; Windahl, Tove; Johansson, Robert; Carlbring, Per; Andersson, Gerhard

    2014-01-01

    OBJECTIVES: Evaluating and comparing the effectiveness of two smartphone-delivered treatments: one based on behavioural activation (BA) and other on mindfulness. DESIGN: Parallel randomised controlled, open, trial. Participants were allocated using an online randomisation tool, handled by an independent person who was separate from the staff conducting the study. SETTING: General community, with recruitment nationally through mass media and advertisements. PARTICIPANTS: 40 participants diagno...

  7. Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Dijkgraaf Marcel G

    2010-03-01

    Full Text Available Abstract Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303

  8. Dry needling and exercise for chronic whiplash - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Souvlis Tina

    2009-12-01

    Full Text Available Abstract Background Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash. Method/Design A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1 dry-needling, advice and exercise or 2 sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted. Discussion This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash. Trial registration ACTRN12609000470291

  9. Systematic review of randomised controlled trials:Probiotics for functional constipation

    Institute of Scientific and Technical Information of China (English)

    Anna; Chmielewska; Hania; Szajewska

    2010-01-01

    AIM:To systematically evaluate and update evidence on the efficacy and safety of probiotic supplementation for the treatment of constipation. METHODS:The MEDLINE,EMBASE,CINAHL,and Cochrane Library databases were searched in May 2009 for randomised controlled trials(RCTs)performed in paediatric or adult populations related to the study aim. RESULTS:We included five RCTs with a total of 377 subjects(194 in the experimental group and 183 in the control group).The participants were adults (three RCTs,n=266)and ...

  10. Randomised controlled trials of veterinary homeopathy: characterising the peer-reviewed research literature for systematic review.

    Science.gov (United States)

    Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen

    2012-10-01

    Systematic review of the research evidence in veterinary homeopathy has never previously been carried out. This paper presents the search methods, together with categorised lists of retrieved records, that enable us to identify the literature that is acceptable for future systematic review of randomised controlled trials (RCTs) in veterinary homeopathy. All randomised and controlled trials of homeopathic intervention (prophylaxis and/or treatment of disease, in any species except man) were appraised according to pre-specified criteria. The following databases were systematically searched from their inception up to and including March 2011: AMED; Carstens-Stiftung Homeopathic Veterinary Clinical Research (HomVetCR) database; CINAHL; Cochrane Central Register of Controlled Trials; Embase; Hom-Inform; LILACS; PubMed; Science Citation Index; Scopus. One hundred and fifty records were retrieved; 38 satisfied the acceptance criteria (substantive report of a clinical treatment or prophylaxis trial in veterinary homeopathic medicine randomised and controlled and published in a peer-reviewed journal), and were thus eligible for future planned systematic review. Approximately half of the rejected records were theses. Seven species and 27 different species-specific medical conditions were represented in the 38 papers. Similar numbers of papers reported trials of treatment and prophylaxis (n=21 and n=17 respectively) and were controlled against placebo or other than placebo (n=18, n=20 respectively). Most research focused on non-individualised homeopathy (n=35 papers) compared with individualised homeopathy (n=3). The results provide a complete and clarified view of the RCT literature in veterinary homeopathy. We will systematically review the 38 substantive peer-reviewed journal articles under the main headings: treatment trials; prophylaxis trials. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  11. The Women's international study of long-duration oestrogen after menopause (WISDOM: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meade Tom W

    2007-02-01

    Full Text Available Abstract Background At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Design Randomised, placebo, controlled, trial. Methods The trial was set in general practices in the UK (384, Australia (94, and New Zealand (24. In these practices 284175 women aged 50–69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 – 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. Results

  12. Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.

    Science.gov (United States)

    Hopewell, Sally; Boutron, Isabelle; Altman, Douglas G; Barbour, Ginny; Moher, David; Montori, Victor; Schriger, David; Cook, Jonathan; Gerry, Stephen; Omar, Omar; Dutton, Peter; Roberts, Corran; Frangou, Eleni; Clifton, Lei; Chiocchia, Virginia; Rombach, Ines; Wartolowska, Karolina; Ravaud, Philippe

    2016-11-28

    The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications. We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision. A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n = 43; n

  13. A randomised controlled trial using the Epidrum for labour epidurals.

    LENUS (Irish Health Repository)

    Deighan, M

    2015-03-01

    The aim of our study was to determine if using the Epidrum to site epidurals improves success and reduces morbidity. Three hundred parturients requesting epidural analgesia for labour were enrolled. 150 subjects had their epidural sited using Epidrum and 150 using standard technique. We recorded subject demographics, operator experience, number of attempts, Accidental Dural Puncture rate, rate of failure to site epidural catheter, rate of failure of analgesia, Post Dural Puncture Headache and Epidural Blood Patch rates. Failure rate in Epidrum group was 9\\/150 (6%) vs 0 (0%) in the Control group (P = 0.003). There were four (2.66%) accidental dural punctures in the Epidrum group and none in the Control group (P = 0.060), and 2 epidurals out of 150 (1.33%) in Epidrum group were re-sited, versus 3\\/150 (2%) in the control group (P = 1.000). The results of our study do not suggest that using Epidrum improves success or reduces morbidity.

  14. A randomised controlled trial evaluating family mediated exercise (FAME therapy following stroke

    Directory of Open Access Journals (Sweden)

    Stokes Emma

    2008-06-01

    Full Text Available Abstract Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744

  15. Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial.

    Science.gov (United States)

    da Costa, David W; Bouwense, Stefan A; Schepers, Nicolien J; Besselink, Marc G; van Santvoort, Hjalmar C; van Brunschot, Sandra; Bakker, Olaf J; Bollen, Thomas L; Dejong, Cornelis H; van Goor, Harry; Boermeester, Marja A; Bruno, Marco J; van Eijck, Casper H; Timmer, Robin; Weusten, Bas L; Consten, Esther C; Brink, Menno A; Spanier, B W Marcel; Bilgen, Ernst Jan Spillenaar; Nieuwenhuijs, Vincent B; Hofker, H Sijbrand; Rosman, Camiel; Voorburg, Annet M; Bosscha, Koop; van Duijvendijk, Peter; Gerritsen, Jos J; Heisterkamp, Joos; de Hingh, Ignace H; Witteman, Ben J; Kruyt, Philip M; Scheepers, Joris J; Molenaar, I Quintus; Schaapherder, Alexander F; Manusama, Eric R; van der Waaij, Laurens A; van Unen, Jacco; Dijkgraaf, Marcel G; van Ramshorst, Bert; Gooszen, Hein G; Boerma, Djamila

    2015-09-26

    In patients with mild gallstone pancreatitis, cholecystectomy during the same hospital admission might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy of interval cholecystectomy. However, evidence to support same-admission cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare same-admission and interval cholecystectomy, with the hypothesis that same-admission cholecystectomy would reduce the risk of recurrent gallstone-related complications without increasing the difficulty of surgery. For this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, inpatients recovering from mild gallstone pancreatitis at 23 hospitals in the Netherlands (with hospital discharge foreseen within 48 h) were assessed for eligibility. Adult patients (aged ≥18 years) were eligible for randomisation if they had a serum C-reactive protein concentration less than 100 mg/L, no need for opioid analgesics, and could tolerate a normal oral diet. Patients with American Society of Anesthesiologists (ASA) class III physical status who were older than 75 years of age, all ASA class IV patients, those with chronic pancreatitis, and those with ongoing alcohol misuse were excluded. A central study coordinator randomly assigned eligible patients (1:1) by computer-based randomisation, with varying block sizes of two and four patients, to cholecystectomy within 3 days of randomisation (same-admission cholecystectomy) or to discharge and cholecystectomy 25-30 days after randomisation (interval cholecystectomy). Randomisation was stratified by centre and by whether or not endoscopic sphincterotomy had been done. Neither investigators nor participants were masked to group assignment. The primary endpoint was a composite of readmission for recurrent gallstone-related complications (pancreatitis, cholangitis

  16. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  17. ROLE OF CELECOXIB IN BENIGN BREAST DISEASE: RANDOMISED CONTROL TRIAL

    Directory of Open Access Journals (Sweden)

    Soumen Das

    2012-06-01

    Full Text Available Benign Breast Disease (BBD, commonest cause of morbidity in females due to breast diseases, still offers therapeutic challenge. Several drug therapies (with Evening Primrose Oil, Danazol etc have been tried, but none made gold standard. Reports on effect of Cox-2 inhibitors are scarce. This randomized control trial aims at determination of effect of Cox- inhibitors (Celecoxib in BBD in comparison to Evening Primrose Oil (EPO . Celecoxib showed better reduction in lump size (in 80% than EPO group (in 50%. Pain reduction was excellent in COX -2 groups as compared to EPO group. Recurrence rate was also lower in Celecoxib group at 10 weeks. Side effects were almost nil in both the groups. Celecoxib is better than EPO in the management of BBD. Short course therapy with COX-2 inhibitors gives good pain relief, greater reduction in lump size, low recurrence with minimum side effects.

  18. The informed consent process in randomised controlled trials: a nurse-led process.

    Science.gov (United States)

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  19. Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial

    Science.gov (United States)

    Mengoni, Silvana E; Gates, Bob; Parkes, Georgina; Wellsted, David; Barton, Garry; Ring, Howard; Khoo, Mary Ellen; Monji-Patel, Deela; Friedli, Karin; Zia, Asif; Irvine, Lisa; Durand, Marie-Anne

    2016-01-01

    Objective To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. Trial design A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. Setting Epilepsy clinics in 1 English National Health Service (NHS) Trust. Participants Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. Intervention Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. Outcome measures 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. Outcome The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. Conclusions All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. Trial registration number ISRCTN

  20. Educational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sladden Michael

    2007-09-01

    Full Text Available Abstract Background Childhood asthma is common in Cape Town, a province of South Africa, but is underdiagnosed by general practitioners. Medications are often prescribed inappropriately, and care is episodic. The objective of this study is to assess the impact of educational outreach to general practitioners on asthma symptoms of children in their practice. Methods This is a cluster randomised trial with general practices as the unit of intervention, randomisation, and analysis. The setting is Mitchells Plain (population 300,000, a dormitory town near Cape Town. Solo general practitioners, without nurse support, operate from storefront practices. Caregiver-reported symptom data were collected for 318 eligible children (2 to 17 years with moderate to severe asthma, who were attending general practitioners in Mitchells Plain. One year post-intervention follow-up data were collected for 271 (85% of these children in all 43 practices. Practices randomised to intervention (21 received two 30-minute educational outreach visits by a trained pharmacist who left materials describing key interventions to improve asthma care. Intervention and control practices received the national childhood asthma guideline. Asthma severity was measured in a parent-completed survey administered through schools using a symptom frequency and severity scale. We compared intervention and control group children on the change in score from pre-to one-year post-intervention. Results Symptom scores declined an additional 0.84 points in the intervention vs. control group (on a nine-point scale. p = 0.03. For every 12 children with asthma exposed to a doctor allocated to the intervention, one extra child will have substantially reduced symptoms. Conclusion Educational outreach was accepted by general practitioners and was effective. It could be applied to other health care quality problems in this setting.

  1. The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John

    2013-01-01

    INTRODUCTION: Drug-induced cancer risk is of increasing interest. Both observational studies and data from clinical trials have linked several widely used treatments to cancer. When a signal for a potential drug-cancer association is generated, substantiation is required to assess the impact...... on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post...

  2. Effectiveness of group body psychotherapy for negative symptoms of schizophrenia: multicentre randomised controlled trial †

    OpenAIRE

    Priebe, S.; Savill, M.; Wykes, T.; Bentall, R P; Reininghaus, U; Lauber, C; Bremner, S; Eldridge, S; Röhricht, F.

    2016-01-01

    Background\\ud Negative symptoms of schizophrenia have a severe impact\\ud on functional outcomes and treatment options are limited.\\ud Arts therapies are currently recommended but more\\ud evidence is required.\\ud \\ud Aims\\ud To assess body psychotherapy as a treatment for negative\\ud symptoms compared with an active control (trial registration:ISRCTN84216587).\\ud \\ud Method\\ud Schizophrenia out-patients were randomised into a\\ud 20-session body psychotherapy or Pilates group. The primary\\ud ou...

  3. A prospective randomised controlled trial of capnography vs. bronchoscopy for Blue Rhino percutaneous tracheostomy.

    Science.gov (United States)

    Mallick, A; Venkatanath, D; Elliot, S C; Hollins, T; Nanda Kumar, C G

    2003-09-01

    A crucial step for successful percutaneous tracheostomy is the introduction of the needle and guide wire into the trachea. Capnography has recently been proposed as one way to confirm tracheal needle placement. In this randomised controlled study, we used capnography in 26 patients and bronchoscopy in 29 patients to confirm needle placement for percutaneous tracheostomy using Blue Rhino kit. The operating times and the incidence of peri-operative complications were similar for both groups. Capnography proved to be as effective as bronchoscopy in confirming correct needle placement.

  4. Randomised, double-blind, placebo-controlled study of pivagabine in neurasthenia.

    Science.gov (United States)

    Pizzolato, G; Cagnin, A; Mancia, D; Caffarra, P; Avanzi, S; Copelli, S; Ciappina, C; Lo Presti, F; Spilimbergo, P G; D'Antonio, E; Di Costanzo, E; Matrango, M; Pastres, P; Urbani, P P; Signorino, M; Simoncelli, M; Provinciali, L; Regnicolo, L; Albano, C; Roccatagliata, G; Rubino, V; Cultrera, S; Fracassi, M

    1997-11-01

    One hundred and eighteen patients with neurasthenia, as defined by ICD 10 (International Classification of Diseases), participated in a randomised, double-blind, placebo-controlled trial of pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg). Pivagabine 1800 mg/d was administered orally for four weeks. At the end of the trial, active medication was significantly superior to placebo on the Clinical Global Impression (CGI) improvement of illness scale. In addition, pivagabine treatment reduced the physical and mental fatigability of patients, and increased their sense of well-being.

  5. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Logan Pip A

    2012-06-01

    Full Text Available Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries, satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect, age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence

  6. Hypotensive effects of hawthorn for patients with diabetes taking prescription drugs: a randomised controlled trial.

    Science.gov (United States)

    Walker, Ann F; Marakis, Georgios; Simpson, Eleanor; Hope, Jessica L; Robinson, Paul A; Hassanein, Mohamed; Simpson, Hugh C R

    2006-06-01

    Hawthorn (Crataegus laevigata) leaves, flowers and berries are used by herbal practitioners in the UK to treat hypertension in conjunction with prescribed drugs. Small-scale human studies support this approach. To investigate the effects of hawthorn for hypertension in patients with type 2 diabetes taking prescribed drugs. Randomised controlled trial. General practices in Reading, UK. Patients with type 2 diabetes (n = 79) were randomised to daily 1200 mg hawthorn extract (n = 39) or placebo (n = 40) for 16 weeks. At baseline and outcome a wellbeing questionnaire was completed and blood pressure and fasting blood samples taken. A food frequency questionnaire estimated nutrient intake. Hypotensive drugs were used by 71% of the study population with a mean intake of 4.4 hypoglycaemic and/or hypotensive drugs. Fat intake was lower and sugar intake higher than recommendations, and low micronutrient intake was prevalent. There was a significant group difference in mean diastolic blood pressure reductions (P = 0.035): the hawthorn group showed greater reductions (baseline: 85.6 mmHg, 95% confidence interval [CI] = 83.3 to 87.8; outcome: 83.0 mmHg, 95% CI = 80.5 to 85.7) than the placebo group (baseline: 84.5 mmHg, 95% CI = 82 to 87; outcome: 85.0 mmHg, 95% CI = 82.2 to 87.8). There was no group difference in systolic blood pressure reduction from baseline (3.6 and 0.8 mmHg for hawthorn and placebo groups, respectively; P = 0.329). Although mean fat intake met current recommendations, mean sugar intake was higher and there were indications of potential multiple micronutrient deficiencies. No herb-drug interaction was found and minor health complaints were reduced from baseline in both groups. This is the first randomised controlled trial to demonstrate a hypotensive effect of hawthorn in patients with diabetes taking medication.

  7. Effectiveness of customised foot orthoses for Achilles tendinopathy: a randomised controlled trial.

    Science.gov (United States)

    Munteanu, Shannon E; Scott, Lisa A; Bonanno, Daniel R; Landorf, Karl B; Pizzari, Tania; Cook, Jill L; Menz, Hylton B

    2015-08-01

    To evaluate the effectiveness of customised foot orthoses in chronic mid-portion Achilles tendinopathy. This was a participant-blinded, parallel-group randomised controlled trial at a single centre (La Trobe University, Melbourne, Australia). One hundred and forty participants aged 18-55 years with mid-portion Achilles tendinopathy were randomised to receive eccentric calf muscle exercises with either customised foot orthoses (intervention group) or sham foot orthoses (control group). Allocation to intervention was concealed. The Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire was completed at baseline, then at 1, 3, 6 and 12 months, with 3 months being the primary end point. Differences between groups were analysed using intention to treat with analysis of covariance. After randomisation into the customised foot orthoses group (n=67) or sham foot orthoses group (n=73), there was 70.7% follow-up of participants at 3 months. There were no significant differences between groups at any time point. At 3 months, the mean (SD) VISA-A score was 82.1 (16.3) and 79.2 (20.0) points for the customised and sham foot orthosis groups, respectively (adjusted mean difference (95% CI)=2.6 (-2.9 to 8.0), p=0.353). There were no clinically meaningful differences between groups in any of the secondary outcome measures. Customised foot orthoses, prescribed according to the protocol in this study, are no more effective than sham foot orthoses for reducing symptoms and improving function in people with mid-portion Achilles tendinopathy undergoing an eccentric calf muscle exercise programme. Australian New Zealand Clinical Trials Registry: number ACTRN12609000829213. 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.

  8. Professional kinesiology practice for chronic low back pain: single-blind, randomised controlled pilot study.

    Science.gov (United States)

    Eardley, S; Brien, S; Little, P; Prescott, P; Lewith, G

    2013-01-01

    Chronic low back pain is a highly prevalent condition with no definitive treatment. Professional Kinesiology Practice (PKP) is a little known complementary medicine technique using non-standard muscle testing; no previous effectiveness studies have been performed. This is an exploratory, pragmatic single-blind, 3-arm randomised sham-controlled pilot study with waiting list control (WLC) in private practice UK (2007-2009). 70 participants scoring ≥4 on the Roland and Morris Disability Questionnaire (RMDQ) were randomised to real or sham PKP receiving 1 treatment weekly for 5 weeks or a WLC. WLC's were re-randomised to real or sham after 6 weeks. The main outcome was a change in RMDQ from baseline to end of 5 weeks of real or sham PKP. With an effect size of 0.7 real treatment was significantly different to sham (mean difference RMDQ score = -2.9, p = 0.04, 95% CI -5.8 to -0.1). Compared to WLC, real and sham groups had significant RMDQ improvements (real -9.0, p < 0.01, 95% CI -12.1 to -5.8; effect size 2.1; sham -6.1, p < 0.01, 95% CI -9.1 to -3.1; effect size 1.4). Practitioner empathy (CARE) and patient enablement (PEI) did not predict outcome; holistic health beliefs (CAMBI) did, though. The sham treatment appeared credible; patients did not guess treatment allocation. 3 patients reported minor adverse reactions. Real treatment was significantly different from sham demonstrating a moderate specific effect of PKP; both were better than WLC indicating a substantial non-specific and contextual treatment effect. A larger definitive study would be appropriate with nested qualitative work to help understand the mechanisms involved in PKP.

  9. Lovastatin for adult patients with dengue: protocol for a randomised controlled trial

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    Whitehorn James

    2012-10-01

    Full Text Available Abstract Background Dengue is the most important vector-borne viral infection of man, with approximately 2 billion people living in areas at risk. Infection results in a range of manifestations from asymptomatic infection through to life-threatening shock and haemorrhage. One of the hallmarks of severe dengue is vascular endothelial disruption. There is currently no specific therapy and clinical management is limited to supportive care. Statins are a class of drug initially developed for lipid lowering. There has been considerable recent interest in their effects beyond lipid lowering. These include anti-inflammatory effects at the endothelium. In addition, it is possible that lovastatin may have an anti-viral effect against dengue. Observational data suggest that the use of statins may improve outcomes for such conditions as sepsis and pneumonia. This paper describes the protocol for a randomised controlled trial investigating a short course of lovastatin therapy in adult patients with dengue. Methods/design A randomised, double-blind, placebo-controlled trial will investigate the effects of lovastatin therapy in the treatment of dengue. The trial will be conducted in two phases with an escalation of dose between phases if an interim safety review is satisfactory. This is an exploratory study focusing on safety and there are no data on which to base a sample size calculation. A target sample size of 300 patients in the second phase, enrolled over two dengue seasons, was chosen based on clinical judgement and feasibility considerations. In a previous randomised trial in dengue, about 10% and 30% of patients experienced at least one serious adverse event or adverse event, respectively. With 300 patients, we will have 80% power to detect an increase of 12% (from 10% to 22% or 16% (from 30% to 46% in the frequency of adverse events. Furthermore, this sample size ensures some power to explore the efficacy of statins. Discussion The development of a

  10. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial.

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    Alison Rushton

    Full Text Available To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome; and efficient working of trial components.A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012 was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres.Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.Blinded assessments were made at 4 weeks post surgery (baseline and 12 weeks post baseline (proposed primary end point. Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation.At discharge, 110 (44% eligible patients gave consent to be contacted. 59 (54% patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD RMDQ was 10.07 (5.58 leaflet and 10.52 (5.94 physiotherapy/leaflet at baseline; and 5.37 (4.91 leaflet and 5.53 (4.49 physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD change -4.53 (6.41, 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59, 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI between change from baseline to twelve weeks was 1.65(-2.46 to 5.75. Mean difference (95%CI between groups at 12 weeks was -0.16 (-3.36 to 3.04. Participant adherence with treatment was good. No adverse events were reported.Both interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a

  11. A randomised controlled trial of group cognitive behavioural therapy for perfectionism.

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    Handley, Alicia K; Egan, Sarah J; Kane, Robert T; Rees, Clare S

    2015-05-01

    Perfectionism is associated with symptoms of anxiety disorders, eating disorders and mood disorders. Treatments targeting perfectionism may reduce the symptoms of these disorders (Egan, Wade, & Shafran, 2011). This study is the first randomised controlled trial to investigate the efficacy of group cognitive behavioural therapy (CBT) for perfectionism. Forty-two participants with elevated perfectionism and a range of anxiety, eating and mood disorders were randomised to group CBT for perfectionism or a waitlist control. The treatment group reported significantly greater pre-post reductions in perfectionism, symptoms of depression, eating disorders, social anxiety, anxiety sensitivity and rumination, as well as significantly greater pre-post increases in self-esteem and quality of life compared to the waitlist control group. The impact of treatment on most of these outcomes was mediated by pre-post change in perfectionism (Concern over Mistakes). Treatment gains were reliable and clinically significant, and were maintained at 6-month follow-up. Findings support group CBT for perfectionism being an efficacious treatment for perfectionism and related psychopathology, as well as increasing self-esteem and quality of life.

  12. Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a stepped-wedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART).

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    Maxwell, Amy E; Dennis, Martin; Rudd, Anthony; Weir, Christopher J; Parker, Richard A; Al-Shahi Salman, Rustam

    2017-03-01

    Research into methods to boost recruitment has been identified as the highest priority for randomised controlled trial (RCT) methodological research in the United Kingdom. Slow recruitment delays the delivery of research and inflates costs. Using electronic patient records has been shown to boost recruitment to ongoing RCTs in primary care by identifying potentially eligible participants, but this approach remains relatively unexplored in secondary care, and for stroke in particular. The REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) is an ongoing RCT of secondary prevention after stroke due to intracerebral haemorrhage. Promoting Recruitment using Information Management Efficiently (PRIME) is a stepped-wedge cluster randomised trial of a complex intervention to help RESTART sites increase their recruitment and attain their own target numbers of participants. Seventy-two hospital sites that were located in England, Wales or Scotland and were active in RESTART in June 2015 opted into PRIME. Sites were randomly allocated (using a computer-generated block randomisation algorithm, stratified by hospital location in Scotland vs. England/Wales) to one of 12 months in which the intervention would be delivered. All sites began in the control state. The intervention was delivered by a recruitment co-ordinator via a teleconference with each site. The intervention involved discussing recruitment strategies, providing software for each site to extract from their own stroke audit data lists of patients who were potentially eligible for RESTART, and a second teleconference to review progress 6 months later. The recruitment co-ordinator was blinded to the timing of the intervention until 2 months before it was due at a site. Staff at RESTART sites were blinded to the nature and timing of the intervention. The primary outcome is the total number of patients randomised into RESTART per month per site and will be analysed in a negative binomial

  13. Transitional care for the highest risk patients: findings of a randomised control study

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    Kheng Hock Lee

    2015-10-01

    Full Text Available Background: Interventions to prevent readmissions of patients at highest risk have not been rigorously evaluated. We conducted a randomised controlled trial to determine if a post-discharge transitional care programme can reduce readmissions of such patients in Singapore.Methods: We randomised 840 patients with two or more unscheduled readmissions in the prior 90 days and Length of stay, Acuity of admission, Comorbidity of patient, Emergency department utilisation score ≥10 to the intervention programme (n = 419 or control (n = 421. Patients allocated to the intervention group received post-discharge surveillance by a multidisciplinary integrated care team and early review in the clinic. The primary outcome was the proportion of patients with at least one unscheduled readmission within 30 days after discharge.Results: We found no statistically significant reduction in readmissions or emergency department visits in patients on the intervention group compared to usual care. However, patients in the intervention group reported greater patient satisfaction (p < 0.001.Conclusion: Any beneficial effect of interventions initiated after discharge is small for high-risk patients with multiple comorbidity and complex care needs. Future transitional care interventions should focus on providing the entire cycle of care for such patients starting from time of admission to final transition to the primary care setting.Trial Registration: Clinicaltrials.gov, no NCT02325752

  14. Reducing Postpartum Weight Retention and Improving Breastfeeding Outcomes in Overweight Women: A Pilot Randomised Controlled Trial

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    Julia Martin

    2015-02-01

    Full Text Available Overweight and obesity is prevalent among women of reproductive age (42% BMI > 25 kg/m2 and parity is associated with risk of weight gain. Weight gain greater than that recommended by the Institute of Medicine (IOM is also associated with lower rates of breastfeeding initiation and duration in women. The aim of this pilot randomised controlled trial is to examine the feasibility of recruiting and maintaining a cohort of pregnant women with the view of reducing postpartum weight retention and improving breastfeeding outcomes. Women (BMI of 25–35 kg/m2 (n = 36 were recruited from the John Hunter Hospital antenatal clinic in New South Wales, Australia. Participants were stratified by BMI and randomised to one of three groups with follow-up to six months postpartum. Women received a dietary intervention with or without breastfeeding support from a lactation consultant, or were assigned to a wait-list control group where the dietary intervention was issued at three months postpartum. Feasibility and acceptability was assessed by participation rates and questionnaire. Analysis of variance and covariance was conducted to determine any differences between groups. Sixty-nine per cent of the participants were still enrolled at six months postpartum. This pilot demonstrated some difficulties in recruiting women from antenatal clinics and retaining them in the trial. Although underpowered; the results on weight; biomarkers and breastfeeding outcomes indicated improved metabolic health.

  15. Improving health-related fitness in adolescents: the CrossFit Teens™ randomised controlled trial.

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    Eather, Narelle; Morgan, Philip James; Lubans, David Revalds

    2016-01-01

    The aim of this study was to evaluate the preliminary efficacy and feasibility of the CrossFit Teens™ resistance training programme for improving health-related fitness and resistance training skill competency in adolescents. This assessor-blinded randomised controlled trial was conducted in one secondary school in the Hunter Region, Australia, from July to September 2013. Ninety-six (96) students (age = 15.4 (.5) years, 51.5% female) were randomised into intervention (n = 51) or control (n = 45) conditions for 8-weeks (60 min twice per week). Waist circumference, body mass index (BMI), BMI-Z score (primary outcomes), cardiorespiratory fitness (shuttle run test), muscular fitness (standing jump, push-up, handgrip, curl-up test), flexibility (sit and reach) and resistance training skill competency were measured at baseline and immediate post-intervention. Feasibility measures of recruitment, retention, adherence and satisfaction were assessed. Significant group-by-time intervention effects were found for waist circumference [-3.1 cm, P CrossFit Teens™ is a feasible and efficacious programme for improving health-related fitness in adolescents.

  16. Persistent occiput posterior: OUTcomes following digital rotation: a pilot randomised controlled trial.

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    Graham, Kathryn; Phipps, Hala; Hyett, Jon A; Ludlow, Joanne P; Mackie, Adam; Marren, Anthony; De Vries, Bradley

    2014-06-01

    To determine the feasibility of a multicentre randomised controlled trial (RCT) to investigate whether digital rotation of the fetal head from occiput posterior (OP) position in the second stage of labour reduces the risk of operative delivery (defined as caesarean section (CS) or instrumental delivery). We conducted the study between December 2010 and December 2011 in a tertiary referral hospital in Australia. A transabdominal ultrasound was performed early in the second stage of labour on women with cephalic, singleton pregnancies to determine the fetal position. Those women with a fetus in the OP position were randomised to either a digital rotation or a sham procedure. In all other ways, participants received their usual intrapartum care. Data regarding demographics, mode of delivery, labour, post natal period and neonatal outcomes were collected. One thousand and four women were consented, 834 achieved full dilatation, and 30 were randomised. An additional portable ultrasound scan and a blinded 'sham' digital rotation were acceptable to women and staff. Operative delivery rates were 13/15 in the digital rotation (four CS and nine instrumental) and 12/15 in the sham (three CS and nine instrumental) groups, respectively. A large double-blinded multicentre RCT would be feasible and acceptable to women and staff. Strategies to improve recruitment such as consenting women with an effective epidural in active labour should be considered. This would be the first RCT to answer a clinically important question which could significantly affect the operative delivery rate in Australia and internationally. © 2014 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  17. Long term follow-up of a randomised controlled trial of services for urinary symptoms

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    Cooper Nicola J

    2011-03-01

    Full Text Available Abstract Background Given the extent and priority of urinary symptoms there is little evidence available to inform service provision in relation to the long term effects of interventions. This study aims to determine the long term (6 year clinical effectiveness and costs of a new continence nurse led service compared to standard care for urinary symptoms. Methods A long term follow-up study of a 2-arm, non-blinded randomised controlled trial that recruited from a community based population between 1998-2000 in Leicestershire and Rutland UK was undertaken. 3746 men and women aged 40 years and over were followed up from the original trial. The continence nurse practitioner (CNP intervention comprised a continence service provided by specially trained nurses delivering evidence-based interventions using pre-determined care pathways. The standard care (SC arm comprised access to existing primary care including General Practitioner and continence advisory services in the area. Primary outcome: Improvement in one or more symptom. Secondary outcomes included: a Leicester Impact scale; b patient perception of problem; c number of symptoms alleviated and cost-effectiveness; all were recorded at long term follow-up (average 6 years post-randomisation. Results Overall at long-term follow-up (average 6 years significantly more individuals in the CNP group (72% had improved (i.e had fewer symptoms compared to those in the SC group (67% (difference of 5% 95% (CI = 0.6 to 9;p = 0.02. Conclusion The differences in outcome between the two randomised groups shown immediately post treatment had decreased by half in terms of symptom improvement at long term follow-up. Although the difference was statistically significant, the clinical significance may not be, although the direction of the difference favoured the new CNP service.

  18. Graduated compression stockings to treat acute leg pain associated with proximal DVT. A randomised controlled trial.

    Science.gov (United States)

    Kahn, S R; Shapiro, S; Ducruet, T; Wells, P S; Rodger, M A; Kovacs, M J; Anderson, D; Tagalakis, V; Morrison, D R; Solymoss, S; Miron, M-J; Yeo, E; Smith, R; Schulman, S; Kassis, J; Kearon, C; Chagnon, I; Wong, T; Demers, C; Hanmiah, R; Kaatz, S; Selby, R; Rathbun, S; Desmarais, S; Opatrny, L; Ortel, T L; Galanaud, J-P; Ginsberg, J S

    2014-12-01

    Acute deep venous thrombosis (DVT) causes leg pain. Elastic compression stockings (ECS) have potential to relieve DVT-related leg pain by diminishing the diameter of distended veins and increasing venous blood flow. It was our objective to determine whether ECS reduce leg pain in patients with acute DVT. We performed a secondary analysis of the SOX Trial, a multicentre randomised placebo controlled trial of active ECS versus placebo ECS to prevent the post-thrombotic syndrome.The study was performed in 24 hospital centres in Canada and the U.S. and included 803 patients with a first episode of acute proximal DVT. Patients were randomised to receive active ECS (knee length, 30-40 mm Hg graduated pressure) or placebo ECS (manufactured to look identical to active ECS, but lacking therapeutic compression). Study outcome was leg pain severity assessed on an 11-point numerical pain rating scale (0, no pain; 10, worst possible pain) at baseline, 14, 30 and 60 days after randomisation. Mean age was 55 years and 60% were male. In active ECS patients (n=409), mean (SD) pain severity at baseline and at 60 days were 5.18 (3.29) and 1.39 (2.19), respectively, and in placebo ECS patients (n=394) were 5.38 (3.29) and 1.13 (1.86), respectively. There were no significant differences in pain scores between groups at any assessment point, and no evidence for subgroup interaction by age, sex or anatomical extent of DVT. Results were similar in an analysis restricted to patients who reported wearing stockings every day. In conclusion, ECS do not reduce leg pain in patients with acute proximal DVT.

  19. Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA: study protocol for a randomised controlled trial

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    Rosenberg Jacob

    2011-08-01

    Full Text Available Abstract Background Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. Methods DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL to the traditional Hartmann's Procedure (HP. Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL, re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40. Discussion HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life. Trial registration British registry (ISRCTN for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287

  20. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

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    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  1. Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder

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    Roberts Christopher

    2011-07-01

    Full Text Available Abstract Background Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years, and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. Methods/design Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. Discussion The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement. Trial Registration ISRCTN62761948 Funding National Institute for Health Research, England.

  2. Improving community ambulation after hip fracture: protocol for a randomised, controlled trial

    Science.gov (United States)

    Orwig, D; Mangione, KK; Baumgarten, M; Terrin, M; Fortinsky, R; Kenny, AM; Gruber-Baldini, AL; Beamer, B; Tosteson, ANA; Shardell, M; Magder, L; Binder, E; Koval, K; Resnick, B; Craik, RL; Magaziner, J

    2017-01-01

    Introduction After a hip fracture in older persons, significant disability often remains; dependency in functional activities commonly persists beyond 3 months after surgery. Endurance, dynamic balance, quadriceps strength, and function are compromised, and contribute to an inability to walk independently in the community. In the United States, people aged 65 years and older are eligible to receive Medicare funding for physiotherapy for a limited time after a hip fracture. A goal of outpatient physiotherapy is independent and safe household ambulation 2 to 3 months after surgery. Current Medicare-reimbursed post-hip-fracture rehabilitation fails to return many patients to pre-fracture levels of function. Interventions delivered in the home after usual hip fracture physiotherapy has ended could promote higher levels of functional independence in these frail and older adult patients. Primary objective To evaluate the effect of a specific multicomponent physiotherapy intervention (PUSH), compared with a non-specific multi-component control physiotherapy intervention (PULSE), on the ability to ambulate independently in the community 16 weeks after randomisation. Design Parallel, two-group randomised multicentre trial of 210 older adults with a hip fracture assessed at baseline and 16 weeks after randomisation, and at 40 weeks after randomisation for a subset of approximately 150 participants. Participants and setting A total of 210 hip fracture patients are being enrolled at three clinical sites and randomised up to 26 weeks after admission. Study inclusion criteria are: closed, non-pathologic, minimal trauma hip fracture with surgical fixation; aged ≥ 60 years at the time of randomisation; community residing at the time of fracture and randomisation; ambulating without human assistance 2 months prior to fracture; and being unable to walk at least 300 m in 6 minutes at baseline. Participants are ineligible if the interventions are deemed to be unsafe or unfeasible

  3. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST: study protocol for a pilot randomised controlled trial

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    McColl Elaine

    2011-06-01

    Full Text Available Abstract Background High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective. The earliest that acute stroke treatments could be initiated is during contact with the emergency medical services (paramedics. However, experience of pre-hospital clinical trials is limited and logistical challenges are likely to be greater than for trials performed in other settings. We report the protocol for a pilot randomised controlled trial of paramedic initiated blood pressure lowering treatment for hypertension in acute stroke. Methods Trial Design: Double blind parallel group external pilot randomised controlled trial. Setting: Participant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals. Participants: Target is recruitment of 60 adults with acute arm weakness due to suspected stroke (within 3 hours of symptom onset and hypertension (systolic BP>160 mmHg. Intervention: Lisinopril 5-10 mg (intervention group, matched placebo (control group, daily for 7 days. Randomisation: Study medication contained within identical pre-randomised "trial packs" carried by research trained paramedics. Outcomes: Study feasibility (recruitment rate, compliance with data collection and clinical data to inform the design of a definitive randomised controlled trial (blood pressure monitoring, National Institute of Health Stroke Scale, Barthel ADL Index, Modified Rankin Scale, renal function. Discussion This pilot study is assessing the feasibility of a randomised controlled trial of paramedic initiated lisinopril for hypertension early after the onset of acute stroke. The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke

  4. A randomised controlled trial of an SMS-based mobile epilepsy education system.

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    Lua, Pei Lin; Neni, Widiasmoro Selamat

    2013-01-01

    We evaluated an epilepsy education programme based on text messaging (SMS). Epilepsy outpatients from three hospitals in Malaysia were randomised into two groups: intervention and control. Patients in the control group were supplied with printed epilepsy educational material while those in the intervention group also received text messages from the Mobile Epilepsy Educational System (MEES). A total of 136 patients completed the study (mean age 31 years; 91% Malay; 51% with an illness duration of more than 5 years). A between-group analysis showed that the awareness, knowledge and attitudes (AKA) about epilepsy did not significantly differ between the groups at baseline (P > 0.05). The intervention patients reported better AKA levels during follow-up compared to the control patients (P epilepsy education is effective in improving AKA.

  5. Fistula Plug in Fistulising Ano-Perineal Crohn's Disease: a Randomised Controlled Trial.

    Science.gov (United States)

    Senéjoux, A; Siproudhis, L; Abramowitz, L; Munoz-Bongrand, N; Desseaux, K; Bouguen, G; Bourreille, A; Dewit, O; Stefanescu, C; Vernier, G; Louis, E; Grimaud, J C; Godart, B; Savoye, G; Hebuterne, X; Bauer, P; Nachury, M; Laharie, D; Chevret, S; Bouhnik, Y

    2016-02-01

    Anal fistula plug [AFP] is a bioabsorbable bioprosthesis used in ano-perineal fistula treatment. We aimed to assess efficacy and safety of AFP in fistulising ano-perineal Crohn's disease [FAP-CD]. In a multicentre, open-label, randomised controlled trial we compared seton removal alone [control group] with AFP insertion [AFP group] in 106 Crohn's disease patients with non- or mildly active disease having at least one ano-perineal fistula tract drained for more than 1 month. Patients with abscess [collection ≥ 3mm on magnetic resonance imaging or recto-vaginal fistulas were excluded. Randomisation was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula closure at Week 12. In all, 54 patients were randomised to AFP group [control group 52]. Median fistula duration was 23 [10-53] months. Median Crohn's Disease Activity Index at baseline was 81 [45-135]. Fistula closure at Week 12 was achieved in 31.5% patients in the AFP group and in 23.1 % in the control group (relative risk [RR] stratified on AGA classification: 1.31; 95% confidence interval: 0.59-4.02; p = 0.19). No interaction in treatment effect with complexity stratum was found; 33.3% of patients with complex fistula and 30.8% of patients with simple fistula closed the tracts after AFP, as compared with 15.4% and 25.6% in controls, respectively [RR of success = 2.17 in complex fistula vs RR = 1.20 in simple fistula; p = 0.45]. Concerning safety, at Week 12, 17 patients developed at least one adverse event in the AFP group vs 8 in the controls [p = 0.07]. AFP is not more effective than seton removal alone to achieve FAP-CD closure. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  6. Timing of insertion of levonorgestrel-releasing intrauterine system: a randomised controlled trial.

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    van der Heijden, Pahh; Geomini, Pmaj; Herman, M C; Veersema, S; Bongers, M Y

    2017-01-01

    The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle. A stratified two-armed non-inferiority randomised controlled trial. Large teaching hospital in Veldhoven, the Netherlands. From October 2013 to May 2014, 60 nulliparous and 60 multiparous women were randomised. Eight women withdrew after randomisation and before insertion took place: therefore, data from 112 women were collected and analysed. Women were randomised to the groups 'during menstruation' (i.e. days 1-7 of menstruation) or 'outside menstruation' (i.e. any day of the cycle after menstruation without the presence of vaginal blood loss) in a ratio of 1 : 1. The primary outcome was pain during insertion, measured by the visual analogue scale (VAS, 0-100 mm). Second, we analysed ease of insertion, bleeding pattern, satisfaction, pregnancy, and expulsion rate. The follow-up time was 3 months. The mean VAS score for nulliparous women was 74 mm (95% confidence interval, 95% CI 67-81) in the 'during menstruation' group, compared with 66 mm (95% CI 59-74) in the 'outside menstruation' group (P = 0.14). The mean VAS score for multiparous women was 30 mm (95% CI 20-40) in the 'during menstruation group', compared with 43 mm (95% CI 32-53) in the 'outside menstruation' group (P = 0.08). There was no difference between the stratified 'during menstruation' group and the 'outside menstruation' group with regards to ease of insertion, satisfaction, bleeding pattern, and median spotting and bleeding days for the use of the LNG-IUS 3 months after insertion. As we did not find that the level of pain perceived during insertion was higher during menstruation, compared with outside menstruation, we conclude that the LNG-IUS can be inserted at any time during the menstrual cycle, especially in the case of nulliparous women. We conducted an RCT on time of insertion of

  7. Acupuncture for chronic neck pain: a pilot for a randomised controlled trial

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    Bland Martin J

    2006-12-01

    Full Text Available Abstract Background Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. Methods Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ at 3 months. The primary analysis was to determine the sample size for the full scale study. Results Of the 227 patients with neck pain identified from the GP database, 28 (12.3% consenting patients were eligible to participate in the pilot and 24 (10.5% were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients. Conclusion This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence

  8. Automation-assisted versus manual reading of cervical cytology (MAVARIC): a randomised controlled trial.

    Science.gov (United States)

    Kitchener, Henry C; Blanks, Roger; Dunn, Graham; Gunn, Lionel; Desai, Mina; Albrow, Rebecca; Mather, Jean; Rana, Durgesh N; Cubie, Heather; Moore, Catherine; Legood, Rosa; Gray, Alastair; Moss, Sue

    2011-01-01

    The standard for reading cervical cytology is for a cytoscreener to manually search across an entire slide for abnormal cells using a conventional microscope. Automated technology can select fields of view to assess abnormal cells, which allows targeted reading by cytoscreeners. In the Manual Assessment Versus Automated Reading In Cytology (MAVARIC) trial, we compared the accuracy of these techniques for the detection of underlying disease. For this randomised controlled trial, women aged 25-64 years undergoing primary cervical screening in Manchester, UK, were randomly assigned (1:2) to receive either manual reading only or paired reading (automation-assisted reading and manual reading), between March 1, 2006, and Feb 28, 2009. In the paired arm, two automated systems were used-the ThinPrep Imaging System and the FocalPoint GS Imaging System. General practices and community clinics were randomised to either ThinPrep or to SurePath (for the FocalPoint system) liquid-based cytology with block randomisation stratified by deprivation index. Samples were then individually randomised to manual reading only or paired reading only. Laboratory staff were unaware of the allocation of each slide and concealment was maintained until the end of the reporting process. The primary outcome was sensitivity of automation-assisted reading relative to manual reading for the detection of underlying cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in the paired arm. This trial is registered, number ISRCTN66377374. 73,266 liquid-based cytology samples were obtained from women undergoing primary cervical screening; 24,688 allocated to the manual-only arm and 48,578 to the paired-reading arm. Automation-assisted reading was 8% less sensitive than manual reading (relative sensitivity 0·92, 95% CI 0·89-0·95), which was equivalent to an absolute reduction in sensitivity of 6·3%, assuming the sensitivity of manual reading to be 79%. Specificity of automation-assisted reading

  9. Managing Injuries of the Neck Trial (MINT: design of a randomised controlled trial of treatments for whiplash associated disorders

    Directory of Open Access Journals (Sweden)

    Williamson Esther M

    2007-01-01

    Full Text Available Abstract Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED, followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI, and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised.

  10. Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Catherine Lombard

    2016-01-01

    Full Text Available Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information.We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters randomised using a computer-generated randomisation list for intervention (n = 21 or control (n = 20. Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women's health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/- SD 6.7 and BMI of 28.8 kg/m(2 (+/- SD 6.9 with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI -0.09 to 0.97 and in the intervention group -0.48 kg (95% CI -0.99 to 0.03 with an unadjusted between group difference of -0.92 kg (95% CI -1.67 to -0.16 or -0.87 kg (95% CI -1.62 to -0.13 adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures.A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included

  11. Increasing organ donation via anticipated regret (INORDAR: protocol for a randomised controlled trial

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    O'Carroll Ronan E

    2012-03-01

    Full Text Available Abstract Background Throughout the world there is an insufficient supply of donor organs to meet the demand for organ transplantations. This paper presents a protocol for a randomised controlled trial, testing whether a simple, theory-based anticipated regret manipulation leads to a significant increase in posthumous organ donor registrations. Methods We will use a between-groups, prospective randomised controlled design. A random sample of 14,520 members of the adult Scottish general public will be contacted via post. These participants will be randomly allocated into 1 of the 4 conditions. The no questionnaire control (NQC group will simply receive a letter and donor registration form. The questionnaire control (QC arm will receive a questionnaire measuring their emotions and non-cognitive affective attitudes towards organ donation. The theory of planned behavior (TPB group will complete the emotions and affective attitudes questionnaire plus additional items assessing their cognitive attitudes towards organ donation, perceived control over registration and how they think significant others view this action. Finally, the anticipated regret (AR group will complete the same indices as the TPB group, plus two additional anticipated regret items. These items will assess the extent to which the participant anticipates regret for not registering as an organ donor in the near future. The outcome variable will be NHS Blood and Transplant verified registrations as an organ donor within 6 months of receiving our postal intervention. Discussion This study will assess whether simply asking people to reflect on the extent to which they may anticipate regret for not registering as an organ donor increases organ donor registration 6 months later. If successful, this simple and easy to administer theory-based intervention has the potential to save lives and money for the NHS by reducing the number of people receiving treatments such as dialysis. This

  12. A randomised controlled study of reflexology for the management of chronic low back pain.

    Science.gov (United States)

    Poole, Helen; Glenn, Sheila; Murphy, Peter

    2007-11-01

    The use of complementary and alternative medicine (CAM) for the management of chronic low back pain (CLBP) continues to rise. However, questions regarding the efficacy of many CAM therapies for CLBP remain unresolved. The present study investigated the effectiveness of reflexology for CLBP. A pragmatic randomised controlled trial was conducted. N=243 patients were randomised to one of three groups: reflexology, relaxation, or non-intervention (usual care). All completed a questionnaire booklet before and after the treatment phase, and at six months follow up. This measured their general health status, pain, functioning, coping strategies and mood. After adjusting for pre-treatment scores repeated measures ANCOVA found no significant differences between the groups pre and post treatment on the primary outcome measures of pain and functioning. There was a main effect of pain reduction, irrespective of group. Trends in the data illustrated the pain reduction was greatest in the reflexology group. Thus, the current study does not indicate that adding reflexology to usual GP care for the management of CLBP is any more effective than usual GP care alone.

  13. Live lecture versus video podcast in undergraduate medical education: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Fukuta Junaid

    2010-10-01

    Full Text Available Abstract Background Information technology is finding an increasing role in the training of medical students. We compared information recall and student experience and preference after live lectures and video podcasts in undergraduate medical education. Methods We performed a crossover randomised controlled trial. 100 students were randomised to live lecture or video podcast for one clinical topic. Live lectures were given by the same instructor as the narrator of the video podcasts. The video podcasts comprised Powerpoint™ slides narrated using the same script as the lecture. They were then switched to the other group for a second clinical topic. Knowledge was assessed using multiple choice questions and qualitative information was collected using a questionnaire. Results No significant difference was found on multiple choice questioning immediately after the session. The subjects enjoyed the convenience of the video podcast and the ability to stop, review and repeat it, but found it less engaging as a teaching method. They expressed a clear preference for the live lecture format. Conclusions We suggest that video podcasts are not ready to replace traditional teaching methods, but may have an important role in reinforcing learning and aiding revision.

  14. Live lecture versus video podcast in undergraduate medical education: A randomised controlled trial

    Science.gov (United States)

    2010-01-01

    Background Information technology is finding an increasing role in the training of medical students. We compared information recall and student experience and preference after live lectures and video podcasts in undergraduate medical education. Methods We performed a crossover randomised controlled trial. 100 students were randomised to live lecture or video podcast for one clinical topic. Live lectures were given by the same instructor as the narrator of the video podcasts. The video podcasts comprised Powerpoint™ slides narrated using the same script as the lecture. They were then switched to the other group for a second clinical topic. Knowledge was assessed using multiple choice questions and qualitative information was collected using a questionnaire. Results No significant difference was found on multiple choice questioning immediately after the session. The subjects enjoyed the convenience of the video podcast and the ability to stop, review and repeat it, but found it less engaging as a teaching method. They expressed a clear preference for the live lecture format. Conclusions We suggest that video podcasts are not ready to replace traditional teaching methods, but may have an important role in reinforcing learning and aiding revision. PMID:20932302

  15. Randomised controlled trial of qigong in the treatment of mild essential hypertension.

    Science.gov (United States)

    Cheung, B M Y; Lo, J L F; Fong, D Y T; Chan, M Y; Wong, S H T; Wong, V C W; Lam, K S L; Lau, C P; Karlberg, J P E

    2005-09-01

    Exercise and relaxation decrease blood pressure. Qigong is a traditional Chinese exercise consisting of breathing and gentle movements. We conducted a randomised controlled trial to study the effect of Guolin qigong on blood pressure. In all, 88 patients with mild essential hypertension were recruited from the community and randomised to Goulin qigong or conventional exercise for 16 weeks. The main outcome measurements were blood pressure, health status (SF-36 scores), Beck Anxiety and Depression Inventory scores. In the qigong group, blood pressure decreased significantly from 146.3+/-7.8/93.0+/-4.1 mmHg at baseline to 135.5+/-10.0/87.1+/-7.7 mmHg at week 16. In the exercise group, blood pressure also decreased significantly from 140.9+/-10.9/93.1+/-3.5 mmHg to 129.7+/-11.1/86.0+/-7.0 mmHg. Heart rate, weight, BMI, waist circumference, total cholesterol, renin and 24 h urinary albumin excretion significantly decreased in both groups after 16 weeks. General health, bodily pain, social functioning and depression also improved in both groups. No significant differences between qigong and conventional exercise were found. In conclusion, Guolin qigong and conventional exercise have similar effects on blood pressure in patients with mild hypertension. While no additional benefits were identified, it is nevertheless an alternative to conventional exercise in the nondrug treatment of hypertension.

  16. Replicability of sight word training and phonics training in poor readers: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    G McArthur

    2015-05-01

    Full Text Available Given the importance of effective treatments for children with reading impairment, paired with growing concern about the lack of scientific replication in psychological science, the aim of this study was to replicate a quasi-randomised trial of sight word and phonics training using a randomised controlled trial (RCT design. One group of poor readers (N = 41 did 8 weeks of phonics training (i.e., phonological decoding and then 8 weeks of sight word training (i.e., whole-word recognition. A second group did the reverse order of training. Sight word and phonics training each had a large and significant valid treatment effect on trained irregular words and word reading fluency. In addition, combined sight word and phonics training had a moderate and significant valid treatment effect on nonword reading accuracy and fluency. These findings demonstrate the reliability of both phonics and sight word training in treating poor readers in an era where the importance of scientific reliability is under close scrutiny.

  17. The effect of 3% and 6% hypertonic saline in viral bronchiolitis: a randomised controlled trial.

    Science.gov (United States)

    Teunissen, Jasmijn; Hochs, Anne H J; Vaessen-Verberne, Anja; Boehmer, Annemie L M; Smeets, Carien C J M; Brackel, Hein; van Gent, René; Wesseling, Judith; Logtens-Stevens, Danielle; de Moor, Ronald; Rosias, Philippe P R; Potgieter, Steph; Faber, Marianne R; Hendriks, Han J E; Janssen-Heijnen, Maryska L G; Loza, Bettina F

    2014-10-01

    Bronchiolitis is a common disorder in young children that often results in hospitalisation. Except for a possible effect of nebulised hypertonic saline (sodium chloride), no evidence-based therapy is available. This study investigated the efficacy of nebulised 3% and 6% hypertonic saline compared with 0.9% hypertonic saline in children hospitalised with viral bronchiolitis. In this multicentre, double-blind, randomised, controlled trial, children hospitalised with acute viral bronchiolitis were randomised to receive either nebulised 3%, 6% hypertonic saline or 0.9% normal saline during their entire hospital stay. Salbutamol was added to counteract possible bronchial constriction. The primary endpoint was the length of hospital stay. Secondary outcomes were need for supplemental oxygen and tube feeding. From the 292 children included in the study (median age 3.4 months), 247 completed the study. The median length of hospital stay did not differ between the groups: 69 h (interquartile range 57), 70 h (IQR 69) and 53 h (IQR 52), for 3% (n=84) and 6% (n=83) hypertonic saline and 0.9% (n=80) normal saline, respectively, (p=0.29). The need for supplemental oxygen or tube feeding did not differ significantly. Adverse effects were similar in the three groups. Nebulisation with hypertonic saline (3% or 6% sodium chloride) although safe, did not reduce the length of stay in hospital, duration of supplemental oxygen or tube feeding in children hospitalised with moderate-to-severe viral bronchiolitis.

  18. Advice to eat fish and mood: a randomised controlled trial in men with angina.

    Science.gov (United States)

    Ness, Andrew R; Gallacher, John E J; Bennett, Paul D; Gunnell, David J; Rogers, Peter J; Kessler, David; Burr, Michael L

    2003-02-01

    People with high intake of fish have lower reported rates of depression and a small trial in psychiatric patients suggested that fish oil supplements reduced episodes of depression and mania. As part of a factorial trial of interventions to reduce mortality in angina 452 men were randomised to advice to eat more fatty fish or no fish advice. Maxepa fish oil capsules were supplied to men who found the fish unpalatable. Fish intake and mood were assessed at baseline and six months. Most men (83%) had mood assessed using the Derogatis Stress Profile at baseline and follow-up. Self reported intake of fish was higher in the fish advice group at six months. There was, however, no difference in depression or anxiety in those allocated to receive fish advice. After controlling for baseline mood, the difference in depression score between those randomised to fish advice and those not was 1.29 (95% CI -0.29 to 2.88) and the difference in anxiety was 0.82 (95% CI -0.57 to 2.22) with positive differences indicating more depression or anxiety in those allocated to the fish arm. This trial provides no evidence that increased fatty fish intake in people without depressive symptoms has any substantial effect on mood.

  19. Preventing hypothermia in elective arthroscopic shoulder surgery patients: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Duff Jed

    2012-07-01

    Full Text Available Abstract Background Patients having arthroscopic shoulder surgery frequently experience periods of inadvertent hypothermia. This common perioperative problem has been linked to adverse patient outcomes such as myocardial ischaemia, surgical site infection and coagulopathy. International perioperative guidelines recommend patient warming, using a forced air warming device, and the use of warmed intraoperative irrigation solutions for the prevention of hypothermia in at-risk patient groups. This trial will investigate the effect of these interventions on patients’ temperature, thermal comfort, and total recovery time. Method/Design The trial will employ a randomised 2 x 2 factorial design. Eligible patients will be stratified by anaesthetist and block randomised into one of four groups: Group one will receive preoperative warming with a forced air warming device; group two will receive warmed intraoperative irrigation solutions; group three will receive both preoperative warming and warmed intraoperative irrigation solutions; and group four will receive neither intervention. Participants in all four groups will receive active intraoperative warming with a forced air warming device. The primary outcome measures are postoperative temperature, thermal comfort, and total recovery time. Primary outcomes will undergo a two-way analysis of variance controlling for covariants such as operating room ambient temperature and volume of intraoperative irrigation solution. Discussion This trial is designed to confirm the effectiveness of these interventions at maintaining perioperative normothermia and to evaluate if this translates into improved patient outcomes. Australian New Zealand Clinical Trials Registry number ACTRN12610000591055

  20. Comparison of Bobath based and movement science based treatment for stroke: a randomised controlled trial.

    Science.gov (United States)

    van Vliet, P M; Lincoln, N B; Foxall, A

    2005-04-01

    Bobath based (BB) and movement science based (MSB) physiotherapy interventions are widely used for patients after stroke. There is little evidence to suggest which is most effective. This single-blind randomised controlled trial evaluated the effect of these treatments on movement abilities and functional independence. A total of 120 patients admitted to a stroke rehabilitation ward were randomised into two treatment groups to receive either BB or MSB treatment. Primary outcome measures were the Rivermead Motor Assessment and the Motor Assessment Scale. Secondary measures assessed functional independence, walking speed, arm function, muscle tone, and sensation. Measures were performed by a blinded assessor at baseline, and then at 1, 3, and 6 months after baseline. Analysis of serial measurements was performed to compare outcomes between the groups by calculating the area under the curve (AUC) and inserting AUC values into Mann-Whitney U tests. Comparison between groups showed no significant difference for any outcome measures. Significance values for the Rivermead Motor Assessment ranged from p = 0.23 to p = 0.97 and for the Motor Assessment Scale from p = 0.29 to p = 0.87. There were no significant differences in movement abilities or functional independence between patients receiving a BB or an MSB intervention. Therefore the study did not show that one approach was more effective than the other in the treatment of stroke patients.

  1. Individual music therapy for mental health care clients with low therapy motivation: multicentre randomised controlled trial.

    Science.gov (United States)

    Gold, Christian; Mössler, Karin; Grocke, Denise; Heldal, Tor Olav; Tjemsland, Lars; Aarre, Trond; Aarø, Leif Edvard; Rittmannsberger, Hans; Stige, Brynjulf; Assmus, Jörg; Rolvsjord, Randi

    2013-01-01

    Music therapy (MT) has been shown to be efficacious for mental health care clients with various disorders such as schizophrenia, depression and substance abuse. Referral to MT in clinical practice is often based on other factors than diagnosis. We aimed to examine the effectiveness of resource-oriented MT for mental health care clients with low motivation for other therapies. This was a pragmatic parallel trial. In specialised centres in Norway, Austria and Australia, 144 adults with non-organic mental disorders and low therapy motivation were randomised to 3 months of biweekly individual, resource-oriented MT plus treatment as usual (TAU) or TAU alone. TAU was typically intensive (71% were inpatients) and included the best combination of therapies available for each participant, excluding MT. Blinded assessments of the Scale for the Assessment of Negative Symptoms (SANS) and 15 secondary outcomes were collected before randomisation and after 1, 3 and 9 months. Changes were analysed on an intention-to-treat basis using generalised estimating equations in longitudinal linear models, controlling for diagnosis, site and time point. MT was superior to TAU for total negative symptoms (SANS, d = 0.54, p avoidance through music, and vitality (all p < 0.01). Individual MT as conducted in routine practice is an effective addition to usual care for mental health care clients with low motivation. Copyright © 2013 S. Karger AG, Basel.

  2. Percutaneous tibial nerve stimulation versus tolterodine for overactive bladder in women: a randomised controlled trial.

    Science.gov (United States)

    Preyer, Oliver; Umek, Wolfgang; Laml, Thomas; Bjelic-Radisic, Vesna; Gabriel, Boris; Mittlboeck, Martina; Hanzal, Engelbert

    2015-08-01

    We performed a randomised controlled trial of percutaneous tibial nerve stimulation (PTNS) versus tolterodine for treating treatment naïve women with overactive bladder (OAB). 36 patients with symptoms of OAB were randomised to 3 months of treatment with weekly PTNS or tolterodine (2mg bid p.o.). The primary outcome measure was the difference of micturitions per 24h. The secondary outcome measure was the impact on quality of life (QoL) measured with a visual analogue scale (VAS) between baseline and after 3 months of therapy. Micturition frequencies did not decline significantly (p=0.13) over time and there were no significant treatment differences (p=0.96). QoL was significantly dependent from its level at baseline (p=0.002) and showed improvement over time compared to baseline measurements but no significant differences between both treatment groups (p=0.07). Incontinence episodes per 24h depended significantly on the level at baseline (p=0.0001) and declined significantly (p=0.03) during 3 months of therapy in both therapy groups. However no significant treatment differences on the reduction of incontinence episodes in 24h could be shown between both therapy groups (p=0.89). PTNS had fewer side effects than tolterodine (p=0.04). PTNS and tolterodine were both effective in reducing incontinence episodes and improving QoL in patients with OAB but not micturition frequencies. PTNS had fewer side effects. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  3. An assessment of quality characteristics of randomised control trials published in dental journals.

    Science.gov (United States)

    Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

    2010-09-01

    The purpose of this study was to investigate the quality of reporting of randomised clinical trials (RCTs) published in dental specialty journals. The journals possessing the highest impact factor (2008 data) in the six major dental specialties were included in the study. The contents of the 24 most recent issues of each journal were hand-searched and research articles identified as randomised controlled trials (RCTs) were selected. Quality evaluation was performed using the modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. The data were analysed using descriptive statistics followed by univariate and multivariate examination of statistical associations (alpha=0.05). Ninety-five RCTs were identified with generally suboptimal scores on quality reporting on key CONSORT areas. Significant differences were found among journals with the Journal of Clinical Periodontology achieving the highest score, followed by the American Journal of Orthodontics and Dentofacial Orthopedics. There was a positive association between quality score and number of authors, involvement of statistician/epidemiologist, and multicentre trials. The quality scores of RCTs in major dental journals are considered suboptimal in key CONSORT areas. This receives critical importance considering that improved quality of RCTs is a fundamental prerequisite for improved dental care. Copyright 2010 Elsevier Ltd. All rights reserved.

  4. Safe household water treatment and storage using ceramic drip filters: a randomised controlled trial in Bolivia.

    Science.gov (United States)

    Clasen, T; Brown, J; Suntura, O; Collin, S

    2004-01-01

    A randomised controlled field trial was conducted to evaluate the effectiveness of ceramic drip filters to improve the microbiological quality of drinking water in a low-income community in rural Bolivia. In four rounds of water sampling over five months, 100% of the samples were free of thermotolerant (faecal) coliforms (TTC) compared to an arithmetic mean TTC count of 1517, 406, 167 and 245 among control households which continued to use their customary sources of drinking water. The filter systems produced water that consistently met WHO drinking-water standards despite levels of turbidity that presented a challenge to other low-cost POU treatment methods. The filter systems also demonstrated an ability to maintain the high quality of the treated water against subsequent re-contamination in the home.

  5. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    DEFF Research Database (Denmark)

    Bello, Segun; Wei, Maoling; Hilden, Jørgen

    2016-01-01

    to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods: Systematic review. We searched Pub......Background: Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided......Med, Google Scholar and Web of Science Citation Index for studies that assessed whether supposedly indistinguishable interventions (experimental and control) in randomized clinical drug trials could be distinguished based on physical properties (e.g. appearance or smell). Two persons decided on study...

  6. Randomised controlled trial of the use of an educational board game in neonatology.

    Science.gov (United States)

    Swiderska, Nina; Thomason, Elinor; Hart, Anna; Shaw, Ben N J

    2013-05-01

    Games have been used in healthcare education to encourage active learning. To investigate whether an educational board game which had been developed in the speciality of neonatology could influence the learning experience of medical students during their neonatal attachment. A randomised controlled trial of using the game was conducted amongst 67 student participants. The average final assessment score was 4.15 points higher in the group of students that played the game compared to the control group (95% CI-0.88-9.17; p = 0.09). The game was well received by the students. Although we cannot conclude firmly that the game produces an effect on learning, this study suggests that educational games should be investigated further in the delivery of undergraduate learning in specialities where exposure is brief.

  7. Effect of preoperative abstinence on poor postoperative outcome in alcohol misusers: randomised controlled trial

    DEFF Research Database (Denmark)

    Tonnesen, H; Rosenberg, J; Nielsen, Hans Jørgen;

    1999-01-01

    often in the intervention group. Surgical stress responses were lower in the intervention group (P LT / =0.05). CONCLUSIONS: One month of preoperative abstinence reduces postoperative morbidity in alcohol abusers. The mechanism is probably reduced preclinical organ dysfunction and reduction......OBJECTIVE: To evaluate the influence of preoperative abstinence on postoperative outcome in alcohol misusers with no symptoms who were drinking the equivalent of at least 60 g ethanol/day. DESIGN: Randomised controlled trial. Setting: Copenhagen, Denmark. SUBJECTS: 42 alcoholic patients without...... liver disease admitted for elective colorectal surgery. INTERVENTIONS: Withdrawal from alcohol consumption for 1 month before operation (disulfiram controlled) compared with continuous drinking. MAIN OUTCOME MEASURES: Postoperative complications requiring treatment within the first month after surgery...

  8. A randomised controlled trial of a client-centred self-care intervention after stroke

    DEFF Research Database (Denmark)

    Guidetti, Susanne; Ytterberg, Charlotte

    2011-01-01

    services and the caregiver burden. METHOD: An intervention group (IG) received CCSCI and a control group (CG) received ordinary training. Forty individuals with stroke (IG n = 19, CG n = 21) were included. Data were collected at 3, 6 and 12 months using established instruments. RESULTS: After 12 months 24......PURPOSE: The aim of this randomised controlled pilot study of a client-centred self-care intervention (CCSCI) in individuals with stroke was to study (i) the feasibility of the study design, (ii) effects up to 12 months on activities of daily living (ADL), use of informal care and home help...... people remained in the study (IG = 10, CG = 14). The data collection method was acceptable to most participants. At 12 months there were no differences in ADL, use of services or caregiver's burden. Both groups improved significantly and clinically important improvements were achieved by 80% in the IG...

  9. Randomised controlled trial of genetic amniocentesis in 4606 low-risk women

    DEFF Research Database (Denmark)

    Tabor, A; Philip, J; Madsen, Mette

    1986-01-01

    Outcome of pregnancy after amniocentesis was studied in a randomised controlled trial of 4606 women, age-range 25-34 years, without known risk of genetic disease. Spontaneous abortion rate was 1.7% in the study group after amniocentesis and 0.7% in the control group after ultrasound (relative risk...... 2.3). In the study group, increased levels of maternal serum alpha-fetoprotein before amniocentesis, perforation of the placenta during amniocentesis, and withdrawal of discoloured amniotic fluid were associated with an increased risk of spontaneous abortion. In the first six weeks after...... amniocentesis/ultrasound scan, amniotic fluid leakage occurred more often in the study group but there was no difference in the rate of vaginal bleeding. Frequency of postural malformations in the infants in the two groups was the same. In the study group, respiratory distress syndrome was diagnosed more often...

  10. A feasibility randomised controlled trial of the DECIDE intervention: dementia carers making informed decisions

    Science.gov (United States)

    Lord, Kathryn; Livingston, Gill

    2017-01-01

    Summary Family carers report high levels of decisional conflict when deciding whether their relative with dementia can continue to be cared for in their own home. We tested, in a feasibility randomised controlled trial, the first decision aid (the DECIDE manual) aiming to reduce such conflict. Twenty family carers received the DECIDE intervention, and 21 received usual treatment. The intervention group had reduced decisional conflict compared with controls (mean difference −11.96, 95% confidence interval −20.10 to −3.83, P=0.005). All carers receiving the intervention completed and valued it, despite some still reporting difficulties with family conflict and problems negotiating services. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license.

  11. The effects of crisis plans for patients with psychotic and bipolar disorders: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Roosenschoon BJ

    2009-07-01

    Full Text Available Abstract Background Crises and (involuntary admissions have a strong impact on patients and their caregivers. In some countries, including the Netherlands, the number of crises and (involuntary admissions have increased in the last years. There is also a lack of effective interventions to prevent their occurrence. Previous research has shown that a form of psychiatric advance statement – joint crisis plan – may prevent involuntary admissions, but another study showed no significant results for another form. The question remains which form of psychiatric advance statement may help to prevent crisis situations. This study examines the effects of two other psychiatric advance statements. The first is created by the patient with help from a patient's advocate (Patient Advocate Crisis Plan: PACP and the second with the help of a clinician only (Clinician facilitated Crisis Plan: CCP. We investigate whether patients with a PACP or CCP show fewer emergency visits and (involuntary admissions as compared to patients without a psychiatric advance statement. Furthermore, this study seeks to identify possible mechanisms responsible for the effects of a PACP or a CCP. Methods/Design This study is a randomised controlled trial with two intervention groups and one control condition. Both interventions consist of a crisis plan, facilitated through the patient's advocate or the clinician respectively. Outpatients with psychotic or bipolar disorders, who experienced at least one psychiatric crisis during the previous two years, are randomly allocated to one of the three groups. Primary outcomes are the number of emergency (after hour visits, (involuntary admissions and the length of stay in hospital. Secondary outcomes include psychosocial functioning and treatment satisfaction. The possible mediator variables of the effects of the crisis plans are investigated by assessing the patient's involvement in the creation of the crisis plan, working alliance

  12. Prenatal vitamin d supplementation and child respiratory health: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Stephen T Goldring

    Full Text Available BACKGROUND: Observational studies suggest high prenatal vitamin D intake may be associated with reduced childhood wheezing. We examined the effect of prenatal vitamin D on childhood wheezing in an interventional study. METHODS: We randomised 180 pregnant women at 27 weeks gestation to either no vitamin D, 800 IU ergocalciferol daily until delivery or single oral bolus of 200,000 IU cholecalciferol, in an ethnically stratified, randomised controlled trial. Supplementation improved but did not optimise vitamin D status. Researchers blind to allocation assessed offspring at 3 years. Primary outcome was any history of wheeze assessed by validated questionnaire. Secondary outcomes included atopy, respiratory infection, impulse oscillometry and exhaled nitric oxide. Primary analyses used logistic and linear regression. RESULTS: We evaluated 158 of 180 (88% offspring at age 3 years for the primary outcome. Atopy was assessed by skin test for 95 children (53%, serum IgE for 86 (48%, exhaled nitric oxide for 62 (34% and impulse oscillometry of acceptable quality for 51 (28%. We found no difference between supplemented and control groups in risk of wheeze [no vitamin D: 14/50 (28%; any vitamin D: 26/108 (24% (risk ratio 0.86; 95% confidence interval 0.49, 1.50; P = 0.69]. There was no significant difference in atopy, eczema risk, lung function or exhaled nitric oxide between supplemented groups and controls. CONCLUSION: Prenatal vitamin D supplementation in late pregnancy that had a modest effect on cord blood vitamin D level, was not associated with decreased wheezing in offspring at age three years. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN68645785.

  13. Outcomes of a randomised controlled trial of a complex genetic counselling intervention to improve family communication.

    Science.gov (United States)

    Hodgson, Jan; Metcalfe, Sylvia; Gaff, Clara; Donath, Susan; Delatycki, Martin B; Winship, Ingrid; Skene, Loane; Aitken, MaryAnne; Halliday, Jane

    2016-03-01

    When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information.

  14. Implementation of physical coordination training and cognitive behavioural training interventions at cleaning workplaces - secondary analyses of a randomised controlled trial

    DEFF Research Database (Denmark)

    Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias;

    2012-01-01

    This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12-w....... However, thorough consideration should be given to feasibility in the design of interventions. The optimal intervention should be tailored to closely match the implementation context and be robust and flexible to minimise susceptibility to changes in work organisation....

  15. Internet based self-help therapy versus waitlist control group for persons with anxiety disorders: A randomised feasibility study

    DEFF Research Database (Denmark)

    Fenger, Morten Munthe; Lindschou, Jane; Gluud, Christian

    ) FearFighter or B) waitlist control group. Participants are persons with a diagnosis of social phobia, agora phobia, phobia or panic disorder. The intervention with FearFighter is a nine step cognitive behavioural self-help therapy program delivered over the internet over nine weeks. Participants...... mental disorders, national authorities call for more evidence based on randomised clinical trials. Objective: To investigate if persons with an anxiety disorder treated in the IBT program FearFighter will improve and recover. Method: A randomised feasibility study with 64 participants allocated to A...

  16. A Randomised Controlled Trial to Determine the Effectiveness of an Early Psychological Intervention with Children Involved in Road Traffic Accidents

    Science.gov (United States)

    Stallard, Paul; Velleman, Richard; Salter, Emma; Howse, Imogen; Yule, William; Taylor, Gordon

    2006-01-01

    Objective: To determine whether an early intervention using a psychological debriefing format is effective in preventing psychological distress in child road traffic accident survivors. Design: Randomised controlled trial. Setting: Accident and Emergency Department, Royal United Hospital, Bath. Subjects: 158 children aged 7-18. Follow-up…

  17. HPV type in plantar warts influences natural course and treatment response: Secondary analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Bruggink, S.C.; Gussekloo, J.; Koning, M.N. de; Feltkamp, M.C.; Bavinck, J.N.; Quint, W.G.V.; Assendelft, W.J.J.; Eekhof, J.A.H.

    2013-01-01

    BACKGROUND: Cryotherapy is effective for common warts, but for plantar warts available treatments often fail. OBJECTIVES: Within a pragmatic randomised controlled trial, we examined whether subgroups of common and plantar warts have a favourable natural course or response to treatment based on wart-

  18. Do sleep hygiene measures and progressive muscle relaxation influence sleep bruxism? Report of a randomised controlled trial

    NARCIS (Netherlands)

    Valiente López, M.; van Selms, M.K.A.; van der Zaag, J.; Hamburger, H.L.; Lobbezoo, F.

    2015-01-01

    The aim of this study was to assess the effects of sleep hygiene measures combined with relaxation techniques in the management of sleep bruxism (SB) in a double-blind, parallel, controlled, randomised clinical trial design. Sixteen participants (mean ± s.d. age = 39·9 ± 10·8 years) were randomly as

  19. Topical glyceryl trinitrate treatment of chronic patellar tendinopathy : a randomised, double-blind, placebo-controlled clinical trial

    NARCIS (Netherlands)

    Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

    2013-01-01

    Objectives To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN

  20. Effects of Dementia-Care Mapping on Residents and Staff of Care Homes : A Pragmatic Cluster-Randomised Controlled Trial

    NARCIS (Netherlands)

    van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M. M.; Donders, Rogier; Zuidema, Sytse U.; Koopmans, Raymond T. C. M.; Vernooij-Dassen, Myrra J. F. J.

    2013-01-01

    Background: The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we

  1. Effect of dry needling of gluteal muscles on straight leg raise: a randomised, placebo controlled, double blind trial

    OpenAIRE

    Huguenin, L; Brukner, P; McCrory, P; P. Smith; Wajswelner, H; Bennell, K

    2005-01-01

    Objectives: To use a randomised, double blind, placebo controlled trial to establish the effect on straight leg raise, hip internal rotation, and muscle pain of dry needling treatment to the gluteal muscles in athletes with posterior thigh pain referred from gluteal trigger points.

  2. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study

    DEFF Research Database (Denmark)

    Novick, D; Gonzalez-Pinto, A; Haro, J M

    2009-01-01

    OBJECTIVES: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. METHODS: EMBLEM (European Mania in Bipolar Evaluation...

  3. Topical glyceryl trinitrate treatment of chronic patellar tendinopathy : a randomised, double-blind, placebo-controlled clinical trial

    NARCIS (Netherlands)

    Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

    Objectives To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN

  4. Walking or vitamin B for cognition in older adults with mild cognitive impairment? A randomised controlled trial

    NARCIS (Netherlands)

    Uffelen, J.G.Z. van; Chinapaw, M.J.M.; Mechelen, W. van; Hopman-Rock, M.

    2008-01-01

    Objective: To examine the effects of aerobic exercise or vitamin B supplementation on cognitive function in older adults with mild cognitive impairment (MCI). Design: Randomised placebo-controlled trial. Setting: General community. Participants: Community-dwelling adults aged 70-80 with MCI.

  5. Effects of Dementia-Care Mapping on Residents and Staff of Care Homes : A Pragmatic Cluster-Randomised Controlled Trial

    NARCIS (Netherlands)

    van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M. M.; Donders, Rogier; Zuidema, Sytse U.; Koopmans, Raymond T. C. M.; Vernooij-Dassen, Myrra J. F. J.

    2013-01-01

    Background: The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we stud

  6. HPV type in plantar warts influences natural course and treatment response: Secondary analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Bruggink, S.C.; Gussekloo, J.; Koning, M.N. de; Feltkamp, M.C.; Bavinck, J.N.; Quint, W.G.V.; Assendelft, W.J.J.; Eekhof, J.A.H.

    2013-01-01

    BACKGROUND: Cryotherapy is effective for common warts, but for plantar warts available treatments often fail. OBJECTIVES: Within a pragmatic randomised controlled trial, we examined whether subgroups of common and plantar warts have a favourable natural course or response to treatment based on

  7. Predictors of employment for people with severe mental illness : results of an international six-centre randomised controlled trial

    NARCIS (Netherlands)

    Catty, Jocelyn; Lissouba, Pascale; White, Sarah; Becker, Thomas; Drake, Robert E.; Fioritti, Angelo; Knapp, Martin; Lauber, Christoph; Roessler, Wulf; Tomov, Toma; Van Busschbach, Jooske; Wiersma, Durk; Burns, Tom; Rossler, W.

    2008-01-01

    Background An international six-centre randomised controlled trial comparing individual placement and support (IPS) with usual vocational rehabilitation for people with serious mental illness found IPS to be more effective for all vocational outcomes. Aims To determine which patients with severe men

  8. Effectiveness of collaborative stepped care for anxiety disorders in primary care : A pragmatic cluster randomised controlled trial

    NARCIS (Netherlands)

    Muntingh, A.D.T.; van der Feltz-Cornelis, C.M.; van Marwijk, H.W.J.; Spinhoven, P.; Assendelft, W.; de Waal, M.W.; Adèr, H.J.; van Balkom, A.J.

    2014-01-01

    Background: Collaborative stepped care (CSC) may be an appropriate model to provide evidence-based treatment for anxiety disorders in primary care. Methods: In a cluster randomised controlled trial, the effectiveness of CSC compared to care as usual (CAU) for adults with panic disorder (PD) or gener

  9. Walking or vitamin B for cognition in older adults with mild cognitive impairment? A randomised controlled trial

    NARCIS (Netherlands)

    Uffelen, J.G.Z. van; Chinapaw, M.J.M.; Mechelen, W. van; Hopman-Rock, M.

    2008-01-01

    Objective: To examine the effects of aerobic exercise or vitamin B supplementation on cognitive function in older adults with mild cognitive impairment (MCI). Design: Randomised placebo-controlled trial. Setting: General community. Participants: Community-dwelling adults aged 70-80 with MCI. Interve

  10. Effects of health education for migrant females with psychosomatic complaints treated by general practitioners. A randomised controlled evaluation study

    NARCIS (Netherlands)

    Kocken, P.L.; Zwanenburg, E.J.-v.; Hoop, T.de

    2008-01-01

    Objective: : The effectiveness of use of migrant health educators in the general practitioners' care for female migrants with psychosomatic problems was evaluated to contribute to the improvement of the care for these patients. Methods: : A randomised controlled trial (RCT) design was used. A total

  11. Cognitive behaviour therapy to prevent complicated grief among relatives and spouses bereaved by suicide : cluster randomised controlled trial

    NARCIS (Netherlands)

    de Groot, M.; de Keijser, J.; Neeleman, J.; Kerkhof, A.; Nolen, W.; Burger, H.

    2007-01-01

    Objective To examine the effectiveness of a family based grief counselling programme to prevent complicated grief among first degree relatives and spouses of someone who had committed suicide. Design Cluster randomised controlled trial with follow-up at 13 months after the suicide. Setting General p

  12. A Randomised Controlled Trial Using Mobile Advertising to Promote Safer Sex and Sun Safety to Young People

    Science.gov (United States)

    Gold, J.; Aitken, C. K.; Dixon, H. G.; Lim, M. S. C.; Gouillou, M.; Spelman, T.; Wakefield, M.; Hellard, M. E.

    2011-01-01

    Mobile phone text messages (SMS) are a promising method of health promotion, but a simple and low cost way to obtain phone numbers is required to reach a wide population. We conducted a randomised controlled trial with simultaneous brief interventions to (i) evaluate effectiveness of messages related to safer sex and sun safety and (ii) pilot the…

  13. Multicentre, randomised controlled trial of a low-cost smoking cessation text message intervention for pregnant smokers (MiQuit)

    OpenAIRE

    Naughton, Felix; Foster, Katharine; Emery, Jo; Cooper, Sue; Sutton, Stephen; Leonardi-Bee, Jo; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

    2016-01-01

    Background: Text message cessation programmes have potential to change smoking behaviour during pregnancy but their effectiveness is unknown. This study aimed to estimate key parameters, including effectiveness and cost-effectiveness, for delivering a definitive effectiveness trial of a pregnancy specific, theory-guided, tailored text message cessation intervention. \\ud \\ud Methods: Multicentre, single-blinded, randomised controlled trial. Pregnant smokers (

  14. A Randomised Controlled Trial Using Mobile Advertising to Promote Safer Sex and Sun Safety to Young People

    Science.gov (United States)

    Gold, J.; Aitken, C. K.; Dixon, H. G.; Lim, M. S. C.; Gouillou, M.; Spelman, T.; Wakefield, M.; Hellard, M. E.

    2011-01-01

    Mobile phone text messages (SMS) are a promising method of health promotion, but a simple and low cost way to obtain phone numbers is required to reach a wide population. We conducted a randomised controlled trial with simultaneous brief interventions to (i) evaluate effectiveness of messages related to safer sex and sun safety and (ii) pilot the…

  15. Mime therapy improves facial symmetry in people with long-term facial nerve paresis: a randomised controlled trial.

    NARCIS (Netherlands)

    Beurskens, C.H.G.; Heymans, P.G.

    2006-01-01

    QUESTION: What is the effect of mime therapy on facial symmetry and severity of paresis in people with facial nerve paresis? DESIGN: Randomised controlled trial. PARTICIPANTS: 50 people recruited from the Outpatient department of two metropolitan hospitals with facial nerve paresis for more than nin

  16. Internet-based stress management for distressed managers: results from a randomised controlled trial.

    Science.gov (United States)

    Persson Asplund, Robert; Dagöö, Jesper; Fjellström, Ida; Niemi, Linnea; Hansson, Katja; Zeraati, Forough; Ziuzina, Masha; Geraedts, Anna; Ljótsson, Brjánn; Carlbring, Per; Andersson, Gerhard

    2017-08-30

    The aim of this randomised controlled trial (RCT) was to evaluate the efficacy of a guided internet-based stress management intervention (iSMI) among distressed managers compared with a attention control group (AC) with full access to treatment-as-usual. A total sample of 117 distressed managers, mainly employed in the healthcare, IT, communication and educational sector, were randomised to either iSMI (n=59) or an AC group (n=58). The iSMI consisted of eight modules including cognitive behavioural stress management and positive management techniques. Participants received a minimal and weekly guidance from a psychologist or master-level psychology student focusing on support, feedback and adherence to the intervention. Self-report data were assessed at pre, post and 6 months after the intervention. The primary outcome was perceived stress (Perceived Stress Scale-14). The secondary outcomes included mental and work-related health outcomes. Participants in the iSMI intervention reported significantly less symptoms of perceived stress (d=0.74, 95% CI 0.30 to 1.19) and burnout (d=0.95, 95% CI 0.53 to 1.37) compared with controls, at postassessment. Significant medium-to-large effect sizes were also found for depression, insomnia and job satisfaction. Long-term effects (6 months) were seen on the mental health outcomes. This is one of the first studies showing that iSMIs can be an effective, accessible and potentially time-effective approach of reducing stress and other mental-related and work-related health symptoms among distressed managers. Future studies are needed addressing distressed managers and the potential of indirect effects on employee stress and satisfaction at work. © 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.

  17. Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial

    Science.gov (United States)

    Williams, Margiad Elen; Hastings, Richard; Charles, Joanna Mary; Evans, Sue; Hutchings, Judy

    2017-01-01

    Introduction Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs. Methods and analysis The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3–8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes. Ethics and dissemination Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016–15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer

  18. Nordic Walking improves daily physical activities in COPD: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Breyer Marie-Kathrin

    2010-08-01

    Full Text Available Abstract Background In patients with COPD progressive dyspnoea leads to a sedentary lifestyle. To date, no studies exist investigating the effects of Nordic Walking in patients with COPD. Therefore, the aim was to determine the feasibility of Nordic Walking in COPD patients at different disease stages. Furthermore we aimed to determine the short- and long-term effects of Nordic Walking on COPD patients' daily physical activity pattern as well as on patients exercise capacity. Methods Sixty COPD patients were randomised to either Nordic Walking or to a control group. Patients of the Nordic Walking group (n = 30; age: 62 ± 9 years; FEV1: 48 ± 19% predicted underwent a three-month outdoor Nordic Walking exercise program consisting of one hour walking at 75% of their initial maximum heart rate three times per week, whereas controls had no exercise intervention. Primary endpoint: daily physical activities (measured by a validated tri-axial accelerometer; secondary endpoint: functional exercise capacity (measured by the six-minute walking distance; 6MWD. Assessment time points in both groups: baseline, after three, six and nine months. Results After three month training period, in the Nordic Walking group time spent walking and standing as well as intensity of walking increased (Δ walking time: +14.9 ± 1.9 min/day; Δ standing time: +129 ± 26 min/day; Δ movement intensity: +0.40 ± 0.14 m/s2 while time spent sitting decreased (Δ sitting time: -128 ± 15 min/day compared to baseline (all: p Conclusions Nordic Walking is a feasible, simple and effective physical training modality in COPD. In addition, Nordic Walking has proven to positively impact the daily physical activity pattern of COPD patients under short- and long-term observation. Clinical trial registration Nordic Walking improves daily physical activities in COPD: a randomised controlled trial - ISRCTN31525632

  19. Exercise therapy for Stress-related mental disorder, a randomised controlled trial in primary care

    Directory of Open Access Journals (Sweden)

    Donker Marieke

    2011-07-01

    Full Text Available Abstract Background to investigate whether a structured physical exercise programme (PEP improves the recovery of general health in patients suffering from Stress-related Mental Disorder (SMD. Method Study design: randomised open trial in general practice. Patients from two regions in the Netherlands were included between September 2003 and December 2005, and followed up for 12 weeks. Intervention: the patients were referred to a physical therapist for instruction in and monitoring of physical exercise of an intermediate intensity. Following the Dutch Guidelines for Healthy Physical Exercise, the patients were instructed to exercise at least five times a week, for at least 30 minutes per day. Control group: usual care from the GP Outcome Primary: improvement of general health after 6 weeks according to the 'general health' dimension of the Short-Form 36. Secondary: total days off work, percentage that resumed work after 6 and 12 weeks, change in distress score and change in remaining SF36 dimensions after 6 and 12 weeks. Results out of 102 randomised patients (mean age 43, 60 (59% female, 70 (68% completed the trial, of whom 31 were in the intervention group. After 6 weeks, the mean (SD general health score was 54.6 (22.1 for the intervention group and 57.5 (19.2 for the controls. The corresponding effect size (Cohen's d with 95% confidence interval from analysis of covariance was -0.06 (-0.41, 0.30 indicating no effect on general health. No significant effects of the intervention were detected for any secondary outcome parameter either. Conclusion Notwithstanding the relatively high drop-out rate, our results suggest that referral to a physical therapist for structured physical exercise is not likely to be very effective in improving recovery from SMD. Trial registry Current Controlled Trials ISRCTN15609105

  20. Effectiveness of a smartphone app in increasing physical activity amongst male adults: a randomised controlled trial.

    Science.gov (United States)

    Harries, Tim; Eslambolchilar, Parisa; Rettie, Ruth; Stride, Chris; Walton, Simon; van Woerden, Hugo C

    2016-09-02

    Smartphones are ideal for promoting physical activity in those with little intrinsic motivation for exercise. This study tested three hypotheses: H1 - receipt of social feedback generates higher step-counts than receipt of no feedback; H2 - receipt of social feedback generates higher step-counts than only receiving feedback on one's own walking; H3 - receipt of feedback on one's own walking generates higher step-counts than no feedback (H3). A parallel group randomised controlled trial measured the impact of feedback on steps-counts. Healthy male participants (n = 165) aged 18-40 were given phones pre-installed with an app that recorded steps continuously, without the need for user activation. Participants carried these with them as their main phones for a two-week run-in and six-week trial. Randomisation was to three groups: no feedback (control); personal feedback on step-counts; group feedback comparing step-counts against those taken by others in their group. The primary outcome measure, steps per day, was assessed using longitudinal multilevel regression analysis. Control variables included attitude to physical activity and perceived barriers to physical activity. Fifty-five participants were allocated to each group; 152 completed the study and were included in the analysis: n = 49, no feedback; n = 53, individual feedback; n = 50, individual and social feedback. The study provided support for H1 and H3 but not H2. Receipt of either form of feedback explained 7.7 % of between-subject variability in step-count (F = 6.626, p smartphone apps that provide step-counts can increase physical activity in young to early-middle-aged men but the provision of social feedback has no apparent incremental impact. This approach may be particularly suitable for inactive people with low levels of physical activity; it should now be tested with this population.

  1. The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis.

    Science.gov (United States)

    Freeman, Daniel; Sheaves, Bryony; Goodwin, Guy M; Yu, Ly-Mee; Nickless, Alecia; Harrison, Paul J; Emsley, Richard; Luik, Annemarie I; Foster, Russell G; Wadekar, Vanashree; Hinds, Christopher; Gumley, Andrew; Jones, Ray; Lightman, Stafford; Jones, Steve; Bentall, Richard; Kinderman, Peter; Rowse, Georgina; Brugha, Traolach; Blagrove, Mark; Gregory, Alice M; Fleming, Leanne; Walklet, Elaine; Glazebrook, Cris; Davies, E Bethan; Hollis, Chris; Haddock, Gillian; John, Bev; Coulson, Mark; Fowler, David; Pugh, Katherine; Cape, John; Moseley, Peter; Brown, Gary; Hughes, Claire; Obonsawin, Marc; Coker, Sian; Watkins, Edward; Schwannauer, Matthias; MacMahon, Kenneth; Siriwardena, A Niroshan; Espie, Colin A

    2017-10-01

    Sleep difficulties might be a contributory causal factor in the occurrence of mental health problems. If this is true, improving sleep should benefit psychological health. We aimed to determine whether treating insomnia leads to a reduction in paranoia and hallucinations. We did this single-blind, randomised controlled trial (OASIS) at 26 UK universities. University students with insomnia were randomly assigned (1:1) with simple randomisation to receive digital cognitive behavioural therapy (CBT) for insomnia or usual care, and the research team were masked to the treatment. Online assessments took place at weeks 0, 3, 10 (end of therapy), and 22. The primary outcome measures were for insomnia, paranoia, and hallucinatory experiences. We did intention-to-treat analyses. The trial is registered with the ISRCTN registry, number ISRCTN61272251. Between March 5, 2015, and Feb 17, 2016, we randomly assigned 3755 participants to receive digital CBT for insomnia (n=1891) or usual practice (n=1864). Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohen's d=1·11; p<0·0001), paranoia (-2·22, -2·98 to -1·45, Cohen's d=0·19; p<0·0001), and hallucinations (-1·58, -1·98 to -1·18, Cohen's d=0·24; p<0·0001). Insomnia was a mediator of change in paranoia and hallucinations. No adverse events were reported. To our knowledge, this is the largest randomised controlled trial of a psychological intervention for a mental health problem. It provides strong evidence that insomnia is a causal factor in the occurrence of psychotic experiences and other mental health problems. Whether the results generalise beyond a student population requires testing. The treatment of disrupted sleep might require a higher priority in mental health provision. Wellcome Trust. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by

  2. Aquatic therapy for boys with Duchenne muscular dystrophy (DMD): an external pilot randomised controlled trial.

    Science.gov (United States)

    Hind, Daniel; Parkin, James; Whitworth, Victoria; Rex, Saleema; Young, Tracey; Hampson, Lisa; Sheehan, Jennie; Maguire, Chin; Cantrill, Hannah; Scott, Elaine; Epps, Heather; Main, Marion; Geary, Michelle; McMurchie, Heather; Pallant, Lindsey; Woods, Daniel; Freeman, Jennifer; Lee, Ellen; Eagle, Michelle; Willis, Tracey; Muntoni, Francesco; Baxter, Peter

    2017-01-01

    Standard treatment of Duchenne muscular dystrophy (DMD) includes regular physiotherapy. There are no data to show whether adding aquatic therapy (AT) to land-based exercises helps maintain motor function. We assessed the feasibility of recruiting and collecting data from boys with DMD in a parallel-group pilot randomised trial (primary objective), also assessing how intervention and trial procedures work. Ambulant boys with DMD aged 7-16 years established on steroids, with North Star Ambulatory Assessment (NSAA) score ≥8, who were able to complete a 10-m walk test without aids or assistance, were randomly allocated (1:1) to 6 months of either optimised land-based exercises 4 to 6 days/week, defined by local community physiotherapists, or the same 4 days/week plus AT 2 days/week. Those unable to commit to a programme, with >20% variation between NSAA scores 4 weeks apart, or contraindications to AT were excluded. The main outcome measures included feasibility of recruiting 40 participants in 6 months from six UK centres, clinical outcomes including NSAA, independent assessment of treatment optimisation, participant/therapist views on acceptability of intervention and research protocols, value of information (VoI) analysis and cost-impact analysis. Over 6 months, 348 boys were screened: most lived too far from centres or were enrolled in other trials; 12 (30% of the targets) were randomised to AT (n = 8) or control (n = 4). The mean change in NSAA at 6 months was -5.5 (SD 7.8) in the control arm and -2.8 (SD 4.1) in the AT arm. Harms included fatigue in two boys, pain in one. Physiotherapists and parents valued AT but believed it should be delivered in community settings. Randomisation was unattractive to families, who had already decided that AT was useful and who often preferred to enrol in drug studies. The AT prescription was considered to be optimised for three boys, with other boys given programmes that were too extensive and insufficiently

  3. A community empowerment strategy embedded in a routine dengue vector control programme: a cluster randomised controlled trial.

    Science.gov (United States)

    Castro, Marta; Sánchez, Lizet; Pérez, Dennis; Carbonell, Nestor; Lefèvre, Pierre; Vanlerberghe, Veerle; Van der Stuyft, Patrick

    2012-05-01

    The non-sustainability of vertically organised dengue vector control programmes led to pleas for changing the emphasis towards community-based strategies. We conducted a cluster randomised controlled trial with 16 intervention and 16 control clusters to test the effectiveness of a community empowerment strategy intertwined with the routine dengue vector control programme in La Lisa, Havana City, Cuba. The intervention included four components on top of routine control: organisation and management; entomological risk surveillance; capacity building; and community work for vector control. In the control clusters, routine activities continued without interference. The community participation score increased from 1.4 to 3.4. Good knowledge of breeding sites increased by 52.8% and 27.5% in the intervention and control clusters, respectively. There were no changes in adequate Aedes aegypti control practices at household level in the control clusters, but in the intervention clusters adequacy increased by 36.2%. At baseline, the Breteau indices (BI) were approximately 0.1 and were comparable; they fluctuated over time but became different with the launch of the community-based dengue control activities in the intervention clusters. Over the intervention period, the BI remained 53% (95% CI 22-92%) lower in these clusters than in the control clusters. The empowerment strategy increased community involvement and added effectiveness to routine A. aegypti control.

  4. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    DEFF Research Database (Denmark)

    Bello, Segun; Wei, Maoling; Hilden, Jørgen

    2016-01-01

    Background: Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided...... published before 1977. The studies differed considerably with regard to design, methodology and analysis. Sixteen of the 36 studies (44 %) concluded inadequate matching. When we adapted high or low thresholds for inadequate matching, the number of trials with inadequate matching was reduced to 12 (33...... to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods: Systematic review. We searched Pub...

  5. Casein improves brachial and central aortic diastolic blood pressure in overweight adolescents: a randomised, controlled trial

    DEFF Research Database (Denmark)

    Arnberg, Karina; Larnkjær, Anni; Michaelsen, Kim F.

    2013-01-01

    Arterial stiffness, blood pressure (BP) and blood lipids may be improved by milk in adults and the effects may be mediated via proteins. However, limited is known about the effects of milk proteins on central aortic BP and no studies have examined the effects in children. Therefore, the present...... stiffness or blood lipid concentrations. A high intake of casein improves DBP in overweight adolescents. Thus, casein may be beneficial for younger overweight subjects in terms of reducing the longterm risk of CVD. In contrast, whey protein seems to increase BP compared with drinking water; however, water...... trial examined the effect of milk and milk proteins on brachial and central aortic BP, blood lipids, inflammation and arterial stiffness in overweight adolescents. A randomised controlled trial was conducted in 193 overweight adolescents aged 12–15 years. They were randomly assigned to drink 1 litre...

  6. Randomised controlled trial of extraarticular gold bead implantation for treatment of knee osteoarthritis: a pilot study

    DEFF Research Database (Denmark)

    Nejrup, Kirsten; Olivarius, Niels de Fine; Jacobsen, Judith L.

    2008-01-01

    The primary objective of this double-blind, randomised, controlled trial was to determine if implanting gold beads at five acupuncture points around the knee joint improves 1-year outcomes for patients with osteoarthritis (OA) of the knee. Participants were 43 adults aged 18-80 years with pain...... and stiffness from non-specific OA of the knee for over a year. The intervention was blinded implantation of gold beads at five acupuncture points around the affected knee through a hypodermic needle, or needle insertion alone. Primary outcome measures were knee pain, stiffness and function assessed...... acupuncture had greater relative improvements in self-assessed outcomes. The treatment was well tolerated. This 1-year pilot study indicates that extraarticular gold bead implantation is a promising treatment modality for patients with OA of the knee. The new treatment should be tested in a larger trial...

  7. A randomised controlled study of mindfulness meditation versus relaxation therapy in the management of tinnitus.

    Science.gov (United States)

    Arif, M; Sadlier, M; Rajenderkumar, D; James, J; Tahir, T

    2017-06-01

    Psychotherapeutic interventions have been adopted effectively in the management of tinnitus for a long time. This study compared mindfulness meditation and relaxation therapy for management of tinnitus. In this randomised controlled trial, patients were recruited for five sessions of mindfulness meditation or five sessions of relaxation therapy. Patients' responses were evaluated using the Tinnitus Reaction Questionnaire as a primary outcome measure, and the Hospital Anxiety and Depression Scale, visual analogue scale and a health status indicator as secondary outcome measures. A total of 86 patients were recruited. Thirty-four patients completed mindfulness meditation and 27 patients completed relaxation therapy. Statistically significant improvement was seen in all outcome measures except the health status indicator in both treatment groups. The change in treatment scores was greater in the mindfulness meditation group than in the relaxation therapy group. This study suggests that although both mindfulness meditation and relaxation therapy are effective in the management of tinnitus, mindfulness meditation is superior to relaxation therapy.

  8. Cereal fibre and type 2 diabetes: time now for randomised controlled trials?

    Science.gov (United States)

    Whincup, Peter H; Donin, Angela S

    2015-07-01

    Diet and nutrition are strongly implicated in the aetiology of type 2 diabetes; low dietary fibre intake could be an important factor. Evidence from prospective observational studies has suggested that it may be low cereal fibre intake, rather than low fruit and vegetable fibre intake, which is particularly important. In this issue of Diabetologia (DOI 10.1007/s00125-015-3585-9 ) Kuijsten et al report on the prospective associations between different dietary fibre sources and type 2 diabetes risk in the European Prospective Investigation of Cancer and Nutrition (EPIC)-Interact study and set their findings in context with a meta-analysis of relevant published prospective studies. The results presented strengthen the evidence implicating cereal fibre as an important determinant of type 2 diabetes risk and suggest that randomised controlled trials examining the effect of cereal fibre supplementation on type 2 diabetes risk are now needed.

  9. Effect of bottles, cups, and dummies on breast feeding in preterm infants: a randomised controlled trial.

    Science.gov (United States)

    Collins, Carmel T; Ryan, Philip; Crowther, Caroline A; McPhee, Andrew J; Paterson, Susan; Hiller, Janet E

    2004-07-24

    To determine the effect of artificial teats (bottle and dummy) and cups on breast feeding in preterm infants. Randomised controlled trial. Two large tertiary hospitals, 54 peripheral hospitals. 319 preterm infants (born at 23-33 weeks' gestation) randomly assigned to one of four groups: cup/no dummy (n = 89), cup/dummy (n = 72), bottle/no dummy (n = 73), bottle/dummy (n = 85). Women with singleton or twin infants Dummies do not affect breast feeding in preterm infants. Cup feeding significantly increases the likelihood that the baby will be fully breast fed at discharge home, but has no effect on any breast feeding and increases the length of hospital stay.

  10. Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial.

    Science.gov (United States)

    Misra, Usha Kant; Kalita, Jayantee; Yadav, Rama Kant

    2007-06-01

    The objective of this study was to compare the efficacy of rizatriptan and ibuprofen in migraine. The study was a randomised placebo-controlled trial in a tertiary care teaching hospital. Migraine patients with rizatriptan 10 mg (53), ibuprofen 400 mg (52) and placebo (50). Efficacy was assessed by headache relief, and headache freedom at 2 h and 24 h. Two-hour headache relief, was noted in 73% in rizatriptan, 53.8% in ibuprofen and 8% in placebo groups. Headache freedom was achieved in 37.7% in rizatriptan, 30.8% in ibuprofen and 2% in placebo groups. Rizatriptan was superior to ibuprofen and placebo in relieving headache at 2 h but not at 24 h. Side effects were noted in 9 patients in rizatriptan, 8 in ibuprofen and 3 in placebo, all of which were nonsignificant. Rizatriptan and ibuprofen are superior to placebo. Rizatriptan is superior to ibuprofen in relieving headache, associated symptoms and functional disability.

  11. Randomised controlled trials of iron chelators for the treatment of cardiac siderosis in thalassaemia major

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    Arun John Baksi

    2014-09-01

    Full Text Available In conditions requiring repeated blood transfusion or where iron metabolism is abnormal, heart failure may result from accumulation of iron in the heart (cardiac siderosis. Death due to heart failure from cardiac iron overload has accounted for considerable early mortality in β-thalassemia major. The ability to detect iron loading in the heart by cardiovascular magnetic resonance using T2* sequences has created an opportunity to intervene in the natural history of such conditions. However, effective and well tolerated therapy is required to remove iron from the heart. There are currently 3 approved commercially available iron chelators: deferoxamine, deferiprone and deferasirox. We review the high quality randomised controlled trials in this area for iron chelation therapy in the management of cardiac siderosis.

  12. Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: climbing mountains or pushing boulders uphill?

    Science.gov (United States)

    Hoddinott, Pat; Britten, Jane; Harrild, Kirsten; Godden, David J

    2007-05-01

    Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this paper, we discuss how choosing which population cluster to randomise can impact on the practicalities of recruitment in primary care. We describe strategies developed through our experiences of recruiting primary care organisations to participate in a national randomised controlled trial of a policy to provide community breastfeeding groups for pregnant and breastfeeding mothers, the BIG (Breastfeeding in Groups) trial. We propose an iterative qualitative approach to recruitment; collecting data generated through the recruitment process, identifying themes and using the constant comparative method of analysis. This can assist in developing successful recruitment strategies and contrasts with the standardised approach commonly used when recruiting individuals to participate in randomised controlled trials. Recruiting primary care population clusters to participate in trials is currently an uphill battle in Britain. It is a complex process, which can benefit from applying qualitative methods to inform trial design and recruitment strategy. Recruitment could be facilitated if health service managers were committed to supporting peer reviewed, funded and ethics committee approved research at national level.

  13. A randomised, double-blind, placebo-controlled trial of tropisetron in patients with schizophrenia

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    Shiraishi Tetsuya

    2010-06-01

    Full Text Available Abstract Background Cognitive deficits in schizophrenia are associated with psychosocial deficits that are primarily responsible for the poor long-term outcome of this disease. Auditory sensory gating P50 deficits are correlated with neuropsychological deficits in attention, one of the principal cognitive disturbances in schizophrenia. Our studies suggest that the α7 nicotinic acetylcholine receptor (α7 nAChR agonist tropisetron might be a potential therapeutic drug for cognitive deficits in schizophrenia. Therefore, it is of particular interest to investigate the effects of tropisetron on the cognitive deficits in patients with schizophrenia. Methods A randomised, placebo-controlled trial of tropisetron in patients with schizophrenia was performed. A total of 40 patients with chronic schizophrenia who had taken risperidone (2 to 6 mg/day were enrolled. Subjects were randomly assigned to a fixed titration of tropisetron (n = 20, 10 mg/day or placebo (n = 20 in an 8-week double-blind trial. Auditory sensory gating P50 deficits and Quality of Life Scale (QLS, Cambridge Neuropsychological Test Automated Battery (CANTAB, and Positive and Negative Syndrome Scale (PANSS scores were measured. Results In all, 33 patients completed the trial. Tropisetron was well tolerated. Administration of tropisetron, but not placebo, significantly improved auditory sensory gating P50 deficits in non-smoking patients with schizophrenia. The score on the rapid visual information processing (sustained visual attention task of CANTAB was significantly improved by tropisetron treatment. Total and subscale scores of PANSS were not changed by this trial. QLS scores in the all patients, but not non-smoking patients, were significantly improved by tropisetron trial. Conclusions This first randomised, double-blind, placebo-controlled trial supports the safety and efficacy of adjunctive tropisetron for treatment of cognitive deficits in schizophrenia.

  14. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Science.gov (United States)

    Eldridge, Sandra M; Lancaster, Gillian A; Campbell, Michael J; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L; Bond, Christine M

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  15. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Directory of Open Access Journals (Sweden)

    Sandra M Eldridge

    Full Text Available We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  16. Study protocol: follow-up home visits with nutrition: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Beck Anne Marie

    2011-12-01

    Full Text Available Abstract Background Geriatric patients are at high risk of re-admission after discharge. Pre-existing nutritional risk amongst these patients is of primary concern, with former nutritional intervention studies being largely ineffective. None of these studies has included individual dietary counselling by a registered dietician or has considered competing medical conditions in the participants. A former randomised study has shown that comprehensive discharge follow-up in geriatric patients homes by general practitioners and district nurses was effective in reducing the re-admission risk in the intervention group compared to the control group. That study did not include a nutritional intervention. The purpose of this study is to assess the combined benefits of an intervention consisting of discharge follow-up in geriatric patients' home by a general practitioner and a registered dietician. Methods/design This single-blind randomised controlled study, will recruit 160 hospitalised geriatric medical patients (65+ y at nutritional risk. Participants will be randomly allocated to receive in their homes, either 12 weeks individualised nutritional counselling by a registered dietician complemented with follow-up by general practitioners or a 12 weeks follow-up by general practitioners alone. Discussion This trial is the first of its kind to provide individual nutritional intervention combined with follow-up by general practitioner as an intervention to reduce risk of re-admission after discharge among geriatric medical patients. The results will hopefully help to guide the development of more effective rehabilitation programs following hospital admissions, which may ultimately lead to reduced health care costs, and improvement in mobility, independence and quality of life for geriatric patients at nutritional risk. Trial Registration ClinicalTrials.gov 2010 NCT01249716

  17. Challenges of a community based pragmatic, randomised controlled trial of weight loss maintenance.

    Science.gov (United States)

    Randell, Elizabeth; McNamara, Rachel; Shaw, Christine; Espinasse, Aude; Simpson, Sharon Anne

    2015-12-18

    Randomised controlled trials (RCTs) have a reputation for being inherently difficult to deliver as planned and often face unforeseen challenges and delays, particularly in relation to organisational and governance difficulties, participant interest, constraints due to allocation of costs, local investigator interest and lengthy bureaucracy. Recruitment is often difficult and the challenges faced often impact on the cost and delivery of a successful trial within the funded period. This paper reflects upon the challenges faced in delivering a pragmatic RCT of weight loss maintenance in a community setting and suggests some potential solutions. The weight loss maintenance in adults trial aimed to evaluate the impact of a 12 month, individually tailored weight maintenance intervention on BMI 3 years from randomisation. Participants were recruited primarily from participant identification centres (PICs)-GP surgeries, exercise on referral schemes and slimming world. The intervention was delivered in community settings. A recruitment strategy implementation plan was drafted to address and monitor poor recruitment. Delays in opening and recruitment were experienced early on. Some were beyond the control of the study team such as; disagreement over allocation of national health service costs and PIC classification as well as difficulties in securing support from research networks. That the intervention was delivered in community settings was often at the root of these issues. Key items to address at the design stage of future trials include feasibility of eligibility criteria. The most effective element of the recruitment implementation plan was to refocus sources of recruitment and target only those who could fulfil the eligibility criteria immediately. Learnings from this trial should be kept in mind by those designing similar studies in the future. Considering potential governance, cost and research network support implications at the design stage of pragmatic trials of

  18. Recruiting older people to a randomised controlled dietary intervention trial - how hard can it be?

    Directory of Open Access Journals (Sweden)

    Pockley A Graham

    2010-02-01

    Full Text Available Abstract Background The success of a human intervention trial depends upon the ability to recruit eligible volunteers. Many trials fail because of unrealistic recruitment targets and flawed recruitment strategies. In order to predict recruitment rates accurately, researchers need information on the relative success of various recruitment strategies. Few published trials include such information and the number of participants screened or approached is not always cited. Methods This paper will describe in detail the recruitment strategies employed to identify older adults for recruitment to a 6-month randomised controlled dietary intervention trial which aimed to explore the relationship between diet and immune function (The FIT study. The number of people approached and recruited, and the reasons for exclusion, will be discussed. Results Two hundred and seventeen participants were recruited to the trial. A total of 7,482 letters were sent to potential recruits using names and addresses that had been supplied by local Family (General Practices. Eight hundred and forty three potential recruits replied to all methods of recruitment (528 from GP letters and 315 from other methods. The eligibility of those who replied was determined using a screening telephone interview, 217 of whom were found to be suitable and agreed to take part in the study. Conclusion The study demonstrates the application of multiple recruitment methods to successfully recruit older people to a randomised controlled trial. The most successful recruitment method was by contacting potential recruits by letter on NHS headed note paper using contacts provided from General Practices. Ninety percent of recruitment was achieved using this method. Adequate recruitment is fundamental to the success of a research project, and appropriate strategies must therefore be adopted in order to identify eligible individuals and achieve recruitment targets. Trial registration number ISRCTN45031464.

  19. A randomised controlled trial of acceptance and commitment therapy (ACT) for psychosis: study protocol.

    Science.gov (United States)

    Thomas, Neil; Shawyer, Frances; Castle, David J; Copolov, David; Hayes, Steven C; Farhall, John

    2014-07-11

    Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis. It is, however, a challenging therapy to deliver and, in the context of increasingly rigorous trials, recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes. Acceptance and commitment therapy shows promise as a briefer, more easily implemented therapy but has not yet been rigorously evaluated in the context of psychosis. The purpose of this trial is to evaluate whether Acceptance and Commitment Therapy could reduce the distress and disability associated with psychotic symptoms in a sample of community-residing patients with chronic medication-resistant symptoms. This is a single (rater)-blind multi-centre randomised controlled trial comparing Acceptance and Commitment Therapy with an active comparison condition, Befriending. Eligible participants have current residual hallucinations or delusions with associated distress or disability which have been present continuously over the past six months despite therapeutic doses of antipsychotic medication. Following baseline assessment, participants are randomly allocated to treatment condition with blinded, post-treatment assessments conducted at the end of treatment and at 6 months follow-up. The primary outcome is overall mental state as measured using the Positive and Negative Syndrome Scale. Secondary outcomes include preoccupation, conviction, distress and disruption to life associated with symptoms as measured by the Psychotic Symptom Rating Scales, as well as social functioning and service utilisation. The main analyses will be by intention-to-treat using mixed-model repeated measures with non-parametric methods employed if required. The model of change underpinning ACT will be tested using mediation analyses. This protocol describes the first randomised controlled trial of Acceptance and commitment therapy in chronic medication-resistant psychosis

  20. What can qualitative research do for randomised controlled trials? A systematic mapping review

    Science.gov (United States)

    O'Cathain, A; Thomas, K J; Drabble, S J; Rudolph, A; Hewison, J

    2013-01-01

    Objective To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. Design Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sources MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteria Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. Conclusions A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit

  1. Reducing Delusional Conviction Through a Cognitive-Based Group Training Game: A Multicentre Randomised Controlled Trial

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    Yasser eKhazaal

    2015-04-01

    Full Text Available AbstractObjective: Michael’s Game is a card game targeting the ability to generate alternative hypotheses to explain a given experience. The main objective was to evaluate the effect of MG on delusional conviction as measured by the primary study outcome: the change in scores on the conviction subscale of the Peters Delusions Inventory (PDI-21. Other variables of interest were the change in scores on the distress and preoccupation subscales of the PDI-21, the Brief Psychiatric Rating Scale, the Beck Cognitive Insight Scale, and belief flexibility assessed with the Maudsley Assessment of Delusions Schedule. Methods: We performed a parallel, assessor-blinded, randomised controlled superiority trial comparing treatment as usual plus participation in Michael’s Game (MG with treatment as usual plus being on a waiting list (TAU in a sample of adult outpatients with psychotic disorders and persistent positive psychotic symptoms at inclusion. Results: The 172 participants were randomised, with 86 included in each study arm. Assessments were performed at inclusion (T1: baseline, at 3 months (T2: post-treatment, and at 6 months after the second assessment (T3: follow-up. At T2, a positive treatment effect was observed on the primary outcome, the PDI-21 conviction subscale (p=0.005. At T3, a sustained effect was observed for the conviction subscale (p=0.002. Further effects were also observed at T3 on the PDI-21 distress (p=0.002 and preoccupation subscales (p=0.001, as well as on one of the MADS measures of belief flexibility (anything against the belief (p=0.001. Conclusions: The study demonstrated some significant beneficial effect of MG. http://www.controlled-trials.com/ISRCTN37178153/Funding: Swiss National Science Foundation Grant 32003B-121038

  2. Ice‐water immersion and delayed‐onset muscle soreness: a randomised controlled trial

    Science.gov (United States)

    Sellwood, Kylie Louise; Brukner, Peter; Williams, David; Nicol, Alastair; Hinman, Rana

    2007-01-01

    Objective To determine if ice‐water immersion after eccentric quadriceps exercise minimises the symptoms of delayed‐onset muscle soreness (DOMS). Design A prospective randomised double‐blind controlled trial was undertaken. 40 untrained volunteers performed an eccentric loading protocol with their non‐dominant leg. Interventions Participants were randomised to three 1‐min immersions in either ice water (5±1°C) or tepid water (24°C). Main outcome measures Pain and tenderness (visual analogue scale), swelling (thigh circumference), function (one‐legged hop for distance), maximal isometric strength and serum creatine kinase (CK) recorded at baseline, 24, 48 and 72 h after exercise. Changes in outcome measures over time were compared to determine the effect of group allocation using independent t tests or Mann–Whitney U tests. Results No significant differences were observed between groups with regard to changes in most pain parameters, tenderness, isometric strength, swelling, hop‐for‐distance or serum CK over time. There was a significant difference in pain on sit‐to‐stand at 24 h, with the intervention group demonstrating a greater increase in pain than the control group (median change 8.0 vs 2.0 mm, respectively, p = 0.009). Conclusions The protocol of ice‐water immersion used in this study was ineffectual in minimising markers of DOMS in untrained individuals. This study challenges the wide use of this intervention as a recovery strategy by athletes. PMID:17261562

  3. How do parents experience being asked to enter a child in a randomised controlled trial?

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    Young Bridget

    2009-02-01

    Full Text Available Abstract Background As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Discussion Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Summary Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future

  4. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial.

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    Kien Hoa Ly

    Full Text Available There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment--including four face-to-face sessions and a smartphone application--was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression.This was a randomised controlled non-inferiority trial (NCT01819025 comparing a blended treatment (n=46 against a full ten-session treatment (n=47 for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment.Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen's d=1.35; CI [-0.82, 3.52] to d=1.47; CI [-0.41, 3.35]; between group d=-0.13 CI [-2.37, 2.09] and d=-0.10 CI [-2.53, 2.33]. At the same time, the blended treatment reduced the therapist time with an average of 47%.We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone application as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression.Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025.

  5. A randomised controlled trial of a smoking cessation intervention delivered by dental hygienists: a feasibility study

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    Jenkins William

    2007-05-01

    Full Text Available Abstract Background Tobacco use continues to be a global public health problem. Helping patients to quit is part of the preventive role of all health professionals. There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking. The aim of this study was to determine the feasibility of undertaking a randomised controlled smoking cessation intervention, utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients. Methods One hundred and eighteen patients who attended consultant clinics in an outpatient dental hospital department (Periodontology were recruited into a trial. Data were available for 116 participants, 59 intervention and 57 control, and were analysed on an intention-to-treat basis. The intervention group received smoking cessation advice based on the 5As (ask, advise, assess, assist, arrange follow-up and were offered nicotine replacement therapy (NRT, whereas the control group received 'usual care'. Outcome measures included self-reported smoking cessation, verified by salivary cotinine measurement and CO measurements. Self-reported measures in those trial participants who did not quit included number and length of quit attempts and reduction in smoking. Results At 3 months, 9/59 (15% of the intervention group had quit compared to 5/57 (9% of the controls. At 6 months, 6/59 (10% of the intervention group quit compared to 3/57 (5% of the controls. At one year, there were 4/59 (7% intervention quitters, compared to 2/59 (4% control quitters. In participants who described themselves as smokers, at 3 and 6 months, a statistically higher percentage of intervention participants reported that they had had a quit attempt of at least one week in the preceding 3 months (37% and 47%, for the intervention group respectively, compared with 18% and 16% for the control group. Conclusion This study has shown the potential that trained dental hygienists

  6. Maternal positioning to correct occiput posterior fetal position during the first stage of labour: a randomised controlled trial.

    Science.gov (United States)

    Guittier, M J; Othenin-Girard, V; de Gasquet, B; Irion, O; Boulvain, M

    2016-12-01

    To evaluate the efficacy of the hands and knees position during the first stage of labour to facilitate the rotation of the fetal head to the occiput anterior position. Randomised controlled trial. Geneva University Hospitals, Switzerland. A total of 439 women with a fetus in the occiput posterior position during the first stage of labour. The women in the intervention group were invited to take a hands and knees position for at least for 10 minutes. Women allocated to the control group received the usual care. For both groups, 15 minutes after randomisation, women completed a short questionnaire to report their perceived pain and the comfort of their position. The rotation of the fetal head in occiput anterior position confirmed by ultrasonography 1 hour after randomisation. One hour after the randomisation, 35 of 203 (17%) fetuses were diagnosed as being in the occiput anterior position in the intervention group compared with 24 of 209 (12%) in the control group. This difference was not statistically significant (relative risk 1.50; 95% CI 0.93-2.43; P = 0.13). The change in the evaluation of comfort between the randomisation and 15 minutes after showed an improvement in 70 and 39 women, no change in 82 and 78 women and a decrease in 56 and 86 women in the intervention and control groups, respectively (P = 0.02). This study could not demonstrate a benefit of the hands and knees position to correct the occiput posterior position of the fetus during the first stage of labour, but the women reported an increase in their comfort level. Hands and knees position does not facilitate rotation into occiput anterior but increases the comfort level of women. © 2016 The Authors. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

  7. Nonadherence to treatment protocol in published randomised controlled trials: a review

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    Dodd Susanna

    2012-06-01

    Full Text Available Abstract This review aimed to ascertain the extent to which nonadherence to treatment protocol is reported and addressed in a cohort of published analyses of randomised controlled trials (RCTs. One hundred publications of RCTs, randomly selected from those published in BMJ, New England Journal of Medicine, the Journal of the American Medical Association and The Lancet during 2008, were reviewed to determine the extent and nature of reported nonadherence to treatment protocol, and whether statistical methods were used to examine the effect of such nonadherence on both benefit and harms analyses. We also assessed the quality of trial reporting of treatment protocol nonadherence and the quality of reporting of the statistical analysis methods used to investigate such nonadherence. Nonadherence to treatment protocol was reported in 98 of the 100 trials, but reporting on such nonadherence was often vague or incomplete. Forty-two publications did not state how many participants started their randomised treatment. Reporting of treatment initiation and completeness was judged to be inadequate in 64% of trials with short-term interventions and 89% of trials with long-term interventions. More than half (51 of the 98 trials with treatment protocol nonadherence implemented some statistical method to address this issue, most commonly based on per protocol analysis (46 but often labelled as intention to treat (ITT or modified ITT (23 analyses in 22 trials. The composition of analysis sets for their benefit outcomes were not explained in 57% of trials, and 62% of trials that presented harms analyses did not define harms analysis populations. The majority of defined harms analysis populations (18 out of 26 trials, 69% were based on actual treatment received, while the majority of trials with undefined harms analysis populations (31 out of 43 trials, 72% appeared to analyse harms using the ITT approach. Adherence to randomised intervention is poorly considered

  8. Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomised controlled trial

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    Wedzicha Jadwiga A

    2007-12-01

    Full Text Available Abstract Background Guidelines recommend inhaled corticosteroids (ICS for patients with severe chronic obstructive pulmonary disease (COPD. Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown. Methods In a pragmatic randomised, double-blind, placebo-controlled trial in 31 practices, 260 COPD patients stopped their usual ICS (median duration of use 8 years and were allocated to 500 mcg fluticasone propionate twice daily (n = 128, or placebo (n = 132. Follow-up assessments took place at three monthly intervals for a year at the patients' practice. Our primary outcome was COPD exacerbation frequency. Secondary outcomes were time to first COPD exacerbation, reported symptoms, peak expiratory flow rate and reliever inhaler use, and lung function and health related quality of life. Results In patients randomised to placebo, COPD exacerbation risk over one year was RR: 1.11 (CI: 0.91–1.36. Patients taking placebo were more likely to return to their usual ICS following exacerbation, placebo: 61/128 (48%; fluticasone: 34/132 (26%, OR: 2.35 (CI: 1.38–4.05. Exacerbation risk whilst taking randomised treatment was significantly raised in the placebo group 1.48 (CI: 1.17–1.86. Patients taking placebo exacerbated earlier (median time to first exacerbation: placebo (days: 44 (CI: 29–59; fluticasone: 63 (CI: 53–74, log rank 3.81, P = 0.05 and reported increased wheeze. In a post-hoc analysis, patients with mild COPD taking placebo had increased exacerbation risk RR: 1.94 (CI: 1.20–3.14. Conclusion Withdrawal of long-term ICS in COPD patients in primary care increases risk of exacerbation shortens time to exacerbation and causes symptom deterioration. Patients with mild COPD may be at increased risk of exacerbation after withdrawal. Trial Registration ClinicalTrials.gov NCT00440687

  9. Can improving working memory prevent academic difficulties? a school based randomised controlled trial

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    Anderson Peter

    2011-06-01

    Full Text Available Abstract Background Low academic achievement is common and is associated with adverse outcomes such as grade repetition, behavioural disorders and unemployment. The ability to accurately identify these children and intervene before they experience academic failure would be a major advance over the current 'wait to fail' model. Recent research suggests that a possible modifiable factor for low academic achievement is working memory, the ability to temporarily store and manipulate information in a 'mental workspace'. Children with working memory difficulties are at high risk of academic failure. It has recently been demonstrated that working memory can be improved with adaptive training tasks that encourage improvements in working memory capacity. Our trial will determine whether the intervention is efficacious as a selective prevention strategy for young children at risk of academic difficulties and is cost-effective. Methods/Design This randomised controlled trial aims to recruit 440 children with low working memory after a school-based screening of 2880 children in Grade one. We will approach caregivers of all children from 48 participating primary schools in metropolitan Melbourne for consent. Children with low working memory will be randomised to usual care or the intervention. The intervention will consist of 25 computerised working memory training sessions, which take approximately 35 minutes each to complete. Follow-up of children will be conducted at 6, 12 and 24 months post-randomisation through child face-to-face assessment, parent and teacher surveys and data from government authorities. The primary outcome is academic achievement at 12 and 24 months, and other outcomes include child behaviour, attention, health-related quality of life, working memory, and health and educational service utilisation. Discussion A successful start to formal learning in school sets the stage for future academic, psychological and economic well-being. If

  10. Water-based exercise in COPD with physical comorbidities: a randomised controlled trial.

    Science.gov (United States)

    McNamara, Renae J; McKeough, Zoe J; McKenzie, David K; Alison, Jennifer A

    2013-06-01

    Land-based exercise is often difficult for people with chronic obstructive pulmonary disease (COPD) who have coexisting obesity or musculoskeletal or neurological conditions. This randomised controlled trial aimed to determine the effectiveness of water-based exercise training in improving exercise capacity and quality of life compared to land-based exercise training and control (no exercise) in people with COPD and physical comorbidities. Participants referred to pulmonary rehabilitation were randomly allocated to a water-based exercise, land-based exercise or the control group. The two exercise groups trained for 8 weeks, completing three sessions per week. 45 out of 53 participants (mean ± SD age 72 ± 9 years; forced expiratory volume in 1 s 59 ± 15% predicted) completed the study. Compared to controls, water-based exercise training significantly increased 6-min walking distance, incremental and endurance shuttle walk distances, and improved Chronic Respiratory Disease Questionnaire (CRDQ) dyspnoea and fatigue. Compared to land-based exercise training, water-based exercise training significantly increased incremental shuttle walk distance (mean difference 39 m, 95% CI 5-72 m), endurance shuttle walk distance (mean difference 228 m, 95% CI 19-438 m) and improved CRDQ fatigue. Water-based exercise training was significantly more effective than land-based exercise training and control in increasing peak and endurance exercise capacity and improving aspects of quality of life in people with COPD and physical comorbidities.

  11. Evaluation of sit-stand workstations in an office setting: a randomised controlled trial.

    Science.gov (United States)

    E F Graves, Lee; C Murphy, Rebecca; Shepherd, Sam O; Cabot, Josephine; Hopkins, Nicola D

    2015-11-19

    Excessive sitting time is a risk factor for cardiovascular disease mortality and morbidity independent of physical activity. This aim of this study was to evaluate the impact of a sit-stand workstation on sitting time, and vascular, metabolic and musculoskeletal outcomes in office workers, and to investigate workstation acceptability and feasibility. A two-arm, parallel-group, individually randomised controlled trial was conducted in one organisation. Participants were asymptomatic full-time office workers aged ≥18 years. Each participant in the intervention arm had a sit-stand workstation installed on their workplace desk for 8 weeks. Participants in the control arm received no intervention. The primary outcome was workplace sitting time, assessed at 0, 4 and 8 weeks by an ecological momentary assessment diary. Secondary behavioural, cardiometabolic and musculoskeletal outcomes were assessed. Acceptability and feasibility were assessed via questionnaire and interview. ANCOVA and magnitude-based inferences examined intervention effects relative to controls at 4 and 8 weeks. Participants and researchers were not blind to group allocation. Forty-seven participants were randomised (intervention n = 26; control n = 21). Relative to the control group at 8 weeks, the intervention group had a beneficial decrease in sitting time (-80.2 min/8-h workday (95 % CI = -129.0, -31.4); p = 0.002), increase in standing time (72.9 min/8-h workday (21.2, 124.6); p = 0.007) and decrease in total cholesterol (-0.40 mmol/L  (-0.79, -0.003); p = 0.049). No harmful changes in musculoskeletal discomfort/pain were observed relative to controls, and beneficial changes in flow-mediated dilation and diastolic blood pressure were observed. Most participants self-reported that the workstation was easy to use and their work-related productivity did not decrease when using the device. Factors that negatively influenced workstation use were workstation design

  12. Effects of a training program after surgically treated ankle fracture: a prospective randomised controlled trial

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    Ekdahl Charlotte S

    2009-09-01

    Full Text Available Abstract Background Despite conflicting results after surgically treated ankle fractures few studies have evaluated the effects of different types of training programs performed after plaster removal. The aim of this study was to evaluate the effects of a 12-week standardised but individually suited training program (training group versus usual care (control group after plaster removal in adults with surgically treated ankle fractures. Methods In total, 110 men and women, 18-64 years of age, with surgically treated ankle fracture were included and randomised to either a 12-week training program or to a control group. Six and twelve months after the injury the subjects were examined by the same physiotherapist who was blinded to the treatment group. The main outcome measure was the Olerud-Molander Ankle Score (OMAS which rates symptoms and subjectively scored function. Secondary outcome measures were: quality of life (SF-36, timed walking tests, ankle mobility tests, muscle strength tests and radiological status. Results 52 patients were randomised to the training group and 58 to the control group. Five patients dropped out before the six-month follow-up resulting in 50 patients in the training group and 55 in the control group. Nine patients dropped out between the six- and twelve-month follow-up resulting in 48 patients in both groups. When analysing the results in a mixed model analysis on repeated measures including interaction between age-group and treatment effect the training group demonstrated significantly improved results compared to the control group in subjects younger than 40 years of age regarding OMAS (p = 0.028, muscle strength in the plantar flexors (p = 0.029 and dorsiflexors (p = 0.030. Conclusion The results of this study suggest that when adjusting for interaction between age-group and treatment effect the training model employed in this study was superior to usual care in patients under the age of 40. However, as only three

  13. PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial.

    Science.gov (United States)

    Kilby, Mark; Khan, Khalid; Morris, Katie; Daniels, Jane; Gray, Richard; Magill, Laura; Martin, Bill; Thompson, Peter; Alfirevic, Zarko; Kenny, Simon; Bower, Sarah; Sturgiss, Stephen; Anumba, Dilly; Mason, Gerald; Tydeman, Graham; Soothill, Peter; Brackley, Karen; Loughna, Pamela; Cameron, Alan; Kumar, Sailesh; Bullen, Phil

    2007-07-01

    The primary objective is to determine whether intrauterine vesicoamniotic shunting for fetal bladder outflow obstruction, compared with conservative, noninterventional care, improves prenatal and perinatal mortality and renal function. The secondary objectives are to determine if shunting for fetal bladder outflow obstruction improves perinatal morbidity, to determine if improvement in outcomes is related to prognostic assessment at diagnosis and, if possible, derive a prognostic risk index and to determine the safety and long-term efficacy of shunting. A multicentre randomised controlled trial (RCT). Fetal medicine units. Pregnant women with singleton, male fetus with isolated lower urinary tract obstruction (LUTO). Following ultrasound diagnosis of LUTO in a male fetus and exclusion of other structural and chromosomal anomalies, participation in the trial will be discussed with the mother and written information given. Consent for participation in the trial will be taken and the mother randomised via the internet to either insertion of a vesicoamniotic shunt or expectant management. During pregnancy, both groups will be followed with regular ultrasound scans looking at viability, renal measurements and amniotic fluid volume. Following delivery, babies will be followed up by paediatric nephrologists/urologists at 4-6 weeks, 12 months and 3 and 5 years to assess renal function via serum creatinine, renal ultrasound and need for dialysis/transplant. The main outcome measures will be perinatal mortality rates and renal function at 4-6 weeks and 12 months measured via serum creatinine, renal ultrasound and need for dialysis/transplant. Wellbeing of Women. ESTIMATED COMPLETION DATE: September 2010. TRIAL ALGORITHM: [flowchart: see text].

  14. Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis.

    Science.gov (United States)

    Dorkin, Henry L; Staab, Doris; Operschall, Elisabeth; Alder, Jeff; Criollo, Margarita

    2015-01-01

    Treatment of infective bronchitis involving Pseudomonas aeruginosa is a cornerstone of care in patients with cystic fibrosis (CF). This phase IIb, randomised, double-blind, placebo-controlled study assessed the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in this population. Patients with CF, ≥12 years of age (N=286), were randomised to ciprofloxacin DPI (32.5 mg (n=93) or 48.75 mg (n=93)), or corresponding placebo (32.5 mg, n=65; 48.75 mg, n=35) twice daily for 28 days. The primary objective was the change in forced expiratory volume in 1 s (FEV1) from baseline (day 0) to end of treatment (day 29) in the intent-to-treat population for ciprofloxacin DPI compared with the corresponding placebo group. The primary effectiveness objective was not met; there were no significant differences in change in FEV1 between ciprofloxacin DPI and the corresponding placebo group for either dose (p=0.154). However, in pooled analyses, FEV1 decline from baseline to treatment end was significantly lower with ciprofloxacin DPI than with placebo (pooled data; p=0.02). Ciprofloxacin DPI showed positive effects on sputum bacterial load and quality of life, but these effects were not maintained at the 4-week follow-up. Ciprofloxacin DPI was well tolerated and there were no significant differences in type/incidence of treatment-emergent adverse events by treatment group (p=0.115). Further investigations are needed to determine the full scope of the beneficial effects of ciprofloxacin DPI for patients with CF. Clinicaltrials.gov NCT00645788; EudraCT 2008-008314-40.

  15. The effect of depot medroxyprogesterone acetate on postnatal depression: a randomised controlled trial.

    Science.gov (United States)

    Singata-Madliki, Mandisa; Hofmeyr, G Justus; Lawrie, Theresa A

    2016-07-01

    Depot medroxyprogesterone acetate (DMPA) is the most commonly used hormonal contraceptive method in South Africa. It is frequently administered in the immediate postnatal period, yet it is unclear whether it affects the risk of postnatal depression (PND). To determine whether DMPA increases the risk of PND compared with the copper-containing intrauterine device (IUD) when administered after delivery. A single-blind randomised controlled trial conducted at two teaching hospitals in East London, South Africa. Eligible, consenting women (N=242) requiring postnatal contraception were randomised to receive DMPA or an IUD within 48 hours of childbirth and interviewed at 1 and 3 months postpartum. Depression was measured using the Beck Depression Inventory (BDI-II) and the Edinburgh Postnatal Depression Scale (EPDS). Resumption of sexual intercourse, menstrual symptoms and breastfeeding rates were also assessed. One-month EPDS depression scores were statistically significantly higher in the DMPA arm compared with IUD arm (p=0.04). Three-month BDI-II scores were significantly higher in the DMPA arm than in the IUD arm (p=0.002) and, according to the BDI-II but not the EPDS, more women in the DMPA arm had major depression at this time-point (8 vs 2; p=0.05). There were no statistically significant differences in other outcome measures except that fewer women had resumed sexual activity by 1 month postpartum in the DMPA arm (13% vs 26%; p=0.02). The possibility that immediate postnatal DMPA use is associated with depression cannot be excluded. These findings justify further research with longer follow-up. PACTR201209000419241. 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/

  16. Auricular Acupuncture and Cognitive Behavioural Therapy for Insomnia: A Randomised Controlled Study

    Directory of Open Access Journals (Sweden)

    L. Bergdahl

    2016-01-01

    Full Text Available Objective. The most effective nonpharmacological treatment for insomnia disorder is cognitive behavioural therapy-insomnia (CBT-i. However CBT-i may not suit everyone. Auricular acupuncture (AA is a complementary treatment. Studies show that it may alleviate insomnia symptoms. The aim of this randomised controlled study was to compare treatment effects of AA with CBT-i and evaluate symptoms of insomnia severity, anxiety, and depression. Method. Fifty-nine participants, mean age 60.5 years (SD 9.4, with insomnia disorder were randomised to group treatment with AA or CBT-i. Self-report questionnaires, the Insomnia Severity Index (ISI, Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16, Epworth Sleepiness Scale (ESS, and Hospital Anxiety and Depression scale (HAD, were collected at baseline, after treatment, and at 6-month follow-up. A series of linear mixed models were performed to examine treatment effect over time between and within the groups. Results. Significant between-group improvements were seen in favour of CBT-i in ISI after treatment and at the 6-month follow-up and in DBAS-16 after treatment. Both groups showed significant within-group postintervention improvements in ISI, and these changes were maintained six months later. The CBT-i group also showed a significant reduction in DBAS-16 after treatment and six months later. Conclusions. Compared to CBT-i, AA, as offered in this study, cannot be considered an effective stand-alone treatment for insomnia disorder. The trial is registered with ClinicalTrials.gov NCT01765959.

  17. Buprenorphine versus dihydrocodeine for opiate detoxification in primary care: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Adams Clive E

    2007-01-01

    Full Text Available Abstract Background Many drug users present to primary care requesting detoxification from illicit opiates. There are a number of detoxification agents but no recommended drug of choice. The purpose of this study is to compare buprenorphine with dihydrocodeine for detoxification from illicit opiates in primary care. Methods Open label randomised controlled trial in NHS Primary Care (General Practices, Leeds, UK. Sixty consenting adults using illicit opiates received either daily sublingual buprenorphine or daily oral dihydrocodeine. Reducing regimens for both interventions were at the discretion of prescribing doctor within a standard regimen of not more than 15 days. Primary outcome was abstinence from illicit opiates at final prescription as indicated by a urine sample. Secondary outcomes during detoxification period and at three and six months post detoxification were recorded. Results Only 23% completed the prescribed course of detoxification medication and gave a urine sample on collection of their final prescription. Risk of non-completion of detoxification was reduced if allocated buprenorphine (68% vs 88%, RR 0.58 CI 0.35–0.96, p = 0.065. A higher proportion of people allocated to buprenorphine provided a clean urine sample compared with those who received dihydrocodeine (21% vs 3%, RR 2.06 CI 1.33–3.21, p = 0.028. People allocated to buprenorphine had fewer visits to professional carers during detoxification and more were abstinent at three months (10 vs 4, RR 1.55 CI 0.96–2.52 and six months post detoxification (7 vs 3, RR 1.45 CI 0.84–2.49. Conclusion Informative randomised trials evaluating routine care within the primary care setting are possible amongst drug using populations. This small study generates unique data on commonly used treatment regimens.

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

    Science.gov (United States)

    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.

  19. Randomised controlled trial of vancomycin for pseudomembranous colitis and postoperative diarrhoea.

    Science.gov (United States)

    Keighley, M R; Burdon, D W; Arabi, Y; Williams, J A; Thompson, H; Youngs, D; Johnson, M; Bentley, S; George, R H; Mogg, G A

    1978-12-16

    The efficacy of vancomycin in pseudomembranous colitis was assessed in a prospective randomised controlled trial. Forty-four patients with postoperative diarrhoea were allocated to five days' treatment with either 125 mg vancomycin six-hourly or a placebo. Sixteen patients had high titres of the neutralised faecal toxin characteristic of pseudomembranous colitis; nine received vancomycin and seven placebo. At the end of treatment faecal toxins were present in one patient given vancomycin compared with five of the controls. Vancomycin caused the disappearance of Clostridum difficile from the stool in all except one patient, whereas toxicogenic strains of Cl difficile persisted in all but one of the controls. Histological evidence of psuedomembranous colitis had disappeared by the end of treatment in six out of seven patients given vancomycin compared with only one out of seven patients given vancomycin compared with only one out of five patients given placebo. In patients with faecal toxins bowel habit had returned to normal in seven of the vancomycin group compared with only one of the controls, but there was no significant difference in clinical response among patients without faecaal toxins. The results suggest that vancomycin eliminates toxin-producing Cl difficile from the colon and is associated with rapid clinical and histological improvement in patients with pseudomembranous colitis.

  20. Comparison communities in a cluster randomised trial innovate in response to 'being controlled'.

    Science.gov (United States)

    Hawe, Penelope; Riley, Therese; Gartrell, Alexandra; Turner, Karen; Canales, Claudia; Omstead, Darlene

    2015-05-01

    We conducted qualitative interviews among primary health care teams and community agencies in eight communities in Victoria, Australia which had (1) agreed to be part of a universal primary care and community development intervention to reduce post natal depression and promote maternal health; and (2) were randomised to the comparison arm. The purpose was to document their experience with and interpretation of the trial. Although 'control' in a controlled trial refers to the control of confounding of the trial result by factors other than allocation to the intervention, participants interpreted 'control' to mean restrictions on what they were allowed to do during the trial period. They had agreed not to use the Edinburgh Post Natal Depression Scale or the SF 36 in clinical practice and not to implement any of the elements of the intervention. We found that no elements of the intervention were implemented. However, the extension of the trial from three to five years made the trial agreement a strain. The imposition of trial conditions also encouraged a degree of lateral thinking and innovation in service delivery (quality improvement). This may have potentially contributed to the null trial results. The observations invite interrogation of intervention theory and consequent rethinking of the way contamination in a cluster trial is defined.

  1. Acceptance and commitment therapy as a web-based intervention for depressive symptoms: randomised controlled trial.

    Science.gov (United States)

    Pots, Wendy T M; Fledderus, Martine; Meulenbeek, Peter A M; ten Klooster, Peter M; Schreurs, Karlein M G; Bohlmeijer, Ernst T

    2016-01-01

    Depression is a highly prevalent disorder, causing a large burden of disease and substantial economic costs. Web-based self-help interventions seem promising in promoting mental health. To compare the efficacy of a guided web-based intervention based on acceptance and commitment therapy (ACT) with an active control (expressive writing) and a waiting-list control condition (Netherlands Trial Register NTR1296). Adults with depressive symptoms from the general population were randomised to ACT (n = 82), expressive writing (n = 67) or waiting-list control (n = 87). The main outcome was reduction in depressive symptoms assessed with the Center for Epidemiological Studies - Depression scale. Significant reductions in depressive symptoms were found following the ACT intervention, compared with the control group (Cohen's d = 0.56) and the expressive writing intervention (d = 0.36). The effects were sustained at 6-month and 12-month follow-up. Acceptance and commitment therapy as a web-based public mental health intervention for adults with depressive symptoms can be effective and applicable. © The Royal College of Psychiatrists 2016.

  2. Efficacy of communication skills training on colorectal cancer screening by GPs: a cluster randomised controlled trial.

    Science.gov (United States)

    Aubin-Auger, I; Laouénan, C; Le Bel, J; Mercier, A; Baruch, D; Lebeau, J P; Youssefian, A; Le Trung, T; Peremans, L; Van Royen, P

    2016-01-01

    Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study was to test if the implementation of a training course focused on communication skills among general practitioners (GP) would increase the delivery of gaiac faecal occult blood test and CRC screening participation among the target population of each participating GP. A cluster randomised controlled trial was conducted with GP's practice as a cluster unit. GPs from practices in the control group were asked to continue their usual care. GPs of the intervention group received a 4-h educational training, built with previous qualitative data on CRC screening focusing on doctor-patient communication with a follow-up of 7 months for both groups. The primary outcome measure was the patients' participation rate in the target population for each GP. Seventeen GPs (16 practices) in intervention group and 28 GPs (19 practices) in control group participated. The patients' participation rate in the intervention group were 36.7% vs. 24.5% in the control group (P = 0.03). Doctor-patient communication should be developed and appear to be one of the possible targets of improvement patients adherence and participation rate in the target population for CRC mass screening.

  3. The effectiveness of the Mitchell Method Relaxation Technique for the treatment of fibromyalgia symptoms: a randomised controlled trial

    OpenAIRE

    2016-01-01

    Objective: To evaluate the effectiveness of the Mitchell Method Relaxation Technique (MMRT) in reducing symptoms of fibromyalgia. Design: A randomised controlled trial was used to compare the effectiveness of self-administered MMRT (n= 67) with attention control (n = 66) and usual care (n = 56) groups. Main Outcome Measures: Primary outcomes included self-reported fatigue, pain, and sleep. Secondary outcomes were daily functioning, quality of life, depression, and coping, anxiety and perceive...

  4. A pharmacy management service for adults with asthma: a cluster randomised controlled trial.

    Science.gov (United States)

    Wong, Lai-Yan; Chua, Siew-Siang; Husin, Abdul-Rahman; Arshad, Hanisah

    2017-05-03

    Although clinical guidelines are available for the management of asthma, this health condition is still poorly managed in many countries. To assess the effects of a Pharmacy Management Service (PharMS) on asthma control of adult patients. This study comprised of a cluster randomised controlled trial (RCT) that was conducted from April 2014 to July 2015 at four government health clinics. The control participants received usual pharmacy service, while the intervention participants were recruited into the PharMS. Each participant was monitored for 6 months, and the outcome measures included asthma control using the Asthma Control Test (ACT), inhaler technique using a checklist and medication adherence using the Malaysian Medication Adherence Scale. A total of 157 participants were recruited: 77 in the control and 80 in the intervention group. At the end of the study, 90% of the intervention participants achieved well-controlled asthma compared to 28.6% in the control group (P < 0.001). The differences in the proportion of participants with correct inhaler technique was also significant, with an adjusted effect size of 0.953 (P < 0.001). In addition, the intervention participants showed significantly higher medication adherence than the control group (92.5% versus 45.5%, P < 0.001). The Generalised Estimated Equation analysis further confirmed that the PharMS (P < 0.001) was significantly related to an improvement in the ACT scores. A community-based asthma management program, the PharMS, that provided asthma education and skill training by a trained pharmacist, resulted in positive and significant improvements in clinical and management outcomes of adult asthma patients.

  5. Are we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial

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    Bone Kerry M

    2009-06-01

    Full Text Available Abstract Background Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms. Methods A post hoc analysis was conducted on data from 93 participants who completed this previously published study. Variables at baseline were investigated as potential predictors of the response on any of the endpoints of flushing, overall menopausal symptoms and depression. Focused tests were conducted using hierarchical linear regression analyses. Based on these findings, analyses were conducted for both groups separately. These findings are discussed in relation to existing literature on placebo effects. Results Distinct differences in predictors were observed between the placebo and active groups. A significant difference was found for study entry anxiety, and Greene Climacteric Scale (GCS scores, on all three endpoints. Attitude to menopause was found to differ significantly between the two groups for GCS scores. Examination of the individual arms found anxiety at study entry to predict placebo response on all three outcome measures individually. In contrast, low anxiety was significantly associated with improvement in the active treatment group. None of the variables found to predict the placebo response was relevant to the treatment arm. Conclusion This study was a post hoc analysis

  6. Effectiveness of topiramate for tobacco dependence in patients with depression; a randomised, controlled trial

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    Alda Marta

    2008-05-01

    Full Text Available Abstract Background Tobacco dependence management is a multi-component intervention that includes pharmacological treatments such as Nicotine Substitution Therapy (NST or bupropion, and psychological therapy. There are some preliminary reports on topiramate efficacy for tobacco dependence. The aim of this study is to determine whether topiramate is as effective as the standard NST treatment for tobacco cessation at 1-year follow-up in patients with depression. Method/design Design: A randomised, controlled trial involving two groups, one of which is the control group consisting of patients on the standard pharmacological treatment for tobacco cessation (NST and the other is the intervention group consisting of patients on topiramate as pharmacological treatment. Setting: 29 primary care health centres in the city of Zaragoza, Spain. Sample: 180 patients, aged 18–65 years, diagnosed with major depression, smoke more than 20 cigarettes/day, who have voluntarily asked for tobacco cessation therapy. Intervention: A multi-component programme for tobacco cessation is offered to all of the patients in the study. This programme is made up of pharmacological therapy + group cognitive-behavioural therapy. Pharmacological therapy consists of NST for the control group and topiramate (200 mg/day for the intervention group. Psychological therapy is made up of 16 sessions of manualised group therapy. Measurements: Cessation will be assessed by patient self-declared abstinence, expired air carbon monoxide levels, and cotinine levels in saliva. Questionnaires on tobacco dependence, anxiety, depression, impulsiveness and self-efficacy will be administered. The interviewers will not know which group the patient belongs to (blind. The assessments will be carried out at baseline, D (cessation day -1, D+1, weeks 1, 2, 3, 4, 6, 8, 10 and 13, and months 4, 5, 6, 8, 10 and 12. Main variables: Tobacco cessation rates and tobacco dependence. Analysis: The analysis will

  7. Chocolate bar as an incentive did not increase response rate among physiotherapists: a randomised controlled trial

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    Dahm Kristin

    2008-06-01

    Full Text Available Abstract Background The aim of this study was to assess the effect of a small incentive, a bar of dark chocolate, on response rate in a study of physiotherapy performance in patients with knee osteoarthritis. Findings Norwegian physiotherapists from private practice were randomised in blocks to an intervention group (n = 1027 receiving a bar of dark chocolate together with a data-collection form, and a control group (n = 1027 that received the data-collection form only. The physiotherapists were asked to prospectively complete the data-collection form by reporting treatments provided to one patient with knee osteoarthritis through 12 treatment sessions. The outcome measure was response rate of completed forms. Out of the 510 physiotherapists that responded, 280 had completed the data-collection form by the end of the study period. There was no difference between the chocolate and no-chocolate group in response rate of those who sent in completed forms. In the chocolate group, 142 (13.8% returned completed forms compared to 138 (13.4% in the control group, ARR = 0.4 (95% CI: -3.44 to 2.6. Conclusion A bar of dark chocolate did not increase response rate in a prospective study of physiotherapy performance. Stronger incentives than chocolate seem to be necessary to increase the response rate among professionals who are asked to report about their practice. Trial Registration Current Controlled Trials register: ISRCTN02397855

  8. Telemonitoring in fasting individuals with Type 2 Diabetes Mellitus during Ramadan: A prospective, randomised controlled study.

    Science.gov (United States)

    Lee, Jun Yang; Wong, Chee Piau; Tan, Christina San San; Nasir, Nazrila Hairizan; Lee, Shaun Wen Huey

    2017-08-31

    We determined the impact of a remote blood glucose telemonitoring program with feedback in type 2 diabetes mellitus patients fasting during Ramadan compared to conventional self-monitoring method. A twelve-week cluster randomised study, with 85 participants who wish to fast for at least 15 days during Ramadan was conducted. Self-measurement and transmission of blood glucose results were performed six times daily during Ramadan. Results were transmitted to a secure website for review with feedback from case manager if necessary. The control group received usual care. The main outcome was the number of participants experiencing hypoglycaemia during Ramadan and at the end of the study. During Ramadan, the number of participants reporting hypoglycaemia was significantly lower in the telemonitoring group [Odds ratio (OR): 0.186, 95% confidence interval: 0.04-0.936; p = 0.04]. Similarly, the proportion of participants reporting symptomatic hypoglycaemia at the end of the study was significantly lower in the telemonitoring group (OR: 0.257, 95% CI: 0.07-0.89; p = 0.03). A reduction of 1.07% in glycated haemoglobin levels was observed in the telemonitoring group compared to 0.24% in the control group (p telemonitoring was a useful adjunct to reduce the risk of hypoglycaemia during Ramadan with no deterioration in glycaemic control.

  9. Sunflower therapy for children with specific learning difficulties (dyslexia): a randomised, controlled trial.

    Science.gov (United States)

    Bull, Leona

    2007-02-01

    The aim of the study was to determine the clinical and perceived effectiveness of the Sunflower therapy in the treatment of childhood dyslexia. The Sunflower therapy includes applied kinesiology, physical manipulation, massage, homeopathy, herbal remedies and neuro-linguistic programming. A multi-centred, randomised controlled trial was undertaken with 70 dyslexic children aged 6-13 years. The research study aimed to test the research hypothesis that dyslexic children 'feel better' and 'perform better' as a result of treatment by the Sunflower therapy. Children in the treatment group and the control group were assessed using a battery of standardised cognitive, Literacy and self-esteem tests before and after the intervention. Parents of children in the treatment group gave feedback on their experience of the Sunflower therapy. Test scores were compared using the Mann Whitney, and Wilcoxon statistical tests. While both groups of children improved in some of their test scores over time, there were no statistically significant improvements in cognitive or Literacy test performance associated with the treatment. However, there were statistically significant improvements in academic self-esteem, and reading self-esteem, for the treatment group. The majority of parents (57.13%) felt that the Sunflower therapy was effective in the treatment of learning difficulties. Further research is required to verify these findings, and should include a control group receiving a dummy treatment to exclude placebo effects.

  10. Internet-Supported Physical Exercise Training for Persons with Multiple Sclerosis-A Randomised, Controlled Study.

    Science.gov (United States)

    Tallner, Alexander; Streber, René; Hentschke, Christian; Morgott, Marc; Geidl, Wolfgang; Mäurer, Mathias; Pfeifer, Klaus

    2016-09-30

    Physical exercise is effective in improving functional outcomes in persons with multiple sclerosis (pwMS). We evaluated the feasibility and effectiveness of internet-based exercise training (e-training) for pwMS on health-related quality of life (HrQoL). Secondary outcomes were muscle strength, aerobic capacity, lung function, physical activity, and fatigue. This is a randomised, controlled trial with a wait-list control group. Data were collected at baseline, after three and six months, and analysed using a hybrid linear model. One-hundred twenty-six pwMS participated in the home-based aerobic (1×/week) and strength training (2×/week) intervention that was supervised and documented via an internet-platform. The intervention group received e-training for six months, and the control group received e-training after a three months waiting period. Significant differences between the groups were only observed for muscle strength (knee flexion (effect size ES = 0.3, p = 0.003), knee extension (ES = 0.24, p = 0.015)), peak expiratory flow (ES = 0.2, p = 0.039), and sports activity (ES = 0.33, p = 0.001) after three months. E-training had no effect on HrQoL but did on muscle strength, lung function, and physical activity. It is a promising and feasible approach to facilitate large-scale, yet individual, training support.

  11. A lifestyle intervention for primary care patients with depression and anxiety: A randomised controlled trial.

    Science.gov (United States)

    Forsyth, Adrienne; Deane, Frank P; Williams, Peter

    2015-12-15

    This study aimed to evaluate the efficacy of a diet and exercise lifestyle intervention on mental health outcomes for patients currently being treated for depression and/or anxiety in primary care. Patients (n=119) referred by general practitioners to the 12-week randomised controlled trial were assigned to either an intervention of six visits to a dual qualified dietitian/exercise physiologist (DEP) where motivational interviewing and activity scheduling were used to engage patients in individually-tailored lifestyle change (focussed on diet and physical activity), or an attention control with scheduled telephone contact. Assessments conducted at baseline (n=94) and 12 weeks (n=60) were analysed with an intent-to-treat approach using linear mixed modelling. Significant improvement was found for both groups on Depression, Anxiety and Stress Scale (DASS) scores, measures of nutrient intake and total Australian modified Healthy Eating Index (Aust-HEI) scores. Significant differences between groups over time were found only for iron intake and body mass index. Patients participating in individual consultations with a dietitian were more likely to maintain or improve diet quality than those participating in an attention control. This study provides initial evidence to support the role of dietitians in the management of patients with depression and/or anxiety.

  12. Intervention for children with word-finding difficulties: a parallel group randomised control trial.

    Science.gov (United States)

    Best, Wendy; Hughes, Lucy Mari; Masterson, Jackie; Thomas, Michael; Fedor, Anna; Roncoli, Silvia; Fern-Pollak, Liory; Shepherd, Donna-Lynn; Howard, David; Shobbrook, Kate; Kapikian, Anna

    2017-07-31

    The study investigated the outcome of a word-web intervention for children diagnosed with word-finding difficulties (WFDs). Twenty children age 6-8 years with WFDs confirmed by a discrepancy between comprehension and production on the Test of Word Finding-2, were randomly assigned to intervention (n = 11) and waiting control (n = 9) groups. The intervention group had six sessions of intervention which used word-webs and targeted children's meta-cognitive awareness and word-retrieval. On the treated experimental set (n = 25 items) the intervention group gained on average four times as many items as the waiting control group (d = 2.30). There were also gains on personally chosen items for the intervention group. There was little change on untreated items for either group. The study is the first randomised control trial to demonstrate an effect of word-finding therapy with children with language difficulties in mainstream school. The improvement in word-finding for treated items was obtained following a clinically realistic intervention in terms of approach, intensity and duration.

  13. Internet-Supported Physical Exercise Training for Persons with Multiple Sclerosis—A Randomised, Controlled Study

    Directory of Open Access Journals (Sweden)

    Alexander Tallner

    2016-09-01

    Full Text Available Physical exercise is effective in improving functional outcomes in persons with multiple sclerosis (pwMS. We evaluated the feasibility and effectiveness of internet-based exercise training (e-training for pwMS on health-related quality of life (HrQoL. Secondary outcomes were muscle strength, aerobic capacity, lung function, physical activity, and fatigue. This is a randomised, controlled trial with a wait-list control group. Data were collected at baseline, after three and six months, and analysed using a hybrid linear model. One-hundred twenty-six pwMS participated in the home-based aerobic (1×/week and strength training (2×/week intervention that was supervised and documented via an internet-platform. The intervention group received e-training for six months, and the control group received e-training after a three months waiting period. Significant differences between the groups were only observed for muscle strength (knee flexion (effect size ES = 0.3, p = 0.003, knee extension (ES = 0.24, p = 0.015, peak expiratory flow (ES = 0.2, p = 0.039, and sports activity (ES = 0.33, p = 0.001 after three months. E-training had no effect on HrQoL but did on muscle strength, lung function, and physical activity. It is a promising and feasible approach to facilitate large-scale, yet individual, training support.

  14. Exercise for health for early postmenopausal women: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Asikainen, Tuula-Maria; Kukkonen-Harjula, Katriina; Miilunpalo, Seppo

    2004-01-01

    Women who pass menopause face many changes that may lead to loss of health-related fitness (HRF), especially if sedentary. Many exercise recommendations are also relevant for early postmenopausal women; however, these may not meet their specific needs because the recommendations are based mainly on studies on men. We conducted a systematic review for randomised, controlled exercise trials on postmenopausal women (aged 50 to 65 years) on components of HRF. HRF consists of morphological fitness (body composition and bone strength), musculoskeletal fitness (muscle strength and endurance, flexibility), motor fitness (postural control), cardiorespiratory fitness (maximal aerobic power, blood pressure) and metabolic fitness (lipid and carbohydrate metabolism). The outcome variables chosen were: bodyweight; proportion of body fat of total bodyweight (F%); bone mineral density (BMD); bone mineral content (BMC); various tests on muscle performance, flexibility, balance and coordination; maximal oxygen consumption (V-dotO(2max)); resting blood pressure (BP); total cholesterol (TC); high-density lipoprotein-cholesterol; low-density lipoprotein-cholesterol; triglycerides; blood glucose and insulin. The feasibility of the exercise programme was assessed from drop-out, attendance and injury rates. Twenty-eight randomised controlled trials with 2646 participants were assessed. In total, 18 studies reported on the effects of exercise on bodyweight and F%, 16 on BMD or BMC, 11 on muscular strength or endurance, five on flexibility, six on balance or coordination, 18 on V-dotO(2max), seven on BP, nine on lipids and two studies on glucose an one on insulin. Based on these studies, early postmenopausal women could benefit from 30 minutes of daily moderate walking in one to three bouts combined with a resistance training programme twice a week. For a sedentary person, walking is feasible and can be incorporated into everyday life. A feasible way to start resistance training is to

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

    Science.gov (United States)

    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

  16. Evaluation of an online Diabetes Needs Assessment Tool (DNAT for health professionals: a randomised controlled trial

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    Kellner Thomas

    2009-07-01

    Full Text Available Abstract Background Continuous medical education is traditionally reliant to a large extent on self-directed learning based on individuals' perceived learning priorities. Evidence suggests that this ability to self-assess is limited, and more so in the least competent. Therefore, it may be of benefit to utilise some form of external assessment for this purpose. Many diabetes educational programmes have been introduced, but few have been assessed for their benefit in a systematic manner. As diabetes is an increasingly prevalent disease, methods for the dissemination and understanding of clinical guidelines need to be explored for their effectiveness. This paper describes the study design of a randomised controlled trial to evaluate the effectiveness of using an interactive online Diabetes Needs Assessment Tool (DNAT, that builds a learning curriculum based on identified knowledge gaps, compared with conventional self-directed learning. The study assesses the effect of these interventions on health professionals' knowledge of diabetes management, evaluates the acceptability of this process of learning and self-reported changes in clinical practice as a result of this novel educational process. Methods Following a baseline assessment, participants will be randomised to undergo a 4-month learning period where they will either be given access to the diabetes learning modules alone (control group or a Diabetes Needs Assessment Tool (DNAT plus the diabetes learning modules (intervention group. On completion of the DNAT, a personalised learning report will be created for each participant identifying needs alongside individualised recommendations of the most appropriate learning modules to meet those requirements. All participants will complete a Diabetes Knowledge Test before and immediately after the allocated learning and the primary outcome will be the state of knowledge at 4 months. Learners will also be surveyed immediately after the learning

  17. Randomised controlled trial evaluation of Tweet2Quit: a social network quit-smoking intervention.

    Science.gov (United States)

    Pechmann, Cornelia; Delucchi, Kevin; Lakon, Cynthia M; Prochaska, Judith J

    2017-03-01

    We evaluated a novel Twitter-delivered intervention for smoking cessation, Tweet2Quit, which sends daily, automated communications to small, private, self-help groups to encourage high-quality, online, peer-to-peer discussions. A 2-group randomised controlled trial assessed the net benefit of adding a Tweet2Quit support group to a usual care control condition of nicotine patches and a cessation website. Participants were 160 smokers (4 cohorts of 40/cohort), aged 18-59 years, who intended to quit smoking, used Facebook daily, texted weekly, and had mobile phones with unlimited texting. All participants received 56 days of nicotine patches, emails with links to the smokefree.gov cessation website, and instructions to set a quit date within 7 days. Additionally, Tweet2Quit participants were enrolled in 20-person, 100-day Twitter groups, and received daily discussion topics via Twitter, and daily engagement feedback via text. The primary outcome was sustained abstinence at 7, 30 and 60 days post-quit date. Participants (mean age 35.7 years, 26.3% male, 31.2% college degree, 88.7% Caucasian) averaged 18.0 (SD=8.2) cigarettes per day and 16.8 (SD=9.8) years of smoking. Participants randomised to Tweet2Quit averaged 58.8 tweets/participant and the average tweeting duration was 47.4 days/participant. Tweet2Quit doubled sustained abstinence out to 60 days follow-up (40.0%, 26/65) versus control (20.0%, 14/70), OR=2.67, CI 1.19 to 5.99, p=0.017. Tweeting via phone predicted tweet volume, and tweet volume predicted sustained abstinence (p<0.001). The daily autocommunications caused tweeting spikes accounting for 24.0% of tweets. Tweet2Quit was engaging and doubled sustained abstinence. Its low cost and scalability makes it viable as a global cessation treatment. NCT01602536. 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/.

  18. Epilation for minor trachomatous trichiasis: four-year results of a randomised controlled trial.

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    Esmael Habtamu

    2015-03-01

    Full Text Available Trachomatous trichiasis (TT needs to be managed to reduce the risk of vision loss. The long-term impact of epilation (a common traditional practice of repeated plucking of lashes touching the eye in preventing visual impairment and corneal opacity from TT is unknown. We conducted a randomized controlled trial of epilation versus surgery for the management of minor TT (fewer than six lashes touching the eye in Ethiopia. Here we report the four-year outcome and the effect on vision and corneal opacity.1300 individuals with minor TT were recruited and randomly assigned to quality trichiasis surgery or repeated epilation using high quality epilation forceps by a trained person with good near vision. Participants were examined six-monthly for two-years, and then at four-years after randomisation. At two-years all epilation arm participants were offered free surgery. At four-years 1151 (88.5% were re-examined: 572 (88% and 579 (89% from epilation and surgery arms, respectively. At that time, 21.1% of the surgery arm participants had recurrent TT; 189/572 (33% of the epilation arm had received surgery, while 383 (67% declined surgery and had continued epilating ("epilation-only". Among the epilation-only group, 207 (54.1% fully controlled their TT, 166 (43.3% had minor TT and 10 (2.6% had major TT (>5 lashes. There were no differences between participants in the epilation-only, epilation-to-surgery and surgery arm participants in changes in visual acuity and corneal opacity between baseline and four-years.Most minor TT participants randomised to the epilation arm continued epilating and controlled their TT. Change in vision and corneal opacity was comparable between surgery and epilation-only participants. This suggests that good quality epilation with regular follow-up is a reasonable second-line alternative to surgery for minor TT for individuals who either decline surgery or do not have immediate access to surgical treatment.

  19. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial

    Science.gov (United States)

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

    2013-01-01

    Background and objectives Increased water intake may benefit kidney function. Prior to initiating a larger randomised controlled trial (RCT), we examined the safety and feasibility of asking adults with chronic kidney disease (CKD) to increase their water intake. Design, setting, participants and measurements Beginning in October 2012, we randomly assigned 29 adults with stage 3 CKD (estimated glomerular filtration rate (eGFR) 30–60 mL/min/1.73 m2 and albuminuria) to one of the two groups of water intake: hydration (n=18) or standard (n=11). We asked the hydration group to increase their water intake by 1.0–1.5 L/day (in addition to usual intake, depending on sex and weight) for 6 weeks, while the control group carried on with their usual intake. Participants collected a 24 h urine sample at baseline and at 2 and 6 weeks after randomisation. Our primary outcome was the between-group difference in change in 24 h urine volume from baseline to 6 weeks. Results (63%)of participants were men, 81% were Caucasians and the average age was 61 years (SD 14 years). The average baseline eGFR was 40 mL/min/1.73 m2 (SD 11 mL/min/1.73 m2); the median albumin to creatinine ratio was 19 mg/mmol (IQR 6–74 mg/mmol). Between baseline and 6-week follow-up, the hydration group's average 24 h urine volume increased by 0.7 L/day (from 2.3 to 3.0 L/day) and the control group's 24 h urine decreased by 0.3 L/day (from 2.0 to 1.7 L/day; between-group difference in change: 0.9 L/day (95% CI 0.4 to 1.5; p=0.002)). We found no significant changes in urine, serum osmolality or electrolyte concentrations, or eGFR. No serious adverse events or changes in quality of life were reported. Conclusions A pilot RCT indicates adults with stage 3 CKD can successfully and safely increase water intake by up to 0.7 L/day in addition to usual fluid intake. Trial registration Registered with Clinical Trials—government identifier NCT01753466. PMID:24362012

  20. MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates, yet evidence for effective post-abortion family planning interventions are limited. This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia. Methods/Design A single blind randomised controlled trial of 500 participants. Clients aged 18 or over, attending for abortion at four Marie Stopes International clinics in Cambodia, owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control (standard care) with a 1:1 allocation ratio. The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support. Clients can respond to message prompts to request a phone call from a counsellor, or alternatively to state they have no problems. Clients requesting to talk to a counsellor, or who do not respond to the message prompts, receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning. The duration of the intervention is 3 months. The control group receive existing standard of care without the additional mobile phone-based support. We hypothesise that the intervention will remind clients about contraceptive methods available, identify problems with side effects early and provide support, and therefore increase use of post-abortion family planning, while reducing discontinuation and unsafe method switching. Participants are assessed at baseline and at 4 months. The primary outcome measure is use of an effective modern contraceptive method at 4 months post abortion. Secondary outcome measures include contraception use, pregnancy and repeat abortion over the 4-month post-abortion period. Risk ratios will be used as

  1. Multidisciplinary transmural rehabilitation for older persons with a stroke: the design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Vluggen Tom PMM

    2012-12-01

    Full Text Available Abstract Background Stroke is one of the major causes of loss of independence, decreased quality of life and mortality among elderly people. About half of the elderly stroke patients discharged after rehabilitation in a nursing home still experience serious impairments in daily functioning one year post stroke, which can lead to difficulties in picking up and managing their social life. The aim of this study is to evaluate the effectiveness and feasibility of a new multidisciplinary transmural rehabilitation programme for older stroke patients. Methods A two group multicentre randomised controlled trial is used to evaluate the effects of the rehabilitation programme. The programme consists of three care modules: 1 neurorehabilitation treatment for elderly stroke patients; 2 empowerment training for patient and informal caregiver; and 3 stroke education for patient and informal caregiver. The total programme has a duration of between two and six months, depending on the individual problems of the patient and informal caregiver. The control group receives usual care in the nursing home and after discharge. Patients aged 65 years and over are eligible for study participation when they are admitted to a geriatric rehabilitation unit in a nursing home due to a recent stroke and are expected to be able to return to their original home environment after discharge. Data are gathered by face-to-face interviews, self-administered questionnaires, focus groups and registration forms. Primary outcomes for patients are activity level after stroke, functional dependence, perceived quality of life and social participation. Outcomes for informal caregivers are perceived care burden, objective care burden, quality of life and perceived health. Outcome measures of the process evaluation are implementation fidelity, programme deliverance and the opinion of the stroke professionals, patients and informal caregivers about the programme. Outcome measures of the

  2. A cluster randomised controlled effectiveness trial evaluating perinatal home visiting among South African mothers/infants.

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    Mary Jane Rotheram-Borus

    Full Text Available Interventions are needed to reduce poor perinatal health. We trained community health workers (CHWs as home visitors to address maternal/infant risks.In a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1 the control, healthcare at clinics (n = 12 neighbourhoods; n = 594 women, or 2 a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme, in addition to clinic care (n = 12 neighbourhoods; n = 644 women. Participants were assessed during pregnancy (2% refusal and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received.Benefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p = 0.008; nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR = 1.25; p = 0.014, have infants with healthy weight-for-age measurements (OR = 1.42; p = 0.045, height-for-age measurements (OR = 1.13, p<0.001, breastfeed exclusively for six months (OR = 3.59; p<0.001, and breastfeed longer (OR = 3.08; p<0.001. Number of visits was positively associated with infant birth weight ≥2500 grams (OR = 1.07; p = 0

  3. Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R B; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John

    2016-09-08

    One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation

  4. Therapy of CF-Patients with Amitriptyline and Placebo - a Randomised, Double-Blind, Placebo-Controlled Phase IIb Multicenter, Cohort-Study

    National Research Council Canada - National Science Library

    Nährlich, Lutz; Mainz, Jochen G; Adams, Constantin; Engel, Corinna; Herrmann, Gloria; Icheva, Vanya; Lauer, Josefine; Deppisch, Caroline; Wirth, Andreas; Unger, Katy; Graepler-Mainka, Ute; Hector, Andreas; Heyder, Susanne; Stern, Martin; Döring, Gerd; Gulbins, Erich; Riethmüller, Joachim

    2013-01-01

    ... and infection susceptibility to pulmonary P. aeruginosa in these mice. To test for a beneficial effect of amitriptyline in vivo, we performed a phase IIb randomised, double-blind, placebo-controlled study...

  5. Comparing exercise interventions to increase persistence with physical exercise and sporting activity among people with hypertension or high normal blood pressure: study protocol for a randomised controlled trial

    National Research Council Canada - National Science Library

    Fife-Schaw, Chris; de Lusignan, Simon; Wainwright, Joe; Sprake, Hannah; Laver, Suzannah; Heald, Victoria; Orton, Julian; Prescott, Matt; Carr, Helen; O'Neill, Mark

    2014-01-01

    .... Four-arm randomised controlled trial. The study tests two types of intervention that are intended to increase physical activity among currently inactive 18- to 74-year-old people with hypertension or high-normal blood pressure...

  6. Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation : cost utility analysis alongside a randomised controlled trial

    NARCIS (Netherlands)

    Hout, van den W.B.; Peul, W.C.; Koes, B.W.; Brand, R.; Kievit, J.; Thomeer, R.T.W.M.

    2008-01-01

    Objective: To determine whether the faster recovery after early surgery for sciatica compared with prolonged conservative care is attained at reasonable costs. Design: Cost utility analysis alongside a randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with sciati

  7. Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomised controlled trial.

    NARCIS (Netherlands)

    Hout, W.B. van den; Peul, W.C.; Koes, B.W.; Brand, R.; Kievit, J.; Thomeer, R.T.

    2008-01-01

    OBJECTIVE: To determine whether the faster recovery after early surgery for sciatica compared with prolonged conservative care is attained at reasonable costs. DESIGN: Cost utility analysis alongside a randomised controlled trial. SETTING: Nine Dutch hospitals. PARTICIPANTS: 283 patients with sciati

  8. Communicating population health statistics through graphs: a randomised controlled trial of graph design interventions

    Directory of Open Access Journals (Sweden)

    Macdonald Robin

    2006-12-01

    Full Text Available Abstract Background Australian epidemiologists have recognised that lay readers have difficulty understanding statistical graphs in reports on population health. This study aimed to provide evidence for graph design improvements that increase comprehension by non-experts. Methods This was a double-blind, randomised, controlled trial of graph-design interventions, conducted as a postal survey. Control and intervention participants were randomly selected from telephone directories of health system employees. Eligible participants were on duty at the listed location during the study period. Controls received a booklet of 12 graphs from original publications, and intervention participants received a booklet of the same graphs with design modifications. A questionnaire with 39 interpretation tasks was included with the booklet. Interventions were assessed using the ratio of the prevalence of correct responses given by the intervention group to those given by the control group for each task. Results The response rate from 543 eligible participants (261 intervention and 282 control was 67%. The prevalence of correct answers in the control group ranged from 13% for a task requiring knowledge of an acronym to 97% for a task identifying the largest category in a pie chart. Interventions producing the greatest improvement in comprehension were: changing a pie chart to a bar graph (3.6-fold increase in correct point reading, changing the y axis of a graph so that the upward direction represented an increase (2.9-fold increase in correct judgement of trend direction, a footnote to explain an acronym (2.5-fold increase in knowledge of the acronym, and matching the y axis range of two adjacent graphs (two-fold increase in correct comparison of the relative difference in prevalence between two population subgroups. Conclusion Profound population health messages can be lost through use of overly technical language and unfamiliar statistical measures. In our

  9. Effect of soya protein on blood pressure: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Dong, Jia-Yi; Tong, Xing; Wu, Zhi-Wei; Xun, Peng-Cheng; He, Ka; Qin, Li-Qiang

    2011-08-01

    Observational studies have indicated that soya food consumption is inversely associated with blood pressure (BP). Evidence from randomised controlled trials (RCT) on the BP-lowering effects of soya protein intake is inconclusive. We aimed to evaluate the effectiveness of soya protein intake in lowering BP. The PubMed database was searched for published RCT in the English language through to April 2010, which compared a soya protein diet with a control diet. We conducted a random-effects meta-analysis to examine the effects of soya protein on BP. Subgroup and meta-regression analyses were performed to explore possible explanations for heterogeneity among trials. Meta-analyses of twenty-seven RCT showed a mean decrease of 2·21 mmHg (95 % CI - 4·10, - 0·33; P = 0·021) for systolic BP (SBP) and 1·44 mmHg (95 % CI - 2·56, - 0·31; P = 0·012) for diastolic BP (DBP), comparing the participants in the soya protein group with those in the control group. Soya protein consumption significantly reduced SBP and DBP in both hypertensive and normotensive subjects, and the reductions were markedly greater in hypertensive subjects. Significant and greater BP reductions were also observed in trials using carbohydrate, but not milk products, as the control diet. Meta-regression analyses further revealed a significantly inverse association between pre-treatment BP and the level of BP reductions. In conclusion, soya protein intake, compared with a control diet, significantly reduces both SBP and DBP, but the BP reductions are related to pre-treatment BP levels of subjects and the type of control diet used as comparison.

  10. Effect of yoga on cognitive functions in climacteric syndrome: a randomised control study.

    Science.gov (United States)

    Chattha, R; Nagarathna, R; Padmalatha, V; Nagendra, H R

    2008-07-01

    To assess the efficacy of an integrated approach of yoga therapy (IAYT) on cognitive abilities in climacteric syndrome. A randomised control study wherein the participants were divided into experimental and control groups. Fourteen centres of Swami Vivekananda Yoga Research Foundation, Bangalore, India. One hundred and eight perimenopausal women between 40 and 55 years with follicle-stimulating hormone level equal to or greater than 15 miu/ml. One hundred and twenty perimenopausal women were randomly allotted into the yoga and the control groups. The yoga group practised a module comprising breathing practices, sun salutation and cyclic meditation, whereas the control group practised a set of simple physical exercises, under supervision (1 hour/day, 5 days/week for 8 weeks). Assessments were made by vasomotor symptom checklist, six-letter cancellation test (SLCT) for attention and concentration and Punit Govil Intelligence Memory Scale (PGIMS) with ten subtests. The Wilcoxon test showed significant (P yoga group, with a trend of significant difference between groups at P = 0.06 on Mann-Whitney test in night sweats. There was no change within or between groups in the control group. The SLCT score and the PGIMS showed significant improvement in eight of ten subtests in the yoga group and six of ten subtests in the control group. The yoga group performed significantly better (P yoga therapy can improve hot flushes and night sweats. It also can improve cognitive functions such as remote memory, mental balance, attention and concentration, delayed and immediate recall, verbal retention and recognition tests.

  11. Changes in body weight and food choice in those attempting smoking cessation: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Leslie Wilma S

    2012-05-01

    Full Text Available Abstract Background Fear of weight gain is a barrier to smoking cessation and significant cause of relapse for many people. The provision of nutritional advice as part of a smoking cessation programme may assist some in smoking cessation and perhaps limit weight gain. The aim of this study was to determine the effect of a structured programme of dietary advice on weight change and food choice, in adults attempting smoking cessation. Methods Cluster randomised controlled design. Classes randomised to intervention commenced a 24-week intervention, focussed on improving food choice and minimising weight gain. Classes randomised to control received “usual care”. Results Twenty-seven classes in Greater Glasgow were randomised between January and August 2008. Analysis, including those who continued to smoke, showed that actual weight gain and percentage weight gain was similar in both groups. Examination of data for those successful at giving up smoking showed greater mean weight gain in intervention subjects (3.9 (SD 3.1 vs. 2.7 (SD 3.7 kg. Between group differences were not significant (p = 0.23, 95% CI −0.9 to 3.5. In comparison to baseline improved consumption of fruit and vegetables and breakfast cereal were reported in the intervention group. A higher percentage of control participants continued smoking (74% vs. 66%. Conclusions The intervention was not successful at minimising weight gain in comparison to control but was successful in facilitating some sustained improvements in the dietary habits of intervention participants. Improved quit rates in the intervention group suggest that continued contact with advisors may have reduced anxieties regarding weight gain and encouraged cessation despite weight gain. Research should continue in this area as evidence suggests that the negative effects of obesity could outweigh the health benefits achieved through reductions in smoking prevalence. Trial registration Current Controlled Trials

  12. Effects of music therapy on drug therapy of adult psychiatric outpatients: A pilot randomised controlled study

    Directory of Open Access Journals (Sweden)

    Mario Degli Stefani

    2016-10-01

    Full Text Available Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in the treatment of psychiatric outpatients. Method: Participants (n = 27 with ICD-10 diagnoses of F20 (schizophrenia, F25 (schizoaffective disorders, F31 (bipolar affective disorder, F32 (depressive episode and F60 (specific personality disorders were randomised to receive group music therapy plus standard care (48 weekly sessions of two hours or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilisers and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage relative to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilisers did not show any significant change in either group. Conclusions: Group music therapy combined with standard drug care is effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discuss the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centred perspective were also discussed.

  13. Efficacy of acupunture in patients with chronic neck pain--a randomised, sham controlled trial.

    Science.gov (United States)

    Sahin, Nilay; Ozcan, Emel; Sezen, Kasim; Karatas, Omer; Issever, Halim

    2010-01-01

    The aim of this study was to compare the efficacy of electroacupuncture and sham acupuncture in the treatment of patients with chronic neck pain. 31 patients with chronic neck pain were included in a randomised, controlled trial. Electric stimulation was given for 30 minutes at low frequency (1-4Hz), pulse width of 200 micros, interrupted wave form. Of the 29 patients who completed the therapy, 13 were assigned to conventional acupuncture and 16 to sham acupuncture groups, receiving 3 sessions a week for a total of 10 sessions, each lasting for 30 minutes. Patients were evaluated before and after therapy and 3 months later by Visual Analogue Scale (VAS) and the bodily pain subscale of the Short Form Health Survey-36 scale. The treating physician was different from the evaluating physician who, like the patient, was blinded. VAS scores in both groups significantly reduced after therapy and at 3 months post-therapy, but the difference between groups was not significant. In respect of bodily pain, there was a significant improvement in the acupuncture group after therapy (P<0.01). Stimulation of conventional acupuncture points was not generally superior to needling ofnonspecific points on the neck, and both treatments were associated with improvement of symptoms. Needles inserted into the neck are likely to be an inappropriate sham control for acupuncture.

  14. Compliance with Sport Injury Prevention Interventions in Randomised Controlled Trials: A Systematic Review.

    Science.gov (United States)

    van Reijen, Miriam; Vriend, Ingrid; van Mechelen, Willem; Finch, Caroline F; Verhagen, Evert A

    2016-08-01

    Sport injury prevention studies vary in the way compliance with an intervention is defined, measured and adjusted for. The objective of this systematic review was to assess the extent to which sport injury prevention randomised controlled trials (RCTs) have defined, measured and adjusted results for compliance with an injury prevention intervention. An electronic search was performed in MEDLINE, PubMed, the Cochrane Center of Controlled Trials, CINAHL (Cumulative Index to Nursing and Allied Health Literature), PEDro (Physiotherapy Evidence Database) and SPORTDiscus. English RCTs, quasi-RCTs and cluster-RCTs were considered eligible. Trials that involved physically active individuals or examined the effects of an intervention aimed at the prevention of sport- or physical activity-related injuries were included. Of the total of 100 studies included, 71.6 % mentioned compliance or a related term, 68.8 % provided details on compliance measurement and 51.4 % provided compliance data. Only 19.3 % analysed the effect of compliance rates on study outcomes. While studies used heterogeneous methods, pooled effects could not be presented. Studies that account for compliance demonstrated that compliance significant affects study outcomes. The way compliance is dealt with in preventions studies is subject to a large degree of heterogeneity. Valid and reliable tools to measure and report compliance are needed and should be matched to a uniform definition of compliance.

  15. A Mediterranean Diet to Improve Cardiovascular and Cognitive Health: Protocol for a Randomised Controlled Intervention Study.

    Science.gov (United States)

    Wade, Alexandra T; Davis, Courtney R; Dyer, Kathryn A; Hodgson, Jonathan M; Woodman, Richard J; Keage, Hannah A D; Murphy, Karen J

    2017-02-16

    The Mediterranean diet has demonstrated efficacy for improving cardiovascular and cognitive health. However, a traditional Mediterranean diet delivers fewer serves of dairy and less dietary calcium than is currently recommended in Australia, which may limit long-term sustainability. The present study aims to evaluate whether a Mediterranean diet with adequate dairy and calcium can improve cardiovascular and cognitive function in an at-risk population, and thereby reduce risk of cardiovascular disease (CVD) and cognitive decline. A randomised, controlled, parallel, crossover design trial will compare a Mediterranean diet supplemented with dairy foods against a low-fat control diet. Forty participants with systolic blood pressure above 120 mmHg and at least two other risk factors of CVD will undertake each dietary intervention for eight weeks, with an eight-week washout period between interventions. Systolic blood pressure will be the primary measure of interest. Secondary outcomes will include measures of cardiometabolic health, dietary compliance, cognitive function, assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB), psychological well-being and dementia risk. This research will provide empirical evidence as to whether the Mediterranean diet can be modified to provide recommended dairy and calcium intakes while continuing to deliver positive effects for cardiovascular and cognitive health. The findings will hold relevance for the field of preventative healthcare and may contribute to revisions of national dietary guidelines.

  16. Acupuncture for the Treatment of Oculomotor Paralysis: A Pilot Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jia-Qi Bi

    2016-01-01

    Full Text Available This study consisted of a single centre randomised controlled trial with two parallel arms: an acupuncture group (n=20 with 27 affected eyes and a sham group (n=20 with 23 affected eyes. Participants in the acupuncture group received acupuncture treatment once daily, three times weekly for four weeks. Participants assigned to the control group received sham acupuncture, the same protocol as that used for the acupuncture group but without insertion of needles into the skin. The primary outcome measure was the cervical range of motion (CROM score. Secondary outcome measures were the palpebral fissure size, response rate, and adverse events. All 40 participants completed the study. In the comparison of acupuncture and sham acupuncture, a significant difference was observed between acupuncture and sham acupuncture in CROM score (21.37±15.16 and 32.21±19.54, resp. (P<0.05 and palpebral fissure size (7.19±2.94 and 5.41±2.45, resp. (P<0.05. Response rate was also significantly different in the acupuncture group (P<0.05. No adverse events were reported in both groups in this study. In summary, it was demonstrated that acupuncture had a feasibility positive effect on oculomotor paralysis.

  17. Sweeten, soother and swaddle for retinopathy of prematurity screening: a randomised placebo controlled trial.

    LENUS (Irish Health Repository)

    O'Sullivan, A

    2012-02-01

    OBJECTIVE: To assess the efficacy of oral sucrose combined with swaddling and non-nutritive suck (NNS) as a method for reducing pain associated with retinopathy of prematurity (ROP) screening. DESIGN: Randomised placebo controlled study. SETTING: Tertiary level neonatal intensive care unit. SAMPLE: 40 infants undergoing primary eye examination for ROP screening. INTERVENTION: The control group were swaddled, and received 0.2 ml of sterile water given by mouth using a syringe and a soother. The intervention group were swaddled, and received 0.2 ml of sucrose 24% given by mouth using a syringe and a soother. RESULTS: 40 infants were included in the study. There was no difference in mean gestational age at birth, mean birth weight or corrected gestational age at first examination between both groups. The sucrose group had a significantly lower median Neonatal Pain, Agitation and Sedation Scale (N-PASS) score during ROP screening, initially following insertion of the speculum (6.5 vs 5, p=0.02) and subsequently during scleral indentation (9.5 vs 7.5, p=0.03). Fewer infants experienced episodes of desaturations or bradycardia in the intervention group (1 vs 4, p=0.18). CONCLUSION: ROP screening is a necessary but recognised painful procedure. Sucrose combined with NNS and swaddling reduced the behavioural and physiological pain responses. However, pain scores remained consistently high and appropriate pain relief for ROP screening remains a challenge.

  18. Recovery of chronically lame dairy cows following treatment for claw horn lesions: a randomised controlled trial.

    Science.gov (United States)

    Thomas, H J; Remnant, J G; Bollard, N J; Burrows, A; Whay, H R; Bell, N J; Mason, C; Huxley, J N

    2016-01-30

    A positively controlled, randomised controlled trial (RCT) was undertaken to test recovery of cows with claw horn lesions resulting in lameness of greater than two weeks duration. Cows on seven commercial farms were mobility scored fortnightly and selected by lameness severity and chronicity. Study cows all received a therapeutic trim then random allocation of: no further treatment (trim only (TRM)), plastic shoe (TS) or plastic shoe and NSAID (TSN). Recovery was assessed by mobility score at 42 (±4) days post treatment by an observer blind to treatment group. Multivariable analysis showed no significant effect of treatment with an almost identical, low response rate to treatment across all groups (Percentage non-lame at outcome: TRM--15 per cent, TS--15 per cent, TSN--16 per cent). When compared with results of a similar RCT on acutely lame cows, where response rates to treatment were substantially higher, it can be concluded that any delay in treatment is likely to reduce the rate of recovery, suggesting early identification and treatment is key. Thirty-eight per cent of animals treated in this study were lame on the contralateral limb at outcome suggesting that both hindlimbs should be examined and a preventive or if necessary a therapeutic foot trim performed when lameness is identified particularly if the duration of lameness is unknown.

  19. Cognitive stimulation for dementia: a systematic review of the evidence of effectiveness from randomised controlled trials.

    Science.gov (United States)

    Aguirre, Elisa; Woods, Robert T; Spector, Aimee; Orrell, Martin

    2013-01-01

    Cognitive stimulation is a psychological intervention widely used in dementia care, which offers a range of activities for people with dementia and provides general stimulation of cognitive abilities. This systematic review evaluates the effectiveness of cognitive stimulation in dementia. The review included studies from the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group, called ALOIS. This yielded ninety-four studies, of which fifteen were randomised controlled trials meeting the inclusion criteria. The analysis included 718 subjects (407 receiving cognitive stimulation and 311 in control groups). Results were subjected to a meta-analysis. A consistent significant benefit to cognitive function was identified following treatment and the benefits appeared to be over and above any medication effects. This remained evident at follow-up up to three months after the end of treatment. In secondary analyses, with smaller total sample sizes, significant benefits were also noted for quality of life and well-being, and on staff ratings of communication and social interaction. No differences in relation to mood, activities of daily living or challenging behaviour were noted. There is consistent evidence that cognitive stimulation interventions benefit cognitive function and aspects of well-being. Cognitive stimulation should be made more widely available in dementia care.

  20. Reading and language intervention for children at risk of dyslexia: a randomised controlled trial.

    Science.gov (United States)

    Duff, Fiona J; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J; Miles, Jeremy N V; Snowling, Margaret J

    2014-11-01

    Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children identified by research criteria as being at risk of dyslexia (n = 56), and their school-identified peers (n = 89). An Experimental group received two 9-week blocks of daily intervention delivered by trained teaching assistants; the Control group received 9 weeks of typical classroom instruction, followed by 9 weeks of intervention. Following mixed effects regression models and path analyses, small-to-moderate effects were shown on letter knowledge, phoneme awareness and taught vocabulary. However, these were fragile and short lived, and there was no reliable effect on the primary outcome of word-level reading. This new intervention was theoretically motivated and based on previous successful interventions, yet failed to show reliable effects on language and literacy measures following a rigorous evaluation. We suggest that the intervention may have been too short to yield improvements in oral language; and that literacy instruction in and beyond the classroom may have weakened training effects. We argue that reporting of null results makes an important contribution in terms of raising standards both of trial reporting and educational practice. © 2014 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

  1. A Mediterranean Diet to Improve Cardiovascular and Cognitive Health: Protocol for a Randomised Controlled Intervention Study

    Science.gov (United States)

    Wade, Alexandra T.; Davis, Courtney R.; Dyer, Kathryn A.; Hodgson, Jonathan M.; Woodman, Richard J.; Keage, Hannah A. D.; Murphy, Karen J.

    2017-01-01

    The Mediterranean diet has demonstrated efficacy for improving cardiovascular and cognitive health. However, a traditional Mediterranean diet delivers fewer serves of dairy and less dietary calcium than is currently recommended in Australia, which may limit long-term sustainability. The present study aims to evaluate whether a Mediterranean diet with adequate dairy and calcium can improve cardiovascular and cognitive function in an at-risk population, and thereby reduce risk of cardiovascular disease (CVD) and cognitive decline. A randomised, controlled, parallel, crossover design trial will compare a Mediterranean diet supplemented with dairy foods against a low-fat control diet. Forty participants with systolic blood pressure above 120 mmHg and at least two other risk factors of CVD will undertake each dietary intervention for eight weeks, with an eight-week washout period between interventions. Systolic blood pressure will be the primary measure of interest. Secondary outcomes will include measures of cardiometabolic health, dietary compliance, cognitive function, assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB), psychological well-being and dementia risk. This research will provide empirical evidence as to whether the Mediterranean diet can be modified to provide recommended dairy and calcium intakes while continuing to deliver positive effects for cardiovascular and cognitive health. The findings will hold relevance for the field of preventative healthcare and may contribute to revisions of national dietary guidelines. PMID:28212320

  2. A randomised controlled trial of blended learning to improve the newborn examination skills of medical students.

    Science.gov (United States)

    Stewart, Alice; Inglis, Garry; Jardine, Luke; Koorts, Pieter; Davies, Mark William

    2013-03-01

    To evaluate the hypotheses that a blended learning approach would improve the newborn examination skills of medical students and yield a higher level of satisfaction with learning newborn examination. Undergraduate medical students at a tertiary teaching hospital were individually randomised to receive either a standard neonatology teaching programme (control group), or additional online access to the PENSKE Baby Check Learning Module (blended learning group). The primary outcome was performance of newborn examination on standardised assessment by blinded investigators. The secondary outcomes were performance of all 'essential' items of the examination, and participant satisfaction. The recruitment rate was 88% (71/81). The blended learning group achieved a significantly higher mean score than the control group (p=0.02) for newborn examination. There was no difference for performance of essential items, or satisfaction with learning newborn examination. The blended learning group rated the module highly for effective use of learning time and ability to meet specific learning needs. A blended learning approach resulted in a higher level of performance of newborn examination on standardised assessment. This is consistent with published literature on blended learning and has implications for all neonatal clinicians including junior doctors, midwifes and nurse practitioners.

  3. Assessing a cognitive music training for older participants: a randomised controlled trial.

    Science.gov (United States)

    Biasutti, Michele; Mangiacotti, Anthony

    2017-04-12

    In a randomised controlled trial, we investigated whether a cognitive training based on rhythm-music and music improvisation exercises had positive effects on executive functions in older participants. Thirty-five residents in a guest home with mild-moderate cognitive impairment and healthy ageing were randomly assigned to an experimental group (n = 18) featuring cognitive music training composed of 12 bi-weekly 70-min sessions, and a control group (n = 17) attended 12 bi-weekly 45-min sessions of gymnastic activities offered by the institute. A neuropsychological test battery was administered at baseline and at the end of treatment, including the Mini-Mental State Examination, verbal fluency test, Trail Making Test A, attentional matrices test and clock-drawing test. Pre-test and post-test comparison showed a significant improvement for the experimental group reflected in the Mini-Mental State Examination (F(1,33) = 13.906; p cognitive protocol based on music-rhythmic exercises and music improvisation exercises is associated with improved cognitive functions in older people with mild-moderate cognitive impairment regardless of the individual's degree of cognitive reserve. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  4. Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial.

    Science.gov (United States)

    Mulders, Marjolein A M; Walenkamp, Monique M J; Goslings, J Carel; Schep, Niels W L

    2016-02-09

    Of all distal radius fractures, 25 % are complete articular fractures (AO/OTA type C fractures). Two thirds of those fractures are displaced and require reduction. According to several International Guidelines, adequately reduced intra-articular distal radius fractures are best treated non-operatively with plaster immobilisation, while surgical fixation is suggested only when the articular step exceeds 2 mm after reduction. However, these recommendations are based on studies that did not differentiate between intra- and extra-articular distal radius fractures. Thus, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be reached. Despite the lack of evidence, an increase in internal fixation of intra-articular distal radius fractures has been observed over the last decade. The aim of this study is to determine the difference in functional outcome following open reduction and plate fixation compared with non-operative treatment with closed reduction and plaster immobilisation in patients with a displaced intra articular distal radius fracture. This multicentre randomised controlled trial will randomise between open reduction and internal plate fixation (intervention group) and closed reduction and plaster immobilisation (control group). All consecutive adult patients from 18 to 65 years with a displaced intra-articular distal radius fracture (AO/OTA type C), which has been adequately reduced at the Emergency Department according to the Dutch National Guidelines, are eligible for inclusion in this study. The primary outcome is function and pain of the wrist assessed with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes are the Disability of the Arm, Shoulder and Hand score (DASH), pain, quality of life (SF-36), range of motion, grip strength, radiological parameters, complications, crossovers and cost-effectiveness of both treatments. A total of 90 patients will be included in this

  5. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

    Directory of Open Access Journals (Sweden)

    Daly Fergus

    2007-03-01

    Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully

  6. Cardiac rehabilitation adapted to transient ischaemic attack and stroke (CRAFTS: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Blake Catherine

    2009-02-01

    Full Text Available Abstract Background Coronary Heart Disease and Cerebrovascular Disease share many predisposing, modifiable risk factors (hypertension, abnormal blood lipids and lipoproteins, cigarette smoking, physical inactivity, obesity and diabetes mellitus. Lifestyle interventions and pharmacological therapy are recognised as the cornerstones of secondary prevention. Cochrane review has proven the benefits of programmes incorporating exercise and lifestyle counselling in the cardiac disease population. A Cochrane review highlighted as priority, the need to establish feasibility and efficacy of exercise based interventions for Cerebrovascular Disease. Methods A single blind randomised controlled trial is proposed to examine a primary care cardiac rehabilitation programme for adults post transient ischemic attack (TIA and stroke in effecting a positive change in the primary outcome measures of cardiac risk scores derived from Blood Pressure, lipid profile, smoking and diabetic status and lifestyle factors of habitual smoking, exercise and healthy eating participation. Secondary outcomes of interest include health related quality of life as measured by the Hospital Anxiety and Depression Scale, the Stroke Specific Quality of Life scale and WONCA COOP Functional Health Status charts and cardiovascular fitness as measured by a sub-maximal fitness test. A total of 144 patients, over 18 years of age with confirmed diagnosis of ischaemic stroke or TIA, will be recruited from Dublin community stroke services and two tertiary T.I.A clinics. Exclusion criteria will include oxygen dependence, unstable cardiac conditions, uncontrolled diabetes, major medical conditions, claudication, febrile illness, pregnancy or cognitive impairment. Participants will be block-statified, randomly allocated to one of two groups using a pre-prepared computer generated randomisation schedule. Both groups will receive a two hour education class on risk reduction post stroke. The

  7. The haemodynamic effects of the perioperative terlipressin infusion in living donor liver transplantation: A randomised controlled study

    Directory of Open Access Journals (Sweden)

    Nagwa Ibrahim

    2015-01-01

    Full Text Available Background and Aims: Liver disease is usually accompanied with a decline in systemic vascular resistance (SVR. We decided to assess effects of the peri-operative terlipressin infusion on liver donor liver transplantation recipients with respect to haemodynamics and renal parameters. Methods: After Ethical Committee approval for this prospective randomised controlled study, 50 recipients were enrolled and allotted to control (n = 25 or terlipressin group (n = 25 with simple randomisation method. Terlipressin was infused at 1.0 μg/kg/h and later titrated 1.0-4.0 μg/kg/h to maintain mean arterial pressure (MAP >65 mmHg and SVR index 0.05 and was sustained post-operatively. Conclusion: Terlipressin improved SVR and MAP with less need for catecholamines particularly post-reperfusion. Terlipressin reduced PPV without hepatic artery vasoconstriction and improved post-operative UOP.

  8. The haemodynamic effects of the perioperative terlipressin infusion in living donor liver transplantation: A randomised controlled study

    Science.gov (United States)

    Ibrahim, Nagwa; Hasanin, Ashraf; Allah, Sabry Abd; Sayed, Eman; Afifi, Mohamed; Yassen, Khaled; Saber, Wesam; Khalil, Magdy

    2015-01-01

    Background and Aims: Liver disease is usually accompanied with a decline in systemic vascular resistance (SVR). We decided to assess effects of the peri-operative terlipressin infusion on liver donor liver transplantation recipients with respect to haemodynamics and renal parameters. Methods: After Ethical Committee approval for this prospective randomised controlled study, 50 recipients were enrolled and allotted to control (n = 25) or terlipressin group (n = 25) with simple randomisation method. Terlipressin was infused at 1.0 μg/kg/h and later titrated 1.0–4.0 μg/kg/h to maintain mean arterial pressure (MAP) >65 mmHg and SVR index 0.05) and was sustained post-operatively. Conclusion: Terlipressin improved SVR and MAP with less need for catecholamines particularly post-reperfusion. Terlipressin reduced PPV without hepatic artery vasoconstriction and improved post-operative UOP. PMID:25838587

  9. A randomised, controlled study of peri-operative low dose s(+)-ketamine in combination with postoperative patient-controlled s(+)-ketamine and morphine after radical prostatectomy.

    NARCIS (Netherlands)

    Snijdelaar, D.G.; Cornelisse, H.B.; Schmid, R.L.; Katz, J.

    2004-01-01

    In a randomised, double-blind prospective study we compared the effects on postoperative pain and analgesic consumption of intra-operative s(+)-ketamine (100 microg.kg-1 bolus and a continuous infusion of 2 microg.kg-1.min-1) followed by postoperative patient-controlled analgesia with morphine (1 mg

  10. A randomised, controlled study of peri-operative low dose s(+)-ketamine in combination with postoperative patient-controlled s(+)-ketamine and morphine after radical prostatectomy.

    NARCIS (Netherlands)

    Snijdelaar, D.G.; Cornelisse, H.B.; Schmid, R.L.; Katz, J.

    2004-01-01

    In a randomised, double-blind prospective study we compared the effects on postoperative pain and analgesic consumption of intra-operative s(+)-ketamine (100 microg.kg-1 bolus and a continuous infusion of 2 microg.kg-1.min-1) followed by postoperative patient-controlled analgesia with morphine (1 mg

  11. Targeting intensive versus conventional glycaemic control for type 1 diabetes mellitus: a systematic review with meta-analyses and trial sequential analyses of randomised clinical trials

    OpenAIRE

    Kähler, Pernille; Grevstad, Berit; Almdal, Thomas; Gluud, Christian; Wetterslev, Jørn; Vaag, Allan; Hemmingsen, Bianca

    2014-01-01

    Objective To assess the benefits and harms of targeting intensive versus conventional glycaemic control in patients with type 1 diabetes mellitus. Design A systematic review with meta-analyses and trial sequential analyses of randomised clinical trials. Data sources The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded and LILACS to January 2013. Study selection Randomised clinical trials that prespecified different targets of glycaemic control in participants at any age with...

  12. Effect of family style mealtimes on quality of life, physical performance, and body weight of nursing home residents: cluster randomised controlled trial

    OpenAIRE

    2006-01-01

    Objective To assess the effect of family style mealtimes on quality of life, physical performance, and body weight of nursing home residents without dementia. Design Cluster randomised trial. Setting Five Dutch nursing homes. Participants 178 residents (mean age 77 years). Two wards in each home were randomised to intervention (95 participants) or control groups (83). Intervention During six months the intervention group took their meals family style and the control group received the usual i...

  13. Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial.

    Science.gov (United States)

    Khanna, Reena; Bressler, Brian; Levesque, Barrett G; Zou, Guangyong; Stitt, Larry W; Greenberg, Gordon R; Panaccione, Remo; Bitton, Alain; Paré, Pierre; Vermeire, Séverine; D'Haens, Geert; MacIntosh, Donald; Sandborn, William J; Donner, Allan; Vandervoort, Margaret K; Morris, Joan C; Feagan, Brian G

    2015-11-07

    Conventional management of Crohn's disease features incremental use of therapies. However, early combined immunosuppression (ECI), with a TNF antagonist and antimetabolite might be a more effective strategy. We compared the efficacy of ECI with that of conventional management for treatment of Crohn's disease. In this open-label cluster randomised controlled trial (Randomised Evaluation of an Algorithm for Crohn's Treatment, REACT), we included community gastroenterology practices from Belgium and Canada that were willing to be assigned to either of the study groups, participate in all aspects of the study, and provide data on up to 60 patients with Crohn's disease. These practices were randomly assigned (1:1) to either ECI or conventional management. The computer-generated randomisation was minimised by country and practice size. Up to 60 consecutive adult patients were assessed within practices. Patients who were aged 18 years or older; documented to have Crohn's disease; able to speak or understand English, French, or Dutch; able to access a telephone; and able to provide written informed consent were followed up for 2 years. The primary outcome was the proportion of patients in corticosteroid-free remission (Harvey-Bradshaw Index score ≤ 4) at 12 months at the practice level. This trial is registered with ClinicalTrials.gov, number NCT01030809. This study took place between March 15, 2010, and Oct 1, 2013. Of the 60 practices screened, 41 were randomly assigned to either ECI (n=22) or conventional management (n=19). Two practices (one in each group) discontinued because of insufficient resources. 921 (85%) of the 1084 patients at ECI practices and 806 (90%) of 898 patients at conventional management practices completed 12 months follow-up and were included in an intention-to-treat analysis. The 12 month practice-level remission rates were similar at ECI and conventional management practices (66·0% [SD 14·0] and 61·9% [16·9]; adjusted difference 2·5%, 95

  14. Effect of exercise training on C reactive protein: a systematic review and meta-analysis of randomised and non-randomised controlled trials.

    Science.gov (United States)

    Fedewa, Michael V; Hathaway, Elizabeth D; Ward-Ritacco, Christie L

    2017-04-01

    C-reactive protein (CRP) is a marker of chronic systemic inflammation frequently used in cardiovascular disease risk assessment. The purpose of this meta-analysis was to provide a quantitative estimate of the magnitude of change in CRP following participation in physical exercise interventions. All studies included in the meta-analysis were peer reviewed and published in English. Human participants were assigned to a non-exercise comparison group or exercise training group, with the intervention lasting ≥2 weeks. CRP levels were measured at baseline, during and/or after completion of the exercise training programme. Random-effects models were used to aggregate a mean effect size (ES), 95% CIs and potential moderators. 83 randomised and non-randomised controlled trials met the inclusion criteria and resulted in 143 effects (n=3769). The mean ES of 0.26 (95% CI 0.18 to 0.34, pexercise training. A decrease in body mass index (BMI; β=1.20, SE=0.25, pExercise training led to a greater reduction in CRP when accompanied by a decrease in BMI (ES=0.38, 95% CI 0.26 to 0.50); however, a significant improvement in CRP occurred in the absence of weight loss (ES=0.19, 95% CI 0.10 to 0.28; both pexercise training is associated with a decrease in CRP levels regardless of the age or sex of the individual; however, greater improvements in CRP level occur with a decrease in BMI or %Fat. 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/.

  15. A novel school-based intervention to improve nutrition knowledge in children: cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ong Ken K

    2010-03-01

    Full Text Available Abstract Background Improving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a novel educational intervention to increase nutrition knowledge among primary school children. Methods We developed a card game 'Top Grub' and a 'healthy eating' curriculum for use in primary schools. Thirty-eight state primary schools comprising 2519 children in years 5 and 6 (aged 9-11 years were recruited in a pragmatic cluster randomised controlled trial. The main outcome measures were change in nutrition knowledge scores, attitudes to healthy eating and acceptability of the intervention by children and teachers. Results Twelve intervention and 13 control schools (comprising 1133 children completed the trial. The main reason for non-completion was time pressure of the school curriculum. Mean total nutrition knowledge score increased by 1.1 in intervention (baseline to follow-up: 28.3 to 29.2 and 0.3 in control schools (27.3 to 27.6. Total nutrition knowledge score at follow-up, adjusted for baseline score, deprivation, and school size, was higher in intervention than in control schools (mean difference = 1.1; 95% CI: 0.05 to 2.16; p = 0.042. At follow-up, more children in the intervention schools said they 'are currently eating a healthy diet' (39.6% or 'would try to eat a healthy diet' (35.7% than in control schools (34.4% and 31.7% respectively; chi-square test p Conclusions The 'Top Grub' card game facilitated the enjoyable delivery of nutrition education in a sample of UK primary school age children. Further studies should determine whether improvements in nutrition knowledge are sustained and lead to changes in dietary behaviour.

  16. Effects of lifestyle exercise on premenopausal bone health: a randomised controlled trial.

    Science.gov (United States)

    Babatunde, Opeyemi; Forsyth, Jacky

    2014-09-01

    Osteoporosis, a slowly evolving public health epidemic, often with an insidious presentation is largely preventable but the optimal dimensions of exercise that may be prescribed for enhancing bone-health among premenopausal adults are yet to be elucidated. Hence, the escalating incidence and burden of prevalence of osteoporosis is yet unabated. Considering that exogenous hormones in the form of hormonal contraception are known to modulate bone mass, investigations of their possible influence on the translation of exercise-induced osteogenic stimuli on the mature bone is pertinent. The aim of this study was to examine the effect of specified lifestyle exercise on bone-health of premenopausal women. Premenopausal women (n = 96, mean age: 22.25 ± 3.5 years; mean BMI: 23.43 ± 3.5 kg/m(2)) participated in a 6-month randomised controlled trial involving home-based rest-interspersed bouts of high-impact exercise for the intervention group and sham exercise for the control group. Approximately half (47) of the participants (24-exercise, 23-control) were on hormonal-based contraception while the other half (49: 24-exercise, 25-control) were not on hormonal contraception. The regime led to a significant 3.7 % increase in broadband ultrasound attenuation of exercisers compared to controls; hormonal contraceptive use did not appear to potentiate the osteogenic effects of the lifestyle exercise regime. The research highlights that short, discrete bouts of high-impact exercise may be a potential public health prescription for enhancing premenopausal bone-health regardless of hormonal contraceptive use.

  17. Computerised attention training for children with intellectual and developmental disabilities: a randomised controlled trial.

    Science.gov (United States)

    Kirk, Hannah E; Gray, Kylie M; Ellis, Kirsten; Taffe, John; Cornish, Kim M

    2016-12-01

    Children with intellectual and developmental disabilities (IDD) experience heightened attention difficulties which have been linked to poorer cognitive, academic and social outcomes. Although, increasing research has focused on the potential of computerised cognitive training in reducing attention problems, limited studies have assessed whether this intervention could be utilised for those with IDD. This study aimed to assess the efficacy of a computerised attention training programme in children with IDD. In a double-blind randomised controlled trial, children (n = 76; IQ attention training condition or a nonadaptive control condition. Both conditions were completed at home over a 5-week period and consisted of 25 sessions, each of 20-min duration. Outcome measures (baseline, posttraining and 3-month follow-up) assessed core attention skills (selective attention, sustained attention and attentional control) and inattentive/hyperactive behaviour. Children in the attention training condition showed greater improvement in selective attention performance compared to children in the control condition (SMD = 0.24, 95% CI 0.02, 0.45). These improvements were maintained 3 months after training had ceased (SMD = 0.26, 95% CI 0.04, 0.48). The attention training programme was not effective in promoting improvements in sustained attention, attentional control or inattentive/hyperactive behaviours. The findings suggest that attention training may enhance some aspects of attention (selective attention) in children with IDD, but the small to medium effect sizes indicate that further refinement of the training programme is needed to promote larger, more global improvements. © 2016 Association for Child and Adolescent Mental Health.

  18. A randomised control trial of experiential learning to promote physical activity.

    Science.gov (United States)

    Cooke, Philip A; Tully, Mark A; Cupples, Margaret E; Gilliland, Andrew E; Gormley, Gerard J

    2013-09-01

    The paucity of training in physical activity (PA) promotion in UK medical schools is a barrier to health professionals' promotion of PA to their patients. Doctors who are more physically active are more likely to counsel patients in this regard. We used a randomised controlled trial (RCT) to examine the effect of an intervention which engaged students in goal-setting, using pedometer step counts, on their PA behaviour and intentions to promote PA in future practice. We invited fourth-year medical students to participate in the study during their four-week placement in primary care. Following baseline pedometer measurement of daily step counts for one week, students were randomly allocated to intervention (individual step count goal-setting) or control groups. Using pedometers, both groups monitored their PA during the following week. Intentions to promote PA were assessed using a questionnaire based on the theory of planned behaviour at baseline, four weeks and nine weeks. Focus groups explored the students' experiences of PA measurement, goalsetting for behaviour change and health promotion teaching. One-hundred and thirty-six students participated (70 intervention; 66 control). The mean change in daily step count was greater ( P =0.001) in the intervention group (1245, 95% CI 762 to 1727) than in the control group (-65, 95% CI -644 to 573). Scores for perceived behavioural control over PA counselling increased in both groups, with a trend for higher scores in the intervention group. Intervention group students described how experience of personal PA behaviour change gave insights into barriers patients may face and improved their confidence in PA counselling. Medical students' personal experience of goal setting in increasing PA appears to lead to a more positive perception of their ability to deliver effective PA promotion in future practice. Inclusion of this learning experience within the undergraduate curriculum may improve doctors' skills in health promotion.

  19. A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma

    Science.gov (United States)

    Bernstein, Jonathan A.; Vandewalker, Mark; Moroni-Zentgraf, Petra; Verri, Daniela; Unseld, Anna; Engel, Michael; Boner, Attilio L.

    2017-01-01

    We present results from the first phase III trial of once-daily tiotropium add-on to inhaled corticosteroids (ICS) plus one or more controller therapies in adolescents with severe symptomatic asthma. In this double-blind, parallel-group trial (NCT01277523), 392 patients aged 12–17 years were randomised to receive once-daily tiotropium 5 µg or 2.5 µg, or placebo, as an add-on to ICS plus other controller therapies over 12 weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1 s (FEV1) within 3 h post-dosing (FEV1(0–3h)) and trough FEV1, respectively, after 12 weeks of treatment. Tiotropium 5 µg provided numerical improvements in peak FEV1(0–3h) response, compared with placebo (90 mL; p=0.104), and significant improvements were observed with tiotropium 2.5 µg (111 mL; p=0.046). Numerical improvements in trough FEV1 response and asthma control were observed with both tiotropium doses, compared with placebo. The safety and tolerability of tiotropium were comparable with those of placebo. Once-daily tiotropium Respimat add-on to ICS plus one or more controller therapies in adolescents with severe symptomatic asthma was well tolerated. The primary end-point of efficacy was not met, although positive trends for improvements in lung function and asthma control were observed. PMID:27811070

  20. Impact on learning of an e-learning module on leukaemia: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Morgulis Yuri

    2012-05-01

    Full Text Available Abstract Background e-learning resources may be beneficial for complex or conceptually difficult topics. Leukaemia is one such topic, yet there are no reports on the efficacy of e-learning for leukaemia. This study compared the learning impact on senior medical students of a purpose-built e-learning module on leukaemia, compared with existing online resources. Methods A randomised controlled trial was performed utilising volunteer senior medical students. Participants were randomly allocated to Study and Control groups. Following a pre-test on leukaemia administered to both groups, the Study group was provided with access to the new e-learning module, while the Control group was directed to existing online resources. A post-test and an evaluation questionnaire were administered to both groups at the end of the trial period. Results Study and Control groups were equivalent in gender distribution, mean academic ability, pre-test performance and time studying leukaemia during the trial. The Study group performed significantly better than the Control group in the post-test, in which the group to which the students had been allocated was the only significant predictor of performance. The Study group’s evaluation of the module was overwhelmingly positive. Conclusions A targeted e-learning module on leukaemia had a significant effect on learning in this cohort, compared with existing online resources. We believe that the interactivity, dialogic feedback and integration with the curriculum offered by the e-learning module contributed to its impact. This has implications for e-learning design in medicine and other disciplines.

  1. The Norwegian tenecteplase stroke trial (NOR-TEST): Randomised controlled trial of tenecteplase vs. alteplase in acute ischaemic stroke

    OpenAIRE

    2014-01-01

    Background: Alteplase is the only approved thrombolytic agent for acute ischaemic stroke. The overall benefit from alteplase is substantial, but some evidence indicates that alteplase also has negative effects on the ischaemic brain. Tenecteplase may be more effective and less harmfull than alteplase, but large randomised controlled phase 3 trials are lacking. The Norwegian Tenecteplase Stroke Trial (NOR-TEST) aims to compare efficacy and safety of tenecteplase vs. alteplase. Methods/Desig...

  2. Efficacy of a multimodal physiotherapy treatment program for hip osteoarthritis: a randomised placebo-controlled trial protocol

    OpenAIRE

    Forbes Andrew; Wrigley Tim V; McManus Fiona; Metcalf Ben; Sims Kevin; Abbott J Haxby; Pua Yong-Hao; Egerton Thorlene; Bennell Kim L; Harris Anthony; Buchbinder Rachelle

    2010-01-01

    Abstract Background Hip osteoarthritis (OA) is a common condition leading to pain, disability and reduced quality of life. There is currently limited evidence to support the use of conservative, non-pharmacological treatments for hip OA. Exercise and manual therapy have both shown promise and are typically used together by physiotherapists to manage painful hip OA. The aim of this randomised controlled trial is to compare the efficacy of a physiotherapy treatment program with placebo treatmen...

  3. Employing crisis postcards with case management in Kaohsiung, Taiwan: 6-month outcomes of a randomised controlled trial for suicide attempters

    OpenAIRE

    Chen, Wei-Jen; Ho, Chi-Kung; Shyu, Shi-Sen; Chen, Cheng-Chung; Lin, Guei-Ging; Chou, Li-Shiu; Fang, Yun-Ju; Yeh, Pin-Yang; Chung, Tieh-Chi; Chou, Frank Huang-Chih

    2013-01-01

    Background Suicide attempts constitute a serious clinical problem and have important implications for healthcare resources. The aim of the present study was to evaluate the effectiveness of case management using crisis postcards over a 6-month follow-up period. Method A randomised controlled trial was conducted in Kaohsiung, Taiwan. Prevention of further suicide attempts was compared between two groups with and without the postcard intervention. The intervention group consisted of 373 partici...

  4. Aged Residential Care Health Utilisation Study (ARCHUS: a randomised controlled trial to reduce acute hospitalisations from residential aged care

    Directory of Open Access Journals (Sweden)

    Foster Susan J

    2012-09-01

    Full Text Available Abstract Background For residents of long term care, hospitalisations can cause distress and disruption, and often result in further medical complications. Multi-disciplinary team interventions have been shown to improve the health of Residential Aged Care (RAC residents, decreasing the need for acute hospitalisation, yet there are few randomised controlled trials of these complex interventions. This paper describes a randomised controlled trial of a structured multi-disciplinary team and gerontology nurse specialist (GNS intervention aiming to reduce residents’ avoidable hospitalisations. Methods/Design This Aged Residential Care Healthcare Utilisation Study (ARCHUS is a cluster- randomised controlled trial (n = 1700 residents of a complex multi-disciplinary team intervention in long-term care facilities. Eligible facilities certified for residential care were selected from those identified as at moderate or higher risk of resident potentially avoidable hospitalisations by statistical modelling. The facilities were all located in the Auckland region, New Zealand and were stratified by District Health Board (DHB. Intervention The intervention provided a structured GNS intervention including a baseline facility needs assessment, quality indicator benchmarking, a staff education programme and care coordination. Alongside this, three multi-disciplinary team (MDT meetings were held involving a geriatrician, facility GP, pharmacist, GNS and senior nursing staff. Outcomes Hospitalisations are recorded from routinely-collected acute admissions during the 9-month intervention period followed by a 5-month follow-up period. ICD diagnosis codes are used in a pre-specified definition of potentially reducible admissions. Discussion This randomised-controlled trial will evaluate a complex intervention to increase early identification and intervention to improve the health of residents of long term care. The results of this trial are expected in early

  5. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in Hemiplegic Cerebral Palsy

    OpenAIRE

    Biagi Laura; Guzzetta Andrea; Cossu Giuseppe; Ferrari Adriano; Sgandurra Giuseppina; Tosetti Michela; Fogassi Leonardo; Cioni Giovanni

    2011-01-01

    Abstract Background Rehabilitation for children with hemiplegic cerebral palsy (HCP) aimed to improve function of the impaired upper limb (UL) uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT) for evaluating the efficacy of Action-Observation Therapy in i...

  6. Randomised placebo-controlled trial on the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis

    OpenAIRE

    Tafazal, Suhayl I.; Ng, Leslie; Sell, Philip

    2006-01-01

    This is a double blind randomised controlled trial to assess the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis. The trial compared the outcome of salmon calcitonin nasal spray to placebo nasal spray in patients with MRI confirmed lumbar spinal stenosis. Lumbar spinal stenosis is one of the commonest conditions encountered by spine surgeons. It more frequently affects elderly patients and lumbar decompression has been used to treat the condition with varia...

  7. Impact of autologous blood injections in treatment of mid-portion Achilles tendinopathy: double blind randomised controlled trial

    OpenAIRE

    Bell, Kevin J; Fulcher, Mark L; Rowlands, David S.; Kerse, Ngaire

    2013-01-01

    Objective To assess the effectiveness of two peritendinous autologous blood injections in addition to a standardised eccentric calf strengthening programme in improving pain and function in patients with mid-portion Achilles tendinopathy. Design Single centre, participant and single assessor blinded, parallel group, randomised, controlled trial. Setting Single sports medicine clinic in New Zealand. Participants 53 adults (mean age 49, 53% men) with symptoms of unilateral mid-portion Achilles ...

  8. Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial

    OpenAIRE

    Mann, Eleanor; Smith, Melanie J; Hellier, Jennifer; Balabanovic, Janet A; Hamed, Hisham; Grunfeld, Elizabeth A; Hunter, Myra S.

    2012-01-01

    Summary Background Hot flushes and night sweats (HFNS) affect 65–85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS. Methods In this randomised controlled trial, we recruited women...

  9. Evaluating the effectiveness of a smartphone app to reduce excessive alcohol consumption: protocol for a factorial randomised control trial.

    Science.gov (United States)

    Garnett, Claire; Crane, David; Michie, Susan; West, Robert; Brown, Jamie

    2016-07-08

    Excessive alcohol consumption is a leading cause of death and morbidity worldwide and interventions to help people reduce their consumption are needed. Interventions delivered by smartphone apps have the potential to help harmful and hazardous drinkers reduce their consumption of alcohol. However, there has been little evaluation of the effectiveness of existing smartphone interventions. A systematic review, amongst other methodologies, identified promising modular content that could be delivered by an app: self-monitoring and feedback; action planning; normative feedback; cognitive bias re-training; and identity change. This protocol reports a factorial randomised controlled trial to assess the comparative potential of these five intervention modules to reduce excessive alcohol consumption. A between-subject factorial randomised controlled trial. Hazardous and harmful drinkers aged 18 or over who are making a serious attempt to reduce their drinking will be randomised to one of 32 (2(5)) experimental conditions after downloading the 'Drink Less' app. Participants complete baseline measures on downloading the app and are contacted after 1-month with a follow-up questionnaire. The primary outcome measure is change in past week consumption of alcohol. Secondary outcome measures are change in AUDIT score, app usage data and usability ratings for the app. A factorial between-subjects ANOVA will be conducted to assess main and interactive effects of the five intervention modules for the primary and secondary outcome measures. This study will establish the extent to which the five intervention modules offered in this app can help reduce hazardous and harmful drinking. This is the first step in optimising and understanding what component parts of an app could help to reduce excessive alcohol consumption. The findings from this study will be used to inform the content of a future integrated treatment app and evaluated against a minimal control in a definitive randomised

  10. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in Hemiplegic Cerebral Palsy

    OpenAIRE

    Biagi Laura; Guzzetta Andrea; Cossu Giuseppe; Ferrari Adriano; Sgandurra Giuseppina; Tosetti Michela; Fogassi Leonardo; Cioni Giovanni

    2011-01-01

    Abstract Background Rehabilitation for children with hemiplegic cerebral palsy (HCP) aimed to improve function of the impaired upper limb (UL) uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT) for evaluating the efficacy of Action-Observation Therapy in i...

  11. Strong gametocytocidal effect of methylene blue-based combination therapy against falciparum malaria: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Boubacar Coulibaly

    Full Text Available BACKGROUND: With the availability of new preventive and curative interventions, global malaria control has been strengthened significantly in recent years. Drugs effective in reducing malaria gametocytaemia might contribute to local elimination and possible long-term eradication. We here report on the effects of methylene blue (MB-based malaria combination therapy on gametocytaemia during a randomised-controlled trial in Burkina Faso. METHODS: An open-label randomised controlled phase II study in 180 children aged 6-10 years with uncomplicated falciparum malaria was conducted in Nouna, north-western Burkina Faso. Children were randomised to MB-artesunate (AS, MB-amodiaquine (AQ, and AS-AQ (local standard of care. Overall follow-up was for 28 days, follow-up for gametocytaemia was for 14 days. FINDINGS: The treatment groups were similar in baseline characteristics and there was only one loss to follow-up. Compared to AS-AQ, both MB-containing regimens were associated with significantly reduced gametocyte carrier rates during follow-up days 3, 7, and 14. This effect was seen both in patients with and without P. falciparum gametocytaemia at baseline. INTERPRETATION: MB reveals pronounced gametocytocidal activity which appears to act against both existing and developing P. falciparum gametocytes. MB-based combination therapy thus has the potential to reduce transmission of P. falciparum malaria in endemic regions, which has important implications for future elimination and eradication strategies. TRIAL REGISTRATION: (ClinicalTrials.gov NCT00354380.

  12. Theory of planned behaviour variables and objective walking behaviour do not show seasonal variation in a randomised controlled trial.

    Science.gov (United States)

    Williams, Stefanie L; French, David P

    2014-02-05

    Longitudinal studies have shown that objectively measured walking behaviour is subject to seasonal variation, with people walking more in summer compared to winter. Seasonality therefore may have the potential to bias the results of randomised controlled trials if there are not adequate statistical or design controls. Despite this there are no studies that assess the impact of seasonality on walking behaviour in a randomised controlled trial, to quantify the extent of such bias. Further there have been no studies assessing how season impacts on the psychological predictors of walking behaviour to date. The aim of the present study was to assess seasonal differences in a) objective walking behaviour and b) Theory of Planned Behaviour (TPB) variables during a randomised controlled trial of an intervention to promote walking. 315 patients were recruited to a two-arm cluster randomised controlled trial of an intervention to promote walking in primary care. A series of repeated measures ANCOVAs were conducted to examine the effect of season on pedometer measures of walking behaviour and TPB measures, assessed immediately post-intervention and six months later. Hierarchical regression analyses were conducted to assess whether season moderated the prediction of intention and behaviour by TPB measures. There were no significant differences in time spent walking in spring/summer compared to autumn/winter. There was no significant seasonal variation in most TPB variables, although the belief that there will be good weather was significantly higher in spring/summer (F = 19.46, p behaviour, or moderate the effects of TPB variables on intention or behaviour. Seasonality does not influence objectively measured walking behaviour or psychological variables during a randomised controlled trial. Consequently physical activity behaviour outcomes in trials will not be biased by the season in which they are measured. Previous studies may have overestimated the extent of

  13. Functional changes in adipose tissue in a randomised controlled trial of physical activity

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    Sjögren Per

    2012-06-01

    Full Text Available Abstract Background A sedentary lifestyle predisposes to cardiometabolic diseases. Lifestyle changes such as increased physical activity improve a range of cardiometabolic risk factors. The objective of this study was to examine whether functional changes in adipose tissue were related to these improvements. Methods Seventy-three sedentary, overweight (mean BMI 29.9 ± 3.2 kg/m2 and abdominally obese, but otherwise healthy men and women (67.6 ± 0.5 years from a randomised controlled trial of physical activity on prescription over a 6-month period were included (control n = 43, intervention n = 30. Detailed examinations were carried out at baseline and at follow-up, including fasting blood samples, a comprehensive questionnaire and subcutaneous adipose tissue biopsies for fatty acid composition analysis (n = 73 and quantification of mRNA expression levels of 13 candidate genes (n = 51, including adiponectin, leptin and inflammatory cytokines. Results At follow-up, the intervention group had a greater increase in exercise time (+137 min/week and a greater decrease in body fat mass (−1.5 kg compared to the control subjects (changes of 0 min/week and −0.5 kg respectively. Circulating concentrations of adiponectin were unchanged, but those of leptin decreased significantly more in the intervention group (−1.8 vs −1.1 ng/mL for intervention vs control, P P P  Conclusions After a 6-month period of increased physical activity in overweight elderly individuals, circulating leptin concentrations decreased despite increased levels of leptin mRNA in adipose tissue. Otherwise, only minor changes occurred in adipose tissue, although several improvements in metabolic parameters accompanied the modest increase in physical activity.

  14. Singing teaching as a therapy for chronic respiratory disease - a randomised controlled trial and qualitative evaluation

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    Kelly Julia L

    2010-08-01

    Full Text Available Abstract Background Despite optimal pharmacological therapy and pulmonary rehabilitation, patients with COPD continue to be breathless. There is a need to develop additional strategies to alleviate symptoms. Learning to sing requires control of breathing and posture and might have benefits that translate into daily life. Methods To test this hypothesis we performed a randomised controlled trial, comparing a six week course of twice weekly singing classes to usual care, in 28 COPD patients. The experience of singing was assessed in a qualitative fashion, through interviews with a psychologist. In addition, we surveyed patients with chronic respiratory conditions who participated in a series of open singing workshops. Results In the RCT, the physical component score of the SF36 improved in the singers (n = 15 compared to the controls (n = 13; +7.5(14.6 vs. -3.8(8.4 p = 0.02. Singers also had a significant fall in HAD anxiety score; -1.1(2.7 vs. +0.8(1.7 p = 0.03. Singing did not improve single breath counting, breath hold time or shuttle walk distance. In the qualitative element, 8 patients from the singing group were interviewed. Positive effects on physical sensation, general well-being, community/social support and achievement/efficacy emerged as common themes. 150 participants in open workshops completed a questionnaire. 96% rated the workshops as "very enjoyable" and 98% thought the workshop had taught them something about breathing in a different way. 81% of attendees felt a "marked physical difference" after the workshop. Conclusion Singing classes can improve quality of life measures and anxiety and are viewed as a very positive experience by patients with respiratory disease; no adverse consequences of participation were observed. Trial Registration Current Controlled Trials - ISRCTN17544114.

  15. The impact of behavioural screening on intervention outcomes in a randomised, controlled multiple behaviour intervention trial

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    Fjeldsoe Brianna S

    2011-03-01

    Full Text Available Abstract Background With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown. Methods Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention, characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups. Results Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also

  16. Posterior superior alveolar nerve blocks: a randomised controlled, double blind trial.

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    Singla, Himanshi; Alexander, Mohan

    2015-06-01

    Local anesthesia has been a boon for dentistry to allay the most common fear of pain among dental patients. Several techniques to achieve anesthesia for posterior maxillae have been advocated albeit with minor differences. We compared two techniques of posterior superior alveolar nerve block (PSANB), the one claimed to be "most accurate" to the one "most commonly used." This study was conducted to assess and compare the efficacy as well as complications of "the straight needle technique" to that of "the bent needle technique" for PSANB. We conducted a prospective, randomised, double blind study on 120 patients divided into two groups, using a 26-gauge, 38 mm long needle with 2 ml of 2 % lignocaine hydrochloride with 1:200,000 adrenaline solution. Objective symptoms were evaluated by a single investigator. Cold test using ice was used to evaluate the status of pulpal anesthesia. Data thus obtained was subjected to statistical analysis. Out of the 120 blocks, 19 blocks failed. Statistical analysis found straight needle technique to be more successful than the bent needle technique (p = 0.002). Both the techniques were equally effective for the first molar region on both right and left side (p = 0.66 on right side and p = 0.20 on left side). However, in the second and third molar region technique A was more effective than B (p = 0.01) on right side only. On Left side, both techniques were equally effective (p = 0.08). Sensitivity of the cold test was 82 % which is quite high but the specificity was 68 % which seems to be falling in the above average range only. Positive predictive value of 75 and negative predictive value of 76 was observed. We did not encounter any complications in this study. To the best of our knowledge, this is the first randomised controlled clinical study on PSANB techniques. This study suggests that the PSANB using the straight needle technique as advocated by Malamed [1] can be routinely and safely used to achieve anesthesia in

  17. Pralidoxime in acute organophosphorus insecticide poisoning--a randomised controlled trial.

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    Michael Eddleston

    2009-06-01

    Full Text Available Poisoning with organophosphorus (OP insecticides is a major global public health problem, causing an estimated 200,000 deaths each year. Although the World Health Organization recommends use of pralidoxime, this antidote's effectiveness remains unclear. We aimed to determine whether the addition of pralidoxime chloride to atropine and supportive care offers benefit.We performed a double-blind randomised placebo-controlled trial of pralidoxime chloride (2 g loading dose over 20 min, followed by a constant infusion of 0.5 g/h for up to 7 d versus saline in patients with organophosphorus insecticide self-poisoning. Mortality was the primary outcome; secondary outcomes included intubation, duration of intubation, and time to death. We measured baseline markers of exposure and pharmacodynamic markers of response to aid interpretation of clinical outcomes. Two hundred thirty-five patients were randomised to receive pralidoxime (121 or saline placebo (114. Pralidoxime produced substantial and moderate red cell acetylcholinesterase reactivation in patients poisoned by diethyl and dimethyl compounds, respectively. Mortality was nonsignificantly higher in patients receiving pralidoxime: 30/121 (24.8% receiving pralidoxime died, compared with 18/114 (15.8% receiving placebo (adjusted hazard ratio [HR] 1.69, 95% confidence interval [CI] 0.88-3.26, p = 0.12. Incorporating the baseline amount of acetylcholinesterase already aged and plasma OP concentration into the analysis increased the HR for patients receiving pralidoxime compared to placebo, further decreasing the likelihood that pralidoxime is beneficial. The need for intubation was similar in both groups (pralidoxime 26/121 [21.5%], placebo 24/114 [21.1%], adjusted HR 1.27 [95% CI 0.71-2.29]. To reduce confounding due to ingestion of different insecticides, we further analysed patients with confirmed chlorpyrifos or dimethoate poisoning alone, finding no evidence of benefit.Despite clear reactivation of

  18. Determinants of rapid weight gain during infancy: baseline results from the NOURISH randomised controlled trial

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    Mihrshahi Seema

    2011-11-01

    Full Text Available Abstract Background Rapid weight gain in infancy is an important predictor of obesity in later childhood. Our aim was to determine which modifiable variables are associated with rapid weight gain in early life. Methods Subjects were healthy infants enrolled in NOURISH, a randomised, controlled trial evaluating an intervention to promote positive early feeding practices. This analysis used the birth and baseline data for NOURISH. Birthweight was collected from hospital records and infants were also weighed at baseline assessment when they were aged 4-7 months and before randomisation. Infant feeding practices and demographic variables were collected from the mother using a self administered questionnaire. Rapid weight gain was defined as an increase in weight-for-age Z-score (using WHO standards above 0.67 SD from birth to baseline assessment, which is interpreted clinically as crossing centile lines on a growth chart. Variables associated with rapid weight gain were evaluated using a multivariable logistic regression model. Results Complete data were available for 612 infants (88% of the total sample recruited with a mean (SD age of 4.3 (1.0 months at baseline assessment. After adjusting for mother's age, smoking in pregnancy, BMI, and education and infant birthweight, age, gender and introduction of solid foods, the only two modifiable factors associated with rapid weight gain to attain statistical significance were formula feeding [OR = 1.72 (95%CI 1.01-2.94, P = 0.047] and feeding on schedule [OR = 2.29 (95%CI 1.14-4.61, P = 0.020]. Male gender and lower birthweight were non-modifiable factors associated with rapid weight gain. Conclusions This analysis supports the contention that there is an association between formula feeding, feeding to schedule and weight gain in the first months of life. Mechanisms may include the actual content of formula milk (e.g. higher protein intake or differences in feeding styles, such as feeding to schedule

  19. Cost-effectiveness analyses for mirtazapine and sertraline in dementia: randomised controlled trial.

    Science.gov (United States)

    Romeo, Renee; Knapp, Martin; Hellier, Jennifer; Dewey, Michael; Ballard, Clive; Baldwin, Robert; Bentham, Peter; Burns, Alistair; Fox, Chris; Holmes, Clive; Katona, Cornelius; Lawton, Claire; Lindesay, James; Livingston, Gill; McCrae, Niall; Moniz-Cook, Esme; Murray, Joanna; Nurock, Shirley; O'Brien, John; Poppe, Michaela; Thomas, Alan; Walwyn, Rebecca; Wilson, Kenneth; Banerjee, Sube

    2013-02-01

    Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes. To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia. A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0-13 weeks and 0-39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods. There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively. In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the

  20. Group therapy for adolescents with repeated self harm: randomised controlled trial with economic evaluation.

    Science.gov (United States)

    Green, J M; Wood, A J; Kerfoot, M J; Trainor, G; Roberts, C; Rothwell, J; Woodham, A; Ayodeji, E; Barrett, B; Byford, S; Harrington, R

    2011-04-01

    To examine the effectiveness and cost-effectiveness of group therapy for self harm in young people. Two arm, single (assessor) blinded parallel randomised allocation trial of a group therapy intervention in addition to routine care, compared with routine care alone. Randomisation was by minimisation controlling for baseline frequency of self harm, presence of conduct disorder, depressive disorder, and severity of psychosocial stress. Adolescents aged 12-17 years with at least two past episodes of self harm within the previous 12 months. Exclusion criteria were: not speaking English, low weight anorexia nervosa, acute psychosis, substantial learning difficulties (defined by need for specialist school), current containment in secure care. Setting Eight child and adolescent mental health services in the northwest UK. Manual based developmental group therapy programme specifically designed for adolescents who harm themselves, with an acute phase over six weekly sessions followed by a booster phase of weekly groups as long as needed. Details of routine care were gathered from participating centres. Primary outcome was frequency of subsequent repeated episodes of self harm. Secondary outcomes were severity of subsequent self harm, mood disorder, suicidal ideation, and global functioning. Total costs of health, social care, education, and criminal justice sector services, plus family related costs and productivity losses, were recorded. 183 adolescents were allocated to each arm (total n = 366). Loss to follow-up was low (self harm, proportional odds ratio of group therapy versus routine care adjusting for relevant baseline variables was 0.99 (95% confidence interval 0.68 to 1.44, P = 0.95) at 6 months and 0.88 (0.59 to 1.33, P = 0.52) at 1 year. For severity of subsequent self harm the equivalent odds ratios were 0.81 (0.54 to 1.20, P = 0.29) at 6 months and 0.94 (0.63 to 1.40, P = 0.75) at 1 year. Total 1 year costs were higher in the group therapy arm (£21,781) than

  1. Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches.

    Science.gov (United States)

    Elliott, Daisy; Husbands, Samantha; Hamdy, Freddie C; Holmberg, Lars; Donovan, Jenny L

    2017-05-31

    The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improve-recruitment and informed consent within a range of clinical trials. A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups

  2. Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial

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    Rathleff Michael S

    2012-01-01

    Full Text Available Abstract Background Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS. In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents. Methods/Design This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years. Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months. Discussion This study is designed to investigate the effectiveness of patient

  3. Endovascular therapy for acute ischaemic stroke: the Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE) randomised, controlled trial

    Science.gov (United States)

    Muir, Keith W; Ford, Gary A; Messow, Claudia-Martina; Ford, Ian; Murray, Alicia; Clifton, Andrew; Brown, Martin M; Madigan, Jeremy; Lenthall, Rob; Robertson, Fergus; Dixit, Anand; Cloud, Geoffrey C; Wardlaw, Joanna; Freeman, Janet; White, Philip

    2017-01-01

    Objective The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA). Design Eligible patients had IVT started within 4.5 hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90 min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0–2 at day 90. Results Ten UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13–21). Median stroke onset to IVT start was 120 min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0–1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0–2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021). Conclusions The trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability

  4. The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders

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    Hiscock Harriet

    2011-01-01

    Full Text Available Abstract Background The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. Methods/Design This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500 with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively to compare outcomes

  5. Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Whitlock, Richard P; Devereaux, P J; Teoh, Kevin H; Lamy, Andre; Vincent, Jessica; Pogue, Janice; Paparella, Domenico; Sessler, Daniel I; Karthikeyan, Ganesan; Villar, Juan Carlos; Zuo, Yunxia; Avezum, Álvaro; Quantz, Mackenzie; Tagarakis, Georgios I; Shah, Pallav J; Abbasi, Seyed Hesameddin; Zheng, Hong; Pettit, Shirley; Chrolavicius, Susan; Yusuf, Salim

    2015-09-26

    Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388. Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared

  6. Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS: a randomised controlled trial

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    Kenyon Sara

    2012-02-01

    Full Text Available Abstract Background Maternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK. Method/Design The aim of this study is to evaluate a lay Pregnancy Outreach Worker (POW service for nulliparous women identified as having social risk within a maternity service that is systematically assessing social risks alongside the usual obstetric and medical risks. The study design is a randomised controlled trial (RCT in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service. The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care from randomisation (before 28 weeks gestation until 6 weeks after birth. The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. The two primary outcomes are engagement with antenatal care, assessed by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy and mother-to-infant bonding will also be collected using validated tools. A sample size of 1316 will provide 90% power (at the 5% significance level to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will

  7. COSMOS: COmparing Standard Maternity care with One-to-one midwifery Support: a randomised controlled trial

    Science.gov (United States)

    McLachlan, Helen L; Forster, Della A; Davey, Mary-Ann; Lumley, Judith; Farrell, Tanya; Oats, Jeremy; Gold, Lisa; Waldenström, Ulla; Albers, Leah; Biro, Mary Anne

    2008-01-01

    Background In Australia and internationally, there is concern about the growing proportion of women giving birth by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies as well as decreased fertility; and significant resource implications. Randomised controlled trials (RCTs) of continuity of midwifery care have reported reduced caesareans and other interventions in labour, as well as increased maternal satisfaction, with no statistically significant differences in perinatal morbidity or mortality. RCTs conducted in the UK and in Australia have largely measured the effect of teams of care providers (commonly 6–12 midwives) with very few testing caseload (one-to-one) midwifery care. This study aims to determine whether caseload (one-to-one) midwifery care for women at low risk of medical complications decreases the proportion of women delivering by caesarean section compared with women receiving 'standard' care. This paper presents the trial protocol in detail. Methods/design A two-arm RCT design will be used. Women who are identified at low medical risk will be recruited from the antenatal booking clinics of a tertiary women's hospital in Melbourne, Australia. Baseline data will be collected, then women randomised to caseload midwifery or standard low risk care. Women allocated to the caseload intervention will receive antenatal, intrapartum and postpartum care from a designated primary midwife with one or two antenatal visits conducted by a 'back-up' midwife. The midwives will collaborate with obstetricians and other health professionals as necessary. If the woman has an extended labour, or if the primary midwife is unavailable, care will be provided by the back-up midwife. For women allocated to standard care, options include midwifery-led care with varying levels of continuity, junior obstetric care and community based general medical practitioner care. Data will be collected at recruitment (self

  8. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.

    Science.gov (United States)

    Kanes, Stephen; Colquhoun, Helen; Gunduz-Bruce, Handan; Raines, Shane; Arnold, Ryan; Schacterle, Amy; Doherty, James; Epperson, C Neill; Deligiannidis, Kristina M; Riesenberg, Robert; Hoffmann, Ethan; Rubinow, David; Jonas, Jeffrey; Paul, Steven; Meltzer-Brody, Samantha

    2017-07-29

    Post-partum depression is a serious mood disorder in women that might be triggered by peripartum fluctuations in reproductive hormones. This phase 2 study investigated brexanolone (USAN; formerly SAGE-547 injection), an intravenous formulation of allopregnanolone, a positive allosteric modulator of γ-aminobutyric acid (GABAA) receptors, for the treatment of post-partum depression. For this double-blind, randomised, placebo-controlled trial, we enrolled self-referred or physician-referred female inpatients (≤6 months post partum) with severe post-partum depression (Hamilton Rating Scale for Depression [HAM-D] total score ≥26) in four hospitals in the USA. Eligible women were randomly assigned (1:1), via a computer-generated randomisation program, to receive either a single, continuous intravenous dose of brexanolone or placebo for 60 h. Patients and investigators were masked to treatment assignments. The primary efficacy endpoint was the change from baseline in the 17-item HAM-D total score at 60 h, assessed in all randomised patients who started infusion of study drug or placebo and who had a completed baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Patients were followed up until day 30. This trial is registered with ClinicalTrials.gov, number NCT02614547. This trial was done between Dec 15, 2015 (first enrolment), and May 19, 2016 (final visit of the last enrolled patient). 21 women were randomly assigned to the brexanolone (n=10) and placebo (n=11) groups. At 60 h, mean reduction in HAM-D total score from baseline was 21·0 points (SE 2·9) in the brexanolone group compared with 8·8 points (SE 2·8) in the placebo group (difference -12·2, 95% CI -20·77 to -3·67; p=0·0075; effect size 1·2). No deaths, serious adverse events, or discontinuations because of adverse events were reported in either group. Four of ten patients in the brexanolone group had adverse events compared with eight of 11 in the placebo group. The most

  9. Task-Specific Balance Training Improves the Sensory Organisation of Balance Control in Children with Developmental Coordination Disorder: A Randomised Controlled Trial

    OpenAIRE

    Fong, Shirley S.M.; Guo, X.; Liu, Karen P.Y.; Ki, W.Y.; Louie, Lobo H.T.; Chung, Raymond C.K.; Macfarlane, Duncan J

    2016-01-01

    Sensory organisation of balance control is compromised in children with developmental coordination disorder (DCD). A randomised controlled trial involving 88 children with DCD was conducted to evaluate the efficacy of a task-specific balance training (functional-movement training, FMT) programme in improving balance deficits in a DCD population. The DCD participants were randomly assigned to either a FMT group or a control group. The FMT group received two training sessions/ week for 3 months...

  10. Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Rodgers, Helen; Shaw, Lisa; Bosomworth, Helen; Aird, Lydia; Alvarado, Natasha; Andole, Sreeman; Cohen, David L; Dawson, Jesse; Eyre, Janet; Finch, Tracy; Ford, Gary A; Hislop, Jennifer; Hogg, Steven; Howel, Denise; Hughes, Niall; Krebs, Hermano Igo; Price, Christopher; Rochester, Lynn; Stamp, Elaine; Ternent, Laura; Turner, Duncan; Vale, Luke; Warburton, Elizabeth; van Wijck, Frederike; Wilkes, Scott

    2017-07-20

    Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. NHS stroke services. adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0-7 must improve by 3 or more points; baseline

  11. A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

    Science.gov (United States)

    2012-01-01

    Background Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034. PMID:22839453

  12. A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

    Directory of Open Access Journals (Sweden)

    Ashby Rebecca L

    2012-07-01

    Full Text Available Abstract Background Negative pressure wound therapy (NPWT is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community, pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC (spun hydrocolloid, alginate or foam dressings. Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8% were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group during follow-up (time to healing 79 days. The mean number of treatment visits per week was 3.1 (NPWT and 5.7 (SC; 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT and 5.0 (SC months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034.

  13. A prospective randomised controlled trial to investigate the effect of local anaesthetic in vivo on cell culture.

    Science.gov (United States)

    Mary O'Brien, C; Breuning, Eleonore; Webb, Jill; Balderson, Debra; Nancarrow, Jeffrey

    2008-10-01

    Cell culture is an important adjunct in the management of major burns in that it enables keratinocytes derived from the patient to be grown and used to attain cover when there is little autologous skin available. The purpose of this prospective randomised trial was to determine if the type of local anaesthetic used to harvest the skin biopsy in vivo affected the subsequent culture of keratinocytes. Lignocaine 1% was compared with a eutectic mixture of local anaesthetic (EMLA) and a control. The subjects recruited were patients undergoing abdominoplasty. Sixteen patients were recruited but two were excluded from final analysis due to infection of the culture medium in one and poor yield from biopsies in all groups in the other. The tissue to be removed from the abdomen was divided into three areas. EMLA was applied to a 5x5 cm randomised area 2 h prior to surgery. Lignocaine 1% was injected into a 5x5 cm randomised area of abdominal skin immediately after anaesthesia. The third 5x5 cm randomised area was used as a control. Three 4-mm punch biopsies were harvested from each site of local anaesthetic application as well as the control area. The Rheinwald & Green method was used to culture these cells [Rheinwald JG, Green H. Serial cultivation of strains of human epidermal keratinocytes: the formation of keratinizing colonies from single cells. Cell 1975;6:331-5.] Cell counts were performed after harvesting keratinocytes from the biopsy and after 10 days of culture. Statistical analysis was undertaken. In conclusion, in contrast to in vitro studies when lignocaine 1% or EMLA is applied in vivo, there is no inhibition of cell culture. In vivo EMLA was also found to significantly increase cell multiplication.

  14. Efficacy of labral repair, biceps tenodesis, and diagnostic arthroscopy for SLAP Lesions of the shoulder: a randomised controlled trial

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    Mowinckel Petter

    2010-10-01

    Full Text Available Abstract Background Surgery for type II SLAP (superior labral anterior posterior lesions of the shoulder is a promising but unproven treatment. The procedures include labral repair or biceps tenodesis. Retrospective cohort studies have suggested that the benefits of tenodesis include pain relief and improved function, and higher patient satisfaction, which was reported in a prospective non-randomised study. There have been no completed randomised controlled trials of surgery for type II SLAP lesions. The aims of this participant and observer blinded randomised placebo-controlled trial are to compare the short-term (6 months and long-term (2 years efficacy of labral repair, biceps tenodesis, and placebo (diagnostic arthroscopy for alleviating pain and improving function for type II SLAP lesions. Methods/Design A double-blind randomised controlled trial are performed using 120 patients, aged 18 to 60 years, with a history for type II SLAP lesions and clinical signs suggesting type II SLAP lesion, which were documented by MR arthrography and arthroscopy. Exclusion criteria include patients who have previously undergone operations for SLAP lesions or recurrent shoulder dislocations, and ruptures of the rotator cuff or biceps tendon. Outcomes will be assessed at baseline, three, six, 12, and 24 months. Primary outcome measures will be the clinical Rowe Score (1988-version and the Western Ontario Instability Index (WOSI at six and 24 months. Secondary outcome measures will include the Shoulder Instability Questionnaire (SIQ, the generic EuroQol (EQ-5 D and EQ-VAS, return to work and previous sports activity, complications, and the number of reoperations. Discussion The results of this trial will be of international importance and the results will be translatable into clinical practice. Trial Registration [ClinicalTrials.gov NCT00586742

  15. A randomised controlled trial of recovery focused CBT for individuals with early bipolar disorder

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    Jones Steven

    2012-11-01

    Full Text Available Abstract Background There is increasing evidence for the effectiveness of structured psychological therapies for bipolar disorder. To date however there have been no psychological interventions specifically designed for individuals with early bipolar disorder. The primary objective of this trial is to establish the acceptability and feasibility of a new CBT based intervention (Recovery focused CBT; RfCBT designed in collaboration with individuals with early bipolar disorder intended to improve clinical and personal recovery outcomes. Methods and design This article describes a single blind randomised controlled trial to assess the feasibility and acceptability of RfCBT compared with treatment as usual. Participants will be recruited from across the North West of England from specialist mental health services and through primary care and self referral. The primary outcome of the study is the feasibility and acceptability of RfCBT as indicated by recruitment to target and retention to follow-up as well as absence of untoward incidents associated with RfCBT. We also intend to estimate the effect size of the impact of the intervention on recovery and mood outcomes and explore potential process measures (self appraisal, stigma, hope and self esteem. Discussion This is the first trial of recovery informed CBT for early bipolar disorder and will therefore be of interest to researchers in this area as well as indicating the wider potential for evaluating approaches to the recovery informed treatment of recent onset severe mental illness in general. Trial registration number ISRCTN43062149

  16. Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial.

    Science.gov (United States)

    Poustie, Vanessa J; Russell, Jayne E; Watling, Ruth M; Ashby, Deborah; Smyth, Rosalind L

    2006-03-18

    To determine whether oral protein energy supplements, used long term in children with cystic fibrosis who are moderately malnourished, improve nutritional and other outcomes. Multicentre randomised controlled trial. Seven specialist paediatric cystic fibrosis centres and their associated shared care clinics and seven smaller paediatric cystic fibrosis clinics. 102 children with cystic fibrosis, aged between 2 and 15 years, who were moderately malnourished. Oral protein energy supplements in addition to usual dietary advice compared with dietary advice alone, for 12 months. Change in body mass index centile over one year. Use of supplements was not associated with a change in body mass index centile (mean difference 2.99 centile points, 95% confidence interval -2.70 to 8.68) or other nutritional and spirometric outcomes in this group of children. Long term use of oral protein energy supplements did not result in an improvement in nutritional status or other clinical outcomes in children with cystic fibrosis who were moderately malnourished. Oral protein energy supplements should not be regarded as an essential part of the management of this group of children. ISRCTN: 95744468.

  17. Randomised, Double Blind, Placebo-Controlled Trial of Echinacea Supplementation in Air Travellers

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    E. Tiralongo

    2012-01-01

    Full Text Available Objective. To identify whether a standardised Echinacea formulation is effective in the prevention of respiratory and other symptoms associated with long-haul flights. Methods. 175 adults participated in a randomised, double-blind placebo-controlled trial travelling back from Australia to America, Europe, or Africa for a period of 1–5 weeks on commercial flights via economy class. Participants took Echinacea (root extract, standardised to 4.4 mg alkylamides or placebo tablets. Participants were surveyed before, immediately after travel, and at 4 weeks after travel regarding upper respiratory symptoms and travel-related quality of life. Results. Respiratory symptoms for both groups increased significantly during travel (P<0.0005. However, the Echinacea group had borderline significantly lower respiratory symptom scores compared to placebo (P=0.05 during travel. Conclusions. Supplementation with standardised Echinacea tablets, if taken before and during travel, may have preventive effects against the development of respiratory symptoms during travel involving long-haul flights.

  18. A guide to performing a peer review of randomised controlled trials.

    Science.gov (United States)

    Del Mar, Chris; Hoffmann, Tammy C

    2015-11-02

    Peer review of journal articles is an important step in the research process. Editors rely on the expertise of peer reviewers to properly assess submissions. Yet, peer review quality varies widely and few receive training or guidance in how to approach the task. This paper describes some of the main steps that peer reviewers in general and, in particular, those performing reviewes of randomised controlled trials (RCT), can use when carrying out a review. It can be helpful to begin with a brief read to acquaint yourself with the study, followed by a detailed read and a careful check for flaws. These can be divided into 'major' (problems that must be resolved before publication can be considered) and 'minor' (suggested improvements that are discretionary) flaws. Being aware of the appropriate reporting checklist for the study being reviewed (such as CONSORT and its extensions for RCTs) can also be valuable. Competing interests or prejudices might corrode the review, so ensuring transparency about them is important. Finally, ensuring that the paper's strengths are acknowledged along with a dissection of the weaknesses provides balance and perspective to both authors and editors. Helpful reviews are constructive and improve the quality of the paper. The proper conduct of a peer review is the responsibility of all who accept the role.

  19. Cholesterol Metabolism and Weight Reduction in Subjects with Mild Obstructive Sleep Apnoea: A Randomised, Controlled Study

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    Maarit Hallikainen

    2013-01-01

    Full Text Available To evaluate whether parameters of obstructive sleep apnoea (OSA associate with cholesterol metabolism before and after weight reduction, 42 middle-aged overweight subjects with mild OSA were randomised to intensive lifestyle intervention (N=23 or to control group (N=18 with routine lifestyle counselling only. Cholesterol metabolism was evaluated with serum noncholesterol sterol ratios to cholesterol, surrogate markers of cholesterol absorption (cholestanol and plant sterols and synthesis (cholestenol, desmosterol, and lathosterol at baseline and after 1-year intervention. At baseline, arterial oxygen saturation (SaO2 was associated with serum campesterol (P<0.05 and inversely with desmosterol ratios (P<0.001 independently of gender, BMI, and homeostasis model assessment index of insulin resistance (HOMA-IR. Apnoea-hypopnoea index (AHI was not associated with cholesterol metabolism. Weight reduction significantly increased SaO2and serum cholestanol and decreased AHI and serum cholestenol ratios. In the groups combined, the changes in AHI were inversely associated with changes of cholestanol and positively with cholestenol ratios independent of gender and the changes of BMI and HOMA-IR (P<0.05. In conclusion, mild OSA seemed to be associated with cholesterol metabolism independent of BMI and HOMA-IR. Weight reduction increased the markers of cholesterol absorption and decreased those of cholesterol synthesis in the overweight subjects with mild OSA.

  20. Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

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    Probst Pascal

    2016-09-01

    Full Text Available Conflicts of interest may lead to biased trial designs and unbalanced interpretation of study results. We aimed to evaluate the reporting of potential conflicts of interest in full publications of surgical randomised controlled trials (RCTs. A systematic literature search was performed in CENTRAL, MEDLINE and EMBASE (1985–2014 to find all surgical RCTs of medical devices and perioperative pharmacological or nutritional interventions. The information on conflicts of interest was evaluated both quantitatively and qualitatively, and the development of stated conflicts over time was studied. Of 7934 articles, 444 met the inclusion criteria. In 93 of 444 trials (20.9%, conflicts of interest were disclosed. In half of the cases, the information provided was insufficient to permit conclusions regarding possible influence on the trials. Information about conflicts of interest has increased continuously during the last decades (1985–1994: 0%, 1995–2004: 2.8% and 2005–2014: 33.0%; p<0.001. Among the 115 industry-funded trials, industry participation was considered as a potential conflict of interest in 24 cases (20.9%. Over the past three decades, only every 10th trial has provided appropriate information on conflicts of interest. However, transparency is crucial for the reliability of evidence-based medicine. There is an urgent need for the full disclosure of all conflicts of interest in surgical publishing and for transparency regarding cooperation between academia and industry.

  1. Sample bias from different recruitment strategies in a randomised controlled trial for alcohol dependence.

    Science.gov (United States)

    Morley, Kirsten C; Teesson, Maree; Sannibale, Claudia; Haber, Paul S

    2009-05-01

    Participants may be recruited from diverse sources for randomised controlled trials (RCT) of treatments for alcohol dependence. A mixed recruitment strategy might facilitate recruitment and increase generalisability at the expense of introducing systematic selection bias. The current study aims to compare the effects of recruitment method on socio-demographics, baseline illness characteristics, treatment retention and treatment outcome measures. A secondary analysis from a previous 12 week RCT of naltrexone, acamprosate and placebo for alcohol dependence was conducted. Participants (n = 169) were obtained via four channels of recruitment including in-patient and outpatient referral, live media and print media solicitation. Baseline parameters, retention in treatment and treatment outcomes were compared in these groups. Relative to in-patient subjects, those recruited via live and print media had significantly lower scores on taking steps, less in-patient rehabilitation admissions and less previous abstinence before entering the trial. Subjects recruited via print media had significantly lower scores of alcohol dependence relative to all other modes recruitment. There were no differences between recruitment strategies on treatment retention or compliance. At outcome, no significant effect of recruitment method was detected. These results suggest that different recruitment methods may be sourcing subjects with different baseline characteristics of illness. Nonetheless, these differences did not significantly impact on treatment retention or outcome, suggesting that in this population it was appropriate to recruit subjects from mixed sources.

  2. Low intensity, long-term outpatient rehabilitation in COPD: a randomised controlled trial

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    Baumann Hans

    2012-09-01

    Full Text Available Abstract Background Most pulmonary rehabilitation programmes currently involve 2–3 sessions per week as recommended by international guidelines. We aimed to investigate whether relevant improvements in physical capabilities and quality of life in patients with chronic obstructive pulmonary disease (COPD could be achieved by a long-term, low intensity, once weekly rehabilitation programme using limited resources. Methods 100 patients with moderate to severe COPD were randomised to a continuous outpatient interdisciplinary rehabilitation programme or standard care. Physiotherapy-led supervised outpatient training sessions were performed once weekly in addition to educational elements. Outcome measures at baseline and after 26 weeks were 6-minute-walk-test, cycle ergometry, and health-related quality of life. Results 37 patients in the training group and 44 patients in the control group completed the study. After 26 weeks there were clinically significant differences between the groups for 6 minute-walk-distance (+59 m, 95% CI 28–89 m, maximum work load (+7.4 Watt, 95% CI 0.5-13.4 Watt and St. George’s Respiratory Questionnaire score (−5 points, 95% CI −10 to −1 points. Total staff costs of the programme per participant were ≤ €625. Conclusion Clinically meaningful improvements in physical capabilities and health-related quality of life may be achieved using long-term pulmonary rehabilitation programmes of lower intensity than currently recommended. Trial registration: clinicaltrials.gov NCT01195402.

  3. Sponsorship bias and quality of randomised controlled trials in veterinary medicine.

    Science.gov (United States)

    Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

    2017-08-14

    Randomised controlled trials (RCTs) are considered the gold standard form of evidence for assessing treatment efficacy, but many factors can influence their reliability including methodological quality, reporting quality and funding source. The aim of this study was to examine the relationship between funding source and positive outcome reporting in veterinary RCTs published in 2011 and to assess the risk of bias in the RCTs identified. A structured search of PubMed was used to identify feline, canine, equine, bovine and ovine clinical trials examining the efficacy of pharmaceutical interventions published in 2011. Funding source and outcomes were extracted from each RCT and an assessment of risk of bias made using the Cochrane risk of bias tool. Literature searches returned 972 papers, with 86 papers (comprising 126 individual RCTs) included in the analysis. There was found to be a significantly higher proportion of positive outcomes reported in the pharmaceutical funding group (P) compared to the non-pharmaceutical (NP) and 'no funding source stated' (NF) groups (P = 56.9%, NP = 34.9%, NF = 29.1%, p < 0.05). A high proportion of trials had an unclear risk of bias across the five criteria examined. We found evidence that veterinary RCTs were more likely to report positive outcomes if they have pharmaceutical industry funding or involvement. Consistently poor reporting of trials, including non-identification of funding source, was found which hinders the use of the available evidence.

  4. Assessment of an electronic voting system within the tutorial setting: A randomised controlled trial [ISRCTN54535861

    Directory of Open Access Journals (Sweden)

    De Young Neville J

    2005-07-01

    Full Text Available Abstract Background Electronic voting systems have been used in various educational settings with little measurement of the educational impact on students. The goal of this study was to measure the effects of the inclusion of an electronic voting system within a small group tutorial. Method A prospective randomised controlled trial was run at the Royal Adelaide Hospital, a teaching hospital in Adelaide, Australia. 102 students in their first clinical year of medical school participated in the study where an electronic voting system was introduced as a teaching aid into a standard tutorial. Long-term retention of knowledge and understanding of the topics discussed in the tutorials was measured and student response to the introduction of the electronic voting system was assessed. Results Students using the electronic voting system had improved long-term retention of understanding of material taught in the tutorial. Students had a positive response to the use of this teaching aid. Conclusion Electronic voting systems can provide a stimulating learning environment for students and in a small group tutorial may improve educational outcomes.

  5. Single high scrotal incision orchidopexy for unilateral palpable testis: A randomised controlled study

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    Almoutaz A. Eltayeb

    2014-01-01

    Full Text Available Background: Bianchi and Squire introduced single high trans-scrotal incision for mobilisation of palpable undescended testes to decrease the potential morbidity of the traditional inguinal approach. This incision has not gained widespread acceptance and there is still a considerable debate about its efficacy. This study evaluated the outcome of high single scrotal incision in comparison to the classic inguinal exploration for unilateral palpable testes regardless to its pre-operative location to assure its validity and safety. Patients and Methods: This was a randomised controlled study conducted on seventy males with palpable unilateral undescended testicles from November 2009 to October 2013. They were divided into two equal groups; group I had high single scrotal incision and group II had the classic inguinal approach. The comparative parameters between both groups were the operative time, intra-and post-operative complications, post-operative pain and scar. Results: There was statistical significant difference between both groups regarding the operative time (P < 0.001. The high scrotal approach (Group I was not completed in three cases and were converted to the classic inguinal approach. No statistical significant difference between both groups regarding the post-operative complications. Conclusions: Single high scrotal incision orchidopexy for palpable undescended testis is safe, has shorter operative time but may not be suitable for proximally lying testis.

  6. Protocol for economic evaluation alongside the IMPLEMENT cluster randomised controlled trial

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    McKenzie Joanne E

    2008-02-01

    Full Text Available Abstract Background The recent development and publication of evidence-based clinical practice guidelines (CPGs for acute low back pain (LBP has resulted in evidence-based recommendations that, if implemented, have the potential to improve the quality and safety of care for acute LBP. While a strategy has been specified for dissemination of the CPG for acute LBP in Australia, there is no accompanying plan for active implementation. Evidence regarding the cost-effectiveness of active implementation of CPGs for acute LBP is sparse. The IMPLEMENT study will consider the incremental benefits and costs of progressing beyond development and dissemination to implementation. Methods/design Cost-effectiveness and cost-utility analyses alongside the IMPLEMENT cluster randomised controlled trial (CRCT from a societal perspective to quantify the additional costs (savings and health gains associated with a targeted implementation strategy as compared with access to the CPG via dissemination only. Discussion The protocol provided here registers our intent to conduct an economic evaluation alongside the IMPLEMENT study, facilitates peer-review of proposed methods and provides a transparent statement of planned analyses. Trial registration Australian New Zealand Clinical Trials Registry ACTRN012606000098538

  7. Vojta therapy and neurodevelopmental treatment in children with infantile postural asymmetry: a randomised controlled trial

    Science.gov (United States)

    Jung, Michael Wilhelm; Landenberger, Margarete; Jung, Tatjana; Lindenthal, Thorsten; Philippi, Heike

    2017-01-01

    [Purpose] Physical therapy is an acknowledged and frequently applied method for infantile postural asymmetry. However, there is not yet sufficient evidence for its effectiveness. [Subjects and Methods] In a randomised controlled trial, the effect of Vojta therapy versus Neurodevelopmental treatment is assessed in infants with postural asymmetry. 65 infants with postural asymmetry were recruited. 37 infants aged six to eight weeks (mean 7.38) were found to be eligible and randomly assigned to two groups, with 19 receiving Vojta and 18 Neurodevelopmental treatment. Using a standardised and blinded video-based assessment, we documented restriction in head rotation and convexity of the spine in prone and supine position before and after therapy. A reduction of at least four points (range of scale 20 points) in postural asymmetry was regarded as a clinically relevant change. [Results] On average a four-point reduction was achieved in both groups within eight weeks. A mean difference (pre-post) between the groups of −2.96 points in favour of Vojta therapy was observed. [Conclusion] While both Neurodevelopmental treatment and Vojta are effective in the treatment of infantile postural asymmetry and comparably well applied by the parents, therapeutic effectiveness is significant greater within the Vojta group. PMID:28265162

  8. Ketamine as the anaesthetic for electroconvulsive therapy: the KANECT randomised controlled trial

    Science.gov (United States)

    Fernie, Gordon; Currie, James; Perrin, Jennifer S.; Stewart, Caroline A.; Anderson, Virginica; Bennett, Daniel M.; Hay, Steven; Reid, Ian C.

    2017-01-01

    Background Ketamine has recently become an agent of interest as an acute treatment for severe depression and as the anaesthetic for electroconvulsive therapy (ECT). Subanaesthetic doses result in an acute reduction in depression severity while evidence is equivocal for this antidepressant effect with anaesthetic or adjuvant doses. Recent systematic reviews call for high-quality evidence from further randomised controlled trials (RCTs). Aims To establish if ketamine as the anaesthetic for ECT results in fewer ECT treatments, improvements in depression severity ratings and less memory impairment than the standard anaesthetic. Method Double-blind, parallel-design, RCT of intravenous ketamine (up to 2 mg/kg) with an active comparator, intravenous propofol (up to 2.5 mg/kg), as the anaesthetic for ECT in patients receiving ECT for major depression on an informal basis. (Trial registration: European Clinical Trials Database (EudraCT): 2011-000396-14 and clinicalTrials.gov: NCT01306760.) Results No significant differences were found on any outcome measure during, at the end of or 1 month following the ECT course. Conclusions Ketamine as an anaesthetic does not enhance the efficacy of ECT. PMID:28254962

  9. Typhoid fever vaccines: systematic review and meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Fraser, Abigail; Paul, Mical; Goldberg, Elad; Acosta, Camilo J; Leibovici, Leonard

    2007-11-01

    We undertook a systematic review and meta-analysis of randomised controlled trials comparing a typhoid fever vaccine with any alternative typhoid fever vaccine or inactive agent. Trials evaluating killed whole-cell vaccines were excluded. The cumulative efficacy at 3 years for the Ty21a and the polysaccharide Vi vaccine were similar: 51% (95%CI 36%, 62%), and 55% (95%CI 30%, 70%), respectively. The cumulative efficacy of the Vi-rEPA vaccine at 3.8 years was higher, 89% (95%CI 76%, 97%), but this vaccine has not yet been licensed for use and was evaluated in only one trial. Adverse events were mild in nature and for most, not significantly more frequent in any of the vaccine groups when compared with placebo. Both the currently licensed Ty21a and Vi vaccine, are safe and efficacious for preventing typhoid fever. Neither vaccine is currently registered for administration to children below 2 years of age. Given the recent finding that typhoid fever also affects infants, development of a conjugate vaccine is warranted.

  10. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study

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    Price Jackie F

    2011-01-01

    Full Text Available Abstract Background Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Methods Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA trial (N = 11, and AAA trial participants who had stopped taking the trial medication (N = 11. A focus group with further participants who had stopped taking the trial medication (N = 6. (Total participants N = 28. Results Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating. Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. Conclusions These results indicate that when planning trials (especially in preventive medicine particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. Trial registration ISRCTN66587262

  11. Reporting quality of randomised controlled trials published in prosthodontic and implantology journals.

    Science.gov (United States)

    Kloukos, D; Papageorgiou, S N; Doulis, I; Petridis, H; Pandis, N

    2015-12-01

    The purpose of this study was to examine the reporting quality of randomised controlled trials (RCTs) published in prosthodontic and implantology journals. Thirty issues of nine journals in prosthodontics and implant dentistry were searched for RCTs, covering the years 2005-2012: The Journal of Prosthetic Dentistry, Journal of Oral Rehabilitation, The International Journal of Prosthodontics, The International Journal of Periodontics & Restorative Dentistry, Clinical Oral Implants Research, Clinical Implant Dentistry & Related Research, The International Journal of Oral & Maxillofacial Implants, Implant Dentistry and Journal of Dentistry. The reporting quality was assessed using a modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. Data were analysed using descriptive statistics followed by univariable and multivariable examination of statistical associations (α = 0·05). A total of 147 RCTs were identified with a mean CONSORT score of 69·4 (s.d. = 9·7). Significant differences were found among journals with the Journal of Oral Rehabilitation achieving the highest score (80·6, s.d. = 5·5) followed by Clinical Oral Implants Research (73·7, s.d. = 8·3). Involvement of a statistician/methodologist was significantly associated with increased CONSORT scores. Overall, the reporting quality of RCTs in major prosthodontic and implantology journals requires improvement. This is of paramount importance considering that optimal reporting of RCTs is an important prerequisite for clinical decision-making.

  12. Hypnosis Antenatal Training for Childbirth (HATCh: a randomised controlled trial [NCT00282204

    Directory of Open Access Journals (Sweden)

    Baghurst Peter

    2006-03-01

    Full Text Available Abstract Background Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. Methods/design A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 and Discussion If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and this trial will provide evidence to guide clinical practice.

  13. Alcohol assessment and feedback by email for university students: main findings from a randomised controlled trial.

    Science.gov (United States)

    McCambridge, Jim; Bendtsen, Marcus; Karlsson, Nadine; White, Ian R; Nilsen, Per; Bendtsen, Preben

    2013-11-01

    Brief interventions can be efficacious in changing alcohol consumption and increasingly take advantage of the internet to reach high-risk populations such as students. To evaluate the effectiveness of a brief online intervention, controlling for the possible effects of the research process. A three-arm parallel groups design was used to explore the magnitude of the feedback and assessment component effects. The three groups were: alcohol assessment and feedback (group 1); alcohol assessment only without feedback (group 2); and no contact, and thus neither assessment nor feedback (group 3). Outcomes were evaluated after 3 months via an invitation to participate in a brief cross-sectional lifestyle survey. The study was undertaken in two universities randomising the email addresses of all 14 910 students (the AMADEUS-1 study, trial registration: ISRCTN28328154). Overall, 52% (n = 7809) of students completed follow-up, with small differences in attrition between the three groups. For each of the two primary outcomes, there was one statistically significant difference between groups, with group 1 having 3.7% fewer risky drinkers at follow-up than group 3 (P = 0.006) and group 2 scoring 0.16 points lower than group 3 on the three alcohol consumption questions from the Alcohol Use Disorders Identification Test (AUDIT-C) (P = 0.039). This study provides some evidence of population-level benefit attained through intervening with individual students.

  14. Dietary outcomes of a community based intervention for mothers of young children: a randomised controlled trial.

    Science.gov (United States)

    Jancey, Jonine Maree; Dos Remedios Monteiro, Sarojini Maria; Dhaliwal, Satvinder S; Howat, Peter A; Burns, Sharyn; Hills, Andrew P; Anderson, Annie S

    2014-09-23

    Unhealthy dietary behaviours are one of the key risk factors for many lifestyle-related diseases worldwide. This randomised controlled trial aimed to increase the level of fruit, vegetable and fibre intake and decrease the fat and sugar consumption of mothers with young children (0-5 years) via the playgroup setting. Playgroups located in 60 neighbourhoods in Perth, Western Australia were randomly assigned to an intervention (n = 249) or control group (n = 272). Those in the intervention group received a 6-month multi-strategy primarily home-based physical activity and nutrition program (data is only presented on dietary behaviours). Data on dietary consumption was collected via the Fat and Fibre Barometer and frequency of serves of fruit and vegetable and cups of soft drink, flavoured drink and fruit juice. The effects of the intervention on continuous outcome measures were assessed using analysis of variance (ANOVA), after adjusting for mother's age and the corresponding variables. The outcomes of the intervention were positive with the intervention group showing statistically significant improvements, when compared to the control group in the overall consumption of fat and fibre (p drinks. This intervention was successful in improving dietary intake in the intervention group participants. The moderate positive outcomes indicate that playgroups potentially provide quite a viable setting to recruit, engage and retain this hard to reach group of mothers of young children in programs that support the adoption of health-enhancing behaviours. This adds valuable information to this under researched area. Australian and New Zealand Clinical Trials Registry ACTRN12609000718246.

  15. Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kang Kyung-Won

    2009-07-01

    Full Text Available Abstract Background Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with persistent allergic rhinitis compared to sham acupuncture treatment or waitlist control. Methods This study consists of a multi-centre (two centres in Korea and two centres in China, randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group. The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for persistent allergic rhinitis. The primary outcome between groups is a change in the self-reported total nasal symptom score (i.e., nasal obstruction, rhinorrhea, sneezing, and itching from baseline at the fourth week. Secondary outcome measures include the Rhinitis Quality of Life Questionnaire score and total non-nasal symptom score (i.e., headache, itching, pain, eye-dropping. The quantity of conventional relief medication used during the follow-up period is another secondary outcome measure. Trial

  16. Reduction of missed appointments at an urban primary care clinic: a randomised controlled study

    Directory of Open Access Journals (Sweden)

    Calmy Alexandra

    2010-10-01

    Full Text Available Abstract Background Missed appointments are known to interfere with appropriate care and to misspend medical and administrative resources. The aim of this study was to test the effectiveness of a sequential intervention reminding patients of their upcoming appointment and to identify the profile of patients missing their appointments. Methods We conducted a randomised controlled study in an urban primary care clinic at the Geneva University Hospitals serving a majority of vulnerable patients. All patients booked in a primary care or HIV clinic at the Geneva University Hospitals were sent a reminder 48 hrs prior to their appointment according to the following sequential intervention: 1. Phone call (fixed or mobile reminder; 2. If no phone response: a Short Message Service (SMS reminder; 3. If no available mobile phone number: a postal reminder. The rate of missed appointment, the cost of the intervention, and the profile of patients missing their appointment were recorded. Results 2123 patients were included: 1052 in the intervention group, 1071 in the control group. Only 61.7% patients had a mobile phone recorded at the clinic. The sequential intervention significantly reduced the rate of missed appointments: 11.4% (n = 122 in the control group and 7.8% (n = 82 in the intervention group (p 1year (OR 2.2; CI: 1.15-4.2, substance abuse (2.09, CI 1.21-3.61, and being an asylum seeker (OR 2.73: CI 1.22-6.09. Conclusion A practical reminder system can significantly increase patient attendance at medical outpatient clinics. An intervention focused on specific patient characteristics could further increase the effectiveness of appointment reminders.

  17. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess.

    Science.gov (United States)

    El-Shawarby, S A; Connell, R J

    2006-10-01

    The purpose of the trial was to determine whether a sustained release preparation of prostaglandin E2 (Propess) is better in inducing labour when compared with the more widely used short-acting (instant-release) preparation (Prostin). A randomised controlled clinical trial involving 100 pregnant women at term with an indication for induction of labour was conducted in a district general hospital in the UK over a 1-year period. Women were randomised to receive one of the two preparations. The study revealed that there was no statistically significant difference in time to onset of labour, duration of labour, total time from induction to delivery, method of delivery, and analgesia requirements. The number of preparations required to induce labour were significantly less in the Propess group. Our data suggest that both Propess and Prostin are safe and effective in induction of labour, for either primips or multips. However, Prostin use is more cost-effective.

  18. Ear Acupuncture versus  local anaestethic for pain relief during perineal repair - a randomised controlled trial

    DEFF Research Database (Denmark)

    Kindberg, Sara

    2007-01-01

    ACUPUNCTURE OR LOCAL ANAESTETICS FOR PAIN RELIEF DURING PERINEAL REPAIR AFTER VAGINAL DELIVERY: A RANDOMISED CONTROLLED TRIAL.   By:  Sara Kindberg. Midwife and PhD student, Sønderborg Hospital, Denmark. Objective: To evaluate acupuncture as a new method of pain relief for postpartum perineal...... are conducted at day 1 or 2, at day 14 and 6 months after delivery. A validated tool for wound healing assessment and pain score is used. Randomisation is stratified on episiotomies and epidural is used for pain during delivery. Main outcome measures: 1. Need for additional pain relief during perineal repair. 2....... Pain experienced during perineal repair reported 1 day after delivery. 3. Wound healing evaluated 1 and 14 days after delivery. 4. Patient satisfaction with the allocated pain relief during perineal repair. Results:  The trial is ongoing until July 2007. Preliminary results will be presented as well...

  19. Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy

    Science.gov (United States)

    Berle, Christine; Li, Wei Hong; Li, Tie; Wang, Fu Chun; Bangrazi, Sergio; Li, Lei; Liguori, Stefano; Liu, Yan Song

    2016-01-01

    Background. Lateral elbow pain is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1–3%. Methods/Design. This study protocol is for a multisite randomised controlled study and is designed to evaluate the clinical efficacy of acupuncture in the treatment of chronic (over three months' duration) lateral elbow pain. Four study sites, in the People's Republic of China, Hong Kong, Italy, and Australia, will recruit 24 participants each. A total of 96 participants will be randomised to either an acupuncture group or a sham laser control group. The primary outcome measure will be the Disabilities of Arm, Shoulder, and Hand questionnaire with secondary outcome measures of Pain-Free Grip Strength Test, Muscle Tension Test, and a pain visual analogue scale. Discussion. Key features for conducting a multisite international acupuncture randomised clinical trial have been detailed in this protocol. Trial Registration. This trial is registered at Australian and New Zealand Clinical Trial Registry ACTRN12613001138774 on 11 October, 2013. PMID:27994627

  20. A multifaceted workplace intervention for low back pain in nurses' aides: a pragmatic stepped wedge cluster randomised controlled trial.

    Science.gov (United States)

    Rasmussen, Charlotte Diana Nørregaard; Holtermann, Andreas; Bay, Hans; Søgaard, Karen; Birk Jørgensen, Marie

    2015-09-01

    This study established the effectiveness of a workplace multifaceted intervention consisting of participatory ergonomics, physical training, and cognitive-behavioural training (CBT) for low back pain (LBP). Between November 2012 and May 2014, we conducted a pragmatic stepped wedge cluster randomised controlled trial with 594 workers from eldercare workplaces (nursing homes and home care) randomised to 4 successive time periods, 3 months apart. The intervention lasted 12 weeks and consisted of 19 sessions in total (physical training [12 sessions], CBT [2 sessions], and participatory ergonomics [5 sessions]). Low back pain was the outcome and was measured as days, intensity (worst pain on a 0-10 numeric rank scale), and bothersomeness (days) by monthly text messages. Linear mixed models were used to estimate the intervention effect. Analyses were performed according to intention to treat, including all eligible randomised participants, and were adjusted for baseline values of the outcome. The linear mixed models yielded significant effects on LBP days of -0.8 (95% confidence interval [CI], -1.19 to -0.38), LBP intensity of -0.4 (95% CI, -0.60 to -0.26), and bothersomeness days of -0.5 (95% CI, -0.85 to -0.13) after the intervention compared with the control group. This study shows that a multifaceted intervention consisting of participatory ergonomics, physical training, and CBT can reduce LBP among workers in eldercare. Thus, multifaceted interventions may be relevant for improving LBP in a working population.

  1. Pressure mapping to prevent pressure ulcers in a hospital setting: A pragmatic randomised controlled trial.

    Science.gov (United States)

    Gunningberg, Lena; Sedin, Inga-Maj; Andersson, Sara; Pingel, Ronnie

    2017-07-01

    Pressure ulcers cause suffering to patients and costs to society. Reducing pressure at the interface between the patient's body and the support surface is a valid clinical intervention for reducing the risk of pressure ulcers. However, studies have shown that knowledge of how to reduce pressure and shear and to prevent pressure ulcers is lacking. To evaluate the effect of a pressure mapping system on pressure ulcer prevalence and incidence in a hospital setting. Pragmatic randomised controlled trial. A geriatric/internal medical ward with 26 beds in a Swedish university hospital. 190 patients were recruited (intervention: n=91; control: n=99) over a period of 9 months. Patients were eligible if they were over 50 years old, admitted to the ward between Sunday 4pm and Friday 4pm, and expected to stay in the ward ≥3 days. The continuous bedside pressure mapping system displays the patient's pressure points in real-time colour imagery showing how pressure is distributed at the body-mat interface. The system gives immediate feedback to staff about the patient's pressure points, facilitating preventive interventions related to repositioning. It was used from admittance to discharge from the ward (or 14 days at most). Both intervention and control groups received standard pressure ulcer prevention care. No significant difference in the prevalence and incidence of pressure ulcers was shown between intervention and control groups. The prevalence of pressure ulcers in the intervention group was 24.2% on day 1 and 28.2% on day 14. In the control group the corresponding numbers were 18.2% and 23.8%. Seven of 69 patients (10.1%) in the intervention group and seven of 81 patients (8.6%) in the control group who had no pressure ulcers on admission developed category 1 and category 2 ulcers during their hospital stay. The incidence rate ratio between the intervention and control groups was 1.13 (95% CI: 0.34-3.79). This study failed to demonstrate a beneficial effect of a

  2. Effects of circuit training as alternative to usual physiotherapy after stroke: randomised controlled trial.

    Science.gov (United States)

    van de Port, Ingrid G L; Wevers, Lotte E G; Lindeman, Eline; Kwakkel, Gert

    2012-05-10

    To analyse the effect of task oriented circuit training compared with usual physiotherapy in terms of self reported walking competency for patients with stroke discharged from a rehabilitation centre to their own home. Randomised controlled trial with follow-up to 24 weeks. Multicentre trial in nine outpatient rehabilitation centres in the Netherlands Patients with stroke who were able to walk a minimum of 10 m without physical assistance and were discharged from inpatient rehabilitation to an outpatient rehabilitation clinic. Patients were randomly allocated to circuit training or usual physiotherapy, after stratification by rehabilitation centre, with an online randomisation procedure. Patients in the intervention group received circuit training in 90 minute sessions twice a week for 12 weeks. The training included eight different workstations in a gym and was intended to improve performance in tasks relating to walking competency. The control group received usual outpatient physiotherapy. The primary outcome was the mobility domain of the stroke impact scale (SIS, version 3.0). Secondary outcomes were standing balance, self reported abilities, gait speed, walking distance, stair climbing, instrumental activities of daily living, fatigue, anxiety, and depression. Differences between groups were analysed according to the intention to treat principle. All outcomes were assessed by blinded observers in a repeated measurement design lasting 24 weeks. 126 patients were included in the circuit training group and 124 in the usual care group (control), with data from 125 and 117, respectively, available for analysis. One patient from the circuit training group and seven from the control group dropped out. Circuit training was a safe intervention, and no serious adverse events were reported. There were no significant differences between groups for the stroke impact scale mobility domain (β=0.05 (SE 0.68), P=0.943) at 12 weeks. Circuit training was associated with

  3. Antenatal mindfulness intervention to reduce depression, anxiety and stress: a pilot randomised controlled trial of the MindBabyBody program in an Australian tertiary maternity hospital

    OpenAIRE

    Woolhouse, Hannah; Mercuri, Kristine; Judd, Fiona; Brown, Stephanie J

    2014-01-01

    Background Mindfulness interventions to reduce psychological distress are well-suited to pregnancy, due to their brief and non-pharmacological nature, but there is a need for more robust evidence determining their usefulness. This pilot study was designed to explore the feasibility of a randomised controlled trial of a mindfulness intervention to reduce antenatal depression, anxiety and stress. Methods The study was designed in two parts 1) a non-randomised trial targeting women at risk of me...

  4. Targeted physiotherapy for patellofemoral joint osteoarthritis: A protocol for a randomised, single-blind controlled trial

    Directory of Open Access Journals (Sweden)

    Schache Anthony G

    2008-09-01

    Full Text Available Abstract Background The patellofemoral joint (PFJ is one compartment of the knee that is frequently affected by osteoarthritis (OA and is a potent source of OA symptoms. However, there is a dearth of evidence for compartment-specific treatments for PFJ OA. Therefore, this project aims to evaluate whether a physiotherapy treatment, targeted to the PFJ, results in greater improvements in pain and physical function than a physiotherapy education intervention in people with symptomatic and radiographic PFJ OA. Methods 90 people with PFJ OA (PFJ-specific history, signs and symptoms and radiographic evidence of PFJ OA will be recruited from the community and randomly allocated into one of two treatments. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of physiotherapy (8 individual sessions over 12 weeks, as well as a home exercise program 4 times/week compared to a physiotherapist-delivered OA education control treatment (8 individual sessions over 12 weeks. Physiotherapy treatment will consist of (i quadriceps muscle retraining; (ii quadriceps and hip muscle strengthening; (iii patellar taping; (iv manual PFJ and soft tissue mobilisation; and (v OA education. Resistance and dosage of exercises will be tailored to the participant's functional level and clinical state. Primary outcomes will be evaluated by a blinded examiner at baseline, 12 weeks and 9 months using validated and reliable pain, physical function and perceived global effect scales. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models, including respective baseline scores as a covariate, subjects as a random effect, treatment condition as a fixed factor and the covariate by treatment interaction. Conclusion This RCT is targeting PFJ OA, an important sub-group of knee OA patients, with a specifically designed conservative intervention. The project's outcome will influence PFJ OA rehabilitation, with the

  5. Patient education in osteoporosis prevention: a systematic review focusing on methodological quality of randomised controlled trials.

    Science.gov (United States)

    Morfeld, Jana-Carina; Vennedey, Vera; Müller, Dirk; Pieper, Dawid; Stock, Stephanie

    2017-06-01

    This review summarizes evidence regarding the effects of patient education in osteoporosis prevention and treatment. The included studies reveal mixed results on a variety of endpoints. Methodological improvem ent of future RCTs (e.g. with regard to randomization and duration of follow-up) might yield more conclusive evidence on the effects of patient education in osteoporosis INTRODUCTION: This review aims to evaluate the effects of patient education on osteoporosis prevention and treatment results. Multiple databases including PubMed and Embase were searched until February 2016. Randomised controlled trials (RCTs) were eligible if they included adults diagnosed with or at risk of osteoporosis and assessed patient education interventions (group- or individual-based). Outcomes regarding osteoporosis management including initiation of and adherence to pharmacological therapy, physical activity, calcium and vitamin D intake, changes in smoking behaviour, fractures, quality of life (QoL) and osteoporosis knowledge were evaluated. The Cochrane collaboration's tool for assessing the risk of bias was used to assess the internal validity of included trials. Fifteen articles (13 different studies) published between 2001 and 2013 were included (group-based education = 7, individual-based education = 5, both = 1). The general risk of bias was considered as moderate to high. The effects on 'bone mineral density (BMD) testing and/or pharmacological therapy' (composite endpoint), 'calcium intake' and 'vitamin D intake' as well as 'osteoporosis knowledge' were statistically significant in favour of the intervention in ≥50% of the studies analysing these outcomes. Differences between the intervention and the control group regarding 'pharmacological therapy', 'medication adherence', 'physical activity', 'fractures' and 'QoL' were found to be statistically significant in <50% of the trials. This review indicates that it is still unclear whether patient education is

  6. Models in the delivery of depression care: A systematic review of randomised and controlled intervention trials

    Directory of Open Access Journals (Sweden)

    Clack Dannielle

    2008-05-01

    Full Text Available Abstract Background There is still debate as to which features, types or components of primary care interventions are associated with improved depression outcomes. Previous reviews have focused on components of collaborative care models in general practice settings. This paper aims to determine the effective components of depression care in primary care through a systematic examination of both general practice and community based intervention trials. Methods Fifty five randomised and controlled research trials which focused on adults and contained depression outcome measures were identified through PubMed, PsycInfo and the Cochrane Central Register of Controlled Trials databases. Trials were classified according to the components involved in the delivery of treatment, the type of treatment, the primary focus or setting of the study, detailed features of delivery, and the discipline of the professional providing the treatment. The primary outcome measure was significant improvement on the key depression measure. Results Components which were found to significantly predict improvement were the revision of professional roles, the provision of a case manager who provided direct feedback and delivered a psychological therapy, and an intervention that incorporated patient preferences into care. Nurse, psychologist and psychiatrist delivered care were effective, but pharmacist delivery was not. Training directed to general practitioners was significantly less successful than interventions that did not have training as the most important intervention. Community interventions were effective. Conclusion Case management is important in the provision of care in general practice. Certain community models of care (education programs have potential while others are not successful in their current form (pharmacist monitoring.

  7. TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation

    Directory of Open Access Journals (Sweden)

    Victor Suresh

    2008-03-01

    Full Text Available Abstract Background Infants born at extreme prematurity (below 28 weeks' gestation are at high risk of developmental disability. A major risk factor for disability is having a low level of thyroid hormone which is recognised to be a frequent phenomenon in these infants. At present it is unclear whether low levels of thyroid hormone are a cause of disability, or a consequence of concurrent adversity. Methods We propose an explanatory multi-centre double blind randomised controlled trial of thyroid hormone supplementation in babies born below 28 weeks' gestation. All infants will receive either levothyroxine or placebo until 32 weeks' corrected gestational age. The primary outcome will be brain growth. This will be assessed by the width of the sub-arachnoid space measured using cranial ultrasound and head circumference at 36 weeks' corrected gestational. The secondary outcomes will be (a thyroid hormone concentrations measured at increasing postnatal age, (b status of the hypothalamic pituitary axis, (c auxological data between birth and 36 weeks' corrected gestational age, (d thyroid gland volume, (e volumes of brain structures (measured by magnetic resonance imaging, (f determination of the extent of myelination and white matter integrity (measured by diffusion weighted MRI and brain vessel morphology (measured by magnetic resonance angiography at expected date of delivery and (g markers of morbidity including duration of mechanical ventilation and chronic lung disease. We will also examine how activity of the hypothalamic-pituitary-adrenal axis modulates the effects of thyroid supplementation. This will contribute to decisions about which confounding variables to assess in large-scale studies. Trial registration Current Controlled Trials ISRCTN89493983

  8. Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Murphy Anna T

    2011-07-01

    Full Text Available Abstract Background Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i movement strategy training combined with falls prevention education, (ii progressive resistance strength training combined with falls prevention education, (iii a generic life-skills social program (control group. Methods/Design People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy. Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes. Discussion This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR

  9. Children Learning About Secondhand Smoke (CLASS II): protocol of a pilot cluster randomised controlled trial.

    Science.gov (United States)

    Siddiqi, Kamran; Huque, Rumana; Jackson, Cath; Parrott, Steve; Dogar, Omara; Shah, Sarwat; Thomson, Heather; Sheikh, Aziz

    2015-08-25

    Exposure to secondhand smoke (SHS) increases children's risk of acquiring chest and ear infections, tuberculosis, meningitis and asthma. Smoking bans in public places (where implemented) have significantly reduced adults' exposure to SHS. However, for children, homes remain the most likely place for them to be exposed to SHS. Additional measures are therefore required to protect children from SHS. In a feasibility study in Dhaka, Bangladesh, we have shown that a school-based smoke-free intervention (SFI) was successful in encouraging children to negotiate and implement smoking restrictions in homes. We will now conduct a pilot trial to inform plans to undertake a cluster randomised controlled trial (RCT) investigating the effectiveness and cost-effectiveness of SFI in reducing children's exposure to SHS. We plan to recruit 12 primary schools in Dhaka, Bangladesh. From these schools, we will recruit approximately 360 schoolchildren in year 5 (10-12 years old), that is, 30 per school. SFI consists of six interactive educational activities aimed at increasing pupils' knowledge about SHS and related harms, motivating them to act, providing skills to negotiate with adults to persuade them not to smoke inside homes and helping families to 'sign-up' to a voluntary contract to make their homes smoke-free. Children in the control arm will receive the usual education. We will estimate: recruitment and attrition rates, acceptability, fidelity to SFI, effect size, intracluster correlation coefficient, cost of intervention and adverse events. Our primary outcome will consist of SHS exposure in children measured by salivary cotinine. Secondary outcomes will include respiratory symptoms, lung function tests, healthcare contacts, school attendance, smoking uptake, quality of life and academic performance. The trial has received ethics approval from the Research Governance Committee at the University of York. Findings will help us plan for the definitive trial. ISRCTN68690577

  10. Exercise augmentation compared to usual care for Post Traumatic Stress Disorder: A Randomised Controlled Trial (The REAP study: Randomised Exercise Augmentation for PTSD

    Directory of Open Access Journals (Sweden)

    van der Ploeg Hidde P

    2011-07-01

    Full Text Available Abstract Background The physical wellbeing of people with mental health conditions can often be overlooked in order to treat the primary mental health condition as a priority. Exercise however, can potentially improve both the primary psychiatric condition as well as physical measures that indicate risk of other conditions such as diabetes mellitus and cardiovascular disease. Evidence supports the role of exercise as an important component of treatment for depression and anxiety, yet no randomised controlled trials (RCT's have been conducted to evaluate the use of exercise in the treatment of people with post traumatic stress disorder (PTSD. This RCT will investigate the effects of structured, progressive exercise on PTSD symptoms, functional ability, body composition, physical activity levels, sleep patterns and medication usage. Methods and design Eighty participants with a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV diagnosis of PTSD will be recruited. Participants will have no contraindications to exercise and will be cognitively able to provide consent to participate in the study. The primary outcome measures will be PTSD symptoms, measured through the PTSD Checklist Civilian (PCL-C scale. Secondary outcome measures will assess depression and anxiety, mobility and strength, body composition, physical activity levels, sleep patterns and medication usage. All outcomes will be assessed by a health or exercise professional masked to group allocation at baseline and 12 weeks after randomisation. The intervention will be a 12 week individualised program, primarily involving resistance exercises with the use of exercise bands. A walking component will also be incorporated. Participants will complete one supervised session per week, and will be asked to perform at least two other non-supervised exercise sessions per week. Both intervention and control groups will receive all usual non-exercise interventions including psychotherapy

  11. Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Dafna Merom

    2016-08-01

    Full Text Available The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i reducing the number of falls and ii improving physical and cognitive fall-related risk factors.A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters were offered twice weekly one-hour social dancing classes (folk or ballroom dancing over 12 mo (80 h in total. Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters were advised to continue with their regular activities.falls during the 12 mo trial and Trail Making Tests.The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12 Survey. Data on falls were obtained from 522 of 530 (98% randomised participants (mean age 78 y, 85% women and 424 (80% attended the 12-mo reassessment, which was lower among folk dance participants (71% than ballroom dancing (82% or control

  12. Efficacy of occupational therapy for patients with Parkinson's disease: a randomised controlled trial.

    Science.gov (United States)

    Sturkenboom, Ingrid H W M; Graff, Maud J L; Hendriks, Jan C M; Veenhuizen, Yvonne; Munneke, Marten; Bloem, Bastiaan R; Nijhuis-van der Sanden, Maria W

    2014-06-01

    There is insufficient evidence to support use of occupational therapy interventions for patients with Parkinson's disease. We aimed to assess the efficacy of occupational therapy in improving daily activities of patients with Parkinson's disease. We did a multicentre, assessor-masked, randomised controlled clinical trial in ten hospitals in nine Dutch regional networks of specialised health-care professionals (ParkinsonNet), with assessment at 3 months and 6 months. Patients with Parkinson's disease with self-reported difficulties in daily activities were included, along with their primary caregivers. Patients were randomly assigned (2:1) to the intervention or control group by a computer-generated minimisation algorithm. The intervention consisted of 10 weeks of home-based occupational therapy according to national practice guidelines; control individuals received usual care with no occupational therapy. The primary outcome was self-perceived performance in daily activities at 3 months, assessed with the Canadian Occupational Performance Measure (score 1-10). Data were analysed using linear mixed models for repeated measures (intention-to-treat principle). Assessors monitored safety by asking patients about any unusual health events during the preceding 3 months. This trial is registered with ClinicalTrials.gov, NCT01336127. Between April 14, 2011, and Nov 2, 2012, 191 patients were randomly assigned to the intervention group (n=124) or the control group (n=67). 117 (94%) of 124 patients in the intervention group and 63 (94%) of 67 in the control group had a participating caregiver. At baseline, the median score on the Canadian Occupational Performance Measure was 4·3 (IQR 3·5-5·0) in the intervention group and 4·4 (3·8-5·0) in the control group. At 3 months, these scores were 5·8 (5·0-6·4) and 4·6 (4·6-6·6), respectively. The adjusted mean difference in score between groups at 3 months was in favour of the intervention group (1·2; 95% CI 0·8-1·6

  13. Educating novice practitioners to detect elder financial abuse: a randomised controlled trial.

    Science.gov (United States)

    Harries, Priscilla; Davies, Miranda; Gilhooly, Ken; Gilhooly, Mary; Tomlinson, Christopher

    2014-02-01

    Health and social care professionals are well positioned to identify and intervene in cases of elder financial abuse. An evidence-based educational intervention was developed to advance practitioners' decision-making in this domain. The objective was to test the effectiveness of a decision-training educational intervention on novices' ability to detect elder financial abuse. The research was funded by an E.S.R.C. grant reference RES-189-25-0334. A parallel-group, randomised controlled trial was conducted using a judgement analysis approach. Each participant used the World Wide Web to judge case sets at pre-test and post-test. The intervention group was provided with training after pre-test testing, whereas the control group were purely given instructions to continue with the task. 154 pre-registration health and social care practitioners were randomly allocated to intervention (n78) or control (n76). The intervention comprised of written and graphical descriptions of an expert consensus standard explaining how case information should be used to identify elder financial abuse. Participants' ratings of certainty of abuse occurring (detection) were correlated with the experts' ratings of the same cases at both stages of testing. At pre-test, no differences were found between control and intervention on rating capacity. Comparison of mean scores for the control and intervention group at pre-test compared to immediate post-test, showed a statistically significant result. The intervention was shown to have had a positive moderate effect; at immediate post-test, the intervention group's ratings had become more similar to those of the experts, whereas the control's capacity did not improve. The results of this study indicate that the decision-training intervention had a positive effect on detection ability. This freely available, web-based decision-training aid is an effective evidence-based educational resource. Health and social care professionals can use the resource to

  14. Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol

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    Myles Judy

    2009-11-01

    Full Text Available Abstract Background A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However, although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlled trial with Offender Managers (OMs as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients. Methods and design Ninety-six OMs from 9 probation areas across 3 English regions (the North East Region (n = 4 and London and the South East Regions (n = 5 will be recruited. OMs will be randomly allocated to one of three intervention conditions: a client information leaflet control condition (n = 32 OMs; 5-minute simple structured advice (n = 32 OMs and 20-minute brief lifestyle counselling delivered by an Alcohol Health Worker (n = 32 OMs. Randomisation will be stratified by probation area. To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire (M-SASQ or the Fast Alcohol Screening Test (FAST. There will be a minimum of 480 clients recruited into the trial. There will be an intention to treat analysis of study outcomes at 6 and 12 months post intervention. Analysis will include client measures (screening result, weekly alcohol consumption, alcohol-related problems, re-offending, public service use and quality of life and implementation measures from OMs (the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention. We will also examine the

  15. Effects of interpretive front-of-pack nutrition labels on food purchases: protocol for the Starlight randomised controlled trial.

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    Volkova, Ekaterina; Neal, Bruce; Rayner, Mike; Swinburn, Boyd; Eyles, Helen; Jiang, Yannan; Michie, Jo; Ni Mhurchu, Cliona

    2014-09-18

    Interpretive front-of-pack nutrition labels are better understood than non-interpretive labels. However, robust evidence on the effects of such labels on consumer food purchases in the real-world is lacking. Our aim is to assess the effects of two interpretive front-of-pack nutrition labels, compared with a non-interpretive label, on the healthiness of consumer food purchases. A five-week (1-week baseline and 4-week intervention) three-arm parallel randomised controlled trial will be conducted using a bespoke smartphone application, which will administer study questionnaires and deliver intervention (Multiple Traffic Light and Health Star Rating) and control (Nutrition Information Panel) labels. To view their allocated nutrition label, participants scan the barcode of packaged food products using their smartphone camera. The assigned label is displayed instantly on the smartphone screen.1500 eligible participants (New Zealand adult smartphone owners who shop in a supermarket at least once a week and are main household shoppers) will be randomised in a 1:1:1 ratio to one of the three nutrition label formats, using computer-generated randomisation sequences. Randomisation will be stratified by ethnicity and interest in healthy eating. Food and beverage purchase data will be collected continuously throughout the study via hard copy till receipts and electronic grocery purchase lists recorded and transmitted using the smartphone application. The primary outcome will be healthiness of food purchases in each trial arm, assessed as mean Food Standards Australia New Zealand nutrient profiling score criterion score for all food and beverages purchased over the intervention period. Secondary outcomes will include saturated fat, sugar, sodium and energy content of food purchases; food expenditure; labelling profile of food purchases (i.e. mean number of Health Star Rating stars and proportion of red, green and amber traffic lights); nutrient profiling score over time and by

  16. Protocol to evaluate the impact of yoga supplementation on cognitive function in schizophrenia: a randomised controlled trial.

    Science.gov (United States)

    Bhatia, Triptish; Mazumdar, Sati; Mishra, Nagendra Narayan; Gur, Raquel E; Gur, Ruben C; Nimgaonkar, Vishwajit Laxmikant; Deshpande, Smita Neelkanth

    2014-10-01

    Schizophrenia (SZ) is a chronic illness that is treated symptomatically. Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy. Yoga can improve cognitive function among healthy individuals. A recent open trial indicated significant benefits of yoga training (YT) in conjunction with conventional pharmacotherapy among patients with SZ. To describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated. Secondarily, the effects of YT on daily functioning living skills are evaluated. Consenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT, adjunctive physical exercise (PE) or treatment as usual (proposed N = 234 total, N = 78 in each group). The trial involves YT or PE 5 days a week and lasts 3 weeks. Participants are evaluated thrice over 6 months. Cognitive functions measured by Trail Making Test, University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures. A total of 309 participants have been randomised as of 31 August 2013, which exceeded beyond 294 proposed after attrition. Once participants begin YT or PE they generally complete the protocol. No injuries have been reported. Short term YT is feasible and acceptable to Indian SZ patients. If beneficial effects of YT are detected, it will provide a novel adjunctive cognitive remediation strategy for SZ patients.

  17. Pressure and pain In Systemic sclerosis/Scleroderma - an evaluation of a simple intervention (PISCES: randomised controlled trial protocol

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    Alcacer-Pitarch Begonya

    2012-02-01

    Full Text Available Abstract Background Foot problems associated with Systemic Sclerosis (SSc/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122

  18. Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.

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    Sabina Sanghera

    Full Text Available OBJECTIVE: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS' and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life. METHODS: 571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY estimated using both EQ-5D and SF-6D. RESULTS: Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100 and generated 0.002 more QALYs. CONCLUSION: Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial.

  19. Exercise and manual physiotherapy arthritis research trial (EMPART: a multicentre randomised controlled trial

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    O'Connell Paul

    2009-01-01

    Full Text Available Abstract Background Osteoarthritis (OA of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC, pain severity (numerical rating scale, patient perceived change (7-point Likert scale, quality of life (SF-36, mood (hospital anxiety and depression scale, patient satisfaction, physical activity (IPAQ and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The

  20. The HOPE social media intervention for global HIV prevention in Peru: a cluster randomised controlled trial.

    Science.gov (United States)

    Young, Sean D; Cumberland, William G; Nianogo, Roch; Menacho, Luis A; Galea, Jerome T; Coates, Thomas

    2015-01-01

    Social media technologies offer new approaches to HIV prevention and promotion of testing. We examined the efficacy of the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. In this cluster randomised controlled trial, Peruvian MSM from Greater Lima (including Callao) who had sex with a man in the past 12 months, were 18 years of age or older, were HIV negative or serostatus unknown, and had a Facebook account or were willing to create one (N=556) were randomly assigned (1:1) by concealed allocation to join intervention or control groups on Facebook for 12 weeks. For the intervention, Peruvian MSM were trained and assigned to be HIV prevention mentors (peer-leaders) to participants in Facebook groups. The interventions period lasted 12 weeks. Participants in control groups received an enhanced standard of care, including standard offline HIV prevention available in Peru and participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants also completed questionnaires on HIV risk behaviours and social media use at baseline and 12 week follow-up. The primary outcome was the number of participants who received a free HIV test at a local community clinic. The facebook groups were analysed as clusters to account for intracluster correlations. This trial is registered with ClinicalTrials.gov, number NCT01701206. Of 49 peer-leaders recruited, 34 completed training and were assigned at random to the intervention Facebook groups. Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted

  1. Doubly blind: a systematic review of gender in randomised controlled trials

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    Susan P. Phillips

    2016-04-01

    Full Text Available Background: Although observational data show social characteristics such as gender or socio-economic status to be strong predictors of health, their impact is seldom investigated in randomised controlled studies (RCTs. Objective & design: Using a random sample of recent RCTs from high-impact journals, we examined how the most often recorded social characteristic, sex/gender, is considered in design, analysis, and interpretation. Of 712 RCTs published from September 2008 to 31 December 2013 in the Annals of Internal Medicine, British Medical Journal, Lancet, Canadian Medical Association Journal, or New England Journal of Medicine, we randomly selected 57 to analyse funding, methods, number of centres, documentation of social circumstances, inclusion/exclusion criteria, proportions of women/men, and reporting about sex/gender in analyses and discussion. Results: Participants’ sex was recorded in most studies (52/57. Thirty-nine percent included men and women approximately equally. Overrepresentation of men in 43% of studies without explicit exclusions for women suggested interference in selection processes. The minority of studies that did analyse sex/gender differences (22% did not discuss or reflect upon these, or dismissed significant findings. Two studies reinforced traditional beliefs about women's roles, finding no impact of breastfeeding on infant health but nevertheless reporting possible benefits. Questionable methods such as changing protocols mid-study, having undefined exclusion criteria, allowing local researchers to remove participants from studies, and suggesting possible benefit where none was found were evident, particularly in industry-funded research. Conclusions: Social characteristics like sex/gender remain hidden from analyses and interpretation in RCTs, with loss of information and embedding of error all along the path from design to interpretation, and therefore, to uptake in clinical practice. Our results suggest that to

  2. Chest physiotherapy using passive expiratory techniques does not reduce bronchiolitis severity: a randomised controlled trial.

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    Rochat, Isabelle; Leis, Patricia; Bouchardy, Marie; Oberli, Christine; Sourial, Hendrika; Friedli-Burri, Margrit; Perneger, Thomas; Barazzone Argiroffo, Constance

    2012-03-01

    Chest physiotherapy (CP) using passive expiratory manoeuvres is widely used in Western Europe for the treatment of bronchiolitis, despite lacking evidence for its efficacy. We undertook an open randomised trial to evaluate the effectiveness of CP in infants hospitalised for bronchiolitis by comparing the time to clinical stability, the daily improvement of a severity score and the occurrence of complications between patients with and without CP. Children slow expiratory technique, slow accelerated expiratory flow, rarely induced cough) or group 2 without CP. All children received standard care (rhinopharyngeal suctioning, minimal handling, oxygen for saturation ≥92%, fractionated meals). Ninety-nine eligible children (mean age, 3.9 months), 50 in group 1 and 49 in group 2, with similar baseline variables and clinical severity at admission. Time to clinical stability, assessed as primary outcome, was similar for both groups (2.9 ± 2.1 vs. 3.2 ± 2.8 days, P = 0.45). The rate of improvement of a clinical and respiratory score, defined as secondary outcome, only showed a slightly faster improvement of the respiratory score in the intervention group when including stethoacoustic properties (P = 0.044). Complications were rare but occurred more frequently, although not significantly (P = 0.21), in the control arm. In conclusion, this study shows the absence of effectiveness of CP using passive expiratory techniques in infants hospitalised for bronchiolitis. It seems justified to recommend against the routine use of CP in these patients.

  3. Evaluation of exercise on individuals with dementia and their carers: a randomised controlled trial

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    Leonard Claire

    2010-05-01

    Full Text Available Abstract Background Almost all of the 820,000 people in the UK with dementia will experience Behavioural and Psychological Symptoms of Dementia (BPSD. However, research has traditionally focused on treating cognitive symptoms, thus neglecting core clinical symptoms that often have a more profound impact on living with dementia. Recent evidence (Kales et al, 2007; Ballard et al, 2009 indicates that the popular approach to managing BPSD - prescription of anti-psychotic medication - can increase mortality and the risk of stroke in people with dementia as well as impair quality of life and accelerate cognitive decline. Consequently, there is a need to evaluate the impact that non-pharmacological interventions have on BPSD; we believe physical exercise is a particularly promising approach. Methods/Design We will carry out a pragmatic, randomised, single-blind controlled trial to evaluate the effectiveness of exercise (planned walking on the behavioural and psychological symptoms of individuals with dementia. We aim to recruit 146 people with dementia and their carers to be randomized into two groups; one will be trained in a structured, tailored walking programme, while the other will continue with treatment as usual. The primary outcome (BPSD will be assessed with the Neuropsychiatric Inventory (NPI along with relevant secondary outcomes at baseline, 6 and 12 weeks. Discussion Designing this study has been challenging both ethically and methodologically. In particular to design an intervention that is simple, measurable, safe, non-invasive and enjoyable has been testing and has required a lot of thought. Throughout the design, we have attempted to balance methodological rigour with study feasibility. We will discuss the challenges that were faced and overcome in this paper. Trial Registration ISRCTN01423159

  4. Pressure ulcers: effectiveness of risk-assessment tools. A randomised controlled trial (the ULCER trial).

    Science.gov (United States)

    Webster, Joan; Coleman, Kerrie; Mudge, Alison; Marquart, Louise; Gardner, Glenn; Stankiewicz, Monica; Kirby, Julie; Vellacott, Catherine; Horton-Breshears, Margaret; McClymont, Alice

    2011-04-01

    To evaluate the effectiveness of two pressure-ulcer screening tools against clinical judgement in preventing pressure ulcers. A single blind randomised controlled trial. A large metropolitan tertiary hospital. 1231 patients admitted to internal medicine or oncology wards. Patients were excluded if their hospital stay was expected to be 2 days or less. Participants allocated to either a Waterlow (n=410) or Ramstadius (n=411) screening tool group or to a clinical judgement group (n=410) where no formal risk screening instrument was used. Incidence of hospital acquired pressure ulcers ascertained by regular direct observation. Use of any devices for the prevention of pressure ulcers, documentation of a pressure plan and any dietetic or specialist skin integrity review were recorded. On admission, 71 (5.8%) patients had an existing pressure ulcer. The incidence of hospital-acquired pressure ulcers was similar between groups (clinical judgement 28/410 (6.8%); Waterlow 31/411 (7.5%); Ramstadius 22/410 (5.4%), p=0.44). Significant associations with pressure injury in regression modelling included requiring a dietetic referral, being admitted from a location other than home and age over 65 years. The authors found no evidence to show that two common pressure-ulcer risk-assessment tools are superior to clinical judgement to prevent pressure injury. Resources associated with use of these tools might be better spent on careful daily skin inspection and improving management targetted at specific risks. The trial was registered with the Australian and New Zealand Clinicat Trials Registry (ACTRN 12608000541303).

  5. Misoprostol dose and route after mifepristone for early medical abortion: a randomised controlled noninferiority trial.

    Science.gov (United States)

    von Hertzen, H; Huong, N T M; Piaggio, G; Bayalag, M; Cabezas, E; Fang, A H; Gemzell-Danielsson, K; Hinh, N D; Mittal, S; Ng, E H Y; Chaturachinda, K; Pinter, B; Puscasiu, L; Savardekar, L; Shenoy, S; Khomassuridge, A; Tuyet, H T D; Velasco, A; Peregoudov, A

    2010-09-01

    To compare 400 and 800 microg sublingual or vaginal misoprostol 24 hours after 200 mg mifepristone for noninferiority regarding efficacy in achieving complete abortion for pregnancy termination up to 63 days of gestation. Placebo-controlled, randomised, noninferiority factorial trial, stratified by centre and length of gestation. Misoprostol 400 or 800 microg, administered either sublingually or vaginally, with follow up after 2 and 6 weeks. Fifteen obstetrics/gynaecology departments in ten countries. Pregnant women (n = 3005) up to 63 days of gestation requesting medical abortion. Two-sided 95% CI for differences in failure of complete abortion and continuing pregnancy, with a 3% noninferiority margin, were calculated. Proportions of women with adverse effects were recorded. Complete abortion without surgical intervention (main); continuing live pregnancies, induction-to-abortion interval, adverse effects, women's perceptions (secondary). Efficacy outcomes analysed for 2962 women (98.6%): 90.5% had complete abortion after 400 microg misoprostol, 94.2% after 800 microg. Noninferiority of 400 microg misoprostol was not demonstrated for failure of complete abortion (difference: 3.7%; 95% CI 1.8-5.6%). The 400-microg dose showed higher risk of incomplete abortion (P abortion (P = 0.47, difference in sublingual minus vaginal -0.7%, 95% CI -2.6-1.2%). A similar pattern was observed for continuing pregnancies (P = 0.21). Fewer women reported adverse effects with vaginal than sublingual administration and with the 400-microg dose than the 800-microg dose. Of the women, 94% were satisfied or highly satisfied with the regimens, 53% preferred the sublingual route and 47% preferred the vaginal route. A 400-microg dose of misoprostol should not replace the 800-microg dose when administered 24 hours after 200 mg mifepristone for inducing abortion in pregnancies up to 63 days. Sublingual and vaginal misoprostol have similar efficacy, but vaginal administration is associated with

  6. Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol

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    van Vuuren Cloete

    2008-04-01

    Full Text Available Abstract Background A major barrier to accessing free government-provided antiretroviral treatment (ART in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults. Methods/design This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a 7400 registering with the programme with CD4 counts of ≤ 350 cells/mL (mainly to evaluate treatment initiation and b 4900 already receiving ART (to evaluate ongoing treatment and monitoring. The primary outcomes will be time to death (in the first group and viral suppression (in the second group. Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register. Trial registration Controlled Clinical Trials ISRCTN46836853

  7. A randomised controlled trial of placental cord drainage to reduce feto-maternal transfusion.

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    Navaneethakrishnan, R; Anderson, A; Holding, S; Atkinson, C; Lindow, S W

    2010-03-01

    To determine whether placental drainage via the umbilical cord prior to placental delivery reduces the size of feto-maternal transfusion and thus the chance of rhesus isoimmunisation in rhesus negative women. A randomised controlled trial conducted in a tertiary hospital setting in the UK compared 18 rhesus negative women who had placental drainage (10 caesarean section and 8 vaginal deliveries) with 18 rhesus negative women where the cord remained clamped until placental delivery (8 caesarean section and 10 vaginal deliveries). Maternal venous blood samples were taken before delivery and at a mean of 142 min after delivery of the placenta, and analysed using flow cytometry to calculate the size of the feto-maternal transfusion. The statistical analysis was performed using SPSS Version 13 statistical software. The main outcome measure was the quantification of the volume of fetal cells in the maternal circulation before and after delivery. In the 72 specimens taken, 40 demonstrated measurable amounts of fetal cells in the maternal circulation. In the 18 women who had placental drainage, the mean (SD) size of the feto-maternal transfusion was 0.50 ml (0.79) before and 0.39 ml (0.58) after delivery. In the 18 women who had a clamped cord, the mean (SD) feto-maternal transfusion was 0.46 ml (0.84) before and 0.78 ml (1.1) after delivery. There was no significant difference between the net feto-maternal transfusions in the two groups (Mann-Whitney U 122.5, p 0.19). Placental drainage does not reduce the amount of feto-maternal transfusion and this method of placental delivery is not recommended to reduce feto-maternal transfusion. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

  8. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies

    Science.gov (United States)

    Williamson, Paula R; Gamble, Carrol; O'Connell Francischetto, Elaine; Metcalfe, Chris; Davidson, Peter; Williams, Hywel; Blazeby, Jane M

    2017-01-01

    Objectives Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or ‘progression’ criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking. This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase. Design A structured literature review and exploration of stakeholders' opinions at a Medical Research Council (MRC) Hubs for Trials Methodology Research workshop. Key stakeholders included triallists, methodologists, statisticians and funders. Results There is considerable variation in the use of progression criteria for RCTs with an internal pilot phase, although 3 common issues predominate: trial recruitment, protocol adherence and outcome data. Detailed and systematic reporting around the decision-making process for stopping, amending or proceeding to a main trial is uncommon, which may hamper understanding in the research community about the appropriate and optimal use of RCTs with an internal pilot phase. 10 top tips for the development, use and reporting of progression criteria for internal pilot studies are presented. Conclusions Systematic and transparent reporting of the design, results and evaluation of internal pilot trials in the literature should be encouraged in order to facilitate understanding in the research community and to inform future trials. PMID:28213598

  9. Filmed v. live social contact interventions to reduce stigma: randomised controlled trial.

    Science.gov (United States)

    Clement, Sarah; van Nieuwenhuizen, Adrienne; Kassam, Aliya; Flach, Clare; Lazarus, Anisha; de Castro, Melanie; McCrone, Paul; Norman, Ian; Thornicroft, Graham

    2012-07-01

    Direct social contact interventions are known to reduce mental health stigma. Filmed social contact may be equally effective and have practical and cost advantages. To compare the effectiveness of a DVD, a live intervention and a lecture control, in reducing stigma, testing the hypotheses that: (a) DVD and live interventions will be equally effective; and (b) the interventions with social contact (DVD/live) will be more effective than the lecture. Cost-effectiveness, process and acceptability are also assessed. Student nurses were randomised to: (a) watch a DVD of service users/informal carers talking about their experiences, (b) watch a similar live presentation, or (c) attend a lecture. Primary outcomes were changes in attitudes (using the Mental Illness: Clinicians Attitudes Scale, MICA), emotional reactions (using the Emotional Reactions to Mental Illness Scale, ERMIS), intended proximity (using the Reported and Intended Behaviour Scale, RIBS), and knowledge (using the Social Contact Intended Learning Outcomes, SCILO), immediately after the intervention and at 4-month follow-up. For the 216 participants, there were no differences between the DVD and live groups on MICA, ERMIS or RIBS scores. The DVD group had higher SCILO (knowledge) scores. The combined social contact group (DVD/live) had better MICA and RIBS scores than the lecture group, the latter difference maintained at 4 months. The DVD was the most cost-effective of the interventions, and the live session the most popular. Our hypotheses were confirmed. This study supports the wider use of filmed social contact interventions to reduce stigma about mental illness.

  10. Comparison of propranolol and pregabalin for prophylaxis of childhood migraine: a randomised controlled trial.

    Science.gov (United States)

    Bakhshandeh Bali, MohammadKazem; Rahbarimanesh, Ali Akbar; Sadeghi, Manelie; Sedighi, Mostafa; Karimzadeh, Parvaneh; Ghofrani, Mohammad

    2015-01-01

    Migraine involves 5-10% of children and adolescents. Thirty percent of children with severe migraine attacks have school absence and reduced quality of life that need preventive therapy. The purpose of this randomised control trial study is to compare the effectiveness, safety and the tolerability of pregabalin toward Propranolol in migraine prophylaxis of children. From May 2011 to October 2012, 99 children 3-15 years referred to the neurology clinic of Mofid Children's Hospital with a diagnosis of migraine enrolled the study. Patients randomly divided into two groups (A&B). We treated children of group A with capsule of pregabalin as children of group B with tablet of propranolol for at least 8 weeks. In this study, 99 patients were examined that 91 children reached the last stage. The group A consistsed of 46 patients, 12(26.1%) girls, 34 (73.9%) boys and the group B consisted of 45 patients, 14(31.1%) girls, 31 (68.9%) boys. Basis of age, gender, headache onset, headache frequency, migraine type, triggering and relieving factors there was no significant difference among these groups (P>0.05). After 4 and 8 weeks of Pregabalin usage monthly headache frequency decreased to 2.2±4.5 and 1.76±6.2 respectively. Propranolol reduced monthly headache frequency up to 3.73±6.11 and 3.34±5.95 later 4 and 8 weeks respectively. There was a significant difference between these two groups according to headache frequency reduction (P=0.04). Pregabalin efficacy in reducing the frequency and duration of pediatric migraine headache is considerable in comparison with propranolol.

  11. Comparison of propranolol and pregabalin for prophylaxis of childhood migraine: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    MohammadKazem Bakhshandeh Bali

    2015-05-01

    Full Text Available Migraine involves 5-10% of children and adolescents. Thirty percent of children with severe migraine attacks have school absence and reduced quality of life that need preventive therapy. The purpose of this randomised control trial study is to compare the effectiveness, safety and the tolerability of pregabalin toward Propranolol in migraine prophylaxis of children. From May 2011 to October 2012, 99 children 3-15 years referred to the neurology clinic of Mofid Children's Hospital with a diagnosis of migraine enrolled the study. Patients randomly divided into two groups (A&B. We treated children of group A with capsule of pregabalin as children of group B with tablet of propranolol for at least 8 weeks. In this study, 99 patients were examined that 91 children reached the last stage. The group A consistsed of 46 patients, 12(26.1% girls, 34 (73.9% boys and the group B consisted of 45 patients, 14(31.1% girls, 31 (68.9% boys. Basis of age, gender, headache onset, headache frequency, migraine type, triggering and relieving factors there was no significant difference among these groups (P>0.05. After 4 and 8 weeks of Pregabalin usage monthly headache frequency decreased to 2.2±4.5 and 1.76±6.2 respectively. Propranolol reduced monthly headache frequency up to 3.73±6.11 and 3.34±5.95 later 4 and 8 weeks respectively. There was a significant difference between these two groups according to headache frequency reduction (P=0.04. Pregabalin efficacy in reducing the frequency and duration of pediatric migraine headache is considerable in comparison with propranolol.

  12. Do early quadriceps exercises affect the outcome of ACL reconstruction? A randomised controlled trial.

    Science.gov (United States)

    Shaw, Triston; Williams, Marie T; Chipchase, Lucy S

    2005-01-01

    A prospective, blinded, randomised controlled trial investigated the effectiveness of quadriceps exercises following anterior cruciate ligament reconstruction. A treatment group (Quadriceps exercise group) performed straight leg raises and isometric quadriceps contractions throughout the first two postoperative weeks, and a second group (No quadriceps exercise group) did not. A battery of outcome measures assessed subjects postoperatively at day one, two weeks, and one, three and six months. A total of 103 patients (Quadriceps exercise n = 48, No quadriceps exercise n = 55) commenced the study with 91 subjects available at final follow up (Quadriceps exercise n = 47, No quadriceps exercise n = 44). Performance of quadriceps exercises significantly improved a number of knee flexion and extension range of motion measurements (p = 0.01 to 0.04). No significant differences were found between the two groups at any postoperative period for quadriceps lag (p = 0.36), functional hop testing (p = 0.49 to 0.51), isokinetic quadriceps strength (p = 0.70 to 0.72), the majority of numerical analogue scores (p = 0.1 to 0.94) and Cincinnati scores (p = 0.10 to 0.84). Subjects performing quadriceps exercises reported significantly higher pain scores with exercise on the first postoperative day (p = 0.02). At six months postoperatively, the Quadriceps exercise subjects reported significantly more favourable Cincinnati scores for symptoms (p = 0.005) and problems with sport (p = 0.05). While average knee laxity was not significantly different between treatment groups over time (p = 0.27 to 0.94), quadriceps exercise performance was associated with a significantly lower incidence of abnormal knee laxity. Isometric quadriceps exercises and straight leg raises can be safely prescribed during the first two postoperative weeks and confer advantages for faster recovery of knee range of motion and stability. It remains to be proven whether the magnitude of differences between groups is

  13. Adolescent standing postural response to backpack loads: a randomised controlled experimental study

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    Pirunsan Ubon

    2002-04-01

    Full Text Available Abstract Background Backpack loads produce changes in standing posture when compared with unloaded posture. Although 'poor' unloaded standing posture has been related to spinal pain, there is little evidence of whether, and how much, exposure to posterior load produces injurious effects on spinal tissue. The objective of this study was to describe the effect on adolescent sagittal plane standing posture of different loads and positions of a common design of school backpack. The underlying study aim was to test the appropriateness of two adult 'rules-of-thumb'-that for postural efficiency, backpacks should be worn high on the spine, and loads should be limited to 10% of body weight. Method A randomised controlled experimental study was conducted on 250 adolescents (12–18 years, randomly selected from five South Australian metropolitan high schools. Sagittal view anatomical points were marked on head, neck, shoulder, hip, thigh, knee and ankle. There were nine experimental conditions: combinations of backpack loads (3, 5 or 10% of body weight and positions (backpack centred at T7, T12 or L3. Sagittal plane photographs were taken of unloaded standing posture (baseline, and standing posture under the experimental conditions. Posture was quantified from the x (horizontal coordinate of each anatomical point under each experimental condition. Differences in postural response were described, and differences between conditions were determined using Analysis of Variance models. Results Neither age nor gender was a significant factor when comparing postural response to backpack loads or conditions. Backpacks positioned at T7 produced the largest forward (horizontal displacement at all the anatomical points. The horizontal position of all anatomical points increased linearly with load. Conclusion There is evidence refuting the 'rule-of-thumb' to carry the backpack high on the back. Typical school backpacks should be positioned with the centre at waist or

  14. A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour.

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    Madhu, Chendrimada; Mahavarkar, Suvarna; Bhave, Sudhir

    2010-07-01

    Cervical dilatation is a poorly understood process. Various drugs have been used to facilitate this process and reduce the duration of labour and thereby reduce feto-maternal complications. The present study is an attempt to compare and evaluate the efficacy of Drotaverine hydrochloride and Valethamate bromide in the process of cervical dilatation and labour augmentation. A prospective randomised trial of 146 low-risk women in spontaneous labour was conducted. 49 women were given Drotaverine (Group 1), 49 women were given Valethamate (Group 2) and 48 women were given placebo (Group 3). At 4 cm of cervical dilatation, elective amniotomy was done and the injection was given intramuscularly, and repeated every hour for a maximum of three doses. There was a statistically significant difference in the mean injection-delivery times (time from first injection to delivery of the baby), which was 183.2 min (SD 78.8) in the Drotaverine group compared to 206.5 min (SD 69.7) in the Valethamate group, and 245 min (SD 70.9) in the control group. The mean cervical dilatation rate (cm/h) was 3 (SD 1.4), 2.4 (SD 0.9) and 1.9 (SD 0.6) in groups 1, 2 and 3, respectively, and these differences were statistically significant. There were no statistically significant differences in the duration of second and third stage of labour. Transient side effects such as foeto-maternal tachycardia, flushing of the face and dryness of mouth were noted with Valethamate. A few patients complained of headache in the Drotaverine group. Both Drotaverine and Valethamate appear to significantly help cervical dilatation and augment first stage of labour. But, Drotaverine is superior to Valethamate with fewer side effects.

  15. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial.

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    Fransen, A F; van de Ven, J; Merién, A E R; de Wit-Zuurendonk, L D; Houterman, S; Mol, B W; Oei, S G

    2012-10-01

    To determine whether obstetric team training in a medical simulation centre improves the team performance and utilisation of appropriate medical technical skills of healthcare professionals. Cluster randomised controlled trial. The Netherlands. The obstetric departments of 24 Dutch hospitals. The obstetric departments were randomly assigned to a 1-day session of multiprofessional team training in a medical simulation centre or to no such training. Team training was given with high-fidelity mannequins by an obstetrician and a communication expert. More than 6 months following training, two unannounced simulated scenarios were carried out in the delivery rooms of all 24 obstetric departments. The scenarios, comprising a case of shoulder dystocia and a case of amniotic fluid embolism, were videotaped. The team performance and utilisation of appropriate medical skills were evaluated by two independent experts. Team performance evaluated with the validated Clinical Teamwork Scale (CTS) and the employment of two specific obstetric procedures for the two clinical scenarios in the simulation (delivery of the baby with shoulder dystocia in the maternal all-fours position and conducting a perimortem caesarean section within 5 minutes for the scenario of amniotic fluid embolism). Seventy-four obstetric teams from 12 hospitals in the intervention group underwent teamwork training between November 2009 and July 2010. The teamwork performance in the training group was significantly better in comparison to the nontraining group (median CTS score: 7.5 versus 6.0, respectively; P = 0.014). The use of the predefined obstetric procedures for the two clinical scenarios was also significantly more frequent in the training group compared with the nontraining group (83 versus 46%, respectively; P = 0.009). Team performance and medical technical skills may be significantly improved after multiprofessional obstetric team training in a medical simulation centre. © 2012 The Authors BJOG An

  16. The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study.

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    Hanneke de Waal

    Full Text Available BACKGROUND: Synaptic loss is a major hallmark of Alzheimer's disease (AD. Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials. OBJECTIVE: To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD. DESIGN: A 24-week randomised, controlled, double-blind, parallel-group, multi-country study. PARTICIPANTS: 179 drug-naïve mild AD patients who participated in the Souvenir II study. INTERVENTION: Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. OUTCOME: In a secondary analysis of the Souvenir II study, electroencephalography (EEG brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma and global network integration (normalised characteristic path length lambda were compared between study groups, and related to memory performance. RESULTS: THE NETWORK MEASURES IN THE BETA BAND WERE SIGNIFICANTLY DIFFERENT BETWEEN GROUPS: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance. CONCLUSIONS: The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude

  17. Impact of text and email messaging on the sexual health of young people: a randomised controlled trial.

    Science.gov (United States)

    Lim, Megan S C; Hocking, Jane S; Aitken, Campbell K; Fairley, Christopher K; Jordan, Lynne; Lewis, Jennifer A; Hellard, Margaret E

    2012-01-01

    To carry out a randomised controlled trial on the effect of a new method of health promotion-email and mobile phone text messages (short messaging service (SMS))-on young people's sexual health. 994 people aged 16-29 were recruited at a music festival to a non-blinded randomised controlled trial. Participants were randomised to either receive sexual health promotion messages (n=507) or the control group (n=487). The 12-month intervention included SMS (catchy sexually transmissible infections prevention slogans) and emails. Participants completed questionnaires at the festival at baseline and online after 3, 6 and 12 months. Outcomes were differences between the control and intervention groups in health-seeking behaviour, condom use with risky partners (new or casual partners or two or more partners within 12 months) and STI knowledge. 337 (34%) completed all three follow-up questionnaires and 387 (39%) completed the final questionnaire. At 12 months, STI knowledge was higher in the intervention group for both male (OR=3.19 95% CI 1.52 to 6.69) and female subjects (OR=2.36 95% CI 1.27 to 4.37). Women (but not men) in the intervention group were more likely to have had an STI test (OR=2.51, 95% CI 1.11 to 5.69), or discuss sexual health with a clinician (OR=2.92, 95% CI 1.66 to 5.15) than their control counterparts. There was no significant impact on condom use. Opinions of the messages were favourable. This simple intervention improved STI knowledge in both sexes and STI testing in women, but had no impact on condom use. SMS and email are low cost, popular and convenient, and have considerable potential for health promotion. Australian Clinical Trials Registry - ACTRN12605000760673.

  18. Functional exercise after total hip replacement (FEATHER a randomised control trial

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    Monaghan Brenda

    2012-11-01

    Full Text Available Abstract Background Prolonged physical impairments in range of movement, postural stability and walking speed are commonly reported following total hip replacement (THR. It is unclear from the current body of evidence what kind of exercises should be performed to maximize patient function and quality of life. Methods/design This will be a single blind multi centre randomized control trial with two arms. Seventy subjects post primary total hip arthroplasty will be randomized into either an experimental group (n=35, or to a control group (n=35. The experimental group will attend a functional exercise class twice weekly for a six week period from week 12 to week 18 post surgery. The functional exercise group will follow a circuit based functional exercise class supervised by a chartered Physiotherapist. The control group will receive usual care. The principal investigator (BM will perform blinded outcome assessments on all patients using validated measures for pain, stiffness, and function using the Western Ontario and Mc Master Universities Osteoarthritis index (WOMAC. This is the primary outcome measurement tool. Secondary outcome measurements include Quality of life (SF-36, 6 min walk test, Visual Analogue Scale, and the Berg Balance score. The WOMAC score will be collated on day five post surgery and repeated at week twelve and week eighteen. All other measurements will be taken at week 12 and repeated at week eighteen. In addition a blinded radiologist will measure gluteus medius cross sectional area using real time ultrasound for all subjects at week 12 and at week 18 to determine if the functional exercise programme has any effect on muscle size. Discussion This randomised controlled trial will add to the body of evidence on the relationship between muscle size, functional ability, balance, quality of life and time post surgery in patients following total hip arthroplasty. The CONSORT guidelines will be followed to throughout. Ethical

  19. Effectiveness of the tailored EBP training program for Filipino physiotherapists: A randomised controlled trial

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    Grimmer-Somers Karen

    2011-04-01

    Full Text Available Astract Background Evidence implementation continues to challenge health professionals most especially those from developing countries. Filipino physiotherapists represent a group of health professionals in a developing country who by tradition and historical practice, take direction from a doctor, on treatment options. Lack of autonomy in decision-making challenges their capacity to deliver evidence-based care. However, this scenario should not limit them from updating and up-skilling themselves on evidence- based practice (EBP. EBP training tailored to their needs and practice was developed to address this gap. This study will be conducted to assess the effectiveness of a tailored EBP-training program for Filipino physiotherapists, in improving knowledge, skills, attitudes and behaviour to EBP. Participation in this program aims to improve capacity to EBP and engage with referring doctors to determine the most effective treatments for their patients. Methods/Design A double blind randomised controlled trial, assessing the effectiveness of the EBP training intervention, compared with a waitlist control, will be conducted. An adequately powered sample of 54 physiotherapists from the Philippines will be recruited and randomly allocated to EBP intervention or waitlist control. Intervention: The EBP program for Filipino physiotherapists is a one-day program on EBP principles and techniques, delivered using effective adult education strategies. It consists of lectures and practical workshops. A novel component in this program is the specially-developed recommendation form, which participants can use after completing their training, to assist them to negotiate with referring doctors regarding evidence-based treatment choices for their patients. Pre and post measures of EBP knowledge, skills and attitudes will be assessed in both groups using the Adapted Fresno Test and the Questions to EBP attitudes. Behaviour to EBP will be measured using activity

  20. Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial.

    Science.gov (United States)

    Salam, Rehana A; Darmstadt, Gary L; Bhutta, Zulfiqar A

    2015-05-01

    Newborn oil massage, a traditional community practice, could potentially benefit thermoregulation and skin barrier function, and prevent serious infections, morbidity and mortality in high-risk preterm infants, but has only been evaluated in limited studies in low income settings. To assess the efficacy of topical coconut oil applications among a cohort of hospital-born preterm infants. A prospective, individually randomised controlled clinical trial. Nursery and neonatal intensive care unit at Aga Khan University Hospital, Pakistan. Of 270 eligible neonates, a consecutive cohort of 258 hospital-born preterm infants (gestational age ≥26 weeks and ≤37 weeks). Twice daily topical application of coconut oil by nurses from birth until discharge and continued thereafter by mothers at home until completion of the 28th day of life. Incidence of hospital-acquired bloodstream infections. Weight gain, skin condition and neonatal mortality. 23% of the enrolled neonates developed clinically suspected sepsis while 14% developed blood culture proven infection. The unadjusted hazard for developing hospital-acquired infection in the control group was 4.7 (95% CI 1.8 to 12.4) compared with the intervention group. After adjusting for gestational age, birth weight, duration of intubation and duration of hospitalisation for possible confounding, the hazard for hospital-acquired infection in the control group was 6.0 (95% CI 2.3 to 16) compared with the intervention group. The rate of hospital-acquired infections in the control and intervention groups was 219.1 and 39.5 per 1000 patient-days, respectively. Mean weight gain was 11.3 g/day higher (95% CI 8.1 to 14.6, peffects such as local irritation or local infection were observed among newborns receiving coconut oil applications. Topical emollient therapy was effective in maintaining skin integrity and reducing the risk of bloodstream infection in preterm infants in a tertiary hospital setting in Pakistan. The effectiveness of

  1. TREC-SAVE: a randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people: study protocol for a randomised controlled trial

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    Ferreira Marco AV

    2011-07-01

    Full Text Available Abstract Background Thousands of people whose aggression is thought due to serious mental illness are secluded or restrained every day. Without fair testing these techniques will continue to be used outside of a rigorous evidence base. With such coercive treatment this leaves all concerned vulnerable to abuse and criticism. This paper presents the protocol for a randomised trial comparing seclusion with restraints for people with serious mental illnesses. Methods/Design Setting-General psychiatric wards of a large psychiatric hospital in Rio de Janeiro, Brazil. Participants-Anyone aggressive or violent suspected or known to have serious mental illness for whom restriction is felt to be indicated by nursing and medical staff, but also for whom they are unsure whether seclusion or restraint would be indicated. Interventions-The standard care of either strong cotton banding to edge of bed with medications as indicated and close observation or the other standard care of use of a minimally furnished seclusion room but with open but barred windows onto the nursing station. Outcomes-time to restrictions lifted, early change of treatment, additional episodes, adverse effects/events, satisfaction with care during episode. Duration-2 weeks. Identifier: ISRCTN 49454276 http://www.controlled-trials.com/ISRCTN49454276

  2. Treatment of missing data in follow-up studies of randomised controlled trials: A systematic review of the literature.

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    Sullivan, Thomas R; Yelland, Lisa N; Lee, Katherine J; Ryan, Philip; Salter, Amy B

    2017-08-01

    After completion of a randomised controlled trial, an extended follow-up period may be initiated to learn about longer term impacts of the intervention. Since extended follow-up studies often involve additional eligibility restrictions and consent processes for participation, and a longer duration of follow-up entails a greater risk of participant attrition, missing data can be a considerable threat in this setting. As a potential source of bias, it is critical that missing data are appropriately handled in the statistical analysis, yet little is known about the treatment of missing data in extended follow-up studies. The aims of this review were to summarise the extent of missing data in extended follow-up studies and the use of statistical approaches to address this potentially serious problem. We performed a systematic literature search in PubMed to identify extended follow-up studies published from January to June 2015. Studies were eligible for inclusion if the original randomised controlled trial results were also published and if the main objective of extended follow-up was to compare the original randomised groups. We recorded information on the extent of missing data and the approach used to treat missing data in the statistical analysis of the primary outcome of the extended follow-up study. Of the 81 studies included in the review, 36 (44%) reported additional eligibility restrictions and 24 (30%) consent processes for entry into extended follow-up. Data were collected at a median of 7 years after randomisation. Excluding 28 studies with a time to event primary outcome, 51/53 studies (96%) reported missing data on the primary outcome. The median percentage of randomised participants with complete data on the primary outcome was just 66% in these studies. The most common statistical approach to address missing data was complete case analysis (51% of studies), while likelihood-based analyses were also well represented (25%). Sensitivity analyses around

  3. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

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    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  4. Vibration therapy reduces CPAP need in a prospective randomised controlled trial

    NARCIS (Netherlands)

    K. Helder MScN (Onno); W.C.J. Hop (Wim); J.B. van Goudoever (Hans)

    2008-01-01

    textabstractBackground: Increased mucus production is a common phenomena following ventilatory support, which might increase morbidity. In order to reduce airway obstruction we tested the effect of vibration therapy on the duration of ventilatory support. Methodology: We conducted a randomised

  5. Exercise therapy for Stress-related mental disorder, a randomised controlled trial in primary care

    NARCIS (Netherlands)

    Quartero, A. Otto; Burger, Huib; Donker, Marieke; de Wit, Niek J.

    2011-01-01

    Background: to investigate whether a structured physical exercise programme (PEP) improves the recovery of general health in patients suffering from Stress-related Mental Disorder (SMD). Method: Study design: randomised open trial in general practice. Patients from two regions in the Netherlands wer

  6. GP-initiated preconception counselling in a randomised controlled trial does not induce anxiety

    NARCIS (Netherlands)

    Jong-Potjer, L.C. de; Elsinga, J.; Cessie, S. le; Pal-de Bruin, K.M. van der; Knuistingh Neven, A.; Buitendijk, S.E.; Assendelft, W.J.J.

    2006-01-01

    Background: Preconception counselling (PCC) can reduce adverse pregnancy outcome by addressing risk factors prior to pregnancy. This study explores whether anxiety is induced in women either by the offer of PCC or by participation with GP-initiated PCC. Methods: Randomised trial of usual care versus

  7. Community based physiotherapeutic exercise in COPD self-management : A randomised controlled trial

    NARCIS (Netherlands)

    Effing, Tanja; Zielhuis, Gerhard; Kerstjens, Huib; van der Valk, Paul; van der Palen, Job

    2011-01-01

    Little is known about effects of community-based physiotherapeutic exercise programmes incorporated in COPD self-management programmes. In a randomised trial, the effect of such a programme (COPE-active) on exercise capacity and various secondary outcomes including daily activity as a marker of beha

  8. Vibration therapy reduces CPAP need in a prospective randomised controlled trial

    NARCIS (Netherlands)

    K. Helder MScN (Onno); W.C.J. Hop (Wim); J.B. van Goudoever (Hans)

    2008-01-01

    textabstractBackground: Increased mucus production is a common phenomena following ventilatory support, which might increase morbidity. In order to reduce airway obstruction we tested the effect of vibration therapy on the duration of ventilatory support. Methodology: We conducted a randomised contr

  9. Effectiveness of alcohol brief intervention delivered by community pharmacists: study protocol of a two-arm randomised controlled trial

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    Dhital Ranjita

    2013-02-01

    Full Text Available Abstract Background There is strong evidence to support the effectiveness of Brief Intervention (BI in reducing alcohol consumption in primary healthcare. Methods and design This study is a two-arm randomised controlled trial to determine the effectiveness of BI delivered by community pharmacists in their pharmacies. Eligible and consenting participants (aged 18 years or older will be randomised in equal numbers to either a BI delivered by 17 community pharmacists or a non-intervention control condition. The intervention will be a brief motivational discussion to support a reduction in alcohol consumption and will take approximately 10 minutes to deliver. Participants randomised to the control arm will be given an alcohol information leaflet with no opportunity for discussion. Study pharmacists will be volunteers who respond to an invitation to participate, sent to all community pharmacists in the London borough of Hammersmith and Fulham. Participating pharmacists will receive 7 hours training on trial procedures and the delivery of BI. Pharmacy support staff will also receive training (4 hours on how to approach and inform pharmacy customers about the study, with formal trial recruitment undertaken by the pharmacist in a consultation room. At three month follow up, alcohol consumption and related problems will be assessed with the Alcohol Use Disorders Identification Test (AUDIT administered by telephone. Discussion The UK Department of Health’s stated aim is to involve community pharmacists in the delivery of BI to reduce alcohol harms. This will be the first RCT study to assess the effectiveness of BI delivered by community pharmacists. Given this policy context, it is pragmatic in design. Trial registration Current Controlled Trials ISRCTN95216873

  10. Recommendations for the analysis of individually randomised controlled trials with clustering in one arm – a case of continuous outcomes

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    Laura Flight

    2016-11-01

    Full Text Available Abstract Background In an individually randomised controlled trial where the treatment is delivered by a health professional it seems likely that the effectiveness of the treatment, independent of any treatment effect, could depend on the skill, training or even enthusiasm of the health professional delivering it. This may then lead to a potential clustering of the outcomes for patients treated by the same health professional, but similar clustering may not occur in the control arm. Using four case studies, we aim to provide practical guidance and recommendations for the analysis of trials with some element of clustering in one arm. Methods Five approaches to the analysis of outcomes from an individually randomised controlled trial with clustering in one arm are identified in the literature. Some of these methods are applied to four case studies of completed randomised controlled trials with clustering in one arm with sample sizes ranging from 56 to 539. Results are obtained using the statistical packages R and Stata and summarised using a forest plot. Results The intra-cluster correlation coefficient (ICC for each of the case studies was small (<0.05 indicating little dependence on the outcomes related to cluster allocations. All models fitted produced similar results, including the simplest approach of ignoring clustering for the case studies considered. Conclusions A partially clustered approach, modelling the clustering in just one arm, most accurately represents the trial design and provides valid results. Modelling homogeneous variances between the clustered and unclustered arm is adequate in scenarios similar to the case studies considered. We recommend treating each participant in the unclustered arm as a single cluster. This approach is simple to implement in R and Stata and is recommended for the analysis of trials with clustering in one arm only. However, the case studies considered had small ICC values, limiting the generalisability

  11. Cryotherapy versus salicylic acid for the treatment of plantar warts (verrucae): a randomised controlled trial.

    Science.gov (United States)

    Cockayne, Sarah; Hewitt, Catherine; Hicks, Kate; Jayakody, Shalmini; Kang'ombe, Arthur Ricky; Stamuli, Eugena; Turner, Gwen; Thomas, Kim; Curran, Mike; Denby, Gary; Hashmi, Farina; McIntosh, Caroline; McLarnon, Nichola; Torgerson, David; Watt, Ian

    2011-06-07

    To compare the clinical effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts. A multicentre, open, two arm randomised controlled trial. University podiatry school clinics, NHS podiatry clinics, and primary care in England, Scotland, and Ireland. 240 patients aged 12 years and over, with a plantar wart that in the opinion of the healthcare professional was suitable for treatment with both cryotherapy and salicylic acid. Cryotherapy with liquid nitrogen delivered by a healthcare professional, up to four treatments two to three weeks apart. Patient self treatment with 50% salicylic acid (Verrugon) daily up to a maximum of eight weeks. Complete clearance of all plantar warts at 12 weeks. Secondary outcomes were (a) complete clearance of all plantar warts at 12 weeks controlling for age, whether the wart had been treated previously, and type of wart, (b) patient self reported clearance of plantar warts at six months, (c) time to clearance of plantar wart, (d) number of plantar warts at 12 weeks, and (e) patient satisfaction with the treatment. There was no evidence of a difference between the salicylic acid and cryotherapy groups in the proportions of participants with complete clearance of all plantar warts at 12 weeks (17/119 (14%) v 15/110 (14%), difference 0.65% (95% CI -8.33 to 9.63), P=0.89). The results did not change when the analysis was repeated but with adjustment for age, whether the wart had been treated previously, and type of plantar wart or for patients' preferences at baseline. There was no evidence of a difference between the salicylic acid and cryotherapy groups in self reported clearance of plantar warts at six months (29/95 (31%) v 33/98 (34%), difference -3.15% (-16.31 to 10.02), P=0.64) or in time to clearance (hazard ratio 0.80 (95% CI 0.51 to 1.25), P=0.33). There was also no evidence of a difference in the number of plantar warts at 12 weeks (incident rate ratio 1.08 (0.81 to 1.43), P=0.62). Salicylic acid and

  12. A randomised controlled trial of caseload midwifery care: M@NGO (Midwives @ New Group practice Options

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    Tracy Sally K

    2011-10-01

    Full Text Available Abstract Background Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant. Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice. We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial. Methods/design A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs. Discussion Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05 to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive

  13. Community based yoga classes for type 2 diabetes: an exploratory randomised controlled trial

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    Drincevic Desanka

    2009-02-01

    Full Text Available Abstract Background Yoga is a popular therapy for diabetes but its efficacy is contested. The aim of this study was to explore the feasibility of researching community based yoga classes in Type 2 diabetes with a view to informing the design of a definitive, multi-centre trial Methods The study design was an exploratory randomised controlled trial with in-depth process evaluation. The setting was two multi-ethnic boroughs in London, UK; one with average and one with low mean socio-economic deprivation score. Classes were held at a sports centre or GP surgery. Participants were 59 people with Type 2 diabetes not taking insulin, recruited from general practice lists or opportunistically by general practice staff. The intervention group were offered 12 weeks of a twice-weekly 90-minute yoga class; the control group was a waiting list for the yoga classes. Both groups received advice and leaflets on healthy lifestyle and were encouraged to exercise. Primary outcome measure was HbA1c. Secondary outcome measures included attendance, weight, waist circumference, lipid levels, blood pressure, UKPDS cardiovascular risk score, diabetes-related quality of life (ADDQoL, and self-efficacy. Process measures were attendance at yoga sessions, self-reported frequency of practice between taught sessions, and qualitative data (interviews with patients and therapists, ethnographic observation of the yoga classes, and analysis of documents including minutes of meetings, correspondence, and exercise plans. Results Despite broad inclusion criteria, around two-thirds of the patients on GP diabetic registers proved ineligible, and 90% of the remainder declined to participate. Mean age of participants was 60 +/- 10 years. Attendance at yoga classes was around 50%. Nobody did the exercises regularly at home. Yoga teachers felt that most participants were unsuitable for 'standard' yoga exercises because of limited flexibility, lack of basic fitness, co-morbidity, and lack

  14. Soya products and serum lipids: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Tokede, Oluwabunmi A; Onabanjo, Temilola A; Yansane, Alfa; Gaziano, J Michael; Djoussé, Luc

    2015-09-28

    Soya proteins and isoflavones have been reported to exert beneficial effects on the serum lipid profile. More recently, this claim is being challenged. The objective of this study was to comprehensively examine the effects of soya consumption on the lipid profile using published trials. A detailed literature search was conducted via MEDLINE (from 2004 through February 2014), CENTRAL (The Cochrane Controlled Clinical Trials Register) and ClinicalTrials.gov for randomised controlled trials assessing the effects of soya on the lipid profile. The primary effect measure was the difference in means of the final measurements between the intervention and control groups. In all, thirty-five studies (fifty comparisons) were included in our analyses. Treatment duration ranged from 4 weeks to 1 year. Intake of soya products resulted in a significant reduction in serum LDL-cholesterol concentration, -4.83 (95% CI -7.34, -2.31) mg/dl, TAG, -4.92 (95% CI -7.79, -2.04) mg/dl, and total cholesterol (TC) concentrations, -5.33 (95% CI -8.35, -2.30) mg/dl. There was also a significant increase in serum HDL-cholesterol concentration, 1.40 (95% CI 0.58, 2.23) mg/dl. The I² statistic ranged from 92 to 99%, indicating significant heterogeneity. LDL reductions were more marked in hypercholesterolaemic patients, -7.47 (95% CI -11.79, -3.16) mg/dl, than in healthy subjects, -2.96 (95% CI -5.28, -0.65) mg/dl. LDL reduction was stronger when whole soya products (soya milk, soyabeans and nuts) were used as the test regimen, -11.06 (95% CI -15.74, -6.37) mg/dl, as opposed to when 'processed' soya extracts, -3.17 (95% CI -5.75, -0.58) mg/dl, were used. These data are consistent with the beneficial effects of soya proteins on serum LDL, HDL, TAG and TC concentrations. The effect was stronger in hypercholesterolaemic subjects. Whole soya foods appeared to be more beneficial than soya supplementation, whereas isoflavone supplementation had no effects on the lipid profile.

  15. A randomised controlled trial of caseload midwifery care: M@NGO (Midwives @ New Group practice Options)

    Science.gov (United States)

    2011-01-01

    Background Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant. Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice.) We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial. Methods/design A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs. Discussion Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05) to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive care of all neonates from 9

  16. The efficacy of a movement control exercise programme to reduce injuries in youth rugby: a cluster randomised controlled trial

    Science.gov (United States)

    Hislop, M D; Stokes, K A; Williams, S; McKay, C D; England, M; Kemp, S P T

    2016-01-01

    Background Injuries to youth rugby players have become an increasingly prominent health concern, highlighting the importance of developing and implementing appropriate preventive strategies. A growing body of evidence from other youth sports has demonstrated the efficacy of targeted exercise regimens to reduce injury risk. However, studies have yet to investigate the effect of such interventions in youth contact sport populations like rugby union. Objective To determine the efficacy of an evidence-based movement control exercise programme compared with a sham exercise programme to reduce injury risk in youth rugby players. Exercise programme compliance between trial arms and the effect of coach attitudes on compliance will also be evaluated. Setting School rugby coaches in England will be the target of the researcher intervention, with the effects of the injury prevention programmes being measured in male youth players aged 14–18 years in school rugby programmes over the 2015–2016 school winter term. Methods A cluster-randomised controlled trial with schools randomly allocated to either a movement control exercise programme or a sham exercise programme, both of which are coach-delivered. Injury measures will derive from field-based injury surveillance, with match and training exposure and compliance recorded. A questionnaire will be used to evaluate coach attitudes, knowledge, beliefs and behaviours both prior to and on the conclusion of the study period. Outcome measures Summary injury measures (incidence, severity and burden) will be compared between trial arms, as will the influence of coach attitudes on compliance and injury burden. Additionally, changes in these outcomes through using the exercise programmes will be evaluated. Trial registration number ISRTCNN13422001. PMID:27900148

  17. Efficacy of manual therapy treatments for people with cervicogenic dizziness and pain: protocol of a randomised controlled trial

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    Reid Susan A

    2012-10-01

    Full Text Available Abstract Background Cervicogenic dizziness is a disabling condition characterised by postural unsteadiness that is aggravated by cervical spine movements and associated with a painful and/or stiff neck. Two manual therapy treatments (Mulligan’s Sustained Natural Apophyseal Glides (SNAGs and Maitland’s passive joint mobilisations are used by physiotherapists to treat this condition but there is little evidence from randomised controlled trials to support their use. The aim of this study is to conduct a randomised controlled trial to compare these two forms of manual therapy (Mulligan glides and Maitland mobilisations to each other and to a placebo in reducing symptoms of cervicogenic dizziness in the longer term and to conduct an economic evaluation of the interventions. Methods Participants with symptoms of dizziness described as imbalance, together with a painful and/or stiff neck will be recruited via media releases, advertisements and mail-outs to medical practitioners in the Hunter region of NSW, Australia. Potential participants will be screened by a physiotherapist and a neurologist to rule out other causes of their dizziness. Once diagnosed with cervciogenic dizziness, 90 participants will be randomly allocated to one of three groups: Maitland mobilisations plus range-of-motion exercises, Mulligan SNAGs plus self-SNAG exercises or placebo. Participants will receive two to six treatments over six weeks. The trial will have unblinded treatment but blinded outcome assessments. Assessments will occur at baseline, post-treatment, six weeks, 12 weeks, six months and 12 months post treatment. The primary outcome will be intensity of dizziness. Other outcome measures will be frequency of dizziness, disability, intensity of cervical pain, cervical range of motion, balance, head repositioning, adverse effects and treatment satisfaction. Economic outcomes will also be collected. Discussion This paper describes the methods for a randomised

  18. IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy - a randomised controlled trial in an interdisciplinary setting

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    Reissfelder Christoph

    2009-10-01

    Full Text Available Abstract Background Intraoperative haemorrhage is a known predictor for perioperative outcome of patients undergoing hepatic resection. While anaesthesiological lowering of central venous pressure (CVP by fluid restriction is known to reduce bleeding during transection of the hepatic parenchyma its potential side effects remain poorly investigated. In theory it may have negative effects on kidney function and tissue perfusion and bears the risk to result in severe haemodynamic instability in case of profound intraoperative blood loss. The present randomised controlled trial evaluates efficacy and safety of infrahepatic inferior vena cava (IVC clamping as an alternative surgical technique to reduce CVP during hepatic resection. Methods/Design The proposed IVC CLAMP trial is a single-centre randomised controlled trial with a two-group parallel design. Patients and outcome-assessors are blinded for the treatment intervention. Patients undergoing elective hepatic resection due to any reason are enrolled in IVC CLAMP. All patients admitted to the Department of General-, Visceral-, and Transplant Surgery, University of Heidelberg for elective hepatic resection are consecutively screened for eligibility and written informed consent is obtained on the day before surgery. The primary objective of this trial is to assess and compare the amount of blood loss during hepatic resection in patients receiving surgical CVP reduction by clamping of the IVC as compared to anaesthesiological CVP without infrahepatic IVC clamping reduction. In addition to blood loss a set of general as well as surgical variables are analysed. Discussion This is a randomised controlled patient and observer blinded two-group parallel trial designed to assess efficacy and safety of infrahepatic IVC clamping during elective hepatectomy. Trial registration ClinicalTrials NCT00732979

  19. Acceptance and commitment therapy for adults with advanced cancer (CanACT): study protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Low, Joseph; Serfaty, Marc; Davis, Sarah; Vickerstaff, Victoria; Gola, Anna; Omar, Rumana Z; King, Michael; Tookman, Adrian; Austen, Janet St John; Turner, Karen; Jones, Louise

    2016-02-11

    One-third of people with cancer experience psychological distress and may suppress distressing thoughts, emotions, and concerns, leading to further problems. Conventional psychological treatments reduce distress by problem solving, but in advanced cancer, when ill health is progressive and death may be approaching, physical and psychological difficulties are complex and have no simple solutions. Acceptance and Commitment Therapy encourages acknowledgement and acceptance of mental experiences, increasing people's ability to work with problems that cannot be solved. Previous pilot work in advanced cancer confirms that distress can be associated with an avoidance of experiencing uncomfortable thoughts and emotions. This feasibility randomised controlled trial of Acceptance Commitment Therapy aims to establish parameters for a larger trial. Fifty-four participants with advanced cancer will be randomly allocated to up to eight sessions (each 1 hour) of Acceptance Commitment Therapy or a talking control. Participants will be recruited from those attending outpatient services and hospice day care at three specialist palliative care units in North and East London, United Kingdom. The primary outcome is a measure of functioning in four areas of life (physical, social/family, emotional, and general activity) using the Functional Assessment of Cancer Therapies--General questionnaire at 3 months after randomisation. Secondary outcomes are (i) acceptance using the Acceptance and Action Questionnaire; (ii) psychological distress using the Kessler Psychological Distress Scale; (iii) physical functioning using a timed walk and sit-to-stand test; and (iv) quality of life measures including the Euroqol-5 Dimensions and ICECAP Supportive Care measures. Qualitative data will be collected at 3 months to explore the participants' experiences of the trial and therapy. Data will be collected on the costs of care. Data generated on the recruitment, retention, and experience of the

  20. Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial

    OpenAIRE

    Allen, Adrian R; Jill M. Newby; Smith, Jessica; Andrews, Gavin

    2015-01-01

    Background This randomised controlled trial (RCT) with two parallel arms will evaluate the efficacy of an internet-delivered six-lesson 10-week cognitive behavioural therapy (iCBT) intervention for posttraumatic stress disorder (PTSD). It will also investigate the association between changes in PTSD symptoms, intolerance of uncertainty (IU) and emotion regulation. Methods/Design Patients with PTSD will be recruited via the research arm of a not-for-profit clinical and research unit in Austral...

  1. The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wilson, Matthew; MacArthur, Christine; Gao Smith, Fang; Homer, Leanne; Handley, Kelly; Daniels, Jane

    2016-12-12

    The commonest opioid used for pain relief in labour is pethidine (meperidine); however, its effectiveness has long been challenged and the drug has known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. Over a third of women receiving pethidine require an epidural due to inadequate pain relief. Epidural analgesia increases the risk of an instrumental vaginal delivery and its associated effects. Therefore, there is a clear need for a safe, effective, alternative analgesic to pethidine. Evidence suggests that remifentanil patient-controlled analgesia (PCA) reduces epidural conversion rates compared to pethidine; however, no trial has yet investigated this as a primary endpoint. We are, therefore, comparing pethidine intramuscular injection to remifentanil PCA in a randomised controlled trial. Women in established labour, requesting systemic opioid pain relief, will be randomised to either intravenously administered remifentanil PCA (intervention) or pethidine intramuscular injection (control) in an unblinded, 1:1 individual randomised trial. Following informed consent, 400 women in established labour, who request systemic opioid pain relief, from NHS Trusts across England will undergo a minimised randomisation by a computer or automated telephone system to either pethidine or remifentanil. In order to balance the groups this minimisation is based on four parameters; parity (nulliparous versus multiparous), maternal age (relief provided by each technique will be recorded every 30 min after time zero, until epidural placement, delivery or transfer to theatre, quantified by Visual Analogue Scale. Incidence of maternal side effects including sedation, delivery mode, foetal distress requiring delivery, neonatal status at delivery and rate of initiation of breastfeeding within the first hour of birth will also be recorded. Maternal satisfaction with her childbirth experience will be determined by a postpartum

  2. The efficacy and tolerability of 'polypills': meta-analysis of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    C Raina Elley

    Full Text Available BACKGROUND: To assess the blood pressure and lipid-lowering efficacy and tolerability of 'polypills' used in cardiovascular disease prevention trials. METHODOLOGY/PRINCIPAL FINDINGS: Systematic review and meta-analysis. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials, Medline, and PubMed databases were searched for eligible trials. Study inclusion criteria: Randomised controlled trials of at least six weeks duration, which compared a 'polypill' (that included at least one anti-hypertensive and one lipid-lowering medication with a placebo (or one active component. OUTCOME MEASURES: Change from baseline in systolic and diastolic blood pressures, and total and LDL-cholesterol; discontinuation of study medication and reported adverse effects. Of 44 potentially eligible studies, six trials (including 2,218 patients without previous cardiovascular disease fulfilled the inclusion criteria. Compared with placebo, 'polypills' reduced systolic blood pressure by -9.2 mmHg (95% confidence interval (CI: -13.4, -5.0 diastolic blood pressure by -5.0 mmHg (95%CI: -7.4, -2.6, total cholesterol by -1.22 mmol/L (95%CI: -1.60, -0.84 and LDL-cholesterol by -1.02 mmol/L (95%CI: -1.37, -0.67. However, those taking a 'polypill' (vs. placebo or component were more likely to discontinue medication (20% vs 14% (Odds ratio: 1.5 (95% CI: 1.2, 1.9. There was no significant difference in reported adverse effects amongst those on a 'polypill' (36% vs. 28% (OR: 1.3 (95%CI: 0.7, 2.5. There was high statistical heterogeneity in comparisons for blood pressure and lipid-lowering but use of random-effects and quality-effects models produced very similar results. CONCLUSIONS/SIGNIFICANCE: Compared with placebo, the 'polypills' reduced blood pressure and lipids. Tolerability was lower amongst those on 'polypills' than those on placebo or one component, but differences were moderate. Effectiveness trials are needed to help clarify the status of 'polypills' in

  3. Healthy eating and obesity prevention for preschoolers: a randomised controlled trial

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    Swinburn Boyd

    2010-04-01

    Full Text Available Abstract Background Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan. The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention, the MEND (Mind Exercise Nutrition Do It! program that is delivered to parents of children aged 2-4 years. Methods/Design This randomised controlled trial will be conducted with 200 parents and their 2-4 year old children who attend the MEND 2-4 program in metropolitan and regional Victoria. Parent-child dyads will attend ten 90-minute group workshops. These workshops focus on general nutrition, as well as physical activity and behaviours. They are typically held at community or maternal and child health centres and run by a MEND 2-4 trained program leader. Child eating habits, physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline, the end of the intervention, and at 6 and 12 months post the intervention. Informed consent will be obtained from all parents, who will then be randomly allocated to the intervention or wait-list control group. Discussion Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2-4 years. It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents, given that parental beliefs, attitudes, perceptions and behaviours appear to impact significantly on the development of early overweight. This is 'solution-oriented' rather than 'problem-oriented' research, with its focus being on prevention rather than intervention. If this is a positive trial, the MEND2-4 program can be implemented as a

  4. HElmet therapy Assessment in infants with Deformed Skulls (HEADS: protocol for a randomised controlled trial

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    van Wijk Renske M

    2012-07-01

    Full Text Available Abstract Background In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly. However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation. Methods/design Pragmatic randomised controlled trial (RCT nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment. At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT; they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, compliance and costs will also be determined. Discussion HEADS will be the first study presenting data from an RCT on the effectiveness of helmet therapy. Outcomes will be important for affected children and their parents, health care professionals and future treatment policies. Our findings are likely to influence the reimbursement policies of health insurance companies. Besides these health outcomes, we will be able to

  5. Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial.

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    Christopher Williams

    Full Text Available BACKGROUND: Access to Cognitive behavioural therapy (CBT for depression is limited. One solution is CBT self-help books. Trial Objectives: To assess the impact of a guided self-help CBT book (GSH-CBT on mood, compared to treatment as usual (TAU. HYPOTHESES: GSH-CBT will have improved mood and knowledge of the causes and treatment of depression compared to the control receiving TAUGuided self-help will be acceptable to patients and staff. METHODS AND FINDINGS: PARTICIPANTS: Adults attending seven general practices in Glasgow, UK with a BDI-II score of ≥14. 141 randomised to GSH-CBT and 140 to TAU. INTERVENTIONS: RCT comparing 'Overcoming Depression: A Five Areas Approach' book plus 3-4 short face to face support appointments totalling up to 2 hours of guided support, compared with general practitioner TAU. PRIMARY OUTCOME: The BDI (II score at 4 months. Numbers analysed: 281 at baseline, 203 at 4 months (primary outcome, 117 at 12 months. OUTCOME: Mean BDI-II scores were lower in the GSH-CBT group at 4 months by 5.3 points (2.6 to 7.9, p<0.001. At 4 and 12 months there were also significantly higher proportions of participants achieving a 50% reduction in BDI-II in the GSH-CBT arm. The mean support was 2 sessions with 42.7 minutes for session 1, 41.4 minutes for session 2 and 40.2 minutes of support for session 3. Adverse effects/Harms: Significantly less deterioration in mood in GSH-CBT (2.0% compared to 9.8% in the TAU group for BDI-II category change. LIMITATIONS: Weaknesses: Our follow-up rate of 72.2% at 4 months is better than predicted but is poorer at 12 months (41.6%. In the GSH-CBT arm, around 50% of people attended 2 or fewer sessions. 22% failed to take up treatment. CONCLUSIONS: GSH-CBT is substantially more effective than TAU. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN13475030.

  6. Sham device v inert pill: randomised controlled trial of two placebo treatments

    Science.gov (United States)

    Kaptchuk, Ted J; Stason, William B; Davis, Roger B; Legedza, Anna R T; Schnyer, Rosa N; Kerr, Catherine E; Stone, David A; Nam, Bong Hyun; Kirsch, Irving; Goldman, Rose H

    2006-01-01

    Objective To investigate whether a sham device (a validated sham acupuncture needle) has a greater placebo effect than an inert pill in patients with persistent arm pain. Design A single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study. Setting Academic medical centre. Participants 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored ≥3 on a 10 point pain scale. Interventions Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks. Main outcomemeasures Arm pain measured on a 10 point pain scale. Secondary outcomes were symptoms measured by the Levine symptom severity scale, function measured by Pransky's upper extremity function scale, and grip strength. Results Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups, but changes were not different between the groups (-0.14, 95% confidence interval -0.52 to 0.25, P = 0.49). Changes in severity scores for arm symptoms and grip strength were similar between groups, but arm function improved more in the placebo pill group (2.0, 0.06 to 3.92, P = 0.04). Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group (-0.33 (-0.40 to -0.26) v -0.15 (-0.21 to -0.09), P = 0.0001) and on the symptom severity scale (-0.07 (-0.09 to -0.05) v -0.05 (-0.06 to -0.03), P = 0.02). Differences were not significant, however, on the function scale or for grip strength. Reported adverse effects were different in the two groups. Conclusions The sham device had greater

  7. Angiotensin converting enzyme inhibitors effect on endothelial dysfunction: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Shahin, Yousef; Khan, Junaid Alam; Samuel, Nehemiah; Chetter, Ian

    2011-05-01

    Several studies have assessed the effect of angiotensin converting enzyme inhibitors (ACEIs) on endothelial dysfunction as measured by brachial flow-mediated vasodilatation (FMD). We conducted a meta-analysis to investigate this effect in comparison to placebo or no treatment and to other antihypertensive agents. MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1996 to October 2010 on randomised controlled trials (RCTs) that assessed the effect of ACEIs on brachial FMD versus placebo or no treatment and ACEIs versus angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs) and β-blockers. Data from included studies were pooled with use of random effects meta-analysis of the weighted mean change differences between the comparator groups. Heterogeneity across studies was assessed with the I(2) statistic. In 10 trials including 1129 patients, treatment with ACEIs (n = 498) versus placebo or no treatment (n = 503) significantly improved brachial FMD (pooled mean change difference 1.26%, 95% C.I. 0.46-2.07, p = 0.002 with significant heterogeneity). In 11 trials which included 805 patients, treatment with ACEIs (n = 264) had a significant effect on brachial FMD when compared with other antihypertensives (ARBs, CCBs and β-blockers) (n = 420) (pooled mean change difference 0.89%, 95% C.I. 0.22-1.56, p = 0.009, I(2) = 83%, p for heterogeneity ACEIs had no significant effect on FMD when compared with ARBs (pooled mean change difference = 0.21%, 95% C.I. -0.24 to 0.66, p = 0.36, I(2) = 0%). However, in 4 trials ACEIs significantly improved FMD when compared with CCBs (pooled mean change difference 2.15%, 95% C.I. 0.55-3.75, p = 0.009, I(2) = 90%, p for heterogeneity ACEIs also had a significant effect on FMD (pooled mean change difference = 0.59%, 95% C.I. 0.05-1.13, p = 0.03, I(2) = 34%, p for heterogeneity = 0.21). This study shows that ACEIs improve brachial FMD which is a marker of endothelial function in

  8. Treating and preventing influenza in aged care facilities: a cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Robert Booy

    Full Text Available BACKGROUND: Influenza is an important cause of morbidity and mortality for frail older people. Whilst the antiviral drug oseltamivir (a neuraminidase inhibitor is approved for treatment and prophylaxis of influenza during outbreaks, there have been no trials comparing treatment only (T versus treatment and prophylaxis (T&P in Aged Care Facilities (ACFs. Our objective was to compare a policy of T versus T&P for influenza outbreaks in ACFs. METHODS AND FINDINGS: We performed a cluster randomised controlled trial in 16 ACFs, that followed a policy of either "T"-oseltamivir treatment (75 mg twice a day for 5 days-or "T&P"-treatment and prophylaxis (75 mg once a day for 10 days for influenza outbreaks over three years, in addition to enhanced surveillance. The primary outcome measure was the attack rate of influenza. Secondary outcomes measures were deaths, hospitalisation, pneumonia and adverse events. Laboratory testing was performed to identify the viral cause of influenza-like illness (ILI outbreaks. The study period 30 June 2006 to 23 December 2008 included three southern hemisphere winters. During that time, influenza was confirmed as the cause of nine of the 23 ILI outbreaks that occurred amongst the 16 ACFs. The policy of T&P resulted in a significant reduction in the influenza attack rate amongst residents: 93/255 (36% in residents in T facilities versus 91/397 (23% in T&P facilities (p=0.002. We observed a non-significant reduction in staff: 46/216 (21% in T facilities versus 47/350 (13% in T&P facilities (p=0.5. There was a significant reduction in mean duration of outbreaks (T=24 days, T&P=11 days, p=0.04. Deaths, hospitalisations and pneumonia were non-significantly reduced in the T&P allocated facilities. Drug adverse events were common but tolerated. CONCLUSION: Our trial lacked power but these results provide some support for a policy of "treatment and prophylaxis" with oseltamivir in controlling influenza outbreaks in ACFs. TRIAL

  9. The effectiveness of video interaction guidance in parents of premature infants: A multicenter randomised controlled trial

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    Tooten Anneke

    2012-06-01

    Full Text Available Abstract Background Studies have consistently found a high incidence of neonatal medical problems, premature births and low birth weights in abused and neglected children. One of the explanations proposed for the relation between neonatal problems and adverse parenting is a possible delay or disturbance in the bonding process between the parent and infant. This hypothesis suggests that due to neonatal problems, the development of an affectionate bond between the parent and the infant is impeded. The disruption of an optimal parent-infant bond -on its turn- may predispose to distorted parent-infant interactions and thus facilitate abusive or neglectful behaviours. Video Interaction Guidance (VIG is expected to promote the bond between parents and newborns and is expected to diminish non-optimal parenting behaviour. Methods/design This study is a multi-center randomised controlled trial to evaluate the effectiveness of Video Interaction Guidance in parents of premature infants. In this study 210 newborn infants with their parents will be included: n = 70 healthy term infants (>37 weeks GA, n = 70 moderate term infants (32–37 weeks GA which are recruited from maternity wards of 6 general hospitals and n = 70 extremely preterm infants or very low birth weight infants (i.e. full term infants and their parents, receiving care as usual, a control group (i.e. premature infants and their parents, receiving care as usual and an intervention group (i.e. premature infants and their parents, receiving VIG. The data will be collected during the first six months after birth using observations of parent-infant interactions, questionnaires and semi-structured interviews. Primary outcomes are the quality of parental bonding and parent-infant interactive behaviour. Parental secondary outcomes are (posttraumatic stress symptoms, depression, anxiety and feelings of anger and hostility. Infant secondary outcomes are behavioral aspects such as crying

  10. Sore throat following three adult supraglottic airway devices: A randomised controlled trial.

    Science.gov (United States)

    L'Hermite, Joël; Dubout, Elisabeth; Bouvet, Sophie; Bracoud, Laure-Hélène; Cuvillon, Philippe; Coussaye, Jean-Emmanuel de La; Ripart, Jacques

    2017-07-01

    Sore throat is a common complaint after surgery. It affects patient satisfaction and can affect activity after discharge. The supraglottic airway device (SAD) offers an alternative to traditional tracheal intubation with potential benefit in preventing sore throat. The aim of this study was to compare the incidence of sore throat following three different SADs, the laryngeal mask airway Unique (LMA-U) and the more recent LMA Supreme (LMA-S) and the I-gel. A randomised single-blind controlled three parallel-group trial. University Hospital of Nîmes, Division of Anaesthesia Intensive Care Pain and Emergency, Nîmes, France, from April 2009 to September 2012. A total of 546 patients scheduled to undergo elective surgery of less than 2 h under general anaesthesia were randomly allocated to receive the LMA-U, the LMA-S or the I-gel. Anaesthesia was induced with propofol and sufentanil and maintained with propofol or with sevoflurane in air-oxygen. After airway device insertion, intra-cuff pressure was adjusted to less than 60 mmHg (LMA-U, LMA-S) and pressure-controlled ventilation initiated. The primary study endpoint was to compare incidence of sore throat 24 h postoperatively (H+24) following placement of the LMA-U, LMA-S and the I-gel. Secondary endpoints were clinical performance (airway leak pressure, dynamic airway compliance, complications during maintenance), ease of use (device insertion time, success on first attempt, ease of insertion and removal) and other adverse events (neck or jaw pain, dysphonia, dysphagia, nausea and vomiting). The authors analysed 177, 174 and 173 patients who received LMA-U, the LMA-S and the I-gel, respectively. The primary endpoint was assessed in 436 patients. In total, 104 patients (23.9%) patients reported a H+24 sore throat, with no difference between groups (P = 0.34). H+24 dysphagia with liquids was higher (P = 0.0065) with the LMA-S (12.1%) compared with LMA-U (5.3%) and I-gel (2.9%). Airway leak pressure (cmH2

  11. Surrendering control, or nothing to lose: Parents' preferences about participation in a randomised trial of childhood strabismus surgery.

    Science.gov (United States)

    Buck, Deborah; Hogan, Vanessa; Powell, Christine J; Sloper, John J; Speed, Chris; Taylor, Robert H; Tiffin, Peter; Clarke, Michael P

    2015-08-01

    Intermittent exotropia is the most common form of divergent strabismus (squint) in children. Evidence regarding its optimum management is limited. A pilot randomised controlled trial has recently been completed (Surgery versus Active Monitoring in Intermittent Exotropia trial) to determine the feasibility of a full randomised controlled trial. To identify drivers for and barriers against parents' participation in Surgery versus Active Monitoring in Intermittent Exotropia and to seek their views on information received, the need for randomisation, and enhancing acceptability. Multiple method qualitative study using semi-structured telephone interviews to explore parents' motivations and trial screening logs to provide an indication of common barriers. Exploratory thematic analysis identified key themes. A total of 48 interviews were conducted (14 participants; 34 non-participants). Barriers included no desire for surgery/preference to 'wait and see', wanting surgery immediately, feeling uncomfortable about 'surrendering control' over decision-making/being managed 'at random', lack of confidence in the effectiveness of surgery, believing the risks outweighed the benefits, and lack of trust. Drivers included desiring surgery, 'nothing to lose', benefits offsetting the risks, and being in a trial would result in better care. Some also mentioned 'doing their bit' for research. Suggestions for enhancing acceptability included allowing choice of treatment group, giving more time for decision-making, expanding on information given, and improving communication. Many felt the necessity of randomisation was adequately explained, but there was some indication that it was misunderstood. Information extracted from the screening logs of 80/89 eligible non-participants indicated the most prevalent barrier was not wanting surgery/preferring to observe (56%), followed by desiring surgery straightaway (15%). Opposition to randomisation/wanting to retain control was recorded in 9% of

  12. Getting the balance right: a randomised controlled trial of physiotherapy and Exercise Interventions for ambulatory people with multiple sclerosis.

    LENUS (Irish Health Repository)

    Coote, Susan

    2009-01-01

    BACKGROUND: People with Multiple Sclerosis have a life long need for physiotherapy and exercise interventions due to the progressive nature of the disease and their greater risk of the complications of inactivity. The Multiple Sclerosis Society of Ireland run physiotherapy, yoga and exercise classes for their members, however there is little evidence to suggest which form of physical activity optimises outcome for people with the many and varied impairments associated with MS. METHODS AND DESIGN: This is a multi-centre, single blind, block randomised, controlled trial. Participants will be recruited via the ten regional offices of MS Ireland. Telephone screening will establish eligibility and stratification according to the mobility section of the Guys Neurological Disability Scale. Once a block of people of the same strand in the same geographical region have given consent, participants will be randomised. Strand A will concern individuals with MS who walk independently or use one stick to walk outside. Participants will be randomised to yoga, physiotherapy led exercise class, fitness instructor led exercise class or to a control group who don\\'t change their exercise habits.Strand B will concern individuals with MS who walk with bilateral support or a rollator, they may use a wheelchair for longer distance outdoors. Participants will be randomised to 1:1 Physiotherapist led intervention, group intervention led by Physiotherapist, group yoga intervention or a control group who don\\'t change their exercise habits. Participants will be assessed by physiotherapist who is blind to the group allocation at week 1, week 12 (following 10 weeks intervention or control), and at 12 week follow up. The primary outcome measure for both strands is the Multiple Sclerosis Impact Scale. Secondary outcomes are Modified Fatigue Impact Scale, 6 Minute Walk test, and muscle strength measured with hand held dynamometry. Strand B will also use Berg Balance Test and the Modified

  13. Getting the Balance Right: A randomised controlled trial of physiotherapy and Exercise Interventions for ambulatory people with multiple sclerosis

    Directory of Open Access Journals (Sweden)

    Larkin Aidan

    2009-07-01

    Full Text Available Abstract Background People with Multiple Sclerosis have a life long need for physiotherapy and exercise interventions due to the progressive nature of the disease and their greater risk of the complications of inactivity. The Multiple Sclerosis Society of Ireland run physiotherapy, yoga and exercise classes for their members, however there is little evidence to suggest which form of physical activity optimises outcome for people with the many and varied impairments associated with MS. Methods and design This is a multi-centre, single blind, block randomised, controlled trial. Participants will be recruited via the ten regional offices of MS Ireland. Telephone screening will establish eligibility and stratification according to the mobility section of the Guys Neurological Disability Scale. Once a block of people of the same strand in the same geographical region have given consent, participants will be randomised. Strand A will concern individuals with MS who walk independently or use one stick to walk outside. Participants will be randomised to yoga, physiotherapy led exercise class, fitness instructor led exercise class or to a control group who don't change their exercise habits. Strand B will concern individuals with MS who walk with bilateral support or a rollator, they may use a wheelchair for longer distance outdoors. Participants will be randomised to 1:1 Physiotherapist led intervention, group intervention led by Physiotherapist, group yoga intervention or a control group who don't change their exercise habits. Participants will be assessed by physiotherapist who is blind to the group allocation at week 1, week 12 (following 10 weeks intervention or control, and at 12 week follow up. The primary outcome measure for both strands is the Multiple Sclerosis Impact Scale. Secondary outcomes are Modified Fatigue Impact Scale, 6 Minute Walk test, and muscle strength measured with hand held dynamometry. Strand B will also use Berg Balance Test

  14. Ear Acupuncture versus  local anaestethic for pain relief during perineal repair - a randomised controlled trial

    DEFF Research Database (Denmark)

    Kindberg, Sara

    2007-01-01

    ACUPUNCTURE OR LOCAL ANAESTETICS FOR PAIN RELIEF DURING PERINEAL REPAIR AFTER VAGINAL DELIVERY: A RANDOMISED CONTROLLED TRIAL.   By:  Sara Kindberg. Midwife and PhD student, Sønderborg Hospital, Denmark. Objective: To evaluate acupuncture as a new method of pain relief for postpartum perineal...... as photos of the acupuncture points. Perspectives:  Basic midwifery services such as providing sufficient pain relief during perineal repair still need improvement. Clinical practice should be improved continuously and thus produce reliable evidence on different pain relief methods. Website:        http...

  15. Oral vitamin B12 for patients suspected of subtle cobalamin deficiency: a multicentre pragmatic randomised controlled trial.

    OpenAIRE

    Ali Giuseppa; Burnand Bernard; Herzig Lilli; Vaucher Paul; Favrat Bernard; Boulat Olivier; Bischoff Thomas; Verdon François

    2011-01-01

    Abstract Background Evidence regarding the effectiveness of oral vitamin B12 in patients with serum vitamin B12 levels between 125-200 pM/l is lacking. We compared the effectiveness of one-month oral vitamin B12 supplementation in patients with a subtle vitamin B12 deficiency to that of a placebo. Methods This multicentre (13 general practices, two nursing homes, and one primary care center in western Switzerland), parallel, randomised, controlled, closed-label, observer-blind trial included ...

  16. A randomised controlled trial of the electric heating pad vs forced-air warming for preventing hypothermia during laparotomy.

    Science.gov (United States)

    Leung, K K; Lai, A; Wu, A

    2007-06-01

    A randomised controlled trial was conducted to compare the efficacy of upper body forced-air warming (Bair Hugger, Augustine Medical model 500/OR, Prairie, MN) with that of an electric heating pad (Operatherm 202, KanMed, Bromma, Sweden) for maintenance of intra-operative body temperature in 60 patients undergoing laparotomy under general anaesthesia. The nasopharyngeal temperature was recorded throughout the operative period. The mean (SD) final temperatures were 36.2 (0.4) degrees C with forced-air warming and 35.5 (1.0) degrees C with electric heating pad (p heating pad for maintenance of body temperature during laparotomy.

  17. Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.

    Directory of Open Access Journals (Sweden)

    Falko F Sniehotta

    Full Text Available BACKGROUND: Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors. METHOD: Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI≥30 kg/m2 adults (age≥18 y with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures. RESULTS: Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44; mean-BMI = 36.73(6.06 with 2.35(1.47 co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation. Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural

  18. Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Evelyn Korkor Ansah

    2009-01-01

    Full Text Available BACKGROUND: Delays in accessing care for malaria and other diseases can lead to disease progression, and user fees are a known barrier to accessing health care. Governments are introducing free health care to improve health outcomes. Free health care affects treatment seeking, and it is therefore assumed to lead to improved health outcomes, but there is no direct trial evidence of the impact of removing out-of-pocket payments on health outcomes in developing countries. This trial was designed to test the impact of free health care on health outcomes directly. METHODS AND FINDINGS: 2,194 households containing 2,592 Ghanaian children under 5 y old were randomised into a prepayment scheme allowing free primary care including drugs, or to a control group whose families paid user fees for health care (normal practice; 165 children whose families had previously paid to enrol in the prepayment scheme formed an observational arm. The primary outcome was moderate anaemia (haemoglobin [Hb] < 8 g/dl; major secondary outcomes were health care utilisation, severe anaemia, and mortality. At baseline the randomised groups were similar. Introducing free primary health care altered the health care seeking behaviour of households; those randomised to the intervention arm used formal health care more and nonformal care less than the control group. Introducing free primary health care did not lead to any measurable difference in any health outcome. The primary outcome of moderate anaemia was detected in 37 (3.1% children in the control and 36 children (3.2% in the intervention arm (adjusted odds ratio 1.05, 95% confidence interval 0.66-1.67. There were four deaths in the control and five in the intervention group. Mean Hb concentration, severe anaemia, parasite prevalence, and anthropometric measurements were similar in each group. Families who previously self-enrolled in the prepayment scheme were significantly less poor, had better health measures, and used

  19. Randomised controlled trial of a new palliative care service: Compliance, recruitment and completeness of follow-up

    Directory of Open Access Journals (Sweden)

    Saleem Tariq

    2008-05-01

    Full Text Available Abstract Background Palliative care has been proposed for progressive non-cancer conditions but there have been few evaluations of service developments. We analysed recruitment, compliance and follow-up data of a fast track (or wait list control randomised controlled trial of a new palliative care service – a design not previously used to assess palliative care. Methods/Design An innovative palliative care service (comprising a consultant in palliative medicine, a clinical nurse specialist, an administrator and a psychosocial worker was delivered to people severely affected by multiple sclerosis (MS, and their carers, in southeast London. Our design followed the MRC Framework for the Evaluation of Complex Interventions. In phase II we conducted randomised controlled trial, of immediate referral to the service (fast-track versus a 12-week wait (standard best practice. Main outcome measures were: compliance (the extent the trial protocol was adhered to, recruitment (target 50 patients, attrition and missing data rates; trial outcomes were Palliative Care Outcome Scale and MS Impact Scale. Results 69 patients were referred, 52 entered the trial (26 randomised to each arm, 5 refused consent and 12 were excluded from the trial for other reasons, usually illness or urgent needs, achieving our target numbers. 25/26 fast track and 21/26 standard best practice patients completed the trial, resulting in 217/225 (96% of possible interviews completed, 87% of which took place in the patient's home. Main reasons for failure to interview and/or attrition were death or illness. There were three deaths in the standard best practice group and one in the fast-track group during the trial. At baseline there were no differences between groups. Missing data for individual questionnaire items were small (median 0, mean 1–5 items out of 56+ items per interview, not associated with any patient or carer characteristics or with individual questionnaires, but were

  20. Intravaginal isosorbide dinitrate or misoprostol for cervical ripening prior to induction of labour: a randomised controlled trial.

    Science.gov (United States)

    Haghighi, L; Homam, H; Raoofi, Z; Najmi, Z

    2013-04-01

    In this randomised double-blind controlled trial, 130 healthy pregnant women with term pregnancy who scheduled for labour induction with Bishop's score misoprostol (25 μg), which were repeated after 4 h as needed. The efficacies of medications were evaluated by predetermined primary and secondary outcome variables for cervical ripening and induction of labour and delivery. There was no significant difference in Bishop's score 8 h after drug administration between the ISDN and misoprostol groups. However, in the ISDN group, labour induction was needed more frequently and the time from start of medication to the beginning of active phase of labour was significantly longer.

  1. Randomised comparison of a simple warfarin dosing algorithm versus a computerised anticoagulation management system for control of warfarin maintenance therapy.

    Science.gov (United States)

    Nieuwlaat, Robby; Hubers, Lowiek M; Spyropoulos, Alex C; Eikelboom, John W; Connolly, Benjamin J; Van Spall, Harriette G C; Schulze, Karleen M; Cuddy, Spencer M; Stehouwer, Alexander C; Schulman, Sam; Connolly, Stuart J

    2012-12-01

    Excellent control of the international normalised ratio (INR) is associated with improved clinical outcomes in patients receiving warfarin, and can be achieved by anticoagulation clinics but is difficult in general practice. Anticoagulation clinics have often used validated commercial computer systems to manage the INR, but these are not usually available to general practitioners. It was the objective of this study to perform a randomised trial of a simple one-step warfarin dosing algorithm against a widely used computerised dosing system. During the period of introduction of a commercial computerised warfarin dosing system (DAWN AC) to an anticoagulation clinic, patients were randomised to have warfarin dose adjustment done according to recommendations of the existing warfarin dosing algorithm or to those of the computerised system. The study tested if the computerised system was non-inferior to the existing algorithm for the primary outcome of time in therapeutic INR range of 2.0-3.0 (TTR), with a one-sided non-inferiority margin of 4.5%. There were 541 patients randomised to commercial computerised system and 527 to the algorithm. Median follow-up was 159 days. A dose recommendation was provided and followed in 91% of occasions for the computerised system and in 90% for the algorithm (p=0.03). The mean TTR was 71.0% (standard deviation [SD] 23.2) for the computerised system and 71.9% (SD 22.9) for the algorithm (difference 0.9% [95% confidence interval: -1.4% to 4.1%]; p-value for non-inferiority=0.002; p-value for superiority=0.34). In conclusion, similar maintenance control of the INR was achieved with a simple one-step dosing algorithm and a commercial computerised management system.

  2. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hart Michael B

    2010-10-01

    Full Text Available Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools in Perth, Australia were recruited to the clustered (by school randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide

  3. The clinical effectiveness of different parenting programmes for children with conduct problems: a systematic review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Taylor Rod S

    2009-03-01

    Full Text Available Abstract Background Conduct problems are common, disabling and costly. The prognosis for children with conduct problems is poor, with outcomes in adulthood including criminal behaviour, alcoholism, drug abuse, domestic violence, child abuse and a range of psychiatric disorders. There has been a rapid expansion of group based parent-training programmes for the treatment of children with conduct problems in a number of countries over the past 10 years. Existing reviews of parent training have methodological limitations such as inclusion of non-randomised studies, the absence of investigation for heterogeneity prior to meta-analysis or failure to report confidence intervals. The objective of the current study was to systematically review randomised controlled trials of parenting programmes for the treatment of children with conduct problems. Methods Standard systematic review methods were followed including duplicate inclusion decisions, data extraction and quality assessment. Twenty electronic databases from the fields of medicine, psychology, social science and education were comprehensively searched for RCTs and systematic reviews to February 2006. Inclusion criteria were: randomised controlled trial; of structured, repeatable parenting programmes; for parents/carers of children up to the age of 18 with a conduct problem; and at least one measure of child behaviour. Meta-analysis and qualitative synthesis were used to summarise included studies. Results 57 RCTs were included. Studies were small with an average group size of 21. Meta-analyses using both parent (SMD -0.67; 95% CI: -0.91, -0.42 and independent (SMD -0.44; 95% CI: -0.66, -0.23 reports of outcome showed significant differences favouring the intervention group. There was insufficient evidence to determine the relative effectiveness of different approaches to delivering parenting programmes. Conclusion Parenting programmes are an effective treatment for children with conduct problems

  4. Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial.

    Science.gov (United States)

    Wake, Melissa; Baur, Louise A; Gerner, Bibi; Gibbons, Kay; Gold, Lisa; Gunn, Jane; Levickis, Penny; McCallum, Zoë; Naughton, Geraldine; Sanci, Lena; Ukoumunne, Obioha C

    2009-09-03

    To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children. Randomised controlled trial nested within a baseline cross sectional survey of body mass index (BMI). Randomisation and outcomes measurement, but not participants, were blinded to group assignment. 45 family practices (66 general practitioners) in Melbourne, Australia. 3958 children visiting their general practitioner in May 2005-July 2006 were surveyed for BMI. Of these, 258 children aged 5 years 0 months up to their 10th birthday who were overweight or obese by International Obesity Taskforce criteria were randomised to intervention (n=139) or control (n=119) groups. Children who were very obese (UK BMI z score >or=3.0) were excluded. Four standard consultations over 12 weeks targeting change in nutrition, physical activity, and sedentary behaviour, supported by purpose designed family materials. Main outcomes measures Primary measure was BMI at 6 and 12 months after randomisation. Secondary measures were mean activity count/min by 7-day accelerometry, nutrition score from 4-day abbreviated food frequency diary, and child health related quality of life. Differences were adjusted for socioeconomic status, age, sex, and baseline BMI. Of 781 eligible children, 258 (33%) entered the trial; attrition was 3.1% at 6 months and 6.2% at 12 months. Adjusted mean differences (intervention - control) at 6 and 12 months were, for BMI, -0.12 (95% CI -0.40 to 0.15, P=0.4) and -0.11 (-0.45 to 0.22, P=0.5); for physical activity in counts/min, 24 (-4 to 52, P=0.09) and 11 (-26 to 49, P=0.6); and, for nutrition score, 0.2 (-0.03 to 0.4, P=0.1) and 0.1 (-0.1 to 0.4, P=0.2). There was no evidence of harm to the child. Costs to the healthcare system were significantly higher in the intervention arm. Primary care screening followed by brief counselling did not improve BMI, physical activity, or

  5. Effectiveness of progressive resistance strength training versus traditional balance exercise in improving balance among the elderly - a randomised controlled trial.

    Science.gov (United States)

    Joshua, Abraham M; D'Souza, Vivian; Unnikrishnan, B; Mithra, Prasanna; Kamath, Asha; Acharya, Vishak; Venugopal, Anand

    2014-03-01

    Falls are important health issues among the elderly people. Most falls in elderly result from abnormal balance control mechanisms. Balance and muscle force generation are directly related, and are associated with age related muscular changes. Studies addressing fall prevention have focused on various group and individualised strength training. However, evidence on strengthening of key muscles necessary for maintaining balance and postural control is lacking. To evaluate the effectiveness of individualised progressive resistance strength training (PRT) programme in improving balance for forward limits of stability in elderly with balance impairment, compared to traditional balance exercise (TBE), and combination of both (COMBI). This randomised controlled trial included three groups; 18 subjects in each aged ≥ 65 years, from the elderly care centres of Mangalore city in Southern India (between June 2008 and December 2012). Block randomisation technique was used and allocation concealment was done using sequentially arranged sealed opaque envelopes. The TBE group received 8 component traditional balance exercise; 4 times a week for 6 months. The PRT group received resistance training for the key muscles of lower extremities, using DeLormes and Watkins protocol. The COMBI group received PRT and TBE alternately (2 days of PRT and 2 days of TBE per week). Functional reach test (FRT) was used for measurement of forward limits of stability. The data was analyzed using Statistical Package for Social Sciences (SPSS) version 15. For functional reach, PRT group had steady progression from baseline to 6 months (pelderly aged ≥65 years.

  6. Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

    Directory of Open Access Journals (Sweden)

    Sierevelt Inger N

    2006-09-01

    Full Text Available Abstract Background The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs published in the most frequently cited general orthopaedic journals. Methods Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instructions for authors of the highest impact general orthopaedic journals. Based upon a priori eligibility criteria, two assessors hand searched all issues of the eligible journal from 2003–2004 for RCTs. The assessors extracted the demographic information and the evidence rating from each included RCT and scored the quality of reporting using the reporting quality assessment tool, which was developed by the Cochrane Bone, Joint and Muscle Trauma Group. Scores were conducted in duplicate, and we reached a consensus for any disagreements. We examined the correlation between the level of evidence rating and the Cochrane reporting quality score. Results We found that only the Journal of Bone and Joint Surgery – American Volume (JBJS-A used a level of evidence rating from 2003 to 2004. We identified 938 publications in the JBJS-A from January 2003 to December 2004. Of these publications, 32 (3.4% were RCTs that fit the inclusion criteria. The 32 RCTs included a total of 3543 patients, with sample sizes ranging from 17 to 514 patients. Despite being labelled as the highest level of evidence (Level 1 and Level II evidence, these studies had low Cochrane reporting quality scores among individual methodological safeguards. The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies. Correlations varied from 0.0 to 0.2 across the 12 items of the Cochrane reporting quality assessment tool (p > 0.05. Among items closely

  7. Dark chocolate or tomato extract for prehypertension: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Frank Oliver R

    2009-07-01

    Full Text Available Abstract Background Flavanol-rich chocolate and lycopene-rich tomato extract have attracted interest as potential alternative treatment options for hypertension, a known risk factor for cardiovascular morbidity and mortality. Treatment of prehypertension (SBP 120–139/DBP 80–89 mmHg may forestall progression to hypertension. However, there has been only limited research into non-pharmacological treatment options for prehypertension. We investigated the effect of dark chocolate or tomato extract on blood pressure, and their acceptability as an ongoing treatment option in a prehypertensive population. Methods Our trial consisted of two phases: a randomised controlled three-group-parallel trial over 12 weeks (phase 1 followed by a crossover of the two active treatment arms over an additional 12-week period (phase 2. Group 1 received a 50 g daily dose of dark chocolate with 70% cocoa containing 750 mg polyphenols, group 2 were allocated one tomato extract capsule containing 15 mg lycopene per day, and group 3 received one placebo capsule daily over 8 weeks followed by a 4-week washout period. In phase 2 the active treatment groups were crossed over to receive the alternative treatment. Median blood pressure, weight, and abdominal circumference were measured 4-weekly, and other characteristics including physical activity, general health, energy, mood, and acceptability of treatment were assessed by questionnaire at 0, 8 and 20 weeks. We analysed changes over time using a linear mixed model, and one time point differences using Kruskal-Wallis, Fisher's-Exact, or t-tests. Results Thirty-six prehypertensive healthy adult volunteers completed the 6-month trial. Blood pressure changes over time within groups and between groups were not significant and independent of treatment. Weight and other characteristics did not change significantly during the trial. However, a marked difference in acceptability between the two treatment forms (chocolate or

  8. Collaborative care for depression in general practice: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Brinck-Claussen, Ursula Ødum; Curth, Nadja Kehler; Davidsen, Annette Sofie; Mikkelsen, John Hagel; Lau, Marianne Engelbrecht; Lundsteen, Merete; Csillag, Claudio; Christensen, Kaj Sparle; Hjorthøj, Carsten; Nordentoft, Merete; Eplov, Lene Falgaard

    2017-07-21

    Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection. The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis. If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in

  9. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

    Directory of Open Access Journals (Sweden)

    Chisholm Katharine

    2012-03-01

    Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressur